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
Applicant’s amendment dated April 7, 2026 is acknowledged. Currently claims 1-4, and 6-21 are pending in this application.
Applicant has not amended claim 19 nor mentioned the claim in their arguments. The previous rejections have therefore been included again in this action.
Applicant’s arguments with respect to claims 1-4, 6-18 and 19-20 have been considered but are moot due to the amendments to the rejections required by the amendments to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the phrase “wherein the wire is embedded in the shaft.” It is unclear how the wire can be both “extending helically around the shaft” and “embedded in the shaft”. Correction is required
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drasler (US 2009/0240202, as previously cited).
Regarding claim 19, Drasler discloses a sheath movable between a collapsed diameter and an expanded diameter, the sheath comprising: a body having a lumen (e.g. expandable lumen as shown in Figures 2A and 2B), and means for actuating the body between the collapsed diameter and the expanded diameter (e.g. tensioning element 90; compression element 85 and movement between Figure 2A -2B; [0036])
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maimon (US 2021/0315697, as previously cited).
Regarding claim 19, Maimon discloses a sheath movable between a collapsed diameter and an expanded diameter, the sheath comprising: a body having a lumen (e.g. as shown in Figures 5A and 5B) and means for actuating the body between the collapsed diameter and the expanded diameter (e.g. translation mechanism 34, rotating nut 36 as shown in Figure 6; and collapsing and expanding of device as taught in [0047]).
Claims 1, 7-10, 15-18 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shitrit (US 2025/0229057).
Regarding claim 1, Shitrit discloses a sheath movable between a collapsed diameter and an expanded diameter (e.g. Title), the sheath comprising:
a body having a lumen and movable between a first configuration and a second configuration (e.g. expandable lumen as shown in Figure 6),
wherein the body has a first diameter size in the first configuration that is smaller than a second diameter size in the second configuration (e.g. D1 and D2 as shown in Figure 6),
wherein the body comprises a shaft made from
a first material (inner layer 102 as shown in Figure 4) and
a wire comprising a second material, the wire extending helically around the shaft (e.g. third layer 106 which wraps helically around the inner layer 102; [0120]).
Regarding claim 7, Shitrit additionally discloses wherein the wire is embedded in the shaft (e.g. third layer 106 is embedded in the first second and fourth layers as shown in Figure 3).
Regarding claim 9, Shitrit additionally discloses wherein the first material comprises a thermoplastic polyurethane elastomer (e.g. polymeric material of layer 102 as disclosed in [0113]).
Regarding claim 10, Shitrit additionally discloses a support member coupled to or formed as part of the body and extending along a longitudinal axis of the body (e.g. second layer 104 as disclosed in Figure 3).
Regarding claim 15, Shitrit additionally discloses wherein the body expands to the second diameter size as a medical device is inserted through the lumen (e.g. as disclosed in Abstract).
Regarding claim 16, Shitrit additionally discloses wherein the wire is arranged to collapse before and after insertion of the medical device to collapse the body to the first diameter size (e.g. as shown in Figure 3).
Regarding claim 17, Shitrit additionally discloses wherein the first diameter size and the second diameter size are inner diameters of the body defined by the lumen (e.g. as shown in Figure 3).
Regarding claim 18, Shitrit additionally discloses wherein the first diameter size and the second diameter size are outer diameters of the body defined by an outer surface of the body (e.g. as shown in Figure 3).
Regarding claim 21, Shitrit additionally discloses wherein the wire extends continuously around the entire circumference of the shalft along at least a portion of a longitudinal length of the shaft (e.g. as shown in Figure 4).
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 1-4, 6, 8-13, and 15-18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Drasler (US 2009/0240202, as previously cited) in view of Shitrit (US 2025/0229057).
Regarding claim 1, Drasler discloses a sheath movable between a collapsed diameter and an expanded diameter (e.g. Figs. 2A-2C), the sheath comprising:
a body having a lumen and movable between a first configuration and a second configuration (e.g. expandable lumen as shown in Figures 2A and 2B),
wherein the body has a first diameter size in the first configuration that is smaller than a second diameter size in the second configuration (e.g. radial dimension 110 as shown in Figures 2A and 2B),
wherein the body comprises a shaft made from:
a first material (e.g. polymeric coating 55 which can be PU, Pebax, PVC or silicone; [0033]) and
a wire comprising a second material (e.g. axial strands which can comprise PET, Dacron, Pebax or metal, for example stainless steel or nitinol; [0037]).
Drasler does not disclose that the wire extends helically around the shaft. Shitrit discloses that it is well known in the art of expandable introducers for a wire to extend helically around the shaft (e.g. third layer 106 which wraps helically around the inner layer 102; [0120]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the helical wire of Shitrit in the device of Drasler since such a modification would provide the system with the predictable results of a reliable means of controlling the diameter of the device.
Regarding claim 2, Drasler additionally discloses a hub coupled to the body (e.g. tensioning element 90); and an actuator coupled to the hub (e.g. compression element 85), wherein—upon actuation—the actuator is configured to cause the body to move between the first configuration and the second configuration (e.g. movement between Figure 2A -2B; [0036])
Regarding claim 3, Drasler additionally discloses wherein, upon actuation, the actuator is configured to pull the wire into the hub to cause the body to move from the second diameter size to the first diameter size (e.g. device can be moved in either direction as taught in [0036]).
Regarding claim 4, Drasler additionally discloses wherein the actuator is a switch movable within a slot in the hub (e.g. holding member 95 as shown in Figure 2A).
Regarding claim 6, Drasler additionally discloses a plurality of wing portions of the body that are collapsible in response to the wire being pulled (e.g. braided fiber 40 can be considered “wing portions” that collapse between Figure 2A and 2B).
Regarding claim 8, Drasler additionally discloses wherein the first material comprises an elastomer (e.g. polymeric coating 55 which can be PU, Pebax, PVC or silicone; [0033]) and wherein the second material comprises a metal (e.g. axial strands which can comprise PET, Dacron, Pebax or metal, for example stainless steel or nitinol; [0037]).
Regarding claim 9, Drasler additionally discloses wherein the first material comprises a thermoplastic polyurethane elastomer (e.g. polymeric coating 55 which can be PU; [0033])
Regarding claim 10, a support member coupled to or formed as part of the body and extending along a longitudinal axis of the body (e.g. braided fibers 40 as shown in Figure 2A).
Regarding claim 11, Drasler additionally discloses wing portions positioned between the wire and the support member (e.g. strange attachments 80 which can be considered “wing portions”)
Regarding claim 12, Drasler additionally discloses wherein the wing portions and the wire are integrally formed from one part (e.g. as shown in Figure 2A)
Regarding claim 13, Drasler additionally discloses wherein the wing portions are arranged perpendicular to the support member in the second configuration and are arranged at an angle less than 90 degrees in the first configuration (e.g. as shown in Figure 2A).
Regarding claim 15, Drasler additionally discloses wherein the body expands to the second diameter size as a medical device is inserted through the lumen (e.g. expansion to second diameter for insertion of interventional catheter as shown in Figure 3B and described in [0043]).
Regarding claim 16, Drasler additionally discloses wherein the wire is arranged to collapse before and after insertion of the medical device to collapse the body to the first diameter size (e.g. collapsing to a first diameter before and after insertion of the medical device as disclosed in [0043]).
Regarding claim 17, Drasler additionally discloses wherein the first diameter size and the second diameter size are inner diameters of the body defined by the lumen (e.g. radial direction 110 showing the two diameter sizes as shown in Figures 2A-2B).
Regarding claim 18, Drasler additionally discloses wherein the first diameter size and the second diameter size are outer diameters of the body defined by an outer surface of the body (e.g. outer diameters can also be measured as shown in Figures 2A-2B),
Regarding claim 20, Drasler additionally discloses the means for actuating comprises a wire and an actuator coupled to the wire and configured to pull the wire to actuate the body to the collapsed diameter (e.g. actuator pulls axial strands 75 as shown in Figures 2A-2B).
Drasler does not disclose that the wire extends helically around the shaft. Shitrit discloses that it is well known in the art of expandable introducers for a wire to extend helically around the shaft (e.g. third layer 106 which wraps helically around the inner layer 102; [0120]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the helical wire of Shitrit in the device of Drasler since such a modification would provide the system with the predictable results of a reliable means of controlling the diameter of the device.
Regarding claim 21, Shitrit additionally discloses wherein the wire extends continuously around the entire circumference of the shalft along at least a portion of a longitudinal length of the shaft (e.g. as shown in Figure 4).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shitrit or Drasler in view of Shitrit.
Regarding claim 14, Shitrit or Drasler in view of Shitrit disclose the claimed invention but does not disclose expressly wherein the first material has a lower durometer value compared to the second material. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the hardness of the materials as taught by Shitrit or Drasler in view of Shitrit with the desired hardness, because Applicant has not disclosed that such hardnesses provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the materials as taught by Shitrit or Drasler in view of Shitrit, because it provides a reliable expandable sheath and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Shitrit or Drasler in view of Shitrit to obtain the invention as specified in the claims.
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 Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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