CTNF 19/057,544 CTNF 98498 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. Claim Rejections - 35 USC § 102 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. 07-07-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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim(s) 1, 4-6, 8, 10-15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McWeeney (US 20050272975 A1) . Regarding claim 1, McWeeney teaches A medical device comprising: a handle (fig. 31, element 3132, [0141], handle 3132); and a shaft extending distally from the handle, wherein the shaft includes: a proximal portion (fig. 31, element 3130, [0141], catheter 3130) configured to remain external to a body lumen of a subject; and a distal portion configured to be inserted into the body lumen of the subject (fig. 31, element 3130, [0141], catheter 3130, catheter has a length that would be within the proximal portion of endoscope 3124 that would not enter the subject and the rest that would); wherein the proximal portion of the shaft has a greater stiffness than the distal portion of the shaft ([0147], proximal section 3182 is stiffer than the deflection section 3184). Regarding claim 4, McWeeney teaches The medical device of claim 1, wherein the proximal portion of the shaft includes one or more of a reflowed or extruded outer jacket, a metal or plastic braid, a metal or plastic coil, or a laser cut plastic or metal tubing (fig. 36b, element 3688, [0155], reinforcement sheath 3688 may be woven or layered structure of fine wire or polymeric elements, i.e. plastic braid). Regarding claim 5, McWeeney teaches The medical device of claim 4, wherein the distal portion of the shaft includes one or more of etched polytetrafluoroethylene, a metal or plastic braid, a reflowed or extruded jacket, or a stiffener (fig. 36b, element 3688, [0155], reinforcement sheath 3688 may be woven or layered structure of fine wire or polymeric elements, i.e. plastic braid). Regarding claim 6, McWeeney teaches The medical device of claim 1, wherein the medical device includes a cholangioscope ([0079], catheter may have an outer diameter of 5 Fr, which would fit inside of a bile duct). Regarding claim 8, McWeeney teaches A medical system including the medical device of claim 1, the medical system further comprising a medical scope having a working channel (fig. 31, element 3172, [0145], biopsy port 3172), wherein the distal portion of the shaft is configured to be inserted into the working channel (fig. 31, element 3130, a section inserted shown), and wherein the proximal portion of the shaft is configured to remain external to the working channel (fig. 31, element 3130, section in loop could not possibly enter the port given the angle). Regarding claim 10, McWeeney teaches The medical system of claim 8, wherein the proximal portion of the shaft has a diameter greater than approximately 4.2 mm ( [0079], diameter of 12Fr, 4mm, contemplated). Regarding claim 11, McWeeney teaches The medical system of claim 8, wherein, in a configuration in which the distal portion of the shaft is inserted into the working channel, the proximal portion of the shaft has a loop shape (fig. 31, element 3130). Regarding claim 12, McWeeney teaches The medical system of claim 11, wherein, in a configuration in which the proximal portion has a loop shape, the greater stiffness of the proximal portion of the shaft inhibits buckling of the proximal portion upon actuation of an actuator of the handle of the medical device ([0080], stiffness of proximal ends should be enough to advance the device). Regarding claim 13, McWeeney teaches The medical system of claim 12, wherein the actuation of the actuator causes a steerable portion of the distal portion of the shaft to articulate ([0141], steerable catheter assembly 3128). Regarding claim 14, McWeeney teaches The medical system of claim 13, wherein the greater stiffness of the proximal portion of the shaft increases an articulation performance of the steerable portion ([0080], stiffness of proximal ends should be enough to advance the device). Regarding claim 15, McWeeney teaches The medical system of claim 8, wherein, in a configuration in which the distal portion of the shaft is inserted into the working channel, a transition between the proximal portion and the distal portion is proximal of a port of the working channel (fig. 31, element 3130, the proximal portion, which remains outside of the patient may be delineated at any point along the length) . 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. 07-22-aia AIA Claim (s) 2, 7, 9, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney as applied to claim s 1, 8 above, and further in view of Nishiie (US 20050059861 A1) . Regarding claim 2, McWeeney teaches The medical device of claim 1, McWeeney does not explicitly teach wherein the proximal portion of the shaft has a greater outer diameter than the distal portion of the shaft. However, Nishiie teaches wherein the proximal portion (fig. 3a, element 15ah, [0028], hard resin portion of the outer sheath resin 15a) of the shaft has a greater outer diameter than the distal portion (fig. 3a, element 15al, [0028], soft resin portion of the outer sheath resin) of the shaft (taper portion at section 15bt [0030]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of McWeeney to include a taper portion as taught in Nishiie in order to vary the flexibility of the shaft (Nishiie [0030]). Regarding claim 7, McWeeney teaches The medical device of claim 1, McWeeney does not explicitly teach wherein the shaft includes a tapered transition between the proximal portion of the shaft and the distal portion of the shaft. However, Nishiie teaches wherein the shaft includes a tapered transition between the proximal portion of the shaft and the distal portion of the shaft (taper portion at section 15bt [0030]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of McWeeney to include a taper portion as taught in Nishiie in order to vary the flexibility of the shaft (Nishiie [0030]). Regarding claim 9, McWeeney teaches The medical system of claim 8, McWeeney does not explicitly teach wherein the proximal portion of the shaft has a greater diameter than the working channel of the medical scope. However, Nishiie teaches wherein the proximal portion of the shaft has a greater diameter than the working channel of the medical scope (taper portion at section 15bt [0030], McWeeney [0086] discloses only a 4Fr device passing through the working channel, hence a tapered portion with lower diameter 4Fr as taught in McWeeney would not fit the larger section). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of McWeeney to include a taper portion as taught in Nishiie in order to vary the flexibility of the shaft (Nishiie [0030]). Regarding claim 16, McWeeney teaches A medical device comprising: a handle (fig. 31, element 3132, [0141], handle 3132); and a shaft extending distally from the handle, wherein the shaft includes: a proximal portion (fig. 31, element 3130, [0141], catheter 3130) configured to remain external to a body lumen of a subject; and a distal portion (fig. 31, element 3130, [0141], catheter 3130, catheter has a length that would be within the proximal portion of endoscope 3124 that would not enter the subject and the rest that would) configured to be inserted into the body lumen of the subject; McWeeney does not explicitly teach wherein the proximal portion of the shaft has a greater outer diameter than the distal portion. However, Nishiie teaches wherein the proximal portion of the shaft has a greater outer diameter than the distal portion (taper portion at section 15bt [0030]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of McWeeney to include a taper portion as taught in Nishiie in order to vary the flexibility of the shaft (Nishiie [0030]). Regarding claim 17, McWeeney in view of Nishiie teaches A medical system including the medical device of claim 16, Further, McWeeney teaches the medical system further comprising a medical scope having a working channel (fig. 31, element 3172, [0145], biopsy port 3172), wherein the distal portion of the shaft is configured to be inserted into the working channel (fig. 31, element 3130, a section inserted shown), wherein the proximal portion of the shaft is configured to remain external to the working channel (fig. 31, element 3130, section in loop could not possibly enter the port given the angle), Further, Nishiie teaches wherein the proximal portion of the shaft has a greater diameter than the working channel of the medical scope (taper portion at section 15bt [0030], McWeeney [0086] discloses only a 4Fr device passing through the working channel, hence a tapered portion with lower diameter 4Fr as taught in McWeeney would not fit the larger section). Regarding claim 18, McWeeney in view of Nishiie teaches The medical system of claim 17, Further, McWeeney teaches wherein, in a configuration in which the distal portion of the shaft is inserted into the working channel, the proximal portion of the shaft has a loop shape (fig. 31, element 3130). Regarding claim 19, McWeeney teaches A medical system comprising: a first medical device including: a first shaft including: a proximal portion (fig. 31, element 3130, [0141], catheter 3130) configured to remain external to a body lumen of a subject; and a distal portion (fig. 31, element 3130, [0141], catheter 3130, catheter has a length that would be within the proximal portion of endoscope 3124 that would not enter the subject and the rest that would) configured to be inserted into the body lumen of the subject; and a second medical device including a second shaft having a working channel (fig. 31, element 3172, [0145], biopsy port 3172); wherein the distal portion of the first shaft is configured to be inserted into the working channel (fig. 31, element 3130, a section inserted shown), McWeeney does not explicitly teach wherein the proximal portion of the first shaft has a greater diameter than a diameter of the working channel. However, Nishiie teaches wherein the proximal portion of the shaft has a greater outer diameter than the distal portion (taper portion at section 15bt [0030]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of McWeeney to include a taper portion as taught in Nishiie in order to vary the flexibility of the shaft (Nishiie [0030]). Regarding claim 20, McWeeney in view of Nishiie teaches The medical system of claim 19, Further, McWeeney teaches wherein the first medical device is a cholangioscope ([0079], catheter may have an outer diameter of 5 Fr, which would fit inside of a bile duct) . 07-22-aia AIA Claim (s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney as applied to claim 1 above, and further in view of Dillon (WO 2018022404 A1) . Regarding claim 3, McWeeney teaches The medical device of claim 1, McWeeney does not explicitly teach wherein the proximal portion of the shaft has a length of approximately 25 cm to approximately 50. cm. However, Dillon teaches wherein the proximal portion of the shaft (fig. 4, element 1204,[0039], intermediate shaft length 1204) has a length of approximately 25 cm to approximately 50. Cm ([0039], length may be about 15-30cm in length which can be readily increased or decreased based on environment). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of McWeeney to be of length 30cm as taught in Dillon in order to adjust to the operating environment target region (Dillon [0039]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday. 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, Michael Carey can be reached at 5712707235. 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. /TIMOTHY TUAN LUU/ Examiner, Art Unit 3795 /MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795 Application/Control Number: 19/057,544 Page 2 Art Unit: 3795 Application/Control Number: 19/057,544 Page 3 Art Unit: 3795 Application/Control Number: 19/057,544 Page 4 Art Unit: 3795 Application/Control Number: 19/057,544 Page 5 Art Unit: 3795 Application/Control Number: 19/057,544 Page 6 Art Unit: 3795 Application/Control Number: 19/057,544 Page 7 Art Unit: 3795 Application/Control Number: 19/057,544 Page 8 Art Unit: 3795 Application/Control Number: 19/057,544 Page 9 Art Unit: 3795 Application/Control Number: 19/057,544 Page 10 Art Unit: 3795 Application/Control Number: 19/057,544 Page 11 Art Unit: 3795 Application/Control Number: 19/057,544 Page 12 Art Unit: 3795
Prosecution Insights