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 .
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1-20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, an updated search was conducted and a new ground(s) of rejection is made in view of newly cited prior art.
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(s) 1-6, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isayama et al. (12390623) in view of Augustin et al. (“Percutaneous transhepatic biliary tract embolization using gelatin sponge”, Acta Radiologica, Volume 60, Issue 10, 2019, Pages 1194-1199).
With respect to claim 1, Isayama et al. teaches of a method for forming an access route to a bile duct forming a tunnel extending to the bile duct region to form an opening into a bile duct region by piercing a needle through patient tissue into a bile duct region (claims 1, 2) and performing an intervention within the bile duct region (col. 8 lines 18-42).
With respect to claims 1 and 11, Isayama et al. teach of method for forming the access route to a bile duct and performing an intervention within the bile duct region but do not explicitly teach of advancing an embolic gel into the opening. In a similar field of endeavor Augustin et al. teach of the use of a gelatin sponge after percutaneous transhepatic biliary drainage (PTBD) (see abstract, page 1194, col. 2 lines 7-page 1195 col. 1 line 1-2). Augustin et al. teach of advancing the gelatin sponge pad into the drainage catheter tract opening to close the opening (page 1195, paragraph 2 lines 17-col. 2 line 13). Augustin et al. therefore teach of the sealing of the catheter drainage tract by delivering an embolic gel material or sponge to enable occlusion (page 1198, col. 2 lines 7-18). With respect to claim 11, Isayama et al. do not teach of the gel material. Augustin et al. teach of the use of the gelatin sponges which are known to exhibit shear-thinning properties as that are made of material that decrease in viscosity when shear stress is applies to aid in the delivery to the target site and teach the use of small cut stripes of hemostatic gelatin sponge (page 1195, col. 2 lines 5-8). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Augustin et al. to modify Isayama et al. to provide closure of percutaneous bioptic puncture tracts with high level of biocompatibility and that is safe in preventing bile leak complications after transhepatic interventions (Augustin, page 1198, col. 1 paragraph 2, lines 4-6 (Discussion section) and col. 2 lines 12-18).
With respect to claim 2, Isayama et al. in view of Augustin et al. teach of performing an intervention within bile duct including injecting a contrast agent into the bile duct region (Isayama, col. 7 lines 20-25).
With respect to claim 3, Isayama et al. in view of Augustin et al. in view of Augustin et al. teach of performing an intervention within the bile duct region including draining the bile duct region (col. 8 lines 43-51).
With respect to claim 4, Isayama et al. in view of Augustin et al. teach of performing an intervention within the bile duct region including dilation of a biliary structure (claims 3-7).
With respect to claim 5, Isayama et al. in view of Augustin et al. teach of performing an intervention within the bile duct of delivering a stent (col. 8 lines 35-51).
With respect to claim 6, Isayama et al. in view of Augustin et al. teach of performing an intervention within the bile duct region includes a tissue biopsy (col. 8 lines 30-33).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isayama et al. in view of Augustin et al. and further in view of Kamada (10391286).
With respect to claims 7-9, Isayama et al. in view of Augustin et al. teach of “when the needle tube 33 pierces the bile duct BD and the distal end of the needle tube 33 reaches the inside of the bile duct BD, the operator stops the advance of the needle tube 33 and fixes it so as not to move with respect to the sheath 31” (col. 7 lines 15-19). Isayama et al. therefore teach of when the distal end of the needle tube reaches the inside of the bile duct and stop the needle tube and fixes it to prevent movement with respect to the sheath (col. 11 lines 35-42) and would therefore under broadest reasonable interpretation, include a stop member within the opening to stop the needle tube and fixes it to prevent movement. However, the reference does not explicitly teach of the step of disposing a stop member within the opening adjacent to the bile duct region.
In a similar field of endeavor Kamada teaches of a biliary tract drainage tube that includes a stopper or a detachment-preventing portion to secure the external drainage tube inside the bile duct (col. 5 lines 5-10, col. 10 lines 15-19). With respect to claim 10, Kamada teaches of the shape of the detachment-preventing portion 4B formed in the narrow-diameter portion 2b of the external drainage tube 2 (col. 7 lines 15-17) and therefore under broadest reasonable interpretation, Kamada teaches of a stop member or detachment-preventing portion to include a narrow diameter portion 2b serving as the stop in having a head and shaft extending from the head. It would be obvious to one of ordinary skill in the art to dispose the stop member within the opening (Kamada) prior to advancing the embolic gel sponge into the opening (Augustin) of the bile duct access needle (Isayama) to secure the drainage tube to the bile duct to prevent detachment of the internal drainage tube.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isayama et al. in view of Augustin et al. and further in view of Burkett. Augustin et al. teach of the use of gelatin sponge which are frequently made radiopaque by soaking in contrast agent for embolization but do not teach of the embolic gel to include a layered silicate mixture. Burkett teaches of the embolic gel or patch material to include gelatin [0102], a layered silicate mixture [0105], and a radiopaque material [0108]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Burkett to provide an alternate to the embolic gel as provided by the Augustin reference to provide an alternate way of bile duct sealing.
Claim(s) 13, 14, 16, 17, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isayama et al. (12390623) in view of Augustin et al. (“Percutaneous transhepatic biliary tract embolization using gelatin sponge”, Acta Radiologica, Volume 60, Issue 10, 2019, Pages 1194-1199) and further in view of Kamada.
With respect to claims 13 and 17, Isayama et al. teaches of a method and system for forming an access route to a bile duct forming a tunnel extending to the bile duct region to form an opening into a bile duct region by piercing a needle through patient tissue into a bile duct region (claims 1, 2) and performing an intervention within the bile duct region (col. 8 lines 18-42).
With respect to claims 13, 14, 17, and 18, Isayama et al. teach of method for forming the access route to a bile duct and performing an intervention within the bile duct region but do not explicitly teach of advancing an embolic gel into the opening. In a similar field of endeavor Augustin et al. teach of the use of a gelatin sponge after percutaneous transhepatic biliary drainage (PTBD) (see abstract, page 1194, col. 2 lines 7-page 1195 col. 1 line 1-2). Augustin et al. teach of advancing the conformable embolic gelatin sponge pad into the drainage catheter tract opening to close the opening (page 1195, paragraph 2 lines 17-col. 2 line 13). Augustin et al. therefore teach of the sealing of the catheter drainage tract by delivering an embolic gel material or sponge to enable occlusion (page 1198, col. 2 lines 7-18). With respect to claims 14 and 18, Isayama et al. do not teach of the gel material. Augustin et al. teach of the use of the gelatin sponges which are known to exhibit shear-thinning properties as that are made of material that decrease in viscosity when shear stress is applies to aid in the delivery to the target site and teach the use of small cut stripes of hemostatic gelatin sponge (page 1195, col. 2 lines 5-8). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Augustin et al. to modify Isayama et al. to provide closure of percutaneous bioptic puncture tracts with high level of biocompatibility and that is safe in preventing bile leak complications after transhepatic interventions (Augustin, page 1198, col. 1 paragraph 2, lines 4-6 (Discussion section) and col. 2 lines 12-18).
With respect to claims 13, 16, 17, and 20, Isayama et al. in view of Augustin et al. teach of “when the needle tube 33 pierces the bile duct BD and the distal end of the needle tube 33 reaches the inside of the bile duct BD, the operator stops the advance of the needle tube 33 and fixes it so as not to move with respect to the sheath 31” (col. 7 lines 15-19). Isayama et al. therefore teach of when the distal end of the needle tube reaches the inside of the bile duct and stop the needle tube and fixes it to prevent movement with respect to the sheath (col. 11 lines 35-42) and would therefore under broadest reasonable interpretation, include a stop member within the opening to stop the needle tube and fixes it to prevent movement. However, the reference does not explicitly teach of the step of disposing a stop member within the opening adjacent to the bile duct region. In a similar field of endeavor Kamada teaches of a biliary tract drainage tube that includes a stopper or a detachment-preventing portion to secure the external drainage tube inside the bile duct (col. 5 lines 5-10, col. 10 lines 15-19). With respect to claims 16 and 20, Kamada teaches of the shape of the detachment-preventing portion 4B formed in the narrow-diameter portion 2b of the external drainage tube 2 (col. 7 lines 15-17) and therefore under broadest reasonable interpretation, Kamada teaches of a stop member or detachment-preventing portion to include a narrow diameter portion 2b serving as the stop in having a head and shaft extending from the head. It would be obvious to one of ordinary skill in the art to dispose the stop member within the opening (Kamada) prior to advancing the embolic gel sponge into the opening (Augustin) of the bile duct access needle (Isayama) to secure the drainage tube to the bile duct to prevent detachment of the internal drainage tube.
Claim(s) 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isayama et al. in view of Augustin et al. in view of Kamada and further in view of Burkett. Augustin et al. teach of the use of gelatin sponge which are frequently made radiopaque by soaking in contrast agent for embolization but do not teach of the embolic gel to include a layered silicate mixture. Burkett teaches of the embolic gel or patch material to include gelatin [0102], a layered silicate mixture [0105], and a radiopaque material [0108]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Burkett to provide an alternate to the embolic gel as provided by the Augustin reference to provide an alternate way of bile duct sealing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAISAKHI ROY whose telephone number is (571)272-7139. The examiner can normally be reached Monday-Friday 7-3 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, Christopher Koharski can be reached at 571-272-7230. 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.
BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797
