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 Amendment
This office action is responsive to the amendment filed 30 March 2026. As directed by the amendment: claim 74 is cancelled. Therefore, claims 66-73 and 75-85 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 30 March 2026, with respect to the rejection(s) of claim(s) 66 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Worley et al. (US 2016/0001042) and Reydel et al. (US 2001/0044595).
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) 66-73 and 75-85 are rejected under 35 U.S.C. 103 as being unpatentable over Chebator et al. (US 2012/0083740) in view of Worley et al. (US 2016/0001042) and Reydel et al. (US 2001/0044595).
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]), wherein the introducer sheath comprises a hub on the proximal end, the hub comprising a hub seam (¶[0022], where the pull tabs are located on the proximal end of the sheath).-;
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 reach the enlarged inside diameter to accommodate passage of the medical device;
Chebator teaches splitting a sheath (¶[0025]-[0028], [0032]-[0033]).
Chebator does not specifically teach positioning a cutting tool such that a blade of the cutting tool is at an angle aligned with the hub seam; and thereafter splitting, with the cutting tool, the introducer sheath axially at least partially along the hub seam to create a longitudinal opening and expose the lumen to permit lateral removal of the introducer sheath from the catheter.
Worley teaches positioning a cutting tool (Fig. 2, 20) such that a blade of the cutting tool is at an angle aligned with the hub seam (Fig. 2, where 20 is aligned with a seam ¶[0047]); and thereafter splitting, with the cutting tool (¶[0047]), the introducer sheath axially at least partially along the hub seam to create a longitudinal opening and expose the lumen to permit lateral removal of the introducer sheath from the catheter (¶[0047], where the splitting part cuts into 18 for removal). The use of a cutting tool such as a knife or scalpel to split a sheath portion is well-known in the art as illustrated by Worley. Additional art such as Reydel et al. (US 2001/0044595) also teaches this practice as it is efficient and effective for making precise lines and cuts when using a removable outer sheath portion. Reydel also teaches predetermined split line (¶[0009]) that can be manually split with something such as a scalpel (¶[0067]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the device of Chebator to use a cutting tool for splitting the introducer sheath as it is well-known practice in the art for removing an outer sheath portion.
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, further comprising pulling on at least one pull tab (Fig. 1, 116) to at least partially 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, further comprising 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 75, Chebator discloses method as in Claim 66, 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 66, 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, wherein the hub comprises 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 66, 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
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 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
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