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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12 and 14-20 have been considered but are moot because the new ground of rejection over Franklin US 2016/0213893 in view of Crocker US 5569184. Crocker (figures 7-11) disclose a central catheter 75 secured on its full circumference within 52 of securement jacketing of portion 12 (figure 11), an inflation lumen 14 therethrough (figure 7, 11), additional heat shrinking sleeves may be used to jacket or surround tubular elements, the shrinkable sleeve contracts around the mandrel and tubular body, the mandrel is thereafter removed to produce lumens in the catheter body, column 17, line 56-column 18, line 16; additionally, outer sleeve 120 may comprise heat shrink material for bonding with catheter elements such as hypotube 118 or central catheters in similar embodiment shown in figure 16, column 19, lines 56-64).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 discloses “at least one internal transition lumen” in lines 2-3. This language is unclear as to whether it is the same or different internal transition lumen as disclosed in claim 1, line 14.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 5, 9, 12, 14, 15, 16, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin US 2016/0213893 in view of Crocker US 5569184.
Regarding claims 1, 9, 12, Franklin discloses a vascular occlusion catheter for at least partial occlusion of a target vessel (paragraph 0001), the vascular occlusion catheter comprising: a proximal catheter shaft (for example, 110 or 310) having at least one internal lumen (210, paragraph 0035, 0049); a distal catheter shaft (for example, 120 or 320) terminating in an atraumatic tip (150, 450; paragraphs 0035, 0045); an occlusion balloon 140 sealingly mounted to the proximal and distal catheter shafts (figures 1, 9, paragraph 0036, expandable occlusion balloon 140 attached at proximal end to catheter and at the distal end to catheter); and a central catheter shaft 130 extending through the proximal catheter shaft, the occlusion balloon and into the distal catheter shaft (figure 1, paragraph 0035, 0051; extends longitudinally through the first catheter member and is coupled at its proximal end to the proximal hub 190 and at its distal end to a proximal section of the third catheter member 120), and the distal catheter shaft being secured to the central catheter shaft on a distal side of the occlusion balloon (figure 5, paragraph 0035, 0038, for example, catheter shaft 120 is coupled at a proximal end to a distal end of the first catheter member 130), wherein the occlusion balloon, the proximal catheter shaft and the distal catheter shaft have a greatest outer diameter of less than seven French (7 Fr) in an uninflated condition (paragraph 0040, catheter system 100 is sufficiently small to pass through a 6 French percutaneous sheath, and may be made smaller or larger depending upon the site or required occlusion), wherein the at least one internal lumen 210 includes a proximal shaft lumen which distally transitions into at least one internal transition lumen (paragraph 0043, catheter 110 lumen 210 extends and transitions along creating annular space 212, the transition lumen adjacent the port 160) axially extending entirely through and fluidly connecting the proximal shaft lumen with an interior of the occlusion balloon (proximal shaft lumen extends into the transition lumen and out port 160, lumen is in fluid communication with the balloon 142, paragraph 0035, figure 3).
Franklin discloses the proximal catheter shaft and the central catheter shaft being secured on a proximal side of the occlusion balloon within hub 190 (figure 6; paragraph 0035, 0048, proximal catheter shaft 110 and central catheter shaft 130 are secured within the hub), but fails to explicitly disclose the proximal catheter shaft being secured to the central catheter shaft on a proximal side of the occlusion balloon, via at least one of welding or bonding, to form a securement jacketing an entire circumferential periphery of the central catheter shaft, wherein the proximal securement between the proximal catheter shaft and the central catheter shaft defines at least one internal transition lumen fluidly connecting the at least one internal lumen with an interior occlusion balloon, the proximal catheter shaft being thermally bonded to the central catheter shaft.
Crocker teaches a vascular occlusion catheter comprising a proximal catheter shaft (figure 7, with tubular body 12, a balloon 32, and a central catheter shaft (surrounding lumen 75, see annotated figure 7 below), the proximal shaft being secured to the central catheter shaft on a proximal side of the occlusion balloon (within catheter shaft lumen 52, figure 7), to form a securement jacketing an entire circumferential periphery of the central catheter shaft (extends through lumen, such as jacketing portion 12, central shaft within lumen 52, figure 11), wherein the proximal securement between the proximal catheter shaft and the central catheter shaft defines at least one internal transition lumen fluidly connecting the at least one internal lumen with an interior occlusion balloon (inflation lumen 14 is in fluid communication with the inflation balloon 30 through port 15, figure 11), the proximal catheter shaft being thermally bonded to the central catheter shaft (heat shrinking sleeves surrounding tubular elements, the tubular elements may be fabricated within the shrinkable tubular sleeves by using mandrels, the shrinkable sleeve contracts around the mandrel and tubular body, the mandrel is thereafter removed to produce lumens in the catheter body, column 17, line 56-column 18, line 16; additionally, outer sleeve 120 may comprise heat shrink material for bonding with catheter elements such as hypotube 118 in similar embodiment shown in figure 16, column 19, lines 56-64), the fabrication of catheter or tubular members may be positioned within a tubular sleeve to form multi lumen components comprising central catheters or a hypotube, or multi-lumen component bodies as known in the art (column 17, lines 56-63), and forming a three component attachment (see annotated figure 7 below).
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Examiner additionally notes that although welding may be a type of thermal bond, the term “thermally bonded” may also be considered a product by process limitation. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Therefore, it would have been obvious to one having ordinary skill in the art to comprise the proximal catheter shaft being secured to the central catheter shaft on a proximal side of the occlusion balloon, via at least one of welding or bonding, to form a securement jacketing an entire circumferential periphery of the central catheter shaft, wherein the proximal securement between the proximal catheter shaft and the central catheter shaft defines at least one internal transition lumen fluidly connecting the at least one internal lumen with an interior occlusion balloon, the proximal catheter shaft being thermally bonded to the central catheter shaft, forming a three-component attachment, as taught by Crocker, to bond components together at a proximal end of a balloon with a securement jacketing an entire circumferential periphery of the central catheter such as by heat shrink tubing material or bonding to secure the components together within catheter device and form a multi lumen device with the balloon.
Regarding claim 5, Franklin discloses wherein the central catheter shaft extends through a first internal lumen of the at least one internal lumen of the proximal catheter shaft (figure 9A, 9C, paragraph 0049, shaft 130 extends through lumen 210) and the at least one internal lumen further includes a second internal lumen (paragraph 0049, first catheter shaft 310 may comprise at least two lumens 210, 330, figure 9A-9D).
Regarding claims 14-16, Franklin discloses wherein at least a segment of a distal neck portion of the occlusion balloon is connected to the distal catheter shaft, the connection between the distal neck portion and the distal catheter shaft at least partially radially overlapping with the connection between the distal catheter shaft and the central catheter shaft along an axial axis of the catheter, thereby forming a distal three-component-attachment (figure 5, along distal portion of shaft 130 with lumen 230 and distal neck of balloon, and proximal portion of 120 all shown overlapping and connected concentrically, as shown in figure 5). Franklin fails to explicitly disclose wherein the occlusion balloon being thermally bonded to the distal catheter shaft is thermally bonded to the central catheter shaft, the three-point attachment is between approximately .5 mm and 20mm in axial length.
Crocker discloses the securement of the balloon to the catheter body is within the range from .05 inches to .1 inch (column 14, lines 8-13), but fails to explicitly disclose the entire three-component attachment is between approximately .5 mm and approximately 20mm in axial length. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the three-component attachment within the same range of the securement of the balloon and catheter body which is within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Further, the term “thermally bonded” is considered a product by process limitation. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Regarding claim 17, Franklin discloses wherein the central catheter shaft extends into a distal internal lumen 220 of the distal catheter shaft (figure 5), a distal window (port 170, figure 5) being formed in a sidewall of the distal catheter shaft and extending into the distal internal lumen (figures 4, 5, 10), and further comprising a distal sensor positioned within the distal window (paragraph 0038, 170 permits introduction of tethered sensors).
Regarding claim 18, Franklin discloses, wherein the distal catheter shaft defines a distal internal lumen 220 terminating in an open distal port proximate the atraumatic tip (figure 5, open distal portion receives atraumatic tip 150, open when the tip is not placed and secured within the lumen, or open to receive the tip), the central catheter shaft distally terminating within the distal internal lumen 220 and being in fluid communication with the open distal port (lumen 220 is in fluid communication with catheter 130/lumen 230, figure 5).
Claim(s) 2, 3, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin US 2016/0213893 in view of Crocker US 5569184, as discussed above, and further in view of Franklin et al. US 2021/0290243.
Regarding claims 2, 3, 10 and 11, Franklin in combination discloses the vascular occlusion catheter essentially as claimed as discussed above, the occlusion balloon comprising a proximal and distal neck portions, wherein each of the proximal and distal neck portions transitions into a generally conical portion (see annotated figure 1 below), wherein at least a segment of a proximal neck portion of the occlusion balloon is attached to the proximal catheter shaft (paragraph 0036, proximal end of balloon 140 attached to proximal catheter shaft 110).
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Franklin fails to discloses wherein a proximal neck portion of the occlusion balloon is thermally bonded to the proximal catheter shaft and a distal neck portion of the occlusion balloon is thermally bonded to the distal catheter shaft, the bond between the proximal neck portion and the proximal catheter shaft at least partially radially overlapping with the bond between the proximal catheter shaft and the central catheter shaft, along an axial axis of the catheter, thereby forming a proximal three-component-attachment, wherein the proximal three-component-attachment is between approximately 0.5 mm and approximately 15 mm in axial length.
Crocker teaches a vascular occlusion catheter comprising a proximal catheter shaft (figure 7, with tubular body 12, a balloon 32, and a central catheter shaft (surrounding lumen 75, see annotated figure 7 below), the proximal shaft being secured to the central catheter shaft on a proximal side of the occlusion balloon (within catheter shaft lumen 52, figure 7), to form a securement jacketing an entire circumferential periphery of the central catheter shaft (extends through lumen, such as jacketing portion 12, central shaft within with in lumen 52, figure 11), wherein the proximal securement between the proximal catheter shaft and the central catheter shaft defines at least one internal transition lumen fluidly connecting the at least one internal lumen with an interior occlusion balloon (inflation lumen 14 is in fluid communication with the inflation balloon 30 through port 15, figure 11), the proximal catheter shaft being thermally bonded to the central catheter shaft (heat shrinking sleeves surrounding tubular elements, the tubular elements may be fabricated within the shrinkable tubular sleeves by using mandrels, the shrinkable sleeve contracts around the mandrel and tubular body, the mandrel is thereafter removed to produce lumens in the catheter body, column 17, line 56-column 18, line 16; additionally, outer sleeve 120 may comprise heat shrink material for bonding with catheter elements such as hypotube 118 in similar embodiment shown in figure 16, column 19, lines 56-64), the fabrication of catheter or tubular members may be positioned within a tubular sleeve to form multi lumen components comprising central catheters or a hypotube, or multi-lumen component bodies as known in the art (column 17, lines 56-63), and forming a three-component attachment (see annotated figure 7 below).
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Crocker discloses the securement of the balloon to the catheter body is within the range from .05 inches to .1 inch (column 14, lines 8-13), but fails to explicitly disclose the entire three-component attachment is between approximately .5 mm and approximately 20mm in axial length. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the three-component attachment within the same range of the securement of the balloon and catheter body which is within the claimed range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Franklin et al. and Crocker et al. to have a bonded overlapping area between .5mm and approximately 15mm in axial length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Franklin et al. in combination with Crocker et al. would not operate differently with a bonded overlapping area between .5mm and approximately 15mm in axial length and the device would function successfully with the claimed range.
Franklin et al. discloses a vascular occlusion catheter for at least partial occlusion of a target vessel (paragraph 0001), the vascular occlusion catheter comprising: a proximal catheter shaft (for example, 11a or 81a; figures 1, 16, paragraph 0052, 0073) having at least one internal lumen (figures 1, 17, lumen receiving 11b, 81b); a distal catheter shaft (11c or 81c (figure 18, paragraph 0073), an occlusion balloon sealingly mounted to the proximal and distal catheter shafts (figure 16A, paragraph 0073, balloon 84 connected to proximal and distal catheter by welding, welding would provide a sealing mount to the catheter shafts); wherein a proximal neck portion 84p of the occlusion balloon (figure 16A) is thermally bonded to the proximal catheter shaft (paragraph 0073, welding to bond the balloon proximal end to the proximal catheter) and a distal neck portion 84d of the occlusion balloon (figure 16A) is thermally bonded to the distal catheter shaft (paragraph 0073, welding the balloon proximal end to the proximal catheter). Franklin et al. further discloses it is known in the art for catheters with balloons to be attached thereto or integrated therewith by bonding using a lap or overlap weld, the balloon overlapping a portion of the catheter to secure the balloon to the catheter (paragraph 0009).
Examiner additionally notes that although welding may be a type of thermal bond, the term “thermally bonded” may also be considered a product by process limitation. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Therefore, it would have been obvious to one having ordinary skill in the art to thermally bond a proximal neck portion of the occlusion balloon to the proximal catheter shaft and thermally bond a distal neck portion of the occlusion balloon to the distal catheter shaft, as taught by Franklin et al., as known in the art to secure a proximal and distal end of a balloon to a catheter.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin US 2016/0213893 in view of Crocker US 5569184 and in view of Franklin et al. US 2021/0290243 as discussed above, and further in view of O’Shaughnessy et al. US 2003/0208255.
Regarding claim 4, Franklin in combination teaches the vascular occlusion catheter as claimed, but fails to explicitly disclose wherein at least one of (i) the proximal neck portion and the corresponding generally conical portion define a radiused transition therebetween, or (ii) the distal neck portion and the corresponding generally conical portion define a radiused transition therebetween.
O’Shaughnessy et al. teaches a balloon 20 being attached to a catheter shaft 30, the balloon comprising a proximal neck portion 22 and distal neck portion 28 (figure 1), the balloon being generally cylindrical in shape between proximal and distal conical sections (24, 26, figure 1), the conical sections and proximal and distal necks may be rounded or radiused, to avoid sharp delineations (paragraph 0020).
Therefore, it would have been obvious to modify Franklin with a balloon having at least one of (i) the proximal neck portion and the corresponding generally conical portion define a radiused transition therebetween, or (ii) the distal neck portion and the corresponding generally conical portion define a radiused transition therebetween, as taught by O’Shaughnessy et al. as is known in the art to provide a balloon having a rounded or radiused transition portion to avoid any sharp delineations.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable Franklin US 2016/0213893 in view of Crocker US 5569184, as discussed above, and further in view of Franklin et al. US 2019/0076152.
Regarding claim 6, Franklin in combination discloses the occlusion catheter essentially as claimed as discussed above, but fail to further comprise a proximal window formed in a sidewall of the proximal catheter shaft and extending into the second internal lumen, a proximal sensor positioned within the proximal window.
Franklin et al. teaches an occlusion catheter 10 (for example, fig. 1C) comprising a proximal catheter 12b having a proximal window or side port formed in a sidewall of the proximal catheter shaft and extending into the second internal lumen, a proximal sensor positioned within the proximal window (paragraph 0109, catheter 12 may also include a proximal side port or proximal pressure sensor 171 near the proximal balloon end 140c that extends into the catheter or lumen for fluid communication during use).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Franklin with a proximal window formed in a sidewall of the proximal catheter shaft and extending into the second internal lumen, a proximal sensor positioned within the proximal window, as taught by Franklin et al., to provide a structure for receiving a sensor and a window for detecting pressure and withdrawing fluids at the target site downstream of the balloon or otherwise provide access to the vessel during use.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin US 2016/0213893 in view of Crocker US 5569184 as discussed above, and further in view of Franklin US 9474882 (hereafter Franklin ‘882).
Regarding claims 7 and 8, Franklin in combination discloses a vascular occlusion catheter essentially as claimed comprising a first and second internal lumen, wherein the proximal catheter shaft is thermally bonded to the central catheter shaft as discussed above , but fails to explicitly disclose wherein the second internal lumen distally terminates proximal to the occlusion balloon, wherein the proximal catheter shaft is thermally bonded to the central catheter shaft distal to the second internal lumen.
Crocker teaches the fabrication of catheter or tubular members may be positioned within a tubular sleeve to form multi lumen components comprising central catheters or a hypotube, or multi-lumen component bodies as known in the art (column 17, lines 56-63), and proximal catheter shaft is thermally bonded to the central catheter shaft as discussed above, but fails to explicitly disclose wherein the second internal lumen distally terminates proximal to the occlusion balloon, wherein the proximal catheter shaft is thermally bonded to the central catheter shaft distal to the second internal lumen.
Franklin ‘882 teaches an occlusion catheter system 10 comprising a proximal catheter 12 having multiple lumens of different configurations may be operably coupled with the guide shaft, occlusion shaft or balloon (figures 4F, 4G, column 11, lines 56-59), a first lumen 12a receiving a center catheter or hypotube (figure 4H), and a second lumen 12b comprising a port 86 for receiving a sensor 82 proximally or distal of the balloon, column 11, lines 45-49), the lumen receiving the sensor terminates at the port or window 86, figure 4H, for example in figure 5 a proximal port from the occlusion balloon 14 allow for the sensors 82). Further, Franklin ‘882 teaches an occlusion catheter system 10 comprising a proximal catheter 12 having multiple lumens of different configurations may be operably coupled with the guide shaft, occlusion shaft or balloon (figures 4F, 4G, column 11, lines 56-59), a first lumen 12a receiving a center catheter or hypotube (figure 4H), and a second lumen 12b comprising a port 86 for receiving a sensor 82 proximally or distal of the balloon, column 11, lines 45-49), the lumen receiving the sensor terminates at the port or window 86, figure 4H, for example in figure 5 a proximal port from the occlusion balloon 14 allow for the sensors 82). Examiner notes the lumen 12b terminates prior to reaching the balloon, and would therefore result in a configuration wherein the proximal catheter shaft is thermally bonded to the central catheter shaft distal to the second internal lumen, as it is bonded adjacent the proximal end of the balloon.
Therefore, it would have been obvious to one having ordinary skill in the art to provide additional lumens as necessary which terminate both proximally or distally to the balloon, as taught by Franklin ‘882 to provide a lumen for housing and placing a sensor proximally to the balloon as desired. Further, to provide and to secure the proximal catheter shaft with the central catheter shaft on a proximal side by thermal bonding, as taught by Franklin ‘882, and wherein the proximal catheter shaft is thermally bonded to the central catheter shaft distal to the second internal lumen to provide a second internal lumen for receiving a proximal sensor for detecting pressure and withdrawing fluids at the target site downstream of the balloon or otherwise provide access to the vessel during use.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin US 2016/0213893 in view of Crocker US 5569184, as discussed above, and further in view of Chou et al. US 2011/0034986.
Regarding claim 19, Franklin discloses the vascular occlusion catheter essentially as claimed as discussed above, wherein the occlusion balloon defines a proximal neck portion (proximal portion 144, figure 1), a distal neck portion (distal portion 146, figure 1) and an intervening central body portion (surrounding intermediate area 115, figure 1), but fails to disclose wherein at least one of the proximal neck portion or the distal neck portion is constructed of a material having a lower durometer than the central body portion.
Chou et al. discloses vascular occlusion catheters 3305 comprising a balloon 3310 which can be designed of layered low and high durometer material in which the reinforcement provides a limit to the expansion dimensions, such that it will not over inflate (paragraph 0432).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Franklin with a balloon wherein at least one of the proximal neck portion or the distal neck portion is constructed of a material having a lower durometer than the central body portion, as taught be Chou et al., to provide a balloon having varying durometer material along the balloon in which the reinforcement provides a limit to the expansion dimensions, such that it will not over inflate.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franklin US 2016/0213893 in view of Crocker US 5569184 in view of Chou et al. US 2011/0034986 and further in view of Keren et al. US 2002/0169413.
Regarding claim 20, Franklin in combination with Crocker and Chou et al. discloses the vascular occlusion catheter essentially as claimed as discussed above, but fails to disclose wherein the at least one of the proximal neck portion or the distal neck portion defines a tensile modulus that is between approximately 0.5% and approximately 80% of a tensile modulus of the central body portion.
Chou et al. discloses vascular occlusion catheters 3305 comprising a balloon 3310 which can be designed of layered low and high durometer material in which the reinforcement provides a limit to the expansion dimensions, such that it will not over inflate (paragraph 0432), but fails to disclose a tensile modulus that is between approximately 0.5% and approximately 80% of a tensile modulus of the central body portion.
Keren et al. discloses the material durometer and tensile modulus may be selected appropriately so as to allow for the above properties to be exhibited with a practical balloon-wall thickness (paragraph 0020).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Franklin with a balloon wherein the at least one of the proximal neck portion or the distal neck portion defines a tensile modulus that is between approximately 0.5% and approximately 80% of a tensile modulus of the central body portion, as taught by Chou et al. and Keren et al. to allow for the appropriate and practical balloon wall thickness for a specific procedure.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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