DETAILED ACTION Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Status of Claims 1. Claims 1- 18 and 24 are pending and currently under consideration for patentability. Claims 19-23 and 25-28 are cancelled via preliminary amendment filed August 18, 2023. Priority 2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Information Disclosure Statement 3. The information disclosure statement (IDS) submitted on August 30, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. Claim Rejections - 35 USC § 103 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. 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. 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 . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 4. Claim(s) 1- 8, 10-14, 16- 18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Pool et al. (US PGPUB 2008/0097487 A1) in view of Kratzberg et al. (US PGPUB 2016/0113654 A1) . 5. With regard to claim s 1 , 2 and 18 , Pool discloses a system (1400 , 160 ; Fig s . 2 0 -25, 51; abstract) comprising: a gastrointestinal banding device (implanted device, 1403 , 160 ) , the device (1403 , 160 ) comprising: a band (restriction device, 1414 , 162 having an inner distensible member, 181 and dynamically adjustable band, 182 ) comprising a first end (secured end, 183) and a second end ( movable end, 184; best seen in Fig s . 24, 25) , the band ( 181, 182 ) extending circumferentially around a central axis to define a central channel having a first diameter (best seen in Figs. 23-25) ; a housing (body portion, 176) coupled to the first end (at 183) of the band (181, 182) and defining a housing slot (central cavity, 180) to accept the second end (184) of the band (181, 182; [0156]) , wherein the housing (176) is disposed outside of the central channel (Figs. 23-25) ; a screw (worm gear, 186) disposed within the housing (176) and comprising at least one thread (of 186; worm gear disclosed as comprising threads in at least [0193]) disposed adjacent to or abutting the band (181, 182; [0158-0159]) ; and a magnet ( internally located driven magnet , 217 , 1402 ) rotatably disposed within a second housing (implantable interface, 164) coupled to the screw (186, via drive transmission, 166) , wherein rotation of the screw (186) causes the second end (184) of the band (181, 182) to move away from or towards the first end (183) of the band (181, 182) such that the first diameter of the central channel changes ( [0030]; [0159]) ; and an external driver (external device, 168, 1406; Figs. 22, 51) comprising: a driver magnet (one or more external drive magnets, 1410 or external drive interface, 169) ; and a handle (handle, 172) coupled to the driver magnet (169, 1410) , wherein rotating the handle (172) of the external driver (168, 1406) rotates the driver magnet (169, 1410) about a turning axis and causes the magnet (217, 1402) of the gastrointestinal banding device (1403, 160) to rotate ( [0151-0152]; [0204-0205]) . W hile Pool discloses a system that utilizes a gastrointestinal banding device, Poole fails to explicitly disclose an arteriovenous fistula banding device within the system. However, Pool provides an explicit suggestion that , while the embodiments shown utilize the device (160) for restriction of the esophagus or stomach, other embodiments of the device can be used for other restriction applications, such as full or partial occlusion of a blood vessels ([0151]). Additionally, within the same field of endeavor, Kratzberg discloses an arteriovenous fistula banding device (magnetically actuated gating device, 10; abstract; [0004]; Figs. 1-3) comprising: a membrane (18); a compression member (16 ) disposed within a housing (12) and disposed adjacent to the membrane (18; Fig. 3); and an actuator (magnetic rotatable member, 14 ) for causing the membrane (18) to move away from or toward the actuator (14) to change a diameter of a central channel upon rotation ([0040-0049]). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gastrointestinal banding device disclosed by Pool to be an arteriovenous fistula banding device, similar to that disclosed by Kratzberg , in order to control the patency of an AVF such that blood flow can be regulated prior to, during, or subsequent to treatment may benefit patients by reducing the complications associated with AVFs and assist with fistula maturation , as suggested by Kratzberg in paragraph [0004]. One having ordinary skill in the art would be further motivated to utilize the banding device as an arteriovenous fistula banding device, in view of the alternate embodiments suggested by Poole in paragraph [0151] . Furthermore, Poole fails to explicitly disclose an embodiment where the magnet (217) is rotatably disposed within the same housing (176) which houses the screw (186). However, Pool provides an explicit suggestion that the appropriate length drive transmission ( 166 ) may be chosen based on what best fits the anatomy of the patient in addition to the chosen surgical configuration ([0161]) . Also, Kratzberg discloses that the compression member (16) and magnetic actuator (14) are rotatably disposed within the same housing (12; [0040-0041]; Fig. 3). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the length of the drive transmission disclosed by Pool so that the drive transmission and magnet are disposed within the same housing as the screw, similar to that disclosed by Kratzberg , in order to provide the device with an appropriate length drive transmission based on what best fits the anatomy of the patient when utilized as an arteriovenous fistula banding device, as suggested by Pool in paragraph [0161] and Kratzberg in paragraph [0151]. 6. With regard to claim 3 , Pool discloses that the central channel (Figs. 24-25) is sized to surround a portion of a gastrointestinal tract , and wherein rotation of the screw (186) to change the first diameter of the central channel changes an inner diameter of the gastrointestinal tract ([0152-0153]) . However, Pool fails to explicitly disclose an embodiment where the central channel is sized to surround and change the inner diameter of an arteriovenous fistula . Kratzberg discloses that the central channel (defined by lengthwise axis, 47) is sized to surround an arteriovenous fistula ([0043]), and wherein rotation of the magnetic actuator (14) to change the first diameter of the central channel changes an inner diameter of the arteriovenous fistula (Figs. 3A vs. 3B; [0049]). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gastrointestinal banding device disclosed by Pool to be an arteriovenous fistula banding device, similar to that disclosed by Kratzberg , in order to control the patency of an AVF such that blood flow can be regulated prior to, during, or subsequent to treatment may benefit patients by reducing the complications associated with AVFs and assist with fistula maturation , as suggested by Kratzberg in paragraph [0004]. One having ordinary skill in the art would be further motivated to utilize the banding device as an arteriovenous fistula banding device, in view of the alternate embodiments suggested by Pool in paragraph [0151]. 7. With regard to claim 4 , Pool discloses that the band (181, 182) further comprises a plurality of teeth (teeth of 181) protruding from an outer side of the band (Figs. 24, 25) , wherein the plurality of teeth is engageable with the at least one thread of the screw (186; [0156-0159]) . 8. With regard to claim 5 , Pool discloses that the band (181, 182) further comprises a plurality of slots (grooves, 185 of 182) extending through the band from an outer side to an inner side (Figs. 24, 25) , wherein the plurality of slots (185) is engageable with the at least one thread of the screw (186; [0156-0159]). 9. With regard to claim 6 , Pool discloses a flow sensor (flow rate measurements and sensors) disposed adjacent to the central channel, the flow sensor configured to measure fluid flow through the central channel (“ sensors integral or incorporated with the gastric band for detecting flow through the gastrointestinal lumen ”; [0175]). 10. With regard to claim 7 , Pool discloses that the first diameter of the central channel is adjustable from 15 mm to 28 mm ( [0210]; Figs. 22-25; [0156-0159]). Kratzberg discloses that the first diameter of the central channel sized and configured to receive a vessel is adjustable in diameter ([ 0043]; [0046]; [0052 ] ; [0087]; [0090] ) . While Pool and Kratzberg fail to explicitly disclose that the first diameter of the central channel is adjustable from 3mm to 15mm , it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first diameter of the central channel disclosed by Poole in view of Kratzberg , to be adjustable from 3mm to 15mm , since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 105 USPQ 233. In the instant case, one having ordinary skill in the art would look to optimize the adjustable range of central channel diameter in order to tailor and control flow through an AVF during maturation. 11. With regard to claim 8 , while Pool and Kratzberg fail to explicitly disclose that a width of the band as measured in a direction parallel to the central axis is in a range from 5mm to 10mm., it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have specified the width of the band disclosed by Pool in view of Kratzberg , to be is in a range from 5mm to 10mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 105 USPQ 233. In the instant case, one having ordinary skill in the art would look to optimize the width of the band in order to tailor and control flow through an AVF during maturation. 12. With regard to claim 10 , Pool, as modified by Kratzberg above, discloses the magnet ( 217, 1402 ) disposed within the housing (176). Pool discloses, in Figure 43, that the housing (402) includes a magnet cover piece (turret, 408) separably couplable to the housing to cover the magnet (410; Fig. 43; [0194-0195]) . Further, Kratzberg discloses a magnet cover piece (cap, 20) separably couplable to the housing (12) to cover the magnet (14; Figs. 1-3; [0040]; [0056-0058]) . Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the housing disclosed by Pool in view of Kratzberg , to include a separable magnet cover piece, similar to that disclosed by Kratzberg and alternate embodiments of Pool, in order to maintain the magnets in their intended configuration, as suggested by Pool in paragraph [0194]. 13. With regard to claim 11 , Pool discloses a suture protrusion (suture tabs, 223; shown in Fig. 30) extending out from the housing in a direction transverse to the band (181, 182), wherein the suture protrusion (223) is disposed outside of the central channel ([0170]). 14. With regard to claim 12 , Pool discloses that the housing (176) further comprises an outer band housing (outer housing, 179; best seen in Fig. 24) enveloping the band (181, 182) and the central channel wherein the second end of the band (183) is contained within the outer band housing (179) regardless of the first diameter of the central channel ([0156]) . 15. With regard to claim 13 , Pool discloses that the outer band housing (179) comprises a track (central cavity, 180) engageable with a portion of the band (181, 182) such that the band follows the track as it extends or retracts to expand or contract the central channel (Fig. 24; [0156-0157]) . 16. With regard to claim 14 , Pool discloses that the second end (183) of the band (181, 18) further comprises a mechanical stop (at end of 180 abutting 181 in combination with attachment portions, 177, 178) to define a maximum diameter of the central channel (best seen in Figs. 23, 24) . 17. With regard to claim 16 , Pool, in alternate embodiments (Figs. 38, 46, 51, 72), discloses t hat t he actuator is a motor (298, 1416, 1132) with a shaft (cylinder, 304) coupled to the screw ([0151]; [0186]; [0196]; [0205]) . Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the actuator disclosed by Pool in view of Kratzberg , to include a motor and shaft , similar to that disclosed by alternate embodiments of Pool, in order to provide an alternate, but well-known, means of driving the screw in a desired rotational direction, as suggested by Pool in paragraph [0186]. 18. With regard to claim 17 , Pool discloses a control system (external device, 1406; Fig. 51), the control system comprising: a flow sensor (flow rate measurements and sensors) disposed adjacent to the central channel, the flow sensor configured to measure fluid flow through the central channel (“ sensors integral or incorporated with the gastric band for detecting flow through the gastrointestinal lumen ”; [0175]) ; and a controller (programmable logic controller, 1418) configured to receive a measured fluid flow, compare the measured fluid flow to a predetermined fluid flow, and drive the actuator to adjust the first diameter of the central channel based on the predetermined fluid flow ([0204-0218]) . 19. With regard to claim 24 , Pool discloses a method of controlling flow through a gastrointestinal lumen (Figs. 20-25, 51; abstract) , the method comprising: providing an gastrointestinal banding device (implanted device, 1403, 160) comprising a band ( restriction device, 1414, 162 having an inner distensible member, 181 and dynamically adjustable band, 182 ) extending circumferentially to define a central channel having a first diameter (Figs. 23-25) , a screw (186) having at least one thread (of 186; worm gear disclosed as comprising threads in at least [0193]) disposed adjacent to or abutting the band (181, 182) , and a magnet ( internally located driven magnet, 217, 1402) coupled to the screw (186, via 166) , wherein the gastrointestinal lumen is disposed within the central channel ( abstract ) ; rotating the magnet (217, 1402) to cause rotation of the screw (186) such that the at least one thread of the screw contacts a portion (185) of the band (181, 182) to expand or contract the central channel to a second diameter ([0030]; [0159]) ; and expanding or contracting an inner diameter of the gastrointestinal lumen such that a fluid flow rate through the gastrointestinal lumen is increased or decreased ([0151-0152]; [0204-0205]). While Pool discloses a method of controlling flow through a gastrointestinal lumen that utilizes a gastrointestinal banding device, Poole fails to explicitly disclose a method of controlling blood flow through an arteriovenous fistula comprising an arteriovenous fistula banding device. However, Pool provides an explicit suggestion that, while the embodiments shown utilize the device (160) for restriction of the esophagus or stomach, other embodiments of the device can be used for other restriction applications, such as full or partial occlusion of a blood vessels ([0151]). Additionally, within the same field of endeavor, Kratzberg discloses a method of controlling blood flow through an arteriovenous fistula ( abstract; [0004]; Figs. 1-3 ), the method comprising: providing an arteriovenous fistula banding device (magnetically actuated gating device, 10) comprising: a membrane (18); a compression member (16) disposed within a housing (12) and disposed adjacent to the membrane (18; Fig. 3); and an actuator (magnetic rotatable member, 14) for causing the membrane (18) to move away from or toward the actuator (14) to change a diameter of a central channel upon rotation ([0040-0049]). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gastrointestinal banding device disclosed by Pool to be an arteriovenous fistula banding device, similar to that disclosed by Kratzberg , in order to control the patency of an AVF such that blood flow can be regulated prior to, during, or subsequent to treatment may benefit patients by reducing the complications associated with AVFs and assist with fistula maturation , as suggested by Kratzberg in paragraph [0004]. One having ordinary skill in the art would be further motivated to utilize the banding device as an arteriovenous fistula banding device, in view of the alternate embodiments suggested by Poole in paragraph [0151]. 20 . Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pool in view of Kratzberg , as applied to claim 1 above, and further in view of Shields et al. (US PGPUB 2017/0035423 A1) . 21 . With regard to claim 9, while Pool discloses that the band (181, 182) is biased toward a curved configuration (Figs. 20-25), Pool and Kratzberg are silent in regard to the device comprising a flexible resin and wherein the device is 3D printed in a curved configuration such that the band is biased towards the curved configuration. However, within the same field of endeavor, Shield discloses a medical device (100) and corresponding method of use for an arteriovenous fistula creation (abstract; Figs. 1-8), the device (100) comprises a flexible resin and wherein the device is 3D printed in a curved configuration ([0021]) . Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the material and means of manufacturing the device disclosed by Pool in view of Kratzberg , to be a 3D printed flexible resin, similar to that disclosed by Shield, in order to utilize alternative well-known modern manufacturing means to allow for the creation of custom, patient specific, implant devices , as suggested by Shields in paragraph [0021]. 22 . Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pool in view of Kratzberg , as applied to claim 4 above, and further in view of O’Shei (US 2,689,998) . 23 . With regard to claim 15, Pool and Kratzberg are silent in regard to the plurality of teeth extend ing only from a distal portion of the band such that a proximal portion of the band defines a minimum diameter of the central channel. However, O’Shei discloses a band or hose clip (abstract; Figs. 1-2), wherein the band (1) includes a plurality of teeth (thread part, 3) which extend only from a distal portion of the band (1) such that a proximal portion (plain end, 2) of the band (1) defines a minimum diameter of the central channel (col. 2, line 34 – col. 3, line 36). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the band disclosed by Pool in view of Kratzberg , to include a plurality of teeth only at a distal portion , similar to that disclosed by O’Shei , in order to lock the band engagement with the screw at a minimum diameter and prevent the screw from being pressed out of engagement with the teeth , as suggested by O’Shei in column 3, lines 26-36. Conclusion 24. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Edmunds, Jr. et al. (US 3,730,186) discloses an adjustable implantable artery-constricting device. Forsell (US 10,952,836) discloses a vaginal operation method for the treatment of urinary incontinence in women. Shaolian et al. (US 11,202,707) discloses an adjustable implant system. 25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ANDREW J MENSH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1594 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9 a.m. - 6 p.m. . 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, FILLIN "SPE Name?" \* MERGEFORMAT Sarah Al-Hashimi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-7159 . 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. /ANDREW J MENSH/ Primary Examiner, Art Unit 3781