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 .
Election/Restriction
This application contains claims directed to the following patentably distinct species:
Species A: (Figs. 1- 2C) claims 21- 25: an embolic capture device (10) comprises a single hollow stent body (12) with a generally cylindrical shape, a proximal end (14) and a distal end (16);
Species B: (Figs. 11A- 13B) claims 26- 30: an embolic capture device (110) having multiple layers of stent body including an inner stent body (120) and an outer stent body (130).
The species are independent or distinct because of the above described mutually exclusive features. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claim is generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the prior art applicable to one invention would not likely be applicable to
another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Helen S. Liu on 4/06/26 a provisional election was made without traverse to prosecute the invention of Species A, claims 21- 25 Affirmation of this election must be made by applicant in replying to this Office action. Species B, Claims 26- 30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 22 is objected to because of the following informalities: line 2- “wherein a first circumferential row of cells of the embolic capture device rotate in a first direction” should be amended to - - wherein a first circumferential row of cells of the embolic capture device rotates in a first direction - - to correct an apparent typographical error. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claims 21- 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8- 9 of U.S. Patent No. 11,857,209 in view of Vale et al. (US Pub. No. 2014/0277079 A1).
Regarding application claim 21, claim 1 of U.S. Patent No. 11,857,209 claims
wherein the embolic capture device comprises a stent body, wherein the stent body comprises a plurality of circumferential rows of cells,
(An embolic capture device comprising: an elongated stent body having a distal end, a proximal end, an axial lumen extending from the distal end to the proximal end, and a luminal surface; at least two connecting struts at the proximal end of the stent body joined together with a distal end of a pusher shaft …wherein a first circumferential row of cells of the plurality of cells along the luminal surface of the elongated stent body have a first cell axis forming a first angle with a longitudinal axis of the stent body, and a second circumferential row of cells of the plurality of cells adjacent to the first circumferential row of cells; it is noted that a first and second circumferential row of cells is equivalent to a plurality of circumferential rows of cells) (See claim 1 of U.S. Pat. No. 11,857,209)
as the embolic capture device expands radially with at least one circumferential row of cells of the embolic capture device rotating along its longitudinal axis of the stent body
(wherein the embolic capture device has a radially collapsed profile during delivery and a radially expanded profile upon deployment, and wherein as the device resumes its radially expanded profile, the first circumferential row of cells rotates around the longitudinal axis of the stent body in a first direction, and the second circumferential row of cells rotates around the longitudinal axis of the stent body in an opposite direction, wherein one of the first direction and the opposite direction is clockwise) (See claim 1 of U.S. Pat. No. 11,857,209).
Claim 1 of U.S. Patent No. 11,857,209 does not claim
(claim 1) a method for removing a blood clot comprising
placing a guide wire across a blood clot,
threading a microcatheter over the guide wire, wherein the microcatheter comprises a distal end,
placing the distal end of the microcatheter distally to the blood clot,
joining a pusher shaft to a proximal end of an embolic capture device,
advancing the pusher shaft distally so that the embolic capture device is placed at a location approximately to the blood clot,
withdrawing the microcatheter proximally to engage the blood clot with the embolic capture device, and
pulling the pusher shaft to withdraw the embolic capture device and the blood clot proximally.
However, Vale teaches a method for removing a blood clot (P. [0008] - - The method of removing the blood clot from a blocked artery) comprising
placing a guide wire across a blood clot (2) (Figs. 4a- 4d) (P. [0159] - - A guidewire (not shown) is inserted in the cerebral artery 1 and is advanced distally across an obstructive clot 2),
threading a microcatheter (4) (Figs. 3a- 4d) over the guide wire, wherein the microcatheter (4) comprises a distal end (5) (Figs. 3a- 4d) (See Fig. 4a) (P. [0159] - - A microcatheter 4 is advanced over the guidewire),
placing the distal end (5) of the microcatheter (4) distally to the blood clot (2) (See Fig. 4a - - showing distal end (5) of microcatheter (4) distal of the blood clot (2)),
joining a pusher shaft (25) (Figs. 3a- 4d) to a proximal end of an embolic capture device (20) (P. [0158] - - Two pull tethers 25 which have distal ends that are attached to most proximal ring element 22, and proximal ends that extend exterior of the artery for maneuvering and control by the physician, are present; it is noted since distal ends are attached and present, pull tethers 25 have been necessarily joined with embolic capture device (20)), wherein the embolic capture device (20) comprises a stent body, wherein the stent body comprises a plurality of circumferential rows of cells (22) (Figs. 3a- 4d) (P. [0158] - - The retrieval device 20 has an elongate member 21 having a distal end that extends interior of the artery and a proximal end that extends exterior of the artery, and a plurality of ring elements 22 configured at the distal end of the elongate member 21),
advancing the pusher shaft (25) distally so that the embolic capture device (20) is placed at a location approximately to the blood clot (2) (See Fig. 4b) (P. [0159] - - the retrieval device 20 of the present invention is advanced through the microcatheter 4 to the clot in the collapsed configuration; it is noted since pusher shaft (25) allows a physician to maneuver the embolic capture device (20) through microcatheter (4), Fig. 4b shows that the pusher shaft (25) necessarily was advanced distally to a location near the blood clot),
withdrawing the microcatheter (4) proximally to engage the blood clot (2) with the embolic capture device (20) as the embolic capture (20) device expands radially (See Figs. 4b, 4c) (P. [0159] - - The microcatheter 4 is retracted when the retrieval device 20 is positioned within or distal of the clot 2 to allow ring elements 22 to reach the expanded configuration … The ring elements 22 engage or capture the clot 2 from the distal surface of the clot 2 and retract the clot 2 proximally towards the microcatheter 4), and
pulling the pusher shaft (25) to withdraw the embolic capture device (20) and the blood clot (2) proximally (See Fig. 4b) (P. [0159] - - The ring elements 22 engage or capture the clot 2 from the distal surface of the clot 2 and retract the clot 2 proximally towards the microcatheter 4; it is noted since pusher shaft (25) allows a physician to maneuver the embolic capture device (20) through microcatheter (4), Fig. 4d shows that the pusher shaft (25) necessarily was pulled proximally toward microcatheter (4)).
Vale further disclosing that the above method for removing a blood clot uses conventionally known techniques in the art of mechanical thrombectomy (Ps. [0001], [0005], [0157] - - The present invention relates generally to the field of distal mechanical thrombectomy, more particularly, to a self-expandable mechanical clot retrieval device used in the treatment of acute ischemic stroke and pulmonary embolism in a patient. The retrieval device is of extremely small size delivered through an intravascular microcatheter and meticulously designed to remain in a collapsed state while advancing through the microcatheter to remove thrombus or embolus from the blocked arteries; Generally, the distal mechanical devices are delivered endovascularly and advanced by guidewire and microcatheter until the device is located distal of the clot where it expands. Thus force is applied to the distal surface of the clot to dislodge it from the artery wall where it is caught and retracted proximally by the retrieval device; As shown generally in FIGS. 1a-1b and 2a-2h, an obstructive clot 2 is occluding a cerebral artery 1 and a guidewire 3 is inserted into the artery 1 using conventionally known techniques).
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 claim 1 of U.S. Pat. No. 11,857,209 to include the method steps for using the mechanical thrombectomy device associated with claim 1 of U.S. Patent No. 11,857,209 according to the teachings of Vale because it is well-known in the art of mechanical thrombectomy that conventionally known method steps of delivering a distal mechanical device via guidewire and microcrater, deploying the device, dislodging clot, and then withdrawing the clot and the device would have yielded predictable results, namely removing a blood clot from a vessel. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding application claim 22, application claim 21 would have been obvious over claim 1 of U.S. Patent No. 11,857,209 in view of Vale, and furthermore, application claim 22 would also have been obvious over claim 1 of U.S. Patent No. 11,857,209 in view of Vale (See claim 1 of U.S. Patent No. 11,857,209 - - and wherein as the device resumes its radially expanded profile, the first circumferential row of cells rotates around the longitudinal axis of the stent body in a first direction, and the second circumferential row of cells rotates around the longitudinal axis of the stent body in an opposite direction, wherein one of the first direction and the opposite direction is clockwise).
Regarding application claim 23, application claim 21 would have been obvious over claim 1 of U.S. Patent No. 11,857,209 in view of Vale, and furthermore, application claim 23 would also have been obvious over claim 1 of U.S. Patent No. 11,857,209 in view of Vale (See claim 1 of U.S. Patent No. 11,857,209 - - and wherein as the device resumes its radially expanded profile, the first circumferential row of cells rotates around the longitudinal axis of the stent body in a first direction, and the second circumferential row of cells rotates around the longitudinal axis of the stent body in an opposite direction, wherein one of the first direction and the opposite direction is clockwise).
Regarding application claim 24, application claim 21 would have been obvious over claim 1 of U.S. Patent No. 11,857,209 in view of Vale, and furthermore, application claim 24 would have been obvious over claim 8 of U.S. Patent No. 11,857,209 in view of Vale (See claim 8 of U.S. Patent No. 11,857,209 - - wherein as the device resumes its radially expanded profile upon deployment, the device is configured to axially rotate at a first speed followed by an axial rotation at a second speed) It is noted since Vale teaches a method for removing a blood clot, 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 “configured to axially rotate” language in claim 8 to the method step of actually axially rotating. Additionally, it is noted axially rotating in a different direction necessarily changes the speed of rotation.
Allowable Subject Matter
Application claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding application claim 25, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, the method for removing a blood clot of claim 21, wherein a first circumferential row of cells of the embolic capture device rotates with a first torque strength, and a second circumferential row of cells of the embolic capture device rotates with a second torque strength, wherein the first torque strength is different from the second torque strength.
Claim 9 of U.S. Patent No. 11,857,209 claims “The embolic capture device of claim 1, wherein as the device resumes its radially expanded profile upon deployment, the device is configured to axially rotate with a first torque strength followed by an axial rotation with a second torque strength.” However, it is not obvious that, after changing the direction of rotation, the first torque strength is necessarily different from the second torque strength as required by application claim 25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771
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