Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Claim 6 recites that the “fluid tube” has an “annular” circular cross section. Figure 3 shows the fluid tube (36) being cut in half. The diameter in the horizontal direction appears to be larger than the diameter in the vertical direction, meaning that this is an oval shape, not a ring or annulus. Based on this, the limitation(s) will be interpreted as including annular and include other rounded shapes as well. Additionally, there was no motivation/criticality found for this shape choice.
Claim 7 recites that the “fluid tube” has an “annular” circular cross section. Figure 3 shows the fluid tube (36) being cut in half. The diameter in the horizontal direction appears to be larger than the diameter in the vertical direction, meaning that this is an oval shape, not a ring or annulus. Based on this, the limitation(s) will be interpreted as including annular and include other rounded shapes as well. Additionally, there was no motivation/criticality found for this shape choice.
Response to Amendment
Support for Applicants amendment to Claims 1 and 7 was not found in the written specification. The drawings appear to show this feature in Figure 2.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable Bagaoisan (US20020026145A1) in view of Kennedy (US20070191810A1), further in view of Gianotti (US20130237950A1).
Claim 1
Bagaoisan teaches a method of manufacturing a balloon catheter (Figures 1-3 teach a balloon catheter (10).), the method comprising: providing a fluid tube (Figures 2-3, Item 32/32a), between an inner surface of a catheter tube and an outer surface of the catheter tube (Figures 2 and 3 show this feature.), the catheter tube includes an inner layer (liner, 35) having an inner layer thickness (Figure 2 shows the liner (35) has a thickness.) and an outer layer contacting the inner layer and having an outer layer thickness (Figure 2 shows the outer layer (material in between the inner layer (35) and the exterior of the tube) contacts the inner layer (35).), the outer layer having an outer surface and an inner surface (Figures 2 and 3 show a cross sectional view of the outer layer (area of 16 having the diagonal lines) where it has a thickness and an outer surface and inner surface.) the outer layer having a proximal end and a distal end (Figure 1 shows the tube (16) has a proximal and distal end. Figure 4 shows the distal end in greater detail w), the fluid tube defined within the outer layer to form a fluid lumen therein extending along a longitudinal direction of the catheter tube (Figure 2 shows the fluid tube (32a) is a lumen extending along the longitudinal direction of the tube. Figure 1 shows the assembly has a port (18) that provides fluid to the balloon through the lumen (32)(See ¶0098). For this to function, the lumen (32/32a) must extend from the port to the balloon (26), which is along the longitudinal direction of the tube (16).), the fluid tube having a distal end terminating within the outer layer (¶0098 discusses two alternatives for termination of the fluid lumen. The first alternative is that the fluid lumen (32) extends to a fill hole that extends through the tubular body (16).) and between the outer surface and the inner surface of the outer layer (Figure 2 shows the fluid lumen (32a) is located between the outer surface and inner surface of the outer layer. Since ¶0098 discloses that the fill hole extends through the tubular body, Bagaoisan teaches that the fluid lumen terminates at a fill hole that is cut through the material of the analogous outer layer and the lumen tube.), the distal end of the fluid tube being spaced apart from the distal end of the outer layer (¶0098 teaches that the fill hole is located within the balloon. Figure 4 shows the tube (16), which comprises the outer layer, extends past the area where the fluid lumen (32) ends within the balloon (26). Therefore, the distal end of the tube (16) is located more distal than the end of the fluid lumen tube.); creating a hole in the catheter tube that allows fluid communication between the fluid lumen to a balloon external to the outer surface of the catheter tube (Figure 1 teaches a balloon (26) that is external to the outer surface of the tube (16). ¶0098 teaches that there is a fill hole that extends through the tubular body (16) to allow fluid communication of the lumen (32) with the balloon.); the outer layer including a distal portion (part of portion “B”) and a proximal portion (A), the distal portion located more toward a distal end of the catheter tube than the proximal portion (Figure 1 shows the distal portion (part of portion “B”) is located more towards the distal end (14) than the proximal portion (A).), the distal portion having a first rigidity and the proximal portion having a second rigidity greater than the first rigidity (¶0012 teaches that the tubular body is formed of materials with greater stiffness at the proximal end, and that it has a more flexible distal end.).
Bagaoisan does not disclose shearing a portion of the catheter tube and the fluid tube to create a hole in the catheter tube, the shearing is performed in a direction lateral to the longitudinal direction of the catheter tube,
However, Kennedy teaches a multi-lumen catheter in Figure 1D, where a side port (182) is created to communicate the interior of one of the lumens (184) with the exterior of the overall tubing. ¶0012 teaches this method includes passing a cutter across the catheter surface transverse to the catheter’s longitudinal axis.
One of ordinary skill would have been motivated to apply the well-known transverse skiving technique of Kennedy to the skived opening formation method in Tanaka in order to use a common practice in the art to cut across the outer sheath and create the desired hole. This practice is shown in Kennedy Figure 1D and described in ¶0012 as allowing access to one lumen while not interrupting the other (See Figure 1D).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the well-known transverse skiving technique of Kennedy to the skived opening formation method in Tanaka because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is the port in Bagaoisan will be formed via transverse cutting/skiving/shearing.
Bagaoisan in view of Kennedy does not explicitly disclose a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. This feature is shown in Applicant’s Figure 2.
However, Gianotti teaches a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. (Figure 4 teaches a catheter having two lumens, including an inflation lumen (130) that extends parallel to the main lumen. The inflation lumen has a plurality of apertures (601) formed in the material between the inflation lumen and the outer surface of the catheter.)
One of ordinary skill would have been motivated to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Bagaoisan in view of Kennedy in order to provide enhanced inflation and deflation of the expandable member. (See Gianotti, ¶0069)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Bagaoisan in view of Kennedy because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is that the single fill hole in Bagaoisan, formed by Kennedy’s technique, will instead by multiple fill holes formed by Kennedy’s technique.
Claim 2
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 1, wherein the direction of the shearing is such that it does not intersect with the inner surface of the catheter tube. (Bagaoisan teaches that the inflation tube (32/32a) is spaced from the inner surface of the catheter tube in Figures 2-3. When using the technique of Kennedy, ¶0012 teaches that the skiving creates a side port that is open to the lumen (184) but is not open to the second lumen. Figure 1D shows these two lumens (184, 186) are spaced from one another, similar to the arrangement in Bagaoisan.)
Claim 3
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 1, wherein the direction of the shearing is across the catheter tube. (When using the technique of Kennedy, ¶0012 teaches the skiving is performed in a direction transverse to the longitudinal axis of the tube.)
Claim 4
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 1, wherein the shearing of the portion of the catheter tube includes shearing of only the outer layer and not the inner layer. (Bagaoisan, Figures 2-3 teach the inner layer (35) is spaced from the outer layer (where item 32/32a is located). The purpose of the side port is to fluidically connect the inflation tube (32/32a) with the balloon. ¶0098 teaches that the fill hole is formed in the tubular body (16), which is the outer layer material. When using the technique of Kennedy, the skiving impacts one lumen (184), but not the other (186). Based on these facts, the combination of reference teaches a skiving of the outer layer of material in Bagaoisan that does not impact the inner layer.)
Claim 5
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 1, wherein the step of providing includes embedding the fluid tube within the catheter tube. (Bagaoisan, Figures 2-3 teach a tube (32/32a) that is located within the material of the outer layer of material of the catheter tube (16). ¶0095 teaches that the tubes (32/32a) are embedded in a Pebax material that is combined with the material of the main lumen (30) tube. This combined Pebax material forms the “outer layer” of material.)
Claim 6
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 5, wherein the fluid tube has a generally circular cross section. (Bagaoisan, Figure 3 shows the tube (32) has a portion that is a circular cross section. Alternatively, as discussed in “Claim Interpretation” above, Applicant’s support for this limitation is found in Figure 3, which shows an oval shape of the fluid tube. Thus the claim is interpreted as requiring “generally circular” cross sections including an oval. In this interpretation, Figure 2 of Bagaoisan teaches the tube (32a) can be an oval.)
Claim 7
Bagaoisan teaches a method of manufacturing a balloon catheter (Figures 1-3 teach a balloon catheter (10).), the method comprising: providing a fluid tube between an inner surface of a catheter tube and an outer surface of the catheter tube (Figures 2-3 teach the fluid tube (32/32a) that is located between an inner surface (35) of the catheter tube (16) and the outer surface of the tube.), the catheter tube having a proximal end and a distal end (Figure 1), the fluid tube has an annular cross section (Figure 3 shows the fluid tube (32) comprises an annular cross section.), the fluid tube defines a fluid lumen therein extending along a longitudinal direction of the catheter tube (Figure 1 shows the assembly has a port (18) that provides fluid to the balloon through the lumen (32)(See ¶0098). For this to function, the lumen (32/32a) must extend from the port to the balloon (26), which is along the longitudinal direction of the tube (16).), the fluid tube having a distal end (¶0098 discusses two alternatives for termination of the fluid lumen. The first alternative is that the fluid lumen (32) extends to a fill hole that extends through the tubular body (16).) terminating within the catheter tube and between the outer surface and the inner surface of the catheter tube (Figure 2 shows the fluid lumen (32a) is located between the outer surface and inner surface of the outer layer. Since ¶0098 discloses that the fill hole extends through the tubular body, Bagaoisan teaches that the fluid lumen terminates at a fill hole that is cut through the material of the analogous outer layer and the lumen tube.), the distal end of the fluid tube being spaced apart from the distal end of the catheter tube (¶0098 teaches that the fill hole is located within the balloon. Figure 4 shows the tube (16), which comprises the outer layer, extends past the area where the fluid lumen (32) ends within the balloon (26). Therefore, the distal end of the tube (16) is located more distal than the end of the fluid lumen tube.), the inner surface of the catheter tube having an annular shape (Figures 2-3 show the inner surface (35) of the tube has an annular shape.); forming a hole in a circular portion of the outer surface of the catheter tube that allows fluid communication between the fluid lumen and a balloon external to the outer surface of the catheter tube. (Figure 1 teaches a balloon (26) that is external to the outer surface of the tube (16). ¶0098 teaches that there is a fill hole that extends through the tubular body (16) to allow fluid communication of the lumen (32) with the balloon. Thus, the hole is formed in the outer surface of the catheter tube. As discussed above, the outer surface of the tube in Bagaoisan meets the “generally circular” requirement of the claim, therefore cutting the surface of this “generally circular” tube results in forming a hole in the “generally circular” portion of the outer surface of the tube. Alternatively, since the portion where the fill hole is to be formed/cut is arcuate, it is a “portion” of a circle and therefore a “circular portion” and it is located on the outer surface.)
Bagaoisan does not explicitly disclose shearing, and that the shearing is performed on a shearing plane in a direction parallel to an outer plane tangent the outer surface of the catheter tube, the fluid tube confined between the outer plane and an inner plane parallel to and offset from the outer plane and contacting the inner surface of the catheter tube.
However, Kennedy teaches the method of forming a port in the side of a catheter tube including shearing a curved portion of the catheter tube, the shearing is performed on a shearing plane in a direction parallel to an outer plane tangent the outer surface of the catheter tube, the fluid tube confined between the outer plane and an inner plane parallel to and offset from the outer plane and contacting the inner surface of the catheter tube. (Figure 1D teaches a side port aperture (182) that provides an opening into one lumen (184) of the catheter (180) and not the other (186). ¶0012 teaches that this side port is formed via passing a cutter along a direction transverse to the catheter longitudinal axis. Kennedy teaches that the tube is curved, such that a “curved portion” of the tube is skived; and also that the hole formed has a curved shape.)
In essence, Kennedy teaches a transverse shearing step that creates an opening that communicates with one lumen, but not the other. The combination of references arrives at a cutting step that meets applicant’s claim language.
One of ordinary skill would have been motivated to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Bagaoisan in order to use a common practice in the art to cut across the outer sheath and create the desired hole. This practice is shown in Kennedy as allowing access to one lumen while not interrupting the other (See Figure 1D).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Bagaoisan because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
Bagaoisan in view of Kennedy does not explicitly disclose a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. This feature is shown in Applicant’s Figure 2.
However, Gianotti teaches a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. (Figure 4 teaches a catheter having two lumens, including an inflation lumen (130) that extends parallel to the main lumen. The inflation lumen has a plurality of apertures (601) formed in the material between the inflation lumen and the outer surface of the catheter.)
One of ordinary skill would have been motivated to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Bagaoisan in view of Kennedy in order to provide enhanced inflation and deflation of the expandable member. (See Gianotti, ¶0069)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Bagaoisan in view of Kennedy because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is that the single fill hole in Bagaoisan, formed by Kennedy’s technique, will instead by multiple fill holes formed by Kennedy’s technique.
Claim 8
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 7, wherein the direction of the shearing is such that it does not intersect with the inner surface of the catheter tube. (Kennedy, Figure 1D shows that the shearing/skiving used in Figure 1D does not impact the second lumen (186). In the catheter of Bagaoisan, the fill port is used for inflating the balloon (see ¶0098), so one of ordinary skill would understand that when using the technique of Kennedy to form the fill port of Bagaoisan that it is important not to impact the main lumen (30) as this would render the filling inoperable.)
Claim 9
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 7, wherein the direction of the shearing is across the catheter tube. (Kennedy, ¶0012 teaches that the direction of cutting is transverse to the longitudinal axis. This direction is “across” the tube.)
Claim 10
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 7, wherein the catheter tube includes an inner layer and an outer layer, and wherein the shearing of the portion of the catheter tube includes shearing only the outer layer and not the inner layer. (The combined invention of Bagaoisan and Kennedy teaches that the shearing impacts only the inflation lumen (32), which does not impact the inner layer (35) of the catheter of Bagaoisan.)
Claim 11
Bagaoisan in view of Kennedy and Gianotti teaches the method of claim 7, wherein the step of providing includes embedding the fluid tube within the catheter tube, (¶0095 teaches heat bonding of plastic material surrounding the lumen (32) to the catheter tube, which forms the structure as shown in Figures 2-3 where the lumen (32) is within the material of the catheter.) the catheter tube has an inner layer (Bagaoisan, Item 35) and an outer layer (The outer layer in Bagaoisan is the Pebax material that surrounds the inner lumen (30) and the inflation lumen (32). See ¶0095.), and wherein the embedding includes embedding the fluid tube within the outer layer of the catheter tube. (Bagaoisan, Figures 2-3 teach a tube (32/32a) that is located within the material of the outer layer of material of the catheter tube (16). ¶0095 teaches that the tubes (32/32a) are embedded in a Pebax material that is combined with the material of the main lumen (30) tube. This combined Pebax material forms the “outer layer” of material.)
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable Mcrae (US20140379012A1) in view of Kennedy (US20070191810A1), further in view of Gianotti (US20130237950A1).
Claim 7
Mcrae teaches a method of manufacturing a balloon catheter (Figure 25 shows a catheter (166) that has a balloon (170) at the end.), the method comprising: providing a fluid tube (178) between an inner surface (Inner surface of 168) of a catheter tube and an outer surface of the catheter tube (outer surface of 168), the catheter tube having a proximal end and a distal end (Figure 25 shows the catheter (166) has a proximal (174) and distal (172) end.), the fluid tube has an annular cross section (Figure 26), the fluid tube defines a fluid lumen therein extending along a longitudinal direction of the catheter tube (¶0116 teaches the inflation lumen (178) extends along the length of the catheter and ¶0121 teaches that the inflation lumen carries a fluid.), the fluid tube having a distal end terminating within the catheter tube (Figure 26 shows the fluid tube (178) within the catheter tube (168). ¶0116 teaches this tube terminates at the balloon (170). ¶0121 teaches the inflation lumen communicates with the balloon with a port. Therefore, the fluid tube (178) terminates at the port, which passes through the wall of the tube (168) to fluidically connect with the balloon.) and between the outer surface and the inner surface of the catheter tube (Figure 26 shows the fluid tube (178) is within the outer and inner surface of the tube (168).), the distal end of the fluid tube being spaced apart from the distal end of the catheter tube (¶0116 teaches the tube (178) terminates at the balloon. The balloon (170) is shown in Figure 25 as being proximal the end of the tube (168).), the inner surface of the catheter tube having an annular shape (Figure 26); and forming a side port in a circular portion of the outer surface of the catheter tube (Figure 26 shows the entire outer surface of the catheter tube is circular.)and the fluid tube to create a hole in the catheter tube that allows fluid communication between the fluid lumen and a balloon external to the outer surface of the catheter tube (¶0121 teaches an inflation port passes through the wall of the catheter body to connect the inflation lumen with the balloon. The balloon is on the external/outer surface of the tube.).
However, Kennedy teaches the method of forming a port in the side of a catheter tube including shearing a curved portion of the catheter tube, the shearing is performed on a shearing plane in a direction parallel to an outer plane tangent the outer surface of the catheter tube, the fluid tube confined between the outer plane and an inner plane parallel to and offset from the outer plane and contacting the inner surface of the catheter tube. (Figure 1D teaches a side port aperture (182) that provides an opening into one lumen (184) of the catheter (180) and not the other (186). ¶0012 teaches that this side port is formed via passing a cutter along a direction transverse to the catheter longitudinal axis. Kennedy teaches that the tube is curved, such that a “curved portion” of the tube is skived; and also that the hole formed has a curved shape.)
In essence, Kennedy teaches a transverse shearing step that creates an opening that communicates with one lumen, but not the other. The combination of references arrives at a cutting step that meets applicant’s claim language.
One of ordinary skill would have been motivated to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Mcrae in order to use a common practice in the art to cut across the outer sheath and create the desired hole. This practice is shown in Kennedy as allowing access to one lumen while not interrupting the other (See Figure 1D).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Mcrae because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
Mcrae in view of Kennedy does not explicitly disclose a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. This feature is shown in Applicant’s Figure 2.
However, Gianotti teaches a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. (Figure 4 teaches a catheter having two lumens, including an inflation lumen (130) that extends parallel to the main lumen. The inflation lumen has a plurality of apertures (601) formed in the material between the inflation lumen and the outer surface of the catheter.)
One of ordinary skill would have been motivated to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Mcrae in view of Kennedy in order to provide enhanced inflation and deflation of the expandable member. (See Gianotti, ¶0069)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Mcrae in view of Kennedy because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is that the single fill hole in Mcrae, formed by Kennedy’s technique, will instead by multiple fill holes formed by Kennedy’s technique.
Claim 12
Mcrae in view of Kennedy and Gianotti teaches the method of claim 7, wherein the inner surface has an inner central axis, the outer surface has an outer central axis offset the inner central axis to form a first region of the catheter tube and a second region of the catheter tube opposing the first region, the first region includes more material than the second region and the fluid tube. (Mcrae, Figure 26 teaches the cross section of the tube (168), where the central axis of the outer circular surface is offset from a central axis of the inner lumen (176). The first region in Mcrae is the lower part in Figure 26, which contains the inflation lumen (178) and has more material than the upper, second region.)
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable Jacques (US20030014008A1) in view of Bagaoisan (US20020026145A1), Kennedy (US20070191810A1), and Gianotti (US20130237950A1), further in view of Garrison (US20150174368A1).
Claim 1
Jacques teaches a method of manufacturing a balloon catheter (Figure 13 teaches a catheter (4) having a balloon (12).), the method comprising: providing a fluid tube (Figure 13, Item 22), between an inner surface of a catheter tube and an outer surface of the catheter tube (Figure 13 shows a cross sectional view where item 22 is located between an inner surface (outer surface of Item 20) and outer surface of the tube (4).), and an outer layer contacting the inner layer and having an outer layer thickness (Figure 13 shows the outer layer (material surrounding Item 20) has a thickness. See also Figures 11 and 12 for larger views.) the outer layer having an outer surface and an inner surface (Figure 13 shows the outer layer has an outer surface (outer surface of the tube) and an inner surface (outer surface of item 20).) the outer layer having a proximal end (6)and a distal end (The distal end is cut off in Figure 13, but is located past the balloon (12) from the proximal end (6).), the fluid tube defined within the outer layer (Figure 13, Item 22) to form a fluid lumen therein extending along a longitudinal direction of the catheter tube (Figure 13), the fluid tube having a distal end terminating within the outer layer (Figure 13 shows the lumen (22) extends through the outer layer and a distal port (23) located within the balloon (12). The Figure shows the lumens (22, 24) end at their ports through the illustration of the tube distal to the ports (23, 25) not including the lumens (22, 24) in the outer layer material.) and between the outer surface and the inner surface of the outer layer (Figures 11-13 show the lumen (22) is within the inner and outer surfaces of the outer layer.), the distal end of the fluid tube being spaced apart from the distal end of the outer layer (¶0038 teaches the lumen (22) extends to a point proximal the distal tip. The distal tip is the distal end of the outer layer.); creating a hole in the catheter tube that allows fluid communication between the fluid lumen to a balloon external to the outer surface of the catheter tube (¶0038 and Figure 13 teach a port (23) that communicates with the balloon (12).); the outer layer including a distal portion (Figure 9, A) and a proximal portion (Figure 9, B), the distal portion located more toward a distal end of the catheter tube than the proximal portion (Figure 9).
Jacques does not explicitly disclose the catheter tube includes an inner layer having an inner layer thickness.
However, Bagaoisan teaches the catheter tube includes an inner layer having an inner layer thickness. (¶0091 teaches a liner (35) provided on the inner surface of the lumen (30).)
One of ordinary skill would have been motivated to combine the known inner layer of Bagaoisan to the catheter of Jacques in order to provide a liner material to reduce the friction forces between the lumen and the surfaces of items inserted into the lumen (See Bagaoisan ¶0091)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to combine the known inner layer of Bagaoisan to the catheter of Jacques because it has been held to be prima facie obvious to combine prior art structures according to known methods to yield predictable results. See MPEP 2143(I)(A).
The predictable result is the main lumen of Jacques will have a liner, which is an inner layer.
Jacques does not disclose shearing a portion of the catheter tube and the fluid tube to create a hole in the catheter tube, the shearing is performed in a direction lateral to the longitudinal direction of the catheter tube,
However, Kennedy teaches a multi-lumen catheter in Figure 1D, where a side port (182) is created to communicate the interior of one of the lumens (184) with the exterior of the overall tubing. ¶0012 teaches this method includes passing a cutter across the catheter surface transverse to the catheter’s longitudinal axis.
One of ordinary skill would have been motivated to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Jacques in order to use a common practice in the art to cut across the outer sheath and create the desired hole. This practice is shown in Kennedy Figure 1D and described in ¶0012 as allowing access to one lumen while not interrupting the other (See Figure 1D).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Jacques because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is the port in Jacques will be formed via transverse cutting/skiving/shearing.
Jacques in view of Bagaoisan and Kennedy does not explicitly disclose a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube.
However, Gianotti teaches a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. (Figure 4 teaches a catheter having two lumens, including an inflation lumen (130) that extends parallel to the main lumen. The inflation lumen has a plurality of apertures (601) formed in the material between the inflation lumen and the outer surface of the catheter.)
One of ordinary skill would have been motivated to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Jacques in view of Bagaoisan and Kennedy in order to provide enhanced inflation and deflation of the expandable member. (See Gianotti, ¶0069)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Jacques in view of Bagaoisan and Kennedy because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is that the single fill hole in Jacques in view of Bagaoisan and Kennedy, will instead by multiple fill holes formed by Kennedy’s technique.
Jacques in view of Bagaoisan, Kennedy and Gianotti does not explicitly disclose the distal portion having a first rigidity and the proximal portion having a second rigidity greater than the first rigidity.
However, Garrison teaches the distal portion having a first rigidity and the proximal portion having a second rigidity greater than the first rigidity. (Garrison teaches a catheter (Figure 1A) that is made to have a distal region that is more flexible than the proximal region (¶0022).)
One of ordinary skill would have been motivated to apply the known multiple rigidities technique of Garrison to the balloon catheter production method of Jacques in view of Bagaoisan, Kennedy and Gianotti in order to successfully navigate the human anatomy and reach target sites within the human body (Garrison ¶0022).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known multiple rigidities technique of Garrison to the balloon catheter production method of Jacques in view of Bagaoisan, Kennedy and Gianotti because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is that the catheter of Jacques will be produced using multiple materials of differing rigidities.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable Jacques (US20030014008A1) in view of Kennedy (US20070191810A1), further in view of Gianotti (US20130237950A1).
Claim 7
Jacques teaches a method of manufacturing a balloon catheter (Figure 13 teaches a catheter (4) having a balloon (12).), the method comprising: providing a fluid tube (22) between an inner surface of a catheter tube and an outer surface of the catheter tube (Figure 13 shows a cross sectional view where item 22 is located between an inner surface (outer surface of Item 20) and outer surface of the tube (4).), the catheter tube having a proximal end (6) and a distal end (10), the fluid tube has an annular cross section (Figure 13), the fluid tube defines a fluid lumen (22) therein extending along a longitudinal direction of the catheter tube (Figure 13.), the fluid tube having a distal end terminating within the catheter tube (Figure 13 shows the lumen (22) extends through the outer layer and a distal port (23) located within the balloon (12). The Figure shows the lumens (22, 24) end at their ports through the illustration of the tube distal to the ports (23, 25) not including the lumens (22, 24) in the outer layer material.)and between the outer surface and the inner surface of the catheter tube (Figures 11-13 show the lumen (22) is within the inner and outer surfaces of the outer layer.), the distal end of the fluid tube being spaced apart from the distal end of the catheter tube (¶0038 teaches the lumen (22) extends to a point proximal the distal tip. The distal tip is the distal end of the outer layer.), the inner surface of the catheter tube having an annular shape (Figure 13); and forming a side port in a circular portion of the outer surface of the catheter tube (Figure 13 shows a port (23) on the outer surface of the tube (4).) and the fluid tube to create a hole in the catheter tube that allows fluid communication between the fluid lumen and a balloon external to the outer surface of the catheter tube (¶0038 and Figure 13 teach a port (23) that communicates with the balloon (12).)
Jacques does not disclose shearing a circular portion of the catheter tube, the shearing is performed on a shearing plane in a direction parallel to an outer plane tangent the outer surface of the catheter tube, the fluid tube confined between the outer plane and an inner plane parallel to and offset from the outer plane and contacting the inner surface of the catheter tube
However, Kennedy teaches the method of forming a port in the side of a catheter tube including shearing a curved portion of the catheter tube, the shearing is performed on a shearing plane in a direction parallel to an outer plane tangent the outer surface of the catheter tube, the fluid tube confined between the outer plane and an inner plane parallel to and offset from the outer plane and contacting the inner surface of the catheter tube. (Figure 1D teaches a side port aperture (182) that provides an opening into one lumen (184) of the catheter (180) and not the other (186). ¶0012 teaches that this side port is formed via passing a cutter along a direction transverse to the catheter longitudinal axis. Kennedy teaches that the tube is curved, such that a “curved portion” of the tube is skived; and also that the hole formed has a curved shape.)
In essence, Kennedy teaches a transverse shearing step that creates an opening that communicates with one lumen, but not the other. The combination of references arrives at a cutting step that meets applicant’s claim language.
One of ordinary skill would have been motivated to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Jacques in order to use a common practice in the art to cut across the outer sheath and create the desired hole. This practice is shown in Kennedy as allowing access to one lumen while not interrupting the other (See Figure 1D).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the well-known transverse skiving technique of Kennedy to the opening formation method in Jacques because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
Jacques in view of Kennedy does not explicitly disclose a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. This feature is shown in Applicant’s Figure 2.
However, Gianotti teaches a plurality of holes formed in the catheter tube and spaced apart by one or more outer layer portions extending to the outer surface of the catheter tube. (Figure 4 teaches a catheter having two lumens, including an inflation lumen (130) that extends parallel to the main lumen. The inflation lumen has a plurality of apertures (601) formed in the material between the inflation lumen and the outer surface of the catheter.)
One of ordinary skill would have been motivated to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Jacques in view of Kennedy in order to provide enhanced inflation and deflation of the expandable member. (See Gianotti, ¶0069)
Therefore, it would have been obvious to one of ordinary skill in the art, at the time the invention was effectively filed, to apply the known multiple inflation port technique of Gianotti to the balloon catheter production method of Jacques in view of Kennedy because it has been held to be prima facie obvious to apply a known technique to a known method/apparatus to yield predictable results. See MPEP 2143(I)(D).
The predictable result is that the single fill hole in Jacques, formed by Kennedy’s technique, will instead by multiple fill holes formed by Kennedy’s technique.
Response to Arguments
Applicant's arguments filed 02/06/2026 have been fully considered but they are not persuasive. Applicant argues that Bagaoisan and McRae do not teach the newly added limitations to Claims 1 and 7.
It is respectfully asserted that Bagaoisan provides a combination of teachings that arrive at the limitations added to claims 1 and 7 and is still relevant to the claims. Bagaoisan teaches that the fluid tube (32) extends within the material of the outer layer in Figure 2. Figure 4 and ¶0098 teach that the lumen (32) extends to a balloon (26). ¶0098 discusses two alternatives for the termination of the lumen, either a fill hole extending through the tubular body (which comprises the outer layer) within the balloon, or terminating within the balloon. A termination at a fill hole, where the fill hole has to extend through the body to reach the balloon, is a termination within the body and the outer layer. As to the limitations regarding the location of the termination, Figure 4 of Bagaoisan teaches that the fluid tube (32) terminates proximal the end of the body (16), which extends to the end of the balloon (26).
It is respectfully asserted that McRae provides a combination of teachings that arrive at the limitations added to claims 1 and 7 and is still relevant to the claims. McRae teaches the fluid tube (178) extends within the material of the outer layer in Figure 26. ¶0116 teaches the lumen extends from a proximal end of the catheter to the balloon. ¶0121 teaches the inflation lumen communicates with the interior of the balloon (170) through a port that passes through the wall of the catheter body (168), which is the analogous outer layer. In combination, McRae teaches the lumen extends through the material of the analogous outer layer and terminates at the balloon, where it then communicates with the balloon through an inflation port passing through the outer layer. As to the limitations regarding the location of the termination, Figure 25 shows the balloon is located proximal to the distal end of the catheter. ¶0116 teaches the lumen extends to the balloon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the PTO-892 Notice of References Cited Form. The following table outlines the most pertinent prior art found during the updated search with relevant sections and interpretations.
Document
Date
Description of Relevant Subject Matter
US20200384242A1
2018-01-18
Figure 4 shows the balloon inflation lumen terminates within the material of the catheter tube at an aperture (15).
US20030014008A1
2001-02-02
Figure 13 shows the balloon inflation lumen (22) terminates at a port (23) within the material of the catheter (4).
US5460610A
1993-10-25
Figure 1 shows the balloon inflation lumen (6, 8) terminates within the material of the catheter.
US20130253417A1
2012-09-21
Figure 5A shows the balloon inflation lumen (302) is made of an embedded tube that terminates proximate the end of the catheter at a skive port (502) within the material of the catheter wall.
US20120277584A1
2012-07-06
Figure 3C shows the fluid tube (320) terminates proximal the end of the tube and within the material of the outer wall of the tube.
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.
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/MICHAEL W HOTCHKISS/Primary Examiner, Art Unit 3726