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 .
Election/Restrictions
Applicant’s election without traverse of Species A, claims 1-6, 8-15, and 17-18, in the reply filed on 3/11/2026 is acknowledged.
Claims 7 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/11/2026.
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, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newhauser et al. US 2007/0213810 (hereafter referred to as Newhauser).
Regarding claims 1 and 10, Newhauser discloses an expandable sheath (a sheath is interpreted as something that can be used as a case or covering; the instant application discloses the tubular frame and coating as the sheath and does not appear to disclose an additional cover over the tubular frame and coating, therefore the examiner considers the sheath to only require a tubular frame as claimed and a coating as claimed) comprising a tubular frame 100a, 600a (figs. 2A-2B; figs. 7A-7H) extending along a longitudinal axis 15 from a proximal end to distal end, the tubular frame comprising: a plurality of radial expansion bands 110a-110b, 610a-610b, each radial expansion band at least partially extending around a circumference of the tubular frame (figs. 2A-2B; figs. 7A-7H), and a plurality of connecting bridges 150, 650 wherein each connecting bridge couples a portion of one radial expansion band to a portion of an adjacent radial expansion band (figs. 2A-2B; figs. 7A-7H), 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, par.124 discloses laser cutting which is conventional), and a coating formed over at least an exterior of the tubular frame (at least pars.113-115 disclose various types of coatings on the external and/or internal surfaces of the frame).
Regarding claims 2 and 11, see figs. 2A-2B and figs. 7A-7H for the radial expansion bands and connecting bridges alternating along the longitudinal axis.
Regarding claims 3 and 12, see figs. 2A-2B and figs. 7A-7H for the radial expansion bands comprising a zig-zag pattern around the circumference of the frame.
Regarding claims 4 and 13, see figs. 2A-2B and figs. 7A-7H for each radial expansion band extending around the circumference of the tubular frame substantially perpendicular to the longitudinal axis.
Regarding claims 6 and 15, see figs. 2A-2B and figs. 7A-7H for continuous radial expansion bands.
Regarding claims 8 and 17, figs. 2A-2B show each connecting bridge 150 comprises portions 166 and 167 and portions 168 and 169 each capable of interfering with/touching one another when the tubular frame is exposed to a compressive force along the longitudinal axis. Specifically, fig.2B shows the portions are capable of interfering with one another since they can bend about their flexing points 160/164 and touch. Additionally, figs. 7A-7H show each connecting bridge 650 comprises portions 667 and 668 capable of interfering with/touching one another when the tubular frame is exposed to a compressive force along the longitudinal axis (see figs. 7E-7H which show at least when the stent is expanded, the portions 667 and 668 of each bridge are capable of interfering with each other when exposed to a compressive force along the longitudinal axis).
Regarding claims 9 and 18, see figs. 2A-2B and 7A-7H for each of the radial expansion bands extending around the entire circumference of the tubular frame.
Claims 1-3, 5, 6, 9-12, 14, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bales, JR. et al. US 2015/0039078 (hereafter referred to as Bales).
Regarding claims 1 and 10, Bales discloses an expandable sheath (fig.1) comprising a tubular frame 100 extending along a longitudinal axis 16 from a proximal end to distal end, the tubular frame comprising a plurality of radial expansion bands 20b-20g, each radial expansion band at least partially extending around a circumference of the tubular frame, and a plurality of connecting bridges 26, wherein each connecting bridge couples a portion of one radial expansion band to a portion of an adjacent radial expansion band (fig.1), wherein the radial expansion bands and connecting bridges are formed by laser cutting the tubular frame (par.43), and a coating formed over at least an exterior of the tubular frame (par.57 discloses coating the entire stent which includes at least an exterior).
Regarding claims 2 and 11, see at least fig.1 for alternating radial expansion bands 20b-20g and connecting bridges 26 along the longitudinal axis 16.
Regarding claims 3 and 12, see figs.1 and 3 for band segments 28 that define a zig-zag pattern around the circumference of the tubular frame.
Regarding claims 5 and 14, see fig.1 for each radial band 20b-20g extending around the circumference obliquely with respect to the longitudinal axis.
Regarding claims 6 and 15, see fig.1 for each radial expansion band 20b-20g comprising a continuous band strut.
Regarding claims 9 and 18, see fig.1 for each of the radial expansion bands 20b-20g extending around the entire circumference of the tubular frame. Par.33 discloses the bands 20 join together end to end and circumscribe the axis 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Each of US9,101,503, US2020/0206004, US2004/0054398, US2012/0016458, US2011/0190861, US2010/0004728, US2007/0055358, and US2004/0088040 discloses an expandable sheath comprising a tubular frame, a plurality of radial expansion bands, a plurality of connecting bridges, and a coating formed over at least an exterior of the tubular frame. US2010/0004728 fig.17 specifically teaches protrusions on opposite sides of a connecting bridge to form a stopping element.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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