DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/31/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 3/30/2026, with respect to the rejection(s) of claim(s) 1, 8 and 17 under Bonnette (US 2016/0220346 A1) and SOS (US 2016/0367285 A1) have been fully considered and are persuasive in light of Applicant’s arguments pointing out the guidewire of Bonnette, upon which the filter assemblies are disposed, serves a materially different purpose compared to the filter catheter and guidewire system of SOS. It would not have been obvious to one of ordinary skill in the art to have modified the system of Bonnette to utilize a separate guidewire since the system of Bonnette is expressly configured to be used without any additional guidewire elements. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sachar (US 2019/0133616 A1) as provided in the non-final rejection below. This office action is non-final in light of the misinterpretation of the references provided in the previous rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Bonnette (US 2016/0220346 A1) (previously of record), further in view of Stigall (US 2016/0066880 A1).
Regarding claim 1, Sachar discloses:
An intravascular filter system (see Fig. 1A and 3B; the filter assembly shown in Fig. 3B will be the main filter embodiment relied upon for the following office action; see Para. [0040]-[0041] mentioning wherein the disclosed embodiments may be combined without departing from the scope of the device; the dual-filter configuration shown in Fig. 3B facilitates the capture and retrieval of long thrombi per Para. [0068] and is thus reasonably combinable into the system of Fig. 1A as a matter of obviousness to obtain the disclosed benefit), comprising:
a positioning guidewire (guidewire 103, see Fig. 1A);
a flexible sleeve positioning tube (catheter 106, see Fig. 1A; the catheter is understood the be flexible to allow navigation through the vasculature) having a proximal positioning tube end and a distal positioning tube end (see Fig. 1A);
a filter catheter (retrieval device 21, see Fig. 3B) having a proximal catheter end and a distal catheter end (see Fig. 3B); and
a filter assembly (braided assembly 19, see Fig. 3B) having a fixed collar (fixed collar 27, see Fig. 3B and Para. [0068]) of at least one expandable filter (see Fig. 3B) statically attached to said filter catheter proximate to the distal catheter end of the filter catheter (see Fig. 3B and Para. [0068]) and a sliding collar of the at least one expandable filter movably coupled to the filter catheter (sliding collar 25, see Fig. 3B and Para. [0068]-[0069]), the sliding collar being axially slidable along an exterior of the filter catheter as the at least one expandable filter expands or contracts (see Para. [0068]-[0069]; axial movement of sliding collar 25 causes expansion and contraction of the filter sections of the braided assembly 19);
wherein said filter catheter is configured for, along with the at least one expandable filter, translating proximally together to pull said at least one expandable filter into the flexible capture sleeve (see Abstract and Para. [0012], [0049], [0071] and [0078] mentioning wherein the retrieval device 21 is configured pulled into the lumen of the catheter 106 which causes the braided assemblies 19 to collapse and be withdrawn therein).
However, while Sachar discloses an alternative embodiment in which a guidewire is configured to be slidably inserted through the filter assembly system to allow a practitioner to remove and reinsert the device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Para. [0073]), Sachar does not expressly disclose:
a flexible capture sleeve attached to said distal positioning tube end of said flexible sleeve positioning tube, said flexible capture sleeve includes fenestration openings, the flexible capture sleeve having an expanded sleeve conformation and a contracted sleeve conformation;
wherein the filter catheter comprises a lumen and is configured for slidable reception of the positioning guidewire through the lumen thereof; and
wherein said filter catheter is configured to translate proximally over the positioning guidewire.
In the same field of endeavor, namely intravascular filter system, Bonnette teaches an intravascular filter system (see Fig. 1) comprising a flexible sleeve positioning tube (positioning tube 16, see Fig. 1), a filter wire (guidewire 22, see Fig. 1), a filter assembly (filters 24 and 26, see Fig. 1) and a flexible capture sleeve (capture sleeve 14, see Fig. 1) attached to the distal end of the flexible sleeve positioning tube (see Fig. 1 and Para. [0086] and [0088]-[0089]); the flexible capture sleeve including fenestration openings (see Fig. 3 showing a zoomed-in image of the capture sleeve having a plurality of fenestration openings, see also Para. [0086]) and comprises an expanded conformation and contracted conformation (see Para. [0089] and [0097] mentioning wherein the capture sleeve is configured to expand and contract); wherein the flexible capture sleeve comprises an expandable and collapsible flared distal end (see Fig. 1 and Para. [0089] and [0097]) configured to better accommodate entry of embolic debris or the filters into the lumen thereof (see Para. [0089]-[0090]) by providing an enlarged distal capture section to increase the capture area of the device.
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 distal end of the catheter 106 of Sachar to include an expandable and collapsible capture sleeve having a flared distal end thereon as taught and suggested by Bonnette to, in this case, provide a flexible, flared distal capture portion onto the distal end of the catheter which would better accommodate entry and capture of embolic debris and/or the braided filter assembly into the lumen thereof (see Bonnette Para. [0089]-[0090]) by providing an enlarged distal capture section having a larger capture region for which to receive and capture debris and/or the braided filters.
In the same field of endeavor, namely intravascular filter systems, Stigall teaches an intravascular filer system (see Figs. 9A-9B) comprising a guidewire (guidewire 924, see Fig, 9A), flexible sleeve positioning tube (first sheath 906, see Fig. 9A), a filter catheter (second sheath 908, see Fig. 9A) and a filter assembly (filters 902 and 904, see Fig. 9A); wherein the filter catheter is configured for slidable reception of the positioning guidewire through the lumen thereof (see Para. [0075] and Figs. 9A-9B); and wherein said filter catheter is configured to translate proximally over the positioning guidewire (see Para. [0075] and [0095]-[0096]) to provide a configuration in which the guidewire can be left in place while allowing a user to remove and reinsert the filter device to the same anatomic position multiple times (for example, to clean the device during the procedure).
Since Sachar discloses in an alternative embodiment (see Figs. 5A-5C and Para. [0073]) wherein a guidewire may be introduced into the system as a separate and independent component to allow a user to remove and reinsert the filter device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Sachar Para. [0073]), 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 retrieval device of the embodiment(s) shown in Fig. 1A and 3B of Sachar to include a lumen extending along the length thereof configured to receive an independent and separate guidewire therethrough as taught and suggested as an alternative guidewire system by Stigall to, in this case, provide a guidewire configuration which allows a user to leave the guidewire in-place after a procedure or operation while permitting reintroduction of the filter system to the same anatomic position multiple times.
Regarding claim 2, the combination of Sachar, Bonnette and Stigall disclose the invention of claim 1, Sachar further discloses wherein said filter assembly further comprises: a proximal expandable filter (braided section 111, see Fig. 3B) having a constrained conformation and an expanded conformation (see Para. [0069]); a distal expandable filter (braided section 112, see Fig. 3B) having a constrained conformation and an expanded conformation (see Para. [0069]); and an intermediate collar (slidable collar 23, see Fig. 3B) positioned between and connecting said proximal expandable filter to said distal expandable filter (see Fig. 3B), wherein said intermediate collar is slidably attached to said filter catheter (see Fig. 3B and Para. [0068]-[0069]).
Regarding claim 4, the combination of Sachar, Bonnette and Stigall disclose the invention of claim 2, Sachar further discloses wherein the fixed collar is attached to one of said proximal expandable filter and said distal expandable filter (see Fig. 3B showing wherein the fixed collar 27 is attached to the proximal filter section 111); and said sliding collar is attached to the other of said proximal expandable filter and said distal expandable filter (see Fig. 3B showing wherein slidable collar 25 is attached to distal filter section 112).
Regarding claim 5, the combination of Sachar, Bonnette and Stigall disclose all of the limitations of the invention of claim 4.
Bonnette further teaches wherein the filter assembly (see Fig. 1) comprises a fixed collar (proximal collar tube 42, see Fig. 2 and Para. [0090]) and sliding collar (distal tube collar 44, see Fig. 2 and Para. [0090]) coupled to the filter wire (see Figs. 1-2 and Para. [0090]); wherein the fixed collar comprises a plurality of holes within which to disposed adhesive to fixedly secure the fixed collar to the filter wire (see Para. [0090]); and wherein the sliding collar comprises a structure of threaded nitinol (see Para. [0090]).
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 fixed collar of Sachar to comprise a plurality of holes therein as taught and suggested by Bonnette to, in this case, provide openings for which to apply an adhesive to fixedly secure the fixed collar of Sachar to the retrieval device (see Bonnette Para. [0090]). Additionally, it would have been obvious to have modified the sliding collar of Sachar to be formed from threaded nitinol strands as taught by Bonnette (see Bonnette Para. [0090]) to provide a more flexible, shape-memory structure with improved durability.
Regarding claim 6, the combination of Sachar, Bonnette and Stigall disclose all of the limitations of the invention of claim 1.
However, Sachar does not expressly disclose a filter delivery catheter defining a central lumen for slidably receiving said filter catheter and said filter assembly; wherein said central lumen of said filter delivery catheter is sized to compress said at least one expandable filter to a constrained conformation when said filter assembly is received within said central lumen of said filter delivery catheter.
Bonnette further teaches a filter delivery catheter (delivery sheath 12, see Fig. 1) defining a central lumen for slidably receiving said filter wire and said filter assembly (see Fig. 1 and Para. [0086], [0090]-[0091] and [0095]-[0097]); wherein said central lumen of said filter delivery catheter is sized to compress said at least one expandable filter to a constrained conformation when said filter assembly is received within said central lumen of said filter delivery catheter (see Para. [0090]-[0091] and [0095]-[0097]) to compress the filter assemblies (in addition to the captured debris) to be as small as possible in order to effectively navigate and place the filters past embolic debris within the vasculature (see Para. [0087]).
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 intravascular filter system of Sachar to include filter delivery catheter configured to, during delivery and retraction of the aspiration catheter and filter assembly, be disposed over and radially encompassing the aspiration catheter 106 and subcomponents (i.e., braided assembly and retrieval device) disposed therein (see Sachar Fig. 1) as taught and suggested by Bonnette to, in this case, provide a delivery catheter which holds the aspiration catheter 106 and filter assembly 19 in a substantially compressed state such that the subcomponents are as small/compressed as possible during navigation to a target site to better and more effectively navigate and place the filter assemblies past the target embolic debris within the vasculature (see Bonnette Para. [0086]-[0087], [0090]-[0091] and [0095]-[0097]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Bonnette (US 2016/0220346 A1) (previously of record), further in view of Stigall (US 2016/0066880 A1), further in view of Krolik (US 2019/0298395 A1) (previously of record).
Regarding claim 3, the combination of Sachar, Bonnette and Stigall disclose all of the limitations of the invention of claim 2.
However, Sachar does not expressly disclose wherein said intermediate collar comprises a fenestrated structure having an axially elongated conformation and an axially compressed conformation.
In the same field of endeavor, namely expandable filter assemblies configured to capturing a thrombus or occlusion within the vasculature, Krolik teaches a filter assembly (expandable basket device 40, see Fig. 1 and Para. [0029]) comprising a proximal expandable filter (basket 42b, see Fig. 1 and Para. [0034]), a distal expandable filter (basket 42a, see Fig. 1 and Para. [0034]) and an intermediate collar (intermediate collar 50, see Fig. 1 and Para. [0038]) slidably attached to an underlying filter catheter (intermediate collar defines a lumen through which core wire 22 extends, see Para. [0040]) comprising a fenestrated structure (see Fig. 1) which provides a flexible tubular structure that is compressed axially when the baskets are moved towards each other to better capture a thrombus within the space between the two adjacent basket members (see Para. [0039]).
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 slidable collar 23 of Sachar to comprise a fenestrated, axially compressible and expandable structure as taught and suggested by Krolik to, in this case, provide a flexible intermediate collar configured to better trap and capture thrombus material lodged between the two adjacent filter members (see Krolik Para. [0039]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Bonnette (US 2016/0220346 A1) (previously of record), further in view of Stigall (US 2016/0066880 A1), further in view of Dinh (US 2021/0113224 A1).
Regarding claim 7, the combination of Sachar, Bonnette and Stigall disclose all of the limitations of the invention of claim 6.
However, none of the combination expressly disclose wherein said filter catheter further comprises: a dilator tip attached to said distal catheter end of said filter catheter, said dilator tip having a tapered tip and a shoulder; wherein said dilator tip is sized such that said shoulder engages said filter delivery catheter when said filter catheter is received within said central lumen of said filter delivery catheter.
In the same field of endeavor, namely intravascular filter devices, Dinh teaches an intravascular filter system (see Figs. 1B) comprising a filter catheter (intermediate shaft 104, see Fig. 1C) upon which a filter assembly (treatment device 130, see Fig. 1C) is disposed (see Fig. 1C and Para. [0024]), a filter delivery catheter (delivery catheter 102, see Figs. 1B-1C) and a dilator tip (distal tip 108, see Figs. 1B-1C) attached to the distal end of the filter catheter (see Fig. 1C); the dilator tip having a tapered tip (see Fig. 1C showing a tapered distal end of the distal tip 108) and a shoulder (shoulder formed between the transition from the largest-diameter tip portion to the adjacent intermediate-diameter central portion, see Fig. 1C); wherein said dilator tip is sized such that said shoulder engages said filter delivery catheter when said filter catheter is received within said central lumen of said filter delivery catheter (see Para. [0030]) to provide a seal for the lumen of the delivery catheter when the filter catheter is retracted therein (see Para. [0030]); the tapered distal tip also provides a tapered distal surface which allows for a more atraumatic navigation through the vasculature to a target site (see Para. [0026] mentioning wherein the distal tip 108 is atraumatic).
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 retrieval device of Sachar to include a tapered, atraumatic distal tip attached at the distal-most portion thereof as taught and suggested by Dinh to, in this case, provide a tapered atraumatic navigation tip surface to prevent damage to the vasculature during navigation to a target site while additionally providing a seal to the lumen of the filter delivery catheter of Bonnette, as incorporated into the device of Sachar, when the retrieval device is retracted therein due to the abutment of the tapered distal tip against the distal end of the filter delivery catheter (see Dinh Para. [0026] and [0030]).
Claim(s) 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Stigall (US 2016/0066880 A1).
Regarding claim 8, Sachar discloses:
An intravascular filter system (see Fig. 1A and 3B; the filter assembly shown in Fig. 3B will be the main filter embodiment relied upon for the following office action; see Para. [0040]-[0041] mentioning wherein the disclosed embodiments may be combined without departing from the scope of the device; the dual-filter configuration shown in Fig. 3B facilitates the capture and retrieval of long thrombi per Para. [0068] and is thus reasonably combinable into the system of Fig. 1A as a matter of obviousness to obtain the disclosed benefit), comprising:
a positioning guidewire (guidewire 103, see Fig. 1A);
an aspiration sheath (catheter 106, see Fig. 1A) having a sheath body defining a sheath central lumen (see Fig. 1A showing a lumen within catheter 106), said sheath body having a proximal sheath end and a distal sheath end (see Fig. 1A) wherein the aspiration sheath comprises a side path defining a side lumen operable connected to said sheath central lumen (see Para. [0064] mentioning wherein the proximal end of the aspiration catheter 106 comprises a y-adaptor for which to connect an external vacuum source; this additional branch constitutes the claimed “side path” connected to the central lumen of the aspiration catheter);
a filter catheter (retrieval device 21, see Fig. 3B) having a proximal catheter end and a distal catheter end (see Fig. 3B); and
a filter assembly (braided assembly 19, see Fig. 3B) having a fixed collar (fixed collar 27, see Fig. 3B and Para. [0068]) of at least one expandable filter (see Fig. 3B) statically attached to said filter catheter proximate the distal catheter end of the filter catheter (see Fig. 3B and Para. [0068]) and a sliding collar of the at least one expandable filter movably coupled to the filter catheter (sliding collar 25, see Fig. 3B and Para. [0068]-[0069]), the sliding collar being axially slidable along an exterior of the filter catheter as the at least one expandable filter expands or contracts (see Para. [0068]-[0069]; axial movement of sliding collar 25 causes expansion and contraction of the filter sections of the braided assembly 19), wherein said filter catheter is configured for, along with the at least one expandable filter, translating proximally together to pull said at least one expandable filter toward said distal sheath end of the sheath body (see Abstract and Para. [0012], [0049], [0071] and [0078] mentioning wherein the retrieval device 21 is configured pulled into the lumen of the catheter 106 which causes the braided assemblies 19 to collapse and be withdrawn therein).
However, while Sachar discloses an alternative embodiment in which a guidewire is configured to be slidably inserted through the filter assembly system to allow a practitioner to remove and reinsert the device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Para. [0073]), Sachar does not expressly disclose:
wherein the filter catheter comprises a lumen and is configured for slidable reception of the positioning guidewire through the lumen thereof; and
wherein said filter catheter is configured to translate proximally over the positioning guidewire.
In the same field of endeavor, namely intravascular filter systems, Stigall teaches an intravascular filer system (see Figs. 9A-9B) comprising a guidewire (guidewire 924, see Fig, 9A), flexible sleeve positioning tube (first sheath 906, see Fig. 9A), a filter catheter (second sheath 908, see Fig. 9A) and a filter assembly (filters 902 and 904, see Fig. 9A); wherein the filter catheter is configured for slidable reception of the positioning guidewire through the lumen thereof (see Para. [0075] and Figs. 9A-9B); and wherein said filter catheter is configured to translate proximally over the positioning guidewire (see Para. [0075] and [0095]-[0096]) to provide a configuration in which the guidewire can be left in place while allowing a user to remove and reinsert the filter device to the same anatomic position multiple times (for example, to clean the device during the procedure).
Since Sachar discloses in an alternative embodiment (see Figs. 5A-5C and Para. [0073]) wherein a guidewire may be introduced into the system as a separate and independent component to allow a user to remove and reinsert the filter device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Sachar Para. [0073]), 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 retrieval device of the embodiment(s) shown in Fig. 1A and 3B of Sachar to include a lumen extending along the length thereof configured to receive an independent and separate guidewire therethrough as taught and suggested as an alternative guidewire system by Stigall to, in this case, provide a guidewire configuration which allows a user to leave the guidewire in-place after a procedure or operation while permitting reintroduction of the filter system to the same anatomic position multiple times.
Regarding claim 11, the combination of Sachar and Stigall disclose the invention of claim 8, Sachar further discloses wherein said filter assembly further comprises: a proximal expandable filter (braided section 111, see Fig. 3B) having a constrained conformation and an expanded conformation (see Para. [0069]); a distal expandable filter (braided section 112, see Fig. 3B) having a constrained conformation and an expanded conformation (see Para. [0069]); and an intermediate collar (slidable collar 23, see Fig. 3B) positioned between and connecting said proximal expandable filter to said distal expandable filter (see Fig. 3B), wherein said intermediate collar is slidably attached to said filter catheter (see Fig. 3B and Para. [0068]-[0069).
Claim(s) 9-10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Stigall (US 2016/0066880 A1), further in view of Bonnette (US 2016/0220346 A1) (previously of record).
Regarding claim 9, the combination of Sachar and Stigall disclose the invention of claim 8, Sachar further discloses wherein said aspiration sheath further comprises: a hub (handle 128, see Fig. 2) attached to said proximal sheath end of said sheath body (see Fig. 2; the Examiner notes that the handle would be coupled to all components of the filter assembly shown in Fig. 1A).
However, Sachar does not expressly disclose wherein said hub comprises a hemostasis valve for operably sealing the sheath central lumen of said sheath body.
In the same field of endeavor, namely intravascular filter devices, Bonnette teaches an intravascular filter system (see Fig. 1) comprising a flexible sleeve positioning tube (positioning tube 16, see Fig. 1), a filter wire (guidewire 22, see Fig. 1) and a filter assembly (filters 24 and 26, see Fig. 1); the intravascular system further includes a hub (proximal handle 20 shown in Figs. 1 and 5, see also Para. [0092] and [0094]) coupled to the flexible sleeve positioning tube (see Figs. 1-5), wherein the hub comprises a hemostasis valve (hemostasis valve 62, see Fig. 5, see also Para. [0092] and [0094]) for operably sealing the sheath central lumen of said flexible sleeve positioning tube (as the function of a hemostasis valve is to prevent back-bleeding, the hemostasis valve of Bonnette is seen to seal the central lumen of the positioning tube 16 unless otherwise stated).
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 handle of Sachar to include a hemostasis valve along the vacuum path of the aspiration catheter 106 as taught and suggested by Bonnette to, in this case, provide a vacuum seal to the lumen of the aspiration catheter coupled thereto (see Bonnette Para. [0092] and [0094]).
Regarding claim 10, the combination of Sachar and Stigall disclose all of the limitations of the invention of claim 8, Sachar further discloses wherein said side path further comprises: a connector for connecting a syringe to said side path to pull a vacuum through the side lumen of the side path and said sheath central lumen of said sheath body (see Para. [0064] mentioning wherein the proximal end of the aspiration catheter 106 comprises a y-adaptor for which to connect an external vacuum source; the external vacuum source may be a syringe).
However, Sachar does not expressly disclose a valve operable control flow through said side path.
In the same field of endeavor, namely intravascular filter devices, Bonnette teaches an intravascular filter system (see Fig. 1) comprising a flexible sleeve positioning tube (positioning tube 16, see Fig. 1), a filter wire (guidewire 22, see Fig. 1) and a filter assembly (filters 24 and 26, see Fig. 1); the intravascular system further includes a hub (proximal handle 20 shown in Figs. 1 and 5, see also Para. [0092] and [0094]) coupled to the flexible sleeve positioning tube (see Figs. 1-5), wherein the hub comprises a hemostasis valve (hemostasis valve 62, see Fig. 5, see also Para. [0092] and [0094]) for operably sealing the sheath central lumen of said flexible sleeve positioning tube (as the function of a hemostasis valve is to prevent back-bleeding, the hemostasis valve of Bonnette is seen to seal the central lumen of the positioning tube 16 unless otherwise stated).
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 handle of Sachar to include a hemostasis valve along the vacuum path of the aspiration catheter 106 as taught and suggested by Bonnette to, in this case, provide a vacuum seal valve to the lumen of the aspiration catheter coupled thereto (see Bonnette Para. [0092] and [0094]).
Regarding claim 15, the combination of Sachar and Stigall disclose all of the limitations of the invention of claim 8.
However, Sachar does not expressly disclose a filter delivery catheter defining a central lumen for slidably receiving said filter catheter and said filter assembly; wherein said central lumen of said filter delivery catheter is sized to compress said at least one expandable filter to a constrained conformation when said filter assembly is received within said central lumen of said filter delivery catheter.
In the same field of endeavor, namely intravascular filter devices, Bonnette teaches an intravascular filter device (see Fig. 1) comprising: a flexible sleeve positioning tube (positioning tube 16, see Fig. 1), a filter wire (guidewire 22, see Fig. 1), a filter assembly (filters 24 and 26, see Fig. 1) and a filter delivery catheter (delivery sheath 12, see Fig. 1) defining a central lumen for slidably receiving said filter catheter and said filter assembly (see Fig. 1 and Para. [0086], [0090]-[0091] and [0095]-[0097]); wherein said central lumen of said filter delivery catheter is sized to compress said at least one expandable filter to a constrained conformation when said filter assembly is received within said central lumen of said filter delivery catheter (see Para. [0090]-[0091] and [0095]-[0097]) to compress the filter assemblies (in addition to the captured debris) to be as small as possible in order to effectively navigate and place the filters past embolic debris within the vasculature (see Para. [0087]).
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 intravascular filter system of Sachar to include filter delivery catheter configured to, during delivery and retraction of the aspiration catheter and filter assembly, be disposed over and radially encompassing the aspiration catheter 106 and subcomponents (i.e., braided assembly and retrieval device) disposed therein (see Sachar Fig. 1) as taught and suggested by Bonnette to, in this case, provide a delivery catheter which holds the aspiration catheter 106 and filter assembly 19 in a substantially compressed state such that the subcomponents are as small/compressed as possible during navigation to a target site to better and more effectively navigate and place the filter assemblies past the target embolic debris within the vasculature (see Bonnette Para. [0086]-[0087], [0090]-[0091] and [0095]-[0097]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Stigall (US 2016/0066880 A1), further in view of Krolik (US 2019/0298395 A1) (previously of record).
Regarding claim 12, the combination of Sachar and Stigall disclose all of the limitations of the invention of claim 11.
However, Sachar does not expressly disclose wherein said intermediate collar comprises a fenestrated structure having an axially elongated conformation and an axially compressed conformation.
In the same field of endeavor, namely expandable filter assemblies configured to capturing a thrombus or occlusion within the vasculature, Krolik teaches a filter assembly (expandable basket device 40, see Fig. 1 and Para. [0029]) comprising a proximal expandable filter (basket 42b, see Fig. 1 and Para. [0034]), a distal expandable filter (basket 42a, see Fig. 1 and Para. [0034]) and an intermediate collar (intermediate collar 50, see Fig. 1 and Para. [0038]) slidably attached to an underlying filter catheter (intermediate collar defines a lumen through which core wire 22 extends, see Para. [0040]) comprising a fenestrated structure (see Fig. 1) which provides a flexible tubular structure that is compressed axially when the baskets are moved towards each other to better capture a thrombus within the space between the two adjacent basket members (see Para. [0039]).
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 slidable collar 23 of Sachar to comprise a fenestrated, axially compressible and expandable structure as taught and suggested by Krolik to, in this case, provide a flexible intermediate collar configured to better trap and capture thrombus material lodged between the two adjacent filter members (see Krolik Para. [0039]).
Regarding claim 13, the combination of Sachar, Stigall and Krolik disclose the invention of claim 12, Sachar further discloses wherein the fixed collar is attached to one of said proximal expandable filter and said distal expandable filter (see Fig. 3B showing wherein the fixed collar 27 is attached to the proximal filter section 111); and a slidable collar (sliding collar 25, see Fig. 3B and Para. [0068]-[0069]) slidably attached to said filter catheter (see Fig. 3B and Para. [0068]-[0069]), said slidable collar is attached to the other of said proximal expandable filter and said distal expandable filter (see Fig. 3B showing wherein slidable collar 25 is attached to distal filter section 112).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Stigall (US 2016/0066880 A1), further in view of Krolik (US 2019/0298395 A1) (previously of record), further in view of Bonnette (US 2016/0220346 A1) (previously of record).
Regarding claim 14, the combination of Sachar, Stigall and Krolik disclose all of the limitations of the invention of claim 13.
However, none of the combination expressly discloses wherein the fixed collar and the slidable collar comprise a fenestrated structure.
In the same field of endeavor, namely filter assemblies configured to capture occlusions/debris from the vasculature, Bonnette further teaches wherein the filter assembly (see Fig. 1) comprises a fixed collar (proximal collar tube 42, see Fig. 2 and Para. [0090]) and sliding collar (distal tube collar 44, see Fig. 2 and Para. [0090]) coupled to the filter wire (see Figs. 1-2 and Para. [0090]); wherein the fixed collar comprises a plurality of holes within which to disposed adhesive to fixedly secure the fixed collar to the filter wire (see Para. [0090]); and wherein the sliding collar comprises a structure of threaded nitinol (see Para. [0090]).
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 fixed collar of Sachar to comprise a plurality of holes therein as taught and suggested by Bonnette to, in this case, provide openings for which to apply an adhesive to fixedly secure the fixed collar of Sachar to the retrieval device (see Bonnette Para. [0090]). Additionally, it would have been obvious to have modified the sliding collar of Sachar to be formed from threaded nitinol strands as taught by Bonnette (see Bonnette Para. [0090]) to provide a more flexible, shape-memory structure with improved durability.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of Stigall (US 2016/0066880 A1), further in view of Bonnette (US 2016/0220346 A1) (previously of record), further in view of Dinh (US 2021/0113224 A1).
Regarding claim 16, the combination of Sachar, Bonnette and Stigall disclose all of the limitations of the invention of claim 15.
However, none of the combination expressly disclose wherein said filter catheter further comprises: a dilator tip attached to said distal catheter end of said filter catheter, said dilator tip having a tapered tip and a shoulder; wherein said dilator tip is sized such that said shoulder engages said filter delivery catheter when said filter catheter is received within said central lumen of said filter delivery catheter.
In the same field of endeavor, namely intravascular filter devices, Dinh teaches an intravascular filter system (see Figs. 1B) comprising a filter catheter (intermediate shaft 104, see Fig. 1C) upon which a filter assembly (treatment device 130, see Fig. 1C) is disposed (see Fig. 1C and Para. [0024]), a filter delivery catheter (delivery catheter 102, see Figs. 1B-1C) and a dilator tip (distal tip 108, see Figs. 1B-1C) attached to the distal end of the filter catheter (see Fig. 1C); the dilator tip having a tapered tip (see Fig. 1C showing a tapered distal end of the distal tip 108) and a shoulder (shoulder formed between the transition from the largest-diameter tip portion to the adjacent intermediate-diameter central portion, see Fig. 1C); wherein said dilator tip is sized such that said shoulder engages said filter delivery catheter when said filter catheter is received within said central lumen of said filter delivery catheter (see Para. [0030]) to provide a seal for the lumen of the delivery catheter when the filter catheter is retracted therein (see Para. [0030]); the tapered distal tip also provides a tapered distal surface which allows for a more atraumatic navigation through the vasculature to a target site (see Para. [0026] mentioning wherein the distal tip 108 is atraumatic).
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 retrieval device of Sachar to include a tapered, atraumatic distal tip attached at the distal-most portion thereof as taught and suggested by Dinh to, in this case, provide a tapered atraumatic navigation tip surface to prevent damage to the vasculature during navigation to a target site while additionally providing a seal to the lumen of the filter delivery catheter of Bonnette, as incorporated into the device of Sachar, when the retrieval device is retracted therein due to the abutment of the tapered distal tip against the distal end of the filter delivery catheter (see Dinh Para. [0026] and [0030]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of SOS (US 2016/0367285 A1) (previously of record), further in view of Bonnette (US 2016/0220346 A1) (previously of record).
Regarding claim 17, Sachar discloses:
A method for removing a clot (see Figs. 6A-6F and Para. [0074]-[0077]), comprising:
wherein a fixed collar (fixed collar 27, see Fig. 3B and Para. [0068]) of a filter assembly (braided assembly 19, see Fig. 3B; Examiner notes that any of the disclosed filter configurations may be used in the method shown in Figs. 6A-6F per Para. [0040]-[0041]; the main embodiments relied upon will be shown in Figs. 1A and 3B; see Para. [0040]-[0041] mentioning wherein the disclosed embodiments may be combined without departing from the scope of the device; the dual-filter configuration shown in Fig. 3B facilitates the capture and retrieval of long thrombi per Para. [0068] and is thus reasonably combinable into the system of Fig. 1A as a matter of obviousness to obtain the disclosed benefit) is statically attached (see Para. [0068]) to the filter catheter (retrieval device 21, see Fig. 3B) and a sliding collar of the filter assembly (sliding collar 25, see Fig. 3B and Para. [0068]-[0069]) is movably coupled to the filter catheter (see Para. [0068]-[0069]; axial movement of sliding collar 25 causes expansion and contraction of the filter sections of the braided assembly 19), the sliding collar being axially slidable along an exterior of the filter catheter as the filter assembly expands or contracts (see Para. [0068]-[0069]; axial movement of sliding collar 25 causes expansion and contraction of the filter sections of the braided assembly 19), and sliding the filter catheter positions said filter assembly distal to the clot (see Figs. 6A-6F; showing wherein the filter catheter to which the braided filter assembly is attached is advanced distally of the target clot; see also Para. [0074]-[0076]);
expanding said filter assembly within said blood vessel distal to said clot (see Figs. 6A-6F showing wherein the filter catheter to which the braided filter assembly is attached is advanced distally of the target clot and expanded; see also Para. [0074]-[0076]);
a flexible sleeve catheter (aspiration catheter 106, see Fig. 1A) disposed over said filter catheter (see Para. [0053] and [0074]-[0076]; see also Figs. 6A-6F showing wherein the retrieval device is retracted until the filter assembly and captured clot are within the lumen of the aspiration catheter), the flexible sleeve catheter having a flexible sleeve (see Para. [0049] mentioning wherein the aspiration catheter is formed from a polymer material; the aspiration catheter is understood to be flexible to allow navigation through the vasculature unless otherwise stated), and sliding the flexible sleeve positions the flexible sleeve proximal to the filter assembly (see Figs. 6A-6F); and
pulling said filter catheter proximally together with the attached expanded filter assembly through said clot and into said flexible sleeve (see Para. [0012], [0049], [0053], [0071] and [0074]-[0078]; see also Figs. 6A-6F).
However, while Sachar discloses an alternative embodiment in which a guidewire is configured to be slidably inserted through the filter assembly system to a location distally beyond the target occlusion to allow a practitioner to remove and reinsert the device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Para. [0073] and [0077]), Sachar does not expressly disclose:
passing a distal guidewire end of a positioning guidewire across a clot located in a blood vessel;
sliding a filter catheter over the positioning guidewire;
sliding the flexible sleeve catheter over said filter catheter.
In the same field of endeavor, namely filter catheters configured for removal of occlusions within a target vessel, SOS teaches a retrieval system (see Figs. 1A-1B) including a guidewire (guidewire 160, see Figs. 1A-1B), a filter assembly (tubular mesh 110, see Fig. 1B-1C) and a flexible sleeve catheter (inner sheath 140, see Figs. 1A-1C); wherein the filter assembly comprises a lumen configured to slidably receive the guidewire therein (see Figs. 1C-1D showing wherein the tubular mesh structure comprises a central lumen for which to slidably receive the guidewire); wherein a method of removing a target occlusion includes advancing the guidewire across a clot located in a target vessel (see Figs. 2A-2B) before sliding the filter assembly over the pre-positioned guidewire to a location distal to the target occlusion (see Figs. 2B-2C) to efficiently guide the placement of the filter assembly to the target location while providing a configuration in which the guidewire can be left in place while allowing a user to remove and reinsert the filter device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Para. [0101]).
Since Sachar discloses in an alternative embodiment (see Figs. 5A-5C and Para. [0073]) wherein a guidewire may be introduced into the system as a separate and independent component to allow a user to remove and reinsert the filter device to the same anatomic position multiple times (for example, to clean the device during the procedure) (see Sachar Para. [0073] and [0077]), 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 retrieval device of the embodiment shown in Fig. 3B of Sachar to include a lumen extending along the length thereof configured to receive an independent and separate guidewire therethrough to be navigated distally beyond a target occlusion as taught and suggested as an alternative guidewire/placement system by Stigall to, in this case, provide a guidewire configuration which allows a user to leave the guidewire in-place after a procedure or operation while permitting reintroduction of the filter system to the same anatomic position multiple times (see Stigall Para. [0101] and Sachar Para. [0073] and [0077]). The separate guidewire configuration additionally facilitates more accurate placement of the retrieval device due to the presence of the pre-positioned guidewire.
Additionally, in the same field of endeavor, namely filter catheters configured for removal of occlusions within a target vessel, Bonnette teaches a retrieval system (see Fig. 1) including a filter wire (guidewire 22, see Fig. 1), a filter assembly (filters 24 and 26, see Fig. 1) positioned thereon (see Fig. 1) and a flexible sleeve catheter (capture sleeve 14, see Fig. 1); wherein after initial capture of a target occlusion, the filter wire may be retracted proximally while the flexible sleeve catheter is advanced distally to intimately urge the debris captured by the filter assembly into the lumen of the flexible sleeve catheter, resulting in a more rapid capture of the target occlusion/debris (see Para. [0101]).
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 device of Sachar to, during retrieval and withdrawal of the target captured occlusion/debris, allow the aspiration catheter 106 to be advanced distally toward the filter assembly during simultaneous proximal retraction of the retrieval device into the lumen of the aspiration catheter as taught and suggested by Bonnette to, in this case, provide a more rapid and controlled retrieval system for capturing the target occlusion/debris (see Bonnette Para. [0101]).
Regarding claim 18, the combination of Sachar, SOS and Bonnette disclose all of the limitations of the method of claim 17, Sachar further discloses wherein said filter assembly comprises a fenestrated structure (see Fig. 3B showing wherein the filters 111 and 112 comprise a fenestrated structure) configured to self-expand when unconstrained (see Para. [0067] mentioning wherein the braided filter assembly may be maintained at various expansion sizes based on the amount of tension in the corresponding activation wires; should the expansion size be pre-set prior to deployment of the filter assemblies from the aspiration catheter, the filter assemblies would self-expand to the set expansion size once removed from the confines of the aspiration catheter).
However, the combination, as currently presented, does not expressly disclose sliding a filter delivery catheter over said filter catheter and said filter assembly to constrain and collapse said filter assembly for movement past said clot.
Bonnette further teaches a filter delivery catheter (delivery sheath 12, see Fig. 1) defining a central lumen for slidably receiving said filter wire and said filter assembly (see Fig. 1 and Para. [0086], [0090]-[0091] and [0095]-[0097]); wherein said central lumen of said filter delivery catheter is sized to compress the at least one expandable filter (24/26, see Fig. 1) to a constrained conformation when said filter assembly is received within said central lumen of said filter delivery catheter (see Para. [0090]-[0091] and [0095]-[0097]) to compress the filter assemblies (in addition to the captured debris) to be as small as possible in order to effectively navigate and place the filters past embolic debris within the vasculature (see Para. [0087]). This compression occurs during navigation to a target site while also occurring during capture of the target debris by distally advancing the delivery sheath over the filter assembly (see Para. [0102]-[0103]).
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 intravascular filter system of Sachar to include filter delivery catheter configured to, during delivery and retraction of the aspiration catheter and filter assembly, be advanced over to radially encompass the aspiration catheter 106 and subcomponents (i.e., braided assembly and retrieval device) disposed therein (see Sachar Fig. 1) as taught and suggested by Bonnette to, in this case, provide a delivery catheter which holds the aspiration catheter 106 and filter assembly 19 in a substantially compressed state such that the subcomponents are as small/compressed as possible during navigation to a target site to better and more effectively navigate and place the filter assemblies past the target embolic debris within the vasculature (see Bonnette Para. [0086]-[0087], [0090]-[0091] and [0095]-[0097] and [0102]-[0103]).
Regarding claim 20, the combination of Sachar, SOS and Bonnette disclose all of the limitations of the method of claim 17.
However, the combination, as currently presented, does not expressly disclose sliding a flexible sleeve sheath over said flexible sleeve catheter to constrain and collapse said flexible sleeve; wherein said flexible sleeve comprises a woven mesh configured to self-expand when unconstrained.
Bonnette further teaches wherein the intravascular filter system (see Fig. 1) comprises a flexible sleeve positioning tube (positioning tube 16, see Fig. 1), a filter wire (guidewire 22, see Fig. 1), a filter assembly (filters 24 and 26, see Fig. 1) and a flexible capture sleeve (capture sleeve 14, see Fig. 1) attached to the distal end of the flexible sleeve positioning tube (see Fig. 1 and Para. [0086] and [0088]-[0089]); the flexible capture sleeve including fenestration openings (see Fig. 3 showing a zoomed-in image of the capture sleeve having a plurality of fenestration openings, see also Para. [0086]) and comprises an expanded conformation and contracted conformation (see Para. [0089] and [0097] mentioning wherein the capture sleeve is configured to expand and contract); wherein the flexible capture sleeve comprises an expandable and collapsible flared distal end (see Fig. 1 and Para. [0089] and [0097]) configured to better accommodate entry of embolic debris or the filters into the lumen thereof (see Para. [0089]-[0090]) by providing an enlarged distal capture section to increase the capture area of the device.
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 distal end of the catheter 106 of Sachar to include an expandable and collapsible capture sleeve having a flared distal end thereon as taught and suggested by Bonnette to, in this case, provide a flexible, flared distal capture portion onto the distal end of the catheter which would better accommodate entry and capture of embolic debris and/or the braided filter assembly into the lumen thereof (see Bonnette Para. [0089]-[0090]) by providing an enlarged distal capture section having a larger capture region for which to receive and capture debris and/or the braided filters.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar (US 2019/0133616 A1) in view of SOS (US 2016/0367285 A1) (previously of record), further in view of Bonnette (US 2016/0220346 A1) (previously of record), further in view of Dinh (US 2021/0113224 A1).
Regarding claim 19, the combination of Sachar, SOS and Bonnette disclose all of the limitations of the method of claim 18, Sachar, as modified by Bonnette, further discloses sliding said filter catheter into the lumen of the filter delivery catheter (see Bonnette Para. [0086]-[0087], [0090]-[0097] and [0102]-[0103]; see also Sachar Para. [0053] mentioning wherein the retrieval device upon which the filter assembly is disposed is configured to be retracted lumen of the aspiration catheter and filter delivery catheter of Bonnette which collapses the filter assemblies).
However, none of either Sachar or Bonnette expressly disclose a dilator tip attached to a distal catheter end of said filter catheter configured to engage a distal end of said filter delivery catheter when retracted therein.
In the same field of endeavor, namely intravascular filter devices, Dinh teaches an intravascular filter system (see Figs. 1B) comprising a filter catheter (intermediate shaft 104, see Fig. 1C) upon which a filter assembly (treatment device 130, see Fig. 1C) is disposed (see Fig. 1C and Para. [0024]), a filter delivery catheter (delivery catheter 102, see Figs. 1B-1C) and a dilator tip (distal tip 108, see Figs. 1B-1C) attached to the distal end of the filter catheter (see Fig. 1C); the dilator tip having a tapered tip (see Fig. 1C showing a tapered distal end of the distal tip 108) and a shoulder (shoulder formed between the transition from the largest-diameter tip portion to the adjacent intermediate-diameter central portion, see Fig. 1C); wherein said dilator tip is sized such that said shoulder engages said filter delivery catheter when said filter catheter is received within said central lumen of said filter delivery catheter (see Para. [0030]) to provide a seal for the lumen of the delivery catheter when the filter catheter is retracted therein (see Para. [0030]); the tapered distal tip also provides a tapered distal surface which allows for a more atraumatic navigation through the vasculature to a target site (see Para. [0026] mentioning wherein the distal tip 108 is atraumatic).
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 retrieval device of Sachar to include a tapered, atraumatic distal tip attached at the distal-most portion thereof as taught and suggested by Dinh to, in this case, provide a tapered atraumatic navigation tip surface to prevent damage to the vasculature during navigation to a target site while additionally providing a seal to the lumen of the filter delivery catheter of Bonnette, as incorporated into the device of Sachar, when the retrieval device is retracted therein due to the abutment of the tapered distal tip against the distal end of the filter delivery catheter (see Dinh Para. [0026] and [0030]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2022/0087694 A1 to van Vaals, US 2019/0336147 A1 to Goyal, US 2019/0298396 A1 to Gamba, US 2019/0175212 A1 to Kitaoka, US 10016206 B1 to Yang, US 2016/0206426 A1 to Khoynezhad and US 2009/0222035 A1 to Schneiderman all disclose thrombectomy catheter devices comprising at least one filter, and wherein an aspiration source can be applied through the lumen of a filter delivery catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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