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 .
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) 12-13, 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sos [US 2015/0025555 A1].
Sos discloses:
Re. claim 12, a dilator [Fig. 3] (“for use with an access sheath system is intended use, not given further patentable weight), the dilator comprising:
a guide sheath [140] having a sheath passageway [the lumen of guide sheath 140]; and
an atraumatic [Par. 0033] tip [120] having a proximal portion [316] and a distal portion [labeled 122 in Fig. 1B], the proximal portion being formed to extend along the sheath passageway [Fig. 3, Par. 0048], the distal portion of the atraumatic tip comprising a tapered distal surface [304], the atraumatic tip being formed to mate with a distal end of the guide sheath [Fig. 3] to protect an artery from the distal end of the guide sheath [Par. 0048].
Re. claim 13, the dilator of claim 12, wherein the atraumatic tip includes a dilator passageway [320] that allows a guidewire to extend therealong and through the atraumatic tip [Fig. 3, Par. 0015, 0048].
Re. claim 17, the dilator of claim 12, wherein the atraumatic tip is moveable relative to the guide sheath and along a longitudinal axis of the guide sheath [see Figs. 2B-K] for forming a first position [Fig. 2B] and a second position [Fig. 2D].
Re. claim 18, the dilator of claim 17, wherein the first position comprises a proximal surface of the atraumatic tip being mated against and at least partially covering the distal end of the guide sheath [Figs. 2B, 3].
Re. claim 19, the dilator of claim 18, wherein the proximal surface is part of a stepped proximal surface of the atraumatic tip [including 320, 312, 314, 318, Fig. 3], the stepped proximal surface being proximal to the tapered surface [Fig. 3].
Re. claim 20, the dilator of claim 19, wherein the stepped proximal surface is positioned a distance away from the distal end of the guide sheath when the dilator is in the second position [Fig. 2D].
Claim Rejections - 35 USC § 103
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) 1-11, 14-16, 21-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sos in view of Barker et al. [US 2008/0200943 A1, hereinafter “Barker”].
Re. claim 14, Sos discloses the dilator of claim 12 above but fails to teach the inflatable balloon tip element. However, Barker teaches, wherein the atraumatic tip of the dilator includes an inflatable balloon tip element [120]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Sos such that the atraumatic tip includes an inflatable balloon element as taught by Barker in order to minimize the cross-sectional area of the entry puncture, while maximizing the available space for the instrument [Barker Par. 0005]
Re. claim 15, Sos as modified by Barker discloses the inflatable balloon tip element as in claim 14 above. Sos further teaches the tip includes a stepped proximal surface that is formed to mate against the distal end of the guide sheath when the inflatable balloon is an inflated state [Fig. 3]. Thus, the combined Sos-Barker as modified above reasonably conveys the benefits of the inflatable balloon tip element includes a stepped proximal surface that is formed to mate against the distal end of the guide sheath when the inflatable balloon is an inflated state, as claimed.
Re. claim 16, Sos as modified by Barker discloses the inflatable balloon tip element as in claim 14 above. Sos teaches the tip element includes a proximal section having a first outer diameter and a distal section having a second outer diameter, the first outer diameter being smaller than the second outer diameter, and the proximal section being formed to couple to the sheath passageway [Annotated Fig. 3].
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Thus, the combined Sos-Barker as modified above reasonably conveys the benefits of the inflatable balloon tip element including a proximal section having a first outer diameter and a distal section having a second outer diameter, the first outer diameter being smaller than the second outer diameter, and the proximal section being formed to couple to the sheath passageway, as claimed.
Re. claim 21, Sos discloses the dilator of claim 17, wherein the second position comprises a flexible extension of the atraumatic tip being radially expanded [110, Fig. 2D] but fails to teach it being positioned along an outer surface of the distal end of the guide sheath. However, Barker teaches the second position comprises a flexible extension balloon [120] of the atraumatic tip being radially expanded [Figs. 1a-b] and positioned along an outer surface of the distal end of the guide sheath [134]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Sos to add a flexible extension of the atraumatic tip being radially expanded and positioned along an outer surface of the distal end of the guide sheath as taught by Barker in order to minimize the puncture area while maximizing the space for the instrument [Barker Par. 0005].
Re. claim 1, Sos discloses an access sheath system [Figs. 1-2 with the tip being the embodiment in Fig. 3], comprising:
an access sheath [170] comprising an elongated sheath body that is sized and shaped to be introduced into an artery [Fig. 2B, Par. 0037], the elongated sheath body comprising an inner lumen extending between a proximal sheath end and a distal sheath end; and a dilator, substantially as set forth with respect to claim 12 above, the atraumatic tip being formed to mate with and cover at least a part of a distal end of the guide sheath to protect the artery from the distal end of the guide sheath [Fig. 3, Par. 0048].
Sos fails to teach the access sheath having a protective distal end with an atraumatic surface. However, Barker teaches, in an access sheath [Fig. 2a, sheath 210], the access sheath comprising a protective distal end having an atraumatic surface [204, Par. 0069]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Sos by adding, to the access sheath, a protective distal end having an atraumatic surface as taught by Barker in order to “deflect tissue radially outward so that it does not impinge or force itself into the interior lumen of the…sheath…during insertion,” Barker Par. 0069]
Re. claim 2, Sos discloses the access sheath system of claim 1, further comprising: a guidewire [160] sized to extend along at least a dilator passageway [320] of the atraumatic tip [Fig. 3, Par. 0015, 0048].
Re. claim 3, the modified Sos discloses the limitations substantially as set forth with respect to claim 14 above.
Re. claim 4, the modified Sos discloses the limitations substantially as set forth with respect to claim 15 above.
Re. claim 5, the modified Sos discloses the limitations substantially as set forth with respect to claim 16 above.
Re. claim 6, Sos discloses the limitations substantially as set forth with respect to claim 17 above.
Re. claim 7, Sos discloses the limitations substantially as set forth with respect to claim 18 above.
Re. claim 8, Sos discloses the limitations substantially as set forth with respect to claim 19 above.
Re. claim 9, Sos discloses the limitations substantially as set forth with respect to claim 20 above.
Re. claim 10, the modified Sos discloses the limitations substantially as set forth with respect to claim 21 above.
Re. claim 11, Sos is silent regarding the arm. Barker further teaches the sheath body of the access sheath includes at least one arm [602, Figs. 6a-b] that, when pulled in a direction away from a longitudinal axis of the sheath body [upward, perpendicular to the longitudinal axis], separates the sheath body into more than one part [102 and 104, Fig. 6b]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Sos-Barker by adding an arm to the sheath body of the access sheath as taught by Barker in order to allow the two parts to move relative to one another [Pars. 0084-0085] which allows the inner parts (e.g. the dilator)to be withdrawn [Barker Par. 0088-0089].
Re. claim 22, Sos as modified by Barker discloses the access sheath system as set forth with respect to claim 1 above.
Sos further discloses a method, comprising:
advancing an access sheath into an artery [Figs. 2A-B], with Sos-Barker teaching the features of the sheath as set forth with respect to claim 1 above; and
advancing a dilator along the inner lumen of the access sheath [Figs. 2B-C], the dilator comprising the features as set forth with respect to claim 1 above.
Re. claim 23, Sos discloses advancing [Par. 0016] a guidewire [160] along a dilator passageway [320] of the atraumatic tip [Fig. 3, Par. 0015, 0048].
Re. claim 24, the modified Sos discloses the limitations substantially as set forth with respect to claim 14 above.
Re. claim 25, the modified Sos discloses the limitations substantially as set forth with respect to claim 15 above.
Re. claim 26, the modified Sos discloses the limitations substantially as set forth with respect to claim 16 above.
Re. claim 27, Sos discloses moving the atraumatic tip relative to the guide sheath and along a longitudinal axis of the guide sheath [see Figs. 2B-K] for forming a first position [Fig. 2B] or a second position[Fig. 2D].
Re. claim 28, Sos discloses the limitations substantially as set forth with respect to claim 18 above.
Re. claim 29, Sos discloses the limitations substantially as set forth with respect to claim 19 above.
Re. claim 30, Sos discloses the limitations substantially as set forth with respect to claim 20 above.
Re. claim 31, the modified Sos discloses the limitations substantially as set forth with respect to claim 21 above.
Re. claim 32, Sos discloses the limitations substantially as set forth with respect to claim 11 above.
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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