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 .
Status of Claims
Claims 1, 5, 7-9, 12-18, and 20-24 are pending and examined on the merits.
Claims 1, 14, 15, 20, and 22 are currently amended.
Claims 2-4, 6, 10-11, 19, and 25-29 are cancelled.
Response to Amendment
Applicant’s amendments filed 08/07/2025 have been fully considered.
Response to Arguments
Applicant provided amendments to independent claims 1, 15, 20, and 22 which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 08/07/2025 have been fully considered but they are moot. Specifically, Casiello (U.S. Pre Grant Pub. No. 2016/0030708 A1), Eskridge (U.S. Pre Grant Pub. No. 2006/0264905 A1), and Holochwost (U.S. Pre Grant Pub. No. 2016/0135829 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious some of the limitations presented via the April 10, 2024 amendments. Hernandez (U.S. Pre Grant Pub. No. 2021/0178045 A1) is introduced as a new secondary reference in the present rejection for disclosing and rendering obvious some of the limitations presented via the amendments.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/07/2025 was filed before the mailing date of the First Office Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 7-9, 12-13, and 15-24 are rejected under 35 U.S.C. 103 as being unpatentable over Casiello (U.S. Pre Grant Pub. No. 2016/0030708 A1), in view of Holochwost (U.S. Pre Grant Pub. No. 2016/0135829 A1), further in view of Stern (U.S. Pre Grant Pub. No. 2018/0250498 A1), and further in view of Hernandez (U.S. Pre Grant Pub. No. 2021/0178045 A1).
Regarding claim 1, Casiello teaches: An aspiration catheter (see catheter 30 at least in Fig. 4), comprising:
a catheter body (see Fig. 4), the catheter body comprises:
a proximal terminus (inherent; see also Claim 1);
a distal terminus (inherent; see also Claim 1);
an inner liner having (at least inherent; see also inner wall 44 in para. [0031]) a continuous inner surface (34) defining a lumen (31), wherein the inner surface includes at least one groove formed therein (see spiraling channel 33) and that extends from the distal terminus at least partially toward the proximal terminus (see at least para. [0030]-[0031] and Fig. 4), and wherein the lumen is configured to be fluidly coupled to a pressure source for aspirating the lumen (see para. [0039]; see also power aspiration in para. [0008]).
Additionally Casiello teaches that various geometries are used to create a spiral flow in the catheter lumen to create catheter channels for vortical fluid flow (see para. [0033]) and that optimal flow rates during power injection of fluids can be achieved by changing the pitch of the rifles in the catheter (see para. [0035]). However, Casiello fails to explicitly teach that the catheter body is configured to be inserted through the vasculature of a patient, that the distal terminus is configured to be positioned proximate to clot material within the vasculature of the patient, that the groove(s) revolve between 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus, or that the lumen is configured to be fluidly coupled to a pressure source for aspirating the lumen thereby aspirating at least a portion of the clot material into the lumen, as required by the claim.
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 angle, pitch, and/or slope of the catheter channel(s) such that the groove(s) revolve about between 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus at least since Casiello teaches that optimization of the catheter can be achieved by altering the angle, pitch, and/or slope of the catheter channel(s) (see para. [0035]), which would alter the number of revolutions per inch of the groove(s). Particularly, pitch is the number of turns per distance, which can be used to determine the number of revolutions per inch. Since applicant has not provided evidence of criticality as to why the dimension disclosed has critical importance to the function of the claimed device (see para. [0068] of Applicant’s Specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
However, Casiello fails to explicitly teach that the catheter body has a size of 24 French or greater, a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Holochwost teaches an analogous reinforced tubular catheter (see Abstract) for removing undesirable material from vascular passageways (see at least Abstract and para. [0010]; para. [0026] defines “undesirable material” as blood clots). Holochwost further teaches that a suction cannula that is advanced within a vessel of a patient (see para. [0010] may be scaled from small to large sizes of 8-22 French (see para. [0044]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello to incorporate the teachings of Holochwost by making the catheter body have a size of 24 French or greater at least since Applicant hasn’t indicated the criticality of such a size (Applicant’s Specification generally discloses that the catheter has a relatively large size of 20-24 French; see para. [0038 and 0041]). Therefore, one of ordinary skill in the art would have reasonably recognized that since Holochwost teaches relatively large sizes of 22 French, a size 24 French catheter can also be used, especially since it has been held that here the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A).
However, neither Casiello nor Holochwost explicitly teach a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Stern teaches an analogous catheter (see Abstract) for treating a thrombus within a patient’s vasculature (see para. [0048]) comprising a catheter 10 and at least one support element 20 such as a braid or coil formed over an inner liner 18 (see para. [0069]). Stern further teaches that support element 20 may include a wire braid over a wire coil (see para. [0084]) and that the wires overlap (see para. [0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost to incorporate the teachings of Stern by including a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner at least because it is well known in the art to provide support to a catheter to prevent kinks and unwanted bending, as taught by Stern (see para. [0003]).
However, neither Casiello, Holochwost, nor Stern explicitly teach the at least one groove terminates distal of the proximal terminus, as required by the claim.
Hernandez teaches an analogous tube section comprising a helical flow path extending along at least a portion of the tube section (see Abstract). Hernandez further teaches that the helical flow path 54 of tube section 42 does not extend into flow inlet 56 (see para. [0050] and Fig. 9).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost further in view of Stern to incorporate the teachings of Hernandez by terminating the groove distal of the proximal terminus at least in order to shorten the helical flow path, as taught by Hernandez (see para. [0050]).
Since Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches an aspiration catheter having each and every claimed structural limitation as in claim 1, the device of Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez will also necessarily function in the same manner as the claimed device. Specifically, the catheter body of Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez is configured to be inserted through the vasculature of a patient, the distal terminus is configured to be positioned proximate to clot material within the vasculature of the patient, and the lumen is configured to be fluidly coupled to a pressure source for aspirating the lumen thereby aspirating at least a portion of the clot material into the lumen, as required by the claim.
Regarding claim 7, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 1. Additionally, Casiello teaches wherein the at least one groove has a spiral shape (see at least para. [0030]).
Regarding claim 8, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 1. Additionally, Casiello teaches wherein the at least one groove comprises a plurality of grooves (see for example Fig. 4 and para. [0030]).
Regarding claim 9, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 8. Additionally, Casiello teaches wherein the plurality of grooves are equally spaced apart about a circumference of the inner surface (see at least Figs. 4 and 8B; see also Figs. 7A-7G).
Regarding claim 15, Casiello teaches: An aspiration catheter (see catheter 30 at least in Fig. 4), comprising:
a catheter body (see Fig. 4), the catheter body comprises:
a proximal terminus (inherent; see also Claim 1);
a distal terminus (inherent; see also Claim 1); and
an inner liner having (at least inherent; see also inner wall 44 in para. [0031]) a continuous inner surface (34) defining a lumen (31) extending along a longitudinal axis (see at least para. [0009]), wherein the inner surface includes a plurality of grooves formed therein (see for example Fig. 4 and para. [0030]), wherein the grooves extend at least partially between the distal terminus and the proximal terminus (see at least para. [0030]-[0031] and Fig. 4), and wherein the grooves revolve circumferentially about the longitudinal axis between the distal terminus and the proximal terminus (see at least para. [0036] and Claim 4), and wherein the lumen is configured to be fluidly coupled to a pressure source for aspirating the lumen (see para. [0039]; see also power aspiration in para. [0008]).
Additionally Casiello teaches that various geometries are used to create a spiral flow in the catheter lumen to create catheter channels for vortical fluid flow (see para. [0033]) and that optimal flow rates during power injection of fluids can be achieved by changing the pitch of the rifles in the catheter (see para. [0035]). However, Casiello fails to explicitly teach that the catheter body is configured to be inserted through the vasculature of a patient, that the distal terminus is configured to be positioned proximate to clot material within the vasculature of the patient, that the groove(s) revolve circumferentially between 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus, or that the lumen is configured to be fluidly coupled to a pressure source for aspirating the lumen thereby aspirating at least a portion of the clot material into the lumen, as required by the claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the modified the angle, pitch, and/or slope of the catheter channel(s) such that the groove(s) revolve about between 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus at least since Casiello teaches that optimization of the catheter can be achieved by altering the angle, pitch, and/or slope of the catheter channel(s) (see para. [0035]), which would alter the number of revolutions per inch of the groove(s). Particularly, pitch is the number of turns per distance, which can be used to determine the number of revolutions per inch. Since applicant has not provided evidence of criticality as to why the dimension disclosed has critical importance to the function of the claimed device (see para. [0068] of Applicant’s Specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
However, Casiello fails to explicitly teach that the catheter body has a size of 24 French or greater, or a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Holochwost teaches an analogous reinforced tubular catheter (see Abstract) for removing undesirable material from vascular passageways (see at least Abstract and para. [0010]; para. [0026] defines “undesirable material” as blood clots). Holochwost further teaches that a suction cannula that is advanced within a vessel of a patient (see para. [0010] may be scaled from small to large sizes of 8-22 French (see para. [0044]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello to incorporate the teachings of Holochwost by making the catheter body have a size of 24 French or greater at least since Applicant hasn’t indicated the criticality of such a size (Applicant’s Specification generally discloses that the catheter has a relatively large size of 20-24 French; see para. [0038 and 0041]). Therefore, one of ordinary skill in the art would have reasonably recognized that since Holochwost teaches relatively large sizes of 22 French, a size 24 French catheter can also be used, especially since it has been held that here the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A).
However, neither Casiello nor Holochwost explicitly teach a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Stern teaches an analogous catheter (see Abstract) for treating a thrombus within a patient’s vasculature (see para. [0048]) comprising a catheter 10 and at least one support element 20 such as a braid or coil formed over an inner liner 18 (see para. [0069]). Stern further teaches that support element 20 may include a wire braid over a wire coil (see para. [0084]) and that the wires overlap (see para. [0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost to incorporate the teachings of Stern by including a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner at least because it is well known in the art to provide support to a catheter to prevent kinks and unwanted bending, as taught by Stern (see para. [0003]).
However, neither Casiello, Holochwost, nor Stern explicitly teach the at least one groove terminates distal of the proximal terminus, as required by the claim.
Hernandez teaches an analogous tube section comprising a helical flow path extending along at least a portion of the tube section (see Abstract). Hernandez further teaches that the helical flow path 54 of tube section 42 does not extend into flow inlet 56 (see para. [0050] and Fig. 9).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost further in view of Stern to incorporate the teachings of Hernandez by terminating the groove distal of the proximal terminus at least in order to shorten the helical flow path, as taught by Hernandez (see para. [0050]).
Since Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches an aspiration catheter having each and every claimed structural limitation as in claim 15, the device of Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez will also necessarily function in the same manner as the claimed device. Specifically, the catheter body of Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez is configured to be inserted through the vasculature of a patient, the distal terminus is configured to be positioned proximate to clot material within the vasculature of the patient, and the lumen is configured to be fluidly coupled to a pressure source for aspirating the lumen thereby aspirating at least a portion of the clot material into the lumen, as required by the claim.
Regarding claims 5, 12-13 and 16, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claims 1, 8, and 15, respectfully. Additionally Casiello teaches that various geometries are used to create a spiral flow in the catheter lumen to create catheter channels for vortical fluid flow (see para. [0033]) and that optimal flow rates during power injection of fluids can be achieved by changing the pitch of the rifles in the catheter (see para. [0035]). However, Casiello, Holochwost, Stern, and Hernandez fail to explicitly teach that the groove(s) revolve between about 0.13–0.15 times per inch, or more than about 0.13 times per inch, about the longitudinal axis between the proximal terminus and the distal terminus, as required by the claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the modified the angle, pitch, and/or slope of the catheter channel(s) such that the groove(s) revolve about between about 0.13–0.15 times per inch (as applied to claims 5, 12, and 16), or more than about 0.13 times per inch (as applied to claim 13), about the longitudinal axis between the proximal terminus and the distal terminus at least since Casiello teaches that optimization of the catheter can be achieved by altering the angle, pitch, and/or slope of the catheter channel(s) (see para. [0035]), which would alter the number of revolutions per inch of the groove(s). Particularly, pitch is the number of turns per distance, which can be used to determine the number of revolutions per inch. Since applicant has not any evidence of criticality to why the dimension disclosed has critical importance to the function of the claimed device (see para. [0068] of Applicant’s Specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 17, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 15. Additionally, Casiello teaches wherein the grooves are equally spaced about a circumference of the inner surface (see at least Figs. 4 and 8B; see also Figs. 7A-7G).
Regarding claim 18, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 15. Additionally, Casiello teaches wherein the grooves extend to the distal terminus (see at least para. [0036] and Claim 3).
Regarding claim 19, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 15. Additionally, Casiello teaches wherein the grooves extend entirely between the distal terminus and proximal terminus (see at least para. [0036] and Claim 3).
Regarding claim 20, Casiello teaches A system for removing material from within a human patient (see at least para. [0001]), the system comprising:
an aspiration catheter (see catheter 30 at least in Fig. 4), wherein the aspiration catheter comprises—
a proximal terminus (inherent; see also Claim 1);
a distal terminus (inherent; see also Claim 1); and
an inner liner having (at least inherent; see also inner wall 44 in para. [0031]) a continuous inner surface (34) defining a lumen (31) extending along a longitudinal axis (see at least para. [0009]), wherein the inner surface includes at least one groove formed therein (see for example Fig. 4 and para. [0030]) and that extends from the distal terminus at least partially toward the proximal terminus (see at least para. [0030]-[0031] and Fig. 4);
a tubing assembly fluidly coupled to the catheter (para. [0039] teaches that a rifled lumen, such as lumen 31 of Fig. 4, can be connected to the distal end 112 of the syringe 110 and that extension tubes can be used) and including a fluid control device (see for example plunger 114 of syringe 110; see also power aspiration in para. [0008]); and
a pressure source (see for example syringe 110; see also power aspiration in para. [0008]) fluidly coupled to the tubing assembly and configured to generate negative pressure (see para. [0039]; see also power aspiration in para. [0008]), wherein the fluid control device is movable between (a) a first position in which the pressure source is fluidly connected to the aspiration catheter via the tubing assembly (a first position can be, for example, when attaching the distal end 112 of the syringe 110 to a rifled lumen, such as lumen 31; see para. [0039]) and (b) a second position in which the pressure source is fluidly disconnected from the aspiration catheter (since syringe 110 is fully capable of being connected and disconnected from a rifled lumen, such as lumen 31, a second position exists when the syringe 110 is disconnected from the catheter), and wherein, with the fluid control device moved to the first position from the second position, the pressure source applies the negative pressure to the catheter (when the syringe 110 is attached to lumen 31, negative pressure can be applied to the catheter, such as, by drawing plunger 114 away from the distal end 112 of the syringe 110).
Additionally Casiello teaches that various geometries are used to create a spiral flow in the catheter lumen to create catheter channels for vortical fluid flow (see para. [0033]) and that optimal flow rates during power injection of fluids can be achieved by changing the pitch of the rifles in the catheter (see para. [0035]). However, Casiello fails to explicitly teach that the system is for removing clot material within a blood vessel of a human patient, that the aspiration catheter is configured to be inserted through the blood vessel, that the distal terminus is configured to be positioned proximate to the clot material within the blood vessel, that the at least one groove revolves between 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus, or that applying the negative pressure to the catheter causes aspiration of at least a portion of the clot material into the catheter, as required by the claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the modified the angle, pitch, and/or slope of the catheter channel(s) such that the groove(s) revolve about between about 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus at least since Casiello teaches that optimization of the catheter can be achieved by altering the angle, pitch, and/or slope of the catheter channel(s) (see para. [0035]), which would alter the number of revolutions per inch of the groove(s). Particularly, pitch is the number of turns per distance, which can be used to determine the number of revolutions per inch. Since applicant has provided evidence of criticality to why the dimension disclosed has critical importance to the function of the claimed device (see para. [0068] of Applicant’s Specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
However, Casiello fails to explicitly teach that the catheter body has a size of 24 French or greater, or a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Holochwost teaches an analogous reinforced tubular catheter (see Abstract) for removing undesirable material from vascular passageways (see at least Abstract and para. [0010]; para. [0026] defines “undesirable material” as blood clots). Holochwost further teaches that a suction cannula that is advanced within a vessel of a patient (see para. [0010] may be scaled from small to large sizes of 8-22 French (see para. [0044]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello to incorporate the teachings of Holochwost by making the catheter body have a size of 24 French or greater at least since Applicant hasn’t indicated the criticality of such a size (Applicant’s Specification generally discloses that the catheter has a relatively large size of 20-24 French; see para. [0038 and 0041]). Therefore, one of ordinary skill in the art would have reasonably recognized that since Holochwost teaches relatively large sizes of 22 French, a size 24 French catheter can also be used, especially since it has been held that here the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A).
However, neither Casiello nor Holochwost explicitly teach a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Stern teaches an analogous catheter (see Abstract) for treating a thrombus within a patient’s vasculature (see para. [0048]) comprising a catheter 10 and at least one support element 20 such as a braid or coil formed over an inner liner 18 (see para. [0069]). Stern further teaches that support element 20 may include a wire braid over a wire coil (see para. [0084]) and that the wires overlap (see para. [0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost to incorporate the teachings of Stern by including a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner at least because it is well known in the art to provide support to a catheter to prevent kinks and unwanted bending, as taught by Stern (see para. [0003]).
However, neither Casiello, Holochwost, nor Stern explicitly teach the at least one groove terminates distal of the proximal terminus, as required by the claim.
Hernandez teaches an analogous tube section comprising a helical flow path extending along at least a portion of the tube section (see Abstract). Hernandez further teaches that the helical flow path 54 of tube section 42 does not extend into flow inlet 56 (see para. [0050] and Fig. 9).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost further in view of Stern to incorporate the teachings of Hernandez by terminating the groove distal of the proximal terminus at least in order to shorten the helical flow path, as taught by Hernandez (see para. [0050]).
Since Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches an aspiration catheter having each and every claimed structural limitation as in claim 20, the device of Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez will also necessarily function in the same manner as the claimed device. Specifically, the system is for removing clot material within a blood vessel of a human patient, the aspiration catheter is configured to be inserted through the blood vessel, and applying the negative pressure to the catheter causes aspiration of at least a portion of the clot material into the catheter, as required by the claim.
Regarding claim 21, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the system as discussed above in claim 20. Additionally, Casiello teaches wherein the lumen extends along a longitudinal axis (see at least para. [0009]), wherein the at least one groove includes a plurality of grooves (see for example Fig. 4 and para. [0030]), wherein the grooves are equally spaced about a circumference of the inner surface (see at least Figs. 4 and 8B; see also Figs. 7A-7G), wherein the grooves extend at least partially from the distal terminus to the proximal terminus (see at least para. [0030] and Fig. 4), and wherein the grooves revolve circumferentially about the longitudinal axis between the proximal terminus and the distal terminus (see at least para. [0036] and Claim 4).
Regarding claim 22, Casiello teaches: A method for removing material from within a blood vessel of a human patient (see para. [0002]-[0007]; para. [0012] discloses that the distal end of the catheter is stabilized to minimize catheter malposition and damage to surrounding vessel walls and structures within the patient; therefore, the catheter is for removing material from within a blood vessel), the method comprising:
advancing a distal portion of an aspiration catheter through the blood vessel (para. [0012] discloses that the distal end of the catheter is stabilized to minimize catheter malposition and damage to surrounding vessel walls and structures within the patient; therefore, Casiello teaches that the distal portion is advanced through the blood vessel) wherein the aspiration catheter extends along a longitudinal axis (see at least para. [0009]) and includes an inner liner including (at least inherent; see also inner wall 44 in para. [0031]) a continuous inner surface (34 in Fig. 4) having at least one groove formed therein (see for example Fig. 4 and para. [0030]), wherein the at least one groove extends from a distal terminus of the aspiration catheter at least partially toward a proximal terminus of the aspiration catheter (see at least para. [0030] and Fig. 4);
coupling a pressure source (see for example plunger 114 of syringe 110; see also power aspiration in para. [0008]) to the aspiration catheter via a fluid control device (see for example syringe 110; see also para. [0039] describing that a rifled lumen can be connected to the distal end 112 of the syringe 110), wherein (a) opening of the fluid control device fluidly connects the pressure source to the aspiration catheter (para. [0039] teaches that Luer locks can be used at the distal end 112, this would allow a user to fluidly connect and disconnect the syringe 110 from the rifled lumen by rotating the syringe 110 in a clockwise and/or counter-clockwise direction; alternatively, for example, moving plunger 114 in a direction away from the distal end 112 can be considered opening of the fluid control device) and (b) closing of the fluid control device fluidly disconnects the pressure source from the aspiration catheter (para. [0039] teaches that Luer locks can be used at the distal end 112, this would allow a user to fluidly connect and disconnect the syringe 110 from the rifled lumen);
activating the pressure source to generate a vacuum while the fluid control device is closed (this step is accomplished by putting the Luer lock at the distal end 112 in a locked position, such as by rotating the syringe 110 in a clockwise and/or counter-clockwise direction, while moving plunger 114 in a direction away from the distal end 112); and
opening the fluid control device to apply the vacuum to the aspiration catheter to thereby aspirate at least a portion of the material into the aspiration catheter (this step is accomplished by putting the Luer lock at the distal end 112 in an open position, such as by rotating the syringe 110 in a clockwise and/or counter-clockwise direction, while moving plunger 114 in a direction away from the distal end 112).
Additionally Casiello teaches that various geometries are used to create a spiral flow in the catheter lumen to create catheter channels for vortical fluid flow (see para. [0033]) and that optimal flow rates during power injection of fluids can be achieved by changing the pitch of the rifles in the catheter (see para. [0035]). However, Casiello fails to explicitly teach that the method is for removing clot, that a distal portion of the aspiration catheter is proximate to the clot material within the blood vessel, or that the at least one groove revolves between 0.10-0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus, as required by the claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the modified the angle, pitch, and/or slope of the catheter channel(s) such that the groove(s) revolve about between about 0.10–0.20 times per inch about the longitudinal axis between the proximal terminus and the distal terminus at least since Casiello teaches that optimization of the catheter can be achieved by altering the angle, pitch, and/or slope of the catheter channel(s) (see para. [0035]), which would alter the number of revolutions per inch of the groove(s). Particularly, pitch is the number of turns per distance, which can be used to determine the number of revolutions per inch. Since applicant has provided evidence of criticality to why the dimension disclosed has critical importance to the function of the claimed device (see para. [0068] of Applicant’s Specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Holochwost teaches an analogous method for removing undesirable material from vascular passageways (see at least Abstract and para. [0010]; para. [0026] defines “undesirable material” as blood clots) including the method step of advancing a distal end of a cannula within a vessel of a patient such that the distal end of the cannula is positioned adjacent undesirable material (see at least para. [0010]). Holochwost further teaches that a suction cannula that is advanced within a vessel of a patient (see para. [0010] may be scaled from small to large sizes of 8-22 French (see para. [0044]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Casiello to incorporate the teachings of Holochwost by removing clots from a blood vessel of a human patient at least because the catheter of Casiello is capable of being used for removing clots while Holochwost discloses that an analogous catheter is for removing clots from a blood vessel (see at least para. [0010 and 0026]. Additionally, one of ordinary skill in the art would have been motivated to combine the method of Casiello with the method steps of Holochwost by advancing the distal portion of the catheter such that it is proximate to the clot material within the blood vessel at least in order to provide a suction force through the distal end so as to remove the undesirable material, as taught by Holochwost (see para. [0010]). One of ordinary skill in the art would have reasonably recognized that in order for the catheter of Casiello to be able to aspirate material, the distal end of the catheter would need to be adjacent to the material being aspirated and would therefore have been motivated to combine the method step of Holochwost with the method of Casiello in order for the device to function as a rifled catheter and vascular access system, as desired by Casiello (see at least para. [0001]).
Additionally, it have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello to incorporate the teachings of Holochwost by making the catheter body have a size of 24 French or greater at least since Applicant hasn’t indicated the criticality of such a size (Applicant’s Specification generally discloses that the catheter has a relatively large size of 20-24 French; see para. [0038 and 0041]). Therefore, one of ordinary skill in the art would have reasonably recognized that since Holochwost teaches relatively large sizes of 22 French, a size 24 French catheter can also be used, especially since it has been held that here the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A).
However, neither Casiello nor Holochwost explicitly teach a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner, or the at least one groove terminates distal of the proximal terminus, as required by the claim.
Stern teaches an analogous catheter (see Abstract) for treating a thrombus within a patient’s vasculature (see para. [0048]) comprising a catheter 10 and at least one support element 20 such as a braid or coil formed over an inner liner 18 (see para. [0069]). Stern further teaches that support element 20 may include a wire braid over a wire coil (see para. [0084]) and that the wires overlap (see para. [0086]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost to incorporate the teachings of Stern by including a plurality of wires each wound in a coil over the inner liner, wherein the plurality of wires at least partially overlap to form an overlapping coil structure over the inner liner at least because it is well known in the art to provide support to a catheter to prevent kinks and unwanted bending, as taught by Stern (see para. [0003]).
However, neither Casiello, Holochwost, nor Stern explicitly teach the at least one groove terminates distal of the proximal terminus, as required by the claim.
Hernandez teaches an analogous tube section comprising a helical flow path extending along at least a portion of the tube section (see Abstract). Hernandez further teaches that the helical flow path 54 of tube section 42 does not extend into flow inlet 56 (see para. [0050] and Fig. 9).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello in view of Holochwost further in view of Stern to incorporate the teachings of Hernandez by terminating the groove distal of the proximal terminus at least in order to shorten the helical flow path, as taught by Hernandez (see para. [0050]).
Regarding claim 23, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the method as discussed above in claim 22. Additionally, Casiello teaches wherein the at least one groove defines a leak path past the clot material when the clot material is aspirated into the aspiration catheter (see at least para. [0032]).
Regarding claim 24, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the method as discussed above in claim 22. Additionally, Casiello teaches wherein the at least one groove generates a helical flow pattern in the lumen when the clot material is aspirated into the aspiration catheter (see for example para. [0033]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Casiello (U.S. Pre Grant Pub. No. 2016/0030708 A1), in view of Holochwost (U.S. Pre Grant Pub. No. 2016/0135829 A1), further in view of Stern (U.S. Pre Grant Pub. No. 2018/0250498 A1), further in view of Hernandez (U.S. Pre Grant Pub. No. 2021/0178045 A1), as applied above to claim 1, and further in view of Eskridge (U.S. Pre Grant Pub. No. 2006/0264905 A1).
Regarding claim 14, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches the invention as discussed above in claim 1. Additionally, Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez teaches:
a braid of wires over the inner liner, wherein the overlapping coil structure extends over the braid (see at least para. [0084] of Stern).
However, neither Casiello, Holochwost, Stern, nor Hernandez explicitly teach an outer sheath over the braid, as required by the claim.
Eskridge teaches an analogous catheter comprising a grooved inner surface (see for example Abstract and Fig. 9). Eskridge further teaches an outer sheath over the braid, the overlapping coil structure, and the inner liner (para. [0025] teaches that catheters may include sheaths and other tubular structures).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Casiello, in view of Holochwost, further in view of Stern, and further in view of Hernandez to incorporate the teachings of Eskridge by having the catheter comprise an outer sheath over the braid, the overlapping coil structure, and the inner liner at least in order to deliver devices, instruments, or the like to target sites within a body, as taught by Eskridge (see para. [0025]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781