CTNF 18/506,802 CTNF 97632 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. Information Disclosure Statement 06-52 The information disclosure statement (IDS) submitted on March 20, 20204 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 4-5 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 4 recites the limitation " wherein a diameter of the second portion is smaller than a diameter of the second portion " . The scope of this limitation is unclear, as it is unclear how the diameter of the second portion can be smaller than its own diameter. The examiner notes that [0027] of the application specification states instead “a first or proximal portion 122 having a diameter ranging from about 0.18 millimeters to about 0.35 millimeters and a second or distal portion 123 which may have a smaller diameter.” Therefore, for examining purposes, the limitation is interpreted as " wherein a diameter of the second portion is smaller than a diameter of the first portion ". Claim 5 is similarly rejected by virtue of its dependency on claim 4. Claim 8 recites the limitation “ the second portion" . There is insufficient antecedent basis for this limitation in the claim. Claim 8, or any claim from which it depends from, does not define the “second portion”. Therefore, for examining purposes, “the second portion” is interpreted to be a new claim limitation. 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. 07-12-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 AIA Claim s 16-17 and 19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Gardner et al. (US 20110071506), hereinafter Gardner . Regarding claim 16, Gardner discloses a method of occluding a vessel (Fig, 2 and [0037], method of occluding a vessel using catheter 10), comprising: disposing an actuator in a first position (Fig. 2 and [0034, 0035], disposing tether 62 (connected to an activation lever/switch) in a first, distal position), wherein a seal member seals a bore of an occlusion member evacuation port of a vessel occlusion device (Fig. 2 and [0035], distal plug 61 of tether seals off a portion of lumen 40 which extends from release port 44 of catheter tube20); inflating an expandable occlusion member with a fluid to occlude a vessel (Fig. 2 and [0029, 0035, 0037], balloon 50 is inflated with fluid to occlude vessel); moving the actuator from the first position to a second position (Fig. 2-3 and [0036], tether is advanced in the proximal direction to a second position), wherein the seal member is displaced to open the bore (Fig. 3 and [0036], tether 62 displaces plug 61 proximally thus opening communication from balloon 50 through lumen 40 to release port 44); and deflating the expandable occlusion member (Fig. 3 and [0035], balloon 50 deflates), wherein the fluid flows from the expandable occlusion member into the bore and out a distal end of the occlusion member evacuation port (Fig, 3 and [0030, 0035], fluid flows from balloon 50, into lumen 40 and out release port 44 opening which can be located at the distal end of lumen 40). Regarding claim 17, Gardner discloses the method of claim 16, further comprising anchoring the vessel occlusion device relative to the vessel when the expandable occlusion member is inflated ([0037], catheter 10 is secured/anchored in vessel when balloon 50 is inflated). Regarding claim 19, Gardner discloses the method of claim 16, further comprising preventing extending the seal member from the occlusion member evacuation port when the actuator is in the first position (Fig. 2 and [0035], tether 62 controls position of plug 61 and maintains the plug 61 in a first position that does not extend to/through release port 44) . 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, 6-8, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 20110071506) in view of Burkholz et al. (US 20210393924), hereinafter Burkholz . Regarding claim 1, Gardner discloses a micro balloon catheter (Fig. 1 and [0001, 0008], balloon catheter assembly 10 for insertion into a vessel of a human, therefore catheter can be of any appropriate size for the desired vessel) , comprising: a catheter (Fig. 1, catheter 20) comprising: a distal end portion (Fig. 1, distal end 24) comprising a vent port (Fig. 1, release port 44); an expandable member (Fig. 1, balloon 50) disposed proximally to the vent port and in fluid communication with the vent port (Fig. 1 and [0028, 0030], balloon 50 is proximal to and in fluid communication with port 44 ); a connector coupled to the catheter (Fig. 1, connector 22 coupled to catheter 20); and a wire (Fig. 1 and [0035], semi-rigid tether (wire) 62 ) and slidingly disposed within the catheter (Fig. 2-3, tether 62 slidingly disposed in catheter 20), wherein a distal portion of the wire is configured to seal the vent port when in the distal position (Fig. 2. distal plug 61 of tether blocks communication of fluid flowing through lumen 40 to the port 44 when tether 62 is in distal position) and to open the vent port when is in the proximal position (Fig. 3, distal plug 61 of tether 62 allows communication of fluid flowing from balloon 50 and through lumen 40 to port 44 when tether 62 is in proximal position). Gardner fails to disclose a handle coupled to the connector, wherein the handle comprises a slide member moveable between a distal position and a proximal position; the wire coupled to the slide member and movable between a distal position and a proximal position. However, Burkholz discloses a handle coupled to the connector (Fig. 1A and 12A, handle device 28, coupled to adapter 26 of catheter 16), wherein the handle comprises a slide member (Fig. 1A and 12A, sliding tab 38) moveable between a distal position (Fig. 1B, sliding tab 38 in distal position) and a proximal position (Fig. 1A, sliding tab 38 in proximal position); the wire coupled to the slide member and movable between a distal position and a proximal position (Fig. 1A-B and 12B and [0063], wire 32 is coupled to sliding tab 38 and is movable with the tab 38 between a corresponding distal position (Fig. 1A) and proximal position (Fig. 1B)). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner to incorporate the disclosures of Burkholz and modify the catheter to comprise a handle coupled to the connector, wherein the handle comprises a slide member moveable between a distal position and a proximal position; the wire coupled to the slide member and movable between a distal position and a proximal position. Doing so would provide an advancement device which may be easily gripped and provides a simple sliding tab movement for the user, resulting in ease of advancing the wire through the catheter(Burkholz, [0008, 0089]). Regarding claim 2 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 1, wherein the expandable member is inflatable with a fluid when the slide member is in the distal position (Fig. 2 and [0035], balloon 50 is inflatable when plug 61 is in distal position (as positioned by the slider being in distal position)). Regarding claim 3 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 1, wherein the expandable member is deflatable when the slide member is in the proximal position (Fig. 3 and [0036], balloon 50 is deflatable when plug 61 is in proximal position (as positioned by the slider being in proximal position)) . Regarding claim 6 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 1, wherein the connector comprises an inflation port (Fig. 1, connector 22 comprises inflation port 46); wherein the catheter comprises a side port disposed within the inflatable member (Fig. 1, side port 42 within balloon 50); wherein the catheter comprises an annular space disposed between an inner wall of the catheter and the wire and extending between the inflation port and the side port (Fig. 1, catheter 20 comprises an annular space surrounding the tether 62 and defined by the walls of lumen 40, extending between port 46 and side port 42); and wherein the inflation port is in fluid communication with the annular space (Fig. 1 and [0027-0029], inflation port 46 and lumen 40 are in fluid communication) and the annular space is in fluid communication with the inflatable member through the side port (Fig. 1 and [0027-0029], lumen 40 and balloon 50 are in fluid communication via side port 42). Regarding claim 7 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 6, wherein the vent port is in fluid communication with the inflatable member through the side port (Fig. 3 and [0026 and 0036], port 44 and balloon 50 are in fluid communication via side port 42). Regarding claim 8 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 6, wherein a cross-sectional area of the second portion (Fig. 1-2, cross-sectional area of a portion of lumen 40 extending distal from port 42 to the release port 44 is the general cross-sectional area of lumen 40) is larger than the cross-sectional area of the annular space (Fig, 1-2, the cross-sectional area of the annular space is the cross-sectional area of lumen 40 minus the cross-sectional area of the tether 62. Therefore, the cross-sectional area of the second portion is larger than the cross-sectional area of the annular space). Regarding claim 10 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 1, wherein the expandable member is a balloon (Fig. 1 and [0028], balloon 50). Regarding claim 11, Gardner discloses a vessel occlusion device (Fig. 1, balloon catheter assembly 10) , comprising: an elongate tube (Fig. 1, catheter tube 20) comprising: a fluid evacuation port (Fig. 1, port 44) ; a vessel occlusion member (Fig. 1, balloon 50) disposed proximally to the fluid evacuation port and in fluid communication with the fluid evacuation port (Fig. 1 and [0028, 0030], balloon 50 is proximal to and in fluid communication with port 44 ) ; a connector coupled to the elongate tube (Fig. 1, connector 22 coupled to catheter 20) ; and a sealing member (Fig. 1 and [0035], tether 62 with distal plug 61) slidingly disposed within the elongate tube (Fig. 2-3, tether 62/plug 61 slidingly disposed in catheter 20) , wherein a portion of the sealing member prevents fluid from flowing through the fluid evacuation port when in the first position (Fig. 2. distal plug 61 of tether blocks communication fluid from lumen 40 to the port 44 when tether 62 is in distal position) and allows fluid to flow through the fluid evacuation port when in the second position (Fig. 3, distal plug 61 of tether 62 allows communication of fluid from lumen 40 to port 44 when tether 62 is in proximal position) . Gardner fails to disclose an actuator coupled to the connector, wherein the actuator comprises a slider moveable between a first position and a second position; the sealing member coupled to the slider and movable between a first position and a second position. However, Burkholz discloses an actuator coupled to the connector (Fig. 1A and 12A, handle device 28, coupled to adapter 26 of catheter 16), wherein the actuator comprises a slider (Fig. 1A and 12A, sliding tab 38) moveable between a first position (Fig. 1B, sliding tab 38 in distal position) and a second position (Fig. 1A, sliding tab 38 in proximal position); the sealing member coupled to the slider and movable between a first position and a second position (Fig. 1A-B and 12B and [0063], wire 32 is coupled to sliding tab 38 and is movable with the tab 38 between a corresponding distal position (Fig. 1A) and proximal position (Fig. 1B)). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner to incorporate the disclosures of Burkholz and modify the catheter to comprise an actuator coupled to the connector, wherein the actuator comprises a slider moveable between a first position and a second position; the sealing member coupled to the slider and movable between a first position and a second position. Doing so would provide an advancement device which may be easily gripped and provides a simple sliding tab movement for the user, resulting in ease of advancing the wire through the catheter(Burkholz, [0008, 0089]). Regarding claim 12 and Gardner, in view of Burkholz, Gardner further discloses the vessel occlusion device of claim 11, wherein the vessel occlusion member is inflatable when the slider is in the first position (Fig. 2 and [0035], balloon 50 is inflatable when plug 61 is in distal position (as positioned by the slider being in distal position)) , and wherein the vessel occlusion member is deflatable when the slider is in the second position (Fig. 3 and [0036], balloon 50 is deflatable when plug 61 is in proximal position (as positioned by the slider being in proximal position)) . 07-22-aia AIA Claim s 4-5 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 20110071506), in view of Burkholz (US 20210393924) , as applied to claim s 1 and 11 above, and further in view of Evans et al. (US 20030139751), hereinafter Evans . Regarding claim 4 and Gardner, in view of Burkholz, Gardner further discloses the micro balloon catheter of claim 1, wherein the vent port comprises a lumen (Fig. 1, vent port 44 comprises lumen 40 which extends from vent port 44) comprising a first portion (Fig. 1 and 3, portion of lumen 40 extending proximal from port 42 towards connector 22) and a second diameter portion (Fig. 1-2, portion of lumen 40 extending distal from port 42 to the release port 44), wherein the distal portion of the wire is configured to seal the vent port when disposed within the second portion (Fig. 2. distal plug 61 of tether 62 seals off communication of fluid to the port 44 when tether 62 is in second portion of lumen 40) , and wherein the distal portion of the wire is configured to open the vent port when disposed within the first portion (Fig. 3, distal plug 61 of tether 62 allows communication of fluid to port 44 when tether 62 is in the first portion of lumen 40) . Gardner, in view of Burkholz, fails to disclose wherein a diameter of the second portion is smaller than a diameter of the second portion. However, Evans discloses wherein a diameter of the second portion is smaller than a diameter of the second portion (Fig. 19 and [0121], lumen for flow resistor 604, (similar to plug 61 of Gardner) has a second lumen portion 602 which has a smaller diameter than a first lumen portion 606). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner, in view of Burkholz, to incorporate the disclosures of Evans and modify the vent port lumen such that a diameter of the second portion is smaller than a diameter of the first portion. Doing so would ensure that the sealing member is able to wholly block fluid flow when positioned at the second portion of the lumen, while allowing fluid flow when positioned in the first portion of the lumen, thus forming an effective flow resistor (Evans, [0021-0022, 0121]). Regarding claim 5 and Gardner, in view of Burkholz and Evans, Gardner further discloses the micro balloon catheter of claim 4, wherein the lumen comprises an open distal end configured to vent fluid from the inflatable member into an exterior environment when the distal portion of the wire is disposed within the first portion (Fig. 4 and [0026, 0030, 0036], release port 44 can be located at the distal most end of catheter 20, thus lumen 40 can comprise an open distal end via release port 44, which when the plug 61 is in the first portion of lumen 40, port 44 can vent the fluid to a collection receptacle external to the body via lumen 30. Alternatively, catheter 20 can be configured to utilize open distal end 21 and vent the fluid into the vessel, as port 44 is in fluid communication with open distal end 21 via lumen 30) . Regarding claim 13 and Gardner, in view of Burkholz, Gardner further discloses the vessel occlusion device of claim 11, wherein the fluid evacuation port comprises a bore (Fig. 1, vent port 44 comprises lumen 40 which extends from vent port 44) comprising a first portion having a first diameter (Fig. 1 and 3, portion of lumen 40 extending proximal from port 42 towards connector 22, with a lumen diameter) and a second diameter portion having a second diameter (Fig. 1-2, portion of lumen 40 extending distal from port 42 to the release port 44, with a lumen diameter), and an open distal end (Fig. 4 and [0026, 0030, 0036], release port 44 can be located at the distal most end of catheter 20, thus lumen 40 can comprise an open distal end via release port 44) . Gardner, in view of Burkholz, fails to disclose wherein the second diameter is smaller than the first diameter. However, Evans discloses wherein the second diameter is smaller than the first diameter (Fig. 19 and [0121], lumen for flow resistor 604, (similar to plug 61 of Gardner) has a second lumen portion 602 which has a smaller diameter than a first lumen portion 606). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner, in view of Burkholz, to incorporate the disclosures of Evans and modify the vent port lumen such the second diameter is smaller than the first diameter. Doing so would ensure that the sealing member is able to wholly block fluid flow when positioned at the second portion of the lumen, while allowing fluid flow when positioned in the first portion of the lumen, thus forming an effective flow resistor (Evans, [0021-0022, 0121]). Regarding claim 14 and Gardner, in view of Burkholz and Evans, Gardner further discloses the vessel occlusion device of claim 13, wherein a distal end of the sealing member is disposed within the second portion when the slider is in the first position to seal the fluid evacuation port (Fig. 2. distal plug 61 of tether 62 seals off communication of fluid to the port 44 when tether 62 is in second portion of lumen 40) , and wherein the distal end of the sealing member is disposed within the first portion when the slider is in the second position to open the evacuation port (Fig. 3, distal plug 61 of tether 62 allows communication of fluid to port 44 when tether 62 is in the first portion of lumen 40) . Regarding claim 15 and Gardner, in view of Burkholz and Evans, Gardner further discloses the vessel occlusion device of claim 14, wherein fluid is configured to flow from the vessel occlusion member, through the bore of the fluid evacuation port, and out the open distal end of the bore when the slider is in the second position (Fig. 3-4 and [0026, 0030, 0036], when tether 62 is in proximal position, fluid is configured to flow from balloon 50, through lumen 40 and out the release port 44 at the distal most end of catheter 20/lumen 40) . 07-22-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 20110071506), in view of Burkholz (US 20210393924) , as applied to claim 1 above, and further in view of Chou et al. (US 20190351182), hereinafter Chou . Regarding claim 9, Gardner, in view of Burkholz, discloses the micro balloon catheter of claim 1. Gardner, in view of Burkholz, fails to disclose wherein the catheter comprises a shape memory metal alloy material, and wherein the vent port comprises a polymeric material. However, Chou discloses wherein the catheter comprises a shape memory metal alloy material (Fig. 2A and [0245], catheter can incorporate Nitinol (SMA) in its material), and wherein the vent port comprises a polymeric material (Fig. 2A and [0227], catheter distal end can be made of polymeric material with distal openings (similar to port 44 at distal end of catheter in Gardner)). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner, in view of Burkholz, to incorporate the disclosures of Chou and modify the catheter to comprise a shape memory metal alloy material, and modify the vent port to comprise a polymeric material. Doing so would provide a catheter with a flexible, soft tip region while also providing the body of the catheter with sufficient mechanical integrity for applying torque and preventing kinking (Chou, [0014, 0227, 0245]) . 07-21-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 20110071506) in view of Ogle (US 20180098778) . Regarding claim 18, Gardner discloses the method of claim 16. Gardner fails to disclose disposing an infusion device over the vessel occlusion device. However, Ogle discloses disposing an infusion device over the vessel occlusion device (Fig.1 and [0069-0070], an infusion catheter 104 can be disposed over the balloon catheter 102 (similar to catheter 20 of Gardner)). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner to incorporate the disclosures of Ogle and modify the method to include disposing an infusion device over the vessel occlusion device. Doing so would provide the overall device with a lumen for infusion and a lumen for balloon functionality, thus the devices together allow for maneuvering to a target vessel location, vessel occlusion, and delivery of infusion fluid (Ogle, [0068-0071]) . 07-21-aia AIA Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 20110071506) in view of Ehrenreich et al. (US 20110288478), hereinafter Ehrenreich . Regarding claim 20, Gardner discloses the method of claim 16. Gardner fails to disclose wherein deflating the expandable occlusion member comprises a deflation time of between one second and five seconds. However, Ehrenreich discloses wherein deflating the expandable occlusion member comprises a deflation time of between one second and five seconds (Fig. 4 and [0007, 0060], balloon 300 can be deflated in less than 5 sec, and preferably deflated in one second). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Gardner to incorporate the disclosures of Ehrenreich and modify the method to include deflating the expandable occlusion member comprises a deflation time of between one second and five seconds. Doing so would provide a catheter with rapid deflation, thus saving time which may be a critical factor during use for some patients (Ehrenreich, [0040, 0060]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm 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, BHISMA MEHTA can be reached at (571) 272-3383. 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. /SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/506,802 Page 2 Art Unit: 3783 Application/Control Number: 18/506,802 Page 3 Art Unit: 3783 Application/Control Number: 18/506,802 Page 4 Art Unit: 3783 Application/Control Number: 18/506,802 Page 5 Art Unit: 3783 Application/Control Number: 18/506,802 Page 6 Art Unit: 3783 Application/Control Number: 18/506,802 Page 7 Art Unit: 3783 Application/Control Number: 18/506,802 Page 8 Art Unit: 3783 Application/Control Number: 18/506,802 Page 9 Art Unit: 3783 Application/Control Number: 18/506,802 Page 10 Art Unit: 3783 Application/Control Number: 18/506,802 Page 11 Art Unit: 3783 Application/Control Number: 18/506,802 Page 12 Art Unit: 3783 Application/Control Number: 18/506,802 Page 13 Art Unit: 3783 Application/Control Number: 18/506,802 Page 14 Art Unit: 3783 Application/Control Number: 18/506,802 Page 15 Art Unit: 3783