CTNF 18/989,240 CTNF 81513 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Benefit Applicant claims benefit to US Provisional 63/613356 (21 December 2023). Formal Matters Claims 1-20 are pending and under examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on 11 March 2025 has been considered by the examiner. A signed copy is attached. 07-30-03-h AIA Claim Interpretation 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1 and 2 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Shamay et al., US 20180325537 (15 November 2018) . Regarding claim 1 , Shamay teaches a method of removing thrombotic material from a treatment site of a patient (¶¶ 208-222 ), the method comprising: introducing an embolic protection device into the patient ( occlusion balloon or filter displaceable over a wire, ¶86 ); deploying the embolic protection device adjacent the treatment site ( occlusion balloon displaceable over a wire proximal to the thrombus or occlusion balloon or filter displaceable over a wire distal to the thrombus, ¶86 ); thrombectomy procedure steps (¶¶ 208-222 ); introducing a thrombectomy device into the patient (¶¶ 208-213 ); conducting a thrombectomy procedure at the treatment site (¶¶ 208-222 ); withdrawing the thrombectomy device from the patient (¶ 214 ); and withdrawing the embolic protection device from the patient (¶ 218 ). Regarding claim 2 , teaches the method of claim 1, as 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) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shamay et al., US 20180325537 (15 November 2018) . Regarding independent claim 20 , Shamay teaches a method of removing thrombotic material from a treatment site of a patient (¶¶ 208-222 ), the method comprising: introducing an access sheath into a first femoral artery of the patient (¶¶ 207-208 ); introducing an embolic protection device into the patient ( occlusion balloon or filter displaceable over a wire, ¶86 ); deploying the embolic protection device adjacent the treatment site ( occlusion balloon displaceable over a wire proximal to the thrombus or occlusion balloon or filter displaceable over a wire distal to the thrombus, ¶86 ); thrombectomy procedure steps (¶¶ 208-222 ); introducing a thrombectomy device into the patient (¶¶ 208-213 ); conducting a thrombectomy procedure at the treatment site (¶¶ 208-222 ); withdrawing the thrombectomy device from the patient (¶¶ 214 ); 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 a specific order of the steps, but does teach general guidance about the order and methodology of steps known in the art (see, for example ¶191). According to MPEP 2144.04, the selection of any order of performing the steps is generally considered prima facie obvious if the steps are known in the prior art and no new or unexpected results arise from a particular sequence ( In re Burhans , 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results). The specification does not provide any disclosure as to the criticality of the order of the steps and there is nothing indicating that a specific order produces a novel or unexpected effect. Accordingly, absent a specific showing that a specific order produces a novel or unexpected effect, the examiner treats the steps as interchangeably obvious . 07-21-aia AIA Claim s 3, 4, 6-9, 11-16, 18, and 19 are rejected 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) . Regarding claim 3 , Shamay teaches the method of claim 2, as set forth above. Shamay does not teach wherein the embolic protection device is introduced through a first 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 ). 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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. 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 Sterman by teaches the method of claim 3, as set forth above. Shamay does not teach wherein the thrombectomy device is introduced through a second femoral vein of the patient. 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 both 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). 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. 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 teaches the method of claim 1, as set forth above. Shamay teaches the method further comprising introducing an access sheath (¶ 207 ) and wherein the embolic protection device ( balloon or filter, ¶207 ) is introduced into the patient through the access sheath, 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 the embolic protection device is introduced through a first femoral vein of the patient. However, Shamay teaches wherein the device ( balloon, ¶207 ) is introduced through a first femoral artery of the patient (¶¶ 207, 231 ). 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 Sterman teaches the method of claim 6, as 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 8 , Shamay teaches the method of claim 1, as set forth above. Shamay teaches the method further comprising introducing an aspiration device into the patient after the thrombectomy device has been withdrawn from the patient (¶ 218 ). Shamay does not teach where the device is introduced into a femoral vein of the patient (¶ 218 ). However, Shamay teaches wherein the embolic protection device ( balloon, ¶207 ) is introduced through a first femoral artery of the patient (¶¶ 207, 231 ). 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 9 , Shamay modified by Sterman teaches the method of claim 8, as set forth above. Shamay 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 (¶¶ 86 , 208-220 ). Regarding claim 10 , Shamay modified by Sterman teaches the method of claim 9, as set forth above. Shamay modified by Sterman does not expressly teach wherein the aspiration device is introduced through a first femoral vein of the patient, and wherein the embolic protection device is introduced through a second 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 also teaches that procedure devices are introduced into the patient through the access sheath, 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 ). See also, thrombectomy procedure steps at ¶¶ 208-220 ). 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 both 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). 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. 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 11 , Shamay modified by Sterman teaches the method of claim 8, as set forth above. Shamay teaches wherein the embolic protection device (balloon, ¶¶ 208-220 ) is introduced through a subclavian artery of the patient (¶ 195 ). Regarding claim 12 , Shamay modified by Sterman teaches the method of claim 8, as set forth above. Shamay teaches wherein both the embolic protection device and the aspiration device are introduced into the patient through the access sheath ( endovascular thromboaspiration ¶17; to aspirate thrombotic debris released during the thrombectomy procedure, ¶86; thrombectomy procedure steps at ¶¶ 208-220 ). Shamay does not teach the method further comprising introducing an access sheath into the 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 also teaches the use of the brachial, subclavian, axillary, internal maxillary artery, and external carotid arteries (¶195) and the subclavian, axillary, common carotid, femoral, and saphenous vessels (¶ 231 ). Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices ( p. 6, lines 29-32 ) for the reasons set forth above in claim 3. Sterman also specifically addresses that both groins are prepared to permit access ( p. 6, lines 29-30 ). Regarding independent claim 13 , Shamay teaches a method of removing thrombotic material from a treatment site of a patient (¶¶ 208-222 ), the method comprising: introducing an embolic protection device into the patient ( occlusion balloon or filter displaceable over a wire, ¶86 ); deploying the embolic protection device adjacent the treatment site ( occlusion balloon displaceable over a wire proximal to the thrombus or occlusion balloon or filter displaceable over a wire distal to the thrombus, ¶86 ); thrombectomy procedure steps (¶¶ 208-222 ); introducing a thrombectomy device into the patient (¶¶ 208-213 ); conducting a thrombectomy procedure at the treatment site (¶¶ 208-222 ); withdrawing the thrombectomy device from the patient (¶¶ 214 ); 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 embolic protection device from the patient (¶ 218 ). Shamay does not teach introducing an access sheath into a femoral vein of the patient. However, Shamay teaches introducing an access sheath (¶ 210 ) is introduced through a first femoral artery of the patient (¶¶ 207, 231 ). 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 14 , Shamay modified Sterman method of claim 13, as 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 Sterman the method of claim 13, as set forth above. Shamay does not teach wherein the embolic protection device is introduced through a first 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 ). 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 16 , Shamay modified Sterman teaches the method of claim 15, as set forth above. Shamay does not teach wherein the thrombectomy device is introduced through a second femoral vein of the patient. 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 and Sterman, given that the prior art included each element claimed, although not necessarily in a single reference. Shamay 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 both 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). 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. 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 18 , Shamay modified by Sterman teaches the method of claim 13, as set forth above. Shamay teaches the method further comprising introducing an aspiration catheter into the patient through the access sheath after the thrombectomy device has been withdrawn from the patient (¶ 218 ). Regarding claim 19 , Shamay modified by Sterman teaches the method of claim 18, as set forth above. Shamay teaches wherein both the embolic protection device and the aspiration device are introduced into the patient through the access sheath (¶¶ 86 , 208-220 ) . 07-21-aia AIA Claim s 5, 10, 17 are rejected 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 . Regarding claim 5 , Shamay teaches the method of claim 1, as set forth above. Shamay does not teach wherein the embolic protection device is introduced through an internal or external jugular vein of the patient and wherein the thrombectomy 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 ). Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices ( p. 6, lines 29-32 ) for the reasons set forth above in claim 3. Sterman also specifically addresses that both groins are prepared to permit access ( p. 6, lines 29-30 ). Hauser teaches the introduction of Mobin-Uddin (“MU”) umbrella filters (BRI: embolic protection device) through peripheral vein access sites such as the jugular or femoral veins ( p. 1, lines 20-21, 27-28 ). Hauser also teaches the combination of using the jugular vein and the femoral vein for access points upstream and downstream side ( p. 11, 26-29 ). 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, Sterman, and Hauser given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Sterman, and Hauser 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 wherein the embolic protection device is introduced through an internal or external jugular vein of the patient and wherein the thrombectomy device is introduced through a femoral vein of the patient. 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. 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. Hauser teaches the introduction of occlusion devices and filters through peripheral vein access sites such as the jugular or femoral veins and also teaches the combination of using the jugular vein and the femoral vein for access points upstream and downstream side depending on the use case and physician's judgment. Because Shamay teaches access through the femoral arteries and “a vain” and Sterman teaches access through both groins and femoral arteries or veins, and Hauser teaches access through the jugular or femoral veins or both, 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 and Hauser’s alternative vascular access solutions. Sterman’s and Hauser’s alternative access sites for catheter entry can be incorporated alongside Shamay’s method (same general location and multiple vascular access points in both groins) and or Hauser’s method (upstream or downstream or both vascular access points) using known access methods without redesigning Shamay’s method. 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 both groins and the femoral arteries or veins in the groin or through the jugular and femoral veins), 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 10 , Shamay modified by Sterman teaches the method of claim 9, as set forth above. Shamay modified by Sterman does not expressly teach wherein the aspiration device is introduced through a first femoral vein of the patient, and wherein the embolic protection device is introduced through a second femoral vein of the patient. However, Shamay teaches the introduction and use of an aspiration device ( endovascular thromboaspiration ¶17; to aspirate thrombotic debris released during the thrombectomy procedure, ¶86; thrombectomy procedure steps ¶¶ 208-222 ) wherein the embolic protection device ( balloon, ¶207 ) is introduced through a first femoral artery of the patient (¶ 207, 231 ). Shamay also teaches the use of the brachial, subclavian, axillary, internal maxillary artery, and external carotid arteries (¶ 195 ) and the subclavian, axillary, common carotid, femoral, and saphenous vessels (¶ 231 ). Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices ( p. 6, lines 29-32 ) for the reasons set forth above in claim 3. Sterman also specifically addresses that both groins are prepared to permit access ( p. 6, lines 29-30 ). Hauser teaches the introduction of Mobin-Uddin (“MU”) umbrella filters (BRI: embolic protection devices) through peripheral vein access sites such as the jugular or femoral veins ( p. 1, lines 20-21, 27-28 ). Hauser also teaches the combination of using the jugular vein and the femoral vein for access points upstream and downstream side ( p. 11, 26-29 ). 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, Sterman, and Hauser given that the prior art included the process steps comprising the use of multiple alternative sites for vascular access and introduction and retraction of devices in the base method steps taught by Shamay. Shamay, Sterman, and Hauser 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 wherein the aspiration device is introduced through a first femoral vein of the patient, and wherein the embolic protection device is introduced through a second femoral vein of the patient. Instead, Shamay teaches the use of femoral arteries in the procedure. Shamay also teaches the use of Brachial, Subclavian, Axillary, Internal Maxillary Artery, and External carotid arteries (¶195) and the Subclavian, Axillary, common Carotid, Femoral, and Saphenous vessels (¶ 231 ). 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 for the method are procedure, physician, and patient-dependent, allowing for the judgment of the skilled practitioner to select among the known alternatives. Hauser teaches the introduction of occlusion devices and filters through peripheral vein access sites such as the jugular or femoral veins and also teaches the combination of using the jugular vein and the femoral vein for access points upstream and downstream side depending on the use case and physician judgment. Hauser teaches the introduction of occlusion devices and filters through peripheral vein access sites such as the jugular or femoral veins and also teaches the combination of using upstream and downstream vascular sites depending on the use case and physician judgment. Because Shamay teaches access through the femoral and other arteries and vessels, Sterman teaches access through both groins along with femoral arteries or veins, and Hauser teaches access through the jugular or femoral veins or both, 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 and Hauser’s alternative vascular access solutions given diverse anatomical and procedural considerations (e.g. depending on the type of clot or the anatomical location of the clot). Sterman’s and Hauser’s alternative access sites for catheter entry can be incorporated alongside Shamay’s method (same general location and multiple vascular access points in both groins) and or Hauser’s method (upstream or downstream or both 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 both groins and the femoral arteries or veins in the groin or through the jugular and femoral veins), 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 Sterman teaches the method of claim 13, as set forth above. Shamay does not teach wherein the embolic protection device is introduced through an internal or external jugular vein of the patient and wherein the thrombectomy 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 ). Sterman teaches surgical catheterization procedures using femoral arteries and veins for access and occlusion devices ( p. 6, lines 29-32 ) for the reasons set forth above in claim 3. Sterman also specifically addresses that both groins are prepared to permit access ( p. 6, lines 29-30 ). Hauser teaches the introduction of Mobin-Uddin (“MU”) umbrella filters (BRI: embolic protection device) through peripheral vein access sites such as the jugular or femoral veins ( p. 1, lines 20-21, 27-28 ). Hauser also teaches the combination of using the jugular vein and the femoral vein for access points upstream and downstream side ( p. 11, 26-29 ). 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, Sterman, and Hauser given that the prior art included each element claimed, although not necessarily in a single reference. Shamay, Sterman, and Hauser 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 wherein the embolic protection device is introduced through an internal or external jugular vein of the patient and wherein the thrombectomy device is introduced through a femoral vein of the patient. 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. 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. Hauser teaches the introduction of occlusion devices and filters through peripheral vein access sites such as the jugular or femoral veins and also teaches the combination of using the jugular vein and the femoral vein for access points upstream and downstream side depending on the use case and physician judgment. Because Shamay teaches access through the femoral arteries and Sterman teaches access through both groins and femoral arteries or veins, and Hauser teaches access through the jugular or femoral veins or both, 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 and Hauser’s alternative vascular access solutions. Sterman’s and Hauser’s alternative access sites for catheter entry can be incorporated alongside Shamay’s method (same general location and multiple vascular access points in both groins) and or Hauser’s method (upstream or downstream or both 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 both groins and the femoral arteries or veins in the groin or through the jugular and femoral veins), 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 . Conclusion No claim is allowed. 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Salmon et al., US 20220117614 (21 April 2022) teaches a thrombectomy system and method of use. Albers et al., US 20220054153 (24 February 2022) teaches a device and method for treatment of deep vein thrombosis and pulmonary embolism. Hopkins et al., US 20130238009 (12 September 2013) teaches vascular devices for emboli thrombus and foreign body removal and methods of use. Walzman et al., US 20200205838 (2 July 2020) teaches methods for transfemoral percutaneous establishment of retrograde blood flow. Nguyen et al., US 20190388111 (26 December 2019) teaches electrically enhanced retrieval of material from vessel lumens. Martin et al., US 20180206865 (26 July 2018) teach retrieval systems and methods of use thereof. Marks et al., US 20200297376 (24 September 2020) teach intravascular thromboembolectomy devices and methods. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHERIE M POLAND/Examiner, Art Unit 3771 /SHAUN L DAVID/Primary Examiner, Art Unit 3771 Application/Control Number: 18/989,240 Page 2 Art Unit: 3771 Application/Control Number: 18/989,240 Page 3 Art Unit: 3771 Application/Control Number: 18/989,240 Page 4 Art Unit: 3771 Application/Control Number: 18/989,240 Page 5 Art Unit: 3771 Application/Control Number: 18/989,240 Page 6 Art Unit: 3771 Application/Control Number: 18/989,240 Page 7 Art Unit: 3771 Application/Control Number: 18/989,240 Page 8 Art Unit: 3771 Application/Control Number: 18/989,240 Page 9 Art Unit: 3771 Application/Control Number: 18/989,240 Page 10 Art Unit: 3771 Application/Control Number: 18/989,240 Page 11 Art Unit: 3771 Application/Control Number: 18/989,240 Page 12 Art Unit: 3771 Application/Control Number: 18/989,240 Page 13 Art Unit: 3771 Application/Control Number: 18/989,240 Page 14 Art Unit: 3771 Application/Control Number: 18/989,240 Page 15 Art Unit: 3771 Application/Control Number: 18/989,240 Page 16 Art Unit: 3771 Application/Control Number: 18/989,240 Page 17 Art Unit: 3771 Application/Control Number: 18/989,240 Page 18 Art Unit: 3771 Application/Control Number: 18/989,240 Page 19 Art Unit: 3771 Application/Control Number: 18/989,240 Page 20 Art Unit: 3771 Application/Control Number: 18/989,240 Page 21 Art Unit: 3771 Application/Control Number: 18/989,240 Page 22 Art Unit: 3771
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