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 04/07/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the 35 U.S.C. § 102 and 103 rejections of claim(s) 1-13 have been considered but are moot in view of the new grounds for rejection.
Applicant has amended claim to recite details with respect to a first and second membrane such that “the first membrane wraps around the end portion to a third membrane that is arranged on the second membrane.” In response to Applicant’s amendment Examiner has added reference Barone (US Pub No.: 2018/0116781). Applicant also modified the rejection in view of Poole to teach an alternate member to act as a support member.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poole (US Pub No.: 2003/0168068).
Regarding claim 4, Poole a covered stent (stent 152, disclosed in [0144] and figure 14, for use in an embodiment in placement of the endoscope in areas like [0127]), comprising a membrane and a support, wherein the membrane comprises a first membrane arranged on an inner surface of the support and as second membrane arranged on an outer surface of the support (parts 110 and 112 in [0119]. As per figure 11A-11C, as the membrane 112 wraps around part 17 with part 110 depicted as being around support part 142, the first and second membrane extend around different portions of part 142) wherein the first membrane bypasses the proximal end of the support and is then folded towards the distal end (part 110 extends and is folded toward both the proximal and distal end in figure 10, where part 110 can be defined as a first membrane); the folded portion of the first membrane forms the second membrane (the folded portion of the first membrane wraps around part 17 and a second membrane); and the third membrane is arranged on an outer surface of the second membrane (shown in figure 17)
Regarding claim 5, Poole discloses the covered stent according to claim 4, wherein the covered stent comprises a plurality of sections of third membranes arranged at intervals in an axial direction (shown in figure 10 with part 114 being a third membrane and part 134 defined as a part of a third membrane in [0122]).
Claim(s) 1-3, 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poole (US Pub No.: 2003/0168068) and Barone (US Pub No.: 2018/0116781).
Regarding claim 1, Poole (US Pub No.: 2003/0168068) discloses a covered stent (stent 152, disclosed in [0144] and figure 14, for use in an embodiment in placement of the endoscope in areas like [0127]). However, the embodiment in figure 14 does not teach a comprising of a membrane and a support, wherein the membrane comprises a first membrane arranged on an inner surface of the support and a second membrane arranged on an outer surface of the support; the first membrane covers an end portion of the support and wraps around the end portion to a third membrane that is arranged on the second membrane and a cross section where the third membrane is located comprises two layers of membranes arranged on the outer surface of the support and one layer of membrane arranged on an inner surface of the support.
Instead, the embodiment shown in figure 10 teaches a comprising of a membrane (first membrane part 110 in [0119] and figure 10, where the stent in the embodiment of [0144] can be used with membrane part 110) and a support (support member 142 in [0133]. Part 17 in figure 10 also supports the membranes as the membranes are placed on part 17), wherein the membrane comprises a first membrane arranged on an inner surface of the support and a second membrane arranged on an outer surface of the support (parts 110 and 112 in [0119]. As per figure 11A-11C, as the membrane 112 wraps around part 17 with part 110 depicted as being around part 142, the first and second membrane extend around different portions of part 142); the first membrane covers an end portion of the support (the liner interfaces with the first membrane as per [0137], and the membrane interfaces with the end of part 17 in figure 10) and a cross section where the third membrane is located comprises two layers of membranes arranged on the outer surface of the support and one layer of membrane arranged on an inner surface of the support (in figure 10, the third membrane is defined as part 114, where parts 136 and 134 are also defined as being part of the third membrane in [0122], the third membrane comprises two layers arranged on the outer surface of the device in figure 10 where parts of the third membrane with the seals (being the boxed parts 134) are the outer surface and the inner surface will be the ends closest to membrane part 112).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the stent embodiment of Poole into the embodiment with the membrane for the purpose of providing an alternative arrangement of the device where the stent of [0144] is used with the endoscope device of [0119] that allows for a lumen to be provided for in the body cavity, as per [0040].
From here, Poole does not teach the first membrane wraps around the end portion to a third membrane that is arranged on the second membrane.
Instead, Barone (US Pub No.: 2018/0116781) teaches wherein the first membrane wraps around the end portion to a third membrane that is arranged on the second membrane (in figure 1, where the membranes are parts 8, 9, and 10 in the last sentence of [0136] and figure 1. Part 9 will be the third membrane where the first membrane is part 10 and the second membrane is part 8 in figure 1. Membrane 9 of Barone will be placed between membranes part 110 and 112 of Poole). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the third membrane layer of Barone into Poole for the purpose of providing a plurality of layers that seal portions of the device while allowing a degree of fluid flow in [0083]-[0084].
Regarding claim 2, Poole in view of Barone teach the covered stent according to claim 1, wherein Poole teaches the third membrane comprises a folded portion of the first membrane (shown in figure 10 with part 114 being the third membrane and the first membrane being defined as part 112 instead of part 110).
Regarding claim 3, Poole in view of Barone teach the covered stent according to claim 2, wherein Poole discloses a proximal end of the second membrane is flush with a proximal end of the support, or the proximal end of the second membrane is closer to a distal end of the covered stent than the proximal end of the support (the bottommost end of part 110 is closer to the bottommost, proximal end of part 17 as per figure 10. These will be the leftmost portions of figure 10 when adjusted such that the reference numbers are in the correct orientation).
Regarding claim 6, Poole in view of Barone teach the covered stent according to claim 1, wherein Poole discloses the covered stent comprises a plurality of sections of third membranes (shown in figure 10 with part 114 being a third membrane and part 134 defined as a part of a third membrane in [0122]), and two adjacent sections of the third membranes are stacked end to end (being the sections of 114 separated by storage member 132 shown in figure 10. Part 132 defined in [0122] as well as the seals 134 comprising four different sections in figure 10).
Regarding claim 7, Poole in view of Barone teach the covered stent according to claim 6, wherein Poole discloses, among the two adjacent sections of third membranes, a distal end portion of the third membrane close to the proximal end covers a proximal end portion of the third membrane close to the distal end (a distal end with the distalmost parts 134 face towards a distal end of part 17 where the proximal end with the proximal most parts 134 face towards the proximal end of part 17).
Regarding claim 8, Poole in view of Barone teach the covered stent according to claim 1, wherein Poole discloses the support comprises a sealing member located at the proximal end portion of the support (part 120 in [0120] is a sealing member that is toward the proximal end of part 17. Additionally, the proximal portion of part 17 appears to be a tool portion, where a sealing at the tool end is implied as a fluid seal for part 17 is disclosed in [0121]); and a distal end of the sealing member is closer to the proximal end of the covered stent than a proximal end of the third membrane (As the stent of [0144] is placed in the body independent of part 17 and the membranes, an arrangement where the distal end of a sealing member is closer to the proximal end of a stent is possible due to the placement of a stent in the body).
Regarding claim 9, Poole in view of Barone teach the covered stent according to claim 1, wherein Poole discloses the distance between a distal end of the third membrane and the proximal end of the support is greater than or equal to 15 mm (as the third membrane can be moved from 50mm to 250mm in [0132], an arrangement where the third membrane is 15mm away from the proximal end of part 17 is present).
Regarding claim 10, Poole in view of Barone teach the covered stent according to claim 1, wherein Barone teaches that the cross section of the covered stent extending away from the third membrane comprises only one layer of membrane arranged on the outer surface of the support and one layer of membrane arranged on the inner surface of the support (only one layer of each membrane 8, 9, and 10 in [0136]. With respect to Poole, only one layer of the membranes 110 and 112 are on either side of part 142). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the third membrane layer of Barone into Poole for the purpose of providing a plurality of layers that seal portions of the device while allowing a degree of fluid flow in [0083]-[0084].
Regarding claim 11, Poole teaches the covered stent according to claim 4. However, Poole does not teach wherein the cross section of the covered stent extending away from the third membrane comprises only one layer of membrane arranged on the outer surface of the support and one layer of membrane arranged on the inner surface of the support. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the third membrane layer of Barone into Poole for the purpose of providing a plurality of layers that seal portions of the device while allowing a degree of fluid flow in [0083]-[0084].
Regarding claim 12, Poole in view of Barone teach the covered stent according to claim 1, wherein Barone teaches the first membrane, the second membrane, the third membrane and the support together define a unitary structure (parts 8, 9 and 10 define part 11 as per [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the third membrane layer of Barone into Poole for the purpose of providing a plurality of layers that seal portions of the device while allowing a degree of fluid flow in [0083]-[0084].
Regarding claim 13, Poole in view of in view of Barone teach the covered stent according to claim 4, wherein Barone teaches the first membrane, the second membrane, the third membrane and the support together define a unitary structure (parts 8, 9 and 10 define part 11 as per [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the third membrane layer of Barone into Poole for the purpose of providing a plurality of layers that seal portions of the device while allowing a degree of fluid flow in [0083]-[0084].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xiao (US Pub No.: 2020/0352752) considered for a stent with multiple coating membranes in [0040]. Prywes (US Pub No.: 2019/0070037) considered for a device comprising multiple stents with a first and second membrane in [0018].
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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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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