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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/01/2025, 11/11/2025, and 12/03/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 01/14/2025 been entered. Claims 1, 16, and 26 have been amended; claims 6, 8-10, 18, and 30 have been cancelled. Accordingly, claims 1-5, 7, 11-17, 19-29, and 31-35 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed on 09/11/2025, with respect to the rejection(s) of claim(s) 1, 16, and 26 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nitzan et al. US 2018/0250456 A1 (previously cited), as cited in the IDS, in view of Levit US 2020/0100792 A1 (newly cited) and Inderbitzen et al. US 5,792,300 A (previously cited).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 11-13, 16-17, 19-29, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al. US 2018/0250456 A1 (previously cited, hereinafter Nitzan), as cited in the IDS, in view of Levit US 2020/0100792 A1 (newly cited, hereinafter Levit) and Inderbitzen et al. US 5,792,300 A (previously cited, hereinafter Inderbitzen).
Regarding claim 1, Nitzan discloses a catheter 701 (Fig. 33 – catheter system 701) comprising:
a catheter body 727+735 (Fig. 33 – indwelling catheter 727 + proximal assembly 735, and Fig. 34 – “proximal assembly tube”); and
a restrictor 739 (Fig. 33-34 – balloon 739) operably coupled to the catheter body 727+735 (Fig. 34 and Par. 159 – “the system 701 preferably further includes a proximal assembly 735 including a sheath 723 and a proximal balloon 739”), wherein the restrictor 739 (Fig. 33-34) comprises a retracted and a deployed configuration (Par. 219 – “For example, the catheter can… inflate/deflate the balloon”), wherein an exterior surface of the restrictor 739 (Fig. 38 – balloon 739 has an exterior surface) comprises a compliant membrane (Par. 212 – “the catheter can include a compliant balloon”);
the restrictor 739 (Fig. 34) is configured to control a predetermined amount of the fluid flow through (Par. 180 – “The catheter also includes a second selectively deployable restriction member (e.g., in the form of a proximal balloon) proximal to the first restriction member. The second restriction member is operatively coupled to a flow regulation component configured to direct a controlled volume of fluid from an upstream side of the second restriction member to a downstream side of the second restriction member”) such that the restrictor 739 (Fig. 33), in the deployed configuration (Fig. 46), creates a region of reduced pressure (Fig. 46 – “low pressure zone”) in the blood vessel (Fig. 46 – jugular vein) downstream of the restrictor 739 (Fig. 46 – the catheter system 701 with the balloon 739/second restriction member creates a low pressure zone downstream of said balloon) and a region of relatively higher pressure in the blood vessel upstream of the restrictor 739 (Fig. 46 – higher pressure region is to the left of balloon 739, and Par. 181).
However, Nitzan does not disclose a compliant membrane comprising at least one biaxial stretch region configured to be relatively compliant in a circumferential direction; and at least one longitudinal stretch resistant region configured for relative stiffness in an axial direction; wherein, when the restrictor is in a deployed configuration, a percentage of axial stretch of the biaxial stretch region comprises a range of 20% to 20% inclusive greater than the percentage of axial stretch of the longitudinal stretch resistant region, wherein the longitudinal stretch resistant region is integral to the membrane and comprises a region of concavity unconnected to the catheter body that is configured to define at least one flow path along the exterior surface of the restrictor between the exterior surface of the restrictor and a wall of a blood vessel when the restrictor is in a deployed configuration inside the blood vessel such that the restrictor is configured to direct fluid through the blood vessel past the restrictor via the at least one flow path, and fluid flow through the flow path.
Levit, in the same field of endeavor of ballon catheter device (Title), teaches a compliant membrane 102 (Fig. 5D – inflatable balloon 102) comprising at least one biaxial stretch region (see annotated Fig. 11A below) configured to be relatively compliant in a circumferential direction (see annotated Fig. 11A below – the biaxial stretch region presents a radially elastic region); and
at least one longitudinal stretch resistant region 505a (Fig. 4C and Fig. 5D – first longitudinal bond 505a) configured for relative stiffness in an axial direction (Fig. 5D and Par. 63 – “FIG. 4B shows the balloon 102 after a first length of the inflatable balloon 102 has been fixedly attached to the catheter shaft 101 along a longitudinal axis of the catheter 101 to form a first longitudinal bond 505a extending thereon and generate a balloon having a heart-shaped cross-section about the catheter with balloon chambers 303a and 303b”; the balloon 102 cannot stretch longitudinally as it is bonded via bond 505a, as seen in Fig. 7A-7B);
wherein, when the restrictor 102 (Fig. 11A) is in a deployed configuration (Fig. 11A), a percentage of axial stretch of the biaxial stretch region (see annotated Fig. 4C below) comprises a range of 20% to 200% (Fig. 11A and Par. 59 – “In some embodiments, the balloon may be fully inflated such that its outer circumference contacts the aorta wall, heretofore defined as 100% inflation. In some embodiments, the balloon may be inflated to 90%, 80%, 70%, 60%, 50%, 40%, or 30% of full inflation. The balloon may alternatively or in combination be inflated within a range from about 99.9% to about 10%, within a range from about 80% to about 20%, or within a range from about 70% to about 30%”) inclusive greater than the percentage of axial stretch of the longitudinal stretch resistant region 505a (Fig. 6D),
wherein the longitudinal stretch resistant region is integral to the membrane 102 (Fig. 4C and Par. 63 – “a first length of the inflatable balloon 102 has been fixedly attached to the catheter shaft 101 along a longitudinal axis of the catheter 101 to form a first longitudinal bond 505a“) and comprises a region of concavity (see annotated Fig. 11A below) that is configured to define at least one flow path (see annotated Fig. 11A below) along the exterior surface of the restrictor 102 (Fig. 11A) between the exterior surface of the restrictor 102 (Fig. 11A) and a wall of a blood vessel 2850 (Fig. 11A – aorta 2850, and Par. 82 – “…allow blood flow through the gaps between the balloon chambers 303a, 303b”) when the restrictor is in a deployed configuration inside the blood vessel 2850 (Fig. 11A) such that the restrictor 102 (Fig. 11A) is configured to direct fluid through the blood vessel past the restrictor via the at least one flow path, and fluid flow through the flow path (Par. 82 – “the balloon chambers 303a, 303b may not completely occlude the aorta 2850 and may allow blood flow through the gaps between the balloon chambers 303a, 303b and the catheter 101”).
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Annotated Fig. 11A of Levit
Inderbitzen, in the same field of endeavor of catheter including a balloon (Abstract), teaches wherein the longitudinal stretch resistant region 62 (Fig. 3 – portion 62, Col. 3, line 51-52 – “Another portion 62 of balloon 12 is made from a non-compliant material and traverses the length of balloon 12”, and Col. 3, line 53-55 – “Portion 62 remains in a substantially fixed position with respect to tubular shaft 14, and does not radially extend away from tubular shaft 14 to a great extent”; thus the longitudinal length where portion 62 exists will not exhibit any elastic deformation) comprises a region of concavity 48 (Fig. 3 – longitudinally extending channel 48) unconnected to the catheter body 14 (Fig. 3 – tubular shaft 14; channel 48 is not connected to tubular shaft 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the balloon mechanism of Nitzan that allows the device to engage with the vessel wall and control a blood flow within the vessel, for the balloon mechanism of Levit, since these mechanisms perform the same function of regulating blood flow within the vessel wall. Simply substituting one restricting balloon means for another would yield the predicable result of regulating blood flow within a blood vessel. See MPEP 2143.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nitzan in view of Levit to have the longitudinal stretch resistant region to be unconnected to the catheter body as taught by Inderbitzen, since The Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 2, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 1. The combination further discloses wherein the flow path (see annotated Fig. 11A of Levit above) comprises at least two inflection points (see annotated Fig. 10A of Levit below – annotated inflection points) formed by the exterior surface 102 of the restrictor 102 (Fig. 10B of Levit).
Examiner notes that once the modification is made as discussed in claim 1, the restrictor of Nitzen will be replaced by the balloon of Levit, including the inflection points in the balloon of Levit. Thus, the limitation is met.
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Annotated Fig. 10B of Levit
Regarding claim 3, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 2. The combination further discloses wherein each of the inflection points (see annotated Fig. 10B of Levit above) defines a transition region (see annotated Fig. 10B of Levit above – inflection points are on the transition region) between a convex surface (see annotated Fig. 10B of Levit above) to a concave surface (see annotated Fig. 10B of Levit above).
Examiner notes that once the modification is made as discussed in claim 1, the restrictor of Nitzen will be replaced by the balloon of Levit, including the transition region of Levit. Thus, the limitation is met.
Regarding claim 4, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 2. The combination further discloses wherein each of the inflection points (see annotated Fig. 10B of Levit above) are defined by a change in curvature around a circumference of the exterior surface 102 (see annotated Fig. 10B of Levit above – inflection points intercept the curvature of the convex surface and the concave surface) of the restrictor 102 (Fig. 10B of Levit).
Examiner notes that once the modification is made as discussed in claim 1, the restrictor of Nitzen will be replaced by the balloon of Levit, including the change in curvature of balloon’s exterior surface of Levit. Thus, the limitation is met.
Regarding claim 5, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 1. The combination further discloses wherein the at least one flow path (see annotated Fig. 10B of Levit above) is disposed between two inflection points (see annotated Fig. 10B of Levit above) defining a concave surface (see annotated Fig. 10B of Levit above – between two annotated inflection points is a flow path, and Par. 82 of Levit – “the balloon chambers 303a, 303b may not completely occlude the aorta 2850 and may allow blood flow through the gaps between the balloon chambers 303a, 303b and the catheter 101”) for promoting fluid flow (Par. 82 of Levit).
Examiner notes that once the modification is made as discussed in claim 1, the restrictor of Nitzen will be replaced by the balloon of Levit, including the flow path between two inflection points of Levit. Thus, the limitation is met.
Regarding claim 7, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 1. The combination further discloses herein the restrictor 102 (Fig. 10B of Levit) is configured to form a plurality of flow paths (see annotated Fig. 10B of Levit above – two flow paths are formed) when the restrictor 102 (Fig. 10B of Levit) is deployed inside the blood vessel (Fig. 11A of Levit).
Examiner notes that once the modification is made as discussed in claim 1, the restrictor of Nitzen will be replaced by the balloon of Levit, including the number of flow paths formed by the vessel wall and the balloon of Levit. Thus, the limitation is met.
Regarding claim 11, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 1. The combination further discloses a pump 711 (Fig. 35 of Nitzan – impeller assembly 711) connected to a distal end 722 (Fig. 35 of Nitzan – distal portion 722) of the catheter body 727+735 (Fig. 33 of Nitzan – impeller assembly 711 fluidly connects with the indwelling catheter 727 and proximal assembly tube 735).
Regarding claim 12, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 11. The combination further discloses wherein the pump 711 (Fig. 40 of Nitzan) comprises an impeller 712 (Fig. 40 of Nitzan – impeller 712) rotatably disposed within an impeller assembly 711 (Fig. 35 and Fig. 40 of Nitzan, and Par. 185 of Nitzan – “The impeller may include more than one (e.g., 2-4, or greater than 4) blades. The rotation speed…”).
Regarding claim 13, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 12. The combination further discloses wherein the impeller assembly 711 (Fig. 35 of Nitzan) comprises an inlet and an outlet (see annotated Fig. 35 of Nitzan below) and, when the impeller 712 (Fig. 35 of Nitzan) is actuated (Par. 199 of Nitzan – “The motor can drive the impeller”), the impeller 712 (Fig. 35 of Nitzan) pumps fluid through the impeller assembly 711 (Fig. 35 of Nitzan, and Par. 199 of Nitzan – “The motor can drive the impeller to induce the low pressure zone by causing fluid to be pumped through the catheter”) via the inlet and the outlet (see annotated Fig. 35 of Nitzan below – the arrows shows flow direction of fluid, entering the annotated inlet and exiting the annotated outlet).
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Annotated Fig. 35 of Nitzan
Regarding claim 16, Nitzan discloses a method for treating edema (Par. 94 – systems and methods to reduce edema conditions, Fig. 46 and Par. 178 – “a method for treating edema”), the method comprising:
inserting a catheter 701 (Fig. 33 - catheter system 701) comprising a restrictor 739 (Fig. 33-34 – balloon) into a blood vessel (Fig. 46 illustrates the catheter system 701 in use, and Par. 180 – “an indwelling catheter configured for placement within a vein of a patient” and “The catheter also includes a second selectively deployable restriction member”), the restrictor 739 (Fig. 33-34) comprising a retracted configuration and a deployed configuration (Par. 180 – “deployable restriction member”, thus indicating a deployed and undeployed state), wherein an exterior surface of the restrictor 739 (Fig. 38 – balloon 739 has an exterior surface) comprises a compliant membrane (Par. 212 – “the catheter can include a compliant balloon”);
the restrictor is configured to control a predetermined amount of the fluid flow through (Par. 180 – “The catheter also includes a second selectively deployable restriction member (e.g., in the form of a proximal balloon) proximal to the first restriction member. The second restriction member is operatively coupled to a flow regulation component configured to direct a controlled volume of fluid from an upstream side of the second restriction member to a downstream side of the second restriction member”); and
deploying the restrictor 739 (Fig. 46 shows a deployed configuration of balloon 739) inside the blood vessel (Fig. 46 – balloon 739 is deployed inside a vein), wherein deploying the restrictor 739 (Fig. 46) controls the flow past the restrictor 739 (Fig. 46, and Par. 180 – “The second restriction member is operatively coupled to a flow regulation component configured to direct a controlled volume of fluid from an upstream side of the second restriction member to a downstream side of the second restriction member”) to create a region of reduced pressure (Fig. 46 – “low pressure zone”) in the blood vessel (Fig. 46 – jugular vein) downstream of the restrictor 739 (Fig. 46 – the catheter system 701 with the balloon 739/second restriction member creates a low pressure zone downstream of said balloon) and a region of relatively higher pressure in the blood vessel upstream of the restrictor 739 (Fig. 46 – higher pressure region is to the left of balloon 739, and Par. 181).
However, Nitzan does not disclose a compliant membrane comprising at least one biaxial stretch region configured to be relatively compliant in a circumferential direction; and at least one longitudinal stretch resistant region configured for relative stiffness in an axial direction, wherein, when the restrictor is in a deployed configuration, a percentage of axial stretch of the biaxial stretch region comprises a range of 20% to 200% inclusive greater than the percentage of axial stretch of the longitudinal stretch resistant region, wherein the longitudinal stretch resistant region is integral to the membrane and comprises a region of concavity unconnected to the catheter body that is configured to define at least one flow path along the exterior surface of the restrictor between the exterior surface of the restrictor and a wall of a blood vessel when the restrictor is in a deployed configuration inside the blood vessel such that the restrictor is configured to direct fluid through the blood vessel past the restrictor via the at least one flow path, and fluid flow through the flow path.
Levit, in the same field of endeavor of ballon catheter device (Title), teaches a compliant membrane 102 (Fig. 5D – inflatable balloon 102) comprising at least one biaxial stretch region (see annotated Fig. 11A above) configured to be relatively compliant in a circumferential direction (see annotated Fig. 11A below – the biaxial stretch region presents a radially elastic region); and
at least one longitudinal stretch resistant region 505a (Fig. 4C and Fig. 5D – first longitudinal bond 505a) configured for relative stiffness in an axial direction (Fig. 5D and Par. 63 – “FIG. 4B shows the balloon 102 after a first length of the inflatable balloon 102 has been fixedly attached to the catheter shaft 101 along a longitudinal axis of the catheter 101 to form a first longitudinal bond 505a extending thereon and generate a balloon having a heart-shaped cross-section about the catheter with balloon chambers 303a and 303b”; the balloon 102 cannot stretch longitudinally as it is bonded via bond 505a, as seen in Fig. 7A-7B), wherein,
when the restrictor 102 (Fig. 11A) is in a deployed configuration (Fig. 11A), a percentage of axial stretch of the biaxial stretch region (see annotated Fig. 4C above) comprises a range of 20% to 200% (Fig. 11A and Par. 59 – “In some embodiments, the balloon may be fully inflated such that its outer circumference contacts the aorta wall, heretofore defined as 100% inflation. In some embodiments, the balloon may be inflated to 90%, 80%, 70%, 60%, 50%, 40%, or 30% of full inflation. The balloon may alternatively or in combination be inflated within a range from about 99.9% to about 10%, within a range from about 80% to about 20%, or within a range from about 70% to about 30%”) inclusive greater than the percentage of axial stretch of the longitudinal stretch resistant region 505a (Fig. 6D),
wherein the longitudinal stretch resistant region is integral to the membrane 102 (Fig. 4C and Par. 63 – “a first length of the inflatable balloon 102 has been fixedly attached to the catheter shaft 101 along a longitudinal axis of the catheter 101 to form a first longitudinal bond 505a“) and comprises a region of concavity (see annotated Fig. 11A above) that is configured to define at least one flow path (see annotated Fig. 11A above) along the exterior surface of the restrictor 102 (Fig. 11A) between the exterior surface of the restrictor 102 (Fig. 11A) and a wall of a blood vessel 2850 (Fig. 11A – aorta 2850, and Par. 82 – “…allow blood flow through the gaps between the balloon chambers 303a, 303b”) when the restrictor is in a deployed configuration inside the blood vessel 2850 (Fig. 11A) such that the restrictor 102 (Fig. 11A) is configured to direct fluid through the blood vessel past the restrictor via the at least one flow path, and fluid flow through the flow path (Par. 82 – “the balloon chambers 303a, 303b may not completely occlude the aorta 2850 and may allow blood flow through the gaps between the balloon chambers 303a, 303b and the catheter 101”).
Inderbitzen, in the same field of endeavor of catheter including a balloon (Abstract), teaches wherein the longitudinal stretch resistant region 62 (Fig. 3 – portion 62, Col. 3, line 51-52 – “Another portion 62 of balloon 12 is made from a non-compliant material and traverses the length of balloon 12”, and Col. 3, line 53-55 – “Portion 62 remains in a substantially fixed position with respect to tubular shaft 14, and does not radially extend away from tubular shaft 14 to a great extent”; thus the longitudinal length where portion 62 exists will not exhibit any elastic deformation) comprises a region of concavity 48 (Fig. 3 – longitudinally extending channel 48) unconnected to the catheter body 14 (Fig. 3 – tubular shaft 14; channel 48 is not connected to tubular shaft 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the balloon mechanism of Nitzan that allows the device to engage with the vessel wall and control a blood flow within the vessel, for the balloon mechanism of Levit, since these mechanisms perform the same function of regulating blood flow within the vessel wall. Simply substituting one restricting balloon means for another would yield the predicable result of regulating blood flow within a blood vessel. See MPEP 2143.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nitzan in view of Levit to have the longitudinal stretch resistant region to be unconnected to the catheter body as taught by Inderbitzen, since The Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 17, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 16. However, the combination currently does not disclose wherein the restrictor is deployed upstream of a lymphatic duct to reduce pressure in the vicinity of the lymphatic duct and facilitating flow of lymph fluid from the duct and into the blood vessel, thereby alleviating symptoms associated with edema.
Nitzan, in the same field of endeavor of catheter system for reducing pressure of a duct (Abstract) and in another embodiment, teaches wherein the restrictor 719 (Fig. 50 – first restrictor 719) is deployed upstream of a lymphatic duct 831 (Fig. 50 – lymphatic duct 831; the restrictor 719 is placed before a region where lymphatic duct 831 intersects blood vessel 835) to reduce pressure in the vicinity of the lymphatic duct (Par. 94 – for reducing pressure at an outflow of a lymphatic duct) and facilitating flow of lymph fluid from the duct and into the blood vessel (Par. 94 – “enabling the lymphatic vessel flow to be at or near normal levels”), thereby alleviating symptoms associated with edema (Par. 94 – “effective to rapidly alleviate conditions of the edema”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified/arranged the restrictor of Nitzan in view of Inderbitzen to be deployed upstream of a lymphatic duct as taught by Nitzan, in order to lower the pressure at the region around the thoracic/lymphatic duct and in turn increases the lymph flow (Par. 94 of Nitzan). The boosted flow of lymph fluid into the circulatory system will reduce swelling, thereby reducing edema conditions (Par. 94 of Nitzan). Also, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to have modified Nitzan in view of Inderbitzen’s placement of the restrictor, as Nitzen teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 19, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 16. The combination further discloses wherein deploying the restrictor 12 (Fig. 46 of Nitzan shows a deployed configuration, and Fig. 3 of Inderbitzen) inside the blood vessel (Fig. 46 of Nitzan) restricts fluid flow to a predetermined amount of flow through the blood vessel (Par. 180 of Nitzan – “The second restriction member is… configured to direct a controlled volume of fluid from an upstream side of the second restriction member to a downstream side of the second restriction member) via the flow path (see annotated Fig. 11A of Levit above, and Par. 59 – “the balloon may be fully inflated such that its outer circumference contacts the aorta wall, heretofore defined as 100% inflation. In some embodiments, the balloon may be inflated to 90%, 80%, 70%, 60%, 50%, 40%, or 30% of full inflation. The balloon may alternatively or in combination be inflated within a range from about 99.9% to about 10%, within a range from about 80% to about 20%, or within a range from about 70% to about 30%”), thereby controlling cardiac preload (Par. 210 of Nitzan – “the preload to the heart is lowered”, resulting from the partially occluding restrictor).
Regarding claim 20, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 16. The combination further discloses wherein, when the restrictor 102 (Fig. 10B of Levit) is in the deployed state (Fig. 11A of Levit), the exterior surface 102 (see annotated Fig. 10A of Levit above) forms at least two inflection points (see annotated Fig. 10A of Levit below – annotated inflection points) defining a transition region (see annotated Fig. 10B of Levit above – inflection points are on the transition region) from a convex (see annotated Fig. 10B of Levit above) to a concave surface (see annotated Fig. 10B of Levit above).
Examiner notes that once the modification is made as discussed in claim 16, the restrictor of Nitzen will be replaced by the balloon of Levit, including the inflection points, transition region, convex and concave of Levit. Thus, the limitation is met.
Regarding claim 21, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 20. The combination further discloses wherein the flow path (see annotated Fig. 10B of Levit above – two flow paths are formed) is formed between the two inflection points (see annotated Fig. 10B of Levit above), the two inflection points (see annotated Fig. 10B of Levit above) defining a convex surface (see annotated Fig. 10B of Levit above) that facilitates fluid flow (Par. 82 of Levit – “the balloon chambers 303a, 303b may not completely occlude the aorta 2850 and may allow blood flow through the gaps between the balloon chambers 303a, 303b and the catheter 101”).
Examiner notes that once the modification is made as discussed in claim 16, the restrictor of Nitzen will be replaced by the balloon of Levit, including the inflection points and convex surface of Levit. Thus, the limitation is met.
Regarding claim 22, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 16. The combination further discloses wherein deployment of the restrictor 102 (Fig. 10B of Levit) creates a plurality of flow paths (see annotated Fig. 10B of Levit above – two flow paths are formed).
Examiner notes that once the modification is made as discussed in claim 16, the restrictor of Nitzen will be replaced by the balloon of Levit, including the number of flow paths formed by the vessel wall and the balloon of Levit. Thus, the limitation is met.
Regarding claim 23, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 16. The combination further discloses wherein the catheter 701 (Fig. 46 of Nitzan) further comprises a pump 711 (Fig. 35 of Nitzan – impeller assembly 711) operably connected to a distal end 722 (Fig. 35 of Nitzan – distal portion 722) of the catheter 701 (Fig. 35 of Nitzan).
Regarding claim 24, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 23. The combination further discloses further comprising activating the pump 711 (Fig. 35 of Nitzan) to pump fluid from the blood vessel (Par. 199 of Nitzan – “The motor can drive the impeller to induce the low pressure zone by causing fluid to be pumped through the catheter”; Fig. 35 has the arros shows the flow direction of fluid).
Regarding claim 25, Nitzan in view of Levit in view of Inderbitzen discloses the invention of claim 23. The combination further discloses wherein the pump 711 (Fig. 40 of Nitzan) comprises an impeller 712 (Fig. 40 of Nitzan – impeller 712) housed within an impeller assembly 711 (Fig. 40 of Nitzan – impeller assembly 711) that is connected to the distal end 722 (Fig. 35 of Nitzan) of the catheter 701 (Fig. 35 of Nitzan).
Regarding claim 26, Nitzan discloses a catheter system 701 (Fig. 33 – catheter system 701) comprising:
a sheath 723 (Fig. 33-34 = sheath 732);
a catheter 727+735 (Fig. 33 – indwelling catheter 727+proximal assembly 735, and Fig. 34 – “proximal assembly tube”) disposed within the sheath 732 (Fig. 33-34); and
a restrictor 739 (Fig. 33-34 – balloon 739) mounted onto the catheter 727+735 (Fig. 33-34, and Par. 159 – “the system 701 preferably further includes a proximal assembly 735 including a sheath 723 and a proximal balloon 739), wherein the restrictor 739 (Fig. 33-34) comprises a retracted and a deployed configuration (Par. 219 – “For example, the catheter can… inflate/deflate the balloon”), wherein an exterior surface of the restrictor 739 (Fig. 38 – balloon 739 has an exterior surface) comprises a compliant membrane (Par. 212 – “the catheter can include a compliant balloon”);
the restrictor 739 (Fig. 34) is configured to control a predetermined amount of the fluid flow through (Par. 180 – “The catheter also includes a second selectively deployable restriction member (e.g., in the form of a proximal balloon) proximal to the first restriction member. The second restriction member is operatively coupled to a flow regulation component configured to direct a controlled volume of fluid from an upstream side of the second restriction member to a downstream side of the second restriction member”) such that the restrictor 739 (Fig. 33), in the deployed configuration (Fig. 46), creates a region of reduced pressure (Fig. 46 – “low pressure zone”) in the blood vessel (Fig. 46 – jugular vein) downstream of the restrictor 739 (Fig. 46 – the catheter system 701 with the balloon 739/second restriction member creates a low pressure zone downstream of said balloon) and a region of relatively higher pressure in the blood vessel upstream of the restrictor 739 (Fig. 46 – higher pressure region is to the left of balloon 739, and Par. 181).
However, Nitzan does not disclose a compliant membrane at least one biaxial stretch region configured to be relatively compliant in a circumferential direction; and at least one longitudinal stretch resistant region configured for relative stiffness in an axial direction, wherein, when the restrictor is in a deployed configuration, a percentage of axial stretch of the biaxial stretch region comprises a range of 20% to 200% inclusive greater than the percentage of axial stretch of the longitudinal stretch resistant region, wherein the longitudinal stretch resistant region is integral to the membrane and comprises a region of concavity unconnected to the catheter body that is configured to define at least one flow path along the exterior surface of the restrictor between the exterior surface of the restrictor and a wall of a blood vessel when the restrictor is in a deployed configuration inside the blood vessel such that the restrictor is configured to direct fluid through the blood vessel past the restrictor via the at least one flow path, and fluid flow through the flow path.
Levit, in the same field of endeavor of ballon catheter device (Title), teaches a compliant membrane 102 (Fig. 5D – inflatable balloon 102) comprising at least one biaxial stretch region (see annotated Fig. 11A above) configured to be relatively compliant in a circumferential direction (see annotated Fig. 11A below – the biaxial stretch region presents a radially elastic region); and
at least one longitudinal stretch resistant region 505a (Fig. 4C and Fig. 5D – first longitudinal bond 505a) configured for relative stiffness in an axial direction (Fig. 5D and Par. 63 – “FIG. 4B shows the balloon 102 after a first length of the inflatable balloon 102 has been fixedly attached to the catheter shaft 101 along a longitudinal axis of the catheter 101 to form a first longitudinal bond 505a extending thereon and generate a balloon having a heart-shaped cross-section about the catheter with balloon chambers 303a and 303b”; the balloon 102 cannot stretch longitudinally as it is bonded via bond 505a, as seen in Fig. 7A-7B), wherein,
when the restrictor 102 (Fig. 11A) is in a deployed configuration (Fig. 11A), a percentage of axial stretch of the biaxial stretch region (see annotated Fig. 4C above) comprises a range of 20% to 200% (Fig. 11A and Par. 59 – “In some embodiments, the balloon may be fully inflated such that its outer circumference contacts the aorta wall, heretofore defined as 100% inflation. In some embodiments, the balloon may be inflated to 90%, 80%, 70%, 60%, 50%, 40%, or 30% of full inflation. The balloon may alternatively or in combination be inflated within a range from about 99.9% to about 10%, within a range from about 80% to about 20%, or within a range from about 70% to about 30%”) inclusive greater than the percentage of axial stretch of the longitudinal stretch resistant region 505a (Fig. 6D),
wherein the longitudinal stretch resistant region is integral to the membrane 102 (Fig. 4C and Par. 63 – “a first length of the inflatable balloon 102 has been fixedly attached to the catheter shaft 101 along a longitudinal axis of the catheter 101 to form a first longitudinal bond 505a“) and comprises a region of concavity (see annotated Fig. 11A above) that is configured to define at least one flow path (see annotated Fig. 11A above) along the exterior surface of the restrictor 102 (Fig. 11A) between the exterior surface of the restrictor 102 (Fig. 11A) and a wall of a blood vessel 2850 (Fig. 11A – aorta 2850, and Par. 82 – “…allow blood flow through the gaps between the balloon chambers 303a, 303b”) when the restrictor is in a deployed configuration inside the blood vessel 2850 (Fig. 11A) such that the restrictor 102 (Fig. 11A) is configured to direct fluid through the blood vessel past the restrictor via the at least one flow path, and fluid flow through the flow path (Par. 82 – “the balloon chambers 303a, 303b may not completely occlude the aorta 2850 and may allow blood flow through the gaps between the balloon chambers 303a, 303b and the catheter 101”).
Inderbitzen, in the same field of endeavor of catheter including a balloon (Abstract), teaches wherein the longitudinal stretch resistant region 62 (Fig. 3 – portion 62, Col. 3, line 51-52 – “Another portion 62 of balloon 12 is made from a non-compliant material and traverses the length of balloon 12”, and Col. 3, line 53-55 – “Portion 62 remains in a substantially fixed position with respect to tubular shaft 14, and does not radially extend away from tubular shaft 14 to a great extent”; thus the longitudinal length where portion 62 exists will not exhibit any elastic deformation) comprises a region of concavity 48 (Fig. 3 – longitudinally extending channel 48) unconnected to the catheter body 14 (Fig. 3 – tubular shaft 14; channel 48 is not connected to tubular shaft 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the balloon mechanism of Nitzan that allows the device to engage with the vessel wall and control a blood flow within the vessel, for the balloon mechanism of Levit, since these mechanisms perform the same function of regulating blood flow within the vessel wall. Simply substituting one restricting balloon means for another would yield the predicable result of regulating blood flow within a blood vessel. See MPEP 2143.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nitzan in view of Levit to have the longitudinal stretch resistant region to be unconnected to the catheter body as taught by Inderbitzen, since The Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 27, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. The combination further discloses wherein the flow path (see annotated Fig. 11A of Levit above) comprises at least two inflection points (see annotated Fig. 10A of Levit below – annotated inflection points) formed by the exterior surface 102 of the restrictor 102 (Fig. 10B of Levit).
Examiner notes that once the modification is made as discussed in claim 26, the restrictor of Nitzen will be replaced by the balloon of Levit, including the inflection points in the balloon of Levit. Thus, the limitation is met.
Regarding claim 28, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. The combination further discloses wherein each of the inflection points (see annotated Fig. 10B of Levit above) defines a transition region (see annotated Fig. 10B of Levit above – inflection points are on the transition region) between a convex (see annotated Fig. 10B of Levit above) to a concave surface (see annotated Fig. 10B of Levit above).
Examiner notes that once the modification is made as discussed in claim 26, the restrictor of Nitzen will be replaced by the balloon of Levit, including the transition region of Levit. Thus, the limitation is met.
Regarding claim 29, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. The combination further discloses wherein the at least one flow path (see annotated Fig. 10B of Levit above) is disposed between two inflection points (see annotated Fig. 10B of Levit above) that define a concave surface (see annotated Fig. 10B of Levit above – between two annotated inflection points is a flow path, and Par. 82 of Levit – “the balloon chambers 303a, 303b may not completely occlude the aorta 2850 and may allow blood flow through the gaps between the balloon chambers 303a, 303b and the catheter 101”) for promoting fluid flow (Par. 82 of Levit).
Examiner notes that once the modification is made as discussed in claim 26, the restrictor of Nitzen will be replaced by the balloon of Levit, including the flow path between two inflection points of Levit. Thus, the limitation is met.
Regarding claim 31, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. The combination further discloses herein the restrictor 102 (Fig. 10B of Levit) comprises a plurality of flow paths (see annotated Fig. 10B of Levit above – two flow paths are formed).
Examiner notes that once the modification is made as discussed in claim 26, the restrictor of Nitzen will be replaced by the balloon of Levit, including the number of flow paths formed by the vessel wall and the balloon of Levit. Thus, the limitation is met.
Regarding claim 32, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. However, the combination currently does not disclose wherein the restrictor is located on the sheath.
Nitzan, in another embodiment, teaches wherein the restrictor 22 (Fig. 13 – restrictor 22) is located on the sheath 28 (Fig. 13 – membrane 28; restrictor 22 wraps around the membrane 28).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter system of the combination to rearrange a sheath onto which a restrictor is mounted as taught by Nitzan, in order to facilitate advancement of the catheter to a location where the catheter is to be released from the sheath (Par. 143 of Nitzan), thereby delivering the restrictor to the desired location. Furthermore, having the sheath as taught by Nitzan can further allow housing other internal structures or provide a lumen to allow passage of internal structures, i.e. a guide wire (Par. 143 of Nitzan). With the sheath 28 of Nitzan, fluid can also be transported from a proximal end of a restrictor to a distal end of said restrictor (Par. 136 of Nitzan). Also, it would be obvious to a person having ordinary skill in the art before the effective filing date of the invention to have modified the combination’s placement of the restrictor, as Nitzan teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 33, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. The combination further discloses further comprising a second restrictor 719 (Fig. 34 of Nitzan – first restrictor 719), the second restrictor 179 mounted onto the catheter 727+735 (Fig. 33-34 of Nitzan) .
Regarding claim 34, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 33. The combination further discloses wherein the second restrictor 719 (Fig. 36 of Nitzan) does not comprise a fluid flow path (Fig. 36 of Nitzan – no grooves/concavity for fluid flow).
Regarding claim 35, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 26. However, the combination currently does not disclose wherein at least one of the catheter or the sheath comprises a pressure sensor.
Nitzan, in another embodiment, teaches the sheath 30 (Fig. 10) comprises a pressure sensor (Fig. 10 and Par. 146 – lumen 36, which is one of the ports of sheath 30, “includes one or more pressure sensors”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath of the combination to further include a pressure sensor as taught by Nitzan, in order to sense pressure at various locations along the vein in which the catheter is implanted, such as between the proximal and distal restrictors (Par. 146 of Nitzan). It is also known in the art for one of ordinary skill in the art to include pressure sensors in catheters for constant monitor of the environment within the vessel.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan in view of Levit in view of Inderbitzen as applied to claim 11 above, and further in view of Flores US 2019/0365973 A1 (previously cited, hereinafter Flores).
Regarding claim 14, Nitzan in view of Levit in view of Inderbitzen suggests the invention of claim 11. However, the combination does not disclose wherein the pump is external to the catheter and is connected to the distal end of the catheter body via a lumen extending through the catheter.
Flores, in the same field of endeavor of catheter pump (Title), teaches wherein the pump 100 (Fig. 1A – pump 100) is external to the catheter 102 (Fig. 1A, Fig. 2C, and Par. 35 – sheath 102; pump 100 comprising impeller housing 104 is external to sheath 102; “…a second state, wherein the impeller housing is external to the sheath…”) and is connected to the distal end of the catheter body 102 (Fig. 1A, and Fig. 2A-2B) via a lumen 116 (Fig. 1A and Fig. 2A – drive cable 116) extending through the catheter 102 (Fig. 1A and Fig. 2A – drive cable 116 traverses through the length of sheath 102 and into the pump 100/impeller housing 104).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump of the combination to have it connected externally to the catheter via a lumen as taught by Flores, in order to create an expandable impeller or axially displaceable blood pump (Par. 17 and Par. 20 of Flores), which will generate sufficient blood flow (Par. 17 of Flores).
Regarding claim 15, Nitzan in view of Levit in view of Inderbitzen in view of Flores suggests the invention of claim 11. The combination further discloses wherein the catheter 701 (Fig. 33 of Nitzan) is configured to actuate the pump 100 (Fig. 2A-2C of Flores demonstrates the pump configuration upon actuation) to suck fluid from the blood vessel to a reservoir outside the catheter body when the catheter 701 (Fig. 35 of Nitzan) is inserted into a blood vessel (Fig. 46 of Nitzan).
However, the combination does not disclose to suck fluid from the blood vessel to a reservoir outside the catheter body when the catheter is inserted into a blood vessel.
Flores, in the same field of endeavor of catheter pump (Title), teaches pump 100 (Fig. 1A) to suck fluid from the blood vessel to a reservoir 676 (Fig. 4B – waste fluid receiver 676, Par. 97 – “catheter blood pump 100… for insertion into… a patient’s vascular system”, and Par. 119 – “waste fluids are withdrawn from drive cable 116”, which is a part of pump 100, and “flows to the waste fluid receiver(s)”) outside the catheter body 102 (Fig. 4A-4B – waste fluid receiver 676 is external to sheath 102).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump of the combination to have it withdraw fluid out of the catheter as taught by Flores, in order to allow other flush fluid/lubricants to enter the catheter (Par. 95 of Flores) and regularly rinse the surgical environment. The ability of the combined pump to suck fluid to an outside reservoir permits a sterile and unobstructed working site for the operators.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781