CTFR 17/393,341 CTFR 87236 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 Arguments 07-37 AIA Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive in view of the new grounds of rejection set forth below addressing the amendments to the claims . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1-13, 15 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al (US 20160361088) further in view of Shriver (US 20140180323) in view of Laduca et al (US 20070276324), and further in view of Vakharia et al (US 20070255299) . Regarding claim 1, Maguire et al (hereafter Maguire) discloses a system for treating a stricture, the system comprising: a handle (172) having a base (176), a first carriage translatable (172) relative to the base, and a second carriage translatable (174) relative to the base; a sheath (180) coupled to the first carriage; a catheter shaft (200) having a proximal end region and a steerable distal end region (130), the proximal end region being coupled to the second carriage (all parts of the device are coupled together to form the system); a needle (120) releasably coupled to the handle, the needle being configured to pass through tissue into a position along the biliary and/or pancreatic tract (figures 14, 15); and a steering member (135 or guidewire 155) having a first end (distal end) attached (member 135, and 155 are attached to the steerable distal end region 130, see figures 5A, 5B, since it is within the lumen thereof and therefore joined with the steerable distal end region) directly to the steerable distal end region of the catheter shaft and a second end (proximal end) disposed adjacent to the handle (all components of the device are coupled together to form the entire system, since the steering member is within the steerable distal end, it is attached directly inside of it). Maguire further teaches it was known in the art at the time of the invention that active or non-passive transition for manipulating the distal section 130 manually by using a pull-wire or other force-transmitting component was a known steering mechanism in the art and a known art-recognized equivalent (paragraph 0056), but does not specifically teach the details of the pull wire comprising a steering member fixedly attached to the steerable distal end region of the catheter shaft. Shriver teaches it was known in the art at the time of the invention to use a ribbon shaped pull wire (13) as a steering member having a first end fixedly attached directly to the steerable distal end region of a catheter shaft and a second end disposed adjacent a handle (16, figure 1C, paragraph 0069), as a non-passive transition for manipulating an articulatable distal section of a catheter shaft at the time of the invention as an art-recognized equivalent active manipulation of a steerable distal section (paragraph 0070). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the passive steering mechanism of Maguire with a non-passive transition comprising a steering member having a first end fixedly attached directly to the steerable distal end region of the catheter shaft and a second end disposed adjacent to the handle, as taught as known by Shriver, since it has been held that mere substitution of art-recognized equivalents involves routine skill in the art. Maguire in view of Shriver does not teach a steering member locking member coupled to the handle for securing the axial position of the steering member relative to the base, relative to the second carriage, or both, and wherein actuation of the steering member locking member actuates the steering member to bend the catheter shaft. Laduca et al (hereafter Laduca) teaches an articulating catheter using steering wires, wherein it was known in the art at the time of the invention to further have a steering member locking member (61, 63, paragraph 0020, 0035) coupled to the handle for securing the axial position of the steering member relative to the base, relative to the second carriage, or both, and wherein actuation of the steering member locking member actuates the steering member to bend the catheter shaft (paragraph 0020) through axial displacement of the steering member locking member (figure 3, paragraph 0035; rotation of member 40 causes axial displacement of pins 61 and 63 along both the longitudinal axis and the lateral axis of the device; paragraph 0042, pin moves proximally) such that when the practitioner does not desire to make the catheter tip articulate one way or the other, the wires can remain in place and the selected optimal tip deflection is maintained during a procedure. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the handle and steering mechanism of Maguire in view of Shriver further comprise a steering member locking member coupled to the handle for securing the axial position of the steering member relative to the base, relative to the second carriage, or both, and wherein actuation of the steering member locking member actuates the steering member to bend the catheter shaft, as taught as known in the art by Laduca, in order to allow the wires to remain in place and the selected optimal tip deflection is maintained during a procedure. Maguire in view of Shriver in view of Laduca do not specifically teach that the steering member locking member includes a collar slidably translatable axially over a region of the handle. Vakharia et al (hereafter Vakharia) further teaches it was known in the art at the time of the invention to utilize a collar (18, 20) slidably translatable axially over a region of a handle coupled to a wire member for securing the axial position of the wire member relative to a base, and wherein axial sliding translation of the collar over the region of the handle causes axial displacement of the wire members in order to selectively apply tension to the wires as an art- recognized equivalent mechanism for imparting tension to steering members to bend a catheter, further comprising a locking mechanism to hold the wires in position once tension is applied (paragraph 0032). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to substitute the steering member locking member mechanism of Laduca with a collar slidably translatable axially over a region of the handle, wherein axial sliding translation of the collar over the region of the handle causes axial displacement of the steering member wires to bend the catheter shaft, as an art-recognized equivalent to the wire tensioning and locking mechanism of Laduca, since it has been held that mere substitution involves routine skill in the art. Regarding claim 2, Maguire in view of Shriver in view of Laduca in view of Vakharia, teaches all of the limitations set forth in claim 1, wherein Maguire discloses the handle includes a first locking member (184) for securing the axial position of the first carriage relative to the base (paragraph 0067). Regarding claim 3, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 1, wherein Maguire discloses the handle includes a second locking member (186) for securing the axial position of the second carriage relative to the base, relative to the first carriage, or both (paragraph 0067). Regarding claim 5, Maguire in view of Shriver in view of Laduca teaches all of the limitations set forth in claim 1, wherein Maguire discloses the base includes a proximal connector (170a) and wherein the needle is secured to the proximal connector (paragraph 0127). Regarding claims 6 and 8, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 1, wherein Shriver teaches the steering member includes a ribbon wire (12, paragraph 0070). Regarding claim 7, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 1, wherein Maguire discloses the catheter shaft (200) has a lumen formed therein and wherein the steering member extends through the lumen (figures 2A, 2B). Regarding claim 8, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 1, wherein Shriver teaches at least a portion of the steering member extends along an outer surface of the catheter shaft (11, figure 2A). Regarding claim 9, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 8, further comprising a sleeve (endoscope) disposed along the portion of the steering member extending along the outer surface of the catheter shaft (paragraph 0053-0055, all of the members can be extended through endoscope). Regarding claim 10, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 1, further comprising an endoscope having a channel formed therein, wherein the catheter shaft is configured to extend within the channel (paragraph 0055). Regarding claims 11 and 15, Maguire teaches a system for treating a stricture, the system comprising: a handle (170) having a base (176), a first telescoping portion(172) coupled to the base, and a second telescoping portion (174) coupled to the base; a sheath (180) coupled to the first telescoping portion; a catheter shaft (200) for non-papillary access to the biliary and/or pancreatic tract (figures 14, 15), the catheter shaft having a guidewire lumen (figures 2A, 2B), a proximal end region (125) and a steerable distal end region (130); wherein the proximal end region is coupled to the second telescoping portion (all parts of the device are coupled together to form the system); a needle (120) having a piercing distal end region (145) and a proximal end region coupled to a connector disposed along the handle (figure 13), the piercing distal end region needle being configured to pass through tissue into a position along the biliary and/or pancreatic tract (figure 4A-5B); a steering wire (135 or alternatively guidewire 155) having a distal end attached (member 135, and 155 are attached to the steerable distal end region 130, see figures 5A, 5B, since it is within the lumen thereof and therefore joined with the steerable distal end region) directly to the steerable distal end region (all components of the device are coupled together to form the entire system, since the steering member is within the steerable distal end, it is attached directly inside of it), and a sleeve (endoscope, paragraph 0053-0055) disposed along the external portion of the steering wire. Maguire does not specifically teach the details of the pull wire comprising a steering member fixedly attached to the steerable distal end region of the catheter shaft. Maguire further teaches it was known in the art at the time of the invention that active or non-passive transition for manipulating the distal section 130 manually by using a pull-wire or other force-transmitting component was a known steering mechanism in the art and a known art-recognized equivalent (paragraph 0056). Shriver teaches it was known in the art at the time of the invention to use a ribbon shaped pull wire (13) as a steering member having a first end fixedly attached directly to the steerable distal end region of a catheter shaft and a second end disposed adjacent a handle (16, figure 1C, paragraph 0069), as a non-passive transition for manipulating an articulatable distal section of a catheter shaft at the time of the invention as an art-recognized equivalent active manipulation of a steerable distal section (paragraph 0070). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the passive steering mechanism of Maguire with a non-passive transition comprising a steering member having a first end fixedly attached directly to the steerable distal end region of the catheter shaft and a second end disposed adjacent to the handle, as taught as known by Shriver, since it has been held that mere substitution of art-recognized equivalents involves routine skill in the art. Maguire in view of Shriver does not teach a steering lock member on the handle for securing the axial position of the steering member relative to the base, relative to the second telescoping portion, or both, and wherein actuation of the steering member locking member actuates the steering member. Laduca et al (hereafter Laduca) teaches an articulating catheter using steering wires, wherein it was known in the art at the time of the invention to further have a steering lock member (61, 63, pins knob, paragraph 0020) on the handle for securing the axial position of the steering member relative to the base, relative to the second telescoping portion, or both, and wherein actuation of the steering member locking member actuates the steering member (paragraph 0020) through axial displacement of the steering member locking member (figure 3, paragraph 0035; rotation of member 40 causes axial displacement of pins 61 and 63 along both the longitudinal axis and the lateral axis of the device; paragraph 0042, pin moves proximally) such that when the practitioner does not desire to make the catheter tip articulate one way or the other, the wires can remain in place and the selected optimal tip deflection is maintained during a procedure. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the handle and steering mechanism of Maguire in view of Shriver further comprise a steering lock member (knob, cog, spring, paragraph 0020) on the handle for securing the axial position of the steering wire relative to the base, relative to the second telescoping portion, or both, and wherein actuation of the steering member locking member actuates the steering member, as taught as known in the art by Laduca, in order to allow the wires to remain in place and the selected optimal tip deflection is maintained during a procedure. Maguire in view of Shriver in view of Laduca do not specifically teach that the steering member locking member includes a collar slidably translatable axially over a region of the handle. Vakharia et al (hereafter Vakharia) further teaches it was known in the art at the time of the invention to utilize a collar (18, 20) slidably translatable axially over a region of a handle coupled to a wire member for securing the axial position of the wire member relative to a base, and wherein axial sliding translation of the collar over the region of the handle causes axial displacement of the wire members in order to selectively apply tension to the wires as an art-recognized equivalent mechanism for imparting tension to steering members to bend a catheter, further comprising a locking mechanism to hold the wires in position once tension is applied (paragraph 0032). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to substitute the steering member locking member mechanism of Laduca with a collar slidably translatable axially over a region of the handle, wherein axial sliding translation of the collar over the region of the handle causes axial displacement of the steering wires to bend the catheter shaft, as an art-recognized equivalent to the wire tensioning and locking mechanism of Laduca, since it has been held that mere substitution involves routine skill in the art. Regarding claim 12, Maguire in view of Shriver in view of Laduca in view of Vakharia all of the limitations set forth in claim 11, wherein Maguire further teaches the handle includes a first locking member (184) for securing the axial position of the first telescoping portion relative to the base (paragraph 0067). Regarding claim 13, Maguire in view of Shriver in view of Laduca in view of Vakharia all of the limitations set forth in claim 11, wherein Maguire further teaches the handle includes a second locking member (186) for securing the axial position of the second telescoping relative to the base, relative to the first telescoping portion, or both (paragraph 0067). Regarding claims 21 and 24, Maguire teaches a system for treating a stricture, the system comprising: a handle (170) having a base (176), a first telescoping portion(172) coupled to the base, and a second telescoping portion (174) coupled to the base; a sheath (180) coupled to the first telescoping portion; a catheter shaft (200) for non-papillary access to the biliary and/or pancreatic tract (figures 14, 15), the catheter shaft having a guidewire lumen (figures 2A, 2B), a proximal end region (125) and a steerable distal end region (130); wherein the proximal end region is coupled to the second telescoping portion (all parts of the device are coupled together to form the system); a needle (120) having a piercing distal end region (145) and a proximal end region coupled to a connector disposed along the handle (figure 13), the piercing distal end region needle being configured to pass through tissue into a position along the biliary and/or pancreatic tract (figure 4A-5B); a steering wire (135 or alternatively guidewire 155) having a distal end attached (member 135, and 155 are attached to the steerable distal end region 130, see figures 5A, 5B, since it is within the lumen thereof and therefore joined with the steerable distal end region) directly to the steerable distal end region (all components of the device are coupled together to form the entire system, since the steering member is within the steerable distal end, it is attached directly inside of it), and a sleeve (endoscope, paragraph 0053-0055) disposed along the external portion of the steering wire. Maguire further teaches the handle includes a first locking member (184) for securing the axial position of the first carriage relative to the base (paragraph 0067). Maguire further teaches the handle includes a second locking member (186) for securing the axial position of the second carriage relative to the base, relative to the first carriage, or both (paragraph 0067). Maguire does not specifically teach the details of the pull wire comprising a steering member fixedly attached to the steerable distal end region of the catheter shaft or that the catheter shaft is configured to bend in response to actuation of the third locking member. Maguire further teaches it was known in the art at the time of the invention that active or non-passive transition for manipulating the distal section 130 manually by using a pull-wire or other force-transmitting component was a known steering mechanism in the art and a known art-recognized equivalent (paragraph 0056). Shriver teaches it was known in the art at the time of the invention to use a ribbon shaped pull wire (13) as a steering member having a first end fixedly attached directly to the steerable distal end region of a catheter shaft and a second end disposed adjacent a handle (16, figure 1C, paragraph 0069), as a non-passive transition for manipulating an articulatable distal section of a catheter shaft at the time of the invention as an art-recognized equivalent active manipulation of a steerable distal section (paragraph 0070). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the passive steering mechanism of Maguire with a non- passive transition comprising a steering member having a first end fixedly attached directly to the steerable distal end region of the catheter shaft and a second end disposed adjacent to the handle, as taught as known by Shriver, since it has been held that mere substitution of art-recognized equivalents involves routine skill in the art. Laduca et al (hereafter Laduca) teaches an articulating catheter using steering wires, wherein it was known in the art at the time of the invention to further have a steering lock member (61, 63, knob, cog, spring, paragraph 0020) on the handle for securing the axial position of the steering member relative to the base (34) , relative to the second telescoping portion (50), or both, and wherein actuation of the locking member actuates the steering member to bend the catheter shaft through axial displacement of the steering member locking member (figure 3, paragraph 0035; rotation of member 40 causes axial displacement of pins 61 and 63 along both the longitudinal axis and the lateral axis of the device; paragraph 0042, pin moves proximally), such that when the practitioner does not desire to make the catheter tip articulate one way or the other, the wires can remain in place and the selected optimal tip deflection is maintained during a procedure. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the handle and steering mechanism of Maguire in view of Shriver further comprise a third locking member (knob, cog, spring, paragraph 0020) on the handle for securing the axial position of the steering member relative to the base, relative to the second telescoping portion, or both, and wherein the catheter shaft is configured to bend in response to actuation of the third locking member, as taught as known in the art by Laduca, in order to allow the wires to remain in place and the selected optimal tip deflection is maintained during a procedure. Maguire in view of Shriver in view of Laduca do not specifically teach that the steering member locking member includes a collar slidably translatable axially over a region of the handle. Vakharia et al (hereafter Vakharia) further teaches it was known in the art at the time of the invention to utilize a collar (18, 20) slidably translatable axially over a region of a handle coupled to a wire member for securing the axial position of the wire member relative to a base, and wherein axial sliding translation of the collar over the region of the handle causes axial displacement of the wire members in order to selectively apply tension to the wires as an art-recognized equivalent mechanism for imparting tension to steering members to bend a catheter, further comprising a locking mechanism to hold the wires in position once tension is applied (paragraph 0032). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to substitute the steering member locking member mechanism of Laduca with a collar slidably translatable axially over a region of the handle, wherein axial sliding translation of the collar over the region of the handle causes axial displacement of the steering member wires to bend the catheter shaft, as an art-recognized equivalent to the wire tensioning and locking mechanism of Laduca, since it has been held that mere substitution involves routine skill in the art. Regarding claim 22, Maguire in view of Shriver view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 21, wherein Maguire discloses the base includes a proximal connector (170a) and wherein the needle is secured to the proximal connector (paragraph 0127). Regarding claim 23, Maguire in view of Shriver view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 21, wherein Maguire discloses an endoscope having a channel formed therein, wherein the catheter shaft is configured to extend within the channel (paragraph 0055). Regarding claim 25, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 21, wherein Laduca teaches the second end of the steering member is located exterior of the handle (figure 2C). Regarding claim 26, Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 1, wherein Laduca teaches the second end of the steering member is positioned proximal of the steering wire locking member along an exterior of the handle (figure 2C). Regarding claim 27, , Maguire in view of Shriver in view of Laduca in view of Vakharia teaches all of the limitations set forth in claim 11, wherein Laduca teaches the second end of the steering member is located exterior of the handle (figure 2C). Conclusion 07-40 AIA 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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST). 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, Darwin Erezo can be reached at (571) 272-4695. 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. /ANH T DANG/Primary Examiner, Art Unit 3771 Application/Control Number: 17/393,341 Page 2 Art Unit: 3771 Application/Control Number: 17/393,341 Page 3 Art Unit: 3771 Application/Control Number: 17/393,341 Page 4 Art Unit: 3771 Application/Control Number: 17/393,341 Page 5 Art Unit: 3771 Application/Control Number: 17/393,341 Page 6 Art Unit: 3771 Application/Control Number: 17/393,341 Page 7 Art Unit: 3771 Application/Control Number: 17/393,341 Page 8 Art Unit: 3771 Application/Control Number: 17/393,341 Page 9 Art Unit: 3771 Application/Control Number: 17/393,341 Page 10 Art Unit: 3771 Application/Control Number: 17/393,341 Page 11 Art Unit: 3771 Application/Control Number: 17/393,341 Page 12 Art Unit: 3771 Application/Control Number: 17/393,341 Page 13 Art Unit: 3771
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