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/Restrictions/ Response to Arguments
Applicant's election with traverse of Group I, claims 1- 9 in the reply filed on 1/30/26 is acknowledged. The traversal is on the ground(s) that it is likely that art discussing an apparatus as described in claim 1 would discuss a method using the apparatus. This is not found persuasive because the method claims are not commensurate with the elected apparatus and would require distinct searching. That is to say, the examiner’s burden is not simply a subjective “likely” search but a complete search. As noted in the Restriction Requirement, mailed 12/02/25, there are many more references relevant to the apparatus invention than are relevant to the method invention since the apparatus could be used in many more materially different processes than the claimed method invention. As such, there are many more prior art references applicable to one invention (apparatus) that would not likely be applicable to another invention (method). For example, the Brady et al. (US Pub. No. 2013/0197567 A1) reference used in the rejection of the apparatus claims below does not disclose applicant’s claimed method.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/852,104, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The original disclosure of prior-filed application, Application No. 16/852,104 does not have support for “a second portion of the clot” operable to be pinched or tweezed feature. Specifically, claim 1 limitations regarding “an expanded state distal of the microcatheter operable to pinch a second portion of the clot” and claim 7 limitations regarding “wherein the inner cage is a plurality of pinching cells operable to tweeze the second portion of the clot” do not have support in the original disclosure of prior-filed application, Application No. 16/852,104.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1- 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is no support in the original disclosure for limitations regarding the applicant’s device being operable to pinch or tweeze “a second portion of the clot” as in the Claim 1 limitation “an expanded state distal of the microcatheter operable to pinch a second portion of the clot” and as in the claim 7 limitation “wherein the inner cage is a plurality of pinching cells operable to tweeze the second portion of the clot.”
Claims 2- 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as being dependent off claim 1.
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 1 and 6- 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 9 and 12 of U.S. Patent No. 11,717,308 in view of Brady et al. (US Pub. No. 2013/0197567 A1).
Regarding application claim 1, claim 1 of U.S. Patent No. 11,717,308 substantially claims application claim 1. However, instead of claiming “a first portion of the clot” and “a second portion of the clot,” claim 1 of U.S. Patent No. 11,717,308 claims “at least a portion of the clot.”
However, Brady teaches a clot retrieval device in the same field of endeavor (Abstract) including a caged portion (2) operable to retrieve a first portion of a clot (51) and a pinching portion (44) operable to pinch a second portion of the clot (51) (P. [0076] - - The frame 7 and engager 2 can also be used to pin the clot between these two elements of the device. This is of particular advantage in ensuring that a firm grip is held on the clot as it is withdrawn against the flow past branch vessels and into larger more proximal vasculature).
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 “at least a portion of the clot” associated with claim 1 of U.S. Patent No. 11,717,308 in order to claim a first and second portion of the clot according to the teachings of Brady because it would provide an advantage in ensuring that a firm grip is held on the clot as it is withdrawn against the flow past branch vessels and into larger more proximal vasculature (Brady - - P. [0076]).
Regarding application claim 6, application claim 6 would have been obvious over claim 1 of U.S. Patent No. 11,717,308 as evidenced by Brady.
Regarding application claim 7, application claim 7 would have been obvious over claim 8 of U.S. Patent No. 11,717,308 as evidenced by Brady.
Regarding application claim 8, application claim 8 would have been obvious over claim 9 of U.S. Patent No. 11,717,308 as evidenced by Brady.
Regarding application claim 9, application claim 9 would have been obvious over claim 12 of U.S. Patent No. 11,717,308 evidenced by Brady.
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- 5 is/are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Brady et al. (US Pub. No. 2013/0197567 A1).
Regarding claim 1, Brady discloses a clot retrieval device for retrieving a clot from a blood vessel, comprising:
a caged portion (2) (Figs. 1- 3, 7, 10- 14), the caged portion (2) comprising a distal end (44) (Fig. 7), a proximal end (42) (Fig. 7), a delivery configuration within a microcatheter (52) (Figs. 9- 14), and a deployed configuration distal of the microcatheter (52) operable to retrieve a first portion of the clot (51) (Figs. 8- 14); and
a pinching portion (7) (Figs. 1- 6) positioned distal of the distal end (44) of the caged portion (2), the pinching portion (7) comprising a collapsed state within the microcatheter (52) and an expanded state distal of the microcatheter operable to pinch a second portion of the clot (51) (P. [0076] - - The frame 7 and engager 2 can also be used to pin the clot between these two elements of the device. This is of particular advantage in ensuring that a firm grip is held on the clot as it is withdrawn against the flow past branch vessels and into larger more proximal vasculature).
Regarding claim 2, Brady further discloses wherein the pinching portion (7) is elongated (See Fig. 1) (Ps. [0049], [0062] - - The frame 7 is connected to a second elongate shaft element which in this case is provided by a support shaft 9. The shaft 9 may be connected at its proximal end to a second element 12 of the handle 4; it is noted that the support shaft 9 portion of the frame is elongated; it is further noted that pinching portion (7) has a length component that extends and contracts depending on the radial expansion of pinching portion (7) as shown in Figs. 4 and 5; The device is positioned so that the capture basket 3 is distal of the clot 51 and at least a portion of the engager 2 is within the clot; it is noted that Figs. 8- 14 procedural steps show an extended engager/ pincher portion during deployment).
Regarding claim 3, Brady further discloses wherein the pinching portion (7) comprises a network (31) (Fig. 6) of struts (33) (Fig. 6) in a tubular shape (Ps. [0056], [0057] - - FIG. 6 illustrates one embodiment of a frame 31 in which the frame 31 is formed in a figure of eight pattern so that frame struts 33 and 34 at crossover point 32 can move relative to each other to facilitate the adjustment of the frame to different vessel diameters; Distal struts 49 act as guide rails in the embodiment shown to facilitate this entry by providing a smooth and snag free surface to contact and pass through the inlet mouth 34 of the frame 31 in FIG. 6 of a capture basket; it is noted that since pinching portion (7) has an inlet mouth connected to the proximal end of the tubular shaped capture basket 3, pinching portion (7) comprises a network (31) of struts (33) in a tubular shape).
Regarding claim 4, Brady further discloses wherein the pinching portion (7) further comprises a proximal portion (34) (Fig. 6) and a distal portion (33) (Fig. 6) (P. [0056] - - FIG. 6 illustrates one embodiment of a frame 31 in which the frame 31 is formed in a figure of eight pattern so that frame struts 33 and 34 at crossover point 32 can move relative to each other to facilitate the adjustment of the frame to different vessel diameters).
Regarding claim 5, Brady further discloses wherein a diameter of the proximal portion (34) is smaller than a diameter of the distal portion (33) (Ps. [0054], [0055] - - In the embodiment illustrated the capture basket 3 has a control tether 6 that can be tensioned to control the expansion of the frame 7 of the clot basket 3 or to increase the radial force of the frame 7 of the clot basket 3. The user can control the diameter to which the frame 7 expands by controlling the position of a movable control element such as a button 30 on the handle 4; it is noted that as the pinching portion (7) is being expanded by controlling the position of button 30, there is an intermediate configuration in which the proximal portion (34) is smaller than a diameter of the distal portion (33); frame 7 and the basket 3 can be set to different diameters by adjusting the position of the button 30; it is noted that the proximal portion (34) being smaller than the distal portion (33) is inherent in the expansion sequence).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771