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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/18/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 8/18/26. The claims 17-37 are pending. Claims 33-37 are withdrawn.
Response to Arguments
No arguments have been filed with respect to the rejections of claims 17-28, 30, and 31 under 35 U.S.C. 102(a)(1) as being anticipated by Zhou (US2019/0030299); the rejection of claim 29 under 35 U.S.C. 103 as being unpatentable over Zhou in view of Korkuch (US2018/0256859); the rejection of claim 32 under 35 U.S.C. 103 as being unpatentable over Zhou. The rejections have been maintained.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/18/2026 was filed after the mailing date of the Final Rejection on 8/3/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 17-28, 30, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou (US2019/0030299).
Regarding claim 17, Zhou discloses a delivery sheath system comprising:
a sheath member (sheath 8) defining a tubular structure extending between a proximal end and a distal end of the sheath member ([0086]);
a ring portion (wherein “ring portion” has been given its broadest reasonable interpretation to encompass a segment of the sheath 8 proximal to the flared portion 78, see Fig. 24) provided at the distal end of the sheath member (see Fig. 24); and
a tip portion (flared portion 78) extending from a distal end of the ring portion (see Fig. 24), the tip portion including a longitudinally extending folding region (see Fig. 25, [0086]) movable between a folded and unfolded configuration ([0086]),
wherein in the folded configuration the tip portion creases along a longitudinally extending edge such that circumferential portions of the tip portion at least partially overlap (see Fig. 25), and a diameter of the tip portion along a majority of a length of the tip portion corresponds to a diameter of the ring portion (the diameter of the tip portion along a majority of a length of the tip portion is interpreted as the diameter at the proximal end of the tip portion, where a “length” is not interpreted as the entirety of the tip portion but a length of the proximal end, where this diameter corresponds to the diameter of the ring portion by extending from the ring portion), wherein, in the unfolded configuration, the tip portion defines an increasing tapered surface having a larger diameter at a distal end of the tip portion (Fig. 24).
Regarding claim 18, Zhou discloses delivery sheath system of claim 17, wherein the tip portion includes a plurality of folding regions circumferentially spaced around the tip portion (see Fig. 25, [0086]).
Regarding claim 19, Zhou discloses the delivery sheath system of claim 18, wherein the plurality of folding regions include a first folding region (folding region between the first longitudinal edge and second longitudinal edge as shown in annotated Fig. 25) defined by a first circumferential portion (outward facing folded surface between first longitudinal edge and second longitudinal edge as shown in annotated Fig. 25), a first and second longitudinal edges (see annotated Fig. 25), and a second circumferential portion (inward facing folded surface between first longitudinal edge and second longitudinal edge as shown in annotated Fig. 25) extending between the first and second longitudinal edges, wherein the first folding region is configured to crease at the first and second longitudinal edges into the folded configuration such that the first and second circumferential portions at least partially overlap (see annotated Fig. 25), and the second circumferential portion is radially inward of the first circumferential portion (see annotated Fig. 25).
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Regarding claim 20, Zhou discloses the delivery sheath system of claim 19, wherein the plurality of folding regions include a second folding region (folding region between the third longitudinal edge and fourth longitudinal edge as shown in annotated Fig. 25-2) defined by a third circumferential portion (outward facing folded surface between first longitudinal edge and second longitudinal edge as shown in annotated Fig. 25-2), a third and fourth longitudinal edge (see annotated Fig. 25-2), and a fourth circumferential portion (inward facing folded surface between first longitudinal edge and second longitudinal edge as shown in annotated Fig. 25-2) extending between the third and fourth longitudinal edges, wherein the second folding region is configured to crease at the third and fourth longitudinal edges into the folded configuration such that the third and fourth circumferential portions at least partially overlap (see annotated Fig. 25-2), and the fourth circumferential portion is radially inward of the third circumferential portion (see annotated Fig. 25-2).
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Regarding claim 21, Zhou discloses the delivery sheath system of claim 20, wherein the first folding region and the second folding region are spaced circumferentially around the tip portion on opposing sides of a fifth circumferential region (see annotated Fig. 25-2), wherein the fifth circumferential region extends between the second and third longitudinal edges (see annotated Fig. 25-2).
Regarding claim 22, Zhou discloses the delivery sheath system of claim 21, wherein, in the folded configuration, the fifth circumferential portion is radially inward of the second and fourth circumferential portions (see annotated Fig. 25-2, where the fifth circumferential portion is interpreted as a portion of the inner lumen wall of the sheath 8).
Regarding claim 23, Zhou discloses the delivery sheath system of claim 21, wherein a width of the fifth circumferential portion measured around the circumference of the tip portion is less than a width of the first and third circumferential portions (the width of the fifth circumferential portion is interpreted as portion of the inner lumen wall of the sheath that is curved, yet has a smaller width than the first and third circumferential portions from annotated Fig. 25 & 25-2).
Regarding claim 24, Zhou discloses the delivery sheath system of claim 21, wherein a width of either of the second and fourth circumferential portions is less than the width of the fifth circumferential portion (the width of the fifth circumferential portion is interpreted as portion of the inner lumen wall of the sheath that is curved and larger than a width of the first and third circumferential portions from annotated Fig. 25 & 25-2).
Regarding claim 25, Zhou discloses the delivery sheath system of claim 17, wherein the ring portion defines an elongated tubular structure having a central lumen extending therethrough (see Fig. 23, [0086]), the central lumen of the ring portion comprising a cylindrically-shaped inner surface, the ring portion further comprising a cylindrically-shaped outer surface (see Fig. 23, [0086]).
Regarding claim 26, Zhou discloses the delivery sheath system of claim 17, wherein an inner diameter of a central lumen extending through the ring portion corresponds to an inner diameter of a central lumen of the sheath member (see Fig. 23).
Regarding claim 27, Zhou discloses the delivery sheath system of claim 17, wherein the diameter of the tip portion in the folded configuration is measured at an outer diameter of the tip portion (outer diameter taken at the proximal end, see Fig. 23), wherein the diameter of the tip portion in the folded configuration corresponds to the diameter of the ring portion (see Fig. 23) along an entire length of the tip portion (the diameter of the tip portion corresponds the diameter of the ring portion by extending from the ring portion, where this diameter corresponds along the entire length of the tip portion by its extension from the ring portion), wherein a diameter of the tip portion in the unfolded configuration is greater than a diameter of the ring portion (see Fig. 24, [0086]).
Regarding claim 28, Zhou discloses the delivery sheath system of claim 17, wherein the tip portion is formed from a conical tubular structure (see tip portion as shown in Figs. 23 and 25 that forms a conical structure with the folded portions), wherein the tip portion further comprises a conically-shaped outer surface when the tip portion is in the unfolded configuration (the tip portion when unfolded forms a cone by extending radially outwardly extending toward a proximal end, see Fig. 24), and a conically-shaped inner surface when the tip portion is in the unfolded configuration (the tip portion forms a cone in the direction toward the proximal end, see Fig. 24).
Regarding claim 30, Zhou discloses the delivery sheath system of claim 17, wherein an inner diameter of a central lumen extending through the tip portion corresponds to an inner diameter of a central lumen of the ring portion (see Fig. 24).
Regarding claim 31, Zhou discloses the delivery sheath system of claim 17, wherein the tip portion and the ring portion form a continuous central lumen extending between a proximal end of the ring portion and a distal end of the tip portion (see Fig. 24).
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 29 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US2019/0030299) in view of Korkuch (US2018/0256859).
Regarding claim 29, Zhou discloses the delivery sheath system of claim 17; yet, does not explicitly disclose wherein an elastic modulus of the ring portion is greater than an elastic modulus of the sheath member. Zhou according to other embodiments teaches the sheath 8 being made of a material that urges the inner tubular layer back to the initial diameter once the implant has passed and the sheath having thick wall and thin wall portions ([0069]); yet does not disclose the elastic modulus being greater at the ring portion than the sheath member. Korkuch teaches a sheath having different elastic modulus at different portions of the sheath (see Abstract) It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the ring portion to have a greater elastic modulus than the sheath member in order to have the tip portion folded back into its original shape for a reduced diameter configuration for removing the sheath after passage or retrieval of an implant ([0069] of Zhou).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US2019/0030299).
Regarding claim 32, Zhou discloses the delivery sheath system of claim 17, further comprising a self- expandable prosthetic heart valve ([0058]), wherein central lumens of both the sheath member and the ring portion are sized and configured to receive the prosthetic heart valve in a compressed configuration ([0058]), and a length of the ring portion at least corresponds to a length of the prosthetic heart valve in a compressed configuration (the length of the ring portion corresponds to a length of the prosthetic heart valve by the prosthetic heart valve passing through the ring portion and extending along the ring portion at some point in delivery), wherein the tip portion moves from the folded to the unfolded configuration in response to the outward directed radial force of the prosthetic heart valve as it passes through the tip portion (the tip portion is at least capable of moving from the folded to the unfolded configuration when the prosthetic heart valve is passed through it, since the sheath 8 can be used for retrieval and delivery of the prosthetic heart valve, [0058], [0086]), wherein movement from the folded configuration to the unfolded configuration causes the tip portion to transition from an elongated cylindrical shape to a conical shape defining an increasing tapered inner surface (the unfolded configuration as shown in Fig. 24 has a substantially conical shape), where the diameter of the distal end of the tip portion is greater than a diameter of a proximal end of the tip portion (see Fig. 24), wherein the prosthetic heart valve at least partially expands from a compressed configuration towards an expanded configuration as it passes through the tip portion (the prosthetic heart valve is capable of partially expanding as it passes through the sheath 8 by the unfolding of the tip portion or the material of the sheath 8, [0086]).
Zhou does not explicitly recite wherein the tip portion is biased towards the folded configuration such that the tip portion moves towards the folded configuration after the prosthetic heart valve passes through the tip portion. Zhou according to other embodiments teaches the sheath 8 being made of a material that urges the inner tubular layer back to the initial diameter once the implant has passed ([0069]). 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 material of the sheath to be made of a material that urges back into the originally folded shape for a reduced diameter configuration for removing the sheath after passage or retrieval of an implant ([0069]).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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