DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 05/22/2026. Claims 13-20 were previously indicated as allowable based on allowable subject matter in claim 13, with claims 14-20 dependent therefrom. The previous Office Action failed to acknowledge the change in dependency of claim 17 from being dependent on allowable claim 13 to being dependent on claim 1. Accordingly, the previous indication of allowable subject matter of claim 17 was made in error. Therefore, this office action is being issued as a non-final office 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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 10-11, 18-20, 22-23, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0043133 A1 to Wong (hereinafter “Wong”) (previously of record) in view of US 2012/0083877 A1 to Nguyen et al. (hereinafter “Nguyen”) (previously made of record on a PTO-892).
Regarding claim 1, Wong discloses (see abstract; Figs. 1-32; and [0050]-[0110]) a sheath (200, Fig. 5) for delivering a medical device (see at least [0050]), wherein the sheath has a proximal end (215) and a distal end (210) (see [0062]) and comprises: a variable diameter inner liner (105) comprising a sheet (100) having a first edge (120) and a second edge (125) and is defined by an inner surface and an outer surface, wherein the sheet is wound in a spiral configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet (see Figs. 3-6, 10-12 and [0050]-[0076]), wherein the inner surface of the sheet defines a lumen (155) of the sheath having a longitudinal axis (shown by dashed line in Fig. 2), wherein the sheet comprises a polymer layer (see [0059]); an outer layer (220) having a predetermined thickness and having an inner surface and outer surface (see Figs. 5-6 and 10-12 and [0062]/[0070]), and wherein the variable diameter inner liner is configured to expand from a first rest diameter dr (Fig. 3) to a second expanded diameter de (Fig. 4) by sliding the first edge of the sheet along at least a portion of the inner surface and sliding the second edge of the sheet along the at least a portion of the outer surface, during application of a radial outward force by passage of a medical device through the lumen of the inner liner (see Figs. 3-6, 10-12 and [0050]-[0076]).
Wong further discloses (claim 2) wherein when the sheath is in an unexpanded rest state, the first and the second edges of the sheath are substantially aligned in a spaced relationship along a vertical axis passing through a thickness of the sheath (see Fig. 3 and [0059]); or when the sheet is in an unexpanded rest state, the inner liner comprises at least two layers of the sheet overlaying each other at at least a portion of a circumference of the sheath (see Fig. 3 and [0059]) (claim 3) wherein the sheath is in a rest state, the first edge of the sheet is substantially aligned with a vertical axis passing through a thickness of the sheath and the second edge circumferentially offset from the vertical axis (see Fig. 3 and [0059], for example when sheet is rolled to a fractional amount of revolutions then there would be an offset); (claim 4) wherein an amount of a lubricant is disposed between at least a portion of the overlying portion of the sheet and at least a portion of the sliding portions of the sheet (see [0055], hydrophilic coating); (claim 10) wherein the outer layer comprises a polyether block amide, a styrene-based elastomer, polyurethane (see [0099]), latex, copolymers thereof, blends thereof or extrudates thereof; (claim 11) wherein at least one layer of the two or more layers comprises polyurethane (see [0099]); and (claim 22) wherein the sheath further comprises an exterior hydrophilic coating disposed on an outer surface of the outer layer (see [0076]).
Wong fails to specifically disclose, with respect to claim 1, wherein the outer layer comprises two or more sub-layers, a second layer of the two or more sub-layers comprises a second polymer layer comprising a second compound composition comprising from greater than 0 wt% to 100 wt% of a second polymer comprising polyether block amide, a polyurethane, or a composition thereof. Nguyen discloses, in the same field of endeavor, an expandable sheath (see abstract; Figs. 39-40; and [0128], [0135]-[0138] & [0167]) comprising an inner layer (108) and an outer layer (110 + 128) wherein the outer layer comprises two or more sub-layers (110 and 128, see Figs. 39-40 and [0135]), a second layer of the two or more sub-layers comprises a second polymer layer comprising a second compound composition comprising from greater than 0 wt% to 100 wt% of a second polymer comprising a polyurethane (see [0128]/[0135]) for the purpose of providing a thin adhesive layer as part of the outer layer so as to provide adhesion between selection portions of the inner and outer layers (see [0135]). Given that Wong discloses that the outer layer is fused to the inner layer (see [0075]), but does not specify the manner of fusing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong’s device with the two sub-layer outer layer taught by Nguyen in order to provide a thin adhesive layer as part of the outer layer so as to provide adhesion between selection portions of the inner and outer layers.
Regarding claim 18, the combination of Wong and Nguyen would further, disclose, as per Nguyen, wherein the second polymer has a Shore D Durometer from about 20D to about 35D (see [0110]).
Regarding claim 19, the combination of Wong and Nguyen would further, disclose, as per Nguyen, wherein the second compound composition is substantially free of an inorganic filler, and/or wherein the second compound composition is substantially free of a solid lubricant filler (see [0128]/[0135], there is no disclosure of an inorganic or solid lubricant filler).
Regarding claim 20, the combination of Wong and Nguyen would further, disclose, as per Nguyen, wherein one or more additional polymer layers are disposed between the first polymer layer and the second polymer layer (see [0135]).
Regarding claim 23, the combination of Wong and Nguyen would further, disclose, as per Nguyen, wherein a first (128) of the two or more sub-layers forms the inner surface of the outer layer (see Figs. 39-40 and [0135]) and a second (110) of the two or more sub-layers forms the outer surface of the outer layer (see Figs. 39-40 and [0135]), wherein the two or more sub-layers are coextruded (see [0167], outer layer co-extruded with adhesive layer), and wherein a predetermined thickness of the outer layer is defined by a combined thickness of the two or more sub-layers (see Figs. 39-40, the two layers 110 and 128 define the thickness of the combination 110 + 128 when co-extruded together).
Regarding claim 24, Wong discloses (see abstract; Figs. 1-32; and [0050]-[0110]) a sheath (200, Fig. 5) for delivering a medical device (see at least [0050]), wherein the sheath has a proximal end (215) and a distal end (210) (see [0062]) and comprises: a variable diameter inner liner (105) comprising a sheet (100) having a first edge (120) and a second edge (125) and is defined by an inner surface and an outer surface, wherein the sheet is wound in a spiral configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet (see Figs. 3-6, 10-12 and [0050]-[0076]), wherein the inner surface of the sheet defines a lumen (155) of the sheath having a longitudinal axis (shown by dashed line in Fig. 2), wherein the sheet comprises a polymer layer (see [0059]); an outer layer (220) having a predetermined thickness and having an inner surface and outer surface (see Figs. 5-6 and 10-12 and [0062]/[0070]), and wherein the variable diameter inner liner is configured to expand from a first rest diameter dr (Fig. 3) to a second expanded diameter de (Fig. 4) by sliding the first edge of the sheet along at least a portion of the inner surface and sliding the second edge of the sheet along the at least a portion of the outer surface, during application of a radial outward force by passage of a medical device through the lumen of the inner liner (see Figs. 3-6, 10-12 and [0050]-[0076]).
Wong fails to specifically disclose, with respect to claim 24, wherein the outer layer comprises two or more continuous tubular-shaped sub-layers. Nguyen discloses, in the same field of endeavor, an expandable sheath (see abstract; Figs. 39-40; and [0128], [0135]-[0138] & [0167]) comprising an inner layer (108) and an outer layer (110 + 128) wherein the outer layer comprises two or more continuous tubular-shaped sub-layers (110 and 128, see Figs. 39-40 and [0135]) for the purpose of providing a thin adhesive layer as part of the outer layer so as to provide adhesion between selection portions of the inner and outer layers (see [0135]). Given that Wong discloses that the outer layer is fused to the inner layer (see [0075]), but does not specify the manner of fusing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong’s device with the two sub-layer outer layer taught by Nguyen in order to provide a thin adhesive layer as part of the outer layer so as to provide adhesion between selection portions of the inner and outer layers.
Claim(s) 5 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong in view of Nguyen, as applied to claim 1 above, and further in view of US 2002/0064653 A1 to Ladika (hereinafter “Ladika”) (previously of record)
The combination of Wong and Nguyen discloses the invention substantially as claimed as discussed above, however, with respect to claim 5, the combination fails to specifically disclose wherein the polymer layer of the sheet comprises a compound material comprising a polyolefin and a lubricious filler, and wherein the lubricious filler is present in an amount from about 5 wt % to about 20 wt % of a total weight of the compound material. Ladika discloses, in the same field of endeavor of materials for sheaths (see [0118]), the known use of a compound material for a sheath comprising a polyolefin and a lubricious filler present in an amount from 5-20 wt % (see [0115]-[0118). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made Wong's sheath (as modified by Nguyen above) out of the polyolefin and lubricious filler as taught by Ladika, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong in view of Nguyen, as applied to claim 1 above, and further in view of US 2010/0094392 A1 to Nguyen et al. (hereinafter “Nguyen2”) (previously of record).
With respect to claim 6, Wong further discloses a tie layer (150 and/or 160) disposed at the outer surface of the sheet (see Fig. 6 and [0064] and/or Fig. 16 and [0078]), when tie layer is interpreted to simply mean a layer between and connecting two other layers. However, if tie layer is interpreted as a layer which adheres two layers together, then Wong (as modified by Nguyen above) would fail to disclose such a tie layer. Additionally, with respect to claim 6, Wong as modified by Nguyen above fails to disclose a tie layer on the outer surface of the sheet comprising polyurethane, with respect to claim 7, wherein the tie layer is disposed at the outer surface of the sheet such that when the sheet is in the spiral configuration, the tie layer is disposed between the overlapping portions and at an outermost surface of the inner liner, and, with respect to claim 8, wherein the tie layer is coextruded with the sheet
Nguyen2 discloses (see abstract; Figs. 24-29D; [0070]-[0077], and [0096]-[0131]) an expandable sheath (see abstract), comprising an inner layer 68, and outer layer 70, and further discloses a tie layer on an outer surface of sheet in the same field of endeavor for the purpose of varying the amount of adhesion between the inner and outer layers while allowing other areas to remain free to slide relative to one another thus allowing for diameter expansion of the sheath (see [0100]); and further discloses a tie layer on an outer surface of sheet comprising polyurethane (polyurethane used to adhere portions of inner and outer layers together (see [0100]/[0125])) coextruded with the sheet (see [0100]) in the same field of endeavor for the purpose of varying the amount of adhesion between the inner and outer layers while allowing other areas to remain free to slide relative to one another thus allowing for diameter expansion of the sheath (see [0100]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong's sheath (as modified by Nguyen above) with the tie layer and polyurethane tie layer adhesive layer taught by Nguyen in order to vary the amount of adhesion between the inner and outer layers while allowing other areas to remain free to slide relative to one another thus allowing for diameter expansion of the sheath.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong in view of Nguyen and Nguyen2, as applied to claim 6 above, in view of US 2016/0296332 A1 to Zhou et al. (hereinafter “Zhou”) (previously of record).
The combination of Wong in view of Nguyen and Nguyen2 above discloses the invention substantially as claimed as discussed above, however, with respect to claim 9, the combination fails to specifically disclose at least one lubricious liner disposed on the tie layer, wherein the at least one lubricious liner is bonded to the sheet with the tie layer. Zhou discloses, in the same field of endeavor, an expandable sheath (see abstract) comprising a lubricious liner bonded on a tie layer (see [0067]) to a sheet (24) for the purpose of providing low resistance to passage of implants and good expansion/recovery (see [0067]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong's sheath (as modified above) with the lubricious liner taught by Zhou in order to provide low resistance to passage of implants and good expansion/recovery.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong in view of Nguyen, as applied to claim 1 above, and further in view of US 2008/0249558 A1 to Cahill (hereinafter “Cahill”) (previously of record).
The combination of Wong and Nguyen discloses the invention substantially as claimed as discussed above, however, with respect to claim 12, Wong fails to specifically disclose wherein the outer layer comprises a styrene-based elastomer having a shore A durometer between 20A to 50A. As set forth above, Wong discloses the use of polyurethane (see [0099]). Cahill discloses, in the same field of endeavor of materials for sheaths (see [0053]), the known interchangeable use of polyurethane or styrene-ethylene-butadiene block copolymer as suitable known, interchangeable materials for making a sheath flexible, the material having a durometer between 5-95A (see [0053]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Wong's sheath (as modified above) by substituting the polyurethane material for the styrene-based elastomer taught by Cahill, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a suitable flexible material for use in a sheath.
Allowable Subject Matter
Claim 21 is allowed.
Claims 13-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claims 1 and 13, none of the prior art of record, alone or in combination, teaches or suggests an expandable sheath/catheter for a medical device with an outer layer comprising the specific chemical composition as set forth in claim 13.
Response to Arguments
Applicant’s arguments filed 05/22/2026 have been considered. As set forth above, the previous office action erroneously indicated allowability of claim 17 as the change in dependency of claim 17 to depend from claim 1 instead of allowable claim 13 was overlooked. Accordingly, this office action is issued as non-final.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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