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 08/21/2026 have been entered. Claims 1-20 remain pending in the application. The amendments overcome the claim objections set forth in the previous office action dated 05/21/2026.
Response to Arguments
Applicant's arguments filed 08/21/2026 have been fully considered but they are not persuasive. Applicant argues on pages 8-9 that the device of Chen fails to teach the newly recited limitations of “portions of the inner layer seals more than one of the plurality of apertures” because in the device of Chen, the inner layer 24 only covers a single aperture 22. However, it is the examiner’s position that for each of the plurality of apertures, there is a respective inner layer which seals it. Each of the covering membranes 24 collectively forming the inner layer and therefore portions of the inner layer which seals more than one of the apertures as claimed. It is the examiner’s position that this interpretation is also consistent with the disclosure of the present invention which teaches multiple segments of inner layer 160 each covering a respective aperture (FIGS 3A-3D). In this disclosure, there is not one singular uniform inner layer that covers multiple apertures. Instead, [0033] discloses “Each of the apertures 152, 155, 156 in the illustrated embodiment are sealed closed to the lumen 120 by the inner layer 160. The inner layer 160 may comprises a plurality of distinct pieces or patches that are configured to seal one or more of the plurality of apertures 152”. Therefore, the interpretation of each covering membrane 24 as forming portions of the inner layer which seal more than one of the apertures is believed to be an appropriate broadest reasonable interpretation and thus the amendments do not overcome the previous rejection in view of Chen.
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) 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (CN 112438823; translation previously attached).
Regarding claim 1, Chen discloses a vascular stent (FIG 7) comprising: a body (100, [0027]) comprising a first open end (Top opening of stent graft as viewed in FIG 7) and a second open end (Bottom opening of stent graft as viewed in FIG 7) with a lumen extending from the first open end to the second open end (While the drawings do not explicitly show the lumen of the stent graft, it is understood from the background disclosure of [0001-0003, 0005, 0008, 0026-0027] that the stent graft device has an open top and bottom and a lumen extending therebetween, see ‘tubular’ shape description), the body comprising: a frame (support frame 40, [0026 and 0028-0032]); a covering (main film 20 and cover film 24, FIG 7, [0032-0035, 0057-0058]), disposed on at least a portion of the frame (FIGs 7-8 show the covering disposed on the frame, [0028 and 0032]), the covering comprising an outer layer (20) and an inner layer (24, FIG 8 shows 24 forms an inner portion of the layer and 20 surrounds 24 and therefore is interpreted as an outer layer) coupled together (FIG 8, [0057]; sewn together by string 29); and a plurality of apertures defined in the outer layer of the covering (Windows 22, which are apertures formed in covering 20. [0005] discloses a plurality of windows such that the desired fenestration can be selected according to a particular intraoperative situation) and sealed by the inner layer of the covering (24 closes the window until its selective removal, upon which the window is opened, [0057-0061]), wherein portions of the inner layer seals more than one of the plurality of apertures (multiple portions 24 seal more than one of the apertures i.e. each aperture is seal by a respective inner layer portion 24), wherein the inner layer is openable at a corresponding location of each of the plurality of apertures to create a corresponding fenestration that extends through the covering ([0061] “When it is necessary to perform the window opening operation on the preset window opening film support 100… remove the window cover film 24 so that the window cover film 24 is completely separated from the main film 20 to form a window”).
Regarding claim 2, Chen discloses a plurality of strings (29, one string is provided for each window, therefore forming a plurality of strings), wherein each string of the plurality of string corresponds to the location of one of the plurality of apertures (FIG 8, [0057], each string 29 of the plurality surrounds an aperture and therefore corresponds to a location of a respective aperture).
Regarding claim 3, Chen discloses a first end and a second end of each string are coupled together ([0057] discloses first and last sections of the sewing thread 29 are tied with slip knots) and a looped portion of each string is partially looped around one of the apertures of the plurality of apertures (The looped portion is interpreted as the middle portion of string 29 which surrounds the window 22, FIG 8) and is disposed between the outer layer and the inner layer (FIG 8, [0057] thread 29 stitches together 20 and 24 and therefore is disposed between the outer and inner layer).
Regarding claim 4, Chen discloses the looped portion of each string is configured to freely slide between the outer layer and the inner layer ([0058 and 0061] “the suture 29 is gradually pulled out from the suture position until the suture structure is completely ineffective”; 29 can freely slide between 24 and 20 as it is being pulled for removal) while the outer layer remains coupled to the inner layer (at least in the beginning stage of each string sliding, the outer layer is still coupled to the inner layer).
Regarding claim 5, Chen discloses when the first end and the second end of each string are pulled in a same direction away from the vascular stent, each string is configured to decouple the inner layer from the outer layer to open the corresponding aperture in the outer layer to the lumen of the vascular stent ([0057-0058, 0061]; although the decoupling of the inner and outer layer is disclosed as occurring when one end of string 29 is pulled, the string is at least configured to perform the same function if both ends were pulled in the same direction. Unraveling of the sewn seam would occur around both sides of the window simultaneously instead of only from one end as described).
Regarding claim 6, Chen discloses the inner layer forms a flap at the corresponding aperture in the outer layer when each string of the plurality of strings is pulled away ([0057-0058, 0061]; upon partial decoupling, there is a state where 24 would create a flap at the aperture because the string will be removed only part way around the window while some segment remains still coupled).
Regarding claim 8, Chen discloses each string of the plurality of strings is removable without creating the corresponding fenestration between the outer layer and the inner layer (The device is provided with multiple windows such that the best location for a particular application can be selected i.e. one or more windows can be left unopened. Each of the strings is removable form the body without creating the fenestration by removing the entire stent device prior to opening the windows. Examiner notes the claim does not specify what the strings are removable from, therefore they are interpreted to be removable from the body of the patient).
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) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 112438823).
Regarding claim 7, Chen discloses the invention substantially as claimed, as set forth above for claim 2.
Chen is silent regarding the inner layer comprises a frangible portion that aligns with the corresponding aperture of the outer layer such that when each string of the plurality of strings is pulled away the frangible portion is removed to form the corresponding fenestration.
However, Chen teaches in the alternative embodiment of FIGs 1-4 that the inner layer (24) can comprise a frangible portion (25, [0034, 0045]) in combination with a pull ring unlocking structure/string (240, [0047-0049]) that aligns with the corresponding aperture of the outer layer (FIG 4) such that when the string is pulled away the frangible portion is removed to form the corresponding fenestration ([0047-0048]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the embodiment of FIG 8 to further comprise the frangible portion that aligns with the corresponding aperture of the outer layer, as taught by the alternative embodiment, such that removal of the string 29 (comparable to removal of pull ring 240) will result in breaking at the frangible portion and removal to form the fenestration.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 112438823) in view of Satasiya et al. (US 2008/0243225).
Regarding claims 9 and 10, Chen discloses the invention substantially as claimed, as set forth above for claim 1.
Chen is silent regarding a plurality of frame strings, wherein a first end and a second end of each frame string are tied together and a looped portion of each frame string is coupled to the frame
wherein when the first end and the second end of each frame string are pulled in a same direction away from the vascular stent, the string is configured to manipulate the frame and change a shape of the frame.
However, Satasiya et al. teaches a vascular stent (10, FIG 1A) with a body having a first and second open ends and a lumen therethrough ([0023]), a frame (12 and 14, [0021-0023]) and a covering (18, FIG 1b, [0021]), and further comprising plurality of frame strings (16, FIG 1a shows there are at least 2), wherein a first end and a second end of each frame string are tied together (at know 23, FIG 2, [0031]) and a looped portion of each frame string is coupled to the frame (FIGs 2 and 3, [0031-0032]) wherein when the first end and the second end of each frame string are pulled in a same direction away from the vascular stent, the string is configured to manipulate the frame and change a shape of the frame ([0032-0033 and 0037-0039] discloses that pulling the string 16 for example at the know such that the first and second ends are pulled int eh same direction, results in a purse string effect that effectively collapses the end of the frame of the stent for removal or repositioning).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Chen to comprise at least a frame string at the distal and proximal end of the frame, as taught by Satasiya et al., for the purpose of providing a commonly known mechanism for controlling the collapsed of each end of the stent into a crimp or constricted diameter, thereby allowing for repositioning or removing a stent from a lumen while reducing the incidence of damage to the lumen or the stent (Satasiya [0040]).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 112438823) in view of van Bibber et al. (US 2016/0310216).
Regarding claim 20, Chen discloses a vascular stent (FIG 7) comprising: a body (100, [0027]) comprising a first open end (Top opening of stent graft as viewed in FIG 7) and a second open end (Bottom opening of stent graft as viewed in FIG 7) with a lumen extending from the first open end to the second open end (While the drawings do not explicitly show the lumen of the stent graft, it is understood from the background disclosure of [0001-0003, 0005, 0008, 0026-0027] that the stent graft device has an open top and bottom and a lumen extending therebetween, see ‘tubular’ shape description), the body comprising: a frame (support frame 40, [0026 and 0028-0032]); a covering (main film 20 and cover film 24, FIG 7, [0032-0035, 0057-0058]), disposed on at least a portion of the frame (FIGs 7-8 show the covering disposed on the frame, [0028 and 0032]), the covering comprising an outer layer (20) and an inner layer (24, FIG 8 shows 24 forms an inner portion of the layer and 20 surrounds 24 and therefore is interpreted as an outer layer) coupled together (FIG 8, [0057]; sewn together by string 29); a plurality of apertures defined in the outer layer of the covering (Windows 22, which are apertures formed in covering 20. [0005] discloses a plurality of windows such that the desired fenestration can be selected according to a particular intraoperative situation) and sealed by the inner layer of the covering (24 closes the window until its selective removal, upon which the window is opened, [0057-0061]), wherein portions of the inner layer seals more than one of the plurality of apertures (multiple portions 24 seal more than one of the apertures i.e. each aperture is seal by a respective inner layer portion 24), a plurality of strings (29, one string is provided for each window, therefore forming a plurality of strings), a first end and a second end of each string are coupled together ([0057] discloses first and last sections of the sewing thread 29 are tied with slip knots) and a looped portion of each string is partially looped around one of the apertures of the plurality of apertures (The looped portion is interpreted as the middle portion of string 29 which surrounds the window 22, FIG 8) and is disposed between the outer layer and the inner layer (FIG 8, [0057] thread 29 stitches together 20 and 24 and therefore is disposed between the outer and inner layer).
Chen is silent regarding a map that outlines each string of the plurality of strings and the corresponding purpose of each string being provided in a kit with the vascular stent.
However, van Bibber et al. discloses an assembly provided for a procedure which comprises a vascular stent (260, FIG 4, [000042]) having a plurality of apertures (265A and 265B) and a map (template 250, FIG 3) which outlines each of the apertures that have been formed in the stent ([0039-0046]). van Bibber et al. further disclose that the map can be referenced on its own in order to determine or calculate arrangement of the treatment anatomy ([0021]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the vascular stent along with a map of the apertures together as a kit, for the purpose of aiding the surgeon in locating the fenestrations upon placement of the stent within to vasculature to increase the accuracy of the positioning. In the device as modified, the map also corresponds to a location of the strings, because the strings surround the apertures, and therefore provides an outline of the strings and the purpose of each string. In this instance, the purpose of each string is to open the fenestration leading to a particular artery.
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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