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 with respect to the claim(s) 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.
Claim Objections
Claim 15 is objected to because of the following informalities: “actuation wire” in line 3 should read “actuator wire” both times it appears in line 3, in order to be consistent with line 2 of the claim. Appropriate correction is required.
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) 1-3, 12-14 and 16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Don Michael et al. (US 2016/0058540). Don Michael discloses an embolic protection system for deploying a device in a diseased vessel of a vasculature, the embolic protection system comprising an embolic protection device including a catheter shaft (e.g., 42), an expandable filter (34) provided at a distal end of the catheter shaft (fig. 1), the expandable filter including a side port (68; see fig. 2 and [0024]) provided in a side wall of the expandable filter between a proximal end and a distal end of the filter, the side port configured to receive a device (e.g., catheter 54 as per par. [0024]) therethrough, and a filter actuator (sheath 30) located at or towards a proximal end of the embolic protection device (e.g., when filter is expanded; see fig. 1), the filter actuator operable to open and close the mouth of the expandable filter (by retraction or advancement relative to filter as per [0015]).
Regarding claim 2, Don Michael discloses a filter dilator disposed through the side port of the expandable filter. In particular, catheter 54, which is received in the side port according to paragraph [0024] of Don Michael, is being considered a filter dilator as it dilates the opening of the side port by pushing aside the flaps that normally close the side port (68) (see [0024]).
Regarding claim 3, the filter actuator of Don Michael is now being considered one of the control wires (38), which is operable to open and close a mouth of the filter by advancing or retracting the filter into/out of sheath (30). Sheath (30) is being considered the claimed loading tool and is configured to receive the embolic protection device (fig. 1) and the filter dilator (54’) through the loading tool 30 (noting sheath 42 and implantation assembly 46 may be removed from assembly of fig. 1 and the dilator may be inserted into side port 68 through lumen of sheath 30; [0014] indicates that catheter 54 may be introduced along same blood vessel path as the other components).
Regarding claim 12, the side port includes a seal (flaps as per [0024] that are normally closed) to enable the device to extend through the side port while retaining embolic material in the expandable filter.
Regarding claim 13, the mouth of the filter is formed at the distal end of the filter and the side port (68) is disposed in a side wall of the expandable filter towards the proximal end of the filter (See fig. 2).
Regarding claim 14, the embolic protection device further comprises a hoop wire ([0020]-[0021] – framework 60 includes a larger diameter ring at distal end of filter), wherein the mouth of the filter is defined by the hoop wire and the hoop wire is actuatable by the filter actuator (30) to open and close the mouth of the expandable filter (advancement or retraction of filter actuator 30 opens/closes mouth of filter, which collapses or allows expansion of the nitinol hoop wire).
Regarding claim 16, the filter dilator comprises a flexible shaft (54, disposed through 68; [0014], [0024]) and a filter dilator tip (e.g., cuff 50) coupled (via filter 34) to the flexible shaft, wherein in a closed configuration, the mouth of the filter is radially compressed against the filter dilator tip (50; as understood in view of the positioning of the filter 34 relative to tip 50 in fig. 2).
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) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael in view of Kratoska et al. (US 6,090,072). Don Michael discloses the invention substantially as stated above except for an introducer configured to receive the loading tool with the embolic protection device and filter dilator disposed through the loading tool.
Kratoska teaches an expandable introducer (50; figs. 2a-2d) that includes an introducer hub adapter (62) configured to facilitate introduction of various intravascular devices with the introducer. Kratoska discloses that the introducer is used to provide an entryway into a patient’s vasculature, provides insertion and withdrawal of intravascular devices through the skin and underlying tissue, and into a vessel, while also minimizing trauma to the skin puncture site and the vessel wall caused by the frequent insertion and removal of intravascular devices (col. 2, ll. 43-54). Additionally, the sheath prevents back bleeding due to the inclusion of a hemostasis valve at its proximal end (col. 2, ll. 55-57). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Don Michael to include an expandable introducer configured to receive the intravascular devices of Don Michael, which include a loading tool, embolic protection device, and filter dilator as discussed above, in view of Kratoska in order to provide an entryway through a patient’s skin and underlying tissue into the patient’s vasculature that prevents back bleeding and can accommodate intravascular devices in a range of sizes.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael in view of Turovskiy et al. (US 2002/0128679). Don Michael discloses the invention substantially as stated above with respect to claim 14, including an actuator wire (38) extending through the catheter shaft (now considered catheter 30), wherein a first end of the actuator wire (38) is coupled to the hoop wire (noting actuator wire is considered coupled to all portions of the filter, either directly or indirectly through one or more intermediate portions of the filter). Don Michael does not disclose that a second end of the actuator wire is coupled to a filter actuator located at or towards a proximal end of the embolic protection device, the filter actuator operable to open and close a mouth of the filter.
Turovskiy discloses another embolic protection system comprising an expandable filter, wherein the filter is coupled to the distal end of an actuator wire (11) housed within a catheter (15). Turovskiy further discloses that the proximal end of the actuator wire is coupled to a filter actuator (sliding mechanism 5; figs. 2A, 2B), wherein the filter actuator is operable to open and close the expandable filter by controlling movement of the filter into and out of sheath (15) via movement of the actuator wire (11) ([0062]). The filter actuator (5) cooperates with a groove (7) in order to allow locking of the filter in the expanded state when desired. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Don Michael to include a filter actuator coupled to a proximal end of actuator wire (38) in view of Turovskiy in order to enhance control over movement of the actuator wire (38) and to allow the filter to be locked in an expanded configuration ([0062]).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael in view of Fisher et al. (US 7,744,571). Don Michael discloses the invention substantially except for a loading tool comprising a loading sleeve extending from a loading hub, the loading hub comprising a seal, wherein the loading sleeve and loading hub are peelable.
Fisher discloses that it is known to introduce a catheter into vasculature via a loading tool (100; fig. 3) comprising a loading sleeve (102) extending from a loading hub (110), the loading hub comprising a seal (150), wherein the loading hub and loading sleeve are peelable (see abstract). The loading tool serves as a temporary conduit for the catheter that is being placed while minimizing blood loss (col. 1, ll. 45-47; col. 2, ll. 50-55). The peelable nature of the loading sleeve and hub facilitates removal of the loading tool when the proximal end of the catheter has a feature larger than that of the inner diameter of the loading tool (col. 1, ll. 55-col. 2, ll. 5). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Don Michael to include a loading tool comprising a peelable loading sleeve and peelable loading hub with a seal as taught by Fisher in order to facilitate introduction of the embolic protection system of Don Michael (system illustrated in fig. 1) while minimizing blood loss and to facilitate removal of the loading tool without interfering with any encumbrances on the embolic protection system.
Allowable Subject Matter
Claims 17 and 18 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 closest prior art discussed above fails to disclose or fairly suggest the additional limitations of claims 17 and 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10,617,510 to Russell et al. discloses a filter having a side port (24) formed in a side wall of the filter between the proximal and distal ends of the filter (see fig. 2f).
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.
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5/21/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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