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 .
Formal Matters
Applicant’s Response and Amendments filed 6 July 2026 is acknowledged. Claims 5, 11, and 16 are cancelled. Claims 1, 3, 4, 6, 10, 12, 13, 17, 19, and 20 are currently amended. Claims 1-4, 6-10, 12-15, and 17-20 are pending and under examination. Claims 1, 13, and 20 are independent claims.
Objections/Rejections Withdrawn
Rejections drawn to cancelled claims are withdrawn as moot.
The rejection of claims 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by Shamay et al., US 20180325537 (15 November 2018), is withdrawn in light of Applicant’s amendments. However, modified rejections are set forth below, necessitated by amendment.
The rejection of claim 20 under 35 U.S.C. 103 as being unpatentable over Shamay et al., US 20180325537 (15 November 2018), is withdrawn in light of Applicant’s amendments. However, modified rejections are set forth below, necessitated by amendment.
The rejection of claims 3, 4, 6-9, 11-16, 18, and 19 under 35 U.S.C. 103 as being unpatentable over Shamay et al., US 20180325537 (15 November 2018) in view of Sterman et al., WO 9418881 A1 (1 September 1994), is withdrawn in light of Applicant’s amendments. However, modified rejections are set forth below, necessitated by amendment.
The rejection of claims 5, 10, 17 under 35 U.S.C. 103 as being unpatentable over Shamay et al., US 20180325537 (15 November 2018) in view of Sterman et al., WO 9418881 A1 (1 September 1994) and further in view of Hauser et al., WO 2005094283 A2 (13 October 2025), is withdrawn in light of Applicant’s amendments. However, modified rejections are set forth below, necessitated by amendment.
Response to Arguments
Applicant argues that the claim amendments directed to the actuated braided filaments overcome the rejections of record. Applicant’s arguments are persuasive. However, modified rejections are required, being necessitated by the amendments, as set forth below.
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.
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.
Claims 1, 2, 8, 9, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shamay et al., US 20180325537 (15 November 2018) in view of Deaton et al., US 20220257279 (18 August 2022).
Regarding claim 1, Shamay teaches a method of removing thrombotic material from a treatment site of a patient (thrombectomy procedure, ¶¶208-222), the method comprising:
introducing (¶210) an access sheath (FIG 1, micro-catheter/flexible pipe 112, ¶154) into the patient (¶210), the access sheath (112) including a lumen extending therein (longitudinal lumen, ¶153); and wherein the access sheath (112) may be configured to aspirate thrombotic material from the patient (¶191),
advancing an embolic protection device (occlusion balloon or filter, ¶86) through the lumen of the access sheath (¶¶86, 153) to a position adjacent the treatment site (¶188), the embolic protection device including an actuation member (FIG 1, handling manipulation apparatus (HMA) 102; ¶¶151,152) coupled to a plurality of filaments (threads, ¶91),
actuating the actuation member (102) in a first direction to shift from an unexpanded configuration to an expanded configuration (¶¶91, 157, 216);
advancing a thrombectomy device (FIG 1, corpus anchor unit 104, ¶¶151, 213) through the lumen of the access sheath (112) to a position adjacent the treatment site (¶¶188, 213);
conducting a thrombectomy procedure at the treatment site (¶¶208-222);
withdrawing the thrombectomy device from the patient (¶215);
withdrawing the embolic protection device from the patient (¶218).
Shamay does not teach wherein the plurality of filaments form a braided filter.
Shamay does not expressly teach actuating the actuation member in a second direction to shift the filter from the expanded configuration to the unexpanded configuration
Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter (¶29). Deaton also teaches that the device includes a proximal handle control (FIGs 24A-C; ¶¶160-161) comprising slider 2411 configured to slide to expand and retract the basket (¶¶160-161). Deaton also teaches methods removing clots using the devices (¶167).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay and Deaton, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay and Deaton teach in the same field of endeavor, that of intravascular catheterization procedures comprising thrombectomy devices.
Although Shamay discloses the claimed base method steps, Shamay does not expressly disclose that the plurality of filaments of the device form a braided fiber or that the actuating the actuation member in a second direction shifts the filter from the expanded to unexpanded configuration. Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter. Deaton also teaches that the device includes a proximal handle control comprising configured to slide to expand and retract the basket. Deaton also teaches a method of removing clots using the devices.
Because Shamay teaches the base method of a thrombectomy procedure, a person of ordinary skill in the art, seeking to optimize the procedure by using commercially available thrombectomy devices or devices with certain anatomically appropriate features such as certain structural components would look to Deaton’s thrombectomy devices comprising a controllably expandable and retractable braided basket. Deaton’s alternative device for thrombectomy procedures can be incorporated alongside Shamay’s method (same general device and controls) without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing a patient thrombectomy procedure) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (utilizing a thrombectomy device comprising components compatible with individual patient anatomy during the procedure), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Shamay modified by Deaton teaches the method of claim 1, as set forth above, for the reasons set forth above.
Shamay teaches wherein the embolic protection device is positioned upstream of the thrombectomy device (occlusion balloon displaceable over a wire proximal to the thrombus or occlusion balloon, ¶86).
Regarding claim 8, Shamay modified by Deaton teaches the method of claim 1, as set forth above, for the reasons set forth above.
Deaton teaches the method further comprising introducing an aspiration device through the lumen of the access sheath (¶183) into the patient after the thrombectomy device has been withdrawn from the patient (¶183).
Regarding claim 9, Shamay modified by Deaton and Sterman teaches the method of claim 8, as set forth above, for the reasons set forth above.
Deaton teaches the method further comprising advancing the aspiration device to a position adjacent the embolic protection device prior to the withdrawing the embolic protection device from the patient, and wherein the aspiration device is configured to aspirate thrombotic material from the embolic protection device (¶183). See also, Shamay ¶191.
Regarding independent claim 20, Shamay teaches a method of removing thrombotic material from a treatment site of a patient (thrombectomy procedure, ¶¶208-222), the method comprising:
introducing an access sheath (FIG 1, micro-catheter/flexible pipe 112, ¶154) into a femoral artery (¶181) of the patient (¶¶207-208);
introducing an embolic protection device (occlusion balloon or filter, ¶86) into the patient (occlusion balloon or filter displaceable over a wire, ¶86);
deploying the embolic protection device (occlusion balloon or filter, ¶86) adjacent the treatment site (¶188);
introducing a thrombectomy device (FIG 1, corpus anchor unit 104, ¶¶151, 213) into the femoral artery (¶181) the patient (¶¶208-213) through the access sheath (¶¶86, 153),
conducting a thrombectomy procedure at the treatment site (¶¶208-222);
withdrawing the thrombectomy device from the patient (¶¶218); and
conducting an aspiration procedure at the treatment site of the patient and the embolic protection device (endovascular thromboaspiration, ¶17; to aspirate thrombotic debris released during the thrombectomy procedure, ¶86; thrombectomy procedure steps ¶¶208-222); and
withdrawing the aspiration device from the patient (¶222);
and withdrawing the embolic protection device from the patient (¶218).
Shamay does not teach wherein the plurality of filaments form a braided filter or wherein the braided filter defines a first porosity and a second porosity different than the first porosity.
Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter (¶29) and wherein the braided filter of the embolic protection device (¶29) defines a first porosity and a second porosity different than the first porosity (¶149; “between 1.2 mm and 7.5 mm^2 in the expanded configuration”, ¶139). Deaton also teaches methods removing clots using the devices (¶167).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay and Deaton, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay and Deaton teach in the same field of endeavor, that of intravascular catheterization procedures comprising thrombectomy devices.
Although Shamay discloses the claimed base method steps, Shamay does not expressly disclose that the plurality of filaments of the device form a braided fiber or that the actuating the actuation member in a second direction shifts the filter from the expanded to unexpanded configuration. Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter. Deaton teaches that the pores of the expandable braided basket have different and variable pore size. The different and variable pore sizes are taught as being in a range “between 1.2 mm and 7.5 mm^2 in the expanded configuration” (¶139). Deaton also teaches a method of removing clots using the devices.
Because Shamay teaches the base method of a thrombectomy procedure, a person of ordinary skill in the art, seeking to optimize the procedure by using commercially available thrombectomy devices or devices with certain anatomically appropriate features such as certain structural components, including expandable braided basked with different and variable pore sizes would look to Deaton’s thrombectomy devices comprising a controllably expandable and retractable braided basket comprising different variable pore sizes. Deaton’s alternative device for thrombectomy procedures can be incorporated alongside Shamay’s method (same general device and controls) without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing a patient thrombectomy procedure) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (utilizing a thrombectomy device comprising components compatible with individual patient anatomy during the procedure), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 3, 4, 6, 7, 10, 12-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shamay et al., US 20180325537 (15 November 2018) in view of Deaton et al., 20220257279 (18 August 2022), and further in view of Sterman et al., WO 9418881 A1 (1 September 1994).
Regarding claim 3, Shamay modified by Deaton teaches the method of claim 2, as set forth above, for the reasons set forth above.
Shamay modified by Deaton does not teach wherein the embolic protection device is introduced through a femoral vein of the patient.
However, Shamay teaches wherein the embolic protection device (balloon, ¶207) is introduced through a first femoral artery of the patient (¶¶207, 231). Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Deaton also teaches that the expandable device and a clot removal device such as an aspirating lumen can be inserted into the same vascular region (¶182). Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge (¶189).
Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not disclose that femoral veins are used. Instead, Shamay teaches the use of femoral arteries in the procedure. Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). Thus, Sterman supports the teachings of Deaton that the selection of multiple sites for access are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives, and that access through a femoral vein of the patient is obvious and optimizable by the treating surgeon.
Because Shamay teaches access through the femoral arteries, Deaton teaches multi-site access through a femoral vein, and Sterman teaches access through the femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Deaton’s and Sterman’s alternative access solutions. The alternative access sites can be incorporated alongside Shamay’s method (same general location and access points) using known access methods without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, based on the teachings of Sterman, the use of Shamay’s device to access a clot in the venous system, then it would be apparent that access through the femoral vein would be obvious to one of ordinary skill based on the fact that Shamay teaches such intervention for arterial access, you access the femoral artery. Because Shamay discloses that it is known to access the femoral artery or femoral vein (as “vain” in ¶21) as needed per the procedure, it would be obvious based on Shamay’s disclosure that the device can be used on a “vain” and that a suitable access point would be the femoral vein.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 4, Shamay modified by Deaton and Sterman by teaches the method of claim 3, as set forth above for the reasons set forth above.
Shamay does not teach wherein the thrombectomy device is introduced through the femoral vein of the patient.
However, Shamay teaches wherein the device ( ¶207) is introduced through a first femoral artery of the patient (¶¶207, 231). Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Sterman teaches surgical catheterization procedures using both groins and femoral arteries and veins for access and occlusion devices (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not expressly disclose that femoral vein is used. Instead, Shamay teaches the use of femoral arteries in the procedure and that device can be used on a “vain”. Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). Sterman also specifically addresses that both groins are prepared to permit access (p. 6, lines 29-30). Thus, Sterman evidences that the selection of the access sites are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives.
Because Shamay teaches access through the femoral arteries and Sterman teaches access through both groins and femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Sterman’s alternative vascular access solutions. Sterman’s alternative access site for catheter entry can be incorporated alongside Shamay’s method (same general location and multiple vascular access points in both groins) using known access methods without redesigning Shamay’s method in light of the teachings of Deaton. Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through both groins and the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 6, Shamay modified by Deaton teaches the method of claim 1, as set forth above, for the reasons set forth above.
Shamay teaches the method further comprising introducing the access sheath (¶207) and wherein the access sheath may be configured to aspirate thrombotic material from the patient (endovascular thromboaspiration ¶17; to aspirate thrombotic debris released during the thrombectomy procedure, ¶86).
Shamay does not teach wherein device is introduced through a femoral vein of the patient.
However, Shamay teaches wherein a device (¶207) is introduced through a first femoral artery of the patient (¶¶207, 231). Shamay also discloses that the device can be used on a “vain” (¶21).
Sterman teaches vascular access into a femoral vein of the patient (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not disclose that femoral veins are used. Instead, Shamay teaches the use of femoral arteries in the procedure. Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). Thus, Sterman evidences that the selection of the access sites are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives.
Because Shamay teaches access through the femoral arteries and Sterman teaches access through the femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Sterman’s alternative access solutions. Sterman’s alternative access site for catheter entry can be incorporated alongside Shamay’s method (same general location and vascular access points) using known access methods without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 7, Shamay modified by Deaton and Sterman teaches the method of claim 6, as set forth above, for the reasons set forth above.
Shamay teaches wherein aspirating thrombotic material from the patient includes aspirating thrombotic material from the treatment site, the embolic protection device or both the treatment site and the embolic protection device (¶¶86, 218).
Regarding claim 10, Shamay modified by Deaton teaches the method of claim 9, as set forth above, for the reasons set forth above.
Shamay modified by Deaton does not expressly teach wherein the aspiration device is introduced through a femoral vein of the patient.
Deaton teaches that the expandable device and a clot removal device such as an aspirating lumen can be inserted into the same vascular region (¶182). Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge (¶189).
Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not disclose that femoral veins are used. Instead, Shamay teaches the use of femoral arteries in the procedure. Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge. Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). Thus, Sterman supports the teachings of Deaton that the selection of multiple sites for access are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives, and that access through a femoral vein of the patient is obvious and optimizable by the treating surgeon.
Because Shamay teaches access through the femoral arteries, Deaton teaches multi-site access through a femoral vein, and Sterman teaches access through the femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Deaton’s and Sterman’s alternative access solutions. The alternative access sites can be incorporated alongside Shamay’s method (same general location and access points) using known access methods without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 12, Shamay modified by Deaton and Sterman teaches the method of claim 8, as set forth above, for the reasons set forth above.
Deaton teaches wherein the braided filter of the embolic protection device (¶29) defines a first porosity and a second porosity different than the first porosity (¶149; “between 1.2 mm and 7.5 mm^2 in the expanded configuration”, ¶139).
Regarding independent claim 13, Shamay teaches a method of removing thrombotic material from a treatment site of a patient (thrombectomy procedure, ¶¶208-222), the method comprising:
introducing (¶210) an access sheath (FIG 1, micro-catheter/flexible pipe 112, ¶154) into the patient (¶210), the access sheath (112) including a lumen extending therein (longitudinal lumen, ¶153)
advancing an embolic protection device (occlusion balloon or filter, ¶86) through the lumen of the access sheath (¶¶86, 153) to a position adjacent the treatment site (¶188), the embolic protection device including an actuation member (FIG 1, handling manipulation apparatus (HMA) 102; ¶¶151,152) coupled to a plurality of filaments (threads, ¶91),
advancing a thrombectomy device (FIG 1, corpus anchor unit 104, ¶¶151, 213) through the lumen of the access sheath (112) to a position adjacent the treatment site (¶¶188, 213);
conducting a thrombectomy procedure at the treatment site (¶¶208-222);
withdrawing the thrombectomy device from the patient (¶215);
conducting an aspiration procedure at the treatment site of the patient and the embolic protection device (endovascular thromboaspiration ¶17; to aspirate thrombotic debris released during the thrombectomy procedure, ¶86; thrombectomy procedure steps ¶¶208-222);
actuating the actuation member (102) in a first direction to shift from an unexpanded configuration to an expanded configuration (¶¶91, 157, 216);
withdrawing the embolic protection device from the patient (¶218).
Shamay does not teach introducing an access sheath into a femoral vein of the patient.
Shamay does not teach wherein the plurality of filaments form a braided filter.
Shamay does not expressly teach actuating the actuation member in a second direction to shift the filter from the expanded configuration to the unexpanded configuration.
However, Shamay teaches wherein the embolic protection device (balloon, ¶207) is introduced through a first femoral artery of the patient (¶¶207, 231). Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter (¶29). Deaton also teaches that the device includes a proximal handle control (FIGs 24A-C; ¶¶160-161) comprising slider 2411 configured to slide to expand and retract the basket (¶¶160-161). Deaton also teaches methods removing clots using the devices (¶167).
Deaton also teaches that the expandable device and a clot removal device such as an aspirating lumen can be inserted into the same vascular region (¶182). Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge (¶189).
Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not disclose that femoral veins are used. Instead, Shamay teaches the use of femoral arteries in the procedure. Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). ). Thus, Sterman supports the teachings of Deaton that the selection of multiple sites for access are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives, and that access through a femoral vein of the patient is obvious and optimizable by the treating surgeon.
Because Shamay teaches access through the femoral arteries, Deaton teaches multi-site access through a femoral vein, and Sterman teaches access through the femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Deaton’s and Sterman’s alternative access solutions. The alternative access sites can be incorporated alongside Shamay’s method (same general location and access points) using known access methods without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, although Shamay discloses the claimed base method steps, Shamay does not expressly disclose that the plurality of filaments of the device form a braided fiber or that the actuating the actuation member in a second direction shifts the filter from the expanded to unexpanded configuration. Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter. Deaton also teaches that the device includes a proximal handle control comprising configured to slide to expand and retract the basket. Deaton also teaches a method of removing clots using the devices.
Because Shamay teaches the base method of a thrombectomy procedure, a person of ordinary skill in the art, seeking to optimize the procedure by using commercially available thrombectomy devices or devices with certain anatomically appropriate features such as certain structural components would look to Deaton’s thrombectomy devices comprising a controllably expandable and retractable braided basket. Deaton’s alternative device for thrombectomy procedures can be incorporated alongside Shamay’s method (same general device and controls) without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing a patient thrombectomy procedure) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (utilizing a thrombectomy device comprising components compatible with individual patient anatomy during the procedure), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 14, Shamay modified by Deaton and Sterman method of claim 13, as set forth above, for the reasons set forth above.
Shamay teaches wherein conducting an aspiration procedure at the treatment site of the patient includes advancing the access sheath to the treatment site and aspirating thrombotic material through a lumen of the access sheath (endovascular thromboaspiration ¶17; to aspirate thrombotic debris released during the thrombectomy procedure, ¶86; thrombectomy procedure steps ¶¶208-222).
Regarding claim 15, Shamay modified by Deaton and Sterman the method of claim 13, as set forth above, for the reasons set forth above.
Shamay does not teach wherein the embolic protection device is introduced through a femoral vein of the patient.
However, Shamay teaches wherein the embolic protection device (¶207) is introduced through a first femoral artery of the patient (¶¶207, 231).
Deaton teaches thrombectomy apparatuses wherein the plurality of filaments form a braided filter (¶29). Deaton also teaches that the device includes a proximal handle control (FIGs 24A-C; ¶¶160-161) comprising slider 2411 configured to slide to expand and retract the basket (¶¶160-161). Deaton also teaches methods removing clots using the devices (¶167).
Deaton also teaches that the expandable device and a clot removal device such as an aspirating lumen can be inserted into the same vascular region (¶182). Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge (¶189).
Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not disclose that femoral veins are used. Instead, Shamay teaches the use of femoral arteries in the procedure. Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). ). Thus, Sterman supports the teachings of Deaton that the selection of multiple sites for access are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives, and that access through a femoral vein of the patient is obvious and optimizable by the treating surgeon.
Because Shamay teaches access through the femoral arteries, Deaton teaches multi-site access through a femoral vein, and Sterman teaches access through the femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Deaton’s and Sterman’s alternative access solutions. The alternative access sites can be incorporated alongside Shamay’s method (same general location and access points) using known access methods without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 17, Shamay modified by Deaton and Sterman teaches the method of claim 13, as set forth above, for the reasons set forth above.
Deaton teaches that the expandable device and a clot removal device such as an aspirating lumen can be inserted into the same vascular region (¶182). Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge (¶189).
Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices (p. 6, lines 29-32).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Shamay, Deaton, and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Deaton, and Sterman teach in the same field of endeavor, that of intravascular catheterization procedures comprising occlusion devices.
Although Shamay discloses the claimed base method steps, Shamay does not disclose that femoral veins are used. Instead, Shamay teaches the use of femoral arteries in the procedure. Shamay’s disclosure also states that the device can be used on a “vain” (¶21).
Sterman specifically addresses that both femoral arteries and veins may be used depending on the particulars of the procedure (p.6, lines 33-36). ). Thus, Sterman supports the teachings of Deaton that the selection of multiple sites for access are procedure and patient-dependent, allowing for the judgment of the skilled practitioner to decide among the known alternatives, and that access through a femoral vein of the patient is obvious and optimizable by the treating surgeon.
Because Shamay teaches access through the femoral arteries, Deaton teaches multi-site access through a femoral vein, and Sterman teaches access through the femoral arteries or veins, a person of ordinary skill in the art, seeking to optimize the procedure based on individual anatomical considerations and physician skill would reasonably consult Deaton’s and Sterman’s alternative access solutions. The alternative access sites can be incorporated alongside Shamay’s method (same general location and access points) using known access methods without redesigning Shamay’s method.
Because the references address the same engineering problem (optimizing vascular catheter access to a patient site) and the proposed modifications are mechanically compatible and implemented by routine engineering and surgical practices (accessing a patient’s vascular system through the femoral arteries or veins in the groin), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 18, Shamay modified by Deaton and Sterman teaches the method of claim 13, as set forth above, for the reasons set forth above.
Deaton teaches the method further comprising introducing an aspiration device through the lumen of the access sheath (¶183) into the patient after the thrombectomy device has been withdrawn from the patient (¶183).
Regarding claim 19, Shamay modified by Deaton and Sterman teaches the method of claim 18, as set forth above, for the reasons set forth above.
Deaton teaches that the expandable device and a clot removal device such as an aspirating lumen can be inserted into the same vascular region (¶182). Deaton also teaches that multiple devices can be inserted through different treatment regions, including from a femoral vein region, and steered to converge (¶189).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Masoud, US 20230347107 (2 November 2023, benefit to 29 April 2022) teaches balloon-assisted neurovascular thrombectomy dual aspiration and distal access catheter system.
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.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
