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 action is entered in response to Applicant's amendment and reply of 12/12/25. The claims 1-16, 21-24 are pending. The claims 1, 6, and 7 are amended. Claims 10-16 are withdrawn. Claims 17-20 have been cancelled. Claims 21-24 are new.
Response to Arguments
Applicant acknowledges the claim limitation of the “surface feature for promoting sliding movement between adjacent sheath fins during expansion and contraction of the sheath is not being interpreted under 35 U.S.C. 112(f).
Applicant’s amendments have overcome the previous specification objections.
Applicant’s amendment to remove the limitation of “a flat inner surface” not shown in the drawings has overcome the drawing objection.
Applicant amendment has overcome the claim objection of claim 7.
Applicant’s amendment has overcome the 35 U.S.C. 112(b) rejection of claim 3.
Applicant’s arguments, filed 12/12/25 with respect to the rejections of claims 1, 4, 5, 7-9 under 35 U.S.C. 102(a)(1) as being anticipated by Thoreson (US2018/0325549) have been fully considered and the amendment overcomes the previous rejection. However, a new grounds of rejection has been made in view of Thoreson (US2018/0325549).
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.
Claims 1-9 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Thoreson (US2018/0325549).
Regarding claim 1, Thoreson discloses a sheath comprising:
a radially expandable cylindrical outer layer (80, [0068]) having a proximal end and a distal end (see Fig. 1, equivalent to outer layer 30; [0068]), and defining a cylindrically shaped lumen (22) extending longitudinally between the proximal end and the distal end (see Figs. 1, 6-8), and having an inner surface (see Figs. 6-8); and
a plurality of sheath fins (82) distributed circumferentially about the inner surface (see Figs. 6-8) and coupled thereto,
wherein each of the sheath fins extends along a length of the inner surface of the outer layer, wherein the sheath is movable between an unexpanded state and an expanded state (see Figs. 6-8), and where in the unexpanded state the sheath fins form a continuous surface of the lumen of the outer layer (when the sheath is in a partially expanded state with slightly more expansion than shown in Fig. 7, the elements 82 would abut each other; therefore, at this partial expansion the elements 82 would form a continuous surface).
Thoreson does not explicitly disclose each of the sheath fins are fixedly coupled to the outer layer. Thoreson according to the embodiment of Figs. 5A-5B teaches an inner layer 40 secured to an outer layer 30 such that at least a portion of the inner layer 40 is circumferentially immovable and/or fixed in place relative to the outer layer 30 ([0062]). Where a bonding agent 60 is used to fixedly secure the inner layer 40 to the outer layer 30. 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 the embodiment of Figs. 6-8 to include a bonding agent in order to have the inner layer move in the same manner when the outer layer is expanded, since the segments moving in the same manner is desired as shown in Figs. 6-8.
Regarding claim 2, Thoreson makes obvious the sheath of claim 1; yet, does not explicitly disclose wherein the sheath fins have a greater stiffness than the outer layer. Thoreson according to another embodiment teaches the inner layer may be formed form a substantially inelastic material and substantially unable to stretch ([0065]). 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 the sheath of Thoreson to have the sheath fins have a greater stiffness than the outer layer in order to resiliently flex a small amount sufficient to allow an inner diameter of the sheath to increase without stretching the inner layer to a larger circumferential length ([0065]).
Regarding claim 3, Thoreson makes obvious the sheath of claim 1; yet, does not explicitly disclose wherein a longitudinal stiffness of the sheath is greater than the radial stiffness of the sheath. Thoreson contemplates materials for the elements 82 and outer layer 80 ([0068]). Where the outer layer 80 is intended to stretch ([0068]). Where embodiments teach the inner layer may be formed form a substantially inelastic material and substantially unable to stretch ([0065]). Where the elements 82 extend longitudinally along the sheath and would therefore provide some degree of radial stiffness ([0068]). 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 modified the sheath of Thoreson to have the longitudinal stiffness of the sheath be greater than the radial stiffness of the sheath in order to resiliently flex a small amount sufficient to allow an inner diameter of the sheath to increase without stretching the inner layer to a larger circumferential dimension ([0065]).
Regarding claim 4, Thoreson makes obvious the sheath of claim 1, wherein each of the sheath fins extend along at least a majority of a total length of the inner surface of the outer layer (the elements 82 are longitudinally oriented elements 82 and extend the length of the sheath 10, [0067]).
Regarding claim 5, Thoreson makes obvious the sheath of claim 1, wherein each of the sheath fins have an arcuate-shaped outer surface and an arcuate-shaped inner surface, in cross-section (the elements 82 are circumferentially oriented as shown in see Figs 6-8 and would therefore have an arcuate shaped outer surface and inner surface).
Regarding claim 6, Thoreson makes obvious the sheath of claim 1, wherein each of the sheath fins have an arcuate-shaped outer surface (see Figs. 6-8); yet, does not explicitly disclose wherein each of the sheath fins have a flat-shaped inner surface. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to have the sheath fins have a flat-shaped inner surface because Applicant has not disclosed that a flat-shaped inner surface 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 the fins of Thoreson, and Applicant’s invention, to perform equally well with either the arcuate surface or the claimed flat surface because both surfaces would perform the same function of controlling an expansion of the outer layer equally well as stated in paragraph [0055] of Applicant’s specification.
Regarding claim 7, Thoreson makes obvious the sheath of claim 1, wherein each of the sheath fins includes a longitudinally extending leading edge (one of the two edges of the element 82, see Fig. 8) and a longitudinally extending trailing edge (the other one of the two edges of the element 82, see Fig. 8),
wherein each of the fins are fixedly coupled to the inner surface of the outer layer from the leading edge to the trailing edge (the fins as modified are fixedly coupled at some portion, and therefore, would the fins would be fixedly coupled from the leading edge to the trailing edge),
wherein the leading edge of each of the sheath fins abuts a trailing edge of an adjacent one of the sheath fins when the sheath is in the unexpanded state (when the sheath is in a partially expanded state with slightly more expansion than shown in Fig. 7, the edges of the elements 82 would abut each other).
Regarding claim 8, Thoreson makes obvious the sheath of claim 7, wherein at least one of the leading and the trailing edge of each of the sheath fins includes a surface feature for promoting sliding movement between adjacent sheath fins during expansion and contraction of the sheath (the surface feature is interpreted as a lubricant covering the surface of the element, which Thoreson discloses in [0069]; as the sheath goes from an unexpanded to expanded configuration the elements 82 move in radial position as the outer layer 80 expands radially outward, [0067]-[0068]; where the surfaces with a coating of the elements 82 allow for sliding since they overlap in and then move to a position with gaps 86 between them, see Figs. 6-8).
Regarding claim 9, Thoreson makes obvious the sheath of claim 1, wherein when the sheath expands from the unexpanded to the expanded state the circumferential spacing between adjacent sheath fins increases to form a gap (86) between each of the sheath fins ([0067]).
Regarding claim 21, Thoreson makes obvious the sheath of claim 1, wherein a portion of the outer layer extending between adjacent fins stretches and/or expands during expansion of the outer layer ([0068]). However, Thoreson does not explicitly disclose wherein a portion of the outer layer coupled to the sheath fins does not stretch and/or expand during expansion of the outer layer. Thoreson teaches portions of the outer layer can remain constant, while gaps between the portions of outer layer increase for expansion (see Figs. 2A-2C, [0065]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the outer layer that expands for the outer layer having portions that do not stretch or expand, since Thoreson teaches having the outer layer with portions that do not stretch or expand is an obvious variant of the outer layer and would have yielded the same predictable result of an outer layer that allows the inner layer to move when the lumen is enlarged ([0065]).
Regarding claim 22, Thoreson makes obvious the sheath of claim 1, wherein each of the sheath fins are radially fixed to the outer layer (the modified invention teaches that the sheath fins 82 would be fixed radially to the outer layer by the bonding, [0062]).
Regarding claim 23, Thoreson makes obvious the sheath of claim 7, wherein the leading edge and the trailing edge of each of the sheath fins form angled surfaces with respect to the outer surface and the inner surface of the sheath fin (see Fig. 6), and wherein the angled surface of the leading edge and the angled surface of the trailing edge abut each other to form the continuous surface (when the outer layer 80 is expanded the elements 82 would abut at some time during the expansion, see Figs. 6-8).
Regarding claim 24, Thoreson makes obvious the sheath of claim 7, wherein at least one of the leading and the trailing edge of each of the sheath fins includes a surface feature for promoting sliding movement between adjacent sheath fins during expansion and contraction of the sheath, wherein the surface feature is at least one of a surface treatment, a lubricant, or a combination thereof (the surface feature is interpreted as a lubricant covering the surface of the element, which Thoreson discloses in [0069]; as the sheath goes from an unexpanded to expanded configuration the elements 82 move in radial position as the outer layer 80 expands radially outward, [0067]-[0068]; where the surfaces with a coating of the elements 82 allow for sliding since they overlap in and then move to a position with gaps 86 between them, see Figs. 6-8).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774