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, see page 1, filed 06/25/2025, with respect to the rejection(s) of claim(s) 1-8, 11-14, and 16-17 under a 102 rejection over Sachar have been fully considered and are persuasive. The examiner agrees that Sachar fails to disclose “wherein when in the expanded configuration a portion of the elongated shaft within the expandable basket is non-concentric with the expandable basket” as required in claim 1 and similarly in claim 13. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sachar in view of Phung et al. (US 20070239201).
Applicant’s arguments with respect to claim(s) 19-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner notes that the amendment of claim 19 to further define that the proximal and distal ends of the expandable basket are closed changes the scope of the claim. However, upon further consideration, a new ground(s) of rejection is made in view of Sachar in view of Phung et al. (US 20070239201).
Claim Objections
Claims 1, 3, and 16 are objected to because of the following informalities:
Claim 1, line 8: “configuration a portion” should recite “configuration, a portion”.
Claim 3 (line 2) and claim 16 (line 2): “the long axis” should recite “a long axis”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-17 and 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 (lines 13-14) and claim 19 (lines 10-11) recites the limitation "a distal end of the expandable braided basket". It is unclear if the distal end of the expandable braided basket described in lines 13-14 of claim 13 and lines 10-11 of claim 19 is meant to further define the distal end of the expandable braided basket introduced in line 7 of claim 1 and line 7 of claim 19 or if the limitation is meant to introduce a new, additional, distal end of the expandable braided basket. For examination purposes “a distal end of the expandable braided basket" is interpreted as “the distal end of the expandable braided basket" such that it further defines the distal end introduced in line 7 of claims 13 and 19.
Claim 13 (line 14) and claim 19 (line 11) recites the limitation "a proximal end of the expandable braided basket". It is unclear if the proximal end of the expandable braided basket described in lines 14 of claim 13 and line 11 of claim 19 is meant to further define the proximal end of the expandable braided basket introduced in line 5 of claim 1 and line 5 of claim 19 or if the limitation is meant to introduce a new, additional, proximal end of the expandable braided basket. For examination purposes “a proximal end of the expandable braided basket" is interpreted as “the proximal end of the expandable braided basket" such that it further defines the proximal end introduced in line 5 of claims 13 and 19.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised 136of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8, 10-14, 16-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US 20190133616) [hereinafter Sachar] in view of Phung et al. (US 20070239201) [hereinafter Phung].
Regarding claim 1, Sachar discloses an expandable scraper device for use within a lumen of a vessel (Figs. 5A-C para. 0048-0049, 0073), the expandable scraper device comprising:
an elongated shaft 118, 125 (Figs. 5A-C, para. 0073); and
an expandable basket 123 coupled at a proximal end (interpreted as end attached to proximal collar 119) to the elongated shaft 118, 125 such that the proximal end of the basket 123 is closed (Figs. 5A-B, para. 0073) and coupled at a distal end (interpreted as end attached to distal collar 122) to the elongated shaft 118, 125 such that the distal end of the basket is closed (Figs. 5A-B, para. 0073), the expandable basket having an unexpanded configuration (see Fig. 5A) and an expanded configuration (see Fig. 5B).
However, Sachar fails to disclose wherein when in the expanded configuration a portion of the elongated shaft within the expandable basket is non- concentric with the expandable basket.
Phung in the same field of endeavor of thrombectomy devices teaches an elongated shaft 16 (Figs. 1-2, para. 0023); and expandable struts 12, 14, coupled at a proximal end (interpreted as end attached to proximal sleeve 18) to the elongated shaft 16 and coupled at a distal end (interpreted as end attached to distal sleeve 20) to the elongated shaft 16 (Figs. 1-2, para. 0020), the expandable struts having an unexpanded configuration (Fig. 3, para. 0028) and an expanded configuration (Fig. 2, para. 0026), wherein when in the expanded configuration (Fig. 2, para. 0026) a portion of the elongated shaft 16 within the expandable struts 12, 14 is non- concentric with the expandable struts 12, 14 (Fig. 2, para. 0023, 0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the elongated shaft in Sachar to be non-concentric with the expandable basket, as taught by Phung in order to allow the expandable basket to simultaneously capture a clot within the lumen and act as a separator to release clot from the vessel wall in the expanded state due to the non-concentric configuration (para. 0032 of Phung).
Regarding claims 13 and 19, Sachar discloses an expandable scraper device for use within a lumen of a vessel (Figs. 5A-C para. 0048-0049, 0073), the expandable scraper device comprising:
an elongated shaft 118 including an inner elongate member 125 slidably disposed within an outer elongate member (interpreted as the outer body of shaft 118) (Figs. 5B-C, para. 0073);
an expandable braided basket 123 (Fig. 5B, para. 0050, 0073) coupled at a proximal end (interpreted as end attached to proximal collar 119) to a distal end region of the outer elongate member 118 such that the proximal end of the basket 123 is closed (Figs. 5A-B, para. 0073) and coupled at a distal end (interpreted as end attached to distal collar 122) to a distal end region of the inner elongate member 125 such that the distal end of the basket 123 is closed, (Figs. 5A-B, para. 0073), the expandable braided basket having an unexpanded configuration (see Fig. 5A) and an expanded configuration (see Fig. 5B);
wherein the inner elongate member 125 extends between a distal end (interpreted as end attached to distal collar 122, see 112(b) rejection above) of the expandable braided basket 123 and a proximal end (interpreted as end attached to proximal collar 119, see 112(b) rejection above) of the expandable braided basket 123 (Fig. 5B, para. 0073) and is positioned within the expandable braided basket 123 (Fig. 5B, para. 0073),
a handle 128 on the shaft 118 (Fig. 7A, para. 0065), the handle including a control 136 configured to expand or contract the expandable braided basket (para. 0065).
However, Sachar fails to disclose wherein the inner elongate member includes a portion that is offset from a midline of the expandable braided basket when the expandable braided basket is in the expanded configuration.
Phung in the same field of endeavor of thrombectomy devices teaches an elongated shaft 16 (Figs. 1-2, para. 0023); and expandable struts 12, 14, coupled at a proximal end (interpreted as end attached to proximal sleeve 18) to the elongated shaft 16 and coupled at a distal end (interpreted as end attached to distal sleeve 20) to the elongated shaft 16 (Figs. 1-2, para. 0020), the expandable struts having an unexpanded configuration (Fig. 3, para. 0028) and an expanded configuration (Fig. 2, para. 0026), wherein when in the expanded configuration (Fig. 2, para. 0026) a portion of the elongated shaft 16 within the expandable struts 12, 14 is non- concentric with the expandable struts 12, 14 (Fig. 2, para. 0023, 0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the inner elongate member in Sachar to be non-concentric with the expandable basket, as taught by Phung in order to allow the expandable basket to simultaneously capture a clot within the lumen and act as a separator to release clot from the vessel wall in the expanded state due to the non-concentric configuration (para. 0032 of Phung).
Regarding claim 2, modified Sachar discloses wherein the expandable basket 123 is an expandable braided basket (Fig. 5B, para. 0050, 0073 of Sachar).
Regarding claims 3 and 16, modified Sachar discloses wherein the expandable braided basket is loosely braided so that it deforms along the long axis to limit the maximum scraping force to 1.5 pounds or less when in the expanded configuration and disposed against a wall of the vessel (Figs. 5A-B, para. 0074-0076 of Sachar disclose the expandable braided basket is deformable from a collapsed configuration to an expanded configuration; para. 0057, see table 2, page 6, of Sachar discloses a maximum radial outward force applied by the braid to the inner surface of the vessel being 1.9 Newtons or 0.43 pounds of force.).
Regarding claims 4 and 17, modified Sachar discloses wherein expandable basket comprises a braid of between 20 and 60 nickel titanium wires (para. 0052, 0054 of Sachar) each having a diameter of between 0.15 mm and 0.35 mm (para. 0054 of Sachar).
Regarding claim 5, modified Sachar discloses further including a control 136 on a handle 128 of the expandable scraper device configured to expand or contract the expandable basket (Fig. 7A, para. 0065 of Sachar).
Regarding claim 6, modified Sachar discloses wherein the control is configured to maintain a pull force of between about 0.2 and 1.5 pounds of force (para. 0065 of Sachar; para. 0057 and table 2 on page 6 of Sachar discloses a maximum pull force of 4.6 Newtons (1.03 pounds of force)).
Regarding claim 7, modified Sachar discloses wherein the control 136 on the handle 128 of the expandable scraper device comprises a finger slider (Fig. 7A, para. 0065 of Sachar) to manually adjust expansion of the expandable basket (para. 0065 of Sachar) to maintain a pull force between about 0.2 and 1.5 pounds of force (para. 0065 of Sachar; para. 0057 and table 2 on page 6 of Sachar discloses a maximum pull force of 4.6 Newtons (1.03 pounds of force)).
Regarding claims 8 and 14, modified Sachar discloses wherein the expandable basket is biased to return to the unexpanded configuration in an unconstrained state (para. 0052 of Sachar).
Regarding claim 10, modified Sachar discloses wherein the shaft 118, 125 includes an inner elongate member 125 which extends between the distal end 122 of the expandable basket 123 and the proximal end 119 of the expandable basket 123 (Fig. 5A, para. 0073), and when the expandable basket 123 of Sachar (Fig. 5B, para. 0073) is in the expanded configuration, at least part of the inner elongate member 125 of Sachar (Fig. 5B, para. 0073) is positioned within the expandable braided basket (Fig. 5B, para. 0073 of Sachar) and is offset from a midline of the expandable basket as taught by Phung (Fig. 2, para. 0023, 0026 of Phung).
Regarding claim 11, modified Sachar discloses wherein the shaft 118, 125 includes a guidewire lumen 124 (Fig. 5C, para. 0073 of Sachar).
Regarding claim 12, modified Sachar discloses wherein the elongated shaft 118, 125 includes an inner elongate member 125 slidably disposed within an outer elongate member (interpreted as the outer body of shaft 118) (Figs. 5B-C, para. 0073 of Sachar), the expandable basket 123 coupled at the proximal end 119 to a distal end region of the outer elongate member 118 (Figs. 5A-B, para. 0073 of Sachar) and at the distal end 125 to a distal end region of the inner elongate member (Figs. 5A-B, para. 0073 of Sachar).
Regarding claim 20, modified Sachar discloses a handle 128 on the shaft 118 (Fig. 7A, para. 0065 of Sachar), the handle including a control 136 configured to expand or contract the expandable braided basket (para. 0065 of Sachar) to maintain a pull force between about 0.2 and 1.5 pounds (para. 0065; para. 0057 and table 2 on page 6 of Sachar discloses a maximum pull force of 4.6 Newtons (1.03 pounds of force)) and when in the expanded configuration (Fig. 5B) and disposed against a wall of the vessel lumen (Figs. 6D-E, para. 0075-0076 of Sachar), the expandable braided basket is configured to apply a maximum scraping force against the wall of the vessel lumen of 1.5 pounds of force or less (para. 0057, see table 2 on page 6 of Sachar which discloses a list of prototype braided baskets having a maximum scraping force of 1.9 Newtons (0.43 pounds of force), see note above).
Regarding claim 21, modified Sachar discloses wherein the proximal end 119 of the expandable braided basket 123 is closed due to coupling to the distal end region of the outer elongate member 118 (Fig. 5B, best described in para. 0050 of Sachar which discloses the proximal end of the expandable braided basket is fixed collar attached to the elongate member, para. 0073 of Sachar) and the distal end 122 of the expandable braided basket 123 is closed due to coupling to the distal end region of the inner elongate member 125 (Fig. 5B para. 0073 of Sachar).
Claim(s) 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US 20190133616) [hereinafter Sachar] in view of Phung et al. (US 20070239201) [hereinafter Phung] as applied to claims 1 and 13 above, and further in view of Lenker et al. (US 20150359549) [hereinafter Lenker].
Regarding claims 9 and 15, modified Sachar discloses all of the limitations set forth above in claims 1 and 13. However, modified Sachar fails to disclose wherein the expandable basket has a length from 3 to 10 cm in the unexpanded configuration.
Lenker in the same field of endeavor teaches an expandable element used to remove obstructions within vasculature (abstract), wherein the expandable element has a length between 12 mm to 100 mm (or 1.2 to 10 cm) when in the unexpanded configuration (Fig. 13B, para. 0121) for the purpose of allowing the basket to fit within vasculature without causing damage (para. 0124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the expandable basket in modified Sachar to include the length of between 1.2 and 10 cm in the unexpanded configuration, as taught by Lenker, in order to allow the basket to fit within vasculature without causing damage (para. 0124 of Lenker).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771