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 Amendment
The amendments filed on 06/29/2026 have been entered. Claims 1-20 remain pending in the application. The amendments overcome the objection of claim 9 set forth in the previous office action dated 03/27/2026.
Response to Arguments
Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive. Applicant argues on page 7 that Ehnes only teaches “a single aperture at each end, neither of which are configured to be sealed via collapsing as claimed”. Examiner disagrees because Ehnes teaches more than a single aperture at each end, see FIG 14A-14B which show at least two apertures 1414/1416 at a single end. Further, either of the apertures are at least configured to be sealed by collapsing because channel is understood to be formed such that it lies flat when not expanded by the passage of a guidewire or bridging stent- see FIG 13C which shows an example of a column formed in the same manner, which lays in such a manner that the aperture can be sealed when not in use receiving a bridging stent. Therefore, applicants’ argument is not persuasive and the newly recited limitations of claim 1 are addressed below.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 1-9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehnes (US 2020/0375722).
Regarding claim 1, Ehnes discloses an implantable device (FIGs 14A-14B, [0073-0074]) comprising: a tubular member (Main stent graft body of 1400) having a first end (Top end as viewed in FIG 14A) and a second end (Bottom end as viewed in FIG 14A), the tubular member forming a primary lumen having a first opening at the first end of the tubular member and a second opening at the second end of the tubular member (Although not shown in the embodiment of FIG 14, main body stent graft is understood to have a primary lumen with first and second openings as illustrated with respect to FIGs 5A-5E, which describes the formation of the implantable device, [0056-0058]), the tubular member including a column positioned within the primary lumen and forming a secondary lumen (Channel 1402 is the secondary lumen positioned within the primary lumen, [0073] discloses channel 1402 can be formed adluminal with respect to the stent structure 1404 and that the channel can be formed using an insulator sheet. [0056-0058] disclose the process of using an insulator sheet to form an adluminal channel. The material of the PTFE layers which surround the channel once the insulator sheet is removed are interpreted as the material structure which forms the column), the tubular member defining a plurality of apertures (1414, 1416, FIG 14A) opening into the secondary lumen ([0073]) at positions longitudinally between the first end and the second end of the tubular member (FIG 14A shows the different longitudinal positions of 1414 and 1416), the column having a column opening (Opening of channel 1402 at the opposite end to 1414, 1416, through which guidewires 1410, 1412 are shown to exit in FIG 14A); wherein the column is configured to receive a bridging stent graft (such as 1408, FIG 14B, [0073]) extending through a selected aperture of the plurality of apertures (As shown in FIG 14B, 1408 can be selected to be received within aperture 1414), wherein the column is configured to collapse and seal a remainder of the plurality of apertures positioned beyond the selected aperture relative to the column opening (Column 1402 is at least configured to be used in such a manner of receiving only one bridging stent 1408. If bridging stent 1406 were not inserted therein, the column is at least configured such that aperture 1416 would remain closed, due to the column wall being a flexible sheet of material which lies flat, FIG 13C, unless otherwise expanded. Therefore, the column is at least configured to collapse and seal the unused aperture); and a stent member (1404) supporting the tubular member ([0073]).
Regarding claim 2, Ehnes discloses the tubular member includes a first graft member defining the primary lumen and a second graft member coupled to the first graft member forming the column (As best described in [0057], the tubular member comprises main body graft 506 and the column is formed by second graft member 508) and defining the secondary lumen between the first and second graft members (The channel/secondary lumen is formed when insulator sheet 502, which is sandwiched between 506 and 508, is removed).
Regarding claim 3, Ehnes discloses the secondary lumen opens into the primary lumen at the proximal opening of the secondary lumen (The opening of the secondary lumen opposite the end of 1414, 1416 opens into the primary lumen. FIG 14B shows that this end is situated at the proximal end of the device).
Regarding claims 4-5, Ehnes discloses the secondary lumen is collapsible and the secondary lumen is unsupported by a stent (Because the secondary lumen in formed adluminally to the stent 1404, there is no stent directly contacting or supporting the lumen and the lumen is free to collapse if a particular pressure were applied to the column wall).
Regarding claim 6-7, Ehnes discloses the stent member includes a plurality of stent rings spaced longitudinally along the tubular member (FIG 14A shows the spacing of stent rings forming stent structure 1404), wherein each of the plurality of apertures is separated from each other by at least one of the plurality of stent rings (See spacing in IFG 14A where 1414 is separated from 1416 by at least one stent ring).
Regarding claim 8, Ehnes discloses each aperture of the plurality of apertures includes a circular shape (Although shown as a slit when closed in FIG 14A, it is understood that apertures 1414, 1416 form a circular shape when opened to receive the tubular shaped branch portions 1406, 1408 as shown in FIG 14B) or a shape defining a rounded portion and a substantially flat portion.
Regarding claim 9, Ehnes discloses the tubular member includes a plurality of secondary lumens including the secondar lumen, the plurality of secondary lumens extending longitudinally along at least a portion of the tubular member and circumferentially spaced from each other (The embodiment of FIG 16C, which [0078] discloses can employ the channel/column arrangement of FIGs 14A-14B, shows an additional secondary lumen formed by 1618. The additional secondary lumen is circumferentially spaced apart from the secondary lumen of 1402).
Regarding claim 12, Ehnes discloses the secondary lumen extends along a secondary lumen axis that extends longitudinally at an angle greater than zero relative to an axis of the primary lumen (FIG 14B shows at least a portion of the column forming 1416 is angled relative to an axis of the primary lumen by an angle greater than zero).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ehnes (US 2020/0375722) in view of Lehnhardt et al. (US 2018/0036011).
Regarding claim 10, Ehnes discloses the invention substantially as claimed, as set forth above for claim 1.
Ehnes is silent regarding a constraining member receiver positioned surrounding at least a portion of the stent member.
However, Lehnhardt et al. teaches an implantable device (100, FIG 1) having a stent member (106) supporting a tubular graft member (104, [0019]) and further comprising a constraining member receiver (118, FIG 1, [0019]) positioned surrounding at least a portion of the stent member (See FIG 1), which receives a constraining member (102).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Ehnes to comprise a constraining member receiver positioned surrounding at least a portion of the stent member, as taught by Lehnhardt et al., for the purpose of configuring the device to be deployed using constraining members which aid in collapsing and releasing device at the desired position during delivery (0020-0022]).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ehnes (US 2020/0375722) in view of Hartley et al. (US 2012/0191180).
Regarding claim 11, Ehnes discloses the invention substantially as claimed, as set forth above for claim 1.
Ehnes is silent regarding the tubular member includes a scallop at the first end.
However, Hartley et al. teaches an implantable device (20, FIG 3) having a stent member (4) supporting a tubular graft member (24, [0051]) wherein the tubular member includes a scallop (25) at the first end (26).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Ehnes such that the tubular member comprises a scallop at the first end, as taught by Hartley et al., for the purpose of configuring the device for use in a particular application such as placement at the thoracic arch of the patient, wherein the scallop prevents occlusion of the left carotid artery ([0051]).
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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