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 1/26/26, with respect to 35 U.S.C. 102(a)(1) as being anticipated by Pal et al. US 2006/0184194 have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) of claims 1, 3, 5 and 6 has been withdrawn. Pal et al. fails to disclose an expanded configuration in which the bristles extend radially outwardly from the core and longitudinally in a proximal direction opposite to the distal direction. Examiner notes claim 15 does not require the expanded configuration in which the bristles extend radially outwardly from the core and longitudinally in a proximal direction opposite to the distal direction, but only an expanded configuration wherein the bristles extend at least radially outward from the core and are configured to contact the lumen. The bristles are flexible and would be configured to extend longitudinally in a proximal direction if placed in that configuration, but is not required by the claim to be during in the expanded deployed configuration.
Applicant's arguments filed 1/26/26 with respect to 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues it would not be obvious to combine Allen in view of Pal. Applicant argues Allen relates to an implantable embolization device which is detachable from the delivery catheter. In contrast, Pal relates to an embolic protection device which is not intended for permanent implantation into the body. However, Examiner notes Allen is being modified to include a recapture mechanism for moving the set of flexible bristles to a lower radial profile. Pal teaches such a mechanism to be used within a catheter, and it is not required that the device itself, whether detachable or non-detachable, be modified. Modifying Allen with a recapture mechanism as taught by Pal would not destroy the function, as it would be configured to move the set of flexible bristles to a lower radial profile if the embolization element of Allen was placed within the recapture mechanism of Pal, with a reasonable expectation of success as required by the claim.
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) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pal et al. US 2006/0184194.
Regarding claims 15, Pal et al. discloses a method of manufacturing the apparatus, comprising: providing a delivery catheter (figure 7, 314); providing a core (hub 322); providing a plurality of flexible bristles 328 configured to extend radially outward from the core and longitudinally in a proximal direction opposite to a direction in which the embolization device is configured to be delivered from a delivery catheter (bristles are flexible and would be configured to extend longitudinally in a proximal direction if placed in that configuration), the bristles having a collapsed delivery configuration (figure 7) and an expanded deployed configuration in which the bristles extend at least radially outward from the core and are configured to contact the lumen and to anchor the device in the lumen (figure 6); and
providing a recapture mechanism 350, actuatable independently of the movement of the delivery catheter over the bristles (paragraph 0031, figures 6, 7 recapture mechanism translated independently of core or hub independently of catheter 314, as the bristles are moved between configurations outside of the catheter), for moving the set of flexible bristles to a lower radial profile (figure 7) than in the expanded deployed (figure 6) configuration before the delivery catheter is moved over the set of flexible bristles (figure 7, outside of catheter 314).
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, 2, 5, 6, 13, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. US 2016/0166257 in view of Pal et al. US 8,632,562.
Regarding claims 1, 5, 6 and 15, Allen et al. discloses an apparatus or method of manufacturing an apparatus comprising: an embolisation device for promoting clot formation in a bodily lumen (for example, paragraph 0677, figures 209-246, embolisation device 1501), the embolisation device comprising a core and a plurality of flexible bristles extending outwardly from the core (for example, see annotated figure 220(c) below), the bristles having a collapsed delivery configuration (figure 220(a)) and an expanded deployed configuration in which the bristles extend at least radially outwardly from the core to contact the lumen and to anchor the device in the lumen (figure 220(c)), and a delivery catheter (see annotated figure 220(c) below), wherein: the embolisation device is configured to be delivered in a distal direction from the delivery catheter to the lumen (figures 220(a)-220(c)); in the expanded deployed configuration, a set of the flexible bristles extend radially outwardly from the core and longitudinally in a proximal direction opposite to the distal direction (figure 220(c), set of bristles extend proximally toward catheter).
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Allen et al. fails to disclose further disclose a recapture mechanism, actuatable independently of the movement of the delivery catheter over the bristles, for moving the set of flexible bristles to a lower radial profile than in the expanded deployed configuration before the delivery catheter is moved over the set of flexible bristles, wherein the recapture mechanism comprises one or more retractable elongate elements each coupled to one or more bristles of the set, such that retracting the elongate elements in the proximal direction moves the set of flexible bristles to the lower radial profile, wherein the retractable elongate elements are slidably mounted or attached to the bristles in the set.
Pal et al. teaches a disclose a recapture mechanism 384 (figures 14, 15, column 14, lines 19-23, mechanism 384 extraction wire 385 with loop 387) , actuatable independently of the movement of the delivery catheter over the bristles (figures 14, 15, bristles and recapture mechanism are both outside of the catheter during use), for moving the set of flexible bristles to a lower radial profile than in the expanded deployed configuration before the delivery catheter is moved over the set of flexible bristles (figure 15 lower profile filter 326 than in figure 14, prior to activating the recapture mechanism), to move the bristles or device from an expanded configuration to an extraction position for removal from the vessel (column 14, lines 31-39), wherein the recapture mechanism comprises one or more retractable elongate elements (extraction wires 385) each coupled to one or more bristles of the set (figure 15, coupled with loops 387), such that retracting the elongate elements in the proximal direction moves the set of flexible bristles to the lower radial profile (moving from figure 14 to figure 15), wherein the retractable elongate elements are slidably mounted or attached to the bristles in the set (mounted with loops 387 which slide over the filter device to collapse, figure 15).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Allen et al. to further comprise a recapture mechanism, as taught by Pal et al. to move the bristles or device from an expanded configuration to an extraction position for removal from the vessel, wherein one or more retractable elongate elements are slidably mounted or attached to the bristles in the set to move to the extraction position for removal or repositioning.
Regarding claim 2, Allen et al. discloses wherein the embolisation device comprises a detach element 1531 at a proximal end of the embolisation device (figure 222), the detach element configured to removably connect to a delivery element 1535 for delivering the embolisation device to a bodily lumen through the delivery catheter (paragraph 0719).
Regarding claim 13, Allen et al. discloses a flow restricting membrane 800 on the core (figure 191) having a collapsed delivery configuration (paragraph 0650, prior to deployment) and an expanded deployed configuration (paragraph 0650, self-expanding after deployment); optionally wherein in the expanded deployed configuration, the flow restricting membrane extends radially outwardly and longitudinally in a proximal direction opposite to the distal direction, and the recapture mechanism is configured to move the flow restricting membrane to a lower radial profile than in the expanded deployed configuration (Examiner notes the membrane is flexible and may be configured to be inserted in this manner, however, it is not required by the claim as indicated by the optional language).
Regarding claim 14, Allen et al. in combination with Pal et al. discloses an embolisation system comprising: a delivery element 1535 for delivering the embolisation device to a bodily lumen through the delivery catheter (paragraph 0719); wherein the recapture mechanism is actuatable to decrease the radial profile the set of flexible bristles to a radial profile smaller than an inner radius of the distal tip of the delivery catheter (figure 15). Examiner notes in combination the bristle embolisation device of Allen et al. is configured to fit within a catheter in the compressed configuration, and in combination with Pal et al., the recapture mechanism would be configured to be actuatable to decrease the radial profile of the flexible bristles as claimed.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen et al. US 2016/0166257 in view of Pal et al. US 8,632,562 and further in view of Eaton US 2015/0245900.
Regarding claim 12, Allen et al. discloses wherein the plurality of bristles may be varying lengths or non-uniform to allow for increased resistance to migration by increasing roughness and undulations (paragraph 0425), but fails to explicitly disclose the plurality of flexible bristles in the set comprise protrusions on the bristles for increasing the surface friction of the bristles.
Eaton teaches a prosthesis deployed within a blood vessel, the outer surface of the device further comprising additional barbs, various shaped member structures, fibers, bristles or other protruding and penetrable media for anchoring into a vessel (paragraph 0052), thereby increasing surface friction of the bristles to prevent against migration.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Allen et al. with bristles that further comprise protrusions, as taught by Eaton, to provide additional structure for anchoring into the vessel to increase surface friction and reduce migration of the device.
Allowable Subject Matter
Claim 3, 4, 7-11 and 16 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3 and 4, Pal et al. US 2006/0184194 teaches a sliding element 350, but fails to disclose bristles in the deployed configuration extending longitudinally in a proximal direction opposite to the distal direction, or wherein the sliding element is a detach element configured to removably connect to a delivery element for delivering the embolisation device to a bodily lumen through the delivery catheter. Pal et al. US 8,632,562 discloses a sliding element (loop 387), but fails to disclose the sliding element mounted on the core proximal to the set of bristles, the sliding element is a detach element configured to removably connect to a delivery element for delivering the embolisation device to a bodily lumen through the delivery catheter.
Regarding claim 7, Allen et al. discloses a mesh 825 (figure 199) on the embolisation device and connected to the set of bristles radially outwardly from the core (figure 199), but fails to disclose the recapture mechanism is configured to retract the mesh in the proximal direction to move the set of bristles to the lower radial profile. Examiner notes the mesh would destroy the recapture mechanism of Pal et al. US 2006/0184194, as the bristles extending through the slots allow for the expansion or collapse, not retracting of a mesh. The recapture mechanism of Pal et al. US 8,632,562 retracts loops to lower the bristle profile. Claims 8, 9 and 16 are dependent upon claim 7.
Regarding claim 10, Pal et al. US 8,632,562 teaches the recapture mechanism comprising a collar (loop 387), but fails to disclose wherein the embolisation device comprises a collar slidably mounted on the core distal to the set of bristles, and the recapture mechanism configured to retract the collar in the proximal direction, such that retracting the collar by the recapture mechanism moves the set of bristles to the lower radial profile. Claim 11 is dependent upon claim 10.
Conclusion
THIS ACTION IS MADE FINAL. 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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/C.C.L/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771