CTFR 17/895,945 CTFR 91181 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 12/19/25. The claims 1-20 are pending. The claims 1, 2, 5, 7, and 8 are amended. Response to Arguments 07-37 AIA Applicant’s arguments, filed 12/19/25 with respect to the rejections of claims 1-18 under 35 U.S.C. 102(a)(1) as being anticipated by Zhou (US2018/0256858) have been fully considered but they are not persuasive. Applicant argues, none of the references describe the thick wall portion as layered, with each layer having a C-shaped cross section as recited in amended claim 1. Examiner disagrees, this amendment does not overcome the prior art. The claims were amended to recite “the thick wall portion having a radially outermost segment and a radially intermediate segment underlying the radially outermost segment, both the radially outermost segment and the radially intermediate segment are C-shaped in cross section”. Examiner interprets the radially outermost segment as a segment of the thick wall portion that is radially outward and the radially intermediate segment as a segment of the thick wall portion underlying the radially outermost segment that is radially inward as shown in annotated Fig. 6C-2 from the rejection of claim 1. These segments being curved and therefore interpreted as C-shaped . Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1-18 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Zhou (US2018/0256858) Regarding claim 1, Zhou discloses an expandable sheath comprising: an elastic outer tubular layer (40; [0054]); and a multisegmented inner tubular layer (42) comprising at least two coextruded segments (62, 64, 60, see Fig. 6C), the at least two coextruded segments having different durometers and different coefficients of friction (rods 60 within the thin wall portion 64 reduce friction, [0062]; and therefore the thick wall portion 62 would have a different coefficients of friction from the thin wall portion 64; the rods 60 within the thin wall portion can have a lower rigidity than the surrounding thin wall portion 64, [0063]; and therefore the thin wall portion can have a lower durometer than the thick wall portion), the inner tubular layer further comprising a thick wall portion (62) integrally connected to a thin wall portion (64), the thick wall portion having a first and second longitudinally extending end (see annotated Fig. 6C), the thin wall portion extending between the first and second longitudinally extending ends (see Fig. 6C), the thick wall portion having a radially outermost segment (outer segment of outlined portion as shown in annotated Fig. 6C-2; alternatively can include some portion of the rod 60) and a radially intermediate segment (inner segment of outlined portion as shown in annotated Fig. 6C-2) underlying the radially outermost segment, both the radially outermost segment and the radially intermediate segment are C-shaped in cross section (see annotated Fig. 6C-2, where the radially intermediate segment and radially outermost segment are both “C” shaped by being a curved portion). wherein the thin wall portion has a lower durometer than the thick wall portion (the rods 60 within the thin wall portion can have a lower rigidity than the surrounding thin wall portion 64, [0063]; and therefore the thin wall portion can have a lower durometer than the thick wall portion), wherein the elastic outer tubular layer and the inner tubular layer are radially movable between an expanded state and a non-expanded state (see Figs. 6A-6B, where the embodiment of Fig. 6C would act in the same manner), wherein in the non-expanded state the elastic outer tubular layer urges the first longitudinally extending end under the second longitudinally extending end of the inner tubular layer (see Fig. 6A, [0044], where the embodiment of Fig. 6C would act in the same manner), wherein in the expanded state the first and second longitudinally extending ends of the inner tubular layer expand apart with the thin wall portion extending circumferentially therebetween (see Fig. 6B, where the embodiment shown in Fig. 6C would act in the same manner), and wherein the outer elastic tubular layer urges the inner tubular layer towards the non-expanded state ([0075]). PNG media_image1.png 436 671 media_image1.png Greyscale PNG media_image2.png 332 538 media_image2.png Greyscale Regarding claim 2, Zhou discloses the expandable sheath of claim 1, wherein the at least two coextruded segments have different arc lengths extending in a circumferential direction around the inner tubular layer (see Fig. 6C). Regarding claim 3, Zhou discloses the expandable sheath of claim 1, wherein the durometer of the inner tubular layer (42) varies radially through the thick wall portion (the thick wall can contain rods 60 with different rigidity, [0062], see Fig. 6C; where different rigidity materials would have a different durometer). Regarding claim 4, Zhou discloses the expandable sheath of claim 1, wherein the coefficient of friction of the inner tubular layer varies radially through the thick wall portion (rod 60 can have a microstructure pattern on its surface to therefore vary the coefficient of friction through the thick wall portion 62, [0075]; where the rod 60 lower the friction between the surfaces of the wall segments, [0045]). Regarding claim 5, Zhou discloses the expandable sheath of claim 1, wherein a radially outermost segment of the thick wall portion is formed of the same material as a radially innermost segment of the thick wall portion (radially outermost segment and radially innermost segment are the top and bottom segments as shown in annotated Fig. 6C-2, [0052]). Regarding claim 6, Zhou discloses the expandable sheath of claim 5, wherein the material of the radially outermost segment and the radially innermost segment of the thick wall portion is HDPE ([0052]). Regarding claim 7, Zhou discloses the expandable sheath of claim 5, wherein the radially intermediate segment of the thick wall portion has a higher durometer than the radially outermost segment and the radially innermost segment (the radially outermost segment is defined by the segment as shown in annotated Fig. 6C-2 and can also include a portion of the rod 60; and radially innermost segment are defined by the rod, and the intermediate segment of the thick wall portion is a segment of the thick wall between the radially outermost segment and radially innermost segment, see Fig. 6C; the rod 60 can be formed with less rigidity than the thick wall portion 64, [0063]). Regarding claim 8, Zhou discloses the expandable sheath of claim 7, wherein the radially intermediate segment of the thick wall portion is C-shaped in cross section that extends between the first and second longitudinally extending ends of the thick wall portion (the portion with the intermediate segment is on the opposite side of the first and second longitudinally extending ends, see annotated Fig. 6C and 6C-2; therefore, the intermediate segment extends between the first and longitudinally extends ends when looking down the vertical axis) and having an arc length that is less than the full arc length of the thick wall portion (see annotated Fig. 6C-2; where the full arc length of the thick wall portion 62 would encompass the arc length of the radially intermediate segment, where the radially intermediate segment is “C” shaped by being a curved portion). Regarding claim 9, Zhou discloses the expandable sheath of claim 7, wherein the radially outermost segment and the radially innermost segment meet at longitudinally extending edges of the radially intermediate segment to fully envelop the radially intermediate segment (the longitudinally extending edges are interpreted as the edge between the radially intermediate segment and the rod 60, see Fig. 6C-2). Regarding claim 10, Zhou discloses the expandable sheath of claim 7, wherein the material of the thin wall portion is continuous with the material of the radially innermost segment and the radially outermost segment of the thick wall portion (the materials are coextruded as one part and therefore interpreted as being continuous, [0062]). Regarding claim 11, Zhou discloses the expandable sheath of claim 1, wherein the thin wall portion comprises a first coextruded material (material of the thin wall portion 64, [0062]) and the thick wall portion comprises the first coextruded material (material of the thick wall portion 62, [0062]) and a second coextruded material (material of the rod 60) positioned radially outward from the first coextruded material ([0061], see Fig. 6C). Regarding claim 12, Zhou discloses the expandable sheath of claim 11, wherein the first coextruded material forms a radially innermost segment of the inner tubular layer (where the radially innermost segment is interpreted as the radially innermost portion of the segment shown in annotated Fig. 6) and the second coextruded material forms a radially outermost segment of the inner tubular layer (rod 60 outer surface, see annotated Fig. 6C). Regarding claim 13, Zhou discloses the expandable sheath of claim 11, wherein the first coextruded material has a lower coefficient of friction than the second coextruded material (rod 60 can have a microstructure pattern on its surface to therefore have a lower coefficient of friction than the material of the thin wall portion 64, [0075]; where the rod 60 lower the friction between the surfaces of the wall segments, [0045]). Regarding claim 14, Zhou discloses the expandable sheath of claim 1, wherein a material of the thin wall portion has a lower durometer than a material of a radially innermost segment and a radially outermost segment of the thick wall portion (the radially innermost segment is interpreted as the top surface of rod 60 and radially outermost segment of the wall portion is interpreted as the bottom surface of rod 60; where the rod 60 can be formed with a higher rigidity than the thin wall portion 64, [0063]). Regarding claim 15, Zhou discloses the expandable sheath of claim 14, wherein the thin wall portion is formed of a different coextruded segment than the radially innermost segment and the radially outermost segment of the thick wall portion (the thin wall portion can be made of a different material than the rod 60 and therefore formed a different coextruded segment, [0063]). Regarding claim 16, Zhou discloses the expandable sheath of claim 1, further comprising a coextruded tie layer (layer that overlaps the rods 60, [0062]), wherein the coextruded tie layer serves to adhere a first coextruded segment (material of the thin wall portion 64, [0062]) to a second coextruded segment (material of the rod 60) (the layer of material adheres the first coextruded segment to the second coextruded segment/rod 60 by the rod 60 being embedded within it, [0062]). Regarding claim 17, Zhou discloses the expandable sheath of claim 1, wherein the thick wall portion makes up greater than 50% of the circumference of a wall of the inner tubular layer (see Fig. 6C). Regarding claim 18, Zhou discloses the expandable sheath of claim 1, wherein the outer tubular layer further comprises a tapered proximal end (taper tube 70), and the outer tubular layer widens nearing the proximal end of the sheath (taper tube 70 is flared at the proximal end, [0050]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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 of this title, 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. 07-21-aia AIA Claim 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US2018/0256858) Regarding claim 19, Zhou discloses the expandable sheath of claim 18; yet, does not explicitly disclose wherein the outer diameter of the outer tubular layer increases nearing the proximal end of the sheath while the inner diameter of the outer tubular layer changes by a value of less than 10% nearing the proximal end of the sheath. Zhou teaches flaring and bonding the inner and outer tubular layers 42, 40 at the proximal end of the sheath 10 ([0050]). Therefore, the inner lumen would be altered by the flaring ([0050]). It would have been an obvious matter of design choice to one having ordinary skill in the art to have the inner diameter of the outer tubular layer change by a value of less than 10% nearing the proximal end of the sheath, since Applicant has not disclosed that having the inner diameter of the outer tubular layer changing by less than 10% provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with other designs (such as a constant inner diameter or changing only slightly) as indicated in the specification paragraph [0129]. Regarding claim 20, Zhou discloses the expandable sheath of claim 18, wherein the outer diameter of the outer tubular layer increases nearing the proximal end of the sheath, the inner diameter of the outer tubular layer increases nearing the proximal end of the sheath ([0050]); yet, does not explicitly disclose the thickness of the outer tubular layer changes by a value of less than 10% nearing the proximal end of the sheath. Zhou teaches the outer tubular layer 40 wall thickness increases proximal the longitudinal rod 60 ([0069]). It would have been an obvious matter of design choice to one having ordinary skill in the art to have the thickness of the outer tubular layer change by a value of less than 10% nearing the proximal end of the sheath, since Applicant has not disclosed that having the thickness of the outer tubular layer changing by less than 10% provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with other designs (such as the wall thickness staying constant or changing only slightly) as indicated in the specification paragraph [00129]. Conclusion 07-39 AIA THIS ACTION IS MADE FINAL. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M.A.M/ /THOMAS C BARRETT/Examiner, Art Unit 3774 SPE, Art Unit 3799 Application/Control Number: 17/895,945 Page 2 Art Unit: 3774 Application/Control Number: 17/895,945 Page 3 Art Unit: 3774 Application/Control Number: 17/895,945 Page 4 Art Unit: 3774 Application/Control Number: 17/895,945 Page 5 Art Unit: 3774 Application/Control Number: 17/895,945 Page 6 Art Unit: 3774 Application/Control Number: 17/895,945 Page 7 Art Unit: 3774 Application/Control Number: 17/895,945 Page 8 Art Unit: 3774 Application/Control Number: 17/895,945 Page 9 Art Unit: 3774
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