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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/22/2026 has been entered. Claims 1-14 and 21-26 are currently pending and under examination.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 1/22/2026 clarifying the language of claims 1 and 23 the 112 rejections made against the claims in the office action of 10/29/2025 have been withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 21 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 to Corbett et al. (Corbett) in view of US 2020/0268442 to Paamand et al. (Paamand) (both previously cited).
In reference to at least claim 1
Corbett discloses a percutaneous circulatory support device (e.g. intravascular blood pump, para. [0019]), comprising: a housing (e.g. housing 102) comprising an inlet (e.g. inlet 105, para. [0020]) and an outlet (e.g. outlet 109, para. [0024]); an impeller disposed within the housing (e.g. impeller 103) and being rotatable relative to the housing to cause blood to flow into the inlet through the housing (e.g. “an impeller blade 103 rotatably coupled to the blood pump 101”, para. [0020]), and out of the outlet (e.g. “housing component 102 includes one or more apertures or openings 109 configured to expel or exhaust blood drawn into the cannula 104 out of the blood pump assembly 100”, para. [0020]); a cannula coupled to the housing (e.g. cannula 104); a distal tip portion (e.g. pigtail extension 106) coupled to the cannula opposite the housing (e.g. pigtail extension 106 is coupled to the cannula 104 opposite housing 102, Fig. 1), the distal tip portion comprising: an inner shaping core configured to maintain a predetermined shape of the distal tip portion (e.g. “distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness…and at a second stiffness”, first layer being the “inner shaping core” that “may specifically be configured to curl or buckle”, para. [0026]); and an outer layer (e.g. “distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness…and at a second stiffness”, second layer being the “outer layer”, para. [0026]). Corbett further discloses that the pigtail extension “distal tip portion” may be composed of a flexible material including a distal section that is composed of two layers of material that is configured to curl or buckle (e.g. “the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness.”, para. [0026]).
However, Corbett does not explicitly teach the inner shaping core being metallic and the outer layer being disposed outwardly from the inner shaping core with the outer layer disposed on opposite lateral sides of the inner shaping core.
Paamand discloses an energy delivery device which discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, para. [0178]). Paamand further discloses portions which include an outer layer(e.g. 22) that surrounds the nitinol or stainless steel core which includes the outer layer disposed on opposite lateral sides of the shaping core (e.g. “ this embodiment includes insulation 22, which may be in the form of an insulating sleeve, which surrounds the guidewire core 17 and the proximal coil 27”, para. [0141]) which provides insulation as is known to those skilled in the art (e.g. para. [0141]-[0142]).
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 device of Corbett to include as the first layer “shaping core” a stainless steel core and as the second layer an insulating layer “outer layer” which surrounds, the shaping core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inner shaping core a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 2
Corbett modified by Paamand renders obvious a device according to claim 1. Corbett further discloses wherein the distal tip portion comprises a proximal section having a first stiffness (e.g. “the proximal section and the distal section have a corresponding diameter. For example, the proximal section 208 may be composed of a single layer of a first material having a first thickness and a first stiffness,”, para. [0026]) and a distal section having a second stiffness (e.g. “the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness”, para. [0026]), the second stiffness being less than the first stiffness (e.g. “the distal section 207 has an overall lower stiffness than the proximal section 208”, para. [0026]).
In reference to at least claim 3
Corbett modified by Paamand renders obvious a device according to claim 1. Paamand further discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, para. [0178]).
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 device of Corbett to include as the first layer “shaping core” a stainless steel core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inner shaping core a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 21
Corbett modified by Paamand renders obvious a device according to claims 1 and 2. Corbett further discloses wherein the inner shaping core comprises a lumen (e.g. 210) configured to receive a guidewire, the guidewire configured to straighten the distal tip portion (e.g. “a conduit 210 for use with a guidewire.”, para. [0026]).
In reference to at least claim 23
Corbett discloses a percutaneous circulatory support device (e.g. intravascular blood pump, para. [0019]), comprising: a housing (e.g. housing 102); one or more blood outlets located on the housing (e.g. outlet 109, para. [0024]); an impeller disposed within the housing (e.g. impeller 103); a cannula having a proximal end coupled to a distal end of the housing (e.g. cannula 104); one or more blood inlets provided in a distal portion of the cannula (e.g. inlet 105, para. [0020]); the impeller being rotatable relative to the housing to cause blood to flow into the one or more blood inlets (e.g. “an impeller blade 103 rotatably coupled to the blood pump 101”, para. [0020]) to the one or more blood outlets (e.g. “housing component 102 includes one or more apertures or openings 109 configured to expel or exhaust blood drawn into the cannula 104 out of the blood pump assembly 100”, para. [0020]); a distal tip portion coupled to a distal end of the cannula distal of the one or more blood inlets and extending distally therefrom (e.g. distal section 207), the distal tip portion comprising: a user shapeable inner shaping core configured to configured to be shaped by a user to maintain a predetermined shape of the distal tip portion (e.g. “distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness…and at a second stiffness”, first layer being the “inner shaping core” that “may specifically be configured to curl or buckle”, para. [0026]); and an outer layer (e.g. “distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness…and at a second stiffness”, second layer being the “outer layer”, para. [0026]). Corbett further discloses that the pigtail extension “distal tip portion” may be composed of a flexible material including a distal section that is composed of two layers of material that is configured to curl or buckle (e.g. “the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness.”, para. [0026]).
However, Corbett does not explicitly teach the inner shaping core being a user shapeable metallic and the outer layer being disposed outwardly the inner shaping core with the outer layer disposed on opposite lateral sides of the inner shaping core.
Paamand discloses an energy delivery device which discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, para. [0178]). Paamand further discloses portions which include an outer layer(e.g. 22) that surrounds the nitinol or stainless steel core which includes the outer layer disposed on opposite lateral sides of the shaping core (e.g. “ this embodiment includes insulation 22, which may be in the form of an insulating sleeve, which surrounds the guidewire core 17 and the proximal coil 27”, para. [0141]) which provides insulation as is known to those skilled in the art (e.g. para. [0141]-[0142]).
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 device of Corbett to include as the first layer “shaping core” a stainless steel core and as the second layer an insulating layer “outer layer” which surrounds, the shaping core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inner shaping core a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 24
Corbett modified by Paamand renders obvious a device according to claim 23. Corbett further discloses wherein the distal tip portion comprises a proximal section having a first stiffness (e.g. “the proximal section and the distal section have a corresponding diameter. For example, the proximal section 208 may be composed of a single layer of a first material having a first thickness and a first stiffness,”, para. [0026]) and a distal section having a second stiffness (e.g. “the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness”, para. [0026]), the second stiffness being less than the first stiffness (e.g. “the distal section 207 has an overall lower stiffness than the proximal section 208”, para. [0026]).
In reference to at least claim 25
Corbett modified by Paamand renders obvious a device according to claim 23. Paamand further discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, para. [0178]).
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 device of Corbett to include as the first layer “shaping core” a stainless steel core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inner shaping core a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
Claim(s) 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 to Corbett et al. (Corbett) in view of US 2020/0268442 to Paamand et al. (Paamand) and US 2018/0064862 to Keenan et al. (Keenan) (previously cited).
In reference to at least claim 4
Corbett modified by Paamand renders obvious a device according to claim 3. Corbett further discloses that the pigtail extension “distal tip portion” may be composed of a flexible material including a distal section that is composed of two layers of material that can include pebax (e.g. “In particular implementations, the distal section of the pigtail extension is composed of pebax”, para. [0010]; “the distal section 207 of the pigtail extension 206 is composed of pebax.”, para. [0030]).
However, Corbett does not explicitly teach the outer layer comprising a radiopaque material.
Keenan discloses a sheath assembly for a catheter pump which discloses a sheath assembly (e.g. “sheath assembly” 88) that includes an outer jacket (e.g. “outer jacket” 156) that includes position markers (e.g. “position marker” 155) that comprise a Pebax material with a radiopaque material that provide the clinician with an estimated real-time position of the distal end of the catheter assembly (e.g. “The position markers 155a-155c can comprise a Pebax 55D material with a radiopaque component, such as 60% tungsten. The distal-most marker 155a can be used during delivery of the catheter assembly 100 to provide the clinician with an estimated real-time position of the distal portion of the catheter assembly 100 as the catheter assembly 100 is inserted into, or removed from, the anatomy of the patient.”, para. [0074]).
Since Corbett discloses the use of pebax material on the distal section, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include as the outer layer a Pebax material with a radiopaque component, as taught by Keenan, in order to provide the clinician with an estimated real-time position of the distal end of the support device (‘862, para. [0074]).
In reference to at least claim 5
Corbett modified by Paamand and Keenan renders obvious a device according to claim 4. Corbett further discloses that distal section of the pigtail extension provides an atraumatic tip for contact with the ventricle wall (e.g. “The distal section 107 of the pigtail extension 106 is flexible compared to the proximal section 108 to provide an atraumatic tip for contact with the ventricle wall.” para. [0024]). Keenan further discloses an atraumatic tip portion (e.g. 150) that includes a sphere-shaped distal end (e.g. “atraumatic tip 150” includes a spherical shape, Fig. 6B) providing atraumatic contact interface when the tip contacts the anatomy (e.g. “An atraumatic tip 150 can be disposed distal the cannula 108, and can be configured to provide an atraumatic contact interface when the tip 150 contacts the anatomy.”, para. [0068]).
Since Corbett discloses the distal end providing an atraumatic tip, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include the atraumatic tip being sphere-shaped, as taught by Keenan, in order to provide an atraumatic contact interface when the distal tip portion contacts the anatomy of the patient (e.g. ‘862, para. [0068]).
In reference to at least claim 6
Corbett modified by Paamand renders obvious a device according to claim 3. Corbett further discloses that distal section of the pigtail extension provides an atraumatic tip for contact with the ventricle wall (e.g. “The distal section 107 of the pigtail extension 106 is flexible compared to the proximal section 108 to provide an atraumatic tip for contact with the ventricle wall.” para. [0024]).
Corbett modified by Paamand does not explicitly teach the atraumatic tip having a sphere-shaped distal end.
Keenan discloses a sheath assembly for a catheter pump which discloses a sheath assembly (e.g. “sheath assembly” 88) that includes an outer jacket (e.g. “outer jacket” 156) that includes position markers (e.g. “position marker” 155) that comprise a Pebax material with a radiopaque material that provide the clinician with an estimated real-time position of the distal end of the catheter assembly (e.g. “The position markers 155a-155c can comprise a Pebax 55D material with a radiopaque component, such as 60% tungsten. The distal-most marker 155a can be used during delivery of the catheter assembly 100 to provide the clinician with an estimated real-time position of the distal portion of the catheter assembly 100 as the catheter assembly 100 is inserted into, or removed from, the anatomy of the patient.”, para. [0074]). Keenan further discloses an atraumatic tip portion (e.g. 150) that includes a sphere-shaped distal end (e.g. “atraumatic tip 150” includes a spherical shape, Fig. 6B) providing atraumatic contact interface when the tip contacts the anatomy (e.g. “An atraumatic tip 150 can be disposed distal the cannula 108, and can be configured to provide an atraumatic contact interface when the tip 150 contacts the anatomy.”, para. [0068]).
Since Corbett discloses the distal end providing an atraumatic tip, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include the atraumatic tip being sphere-shaped, as taught by Keenan, in order to provide an atraumatic contact interface when the distal tip portion contacts the anatomy of the patient (e.g. ‘862, para. [0068]).
In reference to at least claim 7
Corbett modified by Paamand renders obvious a device according to claim 1. Corbett further discloses that distal section of the pigtail extension provides an atraumatic tip for contact with the ventricle wall (e.g. “The distal section 107 of the pigtail extension 106 is flexible compared to the proximal section 108 to provide an atraumatic tip for contact with the ventricle wall.” para. [0024]).
Corbett does not explicitly teach the atraumatic tip having a sphere-shaped distal end.
Keenan discloses a sheath assembly for a catheter pump which discloses a sheath assembly (e.g. “sheath assembly” 88) that includes an outer jacket (e.g. “outer jacket” 156) that includes position markers (e.g. “position marker” 155) that comprise a Pebax material with a radiopaque material that provide the clinician with an estimated real-time position of the distal end of the catheter assembly (e.g. “The position markers 155a-155c can comprise a Pebax 55D material with a radiopaque component, such as 60% tungsten. The distal-most marker 155a can be used during delivery of the catheter assembly 100 to provide the clinician with an estimated real-time position of the distal portion of the catheter assembly 100 as the catheter assembly 100 is inserted into, or removed from, the anatomy of the patient.”, para. [0074]). Keenan further discloses an atraumatic tip portion (e.g. 150) that includes a sphere-shaped distal end (e.g. “atraumatic tip 150” includes a spherical shape, Fig. 6B) providing atraumatic contact interface when the tip contacts the anatomy (e.g. “An atraumatic tip 150 can be disposed distal the cannula 108, and can be configured to provide an atraumatic contact interface when the tip 150 contacts the anatomy.”, para. [0068]).
Since Corbett discloses the distal end providing an atraumatic tip, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include the atraumatic tip being sphere-shaped, as taught by Keenan, in order to provide an atraumatic contact interface when the distal tip portion contacts the anatomy of the patient (e.g. ‘862, para. [0068]).
In reference to at least claims 8-9
Corbett modified by Paamand renders obvious a device according to claims 1 and 2. Corbett further discloses that the pigtail extension “distal tip portion” may be composed of a flexible material including a distal section that is composed of two layers of material that can include pebax (e.g. “In particular implementations, the distal section of the pigtail extension is composed of pebax”, para. [0010]; “the distal section 207 of the pigtail extension 206 is composed of pebax.”, para. [0030]).
However, Corbett does not explicitly teach the outer layer comprising a radiopaque material.
Keenan discloses a sheath assembly for a catheter pump which discloses a sheath assembly (e.g. “sheath assembly” 88) that includes an outer jacket (e.g. “outer jacket” 156) that includes position markers (e.g. “position marker” 155) that comprise a Pebax material with a radiopaque material that provide the clinician with an estimated real-time position of the distal end of the catheter assembly (e.g. “The position markers 155a-155c can comprise a Pebax 55D material with a radiopaque component, such as 60% tungsten. The distal-most marker 155a can be used during delivery of the catheter assembly 100 to provide the clinician with an estimated real-time position of the distal portion of the catheter assembly 100 as the catheter assembly 100 is inserted into, or removed from, the anatomy of the patient.”, para. [0074]).
Since Corbett discloses the use of pebax material on the distal section, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include as the outer layer a Pebax material with a radiopaque component, as taught by Keenan, in order to provide the clinician with an estimated real-time position of the distal end of the support device (‘862, para. [0074]).
In reference to at least claim 10
Corbett discloses a percutaneous circulatory support device (e.g. intravascular blood pump, para. [0019]), comprising: a housing (e.g. housing 102) comprising an inlet (e.g. inlet 105, para. [0020]) and an outlet (e.g. outlet 109, para. [0024]); an impeller disposed within the housing (e.g. impeller 103) and being rotatable relative to the housing to cause blood to flow into the inlet through the housing (e.g. “an impeller blade 103 rotatably coupled to the blood pump 101”, para. [0020]), and out of the outlet (e.g. “housing component 102 includes one or more apertures or openings 109 configured to expel or exhaust blood drawn into the cannula 104 out of the blood pump assembly 100”, para. [0020]); a cannula coupled to the housing (e.g. cannula 104); a distal tip portion (e.g. pigtail extension 106) coupled to the cannula opposite the housing (e.g. pigtail extension 106 is coupled to the cannula 104 opposite housing 102, Fig. 1); an inner shaping core configured to maintain a predetermined shape of the distal tip portion (e.g. “distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness…and at a second stiffness”, first layer being the “inner shaping core” that “may specifically be configured to curl or buckle”, para. [0026]); an outer layer (e.g. “distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness…and at a second stiffness”, second layer being the “outer layer”, para. [0026]). Corbett further discloses that the pigtail extension “distal tip portion” may be composed of a flexible material including a distal section that is composed of two layers of material that is configured to curl or buckle (e.g. “the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness.”, para. [0026]) and that the distal section of the pigtail extension provides an atraumatic tip for contact with the ventricle wall (e.g. “The distal section 107 of the pigtail extension 106 is flexible compared to the proximal section 108 to provide an atraumatic tip for contact with the ventricle wall.” para. [0024]).
However, Corbett does not explicitly teach the inner shaping core being metallic and the outer layer being disposed outwardly from the inner shaping core with the outer layer disposed on opposite lateral sides of the inner shaping core or the atraumatic tip having a sphere-shaped distal end.
Paamand discloses an energy delivery device which discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, para. [0178]). Paamand further discloses portions which include an outer layer(e.g. 22) that surrounds the nitinol or stainless steel core which includes the outer layer disposed on opposite lateral sides of the shaping core (e.g. “ this embodiment includes insulation 22, which may be in the form of an insulating sleeve, which surrounds the guidewire core 17 and the proximal coil 27”, para. [0141]) which provides insulation as is known to those skilled in the art (e.g. para. [0141]-[0142]).
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 device of Corbett to include as the first layer “shaping core” a stainless steel core and as the second layer an insulating layer “outer layer” which surrounds, the shaping core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inner shaping core a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
Regarding the atraumatic tip having a sphere-shaped distal end, Keenan discloses a sheath assembly for a catheter pump which discloses a sheath assembly (e.g. “sheath assembly” 88) that includes an outer jacket (e.g. “outer jacket” 156) that includes position markers (e.g. “position marker” 155) that comprise a Pebax material with a radiopaque material that provide the clinician with an estimated real-time position of the distal end of the catheter assembly (e.g. “The position markers 155a-155c can comprise a Pebax 55D material with a radiopaque component, such as 60% tungsten. The distal-most marker 155a can be used during delivery of the catheter assembly 100 to provide the clinician with an estimated real-time position of the distal portion of the catheter assembly 100 as the catheter assembly 100 is inserted into, or removed from, the anatomy of the patient.”, para. [0074]). Keenan further discloses an atraumatic tip portion (e.g. 150) that includes a sphere-shaped distal end (e.g. “atraumatic tip 150” includes a spherical shape, Fig. 6B) providing atraumatic contact interface when the tip contacts the anatomy (e.g. “An atraumatic tip 150 can be disposed distal the cannula 108, and can be configured to provide an atraumatic contact interface when the tip 150 contacts the anatomy.”, para. [0068]).
Since Corbett discloses the distal end providing an atraumatic tip, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include the atraumatic tip being sphere-shaped, as taught by Keenan, in order to provide an atraumatic contact interface when the distal tip portion contacts the anatomy of the patient (e.g. ‘862, para. [0068]).
In reference to at least claim 11
Corbett modified by Paamand and Keenan renders obvious a device according to claim 10. Corbett further discloses wherein the distal tip portion comprises a proximal section having a first stiffness (e.g. “the proximal section and the distal section have a corresponding diameter. For example, the proximal section 208 may be composed of a single layer of a first material having a first thickness and a first stiffness,”, para. [0026]) and a distal section having a second stiffness (e.g. “the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness”, para. [0026]), the second stiffness being less than the first stiffness (e.g. “the distal section 207 has an overall lower stiffness than the proximal section 208”, para. [0026]).
In reference to at least claim 12
Corbett modified by Paamand and Keenan renders obvious a device according to claim 10. As recited above, see claim 10, Corbett discloses that the pigtail extension "distal tip portion" may be composed of a flexible material including a distal section that is composed of two layers of material that is configured to curl or buckle (e.g. "the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness.", para. [0026]).
Paamand discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, nitinol is a shape-memory material, para. [0178]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device to include as the first layer a nitinol core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the distal tip portion include a nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 13
Corbett modified by Paamand and Keenan renders obvious a device according to claim 10. As recited above, see claim 10, Corbett discloses that the pigtail extension "distal tip portion" may be composed of a flexible material including a distal section that is composed of two layers of material that is configured to curl or buckle (e.g. "the distal section 207 may be composed of two layers of material. In such cases, the two layers may include a first layer of the first material at a second thickness less than the first thickness and a second layer of a second material at a third thickness (the second and third thickness in aggregate corresponding to the first thickness) and at a second stiffness.", para. [0026]).
Paamand discloses that it is known in the art when manufacturing shapable devices to use a shapable material such as nitinol or stainless steel core that allows for the curvature required (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, para. [0178]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device to include as the first layer a stainless steel core, as taught by Paamand, in order to allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the distal tip portion include a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 14
Corbett modified by Paamand and Keenan renders obvious a device according to claim 10. Corbett further discloses that the pigtail extension “distal tip portion” may be composed of a flexible material including a distal section that is composed of two layers of material that can include pebax (e.g. “In particular implementations, the distal section of the pigtail extension is composed of pebax”, para. [0010]; “the distal section 207 of the pigtail extension 206 is composed of pebax.”, para. [0030]).
Keenan further discloses a sheath assembly for a catheter pump which discloses a sheath assembly (e.g. “sheath assembly” 88) that includes an outer jacket (e.g. “outer jacket” 156) that includes position markers (e.g. “position marker” 155) that comprise a Pebax material with a radiopaque material that provide the clinician with an estimated real-time position of the distal end of the catheter assembly (e.g. “The position markers 155a-155c can comprise a Pebax 55D material with a radiopaque component, such as 60% tungsten. The distal-most marker 155a can be used during delivery of the catheter assembly 100 to provide the clinician with an estimated real-time position of the distal portion of the catheter assembly 100 as the catheter assembly 100 is inserted into, or removed from, the anatomy of the patient.”, para. [0074]).
Since Corbett discloses the use of pebax material on the distal section, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Keenan to include as the outer layer a Pebax material with a radiopaque component, as taught by Keenan, in order to provide the clinician with an estimated real-time position of the distal end of the support device (‘862, para. [0074]).
Claim(s) 22 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0328382 to Corbett et al. (Corbett) in view of US 2020/0268442 to Paamand et al. (Paamand) as applied to claims 1 and 23 further in view of US 2020/0330664 to Ship et al. (Ship) (previously cited).
In reference to at least claim 22 and 26
Corbett modified by Paamand renders obvious a device according to claims 1 and 23. Corbett modified by Paamand does not explicitly teach wherein the inner shaping core is devoid of a lumen.
Ship discloses a distal extension from a blood pump system that has variable stiffness which discloses an embodiment in which the distal extension is solid all the way through (e.g. “In such implementations, the distal extension may comprise a partial lumen, or the distal extension may be solid throughout its length.”, para. [0022]) allowing insertion within the vasculature without the use of a guidewire and fully “wireless access” of the pump into the ventricle (e.g. para. [0005], [0022]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Corbett modified by Paamand to include within the distal tip portion an extension that is solid throughout the length, as taught by Ship, in order to allow insertion within the vasculature without the use of a guidewire and/or fully “wireless access” of the pump into the heart (e.g. ‘664, [0005], [0022]).
Response to Arguments
Claim Rejections – 35 USC 102
Applicant’s arguments, see pgs. 6-7, filed 1/22/2026, with respect to 35 USC 102 rejection against claims 10-11 using Tuval have been fully considered and are persuasive in view of the claim amendments to claim 10 adding language regarding a metallic inner shaping core and an outer layer. The 35 USC 102 rejection against claims 10-11 using Tuval has been withdrawn.
Claim Rejections – 35 USC 103
Regarding claim 1, applicant argues that there is “no reason to modify the pigtail extension of Corbett to include a metallic inner shaping core configured to maintain a predetermined shape”, see pg. 8 of response filed 1/22/2026. This is not persuasive. As stated within the rejection the motivation to combine the teachings of Paamand with Corbett would provide the shaping core being made of materials that allow for the sharp curvature required (‘442, para. [0178]). Additionally or alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inner shaping core a steel material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
Regarding claim 1, applicant argues that “Modifying the pigtail extension of Corbett to be rigid enough to maintain a predetermined shape would change the principle operation as taught by Corbett…As such, Paamand cannot be used to modify the device of Corbett as done in the office action”, see pg. 8-9 of response filed 1/22/2026. This is not persuasive. Applicant states that modifying Corbett with the teachings of Paamand would make the pigtail extension too rigid to curl or buckle upon contacting a tissue wall, however Paamand does not state that utilizing a metallic shapeable core requires a rigid structure. Paamand discloses shapable material such as nitinol or stainless steel core (e.g. “Such devices may be made with shapable material. Such devices may have a nitinol or stainless steel core with a construction that allows for the sharp curvatures required for shaping the device as is known to the skilled person.”, nitinol is a shape-memory material, para. [0178]), therefore the shapable core would still allow Paamand to provide the curl or buckle.
Regarding claim 23, applicant argues that “Nowhere does Corbett teach or suggest that the pigtail extension is configured to be shape by a user. Instead the configuration of Corbett appears to be set at manufacture”, see pg. 9 of response filed 1/22/2026. This is not persuasive. Corbett discloses that the pigtail extension is configured to curl or buckle when against the patient’s tissue (e.g. “may specifically be configured to curl or buckle”, para. [0026]) and the user is inserting the device creating contact with the patient’s tissue causing the pigtail extension to curl or buckle when contacted. Further, the combination of Corbett and Paamand provides a pigtail extension made of a shapeable material. The modified device would include the distal tip portion being made from a user shapeable material including a flexible metal material such as nitinol or stainless steel having shapable properties to create the desired curvature required including the curvature shown within the distal tip portion of Corbett.
Regarding claim 1 and 23, applicant argues that “Paamand…does not properly remedy the shortcomings of Corbett with respect to claims 1 and 23”, see pg. 9 of response filed 1/22/2026. This is not persuasive. Arguments regarding the combination of Corbett and Paamand have been fully addressed above with respect to claim 1.
Regarding claims 4-9, applicant does not provide separate arguments for claims 4-9 and only states that the claims are allowable in view of the allowability of claim 1, see pg. 9 of response filed 1/22/2026. The arguments regarding claim 1 have been fully addressed above, therefore the arguments regarding claims 4-9 have been fully addressed within the response to the 103 rejection using Corbett in view of Paamand provided above.
Regarding claims 10-11 and 14, applicant’s arguments, see 9-10, filed 1/22/2026, with respect to the rejection(s) of claim(s) 10-11 and 14 under 35 USC 103 using Corbett in view of Keenan have been fully considered and are persuasive in view of the claim amendments to claim 10 adding language regarding a metallic inner shaping core and an outer layer. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2020/0268442 to Paamand et al, see rejection above.
Regarding claims 12-13, applicant does not provide separate arguments for claims 12-13 and only states that the claims are allowable in view of the allowability of claim 10, see pg. 10 of response filed 1/22/2026. The arguments regarding claim 10 have been fully addressed above, therefore the arguments regarding claims 12-13 have been fully addressed within the response to the 103 rejection using Corbett in view of Paamand and Keenan provided above.
Regarding claims 22 and 26, applicant does not provide separate arguments for claims 22 and 26 and only states that the claims are allowable in view of the allowability of claim 1, see pg. 10 of response filed 1/22/2026. The arguments regarding claim 1 have been fully addressed above, therefore the arguments regarding claims 422 and 26 have been fully addressed within the response to the 103 rejection using Corbett in view of Paamand provided above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER MCDONALD can be reached at (571)270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER L GHAND/Examiner, Art Unit 3796