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 Arguments
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive in view of the rejections set forth below addressing the amended limitations to the claims.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites the limitation “the aspiration member” in the second to last line of the claim. It is suggested this limitation be changed to “the expandable aspiration member” to consistently refer to the expandable aspiration member in the previous lines of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-6 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kusleika et al (US7578830).
Regarding claim 1, Kusleika discloses a thrombectomy device comprising: a delivery catheter (20); and an expandable funnel (30) configured to be movably disposed within the delivery catheter in a retracted position (figure 9) and at least partially outside the delivery catheter in an extended position (figures 8) comprising a non-permeable covering (C:12, L:54-55) comprising one or more biocompatible elastomeric materials (flexible metal hoop) to allow funnel resheathing into the delivery catheter , a diameter of a distal end of the expandable funnel being greater in the extended position than in the retracted position (figures 8, 9), the expandable funnel in its extended position being configured to adapt its shape and length to a surrounding blood vessel (C:10, L:60-61) such that the expandable funnel is configured to provide a constant outward radial force against the interior of the blood vessel along the entire length of the distal end of the expandable funnel (Since the length of the distal end has a constant diameter, the device would be capable of delivering a constant outward force against the interior of an arbitrary blood vessel. Furthermore, it is noted that this is a functional limitation that would be dependent on the characteristics of the blood vessel), wherein in the extended position, the delivery catheter is proximally disposed at a distance from the distal end of the expandable funnel (figure 8).
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Regarding claim 2, Kusleika discloses all of the limitations set forth in claim 1 further comprising a tapered dilator catheter (12 or alternatively 74) configured to be movably disposed within the delivery catheter (figures 10, 11, 13), wherein the expandable funnel (30) is configured to remain within the delivery catheter after the dilator catheter has been removed (Figure 12; C:18, L:19-35).
Regarding claim 3, Kusleika discloses all of the limitations set forth in claim 2 wherein the delivery catheter, the dilator catheter, the expandable funnel are oriented on the same axis (figures 8 and 13).
Regarding claim 4, Kusleika discloses all of the limitations set forth in claim 1, wherein the length of the expandable funnel is configured to be inversely adaptable to a diameter of the blood vessel when the expandable funnel is in the extended position (since the device of Kusleika is expandable and shape memory, it would be capable of being inversely adaptable to a diameter of the blood vessel when the expandable funnel is in the extended position. Functional limitations are not given full patentable weight. As long as the prior art is capable of performing the recited function, the prior art meets the limitations and does not need to be explicitly disclosed in the prior art).
Regarding claim 5, Kusleika discloses all of the limitations set forth in claim 4, wherein the constant outward radial force against the interior of the blood vessel is configured to be constant as the diameter of the blood vessel changes (since the device of Kusleika is expandable and shape memory and has a constant diameter along its length, it would be capable of having a constant outward radial force against the interior of the blood vessel as the diameter of an arbitrary blood vessel changes. Functional limitations are not given full patentable weight. As long as the prior art is capable of performing the recited function, the prior art meets the limitations and does not need to be explicitly disclosed in the prior art. Furthermore, it is noted that this is a functional limitation that would be dependent on the characteristics of the blood vessel, and the characteristics of the blood vessel can be selected to meet these limitations).
Regarding claim 6, Kusleika discloses all of the limitations set forth in claim 1, wherein the expandable funnel is configured to aspirate the thrombus (C:1, L:40-45, C:15, L:50-55).
Regarding claim 11, Kusleika discloses all of the limitations set forth in claim 1, wherein the shape memory material comprises nitinol (C:12, L:58-67).
Regarding claim 12, Kusleika discloses all of the limitations set forth in claim 1, further comprising a resheathing element (40) adapted to reintroduce the expandable funnel into the delivery catheter (shaft 40 is pulled to reintroduce funnel into delivery catheter 20).
Regarding claim 13, Kusleika discloses all of the limitations set forth in claim 12, wherein the resheathing element comprises a cannula (40).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 7-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika et al (US7578830), as applied to claims 1 and 6 above, and further in view of Hart et al (US 5971938).
Regarding claim 7, Kusleika discloses all of the limitations set forth in claim 6, wherein Kusleika further teaches it was known in the art to apply aspiration to a proximal containment member for extracting embolic material (C:1, L:40-45, C:15, L:50-55), but does not specifically disclose an aspiration catheter having a distal end and a proximal end, the distal end connected to a proximal end of the expandable funnel and the proximal end in communication with an aspiration device. However, Hart et al (hereafter Hart) teaches a similar clot retrieval device comprising an expandable funnel configured to stop blood flow when expanded in the blood vessel (C:12, L:59-67; C:4, L:10-12), wherein it was known in the art at the time of the invention to include an aspiration catheter (36) having a distal end and a proximal end (70), the distal end connected to a proximal end of the expandable funnel (figure 3) and the proximal end in communication with an aspiration device (C:7, L:40-50 ) to assist in the removal process of occluding material extruded into the expandable funnel (C:12, L:40-51). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include an aspiration catheter having a distal end and a proximal end, the distal end connected to a proximal end of the expandable funnel and the proximal end in communication with an aspiration device on the device of Kusleika, as taught as known in the art for clot retrieval devices at the time of the invention by Hart, in order to assist in the removal process of occluding material extruded into the expandable funnel.
Regarding claim 8, Kusleika discloses all of the limitations set forth in claim 1, wherein Kusleika further teaches it was known in the art to apply aspiration to a proximal containment member for extracting embolic material (C:1, L:40-45, C:15, L:50-55), but does not specifically disclose an aspiration catheter having a distal end and a proximal end, the distal end connected to a proximal end of the expandable funnel and the proximal end in communication with an aspiration device configured to aspirate the retained thrombus within the expandable funnel. However, Hart et al (hereafter Hart) teaches a similar clot retrieval device comprising an expandable funnel configured to stop blood flow when expanded in the blood vessel (C:12, L:59-67; C:4, L:10-12), wherein it was known in the art at the time of the invention to include an aspiration catheter (36) having a distal end and a proximal end (70), the distal end connected to a proximal end of the expandable funnel (figure 3) and the proximal end in communication with an aspiration device (C:7, L:40-50 ) to assist in the removal process of the retained thrombus within the expandable funnel (C:12, L:40-51). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include an aspiration catheter having a distal end and a proximal end, the distal end connected to a proximal end of the expandable funnel and the proximal end in communication with an aspiration device configured to aspirate the retained thrombus within the expandable funnel on the device of Kusleika, as taught as known in the art for clot retrieval devices at the time of the invention by Hart, in order to assist in the removal process of occluding material extruded into the expandable funnel.
Regarding claim 9, Kusleika discloses all of the limitations set forth in claim 8, wherein an amount of aspiration would be configured to be increased based on the constant outwards radial force against the interior of the blood vessel (applying or removing air under positive or negative pressure can be increased or decreased. Functional limitations are not given full patentable weight. As long as the prior art is capable of performing the recited functions, the prior art meets the limitations).
Regarding claim 14 Kusleika discloses all of the limitations set forth in claim 1, wherein Kusleika further teaches it was known in the art to apply aspiration to a proximal containment member for extracting embolic material (C:1, L:40-45, C:15, L:50-55), but does not specifically disclose an aspiration funnel catheter extends proximally from a proximal opening of the expandable funnel, the aspiration funnel catheter being configured to aspirate the thrombus within the expandable funnel. However, Hart et al (hereafter Hart) teaches a similar clot retrieval device comprising an expandable funnel configured to stop blood flow when expanded in the blood vessel (C:12, L:59-67; C:4, L:10-12), wherein it was known in the art at the time of the invention to include an aspiration funnel catheter (36) extends proximally from a proximal opening of the expandable funnel (figure 3, C:7, L:40-50 ) being configured to aspirate the thrombus within the expandable funnel to assist in the removal process of the retained thrombus within the expandable funnel (C:12, L:40-51). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include an aspiration funnel catheter extending proximally from a proximal opening of the expandable funnel configured to aspirate the thrombus within the expandable funnel in the device of Kusleika, as taught as known in the art for clot retrieval devices at the time of the invention by Hart, in order to assist in the removal process of occluding material extruded into the expandable funnel.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kusleika et al (US7578830), as applied to claim 1 above, and further in view of Rosenbluth et al (US 20140155908).
Regarding claim 10, Kusleika discloses all of the limitations set forth in claims 1, but does not specifically disclose the diameter of the funnel. However, Rosenbluth et al (hereafter Rosenbluth) teaches it was known in the art at the time of the invention that clot treatment devices can be used in vessels with diameters ranging from 2mm to 15mm (paragraph 0066). Therefore, since the funnel of Kusleika is configured to conform to the inner diameter of a blood vessel and Rosenbluth teaches 2mm to 15mm is a known range for the inner diameter of blood vessels, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the funnel of Kusleika have a diameter at its distal end of between 2 millimeters and 15 millimeters, since when the general working a mere change in size of a device involves routine skill in the art. Additionally, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kusleika et al (US 7578830), as applied to claim 1 above, and further in view of Dubrul et al (US 6695858).
Regarding claims 15-16, Kusleika discloses a system for extraction of vascular thrombi from a blood vessel comprising the thrombectomy device of claim 1, Kusleika further teaches a first radiomarker (272), and a second radiomarker (274) wherein the first radiomarker is arranged and configured to indicate a location of the distal end of the funnel, and the second radiomarker is arranged and configured to indicate a location of the thrombus (the device can be positioned such that the thrombus is adjacent the second radiopaque marker 274). Kusleika further teaches the radiopaque markers can be viewed under fluoroscopy, however Kusleika does not teach an imaging device, a communications channel, a control module, a data storage device, and a guidance system, wherein the control module is guided by a computer-assisted controller. However, Dubrul et al (hereafter Dubrul) teaches it was known in the art to couple an intravascular device with an imaging device (imaging device), a communications channel (fluid source), a control module (controller), a data storage device (processor), and a guidance system (guidance device), wherein the control module is guided by a computer-assisted controller (robotic system) (C:28, L:20-41) in order to allow the surgeon to perform a variety of microsurgical procedures through small incisions to perform precise and delicate maneuvers. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to couple the interventional device of Dubrul with a communications channel, control module, data storage device, and guidance system, wherein the control module is guided by a computer-assisted controller, as taught as known in the art by Keogh, in order to allow the surgeon to perform precise and delicate maneuvers during a procedure.
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.
Claims 1-3, 6-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-13 of U.S. Patent No. 12, 161,352 in view of Kusleika et al (US 7578830). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5, 8-13 of U.S. Patent No. 12, 161,352 recites the claimed delivery catheter and expandable aspiration funnel, except for the expandable funnel is configured to provide a constant outward radial force against the interior of the blood vessel along the entire length of the distal end of the expandable funnel. However, Kusleika discloses a thrombectomy device comprising: a delivery catheter (20); and an expandable funnel (30) configured to be movably disposed within the delivery catheter in a retracted position (figure 9) and at least partially outside the delivery catheter in an extended position (figures 8) comprising a non-permeable covering (C:12, L:54-55), a diameter of a distal end of the expandable funnel being greater in the extended position than in the retracted position (figures 8, 9), the expandable funnel in its extended position being configured to adapt its shape and length to a surrounding blood vessel (C:10, L:60-61) such that the expandable funnel is configured to provide a constant outward radial force against the interior of the blood vessel along the entire length of the distal end of the expandable funnel (The length of the distal end has a constant diameter to exert a constant outward radial force along the length), a biocompatible elastomeric material to allow funnel resheathing into the delivery catheter (see rejection above). Therefore, it would have been obvious to one with ordinary skill in the art to further make claims 1-5 and 8-13 of U.S. Patent No. 12, 161,352 provide a constant outward radial force against the interior of the blood vessel along the entire length of the distal end of the expandable funnel, as taught as known in the art by Kusleika to engage the blood vessel and a biocompatible elastomeric material to allow funnel resheating into the delivery catheter, wherein in the extended position, the delivery catheter is proximally disposed at a distance from the distal end of the expandable aspiration member.
Instant Application
1, 6-9, 14
2
3
10
11
12
13
15
16
17
Patent 12161352
1
2
3
7
6
11
12
12
13
15
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11013523. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11013523 recites the claimed delivery catheter and expandable aspiration member. Therefore, patent claim 4 is in essence a “species” of the generic invention of application claim 17 and therefore claim 17 of the instant application is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application
claim 17 is anticipated by patent claim 4, it is not patentably distinct from Patent claim 4.
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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/Primary Examiner, Art Unit 3771
