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 .
Response to Arguments
Applicant's arguments filed 2/23/2026 have been fully considered but they are not persuasive. The rejection relies on the embodiment of the revascularization device 300 shown in fig. 4 of Vale, which meets the structural limitations of the revascularization device as claimed. Applicant argues that the cited paragraph [0428] of Vale relied upon in the rejection uses a clot retrieval device 200 and thus does not teach the claimed “removing the revascularization device to …. achieve an approximately 80% revascularization rate” with the revascularization device 300 shown in fig. 4 of Vale. The examiner respectfully disagrees. Paragraph [0421] states that a clot retrieval device “such as clot retrieval device 200” (emphasis added) was used for 90% of the passes. The phrase “such as” does not preclude use of the other clot retrieval device disclosed in Vale. Vale expressly discloses that selection of which revascularization device between the “stent retriever” shown in fig. 3 and the “pinch retriever” shown in fig. 4 relates to the fibrin content of the clots and discloses analyzing clot material before a revascularization device is selected in order to select the proper retrieval device (see [0020]). Thus, any time the analyzed clot is fibrin-rich, Vale discloses passing the revascularization device shown in fig. 4 as the first -line device. It is understood then that Vale discloses passing the revascularization device shown in fig. 4 of Vale when the clot is fibrin rich until it achieves “approximately 80% revascularization rate after last pass of the revascularization device under a modified treatment in cerebral infarction score of equal to or greater than grade 2b (mTICI>2b)”, as this is a desired result according to Vale. The structure of the revascularization device of the instant application (shown in fig. 3) is identical to the structure of the revascularization device of fig. 4 of Vale and thus the revascularization device shown in fig. 4 is clearly capable of achieving this revascularization rate.
Claim 12 no longer invokes 35 USC 112f in view of the amendment made to the claim which replaces “one or more clot gripping features” with “one or more clot gripping structures in the form of a spiral shape”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 and 9-12 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Vale et al. WO 2020/039258 A1 (note: citations taken from US 2021/0315599, which corresponds to WO 2020/039258 A!).
Regarding claim 1, Vale discloses a method for restoring blood flow in neuro vasculature of a human patient experiencing ischemic stroke ([0014], [0316]), the method comprising identifying a respective human patient within a plurality of human patients at risk of comprising a thrombus (step 510; [0324]-[0330] – angiographic confirmation of an occlusion), passing a revascularization device (300; fig. 4) as a first-line device to a blood vessel of the respective human patient of the plurality of human patients for retrieving a thrombus ([0335]; see claim 208 – pinch type revascularization device, illustrated in fig. 4, used as first-line device if clot is a fibrin-rich clot), wherein the revascularization device comprises a collapsed delivery configuration and an expanded deployed configuration ([0338]), a proximal pinch section (321; fig. 4) having a spiral shape ([0322]) comprising a spiral pitch and a distal section (322) comprising a barrel shape, and removing the revascularization device ([0338]) to restore perfusion to the blood vessel and achieve approximately 80% revascularization rate ([0428]) after last pass of the revascularization device under a modified treatment in cerebral infarction score of equal to or greater than 2b (mTICI>2b) for the plurality of human patients comprising a thrombus within a predetermined time period of natural stroke symptom onset ([0316]). In particular, Vale discloses achieving a revascularization rate of 90% (par. [0428]) for a mTICI>2b, which falls within the claimed range of approximately 80%, noting that the instant application states that “approximately” refers to a range of values ±20% of the recited value (see [0050] of instant application’s specification as filed 8/23/2023). Thus, “approximately 80%” as recited in the claims is understood to refer to the range of 60-100%.
Regarding claim 2, the method comprises detecting, prior to the step of passing the revascularization device as the first-line device, an initial revascularization rate of the respective human patient of the plurality of human patients less than a grade 2b (mTICI<2b). As understood in view of the table in fig. 36, some of the patients have an initial revascularization rate (i.e., before first pass of device) less than a grade 2b as they remain below grade 2b (i.e., 0-2a) after the first pass. Note also that par. [0325] includes that the clinical history of the patient, which is considered at step 510 (fig. 5), may include a mTICI of 0-1 (and thus a mTICI <2b was “detected” prior to the step of passing the revascularization device to the blood vessel).
Regarding claim 3, removing the revascularization device to restore perfusion to the blood vessel and achieve approximately 80% revascularization rate for the plurality of human patients under the modified treatment in cerebral infarction score of equal to or greater than grade 2b (mTICI>2b) comprises less than three passes of the revascularization device as the first-line device (e.g., see fig. 36, wherein 12 patients had a revascularization rate of mTICI of 3 after just two passes of the device, wherein a mTICI of 3 is described as complete antegrade reperfusion, i.e., 100%, of a previously occluded target artery ischemic territory as per [0315]; as noted above, “approximately 80%” is understood to encompass the range of 60-100%).
Regarding claim 4, removing the revascularization device to restore perfusion to the blood vessel and achieve approximately 80% revascularization rate for the plurality of human patients under the modified treatment in cerebral infarction score of equal to or greater than grade 2b (mTICI>2b) comprises an average of approximately 2.4 passes of the revascularization device as the first-line device (see [0423] – on average 2.4 passes required to retrieve clots with no ICA involvement; final 90% revascularization rate for mTICI>2b as per par. [0428]).
Regarding claim 5, the method of Vale further comprises reducing, by the step of passing the revascularization device as the first-line device, post-procedural clinical complications selected from at least one of vessel dissection, vessel perforation, hematoma, emboli in new territory, infarction in new territory, or hemorrhagic transformation. In particular, the method of Vale is considered to reduce the chance of post-procedural emboli in new territory by successfully retrieving clot material that, if dislodged, would become emboli that may be carried within the blood stream to new territory.
Regarding claim 6, the method is performed within at least 11 hours of stroke symptom onset ([0316] – within 8 hours of symptom onset).
Regarding claim 7, the thrombus is positioned in an internal carotid artery, a M1 segment and/or a M2 segment of a middle cerebral artery, a vertebral artery, or a basilar artery of the human patient (see fig. 36, noting “occlusion site” portion of table).
Regarding claim 9, the revascularization device is configured to position the thrombus against a wall of the blood vessel and then pinch at least a portion of the thrombus with the proximal pinch section ([0323], noting also that figure 4 of Vale is identical to fig. 3 of the instant application except for the reference numbers).
Regarding claim 10, wherein, in the expanded deployed configuration, the revascularization device comprises peaks of the proximal pinch section that are laterally spaced- apart and when under tension, pinch the thrombus between the peaks (undulating struts form laterally spaced apart peaks as shown in fig. 4, and when device is under tension, lateral edges of cells pinch down on thrombus). Note that the structure illustrated in fig. 4 of Vale is identical to the structure illustrated in fig. 3 of the instant application, which is the only illustration of the revascularization device.
Regarding claim 11, the proximal pinch section comprising a plurality of cells defined by struts and crowns connected to corresponding struts and crowns, and wherein at least some of the struts or the crowns of the proximal pinch section are aligned with a wave-like form to enhance embedding of clot (see fig. 4, noting undulating shape of struts). In the examiner-annotated figure 4 of Vale below, two crowns and two struts of a cell are labelled.
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Regarding claim 12, the proximal pinch section comprises one or more clot gripping structures in the form of a spiral shape (e.g., see cells of 321, arranged in spiral shape according to [0322]; noting figure 4 of Vale is identical to fig. 3 of the instant application, except for the reference numbers).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 5/5/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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