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 Arguments
Applicant's arguments filed 7/2/2026 have been considered but they are moot in view of the new grounds of rejection necessitated by the amendments.
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.
Claims 1-4, 6, 8-13, 15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krolik et al. US 2007/0055358 (hereafter referred to as Krolik; cited by the examiner in the previous office action).
Regarding claims 1 and 10, Krolik discloses an expandable sheath (fig.7) comprising: a tubular frame 140 (140 is a stent and stents are tubular) extending along a longitudinal axis 146 from a proximal end 144 to distal end 142, the tubular frame comprising: a plurality of radial expansion bands 149a and 149b, each radial expansion band at least partially extending around a circumference of the tubular frame, each radial expansion band comprising a band strut (considered the strut material of each band), each band strut comprising a plurality of end portions 109, and a plurality of connecting bridges 111, wherein each connecting bridge couples an end portion of the band strut of one radial expansion band to an end portion of the band strut of an adjacent radial expansion band (fig.7 shows each connecting bridge 111 couples adjacent bands), wherein the radial expansion bands and connecting bridges are formed by laser cutting the tubular frame (while this is a product-by-process claim limitation and given little patentable weight as discussed in MPEP 2113, pars.161 and 216 disclose laser cutting which is conventional), and wherein each end portion of the plurality of end portions of at least one band strut of at least one radial expansion band of the plurality of radial expansion bands connects to a connecting bridge of the plurality of connecting bridges (fig.7 shows every end portion 109 is directly connected to a connecting bridge), and a coating formed over at least an exterior of the tubular frame (pars. 163-165 disclose an exterior coating on any embodiment).
Regarding claims 2 and 11, see fig.7 for the bands 149 alternating with the connecting bridges 111 along the longitudinal axis.
Regarding claims 3 and 12, see fig.7 for bands 149 defining a zig-zag pattern around the circumference of the tubular frame.
Regarding claims 4 and 13, see fig.7 for bands extending substantially perpendicularly to the longitudinal axis.
Regarding claims 6, 9, 15, and 18, see fig.7 for continuous circumferential bands 149a, 149b.
Regarding claims 8 and 17, see fig.7 which shows each connecting bridge 111 comprises portions capable of interfering with one another when the tubular frame is compressed along the longitudinal axis. The location and shape of the connecting bridges of Krolik are the same as the instant application. Therefore at least the legs of each bridge can interfere with another upon enough compressive force.
Regarding claim 19, see fig.7 for each end portion 109 being a bent end portion wherein the plurality of bent end portions comprises first and second bent end portions (considered the peaks and valleys) which are connected by straight portions 108 (fig.7 shows each band 149a, 149b comprises alternating bent portions 109 and straight portions 108 forming the zig-zag pattern).
Claims 1-3, 5, 6, 8-12, 14, 15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. CN 1605366 A (hereafter referred to as Ma; cited in IDS; refer to the attached translation for passages referenced herein).
Regarding claims 1 and 10, Ma discloses an expandable sheath comprising: a tubular frame extending along a longitudinal axis from a proximal end to distal end (fig.1 shows the stent laid flat as discloses in the middle of page 4 of the translation; stents are tubular), the tubular frame comprising: a plurality of radial expansion bands 2 (the oblique bands 2), each radial expansion band at least partially extending around a circumference of the tubular frame (fig.1), each radial expansion band comprising a band strut (considered the strut material of each band), each band strut comprising a plurality of end portions (considered the peaks and valleys of each band), and a plurality of connecting bridges 3, wherein each connecting bridge couples an end portion of the band strut of one radial expansion band to an end portion of the band strut of an adjacent radial expansion band (fig.1), and wherein each end portion of the plurality of end portions of at least one band strut of at least one radial expansion band of the plurality of radial expansion bands connects to a connecting bridge of the plurality of connecting bridges (fig.1 shows every bent end portion of the bands, not at the ends, are directly connected to a connecting bridge), and a coating formed over at least an exterior of the tubular frame (see translation page 3 par.7 which discloses the outer surface of the stent comprises grooves or blind holes that are coated). Regarding the limitation “wherein the radial expansion bands and connecting bridges are formed by laser cutting the tubular frame”, this is a product-by-process claim limitation and given little patentable weight as discussed in MPEP 2113. The final product of Ma is the same as the claimed stent structure and the stent being formed by laser cutting does not distinguish over the one-piece stent of Ma.
Regarding claims 2 and 11, see fig.1 for the bands 2 alternating with the connecting bridges 3 along the longitudinal axis.
Regarding claims 3 and 12, see fig.1 for bands defining a zig-zag pattern around the circumference of the tubular frame.
Regarding claims 5 and 14, see fig.1 for bands extending obliquely to the longitudinal axis.
Regarding claims 6, 9, 15, and 18, see fig.1 for continuous circumferential bands 2.
Regarding claims 8 and 17, see fig.1 which shows each connecting bridge 3 comprises portions capable of interfering with one another when the tubular frame is compressed along the longitudinal axis. The location and shape of the connecting bridges of Ma are the same as the instant application. Therefore at least the legs of each bridge can interfere with another upon enough compressive force.
Regarding claim 19, see fig.1 for each end portion being a bent end portion wherein the plurality of bent end portions comprises first and second bent end portions (considered the peaks and valleys) which are connected by straight portions (fig.1 shows each band 2 comprises alternating bent portions and straight portions forming the zig-zag pattern).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kveen et al. US 2003/0050690 discloses a stent comprising a plurality of obliquely angled radial expansion bands wherein each bent end portion of the bands is directly connected to a connecting bridge. Gregovich US 2005/0187606, Nguyen et al. US 2016/0310270, and Arbefeuille et al. US 2020/0246165 each disclose a stent comprising a plurality of radial expansion bands wherein at least one expansion band comprises each bent end portion of the band is directly connected to a connecting bridge.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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