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 .
Specification
The amendment made to the specification, filed on 5/15/2026 is accepted.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered, but are moot in view of the new grounds of rejection.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kick et al. (Pub. No.: US 2005/0222576 A1; hereinafter “Kick”).
Kick discloses the following regarding claim 1: an expandable sheath for protecting a surface of a blood vessel from the introduction of a medical device within the blood vessel, the sheath comprising: an elongated inner member (14) movable between an unexpanded (Figs. 1A-1B; para. 0035) and an expanded (Figs. 2A-2B; para. 0035) configuration, the inner member including a first circumferential portion (portion of element 14 located closer to the label for element 12) adjacent a proximal end of the inner member (Figs. 1A, 2A) and a second circumferential portion (portion of element 14 located closer to the label for element 30) extending in a distal direction from the first circumferential portion (Figs. 1A, 2A), the second circumferential portion is helically coiled (Figs. 1A-1B) around a longitudinal axis (central axis of element 14) of the inner member (Figs. 1A-1B) and forming a central lumen (30) therethrough, at least the second circumferential portion of the inner member including first (inner edge) and second (outer edge) longitudinal edges, where in the unexpanded configuration the first and second longitudinal edges overlap (Figs. 1A-1B), and movement of the inner member toward the unexpanded configuration causes an outer surface of an underlying portion (outer surfaces of the helical coil) of the inner member to slide along an inner surface of a corresponding overlying portion of the inner member and reduces the circumferential overlap of the first and second longitudinal edges (Figs. 1A-2B; paras. 0036-0038, 0047); an elastomeric outer member extending over the inner member (para. 0053); and a hub (12) provided at a proximal end of the sheath (Fig. 2A), where a proximal end of the inner member and outer member are coupled to the hub (Fig. 2A).
Kick discloses the following regarding claim 2: the sheath of claim 1, wherein, when the inner member is in the expanded configuration, a gap is formed between the first and second longitudinal edges along at least a portion of a length of the inner member (Figs. 2A-2B).
Kick discloses the following regarding claim 3: the sheath of claim 2, wherein the portion of the inner member extends from a distal end of the inner member in a direction toward a proximal end of the inner member (Figs. 1A, 2A).
Kick discloses the following regarding claim 4: the sheath of claim 1, wherein at least a portion of an outer diameter of the inner member steadily decreases in a direction toward a distal end of the inner member (Fig. 3B; para. 0065).
Kick discloses the following regarding claim 5: the sheath of claim 1, wherein the inner member is composed of a relatively stiff polymeric material such that the inner member is composed of a material having a greater stiffness than the outer member (paras. 0047, 0053).
Kick discloses the following regarding claim 6: the sheath of claim 1, wherein the elastomeric outer member forms a continuous cylindrical layer (Figs. 1A-2B; para. 0053), wherein the first circumferential portion is cylindrical (Figs. 1A-2B).
Kick discloses the following regarding claim 7: the sheath of claim 1, wherein the inner member is positioned within a lumen (formed by the outer-most portion of the sheath over element 14) formed by the elastomeric outer member, and positioned in contact with an inner surface of the lumen of the elastomeric outer member (para. 0053).
Kick discloses the following regarding claim 8: the sheath of claim 1, wherein the elastomeric outer member exerts a compressive force onto the inner member to bias the inner member toward the unexpanded configuration (para. 0053, when the device is in its contracted configuration, the physical presence of the outer member provides a compressive force), wherein the second circumferential portion is helically coiled in a single circumferential direction (Figs. 1A-1B; para. 0053).
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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