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 .
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 17/560029 which is now abandoned, the paragraph should be updated to reflect the current status of the related application.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “securement member configured to inhibit expansion of the distal end of the enveloper member when the securement member is secured and configured to allow the distal end of the enveloper member to expand when the securement member is released.” in claims 5-7 and 16-18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, “securement member..” has been interpreted to include a resilient portion of the enveloper member such as a resilient portion of a braided mesh enveloper member and equivalents thereof as disclosed within the specification, see para. [0061] of published application US 2022/0193392.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-20 are 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. Claims 1 and 11 recite the limitation "the percutaneous medical device" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “the tether assembly is configured to withdrawal of the enveloper member proximally from covering the expandable cannula.” it is unclear what applicant is attempting to encompass when reciting “the tether assembly is configured to withdrawal of the enveloper member proximally from covering the expandable cannula.” Does applicant mean that the tether assembly is configured to withdraw the enveloper member proximally? Clarification is required. Claims 2-10 and 12-20 directly or indirectly depend from claims 1 and 11 and are also rejected to for the reasons stated above regarding claims 1 and 11. For the purpose of examination, as best understood, claims 1 and 11 have been interpreted to include the expandable cannula of the blood pump being the percutaneous medical device.
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) 1-2,5-7,11-12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No 8,641,752 to Holm (Holm) in view of US 2019/0015570 to Muller (Muller).
In reference to at least claim 1
Holm discloses a delivery device for percutaneous medical device (e.g. percutaneous insertion, Col. 3, ll. 27 – 50); the delivery device comprising: an enveloper member that includes an enveloper wall (e.g. protective sleeve 20, Figs. 1-6) an enveloper aperture that is formed at the enveloper wall such that the enveloper member is configured to receive a deployment portion of the percutaneous medical device through the enveloper aperture (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21), and a tether assembly extending from the enveloper wall (e.g. deployment line 42, sleeve retraction line 44 and main deployment line 46, Figs. 3-5); the enveloper member configured to removably cover the deployment portion with the enveloper wall (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21); and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. pulled away from the device using deployment line 42, sleeve retraction line 44 and main deployment line 46, Col. 5, ll. 1-8, 24-45).
Holm further discloses that the enveloper member is configured to receive a deployment portion of a percutaneous medical device (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21), and to removably cover the deployment portion with the enveloper wall (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21); and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. pulled away from the device using deployment line 42, sleeve retraction line 44 and main deployment line 46, Col. 5, ll. 1-8, 24-45). However, Holm does not explicitly teach the percutaneous device being a percutaneous blood pump including an expandable cannula.
Muller, within the same field of endeavor, discloses a percutaneous blood pump (e.g. Fig. 2) that includes an expandable cannula (e.g. 202, para. [0027]). Muller discloses that it is known in the art to use a convenient manner of placement of the pump within the heart such as percutaneous access and delivery using Seldinger techniques or other methods familiar to cardiologists (e.g. “One convenient manner of placement of the distal portion of the pump 10 in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable the pump 10 to be used in emergency medicine, a catheter lab and in other non-surgical settings.”, para. [0035]).
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 system of Holm to include as the percutaneous medical device a percutaneous blood pump that includes an expandable cannula and the enveloper member surrounding the expandable cannula in a constrained configuration for delivery of the blood pump, as taught by Muller, since Mueller discloses that any known technique may be used for the placement of the percutaneous blood pump and would have yielded the predictable result of a convenient manner of placement (‘570, para. [0035]).
In reference to at least claim 2
Holm modified by Muller renders obvious a system according to claim 6. Muller further discloses an introducer defining a delivery lumen, wherein the tether assembly extends through the delivery lumen (e.g. catheter 12 and introducer 14, Figs. 2-3, Col. 3, ll. 51-61).
In reference to at least claim 5-6
Holm modified by Muller renders obvious a system according to claim 1. Holm further discloses wherein a distal portion of the enveloper member includes a securement member that is configured to inhibit expansion of the distal portion of the enveloper member when the securement member is secured and to allow the distal portion of the enveloper member to expand when the securement member is released (e.g. hinge fingers 25a which inhibit expansion when in the secured and allow expansion when released, Fig. 4, Col. 4,ll. 43-67).
In reference to at least claim 7
Holm modified by Muller renders obvious a system according to claim 6. Holm does not explicitly teach the securement member comprising silicone. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the securement member comprise silicone, 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 11
Holm discloses a delivery device for percutaneous medical device (e.g. percutaneous insertion, Col. 3, ll. 27 – 50); the delivery device comprising: an enveloper member that includes an enveloper wall (e.g. protective sleeve 20, Figs. 1-6) an enveloper aperture that is formed at the enveloper wall such that the enveloper member is configured to receive a deployment portion of the percutaneous medical device through the enveloper aperture (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21), and a tether assembly extending from the enveloper wall (e.g. deployment line 42, sleeve retraction line 44 and main deployment line 46, Figs. 3-5); the enveloper member configured to removably cover the deployment portion with the enveloper wall (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21); and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. pulled away from the device using deployment line 42, sleeve retraction line 44 and main deployment line 46, Col. 5, ll. 1-8, 24-45).
Holm further discloses that the enveloper member is configured to receive a deployment portion of a percutaneous medical device (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21), and to removably cover the deployment portion with the enveloper wall (e.g. overlay a deployment portion of a percutaneous medical device 16, Figs. 1-6, Col. 4, ll 5-21); and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. pulled away from the device using deployment line 42, sleeve retraction line 44 and main deployment line 46, Col. 5, ll. 1-8, 24-45). However, Holm does not explicitly teach the percutaneous device being a circulatory support device including a percutaneous blood pump having an expandable cannula with a proximal end coupled to an elongate shaft of the circulatory support device and a distal end coupled to a distal tip of the circulatory support device.
Muller, within the same field of endeavor, discloses a circulatory support device that includes a percutaneous blood pump (e.g. Fig. 2) that includes an expandable cannula with a proximal end coupled to an elongate shaft of the circulatory support device and a distal end coupled to a distal tip of the circulatory support device (e.g. 202, with the proximal end coupled to elongated body 96 and the distal end coupled to a distal tip, Fig. 2, para. [0027]). Muller discloses that it is known in the art to use a convenient manner of placement of the pump within the heart such as percutaneous access and delivery using Seldinger techniques or other methods familiar to cardiologists (e.g. “One convenient manner of placement of the distal portion of the pump 10 in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable the pump 10 to be used in emergency medicine, a catheter lab and in other non-surgical settings.”, para. [0035]).
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 system of Holm to include as the percutaneous medical device a percutaneous blood pump having an expandable cannula with a proximal end coupled to an elongate shaft of the circulatory support device and a distal end coupled to a distal tip of the circulatory support device and using the enveloper member to surround the expandable cannula in a constrained configuration for delivery of the blood pump, as taught by Muller, since Mueller discloses that any known technique may be used for the placement of the percutaneous blood pump and would have yielded the predictable result of a convenient manner of placement (‘570, para. [0035]).
In reference to at least claim 12
Holm modified by Muller renders obvious a system according to claim 11. Muller further discloses wherein the proximal end of the expandable cannula is coupled to the elongate shaft via an adaptor (e.g. cannula 202 has a proximal end coupled to elongated body 96, Fig. 2, para. [0027]).
In reference to at least claim 15-16
Holm modified by Muller renders obvious a system according to claim 11. Holm further discloses wherein a distal portion of the enveloper member includes a securement member that is configured to inhibit expansion of the distal portion of the enveloper member when the securement member is secured and to allow the distal portion of the enveloper member to expand when the securement member is released (e.g. hinge fingers 25a which inhibit expansion when in the secured and allow expansion when released, Fig. 4, Col. 4,ll. 43-67).
In reference to at least claim 17
Holm modified by Muller renders obvious a system according to claim 16. Holm does not explicitly teach the securement member comprising silicone. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the securement member comprise silicone, 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 18
Holm modified by Muller renders obvious a system according to claim 15. Holm further discloses wherein the tether assembly is configured to cause the securement member to expand when the tether assembly is pulled proximally (e.g. hinge fingers 25a which inhibit expansion when in the secured and allow expansion when released, Fig. 4, Col. 4,ll. 43-67).
In reference to at least claim 19
Holm modified by Muller renders obvious a system according to claim 15. The modified device would place the enveloper member over the percutaneous medical device which is the blood pump leaving the elongated shaft extending proximal of the enveloper member.
In reference to at least claim 20
Holm modified by Muller renders obvious a system according to claim 11. Holm further discloses an introducer defining a delivery lumen, wherein the tether assembly extends through the delivery lumen (e.g. catheter 12 and introducer 14, Figs. 2-3, Col. 3, ll. 51-61). The modified device would place the enveloper member over the percutaneous medical device which is the blood pump leaving the elongated shaft extending through the delivery lumen.
Claim(s) 1-2,5-7,10-12 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0323670 to Honeyfield et al. (Honeyfield – cited by applicant) in view of US 20190015570 to Muller (Muller).
In reference to at least claim 1
Honeyfield discloses a medical delivery system comprising: an enveloper member that includes an enveloper wall (e.g. cover 1300, 4300 and constraining member 1400, 4400, Figs. 1-7) the enveloper member is configured to receive a deployment portion of the percutaneous medical device through the enveloper aperture (e.g. cover 1300, 4300 and constraining member 1400, 4400. overlay a deployment portion of the medical device 1100, Figs. 1-7), and a tether assembly extending from the enveloper wall (e.g. tether 1312, 4312 and rip cord 1408,4408, Fig. 1-7); the enveloper member configured to removably cover the deployment portion with the enveloper wall (e.g. cover 1300 and 4300 overlay a deployment portion of the medical device 1100, Figs. 1-7); and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. tether 1312, 4312 and rip cord 1408,4408 are pulled to remove cover 1300, 4300 and constraining member 1400, 4400 from covering the medical device, Fig. 1-7, para. [0066], [0079], [0080]-[0082], [0085]-[0086], [0094], [0096]).
Honeyfield discloses that the enveloper member is configured to receive a deployment portion of the percutaneous medical device through the enveloper aperture (e.g. cover 1300, 4300 and constraining member 1400, 4400. overlay a deployment portion of the medical device 1100, Figs. 1-7) and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. tether 1312, 4312 and rip cord 1408,4408 are pulled to remove cover 1300, 4300 and constraining member 1400, 4400 from covering the medical device, Fig. 1-7, para. [0066], [0079], [0080]-[0082], [0085]-[0086], [0094], [0096]). However, Honeyfield does not explicitly teach the percutaneous device being a percutaneous blood pump including an expandable cannula.
Muller, within the same field of endeavor, discloses a percutaneous blood pump (e.g. Fig. 2) that includes an expandable cannula (e.g. 202, para. [0027]). Muller discloses that it is known in the art to use a convenient manner of placement of the pump within the heart such as percutaneous access and delivery using Seldinger techniques or other methods familiar to cardiologists (e.g. “One convenient manner of placement of the distal portion of the pump 10 in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable the pump 10 to be used in emergency medicine, a catheter lab and in other non-surgical settings.”, para. [0035]).
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 system of Honeyfield to include as the percutaneous medical device a percutaneous blood pump that includes an expandable cannula and the enveloper member surrounding the expandable cannula in a constrained configuration for delivery of the blood pump, as taught by Muller, since it Mueller discloses that any known technique may be used for the placement of the percutaneous blood pump and would have yielded the predictable result of a convenient manner of placement (‘570, para. [0035]).
In reference to at least claim 2
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses an introducer defining a delivery lumen, wherein the tether assembly extends through the delivery lumen (e.g. inserted through an introducer sheath, para. [0137]).
In reference to at least claim 5-6
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses wherein a distal portion of the enveloper member includes a securement member that is configured to inhibit expansion of the distal portion of the enveloper member when the securement member is secured and to allow the distal portion of the enveloper member to expand when the securement member is released (e.g. “enveloper member” includes constraining member 1400, 4400 that overlays and constrains a deployment portion of the medical device 1100, Figs. 1-7, para. [0041], [0060]-[0064], [0075], [0081]-[0084]).
In reference to at least claim 7
Honeyfield modified by Muller renders obvious a system according to claim 16. Honeyfield does not explicitly teach the securement member comprising silicone. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the securement member comprise silicone, 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 10
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses wherein the enveloper member is a braided mesh enveloper member (e.g. knit-braid structure, para. [0063]-[0066]).
In reference to at least claim 11
Honeyfield discloses a medical delivery system comprising: an enveloper member that includes an enveloper wall (e.g. cover 1300, 4300 and constraining member 1400, 4400, Figs. 1-7) the enveloper member is configured to receive a deployment portion of the percutaneous medical device through the enveloper aperture (e.g. cover 1300, 4300 and constraining member 1400, 4400. overlay a deployment portion of the medical device 1100, Figs. 1-7), and a tether assembly extending from the enveloper wall (e.g. tether 1312, 4312 and rip cord 1408,4408, Fig. 1-7); the enveloper member configured to removably cover the deployment portion with the enveloper wall (e.g. cover 1300 and 4300 overlay a deployment portion of the medical device 1100, Figs. 1-7); and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. tether 1312, 4312 and rip cord 1408,4408 are pulled to remove cover 1300, 4300 and constraining member 1400, 4400 from covering the medical device, Fig. 1-7, para. [0066], [0079], [0080]-[0082], [0085]-[0086], [0094], [0096]).
Honeyfield discloses that the enveloper member is configured to receive a deployment portion of the percutaneous medical device through the enveloper aperture (e.g. cover 1300, 4300 and constraining member 1400, 4400. overlay a deployment portion of the medical device 1100, Figs. 1-7) and the tether assembly configured to facilitate removal of the enveloper member from covering the deployment portion and to facilitate withdrawal of the enveloper member from a delivery lumen (e.g. tether 1312, 4312 and rip cord 1408,4408 are pulled to remove cover 1300, 4300 and constraining member 1400, 4400 from covering the medical device, Fig. 1-7, para. [0066], [0079], [0080]-[0082], [0085]-[0086], [0094], [0096]). However, Honeyfield does not explicitly teach the percutaneous device being a circulatory support device including a percutaneous blood pump having an expandable cannula with a proximal end coupled to an elongate shaft of the circulatory support device and a distal end coupled to a distal tip of the circulatory support device.
Muller, within the same field of endeavor, discloses a circulatory support device that includes a percutaneous blood pump (e.g. Fig. 2) that includes an expandable cannula with a proximal end coupled to an elongate shaft of the circulatory support device and a distal end coupled to a distal tip of the circulatory support device (e.g. 202, with the proximal end coupled to elongated body 96 and the distal end coupled to a distal tip, Fig. 2, para. [0027]). Muller discloses that it is known in the art to use a convenient manner of placement of the pump within the heart such as percutaneous access and delivery using Seldinger techniques or other methods familiar to cardiologists (e.g. “One convenient manner of placement of the distal portion of the pump 10 in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable the pump 10 to be used in emergency medicine, a catheter lab and in other non-surgical settings.”, para. [0035]).
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 system of Honeyfield to include as the percutaneous medical device a percutaneous blood pump having an expandable cannula with a proximal end coupled to an elongate shaft of the circulatory support device and a distal end coupled to a distal tip of the circulatory support device and using the enveloper member to surround the expandable cannula in a constrained configuration for delivery of the blood pump, as taught by Muller, since Mueller discloses that any known technique may be used for the placement of the percutaneous blood pump and would have yielded the predictable result of a convenient manner of placement (‘570, para. [0035]).
In reference to at least claim 12
Honeyfield modified by Muller renders obvious a system according to claim 11. Muller further discloses wherein the proximal end of the expandable cannula is coupled to the elongate shaft via an adaptor (e.g. cannula 202 has a proximal end coupled to elongated body 96, Fig. 2, para. [0027]).
In reference to at least claim 14
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses wherein the enveloper member is a braided mesh enveloper member (e.g. knit-braid structure, para. [0063]-[0066]).
In reference to at least claim 15-16
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses wherein a distal portion of the enveloper member includes a securement member that is configured to inhibit expansion of the distal portion of the enveloper member when the securement member is secured and to allow the distal portion of the enveloper member to expand when the securement member is released (e.g. “enveloper member” includes constraining member 1400, 4400 that overlays and constrains a deployment portion of the medical device 1100, Figs. 1-7, para. [0041], [0060]-[0064], [0075], [0081]-[0084]).
In reference to at least claim 17
Honeyfield modified by Muller renders obvious a system according to claim 16. Honeyfield does not explicitly teach the securement member comprising silicone. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the securement member comprise silicone, 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 18
Honeyfield modified by Muller renders obvious a system according to claim 15. Honeyfield further discloses wherein the tether assembly is configured to cause the securement member to expand when the tether assembly is pulled proximally (e.g. “enveloper member” includes constraining member 1400, 4400 that overlays and constrains a deployment portion of the medical device 1100, Figs. 1-7, para. [0041], [0060]-[0064], [0075], [0081]-[0084]).
In reference to at least claim 19
Honeyfield modified by Muller renders obvious a system according to claim 15. The modified device would place the enveloper member over the percutaneous medical device which is the blood pump leaving the elongated shaft extending proximal of the enveloper member.
In reference to at least claim 20
Honeyfield modified by Muller renders obvious a system according to claim 11. Honeyfield further discloses an introducer defining a delivery lumen, wherein the tether assembly extends through the delivery lumen (e.g. inserted through an introducer sheath, para. [0137]). The modified device would place the enveloper member over the percutaneous medical device which is the blood pump leaving the elongated shaft extending through the delivery lumen.
Claim(s) 3 and 13 and is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No 8,641,752 to Holm (Holm) in view of US 20190015570 to Muller (Muller) as applied to claims 1 and 11 further in view of US 2007/0021768 to Nance et al. (Nance).
In reference to at least claim 3
Holm modified by Muller renders obvious a system according to claim 1. Holm further discloses the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member (e.g. tapered at a distal end of protective sleeve 20).
However, Holm does not explicitly teach the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member.
Nance, in the analogous art of percutaneous delivery access, discloses a jacket 200 “enveloper member that includes an enveloper wall” configured to receive a deployment portion of the percutaneous medical device (e.g. percutaneous access sheath 100 is received in jacket 200, Fig. 3), therein, the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member (e.g. jacket 200 contains a distally tapering section 208 and 212, Figs. 2,2A, para. [0074]), and the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member (e.g. jacket 200 contains a proximally tapering section near proximal end 202, Figs. 2, 2A). Nance discloses that the device provides improved access technology, which allows a device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments (e.g. para. [0012]) and improves protection of the surrounding tissue from damage (e.g. para. [0078]).
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 system of Holm modified by Muller to include along with the distally tapered portion of the enveloper member a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member, as taught by Nance, in order to allow the device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments and improve protection of the surrounding tissue from damage (e.g.’768, para. [0012], [0078]).
In reference to at least claim 13
Holm modified by Muller renders obvious a system according to claim 11. Holm further discloses the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member (e.g. tapered at a distal end of protective sleeve 20).
However, Holm does not explicitly teach the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member.
Nance, in the analogous art of percutaneous delivery access, discloses a jacket 200 “enveloper member that includes an enveloper wall” configured to receive a deployment portion of the percutaneous medical device (e.g. percutaneous access sheath 100 is received in jacket 200, Fig. 3), therein, the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member (e.g. jacket 200 contains a distally tapering section 208 and 212, Figs. 2,2A, para. [0074]), and the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member (e.g. jacket 200 contains a proximally tapering section near proximal end 202, Figs. 2, 2A). Nance discloses that the device provides improved access technology, which allows a device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments (e.g. para. [0012]) and improves protection of the surrounding tissue from damage (e.g. para. [0078]).
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 system of Holm modified by Muller to include along with the distally tapered portion of the enveloper member a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member, as taught by Nance, in order to allow the device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments and improve protection of the surrounding tissue from damage (e.g.’768, para. [0012], [0078]).
Claim(s) 3 and 13 and is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0323670 to Honeyfield et al. (Honeyfield) in view of US 20190015570 to Muller (Muller) as applied to claims 1 and 11 further in view of US 2007/0021768 to Nance et al. (Nance).
In reference to at least claim 3
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member (e.g. cover 1300, 4300 and constraining member 1400, 4400 taper towards a proximal end, Figs. 1-7). However, Honeyfield does not explicitly teach the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member.
Nance, in the analogous art of percutaneous delivery access, discloses a jacket 200 “enveloper member that includes an enveloper wall” configured to receive a deployment portion of the percutaneous medical device (e.g. percutaneous access sheath 100 is received in jacket 200, Fig. 3), therein, the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member (e.g. jacket 200 contains a distally tapering section 208 and 212, Figs. 2,2A, para. [0074]), and the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member (e.g. jacket 200 contains a proximally tapering section near proximal end 202, Figs. 2, 2A). Nance discloses that the device provides improved access technology, which allows a device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments (e.g. para. [0012]) and improves protection of the surrounding tissue from damage (e.g. para. [0078]).
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 system of Honeyfield modified by Muller to include along with the proximally tapered portion of the enveloper member a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member, as taught by Nance, in order to allow the device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments and improve protection of the surrounding tissue from damage (e.g.’768, para. [0012], [0078]).
In reference to at least claim 13
Honeyfield modified by Muller renders obvious a system according to claim 11. Honeyfield further discloses the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member (e.g. cover 1300, 4300 and constraining member 1400, 4400 taper towards a proximal end, Figs. 1-7). However, Honeyfield does not explicitly teach the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member.
Nance, in the analogous art of percutaneous delivery access, discloses a jacket 200 “enveloper member that includes an enveloper wall” configured to receive a deployment portion of the percutaneous medical device (e.g. percutaneous access sheath 100 is received in jacket 200, Fig. 3), therein, the enveloper member having a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member (e.g. jacket 200 contains a distally tapering section 208 and 212, Figs. 2,2A, para. [0074]), and the enveloper member having a proximally tapered portion progressively decreasing in diameter in a proximal direction to a proximal end of the enveloper member (e.g. jacket 200 contains a proximally tapering section near proximal end 202, Figs. 2, 2A). Nance discloses that the device provides improved access technology, which allows a device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments (e.g. para. [0012]) and improves protection of the surrounding tissue from damage (e.g. para. [0078]).
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 system of Honeyfield modified by Muller to include along with the proximally tapered portion of the enveloper member a distally tapered portion progressively decreasing in diameter in a distal direction to a distal end of the enveloper member, as taught by Nance, in order to allow the device to be percutaneously passed through a small diameter tissue tract, while accommodating the introduction of relatively large diameter instruments and improve protection of the surrounding tissue from damage (e.g.’768, para. [0012], [0078]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0323670 to Honeyfield et al. (Honeyfield) in view of US 20190015570 to Muller (Muller) as applied to claims 1 further in view of US 2003/0181942 to Sutton et al. (Sutton).
In reference to at least claim 4
Honeyfield modified by Muller renders obvious a system according to claim 1. Honeyfield further discloses that the tether may be formed from a separate material that is subsequently coupled to an end of the cover (e.g. para. [0079]) but does not explicitly teach the tether assembly including a collar to connect the tether assembly to the enveloper member at the proximal end of the enveloper member.
Sutton teaches an atrial appendage blood filtration system which discloses a percutaneous delivery of blood filtration devices (e.g. abstract, claim 58) and the use of a tether assembly that includes a tether wire that is attached to a wire frame of an implant device (e.g. para. [0010]) in which portions of the tether wire attached to the implant have a reduced diameter to reduce coupling stiffness of the tether wire (e.g. para. [0016]). The tether assembly includes portions that are encase in a flexible material such as a flex coil whose diameter is selected to fit inside the implant sheath and an end that terminates in a fixture 430 such as a threaded screw for attaching to an implant device (e.g. Fig. 3a, 4a, para. [0083]-[0084], [0095]).
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 system of Honeyfield modified by Muller to include the tether assembly having portions that are encased in a flexible material such as a flex coil and an end that terminates in a fixture such as a threaded screw which together form a “collar” for coupling the tether assembly to the enveloper member, as taught by Sutton, to provide a coupling connection that reduces the coupling stiffness of the tether to the enveloper member allowing the enveloper member with tether to be detached or release from the medical device without significant recoil (e.g. ‘942, para. [0016], [0090]).
Claim(s) 8-9 and is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No 8,641,752 to Holm (Holm) in view of US 20190015570 to Muller (Muller) as applied to claim 1 further in view of US Patent No. 6,190,357 to Ferrari et al. (Ferrari).
In reference to at least claims 8-9
Holm modified by Muller renders obvious a system according to claim 1. Muller further discloses the expandable cannula including a mesh and forming a conduit through the cannula (e.g. 202). However, Holm modified by Muller does not explicitly teach the mesh being a braided mesh coated with a polymer membrane to form a conduit through the cannula.
Ferrari, in the analogous art of devices using percutaneous delivery access, discloses an expandable cannula with a braided sheath (e.g. 37, Figs 9A-9C) that includes a braided mesh (e.g. “An alternative embodiment of the expandable braided mesh cannula can be seen with reference to FIGS. 9(b-c). The cannula 42 is introduced into the target vessel via a percutaneous incision or a direct cut-down procedure as explained in detail below. In order to facilitate the insertion of the cannula and prevent trauma to the interior of the vessel, the cannula is contracted by axially stretching the braided mesh sheath 37..”, Col. 11, l. 45-Col. 12, l. 7) coated with a polymer membrane to form a conduit through the cannula (e.g. “The sheath 37 may be coated with an impermeable, flexible membrane such as silicone or polyurethane.”, Col. 12, ll. 1-7).
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 system of Holm modified by Muller to include the mesh being a braided mesh coated with a polymer membrane to form a conduit through the cannula, as taught by Ferrari, in order to provide a material that has some resilience and is well suited for various sized vessel lumens to fit a variety of patients and applications (‘357, Col. 8, ll. 54-57).
Claim(s) 8-9 and is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0323670 to Honeyfield et al. (Honeyfield) in view of US 20190015570 to Muller (Muller) as applied to claim 1 further in view of US Patent No. 6,190,357 to Ferrari et al. (Ferrari).
In reference to at least claims 8-9
Honeyfield modified by Muller renders obvious a system according to claim 1. Muller further discloses the expandable cannula including a mesh and forming a conduit through the cannula (e.g. 202). However, Honeyfield modified by Muller does not explicitly teach the mesh being a braided mesh coated with a polymer membrane to form a conduit through the cannula.
Ferrari, in the analogous art of devices using percutaneous delivery access, discloses an expandable cannula with a braided sheath (e.g. 37, Figs 9A-9C) that includes a braided mesh (e.g. “An alternative embodiment of the expandable braided mesh cannula can be seen with reference to FIGS. 9(b-c). The cannula 42 is introduced into the target vessel via a percutaneous incision or a direct cut-down procedure as explained in detail below. In order to facilitate the insertion of the cannula and prevent trauma to the interior of the vessel, the cannula is contracted by axially stretching the braided mesh sheath 37..”, Col. 11, l. 45-Col. 12, l. 7) coated with a polymer membrane to form a conduit through the cannula (e.g. “The sheath 37 may be coated with an impermeable, flexible membrane such as silicone or polyurethane.”, Col. 12, ll. 1-7).
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 system of Honeyfield modified by Muller to include the mesh being a braided mesh coated with a polymer membrane to form a conduit through the cannula, as taught by Ferrari, in order to provide a material that has some resilience and is well suited for various sized vessel lumens to fit a variety of patients and applications (‘357, Col. 8, ll. 54-57).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2015/0250630 to Irwin et al. which teaches an implantable medical device constraint and deployment apparatus. US 2023/0248960 to Liu et al. which teaches a constraint delivery.
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