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 Amendment
The amendment filed January 23rd 2026 has been entered. Claims 1-23 are pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed October 23rd 2025.
Claim Objections
Claims 2, 10, and 14 are objected to because of the following informalities:
Regarding claim 2, “the outer surface” should be corrected to “an outer surface” for claim language consistency.
Regarding claim 10, “the polymer is” should be corrected to “the polymeric material is” for claim language consistency.
Regarding claim 14, “the relative fluid” should be corrected to “a relative fluid” for claim language consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chomas (US 20120089102 A1).
Regarding claim 1, Chomas discloses a therapeutic device (delivery apparatus 2300, [0106] & Fig. 33) for delivery of a therapeutic agent within a vessel of a patient (apparatus 2300 configured for delivery of embolization agent, see [0003] and [0106] & Fig. 33; the Examiner notes that the agent is referenced as 2324 in Fig. 33 but not included in the written specification), the vessel having a vessel wall (artery 2320, [0106] & Fig. 33), the device comprising:
a) a catheter having a proximal end and distal end (inner catheter 2304, [0106] & Fig. 33);
b) a vessel occluder mounted adjacent the distal end of the catheter (wire framework 2306, collar 2310, and first sleeve portion 2311 are being interpreted as the vessel occluder, [0106] & Fig. 33; sleeve 2311 acting as an occluder not allowing the embolizing agent through); and
c) a flexible cover attached to the catheter and adapted to extend over and between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel (second sleeve 2312, being structured to collapse, is being interpreted as the flexible cover, [0106] & Fig. 33; sleeve 2312 attached to catheter 2304 through connection to first sleeve 2311, [0106]; while all of valve 2305 is advanced through the vessel, sleeve 2312 is positioned over and between sleeve 2311 and the wall of artery 2320 considering sleeve 2312 is closer to the distal opening of outer catheter 2301, [0106] & Fig. 33; sleeve 2312 can alternatively be interpreted as positioned over and between sleeve 2311 and the wall of artery 2320 when observing valve 2305 in a longitudinal/vertical orientation), and automatically move away from the occluder when predetermined pressure conditions inside the vessel are met (sleeve 2312 configured to collapse in response to reverse blood flow conditions 2322b, this is being interpreted as sleeve 2312 automatically moving away from collar 2310, sleeve 2311, and framework 2306 as these components are stationary in reverse blood flow conditions, see [0106] & Fig. 33; reverse blood flow disclosed as applying flow pressure, [0075]).
Regarding claim 2, Chomas discloses all the limitations of claim 1. Chomas further discloses the therapeutic device wherein a portion of the cover is sandwiched between the outer surface of the catheter and a distal end of the occluder (sleeve 2312 seen sandwiched between the outer surface of the distalmost end of catheter 2304 and a distal end of sleeve 2311, see Fig. 33).
Regarding claim 3, Chomas discloses all the limitations of claim 1. Chomas further discloses the therapeutic device wherein the cover is fixed to the catheter at a location distally of a distal end of the occluder (as sleeve 2312 collapses in response to blood flow in the reverse direction 2322b, the sleeve can be interpreted as being fixed to catheter 2304, [0106] & Fig. 33; sleeve 2312 collapsing and coming into contact with catheter 2304 at a location distally of a distal end of sleeve 2311).
Regarding claim 4, Chomas discloses all the limitations of claim 1. Chomas further discloses the therapeutic device wherein the cover is self-expanding (sleeve 2312 collapses in response to reverse blood flow conditions 2322b and would inherently open up in response to forward blood flow 2322a, [0106] & Fig. 33).
Regarding claim 6, Chomas discloses all the limitations of claim 1. Chomas further discloses the therapeutic device wherein the cover is impermeable (sleeve 2312 is impermeable to embolizing agent, [0106]).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chomas (US 20120089102 A1), as applied to claim 1 above, and further evidenced by Slater (US 20050107738 A1).
Regarding claim 5, Chomas discloses all the limitations of claim 1. However, the embodiment of Fig. 33 of Chomas fails to explicitly disclose the therapeutic device wherein the cover is made from lubricous material. However, embodiment of Fig. 19-23 of Chomas teaches a therapeutic device (delivery apparatus 1900, [0102] & Fig. 19) wherein the cover (valve flaps 1912, [0102] & Fig. 19) is made from lubricous material (“The valve flaps 1912 are preferably constructed in a manner similar to above described valve structures”, [0102]; valve 203 is composed of polymeric filament such as fluorinated polymers, [0062]; as is well known in the art, and further evidenced by Slater, fluorinated polymers, such as PFTE, are lubricious, see [0222] of Slater).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment of Fig. 33 of Chomas with the embodiment of Fig. 19-23 of Chomas to include the cover being made from lubricous material since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
The prior art also indicates “It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed”, [0123].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chomas (US 20120089102 A1), as applied to claim 1 above, and further in view of Olson (US 20210236135 A1).
Regarding claim 8, Chomas discloses all the limitations of claim 1. However, Chomas fails to explicitly disclose the therapeutic device wherein the cover is made from an elastomeric material. However, Olson discloses a therapeutic device (abstract and Fig. 1-3) wherein the cover is made from an elastomeric material (fluid impermeable membrane 72 can include elastomeric natural and artificial rubbers, etc., [0034] & Fig. 3). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the cover of Chomas with Olson to include the cover being made from an elastomeric material since Olson teaches elastomeric materials to be art effectives materials for a cover provided on an occlusion device.
Additionally, Chomas places no criticality on the materials of the valve, filter, catheter, etc. stating that “… while various materials have been listed for the valve filaments, the valve filter, the catheter, and the deployment means, it will be appreciated that other materials can be utilized for each of them” ([0123]).
Claim(s) 7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chomas (US 20120089102 A1), as applied to claim 1 above.
Regarding claim 7, Chomas discloses all the limitations of claim 1. However, the embodiment of Fig. 33 of Chomas fails to explicitly disclose the therapeutic device wherein the cover is semi-permeable. However, embodiment of Fig. 19-23 of Chomas teaches a therapeutic device (delivery apparatus 1900, [0102] & Fig. 19) wherein the cover is semi-permeable (valve flaps 1912 structured to permit blood and/or contrast agent to pass through while blocking embolizing agent, [0102]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment of Fig. 33 of Chomas with the embodiment of Fig. 19-23 of Chomas to include the cover being semi-permeable since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
The prior art also indicates “It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed” (see [0123]).
Regarding claim 9, Chomas discloses all the limitations of claim 1. However, the embodiment of Fig. 33 of Chomas fails to explicitly disclose the therapeutic device wherein the cover is made from a polymeric material. However, embodiment of Fig. 19-23 of Chomas teaches a therapeutic device (delivery apparatus 1900, [0102]) wherein the cover is made from a polymeric material (valve flaps 1912 comprised of filamentary structure overlaid with a polymer coating, [0102]; “The valve flaps 1912 are preferably constructed in a manner similar to above described valve structures”; valve 203 disclosed as being made of polymer filaments, see [0062] and [0102]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the embodiment of Fig. 33 of Chomas with the embodiment of Fig. 19-23 of Chomas to include the cover being made from a polymeric material since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
The prior art also indicates “It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed” ([0123]).
Regarding claim 10, Chomas, as modified, discloses all the limitations of claim 9. Chomas, as modified, further discloses the therapeutic device wherein the polymer is pellethane (the filter may be made of pellethane, [0072]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable Chomas (US 20120089102 A1), as applied to claim 1 above, and further in view of Webler (US 20070129752 A1).
Regarding claim 11, Chomas discloses all the limitations of claim 1. Chomas further discloses the therapeutic device wherein the catheter comprises a distal orifice (catheter 2304 including a distal orifice to allow for the therapy delivery, [0003]).
However, Chomas fails to explicitly disclose the therapeutic device wherein the catheter [includes] side holes proximal of the distal orifice, and the occluder extends over the side holes.
However, Webler teaches a therapeutic device (abstract) wherein a catheter [includes] side holes proximal of the distal orifice, and the occluder extends over the side holes (holes 60 provided proximally to the distal orifice of catheter 50, [0043] and [0050] & Fig. 6; occlusion device 54 extending over holes 60). Webler discloses the “the flush may be contrast (an image enhancing agent), a contrast solution, a therapeutic solution, an energy transmission enhancing solution and/or any other fluid solution)”([0050]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Chomas with Webler to include side holes proximal of the distal orifice, and the occluder extending over the side holes, since such a modification would provide more openings for a therapeutic to be released through and provide structure to aid in the deployment of the occlusion device and yield predictable results pertaining to rapid device deployment (see [0046] and [0050] of Webler). As modified, the deployment of wire framework 2306, collar 2310, and first sleeve portion 2311 would be aided by flush flow coming from holes 60, which would be included on catheter 2304 inside of wire framework 2306, collar 2310, and first sleeve portion 2311.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable Chomas (US 20120089102 A1), in view of Webler (US 20070129752 A1), and further in view of Chomas (US 20200038586 A1), hereafter referred to as Chomas ‘586.
Regarding claims 12-13, Chomas, as modified, discloses all the limitations of claim 11. However, Chomas fails to explicitly disclose the therapeutic device further comprising a pressure sensor at the distal end of the catheter, wherein the cover is located between the side holes and the pressure sensor.
However, Chomas ‘586 teaches a therapeutic device (catheter arrangement 12, [0032] and abstract & Fig. 1) further comprising a pressure sensor at the distal end of the catheter (pressure sensor 26 located near distal end 23 and distal of the occluder 14, [0034] and [0036] & Fig. 2 of Chomas ‘586).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Chomas, as modified, with Chomas ‘586 to include a pressure sensor at the distal end of the catheter since such a modification would provide real-time feedback regarding sensed pressure to help determine whether to inject the therapeutic agent at higher or lower flow rate to maintain desired pressure levels ([0036]-[0037]of Chomas ‘586). As modified, pressure sensor 26 of Chomas ‘586 would be provided on the distal end of catheter 2304 of Chomas. This would render sleeve 2312 between holes 60 of Webler and the pressure sensor 26.
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk (US 20180263752 A1), in view of Richter (US 20140277096 A1).
Regarding claim 14, Pinchuk discloses a therapeutic device for delivery of a therapeutic agent within a vessel of a patient during a vascular procedure (microvalve device 1300, see abstract & Fig. 27), the vessel having a vessel wall (vessel 362 having a wall, [0060] & Fig. 6A; vessel wall 1262, [0097] & Fig. 25), comprising:
a) a flexible catheter sized for introduction into the vessel (flexible infusion catheter 1308, [0098] & Fig. 27), the catheter having a proximal end and a distal end, an outer surface, a lumen extending between the proximal and distal ends and opening at a distal orifice (proximal end 1310, distal end 1312, an outer surface of catheter 1308, a lumen opening at a distal orifice 1358 to allow for infusate injection, [0097]-[0098] & see Fig. 26-27); and
b) an occluder mounted adjacent the distal end of the catheter, the occluder having a proximal side and a distal side (filter valve 1314 mounted adjacent distal end 1312; “The proximal portions 1332 are attached circumferentially about at an outer surface 1318 of the catheter 1308 at a location proximal of the orifice 1358… and the distal portions 1336 of the strands are inverted back into the filter valve 1314 and coupled circumferentially about the outer surface 1318 of the catheter 1308.”, [0098] & Fig. 27), the occluder adapted to dynamically change shape in response to the relative fluid pressure at the proximal and distal sides of the occluder (“the filter valve 1314 expands outward and is adapted to dynamically open and close in response to local fluid pressure conditions about the proximal and distal portions of the filter valve, as described above. “, [0100] & Fig. 27; also see [0094] & Fig. 20-23),
wherein, at a first fluid pressure condition in the vessel with fluid pressure higher on the proximal side than on the distal side of the occluder, the occluder moves into a first configuration with a first diameter permitting proximal to distal flow of blood about the occluder and through the vessel (“In a forward (downstream) flow condition (higher pressure at the proximal portion 1134 than at the distal portion 1136 of the filter valve), the filter valve will automatically partially collapse to allow forward flowing fluid to pass the filter valve.”, [0095] & Fig. 22; the collapsed filter valve having a first diameter; the Examiner notes that filter 1314 is configured to dynamically open and close as described with respect to filters 1114 and 1214, [0100]),
and, at a second fluid pressure condition in the vessel with fluid pressure higher on the distal side than on the proximal side of the occluder, the occluder moves into a second configuration with a relatively larger second diameter sized to contact the vessel wall and preventing the passage of fluid in the vessel and past the occluder (“Referring to FIG. 23, in a reverse (upstream or reflux) flow condition (higher pressure at the distal portion 1136 than at the proximal portion 1134 of the filter valve, shown by arrow 1164), the distal portion 1136 of the filter valve will automatically longitudinally collapse toward the proximal portion 1134, and may even fully or partially invert, and forces the filter valve 1114 into a wide open configuration across the vessel 1162 so as to form a barrier to flow passed the filter valve…”, [0095] & Fig. 23; the expanded filter valve having a larger, wide open, second diameter; the Examiner notes that filter 1314 is configured to dynamically open and close as described with respect to filters 1114 and 1214, [0100]).
The Examiner notes that Pinchuk discloses that the “the filter valve is designed to permit the blood to reflux through the pores of the filter valve while still blocking the passage of the embolic agent” but also explicitly contemplates that “it is not necessary that blood and contrast agent be permitted to reflux through the valve.” (emphasis added) (see [0079]).
However, Pinchuk fails to explicitly disclose c) a flexible cover attached to the catheter and adapted to extend over and between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel, and automatically move away from the occluder when the first fluid pressure conditions are present.
However, Richter teaches a therapeutic device for delivery within a vessel of a patient during a vascular procedure (a single-unit percutaneous temporary valve-filter device with valve filter device 60, [0053] & Fig. 4A-4B) comprising a flexible cover attached to the catheter and adapted to extend over and between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel (first disk 61, which is being interpreted as the flexible cover, attached to the center of disk 62, which is being interpreted as the occluder, and catheter 20 and adapted to lie on top of, or extend over, disk 62 between a portion of disk 62 and vessel wall 16, [0053]-[0054]; disk 62 functioning as an embolic filter, [0053]; also see [0058]), and automatically move away from the occluder when the first fluid pressure conditions are present (disk 61 configured to automatically move away from disk 62 when pressure conditions are higher on one side of disk 62 than on the other side, [0053]-[0054]; “During systole, the first disk 61 may fold toward the center, for example toward the delivery device 20 sufficiently to allow blood flow through the vessel, as illustrated in FIG. 4B”). Richter teaches a delivery device that includes both a flexible, movable disk 61 and a filtering mesh disk 62.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the therapeutic device of Pinchuk with Richter to include a flexible cover attached to the catheter and adapted to extend over and between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel, and automatically move away from the occluder when the first fluid pressure conditions are present, since
such a modification would provide structure to prevent retrograde blood flow through the vessel in order to better control infusate delivery and yield the same predictable results pertaining to maintaining unidirectional blood flow while providing filtering means (see [0029]-[0030] and [0053]-[0054] of Richter).
As modified, first disk 61 of Richter would be provided downstream of filter valve 1314 of Pinchuk, attached at the distal end of valve 1314 where distal portions 1336 couple to the outer surface 1318 of catheter 1308 of Pinchuk, the attachment being at a longitudinal center of valve 1314, similarly to how disk 61 is attached to disk 62 of Richter “in the center where they are connected to the delivery device 20” ([0054] of Richter).
Regarding claim 15, Pinchuk discloses all the limitations of claim 14. Pinchuk further discloses the therapeutic device according wherein the occluder has,
i) a plurality of elastic filamentary strands in a tubular braid (valve 1314 having a braided multi-strand construct made from polymer filaments and/or metal strands 1330, [0098] & Fig. 27), the strands having proximal portions, central portions, and distal portions (“The strands 1330 each include a proximal portion 1332, a central portion 1334, and a distal portion 1336.”, [0098] & Fig. 27),
the distal portions longitudinally fixed to the outer surface of the catheter at the first location, the proximal portion longitudinally fixed to the outer surface of the catheter at the second location, and the central portions biased to extend radially outward from the outer surface between the proximal and distal portions (“The proximal portions 1332 are attached circumferentially about at an outer surface 1318 of the catheter 1308 at a location proximal of the orifice 1358, the central portions 1334 extend radially outward and toward the orifice 1358, and the distal portions 1336 of the strands are inverted back into the filter valve 1314 and coupled circumferentially about the outer surface 1318 of the catheter 1308. The distal portions 1336 are preferably fixed to the outer surface 1318”, [0098] & Fig. 27); and
ii) a polymeric material coated onto the filamentary strands to form a barrier to passage of the therapeutic agent (“The proximal and central portions 1332, 1334 of the strands are coated in a polymeric filter 1370 that extends between and across the strands 1330.“, [0098] & Fig. 27; the polymeric filter forms a barrier to passage of embolic agent, [0075]).
Regarding claim 16, Pinchuk, as modified, discloses all the limitations of claim 15. Pinchuk further discloses the therapeutic device wherein: the polymeric material is coated onto at least proximal portions of the strands and at least a portion of the central portions of the strands, and the distal portions of the strands sufficiently absent of the polymeric material such that the therapeutic agent can flow through the occluder between the distal portions (“The proximal and central portions 1332, 1334 of the strands are coated in a polymeric filter 1370 that extends between and across the strands 1330. Optionally, the distal portions 1336 of the strands may also be coated in the polymeric filter, although the illustrated filter valve is provided with an uncoated distal portion.”, [0098] & Fig. 27; infusate would flow through uncoated distal portions 1336, like infusate 1288 seen flowing through polymeric filter free distal portion 1236 of filter valve 1214, Fig. 26).
Regarding claim 17, Pinchuk, as modified, discloses all the limitations of claim 15. Pinchuk further discloses the therapeutic device wherein the distal portions of the strands are inverted to be at least partially located radially within the central portions of the strands (distal portions 1336 are inverted back into filter valve 1314, [0098] & Fig. 27; strands of distal portion 1336 would inherently be at least partially located radially within central portion 1334, Fig. 27).
Regarding claim 18, Pinchuk, as modified, discloses all the limitations of claim 15. Pinchuk further discloses the therapeutic device wherein the strands are made of nickel titanium alloy (the braided construct may be made of metal, including Nitinol, and/or polymer filaments, [0098] & Fig. 27).
Claim(s) 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk (US 20180263752 A1), in view of Webler (US 20070129752 A1), and further in view of Richter (US 20140277096 A1).
Regarding claim 19, Pinchuk discloses a therapeutic device for delivery of a therapeutic agent within a vessel of a patient during a vascular procedure (microvalve device 1300, see abstract & Fig. 27), the vessel having a vessel wall (vessel 362 having a wall, [0060] & Fig. 6A; vessel wall 1262, [0097] & Fig. 25), comprising:
a) a flexible catheter sized for introduction into the vessel (flexible infusion catheter 1308, [0098] & Fig. 27), the catheter having a proximal end and a distal end, an outer surface, a lumen extending between the proximal and distal ends and opening at a distal orifice (proximal end 1310, distal end 1312, an outer surface of catheter 1308, a lumen opening at a distal orifice 1358 to allow for infusate injection, [0097]-[0098] & see Fig. 26-27); and
b) an occluder mounted adjacent the distal end of the catheter, the occluder having a proximal side and a distal side (filter valve 1314 mounted adjacent distal end 1312; “The proximal portions 1332 are attached circumferentially about at an outer surface 1318 of the catheter 1308 at a location proximal of the orifice 1358… and the distal portions 1336 of the strands are inverted back into the filter valve 1314 and coupled circumferentially about the outer surface 1318 of the catheter 1308.”, [0098] & Fig. 27), the occluder adapted to dynamically change shape in response to the relative fluid pressure at the proximal and distal sides of the occluder (“the filter valve 1314 expands outward and is adapted to dynamically open and close in response to local fluid pressure conditions about the proximal and distal portions of the filter valve, as described above. “, [0100] & Fig. 27; also see [0094] & Fig. 20-23),
wherein, at a first fluid pressure condition in the vessel with fluid pressure higher on the proximal side than on the distal side of the occluder, the occluder moves into a first configuration with a first diameter permitting proximal to distal flow of blood about the occluder and through the vessel (“In a forward (downstream) flow condition (higher pressure at the proximal portion 1134 than at the distal portion 1136 of the filter valve), the filter valve will automatically partially collapse to allow forward flowing fluid to pass the filter valve.”, [0095] & Fig. 22; the collapsed filter valve having a first diameter; the Examiner notes that filter 1314 is configured to dynamically open and close as described with respect to filters 1114 and 1214, [0100]), and,
at a second fluid pressure condition in the vessel with fluid pressure higher on the distal side than on the proximal side of the occluder, the occluder moves into a second configuration with a relatively larger second diameter sized to contact the vessel wall and prevent the passage of fluid in the vessel and past the occluder (“Referring to FIG. 23, in a reverse (upstream or reflux) flow condition (higher pressure at the distal portion 1136 than at the proximal portion 1134 of the filter valve, shown by arrow 1164), the distal portion 1136 of the filter valve will automatically longitudinally collapse toward the proximal portion 1134, and may even fully or partially invert, and forces the filter valve 1114 into a wide open configuration across the vessel 1162 so as to form a barrier to flow passed the filter valve…”, [0095] & Fig. 23; the expanded filter valve having a larger, wide open, second diameter; the Examiner notes that filter 1314 is configured to dynamically open and close as described with respect to filters 1114 and 1214, [0100]).
The Examiner notes that Pinchuk discloses that the “the filter valve is designed to permit the blood to reflux through the pores of the filter valve while still blocking the passage of the embolic agent” but also explicitly contemplates that “it is not necessary that blood and contrast agent be permitted to reflux through the valve.” (emphasis added) (see [0079]).
However, Pinchuk fails to explicitly disclose the catheter having a lumen opening at a plurality of side holes proximal of the distal orifice and the occluder extending over the side holes and
c) a flexible cover attached to the flexible catheter and adapted to extend between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel, to automatically move away from the occluder when the first fluid pressure conditions are present, and to automatically move toward the occluder to extend between a portion of the occluder and the vessel wall when the second fluid pressure conditions are present.
However, Webler teaches a therapeutic device (abstract) comprising a catheter having a lumen opening at a plurality of side holes proximal of the distal orifice and the occluder extending over the side holes (holes 60 provided proximally to the distal orifice of catheter 50, [0043] and [0050] & Fig. 6; holes 60 being openings to inner diameter 58 of catheter 50, [0043] & Fig. 6; occlusion device 54 extending over holes 60).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Pinchuk with Webler to include a lumen opening at a plurality of side holes proximal of the distal orifice and the occluder extending over the side holes since such a modification would provide more openings for a therapeutic to be released through and provide structure to aid in the deployment of the occlusion device and yield predictable results pertaining to rapid device deployment and therapeutic delivery (see [0037], [0046], and [0050] of Webler). The Examiner notes that Webler discloses the “the flush may be contrast (an image enhancing agent), a contrast solution, a therapeutic solution, an energy transmission enhancing solution and/or any other fluid solution)”([0050]).
Further, Richter teaches a therapeutic device for delivery within a vessel of a patient during a vascular procedure (a single-unit percutaneous temporary valve-filter device with valve filter device 60, [0053] & Fig. 4A-4B) comprising a flexible cover attached to the flexible catheter and adapted to extend between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel (first disk 61, which is being interpreted as the flexible cover, attached to the center of disk 62, which is being interpreted as the occluder, and catheter 20 and adapted to lie on top of, or extend over, disk 62 between a portion of disk 62 and vessel wall 16, [0053]-[0054), to automatically move away from the occluder when the first fluid pressure conditions are present (disk 61 configured to automatically move away from disk 62 when pressure conditions are higher upstream of disk 62 than downstream of disk 62, [0053]-[0054] & Fig. 4A-4B; “During systole, the first disk 61 may fold toward the center, for example toward the delivery device 20 sufficiently to allow blood flow through the vessel, as illustrated in FIG. 4B), and to automatically move toward the occluder to extend between a portion of the occluder and the vessel wall when the second fluid pressure conditions are present (disk 61 configured to automatically move toward disk 62, and lie on top of disk 62, when pressure conditions are higher downstream of disk 62 than upstream of disk 62, [0053]-[0054] & Fig. 4A-4B; “During systole, the first disk 61 may fold toward the center, for example toward the delivery device 20 sufficiently to allow blood flow through the vessel, as illustrated in FIG. 4B). Richter teaches a delivery device that includes both a flexible, movable disk 61 and a filtering mesh disk 62.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the therapeutic device of Pinchuk, as modified, with Richter to include a flexible cover attached to the flexible catheter and adapted to extend between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel, to automatically move away from the occluder when the first fluid pressure conditions are present, and to automatically move toward the occluder to extend between a portion of the occluder and the vessel wall when the second fluid pressure conditions are present, since such a modification would provide structure to prevent retrograde blood flow through the vessel in order to better control infusate delivery and yield the same predictable results pertaining to maintaining unidirectional blood flow while providing filtering means (see [0029]-[0030] and [0053]-[0054] of Richter).
As modified, first disk 61 of Richter would be provided downstream of filter valve 1314 of Pinchuk, attached at the distal end of valve 1314 where distal portions 1336 couple to the outer surface 1318 of catheter 1308 of Pinchuk, the attachment being at a longitudinal center of valve 1314, similarly to how disk 61 is attached to disk 62 of Richter “in the center where they are connected to the delivery device 20” ([0054] of Richter).
Regarding claim 21, Pinchuk discloses a therapeutic device for delivery of a therapeutic agent within a vessel of a patient during a vascular procedure (microvalve device 1300, see abstract & Fig. 27), the vessel having a vessel wall (vessel 362 having a wall, [0060] & Fig. 6A; vessel wall 1262, [0097] & Fig. 25), comprising:
a) a flexible catheter sized for introduction into the vessel (flexible infusion catheter 1308, [0098] & Fig. 27), the catheter having a proximal end and a distal end, an outer surface, a lumen extending between the proximal and distal ends and opening at a distal orifice (proximal end 1310, distal end 1312, an outer surface of catheter 1308, a lumen opening at a distal orifice 1358 to allow for infusate injection, [0097]-[0098] & see Fig. 26-27); and
b) an occluder mounted adjacent the distal end of the catheter (filter valve 1314 mounted adjacent distal end 1312, [0098] & Fig. 27), the occluder having a maximum diameter (“Referring to FIG. 23, in a reverse (upstream or reflux) flow condition (higher pressure at the distal portion 1136 than at the proximal portion 1134 of the filter valve, shown by arrow 1164), the distal portion 1136 of the filter valve will automatically longitudinally collapse toward the proximal portion 1134, and may even fully or partially invert, and forces the filter valve 1114 into a wide open configuration across the vessel 1162 so as to form a barrier to flow passed the filter valve…”, [0095] & Fig. 23; the expanded filter valve having a large, wide open, maximum diameter; the Examiner notes that filter 1314 is configured to dynamically open and close as described with respect to filters 1114 and 1214, [0100]) and
a proximal fluid impermeable side and a distal fluid permeable side located on opposite sides of the maximum diameter (“The strands 1330 each include a proximal portion 1332, a central portion 1334, and a distal portion 1336… the central portions 1334 extend radially outward and toward the orifice 1358, and the distal portions 1336 of the strands are inverted back into the filter valve 1314 and coupled circumferentially about the outer surface 1318 of the catheter 1308... The proximal and central portions 1332, 1334 of the strands are coated in a polymeric filter 1370 that extends between and across the strands 1330. Optionally, the distal portions 1336 of the strands may also be coated in the polymeric filter, although the illustrated filter valve is provided with an uncoated distal portion.”, [0098] & Fig. 27; the polymeric filter forms a barrier to passage of embolic agent, [0075]), the occluder adapted to dynamically change shape in response to the relative fluid pressure at the proximal and distal sides of the occluder (“the filter valve 1314 expands outward and is adapted to dynamically open and close in response to local fluid pressure conditions about the proximal and distal portions of the filter valve, as described above. “, [0100] & Fig. 27; also see [0094] & Fig. 20-23).
However, Pinchuk fails to explicitly disclose the catheter having a lumen opening at a plurality of side holes proximal of the distal orifice and the occluder extending over the side holes and
c) a flexible cover attached to the flexible catheter and adapted to extend between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel, and automatically move away from the occluder when the relative fluid pressure at the proximal and distal sides of the occluder permit antegrade flow.
However, Webler teaches a therapeutic device (abstract) comprising a catheter having a lumen opening at a plurality of side holes proximal of the distal orifice and the occluder extending over the side holes (holes 60 provided proximally to the distal orifice of catheter 50, [0043] and [0050] & Fig. 6; holes 60 being openings to inner diameter 58 of catheter 50, [0043] & Fig. 6; occlusion device 54 extending over holes 60).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Pinchuk with Webler to include a lumen opening at a plurality of side holes proximal of the distal orifice and the occluder extending over the side holes since such a modification would provide more openings for a therapeutic to be released through and provide structure to aid in the deployment of the occlusion device and yield predictable results pertaining to rapid device deployment and therapeutic delivery (see [0037], [0046], and [0050] of Webler). The Examiner notes that Webler discloses the “the flush may be contrast (an image enhancing agent), a contrast solution, a therapeutic solution, an energy transmission enhancing solution and/or any other fluid solution)”([0050]).
Further, Richter teaches a therapeutic device for delivery within a vessel of a patient during a vascular procedure (a single-unit percutaneous temporary valve-filter device with valve filter device 60, [0053] & Fig. 4A-4B) comprising a flexible cover attached to the flexible catheter and adapted to extend between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel (first disk 61, which is being interpreted as the flexible cover, attached to the center of disk 62, which is being interpreted as the occluder, and catheter 20 and adapted to lie on top of, or extend over, disk 62 between a portion of disk 62 and vessel wall 16, [0053]-[0054), and automatically move away from the occluder when the relative fluid pressure at the proximal and distal sides of the occluder permit antegrade flow (disk 61 configured to automatically move away from disk 62 during forward, antegrade blood flow, when fluid pressure conditions are higher upstream of disk 62 than downstream of disk 62, [0053]-[0054] & Fig. 4A-4B; “During systole, the first disk 61 may fold toward the center, for example toward the delivery device 20 sufficiently to allow blood flow through the vessel, as illustrated in FIG. 4B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the therapeutic device of Pinchuk, as modified, with Richter to include a flexible cover attached to the flexible catheter and adapted to extend between a portion of the occluder and the vessel wall when the occluder is advanced through the vessel, and automatically move away from the occluder when the relative fluid pressure at the proximal and distal sides of the occluder permit antegrade flow, since such a modification would provide structure to prevent retrograde blood flow through the vessel in order to better control infusate delivery and yield the same predictable results pertaining to maintaining unidirectional blood flow while providing filtering means (see [0029]-[0030] and [0053]-[0054] of Richter).
As modified, first disk 61 of Richter would be provided downstream of filter valve 1314 of Pinchuk, attached at the distal end of valve 1314 where distal portions 1336 couple to the outer surface 1318 of catheter 1308 of Pinchuk, the attachment being at a longitudinal center of valve 1314, similarly to how disk 61 is attached to disk 62 of Richter “in the center where they are connected to the delivery device 20” ([0054] of Richter).
Claim(s) 20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk (US 20180263752 A1), in view of Webler (US 20070129752 A1), in view of Richter (US 20140277096 A1), and further in view of Chomas ‘586 (US 20200038586 A1).
Regarding claim 20, Pinchuk, as modified, discloses all the limitations of claim 19. However, Pinchuk fails to explicitly disclose the therapeutic device further comprising a pressure sensor at the distal end of the catheter. However, Chomas ‘586 teaches a therapeutic device (catheter arrangement 12, [0032] and abstract & Fig. 1) further comprising a pressure sensor at the distal end of the catheter (pressure sensor 26 located near distal end 23 and distal of the occluder 14, [0034] and [0036] & Fig. 2 of Chomas ‘586).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Pinchuk, as modified, with Chomas ‘586 to include a pressure sensor at the distal end of the catheter since such a modification would provide real-time feedback regarding sensed pressure to help determine whether to inject the therapeutic agent at higher or lower flow rate to maintain desired pressure levels ([0036]-[0037]of Chomas ‘586). As modified, pressure sensor 26 of Chomas ‘586 would be provided on the distal end of catheter 1208 of Pinchuk.
Regarding claims 22-23, Pinchuk, as modified, discloses all the limitations of claim 21. However, Pinchuk fails to explicitly disclose the therapeutic device further comprising a pressure sensor at the distal end of the catheter, and wherein the pressure sensor is located distal of the occluder. However, Chomas ‘586 teaches a therapeutic device (catheter arrangement 12, [0032] and abstract & Fig. 1) further comprising a pressure sensor at the distal end of the catheter, and wherein the pressure sensor is located distal of the occluder (pressure sensor 26 located near distal end 23 and distal of the occluder 14, [0034] and [0036] & Fig. 2 of Chomas ‘586).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Pinchuk, as modified, with Chomas ‘586 to include a pressure sensor at the distal end of the catheter, and wherein the pressure sensor is located distal of the occluder, since such a modification would provide real-time feedback regarding sensed pressure to help determine whether to inject the therapeutic agent at higher or lower flow rate to maintain desired pressure levels ([0036]-[0037]of Chomas ‘586).
Response to Arguments
Applicant's arguments filed January 23rd 2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Chomas does not teach a flexible cover attached to the catheter and adapted to extend over and between a portion of the vessel occluder and the vessel wall when the vessel occluder is advanced through the vessel, the Examiner finds that while all of valve 2305 is advanced through the vessel, sleeve 2312 can reasonably be interpreted as positioned over and between sleeve 2311 and the wall of artery 2320 considering sleeve 2312 is closer to the distal opening of outer catheter 2301 (see [0106] & Fig. 33). Sleeve 2312 can alternatively be interpreted as positioned over and between sleeve 2311 and the wall of artery 2320 when observing valve 2305 in a longitudinal/vertical orientation. There is no language in the claims delimiting a frame of reference with respect to how the extension of the cover can be viewed. There is also no language in the claims limiting which specific parts of the occluder the cover is extended over.
In response to Applicant’s arguments that Chomas does not teach a flexible cover adapted to automatically move away from the vessel occluder when predetermined pressure conditions inside the vessel are met, the Examiner finds that sleeve 2312 is structured to expand, like a windsock, and collapse in reverse flow conditions (“the blood flows between the inner catheter 2304 and the sleeves 2311, 2312, similar to air flowing through a windsock. However, at least the second sleeve 2312 is structured to collapse in response to reverse blood flow conditions 2322b”, [0106]). The collapse of sleeve 2312 can be interpreted as automatic movement of sleeve 2312 away framework 2306, collar 2310, and sleeve 2311, as sleeve 2312 moves toward catheter 2304 and away from portions of the occluder ([0106] & Fig. 33). Sleeve 2312 can collapse while framework 2306, collar 2310, and sleeve 2311 remain stationary.
Applicant’s arguments with respect to the independent claims 14, 19, and 21 and the dependent claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jalgaonkar (US 20200345978 A1).
Jalgaonkar teaches a catheter 10 including a lumen 38 for drug infusion at a distal end 18 of the elongate body 14 of catheter 10 ([0088] and [0093] & Fig. 1-2). Catheter 10 includes an expandable member 22 made of a wire mesh configured to act as a filter and prevent retrograde flow of a substance (an embolic agent) through vasculature ([0084], [0087]-[0088], and [0100]-[0101] & Fig. 1-2 & 7A-7B). Expandable member 22 may include a fluid impermeable occlusive material 130, attached to expandable member 22 at only the proximal end 134 of material 130, configured to reduce or prevent retrograde blood flow and move away from/toward member 22 in response to different blood flow conditions ([0125], [0127]-[0128], and [0103]-[0132] & Fig. 7A-7B).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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