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 .
Response to Amendment
The Amendment filed 12/15/25 has been entered. Claims 1, 6 and 20 are amended. Claims 21- 26 are added. Claims 1- 26 are being addressed by this Action.
Response to Arguments
Applicant’s arguments, see applicant’s Remarks, filed 12/15/25, with respect to the rejection(s) of claim(s) 1- 20 under 35 USC 102(a)(1) as being anticipated by Vale have been fully considered and are persuasive because Vale does not disclose the newly added limitation regarding the revascularization device including a collapsed delivery configuration and an expanded deployed configuration, the device including: a proximal pinch section including a spiral shape including a spiral pitch; and a distal section including a barrel shape. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vale et al. (US Pub. No. 2020/0085444 A1) and Casey et al. (US Pub. No. 2019/0000492 A1). It is noted that the Casey reference is relied upon for the newly added limitation features used in applicant’s arguments against Vale.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1- 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale et al. (US Pub. No. 2020/0085444 A1) in view of Casey et al. (US Pub. No. 2019/0000492 A1).
Regarding claims 1 and 21- 26, Vale discloses a method or use of restoring blood flow in neurovasculature by removing thrombus in a plurality of human patients experiencing ischemic stroke, the method or use comprising (P. [0157]):
passing a revascularization device by, through, or about a cerebral occlusion in a blood vessel of one of the plurality of human patients; then (P. [0158])
passing the revascularization device by, through, or about the cerebral occlusion in the blood vessel of the one of the plurality of human patients to restore perfusion to the blood vessel and achieve at least approximately 88% final revascularization rate for the plurality of human patients under the modified treatment in cerebral infarction score of equal to or greater than a grade of 2b (mTICI>2b) (P. [0159]).
Vale does not explicitly disclose
(claim 1) the revascularization device including a collapsed delivery configuration and an expanded deployed configuration, the device including: a proximal pinch section including a spiral shape including a spiral pitch; and a distal section including a barrel shape as claimed;
(claim 21) the revascularization device comprises peaks of the proximal pinch section are laterally spaced-apart and when under tension the proximal pinch section is configured to pinch the cerebral occlusion between the peaks;
(claim 22) the revascularization device comprises in the expanded configuration, the revascularization device comprises peaks of the proximal pinch section are laterally spaced-apart and when under tension the proximal pinch section is configured to pinch the cerebral occlusion between the peaks;
(claim 23) the proximal pinch section including a plurality of cells defined by struts and crowns connected to corresponding struts and/or crowns, and wherein at least some of the struts and/or crowns of the clot engaging section are aligned with the wave- like form to enhance embedding of clot
(claim 24) the proximal pinch section is substantially curvilinear in the collapsed and expanded configurations.
(claim 25) the proximal pinch section comprises a transverse cross section between peaks including both flat and curved sections.
(claim 26) the proximal pinch section comprises a flat shape in transverse cross section
However, Casey teaches a method or use of restoring blood flow in neurovasculature by removing thrombus in a plurality of human patients experiencing ischemic stroke in the same field of endeavor (P. [0002])
(claim 1) the revascularization device (3020) (Fig. 59) including a collapsed delivery configuration and an expanded deployed configuration (Abstract), the device (3020) including: a proximal pinch section (3021) (Fig. 59) including a spiral shape including a spiral pitch; and a distal section (3022) (Fig. 59) including a barrel shape as claimed (Ps. [0201], [0202] - - the proximal pinch section 3021 is heat set into a spiral shape. The spiral may have the following features: spiral pitch—14 mm (within a range of 10-25 mm); A longitudinal centre axis of the distal barrel section 3022 may be offset from a centre line of the spiral to assist in achieving uniform (low strain) connection between the sections);
(claim 21) the revascularization device (3020) comprises peaks of the proximal pinch section (3021) are laterally spaced-apart and when under tension the proximal pinch section (3021) is configured to pinch the cerebral occlusion between the peaks (See Fig. 59 - - it is noted that Casey’s revascularization device (3020) has the same structure of applicant’s revascularization device (200) shown in applicant’s Fig. 3);
(claim 22) the revascularization device (3020) comprises in the expanded configuration (Fig. 59), the revascularization device (3020) comprises peaks of the proximal pinch section (3021) are laterally spaced-apart and when under tension the proximal pinch section (3021) is configured to pinch the cerebral occlusion between the peaks (See Fig. 59 - - it is noted that Casey’s revascularization device (3020) has the same structure of applicant’s revascularization device (200) shown in applicant’s Fig. 3);
(claim 23) the proximal pinch section (3021) including a plurality of cells defined by struts and crowns connected to corresponding struts and/or crowns, and wherein at least some of the struts and/or crowns of the clot engaging section are aligned with the wave- like form to enhance embedding of clot (See Fig. 59 - - it is noted that Casey’s revascularization device (3020) has the same structure of applicant’s revascularization device (200) shown in applicant’s Fig. 3);
(claim 24) the proximal pinch section (3021) is substantially curvilinear in the collapsed and expanded configurations (See Fig. 59 - - it is noted that Casey’s revascularization device (3020) has the same structure of applicant’s revascularization device (200) shown in applicant’s Fig. 3);
(claim 25) the proximal pinch section (3021) comprises a transverse cross section between peaks including both flat and curved sections (See Fig. 59 - - it is noted that Casey’s revascularization device (3020) has the same structure of applicant’s revascularization device (200) shown in applicant’s Fig. 3);
(claim 26) the proximal pinch section (3021) comprises a flat shape in transverse cross section (See Fig. 59 - - it is noted that Casey’s revascularization device (3020) has the same structure of applicant’s revascularization device (200) shown in applicant’s Fig. 3).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the revascularization device associated with Vale such that it includes a collapsed delivery configuration and an expanded deployed configuration, the device including: a proximal pinch section including a spiral shape including a spiral pitch and struts forming peaks; and a distal section including a barrel shape according to the teachings of Casey because it would provide a clot removal device for performing the method or use of restoring blood flow in neurovasculature by engaging and pinching clot on movement from the deployed configuration to the clot pinching configuration in order to facilitate removal of the clot as it increases the grip of the device on the clot, thereby improving retention of the clot during retraction to the access guide catheter or sheath (Casey - - Ps. [0003], [0006], [0125]).
Regarding claim 2, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the step of passing the revascularization device comprises retracting the revascularization device, after being passed by, through or about the cerebral occlusion, while pinching the cerebral occlusion (P. [0160]).
Regarding claim 3, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the revascularization device being configured to remove the cerebral occlusion or portions thereof that are fibrin-rich (P. [0161]).
Regarding claim 4, Vale in view of Casey discloses the method of claim 1, Vale further disclosing wherein the plurality of human patients comprising at least approximately 50 patients (P. [0162]).
Regarding claim 5, Vale further discloses wherein the plurality of human patients comprising at least approximately 80 patients (P. [0163]).
Regarding claim 6, Vale in view of Casey discloses the method of claim 1, Vale further disclosing further comprising: confirming angiographically, after the step of passing the first stent retriever device, that the revascularization rate is less than a grade of 2b (mTICI<2b) (Ps. [0164], [0165]).
Regarding claim 7, Vale in view of Casey discloses the method of claim 6, Vale further disclosing inclusion criteria for the plurality of human patients comprising: Aged > 18; and mRS 0-1 prior to a stroke corresponding to the cerebral occlusion (Ps. [0166]- [0168]).
Regarding claim 8, Vale in view of Casey discloses the method of claim 1, Vale further disclosing exclusion criteria for the plurality of human patients comprising (P. [0169]):
Patients in observational, natural history, and/or epidemiological studies involving intervention (P. [0170]);
Confirmation of positive pregnancy test according to site specific standard of care (P. [0171]);
Patients who had direct aspiration via syringe/mechanical pump during the first and/or second pass attempt prior to the revascularization device (P. [0172]);
All patients with severe hypertension on presentation (SBP > 220 mmHg and/or DBP > 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications was indicated, with hypertension that remained severe and sustained despite intravenous antihypertensive therapy (SBP >185 mmHg and/ or DBP >110 mmHg) (P. [0173]);
Known cerebral vasculitis (P. [0174]);
Known cancer with life expectancy less than 12 months (P. [0175]);
Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion (P. [0176]);
Intracranial stenosis that prevented access to the site of occlusion (P. [0177]);
Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation (P. [0178]);
Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma) (P. [0179]);
Evidence of dissection in the extra or intracranial cerebral arteries (P. [0180]); and
Occlusions in multiple vascular territories (i.e. bilateral anterior circulation, or anterior/posterior circulation) (P. [0181]).
Regarding claim 9, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the method or use being performed within approximately 6 hours of stroke symptom onset (P. [0182]).
Regarding claim 10, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the method or use being performed within approximately 8 hours of stroke symptom onset (P. [0183]).
Regarding claim 11, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the method or use being performed within approximately 24 hours of stroke symptom onset (P. [0184]).
Regarding claim 12, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the cerebral occlusion being 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 patient, the patient being a human (P. [0185]).
Regarding claim 13, Vale in view of Casey discloses the method of claim 1, Vale further disclosing the revascularization device having a collapsed delivery configuration and an expanded deployed configuration, the revascularization device comprising a proximal pinch section comprising a spiral shape comprising a spiral pitch; and a distal section comprising a barrel shape (P. [0186]).
Regarding claim 14, Vale in view of Casey discloses the method of claim 13, Vale further disclosing wherein, in the expanded configuration, the revascularization device comprises peaks of the proximal pinch section are laterally spaced-apart and when under tension, the method or use comprising: pinching the cerebral occlusion between the peaks (Ps. [0187]- [0190]).
Regarding claim 15, Vale in view of Casey discloses the method of claim 13, Vale further disclosing the proximal pinch section comprising a plurality of cells defined by struts and crowns connected to corresponding struts and/or crowns, and wherein at least some of the struts and/or crowns of the clot engaging section are aligned with the wave-like form to enhance embedding of clot (P. [0191]).
Regarding claim 16, Vale in view of Casey discloses the method of claim 13, Vale further disclosing the proximal pinch section comprising one or more clot gripping features (P. [0192]).
Regarding claim 17, Vale in view of Casey discloses the method of claim 13, Vale further disclosing the proximal pinch section is substantially curvilinear in the collapsed and expanded configurations (P. [0193]).
Regarding claim 18, Vale in view of Casey discloses the method of claim 13, Vale further disclosing the proximal pinch section comprises a transverse cross section between peaks comprising both flat and curved sections (P. [0194]).
Regarding claim 19, Vale in view of Casey discloses the method of claim 13, Vale further disclosing the proximal pinch section comprises a flat shape in transverse cross section (P. [0195]).
Regarding claim 20, Vale discloses method or use of restoring blood flow in neurovasculature by removing thrombus in a plurality of human patients experiencing ischemic stroke, the method or use comprising (P. [0196]):
passing a first stent retriever device by, through, or about a cerebral occlusion in a blood vessel of one of the plurality of human patients; then (P. [0197])
passing a revascularization device by, through, or about the cerebral occlusion in the blood vessel of the one of the plurality of human patients to restore perfusion to the blood vessel and achieve at least approximately 33% FPE (mTICI greater than or equal to 2c) after a first pass (P. [0196]).
Vale does not explicitly disclose
(claim 20) the revascularization device including a collapsed delivery configuration and an expanded deployed configuration, the revascularization device including: a proximal pinch section including a spiral shape including a spiral pitch; and a distal section including a barrel shape as claimed.
However, Casey teaches a method or use of restoring blood flow in neurovasculature by removing thrombus in a plurality of human patients experiencing ischemic stroke in the same field of endeavor (P. [0002])
(claim 20) the revascularization device (3020) (Fig. 59) including a collapsed delivery configuration and an expanded deployed configuration (Abstract), the device (3020) including: a proximal pinch section (3021) (Fig. 59) including a spiral shape including a spiral pitch; and a distal section (3022) (Fig. 59) including a barrel shape as claimed (Ps. [0201], [0202] - - the proximal pinch section 3021 is heat set into a spiral shape. The spiral may have the following features: spiral pitch—14 mm (within a range of 10-25 mm); A longitudinal centre axis of the distal barrel section 3022 may be offset from a centre line of the spiral to assist in achieving uniform (low strain) connection between the sections).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the revascularization device associated with Vale such that it includes a collapsed delivery configuration and an expanded deployed configuration, the device including: a proximal pinch section including a spiral shape including a spiral pitch; and a distal section including a barrel shape according to the teachings of Casey because it would provide a clot removal device for performing the method or use of restoring blood flow in neurovasculature by engaging and pinching clot on movement from the deployed configuration to the clot pinching configuration in order to facilitate removal of the clot as it increases the grip of the device on the clot, thereby improving retention of the clot during retraction to the access guide catheter or sheath (Casey - - Ps. [0003], [0006], [0125]).
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.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771