CTNF 17/935,247 CTNF 85041 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. Allowable Subject Matter The indicated allowability of claims 8-10 is withdrawn in view of the newly discovered references to Zhang and Kleinhaus (cited below). Rejections based on the newly cited references follow. Because of this, this office action is made non-final. Terminal Disclaimer 14-23 AIA The terminal disclaimer filed on 3/12/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11,452,849 and US Patent Application No. 18/903,408 has been reviewed and is accepted. The terminal disclaimer has been recorded. 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 20 is rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kleinhaus (PG PUB 2020/0086095) . Re claim 20, Kleinhaus discloses a catheter system (Fig 6; it is noted that all reference characters cited below refer to Fig 6 unless otherwise noted) comprising: a catheter 200 including a cylindrical catheter body (the structure of 200 itself); and a guide device 100 comprising a leading structure (the structure 100 itself) including a cone (the portion of 100 having ribs 102, as seen in Fig 6 and labeled in Fig A below) and a sleeve (the portion of 100 that does not have ribs 102, as seen in Fig 6 and labeled below; also labeled in Fig 2 as 104) extending forward from the cone (as seen in Fig 6), wherein the cone comprises slots (the empty space between adjacent ribs 102, as best seen in Fig 5) for fluid passage (due to the tapered shape of the cone, fluid distal to the cone can pass between the distal ends of the slots to the proximal ends of the slots), wherein, in use, the guide device and the catheter body are coaxially arranged (as seen in Fig 6 and described in Para 55, the distal end of the sheath 200 is received over the proximal end of the guide device 100), the cone is forward of the catheter, and the sleeve extends forward from the cone (as seen in Fig 6) . PNG media_image1.png 395 582 media_image1.png Greyscale 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, 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 s 1-3, 6, 7, 9, 11-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US Pat 6,120,480) in view of Kleinhaus (PG PUB 2020/0086095) . Re claim 1, Zhang discloses a catheter system (Fig 1; it is noted that all reference characters cited below refer to Fig 1-3 unless otherwise noted) comprising: a catheter body 14 that defines a longitudinally extending interior lumen (within which the guide device 12 resides in Fig 1); and a guide device 12 comprising: a conduit member 32 for insertion into the interior lumen of the catheter body (as seen in Fig 1); a leading structure 20 including a cone 48; and an inner guide hole 34 (Fig 8) extending longitudinally through the leading structure and the conduit member (as seen in Fig 8), wherein, in use, the guide device and the catheter body are coaxially arranged, and the cone is forward of the catheter body. Zhang does not disclose that the conduit member comprises grooves, that the leading structure includes a sleeve extending forward from the cone, and the cone comprises slots that are connected to the grooves for fluid passage. Kleinhaus, however, discloses a guide device (Fig 6; it is noted that all reference characters cited below refer to Fig 6 unless otherwise noted) comprising: a conduit member 200 comprising grooves 206 (Para 55) and a leading structure 100 including a cone (the portion of 100 having ribs 102, as seen in Fig 6 and labeled in Fig A above), comprising slots (the empty space between adjacent ribs 102, as best seen in Fig 5), and a sleeve (the portion of 100 that does not have ribs 102, as seen in Fig 6 and labeled below; also labeled in Fig 2 as 104) extending forward from the cone (as seen in Fig 6), wherein the slots are connected to the grooves for fluid passage (due to the tapered shape of the cone and the connection between the peaks 202 and the ribs 102 (Para 55), fluid distal to the cone can pass between the distal ends of the slots and the proximal ends of the passages). Kleinhaus teaches that providing grooves and slots proximal to a smooth surfaced sleeve reduces the outer surface area of the conduit member and the leading structure which results in reducing the friction force as the guide device is moved through tissue (Para 47,50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhang to include the conduit member with grooves, a sleeve extending forward from the cone, and the cone with slots connected to the grooves for fluid passage, as taught by Kleinhaus, for the purpose of reducing the friction force as the guide device is moved through tissue (Para 47,50). Re claim 2, Zhang discloses that the cone comprises a shoulder 50 (best seen in Fig 8) and a tapered exterior that increases diametrically from the sleeve to the shoulder (as seen in Fig 8). Re claim 3, Zhang discloses that a back of the shoulder abuts a distal end of the catheter body to register insertion of the guide device in the catheter body (as seen in Fig 8). Re claim 6, Zhang as modified by Kleinhaus in the rejection of claim 1 disclose all the claimed features with Kleinhaus teaching that the grooves extend longitudinally along the exterior of the conduit member (as seen in Fig 6). The motivation cited in the rejection of claim 1 also applies to this claim. Re claim 7, Zhang as modified by Kleinhaus in the rejection of claim 1 disclose all the claimed features with Kleinhaus teaching that the grooves are evenly distributed around the exterior of the conduit member (as seen in Fig 6). The motivation cited in the rejection of claim 1 also applies to this claim. Re claim 9, Zhang as modified by Kleinhaus in the rejection of claim 1 discloses all the claimed features with Kleinhaus teaching that the leading structure comprises openings (at the distal-most end of the valleys 206) by which the slots are connected to the grooves (as seen in Fig 6, Para 55). The motivation cited in the rejection of claim 1 also applies to this claim. Re claim 11, Zhang discloses a catheter system (Fig 1; it is noted that all reference characters cited below refer to Fig 1-3 unless otherwise noted) comprising: a catheter (Fig 3) including a cylindrical catheter body 14 that defines a longitudinally extending interior lumen (within which the guide device 12 resides in Fig 1); and a guide device 12 comprising: a conduit member 32 for insertion into the interior lumen of the catheter body (as seen in Fig 1); a leading structure 20 connected to a forward end of the conduit member (as seen in Fig 2), the leading structure including a cone 48; and an inner guide hole 34 (Fig 8) extending longitudinally through the leading structure and the conduit member (as seen in Fig 8). Zhang does not disclose that the leading structure includes a sleeve extending forward from the cone and the cone comprises slots for fluid passage. Kleinhaus, however, discloses a guide device (Fig 6; it is noted that all reference characters cited below refer to Fig 6 unless otherwise noted) comprising: a conduit member 200 and a leading structure 100 including a cone (the portion of 100 having ribs 102, as seen in Fig 6 and labeled in Fig A above), comprising slots (the empty space between adjacent ribs 102, as best seen in Fig 5) for fluid passage (due to the tapered shape of the cone, fluid distal to the cone can pass between the distal ends of the slots and the proximal ends of the slots), and a sleeve (the portion of 100 that does not have ribs 102, as seen in Fig 6 and labeled below; also labeled in Fig 2 as 104) extending forward from the cone (as seen in Fig 6). Kleinhaus teaches that providing slots proximal to a smooth surfaced sleeve reduces the outer surface area of the leading structure which results in reducing the friction force as the guide device is moved through tissue (Para 47,50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhang to include a sleeve extending forward from the cone and the cone with slots for fluid passage, as taught by Kleinhaus, for the purpose of reducing the friction force as the guide device is moved through tissue (Para 47,50). Re claim 12, Zhang discloses that the inner guide hole has a uniform inner diameter along the sleeve, the cone, and the conduit member (as seen in Fig 8). Re claim 13, Zhang discloses that the catheter body comprises a rearward end (to the left in Fig 3) and an opposite distal end (to the right in Fig 3), the rearward end of the catheter body has a tapered entrance (as seen in Fig 6), and the interior lumen extends from the tapered entrance to the distal end (as seen in Fig 1 since the guide device resides therein). Re claim 19, Zhang discloses that the guide device is removed from the catheter by rearward withdrawal of the guide device (Col 7, Lines 42-44) . 07-21-aia AIA Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US Pat 6,120,480)/Kleinhaus (PG PUB 2020/0086095) in view of Lorenzo et al. (PG PUB 2018/0200478) . Re claim 4, Zhang disclose that an uncompressed outer diameter of the shoulder of the cone is greater than an inner diameter of the interior lumen of the catheter body (as seen in Fig 8), wherein the shoulder is passed through the distal end and into and along the interior lumen (Col 7, Lines 42-44 and 55-67), but does not disclose that the cone is deformable to permit deformation for the shoulder to pass. Lorenzo, however, teaches a guide device 10 (Fig 1) comprising a conduit member (the entire portion of device 10 extending proximally from tip 16, labeled in Fig B below) for insertion into the interior lumen of a catheter body 20 (as seen in Fig 1; Para 42) and a leading structure 16 connected to a forward end of the conduit member (as seen in Fig 1), the leading structure including a cone (labeled in Fig B below) and a sleeve (labeled in Fig B below) extending forward from the cone (as seen in Fig 2), wherein the cone comprises a shoulder (at the proximal-most end thereof, directly connected to the distal-most end of the conduit member in Fig B below) that abuts a distal end of the catheter body (as seen in Fig 7, Para 51) wherein an uncompressed diameter of the shoulder is greater than an inner diameter the lumen of the catheter body (as seen in Fig 7, Para 51) and the cone is deformable (Para 47, “becomes softer with warmer temperatures”) to permit deformation to pass the shoulder through the distal end of the catheter body and into and along the lumen of the catheter body (as seen in Fig 2; Para 55) for the purpose of operatively positioning the leading structure during use (Para 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhang/Kleinhaus to include the cone so that it is deformable to permit deformation for the shoulder to pass, as taught by Lorenzo, for the purpose of operatively positioning the leading structure during use (Para 47) . PNG media_image2.png 320 544 media_image2.png Greyscale 07-21-aia AIA Claim s 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US Pat 6,120,480)/Kleinhaus (PG PUB 2020/0086095) in view of Pal (PG PUB 2006/0263145) . Re claims 14-16, Zhang/Kleinhaus discloses all the claimed features except that the catheter body has a longitudinally extending layered wall comprising a stiffening member, an inner liner, and an outer cover (as required by claim 14), wherein the stiffening member comprises a helical spring extending from the tapered entrance toward the distal end (as required by claim 15) and wherein the inner liner extends within the stiffening member and defines an interior surface of the interior lumen, and the outer cover surrounds the stiffening member and defines an exterior surface of the catheter body (as required by claim 16). Pal, however, teaches a catheter body 80 (Fig 3,4) having a longitudinally extending layered wall (formed by layers 42+43+44, as seen in Fig 3; Para 86) comprising a stiffening member 43 (Fig 3), an inner liner 44 (Fig 3), and an outer cover 42 (Fig 3), wherein the stiffening member comprises a helical spring (“spiral coil”, Para 86) extending from an entrance of the catheter body toward a distal end of the catheter body (Para 86), wherein the inner liner extends within the stiffening member and defines an interior surface of an interior lumen 81 (Fig 3) of the catheter body (as seen in Fig 3), and wherein the outer cover surrounds the stiffening member and defines an exterior surface of the catheter body (as seen in Fig 3); Pal teaches that providing such a layered wall provides inner and outer slidable surfaces for easier insertion and removal and the catheter (Para 86) and provides structural reinforcement to the wall (Para 87). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhang/Kleinhaus to include the catheter body with a layered wall comprising a stiffening member, an inner liner and an outer cover, as taught by Pal, for the purpose of providing inner and outer slidable surfaces for easier insertion and removal and the catheter (Para 86) and providing structural reinforcement to the wall (Para 87) . 07-21-aia AIA Claim s 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US Pat 6,120,480)/Kleinhaus (PG PUB 2020/0086095) in view of Tanaka et al. (PG PUB 2011/0270229) . Re claims 17 and 18, Zhang/Kleinhaus discloses all the claimed features except that the catheter comprises a radiopaque area proximate to and at the distal end (as required by claim 17), wherein the radiopaque area comprises a cylindrical band, between an outer cover and inner liner, and rearward of the distal end (as required by claim 18). Tanaka, however, teaches a catheter 10 (Fig 1,3) comprising a radiopaque area 66 (Fig 1) proximate to and at a distal end of the catheter (wherein the distal end extends from the half-way point of the band 66 leftward in Fig 1 to the distal-most end of the catheter; Para 53), wherein the radiopaque area comprises a cylindrical band (“ring-form”, Para 53) between an outer cover 64 (Fig 1) and an inner liner 21 (Fig 1) and rearward of the distal end (as set forth above, the distal half of the band 66 resides in the “distal end” and the proximal half of the band 66 resides rearward of the “distal end”) for the purpose of confirming position of the distal end portion of the catheter (Para 139). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhang/Kleinhaus to include a radiopaque area, as taught by Tanaka, for the purpose of confirming position of the distal end portion of the catheter (Para 139) . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 10 is 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. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: Dependent claim 10 requires the openings [by which the slots are connected to the grooves], in use, to slow a volume flow rate of a fluid in order to safely fill a vessel. The openings of Kleinhaus are not structured to “slow a volume of flow rate of a fluid in order to safely fill a vessel” as claimed nor would it have been obvious to modify Kleinhaus to include an opening between the slots and the grooves that would “slow a volume of flow rate of a fluid in order to safely fill a vessel” . Response to Arguments Applicant's arguments filed 3/12/2026 have been fully considered but are moot in view of the present rejections. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm. 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, Kevin Sirmons can be reached at (571)272-4965. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KAMI A BOSWORTH/Primary Examiner, Art Unit 3783 Application/Control Number: 17/935,247 Page 2 Art Unit: 3783 Application/Control Number: 17/935,247 Page 3 Art Unit: 3783 Application/Control Number: 17/935,247 Page 4 Art Unit: 3783 Application/Control Number: 17/935,247 Page 5 Art Unit: 3783 Application/Control Number: 17/935,247 Page 6 Art Unit: 3783 Application/Control Number: 17/935,247 Page 7 Art Unit: 3783 Application/Control Number: 17/935,247 Page 8 Art Unit: 3783 Application/Control Number: 17/935,247 Page 9 Art Unit: 3783 Application/Control Number: 17/935,247 Page 10 Art Unit: 3783 Application/Control Number: 17/935,247 Page 11 Art Unit: 3783 Application/Control Number: 17/935,247 Page 12 Art Unit: 3783 Application/Control Number: 17/935,247 Page 13 Art Unit: 3783