DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 11 March 2026.
Notice of 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 .
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.
Response to Arguments
The objection to the drawings is withdrawn in light of the amendments to the claims.
The rejections under 35 USC 112(b) are withdrawn in light of the claim amendments filed 11 March 2026.
Regarding the prior art, independent claim 1 was amended to incorporate the limitations of dependent claim 2. Applicant argues Wang’597 fails to teach the distal filter is configured to be positioned in a left subclavian artery and the proximal filter is configured to be positioned in an innominate artery, as recited in amended claim 1 because the left subclavian artery is generally considered to be smaller than the innominate artery and therefore, it is not proper to assert Wang’s distal and proximal filters can be placed in either artery. This argument is not persuasive.
MPEP 716.01(c) indicates arguments presented by the applicant cannot take the place of evidence in the record. In this case, Applicant’s statement about relative sizes of the left subclavian and the innominate arteries is not supported by evidence and is a mere allegation.
Even if Applicant were to provide evidence that the left subclavian artery is generally considered to be smaller than the innominate artery, it would not overcome the rejection under Wang’597. Wang’597’s distal filter 220 is disclosed as moving between a collapsed and fully expanded configuration (see Figures 5-8). At the very least, the distal filter 220 is configured to be positioned in the left subclavian artery in a partially expanded configuration. The proximal filter 230 is configured to be positioned in the innominate artery, even if it doesn’t expand to filter the entirety of the arterial lumen.
Further, the assertion that the distal and proximal filters can be placed in either the left subclavian or innominate arteries is supported by Wang. Paragraph [0036] states:
“For the purpose of illustration, use of the medical device(s) described herein will be explained as though the medical device is inserted via the left subclavian artery 150. However, one of skill in the art will appreciate that the medical device may be inserted via the right subclavian artery 180, via the aorta, or other suitable routes.”
The rejection is updated to reflect the claim amendments but is otherwise maintained.
Claim Objections
Claim 1 is objected to because of the following informalities: line 6 recites “the ostium of the a left common carotid artery”. This should read either “the” or “a”, but not both. Appropriate correction is required.
Priority
The claims are supported by provisional application 62/607,801. The application is granted a priority date of 19 December 2017.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US Patent Publication 2014/0100597).
Claim 1: Wang’597 discloses an embolic protection device for isolating the cerebral vasculature (paragraph [0002] comprising:
a filter assembly (210; Figure 2) including
a distal filter (220) that is configured to be placed in a left subclavian artery (Figure 8 shows the distal filter 220 in the innominate artery and the proximal filter 230 is in the left subclavian artery but paragraph [0036] discloses the device 210 can be inserted via the right subclavian artery. In that situation, the distal filter would be positioned in the left subclavian artery and the proximal filter would be positioned in the innominate artery. Further, the distal filter 220 passes through the left subclavian artery during delivery and could be placed in the left subclavian artery at least in a partially expanded state);
a proximal filter (230) that is configured to be placed in an innominate artery (Figure 8 shows the distal filter 220 in the innominate artery and the proximal filter 230 is in the left subclavian artery but paragraph [0036] discloses the device 210 can be inserted via the right subclavian artery. In that situation, the distal filter would be positioned in the left subclavian artery and the proximal filter would be positioned in the innominate artery. Further, the proximal filter 230 could be placed in the innominate artery even if it doesn’t expand to filter the entirety of the arterial lumen),
a deflector (240) that is configured to be positioned across the ostium of the left common carotid artery (paragraph [0034]), and
a filter wire (200) coupled to at least one of the distal filter and the proximal filter,
wherein the distal filter and the proximal filter are linked by the deflector (Figure 2).
Claims 3 and 4: Wang’597 teaches the distal filter (220) includes an expandable frame (224; paragraph [0032], a porous filter material (226) and the proximal filter (230) includes an expandable frame (234; paragraph [0033], a porous filter material (236).
Claim 5: Wang’597 teaches the deflector (240) includes a porous filter material (246) and the filter material is coupled to and extends between the distal filter and the proximal filter (Figure 2).
Claim 6: Wang’597 teaches the filter wire (200) is configured to position and/or maintain the filter at the desired target location (paragraph [0030] disclose the filter assembly 210 is slidably disposed about/over the wire 200; Figures 3-8 show how wire is used to position the filter assembly 210).
Claim 7: Wang’597 teaches the filter wire (200) is configured to extend through a lumen of a delivery sheath to a point outside the body where the filter wire can be manipulated by a user (the delivery sheath is a not a positively recited element of the invention. Filter wire 200 extends through a delivery sheath (250); Figure 2).
Claim 8, 15: In Wang’597, the lumen of the delivery sheath is configured to receive other medical devices (the delivery sheath is not a positively recited element of the invention. Wang’597’s delivery sheath 250 could receive other medical devices based on its size and shape and intended use as a catheter used for delivering filter 210, including an angiography or pigtail catheter, or a TAVR procedural catheter).
Claim 9: In Wang’597, the delivery sheath is curved and/or steerable to facilitate navigation from the right radial artery or right brachial artery to the left subclavian artery (The delivery sheath is not a positively recited element of the claim. Wang’597’s delivery sheath 250 is disclosed placed in other arteries in paragraph [0036]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wang’597.
Claim 14: Wang’597 does not explicitly disclose the deflector (240) includes an expandable frame.
However, in an alternate embodiment of Figure 11, Wang’597 teaches a similar device including a distal filter element (420) having an expandable frame (424), a proximal filter element (430) having an expandable support frame (434) and a deflector (440) having a support frame (444; paragraph [0051]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Wang’597 in Figure 2, such that the deflector has a support frame, as taught by Wang’597 in Figure 11, in order to aid in fully expanding the deflector so that it fully covers the ostium to a respective vessel and more effectively prevents debris from entering the cerebral vasculature.
Claims 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang’597, as applied to claim 1, further in view of Purcell et al. (US Patent Publication 2016/0310255).
Claim 11: Wang’597 teaches the limitations of claim 11 except for a handle coupled to a proximal end of the embolic protection device.
Like Wang’597, Purcell’255 teaches a filter assembly (218) for placement in the branches of the aortic arch (paragraph [0052]). Purcell’255 teaches providing the filter assembly device with a delivery sheath (210) and a handle (206) coupled to a proximal end region of the embolic protection device (200) and configured to be articulated (via movement of 214, 216 or 208) to facilitate deployment of the filter assembly and/or navigation of the delivery sheath (paragraph [0055], [0056]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Wang’597 by providing a handle coupled to the proximal end of the embolic protection device, as taught by Purcell’255, in order to allow the surgeon to advance/retract a delivery sheath and/or the filter assembly relative to one another from outside of the body during delivery to a target location within a vessel.
Claim 12: Wang’597 teaches the distal and proximal filters have an opening (openings in the porous filter material as described in paragraph [0035]).
Claim 13, 16: Wang teaches the proximal filter, the distal filter, and the deflector comprise a filter membrane in the form of a polyurethane film (paragraphs [0035], [0054]).
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 25 March 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771