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The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 21-27 and 30-39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10-12, 13, 25, and 35-36 of U.S. Patent No. 11,554,003. Although the claims at issue are not identical, they are not patentably distinct from each other as detailed below.
Below is a chart showing the comparison of the current applications claim limitations with the claims of U.S. Patent No. 11,554,003. Bolded claim language shows identical claim limitation wording with the underlined portion showing the limitation wording that differs between the claims.
Application 18/084230
U.S. Patent No. 11,554,003
21. A filtration device for filtering one or more therapeutic agents in blood flowing in a blood vessel, the filtration device comprising: an elongate control member; an elongated filter member having a proximal end and a distal end carried on the control member such that the control member may be used to displace the elongated filter member out a distal end of a catheter; a plurality of channels formed in the filter member extending between the proximal end and the distal end of the filter member; wherein the filter member is dimensioned for positioning within a blood vessel of a human or non-human animal; and wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the channels.
1. A filtration device for filtering one or more therapeutic agents in blood flowing in a blood vessel, the filtration device comprising: an elongate control member; a solid elongated member having a proximal end and a distal end carried on the control member such that the control member may be used to displace the solid elongated member out a distal end of a catheter; a plurality of channels formed in the solid elongated member, wherein the plurality of channels are parallel to each other and extend from the proximal end to the distal end along a longitudinal axis of the solid elongated member; wherein the filtration device is dimensioned for positioning within a blood vessel of a human or non-human animal; and wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the channels.
22. The filtration device according to claim 21, wherein the filter member comprises a cylindrical member comprising a frustoconical leading edge at one of the proximal and distal ends and an opposite planar edge at the other of the proximal and distal ends, and wherein the channels extend from the frustoconical leading edge to the planar edge.
2. The filtration device according to claim 1, wherein the solid elongated member comprises a cylindrical member comprising a frustoconical leading edge opposite a planar edge; the plurality of channels formed in the solid elongated member, wherein the channels extend from the frustoconical leading edge to the planar edge.
23. The filtration device according to claim 21, wherein the filter member is a cylindrical member comprising a first planar edge at the proximal end opposite a second planar edge at the distal end, and wherein the plurality of channels extend from the first planar edge to the second planar edge.
3. The filtration device according to claim 1, wherein the solid elongated member is a cylindrical member comprising a first planar edge opposite a second planar edge and the plurality of channels extend from the first planar edge to the second planar edge.
24. The filtration device according to claim 21, wherein a channel of the plurality of channels is located along a central axis of the filter member and a remaining plurality of channels are arranged concentrically around the central channel.
4. The filtration device according to claim 1, wherein a channel of the plurality of channels is located in the center of the device and remaining plurality of channels are arranged concentrically around the central channel.
25. The filtration device according to claim 21, wherein the filter member is cylindrical and is dimensioned to (a) fill a cross-section of the blood vessel, (b) have a diameter smaller than the blood vessel diameter, or (c) have a diameter larger than the blood vessel diameter.
5. The filtration device according to claim 1, wherein the solid elongated member is cylindrical and is dimensioned to (a) fill a cross-section of the blood vessel, (b) have a diameter smaller than the blood vessel diameter, or (c) have a diameter larger than the blood vessel diameter.
26. The filtration device according to claim 21, wherein a surface of the filter member at one or more edges and the surfaces of the plurality of channels of the filter member are functionalized to bind to a first therapeutic agent or to a plurality of therapeutic agents.
6. The filtration device according to claim 1, wherein a surface of the device at one or more edges and the surfaces of the plurality of channels of the device are functionalized to bind to a first therapeutic agent or to a plurality of therapeutic agents.
27. The filtration device according to claim 21, wherein the plurality of channels comprise a circular or an oval shaped opening at one of the proximal and distal ends of the filter member.
7. The filtration device according to claim 1, wherein the plurality of channels comprise a circular or an oval shaped opening at an edge of the device.
30. The filtration device according to claim 21, wherein a periphery of the plurality of channels comprises a cylindrical cross-section between the proximal and distal ends.
10. The filtration device according to claim 1, wherein the periphery of the plurality of channels comprise a cylindrical shape along the length of the channels.
31. The filtration device according to claim 21, wherein an outer surface of the filter member and interior surfaces of the channels are functionalized with a moiety for binding to a first therapeutic agent.
11. The filtration device according to claim 1, wherein the outer surface of the device and the interior surface of the channels is functionalized with a moiety for binding to a first therapeutic agent.
32. The filtration device according to claim 21, wherein one or both of an outer surface of the filter member and interior surfaces of the channels are functionalized with a plurality of moieties for binding to a plurality of therapeutic agents.
12. The filtration device according to claim 1, wherein the outer surface of the device and/or the interior surface of the channels is functionalized with a plurality of moieties for binding to a plurality of therapeutic agents.
33. The filtration device according to claim 21, wherein the elongated filter member comprises a biocompatible polymer-casted scaffold.
35. The filtration device according to claim 1, wherein the solid elongated member comprises a biocompatible-polymer-casted scaffold.
34. The filtration device according to claim 21, wherein the elongated filter member comprises a structure configured to expand within the blood vessel when the structure is displaced out the distal end of the catheter.
36. The filtration device according to claim 1, wherein the solid elongated member comprises a structure configured to expand within the blood vessel when the structure is displaced out the distal end of the catheter.
35. The filtration device according to claim 21, wherein the plurality of channels extend substantially parallel to a longitudinal axis of the filter member between the proximal and distal ends.
1. A filtration device…wherein the plurality of channels are parallel to each other and extend from the proximal end to the distal end along a longitudinal axis of the solid elongated member;
37. A system for filtering one or more therapeutic agents in blood flowing in a blood vessel, the filtration device comprising: a catheter comprising a lumen and a distal end sized for introduction into a blood vessel downstream from a target tissue site; a filtration device comprising an elongated filter member having a proximal end and a distal end, a plurality of channels formed in the filter member that extend between the proximal end and the distal end; and an elongated control member carrying the filtration device such that the control member may be used to displace the filter member out a distal end of the catheter within the blood vessel downstream from the target tissue site, wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the channels.
37. A system for filtering one or more therapeutic agents in blood flowing in a blood vessel, the filtration device comprising: a catheter comprising a lumen and a distal end sized for introduction into a blood vessel downstream from a target tissue site; a filtration device comprising a solid elongated member having a proximal end and a distal end, a plurality of channels formed in the solid elongated member that extend substantially parallel to each other between the proximal end and the distal end of the solid elongated member; and an elongated control member carrying the filtration device such that the control member may be used to displace the solid elongated member out a distal end of a catheter within the blood vessel downstream from the target tissue site, wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the channels.
38. The system according to claim 37, wherein the filter member is configured to expand within the blood vessel when the filter member is displaced out the distal end of the catheter.
38. The system according to claim 37, wherein the solid elongated member comprises a structure configured to expand within the blood vessel when the structure is displaced out the distal end of the catheter.
39. The system according to claim 38, wherein the filter member is configured to expand to occupy the entire cross-sectional area of the blood vessel to direct blood flowing within the blood vessel through the channels.
39. The system according to claim 38, wherein the structure is configured to expand to occupy the entire cross-sectional area of the blood vessel to direct blood flowing through the blood vessel through the channels.
40. The system according to claim 37, wherein the plurality of channels extend substantially parallel to a longitudinal axis of the filtration device between the proximal and distal ends.
37. a plurality of channels formed in the solid elongated member that extend substantially parallel to each other between the proximal end and the distal end of the solid elongated member
37. A system for filtering one or more therapeutic agents in blood flowing in a blood vessel, the filtration device comprising: a catheter comprising a lumen and a distal end sized for introduction into a blood vessel downstream from a target tissue site; a filtration device comprising an elongated filter member having a proximal end and a distal end, a plurality of channels formed in the filter member that extend between the proximal end and the distal end; and an elongated control member carrying the filtration device such that the control member may be used to displace the filter member out a distal end of the catheter within the blood vessel downstream from the target tissue site, wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the channels.
1. A filtration device for filtering one or more therapeutic agents in blood flowing in a blood vessel, the filtration device comprising: an elongate control member; a solid elongated member having a proximal end and a distal end carried on the control member such that the control member may be used to displace the solid elongated member out a distal end of a catheter; a plurality of channels formed in the solid elongated member, wherein the plurality of channels are parallel to each other and extend from the proximal end to the distal end along a longitudinal axis of the solid elongated member; wherein the filtration device is dimensioned for positioning within a blood vessel of a human or non-human animal; and wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the channels.
57. The system according to claim 37, wherein the filter member comprises a cylindrical member comprising a frustoconical leading edge at one of the proximal and distal ends and an opposite planar edge at the other of the proximal and distal ends, and wherein the channels extend from the frustoconical leading edge to the planar edge.
2. The filtration device according to claim 1, wherein the solid elongated member comprises a cylindrical member comprising a frustoconical leading edge opposite a planar edge; the plurality of channels formed in the solid elongated member, wherein the channels extend from the frustoconical leading edge to the planar edge.
58. The system according to claim 37, wherein the filter member is a cylindrical member comprising a first planar edge at the proximal end opposite a second planar edge at the distal end, and wherein the plurality of channels extend from the first planar edge to the second planar edge.
3. The filtration device according to claim 1, wherein the solid elongated member is a cylindrical member comprising a first planar edge opposite a second planar edge and the plurality of channels extend from the first planar edge to the second planar edge.
59. The system according to claim 37, wherein a channel of the plurality of channels is located along a central axis of the filter member and a remaining plurality of channels are arranged concentrically around the central channel.
4. The filtration device according to claim 1, wherein a channel of the plurality of channels is located in the center of the device and remaining plurality of channels are arranged concentrically around the central channel.
60. The system according to claim 37, wherein the filter member is cylindrical and is dimensioned to (a) fill a cross-section of the blood vessel, (b) have a diameter smaller than the blood vessel diameter, or (c) have a diameter larger than the blood vessel diameter.
5. The filtration device according to claim 1, wherein the solid elongated member is cylindrical and is dimensioned to (a) fill a cross-section of the blood vessel, (b) have a diameter smaller than the blood vessel diameter, or (c) have a diameter larger than the blood vessel diameter.
61. The system according to claim 37, wherein a surface of the filter member at one or more edges and the surfaces of the plurality of channels of the filter member are functionalized to bind to a first therapeutic agent or to a plurality of therapeutic agents.
6. The filtration device according to claim 1, wherein a surface of the device at one or more edges and the surfaces of the plurality of channels of the device are functionalized to bind to a first therapeutic agent or to a plurality of therapeutic agents.
62. The system according to claim 37, wherein the plurality of channels comprise a circular opening at one of the proximal and distal ends of the filter member.
7. The filtration device according to claim 1, wherein the plurality of channels comprise a circular or an oval shaped opening at an edge of the device.
63. The system according to claim 37, wherein a periphery of the plurality of channels comprises a cylindrical cross-section between the proximal and distal ends.
10. The filtration device according to claim 1, wherein the periphery of the plurality of channels comprise a cylindrical shape along the length of the channels.
64. The system according to claim 37, wherein an outer surface of the filter member and interior surfaces of the channels are functionalized with a moiety for binding to a first therapeutic agent.
11. The filtration device according to claim 1, wherein the outer surface of the device and the interior surface of the channels is functionalized with a moiety for binding to a first therapeutic agent.
65. The system according to claim 37, wherein one or both of an outer surface of the filter member and interior surfaces of the channels are functionalized with a plurality of moieties for binding to a plurality of therapeutic agents.
12. The filtration device according to claim 1, wherein the outer surface of the device and/or the interior surface of the channels is functionalized with a plurality of moieties for binding to a plurality of therapeutic agents.
66. The system according to claim 37, wherein the elongated filter member comprises a biocompatible polymer-casted scaffold.
35. The filtration device according to claim 1, wherein the solid elongated member comprises a biocompatible-polymer-casted scaffold.
67. The system according to claim 37, wherein the elongated filter member comprises a structure configured to expand within the blood vessel when the structure is displaced out the distal end of the catheter.
36. The filtration device according to claim 1, wherein the solid elongated member comprises a structure configured to expand within the blood vessel when the structure is displaced out the distal end of the catheter.
Regarding claims 21, 25, 33, and 34, as can be seen from the claim mapping above, the current application claim limitations differ from U.S. Patent No. 11,554,003 claims 1, 5, 35, and 36 respectively in that they are broader, not requiring the limitations of being solid and the plurality of channels being parallel to each other and extend from the proximal end to the distal end along a longitudinal axis of the solid elongated member, with the current claim only requiring the channels to extend between the proximal and distal ends. The narrower scope of the claims of U.S. Patent NO. 11,554,003 are seen to anticipate the claimed device of the current invention as a solid elongated member is encompassed in the scope of the filter member of the current applications claims, and the patent claim language of the plurality of channels being parallel to each other and extending from the proximal end to the distal end anticipates the limitation of “extending between” in that a channel that is parallel and extends from a proximal end to a distal end is necessarily between the proximal end and the distal end in the space of the extension.
Regarding claim 22, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 2 of U.S. Patent No. 11,554,003 further anticipates the filter member comprising a cylindrical member comprising a frustoconical leading edge and an opposite planner edge wherein the channels extend from the frustoconical leading edge to the planar edge. Claim 1 from which Claim 2 is dependent further anticipates the plurality of channels extending from the proximal end to the distal end and due to the requirement of the channels to also extend from the frustoconical leading edge to the planar edge in claim 2 requires the placement of the frustoconical leading edge and planar edge to be opposite one another at the proximal and distal ends and therefore the current claim 22 is anticipated by claim 2 of U.S. Patent No. 11,554,003.
Regarding claim 23, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 3 of U.S. Patent No. 11,554,003 further anticipates the filter member being a cylindrical member comprising a first planar edge opposite a second planar edge and wherein the plurality of channels extend from the first planar edge to the second planar edge.
Claim 3 does not expressly anticipate the limitations of the first planar edge and the second planar edge being at the proximal end and at the distal end respectively, however, Claim 3 is dependent upon claim 1 which contains the limitation of the channels extending from the proximal end to the distal end and claim 3 requires the channels to extend from the first planar edge to the second planar edge which would thus require the first planar edge and second planar edge located opposite one another to be located such that one was located at a proximal end and one located at a distal end and as such anticipates a first planar edge at the proximal end and a second planar edge at the distal end.
Regarding claim 24, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 4 of U.S. Patent No. 11,554,003 further anticipates a channel of the plurality of channels being in the center of the device and the remaining plurality of channels being arranged concentrically around the central channel with claim 1 stating that the channels are formed in the elongate member and therefore the difference in language of “along a central axis of the filter member” is anticipated by “in the center of the device” as a channel formed in the elongated member and in the center of the device stipulates a central location of the elongate member and a channel positioned in the center of the elongate member would necessarily be located along a central axis as a central axis would necessarily pass through the center.
Regarding claim 26, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 6 of U.S. Patent No. 11,554,003 further anticipates a surface of the device at one or more edges and the surfaces of the plurality of channels of the device are functionalized to bind to a first therapeutic agent or to a plurality of therapeutic agents. Claim 6 differs from claim 26 in that it states the surface being a surface of the device rather than a surface of the filter member and therefore differs in scope in that the claim does not necessarily define the edges as those of the filtration member, however, one of ordinary skill in the art would have concluded that the invention defined in the claim at issue would have been an obvious variation of the invention defined in claim 6 of U.S. Patent No. 11,554,003 as the patent at hand defines the edges as being the edges of the filter member that are functionalized within its specification and provides no mention to functionalizing edges that are not related to the filter member and as such would constitute the edges of the device to which the surfaces are functionalized stated in claim 6 as being the edges of the filter member.
Regarding claim 27, U.S. Patent No. 11,554,003 claim 1 anticipates claim 21. Claim 25 dependent upon claim 13 which includes all the limitations of claim 1 further anticipates the plurality of channels comprising a circular [shaped] opening at the planar edge wherein the plurality of channels extend from the first planar edge to the second planar edge which would thus require the first planar edge and the second planar edge to be located at the proximal and distal ends as the channels extend from the proximal and distal ends as disclosed in claim 1 and as such the opening would be at one of the proximal and distal ends as required by the claim limitations.
Regarding claim 30, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 10 of U.S. Patent No. 11,554,003 further anticipates a periphery of the plurality of channels comprising a cylindrical shape along the length of the channels. While the language differs from the currently claimed 30 in that it does not state a cylindrical cross-section between the proximal and distal ends, the requirement of claim 1 for the channels to extend from the proximal end to the distal end along a longitudinal axis and thus along the length would necessarily comprise a cylindrical cross-section at a point between the proximal and distal ends of the device.
Regarding claim 31, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 11 of U.S. Patent No. 11,554,003 further anticipates the outer surface of the device and the interior surface of the channels is functionalized with a moiety for binding to a first therapeutic agent. Claim 11 differs from claim 31 in that it states the outer surface being an outer surface of the device rather than an outer surface of the filter member and therefore differs in scope in that the claim does not necessarily define the outer surface as that of the filtration member, however, one of ordinary skill in the art would have concluded that the invention defined in the claim at issue would have been an obvious variation of the invention defined in claim 11 of U.S. Patent No. 11,554,003 as the patent at hand defines the outer surface as being the outer surface of the filter member that are functionalized within its specification and provides no mention to functionalizing outer surfaces that are not related to the filter member and as such would constitute the outer surface of the device to which the surfaces are functionalized stated in claim 11 as being the outer surface of the filter member.
Regarding claim 32, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 12 of U.S. Patent No. 11,554,003 further anticipates one or both of (and/or) an outer surface of the device and interior surface of the channels being functionalized with a plurality of moieties for binding to a plurality of therapeutic agents. Claim 12 differs from claim 31 in that it states the outer surface being an outer surface of the device rather than an outer surface of the filter member and therefore differs in scope in that the claim does not necessarily define the outer surface as that of the filtration member, however, one of ordinary skill in the art would have concluded that the invention defined in the claim at issue would have been an obvious variation of the invention defined in claim 12 of U.S. Patent No. 11,554,003 as the patent at hand defines the outer surface of the device as being the outer surface of the filter member that are functionalized within its specification and provides no mention to functionalizing outer surfaces that are not related to the filter member and as such would constitute the outer surfaces of the device to which the surfaces are functionalized stated in claim 12 as being the outer surface of the filter member.
Regarding claim 35, U.S. Patent No. 11,554,003 anticipates claim 21. Claim 2 of U.S. Patent No. 11,554,003 further anticipates the plurality of channels extending substantially parallel and along a longitudinal axis from the proximal end to the distal end. As such claim 2 anticipates the plurality of channels extending substantially parallel to the longitudinal axis of the elongated member between the proximal and distal ends as they extend along the longitudinal axis and are parallel to each other and the extension along a longitudinal axis necessitates the channels extending in the direction of the longitudinal axis and thus substantially parallel to it.
Regarding claims 37-39, Claims 37-39 of U.S. Patent No. 11,554,003 are seen to anticipate these claims as the difference in scope between the current claims 37-39 and U.S. Patent No. 11,554,003 claims 37-39 are simply that the current claims are broader, not requiring the limitations of being solid, the plurality of channels being parallel to each other or a structure configured to expand. The narrower scope of the claims of U.S. Patent NO. 11,554,003 are seen to anticipate the claimed device of the current invention as a solid elongated member is encompassed in the scope of the filter member of the current applications claims, the “structure” as detailed by U.S. Patent No. 11,554,003 is comprised by the elongate member and thus part of the filter member.
Claim 37, 40, and 57-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10-12, 13, 25, and 35-36 of U.S. Patent No. 11,554,003 in view of Hetts et al. (WIPO Publication 2014/100201). Although the claims at issue are not identical, they are not patentably distinct from each other as detailed below.
Regarding claims 37, U.S. Patent No. 11,554,003 claim 1 is seen to differ in scope to currently claimed 37 of the present application in that the current claims are broader, not requiring the limitations of being solid, the plurality of channels being parallel to each other or comprising a catheter comprising a lumen and a distal end sized for introduction into a blood vessel downstream from a target tissue site, as seen in the claim mapping above.
With regard the limitation of being solid, the narrower scope of the claims of U.S. Patent NO. 11,554,003 are seen to anticipate the claimed device of the current invention as a solid elongated member is encompassed in the scope of the filter member of the current applications claims.
Regarding the catheter, however, in view of the teachings of Hetts, which teaches a catheter 1001 comprising a lumen (space through which control member 1007 is seen passing through in Fig. 10) and a distal end sized for introduction into a blood vessel 1050 downstream (Abstract filtration device is positioned downstream) from a target tissue site that has a filtration device 1000 displaced from it (Fig. 10 shows displacement of filtration device from a distal end of a catheter that is sized to be introduced into a blood vessel 1050), it would have been obvious to one of ordinary skill in art to have included the filtration device of claim 1 in a system comprising the catheter as claimed in the current applications claim 37 for the purpose of delivering the filtration device to the patient’s blood vessel such that the device could function as intended to filter a therapeutic agent in the blood out of the blood. As the differences of claims 37 and 57-67 over the claims of U.S. Patent No. 11,554,003 are seen to have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of Hetts and as such are not considered patentable differences over the claims of U.S. Patent No. 11,554,003.
Regarding claim 40, U.S. Patent No. 11,554,003 in view of Hetts renders obvious claim 37 as detailed above. Claim 2 of U.S. Patent No. 11,554,003 further anticipates the plurality of channels extending substantially parallel and along a longitudinal axis from the proximal end to the distal end. As such claim 2 anticipates the plurality of channels extending substantially parallel to the longitudinal axis of the elongated member between the proximal and distal ends as they extend along the longitudinal axis and are parallel to each other and the extension along a longitudinal axis necessitates the channels extending in the direction of the longitudinal axis and thus substantially parallel to it.
Regarding claim 57, U.S. Patent No. 11,554,003 in view of Hetts renders obvious claim 37 as detailed above. Claim 2 of U.S. Patent No. 11,554,003 further anticipates the filter member comprising a cylindrical member comprising a frustoconical leading edge and an opposite planer edge wherein the channels extend from the frustoconical leading edge to the planar edge. Claim 1 from which Claim 2 is dependent further anticipates the plurality of channels extending from the proximal end to the distal end and due to the requirement of the channels to also extend from the frustoconical leading edge to the planar edge in claim 2 requires the placement of the frustoconical leading edge and planar edge to be opposite one another at the proximal and distal ends and therefore the current claim 57 is anticipated by claim 2 of U.S. Patent No. 11,554,003.
Regarding claim 58, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 3 of U.S. Patent No. 11,554,003 further anticipates the filter member being a cylindrical member comprising a first planar edge opposite a second planar edge and wherein the plurality of channels extend from the first planar edge to the second planar edge.
Claim 3 does not expressly anticipate the limitations of the first planar edge and the second planar edge being at the proximal end and at the distal end respectively, however, Claim 3 is dependent upon claim 1 which contains the limitation of the channels extending from the proximal end to the distal end and claim 3 requires the channels to extend from the first planar edge to the second planar edge which would thus require the first planar edge and second planar edge located opposite one another to be located such that one was located at a proximal end and one located at a distal end and as such anticipates a first planar edge at the proximal end and a second planar edge at the distal end.
Regarding claim 59, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 4 of U.S. Patent No. 11,554,003 further anticipates a channel of the plurality of channels being in the center of the device and the remaining plurality of channels being arranged concentrically around the central channel with claim 1 stating that the channels are formed in the elongate member and therefore the difference in language of “along a central axis of the filter member” is anticipated by “in the center of the device” as a channel formed in the elongated member and in the center of the device stipulates a central location of the elongate member and a channel positioned in the center of the elongate member would necessarily be located along a central axis as a central axis would necessarily pass through the center.
Regarding claims 60, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 5 further anticipates the elongated member being cylindrical and is dimensioned to (a) fill a cross-section of the blood vessel, (b) have a diameter smaller than the blood vessel diameter, or (c) have a diameter larger than the blood vessel diameter.
Regarding claim 61, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 6 of U.S. Patent No. 11,554,003 further anticipates a surface of the device at one or more edges and the surfaces of the plurality of channels of the device are functionalized to bind to a first therapeutic agent or to a plurality of therapeutic agents. Claim 6 differs from claim 61 in that it states the surface being a surface of the device rather than a surface of the filter member and therefore differs in scope in that the claim does not necessarily define the edges as those of the filtration member, however, one of ordinary skill in the art would have concluded that the invention defined in the claim at issue would have been an obvious variation of the invention defined in claim 6 of U.S. Patent No. 11,554,003 as the patent at hand defines the edges as being the edges of the filter member that are functionalized within its specification and provides no mention to functionalizing edges that are not related to the filter member and as such would constitute the edges of the device to which the surfaces are functionalized stated in claim 6 as being the edges of the filter member.
Regarding claim 62, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 25 dependent upon claim 13 which includes all the limitations of claim 1 further anticipates the plurality of channels comprising a circular [shaped] opening at the planar edge wherein the plurality of channels extend from the first planar edge to the second planar edge which would thus require the first planar edge and the second planar edge to be located at the proximal and distal ends as the channels extend from the proximal and distal ends as disclosed in claim 1 and as such the opening would be at one of the proximal and distal ends as required by the claim limitations.
Regarding claim 63, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 10 of U.S. Patent No. 11,554,003 further anticipates a periphery of the plurality of channels comprising a cylindrical shape along the length of the channels. While the language differs from the currently claimed 63 in that it does not state a cylindrical cross-section between the proximal and distal ends, the requirement of claim 1 for the channels to extend from the proximal end to the distal end along a longitudinal axis and thus along the length would necessarily comprise a cylindrical cross-section at a point between the proximal and distal ends of the device.
Regarding claim 64, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 11 of U.S. Patent No. 11,554,003 further anticipates the outer surface of the device and the interior surface of the channels is functionalized with a moiety for binding to a first therapeutic agent. Claim 11 differs from claim 64 in that it states the outer surface being an outer surface of the device rather than an outer surface of the filter member and therefore differs in scope in that the claim does not necessarily define the outer surface as that of the filtration member, however, one of ordinary skill in the art would have concluded that the invention defined in the claim at issue would have been an obvious variation of the invention defined in claim 11 of U.S. Patent No. 11,554,003 as the patent at hand defines the outer surface as being the outer surface of the filter member that are functionalized within its specification and provides no mention to functionalizing outer surfaces that are not related to the filter member and as such would constitute the outer surface of the device to which the surfaces are functionalized stated in claim 11 as being the outer surface of the filter member.
Regarding claim 65, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 12 of U.S. Patent No. 11,554,003 further anticipates one or both of (and/or) an outer surface of the device and interior surface of the channels being functionalized with a plurality of moieties for binding to a plurality of therapeutic agents. Claim 12 differs from claim 65 in that it states the outer surface being an outer surface of the device rather than an outer surface of the filter member and therefore differs in scope in that the claim does not necessarily define the outer surface as that of the filtration member, however, one of ordinary skill in the art would have concluded that the invention defined in the claim at issue would have been an obvious variation of the invention defined in claim 12 of U.S. Patent No. 11,554,003 as the patent at hand defines the outer surface of the device as being the outer surface of the filter member that are functionalized within its specification and provides no mention to functionalizing outer surfaces that are not related to the filter member and as such would constitute the outer surfaces of the device to which the surfaces are functionalized stated in claim 12 as being the outer surface of the filter member.
Regarding claims 66, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claims 35 further anticipates the elongated member comprising a biocompatible-polymer-casted scaffold.
Regarding claim 67, U.S. Patent No. 11,554,003 claim 1 in view of Hetts renders obvious claim 37 as detailed above. Claim 36 further anticipates the elongated member comprising a structure configured to expand within the blood vessel when the structure is displaced out the distal end of the catheter.
Claim Rejections - 35 USC § 102
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.
Claim(s) 21, 25-26, 31-34, 37-39, 60-61, and 64-67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hetts (WIPO Publication 2014/100201).
Regarding claim 21, Hetts discloses a filtration device 500 for filtering one or more therapeutic agents in blood flowing 551 in a blood vessel 550, the filtration device comprising:
An elongate control member 507;
An elongated filter member 503 having a proximal end (Fig. 5 end closest to catheter 501) and distal end (end distal to catheter in Fig. 5) carried on the control member such that the control member may be used to displace the elongated filter member out a distal end of a catheter (Page 14 lines 19-27 the elongated control member is operably coupled to the frame structure and is used to displace the frame structure and porous membranes horizontally along the central axis of the catheter…frame structure is biased to an expanded state so that when the frame structure is displaced outside the distal end of the catheter, the frame structure is expanded to occupy the cross sectional area of the blood vessel);
A plurality of channels (pores of porous singular porous membrane Page 14 line 17 single membrane composed of the filtration material; line 20 porous) formed in the filter member (pores formed in membrane) extending between the proximal end and the distal end of the filter member (Page 15 lines 1-3 blood passes through the porous frame structure, the passage of blood through the membrane shows the extension from the distal side of the membrane to the proximal side and thus the extension of the channels therebetween);
Wherein the filter member is dimensioned for positioning within a blood vessel 550; and
Wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the porous membranes (Page 15 lines 1-3, porous membrane composed of the filtration material and thus surfaces that define pores…the therapeutic agent is filtered by the membranes composed of the filtration material).
Regarding claim 25, Hetts discloses the filtration device according to claim 21. Hetts further discloses the filter member being cylindrical (Page 14 line 31 conical shaped) and being dimensioned to fill a cross-section of the blood vessel (Page 14 lines 23-24 expanded to occupy the cross sectional area of the blood vessel).
Regarding claim 26, Hetts discloses the filtration device according to claim 21. Hetts further discloses a surface of the filter member at one or more edges and the surface of the plurality of channels of the filter member being functionalized to bind to a first therapeutic agent (Page 14 lines 13-16, membrane is composed of filtration material and thus the entirety of the membrane including its surfaces would be functionalized to bind to therapeutic agent..made from material impregnated with filtration material having binding properties).
Regarding claim 31, Hetts discloses the filtration device according to claim 21. Hetts further discloses an outer surface of the filter member and interior surfaces of the channels being functionalized with a moiety for binding to a first therapeutic agent (Page 14 lines 13-16, membrane is composed of filtration material and thus the entirety of the membrane including its surfaces would be functionalized to bind to therapeutic agent..made from material impregnated with filtration material having binding properties).
Regarding claim 32, Hetts discloses the filtration device according to claim 21. Hetts further discloses both and outer surface of the filter member and interior surfaces of the channels being functionalized with a plurality of moieties for binding to a plurality of therapeutic agents (Page 14 lines 13-16, membrane is composed of filtration material and thus the entirety of the membrane including its surfaces would be functionalized to bind to therapeutic agent..made from material impregnated with filtration material having binding properties; Page 21 the filtration material may include one or more types of material having properties that…bind…one or more therapeutic agents).
Regarding claim 33, Hetts discloses the filtration device according to claim 21. Hetts further discloses the elongated filter member comprising a biocompatible polymer-scaffold (Page 8 lines 29-35 and Page 9 lines 1-9, frame structure made from any variety of materials such as polymeric materials..constructed to be non-thrombogenic).
Hetts does not expressly disclose the scaffold being casted however, the claimed phrase of “casted” is being treated as a product by process limitation as a material that results from the casting process. As set forth in MPEP 2113, “Even 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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of being casted imparts structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “casted” is being given very little patentable weight.
Regarding claim 34, Hetts discloses the filtration device according to claim 21. Hetts further discloses the elongated filter member comprising a structure configured to expand within the blood vessel when the structure is displaced out of the distal end of the catheter (Page 14 frame structure biased to expand when the frame structure is displaced outside the distal end of the catheter).
Regarding claim 37, Hetts discloses a system (Fig. 5, embodiment with singular porous membrane Page 14 line 17 single membrane) for filtering one or more therapeutic agents in blood flowing 551 in a blood vessel 550, the filtration device comprising:
A catheter 501 comprising a lumen (Fig. 5 lumen through which 507 extends) and a distal end sized for introduction into a blood vessel downstream from a target tissue site (Fig. 5 shows distal end of 500 positioned within blood vessel 550)
A filtration device 503 an elongated filter member 503 having a proximal end (Fig. 5 end closest to catheter 501) and distal end (end distal to catheter in Fig. 5), a plurality of channels (pores of porous singular porous membrane Page 14 line 17 single membrane composed of the filtration material; line 20 porous) formed in the filter member (pores formed in membrane) extending between the proximal end and the distal end of the filter member (Page 15 lines 1-3 blood passes through the porous frame structure, the passage of blood through the membrane shows the extension from the distal side of the membrane to the proximal side and thus the extension of the channels therebetween);
An elongate control member 507 carrying the filtration device such that the control member may be used to displace the elongated filter member out a distal end of a catheter within the blood vessel 550 downstream from the target tissue(Abstract, positioned downstream from a target tissue; Page 14 lines 19-27 the elongated control member is operably coupled to the frame structure and is used to displace the frame structure and porous membranes horizontally along the central axis of the catheter…frame structure is biased to an expanded state so that when the frame structure is displaced outside the distal end of the catheter, the frame structure is expanded to occupy the cross sectional area of the blood vessel);;
Wherein surfaces of the channels are functionalized to bind to a therapeutic agent in blood flowing through the porous membranes (Page 15 lines 1-3, porous membrane composed of the filtration material and thus surfaces that define pores…the therapeutic agent is filtered by the membranes composed of the filtration material).
Regarding claim 38, Hetts discloses the filtration device according to claim 37. Hetts further discloses the filter member being configured to expand within the blood vessel when the filter member is displaced out the distal end of the catheter (Page 14 lines 21-24 frame structure is biased to an expanded state so that when the frame structure is displaced outside the distal end of the catheter, the frame structure is expanded to occupy the cross-sectional area of the blood vessel).
Regarding claim 39, Hetts discloses the filtration device according to claim 38. Hetts further discloses the filter member being configured to expand to occupy the entire cross-sectional area of the blood vessel to direct blood flowing within the blood vessel through the channels (Page 14 lines 21-24 frame structure is biased to an expanded state so that when the frame structure is displaced outside the distal end of the catheter, the frame structure is expanded to occupy the cross-sectional area of the blood vessel).
Regarding claim 60, Hetts discloses the filtration device according to claim 37. Hetts further discloses the filter member being cylindrical (Page 14 line 31 conical) and dimensioned to fill a cross section of the blood vessel (Page 14 lines 21-24 frame structure is biased to an expanded state so that when the frame structure is displaced outside the distal end of the catheter, the frame structure is expanded to occupy the cross-sectional area of the blood vessel).
Regarding claim 61, Hetts discloses the filtration device according to claim 37. Hetts further discloses a surface of the filter member at one or more edges and the surface of the plurality of channels of the filter member being functionalized to bind to a first therapeutic agent (Page 14 lines 13-16, membrane is composed of filtration material and thus the entirety of the membrane including its surfaces would be functionalized to bind to therapeutic agent..made from material impregnated with filtration material having binding properties).
Regarding claim 64, Hetts discloses the filtration device according to claim 37. Hetts further discloses an outer surface of the filter member and interior surfaces of the channels being functionalized with a moiety for binding to a first therapeutic agent (Page 14 lines 13-16, membrane is composed of filtration material and thus the entirety of the membrane including its surfaces would be functionalized to bind to therapeutic agent..made from material impregnated with filtration material having binding properties).
Regarding claim 65, Hetts discloses the filtration device according to claim 37. Hetts further discloses both and outer surface of the filter member and interior surfaces of the channels being functionalized with a plurality of moieties for binding to a plurality of therapeutic agents (Page 14 lines 13-16, membrane is composed of filtration material and thus the entirety of the membrane including its surfaces would be functionalized to bind to therapeutic agent..made from material impregnated with filtration material having binding properties; Page 21 the filtration material may include one or more types of material having properties that…bind…one or more therapeutic agents).
Regarding claim 66, Hetts discloses the filtration device according to claim 37. Hetts further discloses the elongated filter member comprising a biocompatible polymer-scaffold (Page 8 lines 29-35 and Page 9 lines 1-9, frame structure made from any variety of materials such as polymeric materials..constructed to be non-thrombogenic).
Hetts does not expressly disclose the scaffold being casted however, the claimed phrase of “casted” is being treated as a product by process limitation as a material that results from the casting process. As set forth in MPEP 2113, “Even 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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of being casted imparts structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “casted” is being given very little patentable weight.
Regarding claim 67, Hetts discloses the filtration device according to claim 37. Hetts further discloses a structure (frame structure) being configured to expand within the blood vessel when the filter member is displaced out the distal end of the catheter (Page 14 lines 21-24 frame structure is biased to an expanded state so that when the frame structure is displaced outside the distal end of the catheter, the frame structure is expanded to occupy the cross-sectional area of the blood vessel).
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) 24, 27, 30, 35, 40, 59, and 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hetts (WIPO Publication 2014/100201) in view of Johnson et al. (U.S. Publication 2013/0238010).
Regarding claims 24 and 59, Hetts discloses the filtration device according to claim 21 and the system according to claim 37. Hetts does not expressly a channel of the plurality of channels being located along a central axis of the filter member and remaining a remaining plurality of channels being arranged concentrically around the central channel.
However, Johnson, in the same field of endeavor of filtration devices for blood, teaches the ability to adjust the size, shape, density, orientation, and distribution of channels on a membrane for the purpose of controlling the flow rate profile through the filter membrane (¶0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the channels to be in the Hetts to have one channel located along a central axis of the filter member and a remaining plurality of channels arranged concentrically around the central channel since this claimed position of channels does not change the channels’ ability to function as channel for blood flow therethrough. Since applicant has not given any criticality to why the position of the channel disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Furthermore, Johnson discloses the ability to manipulate the positioning of channels (distribution) on a membrane and as such one of ordinary skill in the art would have been expected to have success in the rearrangement of the channels of Hetts.
Regarding claims 27, 30, 62, and 63, Hetts discloses the filtration device according to claim 21 and the system according to claim 37. Hetts does not expressly disclose or suggest the plurality of channels comprising a circular opening at one of the proximal and distal ends of the filter member or a periphery of the plurality of channels comprising a cylindrical cross-section between the proximal and distal ends.
However, Johnson, in the same field of endeavor of filtration devices for blood, teaches providing a membrane with pores that are circular, ellipsoid, oval, or oblong and adjusting the pore shape for the purpose of controlling the flow rate profile through the filter membrane (¶0091 the pore shape can be adjusted to control the flow rate profile through the filter membrane).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the channels of Hetts to have been circular in cross-section and as such comprise a circular opening, as taught by Johnson for the purpose of controlling the flow rate profile through the filter membrane.
Regarding claims 35 and 40, Hetts discloses the filtration device according to claim 21 and the system according to claim 37. Hetts does not expressly disclose or suggest the plurality of channels extending substantially parallel to a longitudinal axis of the filtration device between the proximal and distal ends.
However, Johnson, in the same field of endeavor of filtration devices for blood, teaches adjusting the orientation of channels in a membrane in order to adjust or control the flow rate profile through the filter membrane (¶0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have adjusted the plurality of channels to extend substantially parallel to a longitudinal axis of the filtration device since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation and is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Johnson discloses pore orientation as a variable that effects the flow rate profile through the filter membrane. Orientation of a pores’ axis in a manner perpendicular to blood flow would have the effect of slowing or impeding blood flow therethrough, with the orientation of a pores' central axis in a manner parallel to blood flow providing less flow resistance. As such it would have been obvious to one of ordinary skill in the art to have optimized the orientation of the channels of Hetts to arrive at the desired channel orientation.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art consists of the disclose of Hetts et al. (WIPO Publication 2014/100201).
Regarding to claims 22, 23, 57, and 58, Hetts anticipates the filtration device according to claim 21 and the system according to claim 37. Hetts further disclose the filter member being a cylindrical member comprising a frustoconical leading edge having a first planar edge at the proximal end and an opposite second planar edge at the distal end.
Hetts fails to disclose the channels extending from the frustoconical leading first planar edge to the second planar edge which would require extension of the channels from the proximal end to the distal end of the cylindrical member. While the device of Hetts comprises the channels (pores) extending between the proximal and distal ends of the device, these channels do not span the entire distance between the proximal end and the distal ends of the device and therefore do not disclose or suggest the limitation of extending from an edge at the proximal end to an edge at the distal end as required by claims’ 22, 23, 57, and 58 current limitations.
It is not seen to have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have modified the device of Hetts to have arrived at this claimed feature as it is not presented in the prior art and the current structure of the membrane of Hetts is not seen to have been capable of accommodating channels that extend in the claimed manner.
For this reason, claims 22, 23, 57, and 58 are seen to include allowable subject matter that if included in independent form as currently claimed would be considered allowable.
Examiner notes that these claims are currently rejected under a non-statutory double patenting rejection that would require the filing of a terminal disclaimer as well as the inclusion into the claim limitations of their corresponding independent claims in order to be considered allowable.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ferren et al. (U.S. Publication 2007/0225634) discloses an intraluminal device for filtration of blood.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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