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 .
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) 66-85 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chebator et al. (US 2012/0083740).
Regarding claim 66, Chebator discloses a method of introducing a medical device through an introducer sheath (Abstract), comprising the steps of:
providing an expandable, peel away introducer sheath (Fig. 1, 100) having a proximal end (Fig. 1, 104), a distal end (Fig. 1, 106), and a tubular side wall (Fig. 1, 102) defining a central lumen selectively enlargeable from a relaxed inside diameter to an enlarged inside diameter (¶[0020]-[0021]);
positioning the introducer sheath into a vessel of a patient while in a relaxed inside diameter configuration (¶[0025]-[0027]);
providing a catheter (Fig. 2, 150) carrying a medical device (Fig. 2, 152) which has an outside diameter that is larger than the relaxed inside diameter (Fig. 3B, where the end 156 is larger than the relaxed inside diameter as shown by the protrusion);
advancing the medical device distally through the lumen causing an expansion zone of the side wall in the vicinity of the medical device to momentarily reach the enlarged inside diameter to accommodate passage of the medical device; and thereafter splitting the introducer sheath axially to create a longitudinal opening and expose the lumen to permit lateral removal of the introducer sheath from the catheter (¶[0025]-[0028], [0032]-[0033]).
Regarding claim 67, Chebator discloses a method as in Claim 66, wherein the expansion zone progressively advances distally along the tubular side wall in response to distal advance of the medical device (¶[0026]).
Regarding claim 68, Chebator discloses a method as in Claim 67, wherein the medical device comprises a mechanical circulatory support device (¶[0034], where the catheter and other deliverables from the device can be placed for use such as circulatory support).
Regarding claim 69, Chebator discloses a method as in Claim 66, wherein splitting the introducer sheath comprises pulling on at least one pull tab (Fig. 1, 116) to create the longitudinal opening (¶[0022]).
Regarding claim 70, Chebator discloses a method as in Claim 66, further comprising the step of coupling an insertion tool (Fig. 2, 160) to the proximal end prior to the advancing step (¶[0028], [0041]).
Regarding claim 71, Chebator discloses a method as in Claim 69, wherein splitting the introducer sheath comprises pulling on two opposing pull tabs to axially split the introducer sheath into two pieces (¶[0022]).
Regarding claim 72, Chebator discloses a method as in claim 70, wherein the insertion tool (Fig. 2, 160) comprises an extension tube (Fig. 2, 162) configured to be advanced into [[a]]the patient (¶[0024]).
Regarding claim 73, Chebator discloses a method as in Claim 72, further comprising a step of advancing the extension tube of the insertion tool into the vessel of the patient following a removal of the introducer sheath from the catheter (¶[0024], [0026]).
Regarding claim 74, Chebator discloses a method as in Claim 66, wherein creating the longitudinal opening occurs in a hub on the proximal end of the introducer sheath (¶[0022], where the pull tabs are located on the proximal end of the sheath).
Regarding claim 75, Chebator discloses method as in Claim 74, wherein the longitudinal opening is formed by splitting the hub axially into two pieces (¶[0022]).
Regarding claim 76, Chebator discloses a method as in Claim 75, further comprising a removable retainer for retaining the two pieces together (¶[0022], where the perforation is formed to retain the two pieces until acted upon).
Regarding claim 77, Chebator discloses a method as in Claim 74, wherein the longitudinal opening is formed by splitting the hub axially into two halves (¶[0022]).
Regarding claim 78, Chebator discloses a method as in Claim 77, further comprising a pull tab on each half (¶[0022], where 116 is positioned on either side of the longitudinal opening portion and the perforations).
Regarding claim 79, Chebator discloses a method as in Claim 78, wherein a first pull tab on a first half wraps around at least a portion of the hub connecting the first half to a second half (¶[0022], where the tabs are designed to fold outwards around the center of 116 and can touch each other when in an open state).
Regarding claim 80, Chebator discloses a method as in Claim 79, wherein the first pull tab removably mates with the second pull tab on the second half (¶[0022], where the pull tables of 116 are mated when they are in a non-open state by the connection formed on 116).
Regarding claim 81, Chebator discloses a method as in Claim 74, further comprising a step of engaging an accessory device to a locking mechanism on the hub (¶[0041]).
Regarding claim 82, A method as in Claim 81, wherein the accessory device comprises a dilator (Fig. 4C, where 150 has a portion to hold the penetrating portion 220) and wherein the dilator is configured to releasably hold an expandable atraumatic distal tip in a compressed state (Fig. 4A-C, where 150 hold the tip of 210 in a compressed state at a distal end until the tip exits).
Regarding claim 83, Chebator discloses a method as in Claim 82, wherein the dilator comprises a handle with an actuator configured to release the expandable atraumatic distal tip from the compressed state (¶[0024], where 160 has the capability to control the flow of fluid in the device which includes opening or closing the distal tip from a compressed state.).
Regarding claim 84, Chebator discloses a method as in Claim 66, wherein the introducer sheath further comprises a radially expandable structural layer comprising braided, woven, or knitted fibers (¶[0027], [0034], where the types of materials listed include materials that can be braided, woven or knitted).
Regarding claim 85, Chebator discloses a method as in Claim 84, wherein the structural layer overlaps on itself for at least a portion of a circumference of the introducer sheath (¶[0027], [0034], where the material can be of different types and can be layered however necessary).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783