CTNF 18/438,738 CTNF 70292 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 Objections Claim 13 is objected to because of the following informalities : Claim 13 recites "a plurality of peripheral lumen ports extending through the side wall and in fluid communication with the plurality of peripheral lumens" as the final element of the claim. However, the claim is missing the conjunction "and" before this final element , which renders the claim grammatically ambiguous as to whether this element is a separate limitation of the system or a continuation of the preceding clause. Applicant is required to correct this grammatical deficiency. 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 19 and 20 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 19 recites " a plurality of inner lumen ports extending through the side wall and in fluid communication with the inner lumen; and a plurality of outer lumen ports extending through the side wall and in fluid communication with the plurality of outer lumens ." However, the term " the side wall " lacks antecedent basis in claim 19. The claim recites "the elongate catheter shaft including a treatment zone" but never introduces " a side wall " of the elongate catheter shaft before referring to " the side wall. " This renders the claim indefinite because a person of ordinary skill in the art cannot determine the scope of the claimed "side wall." Claim 20 is rejected because it depends from claim 19 and therefore inherits the indefiniteness of claim 19. 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. 07-21-aia AIA Claim s 1-9, 11-12, 13-15, 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Christian Evans et al. (US 2005/0209578A1; hereinafter “Evans”) in view of Tran et al. (US 2014/0088630A1; hereinafter “Tran”) . Independent claim 1 recites a system for treating a vascular region, the system comprising : an elongate catheter shaft having a proximal region and a distal region, the elongate catheter shaft including: an inner lumen extending through the elongate catheter shaft, the inner lumen adapted to allow a cooling media to pass therethrough; a plurality of cooling media ports in fluid communication with the inner lumen; a drug delivery lumen extending adjacent to the inner lumen; and a plurality of drug delivery ports in fluid communication with the drug delivery lumen; and an ultrasound catheter adapted to be disposed within the inner lumen, the ultrasound catheter including a plurality of ultrasound transducers. In relation to independent claim 1 , the combination of Evans in view of Tran discloses the following limitations: Regarding the limitation of "a system for treating a vascular region ," Evans discloses at Paragraph [0051]: "FIG. 1 schematically illustrates an ultrasonic catheter 10 configured for use in the large vessels of a patient's anatomy. For example, the ultrasonic catheter 10 illustrated in FIG. 1 can be used to treat long segment peripheral arterial occlusions, such as those in the vascular system of the leg." Regarding the limitation of "an elongate catheter shaft having a proximal region and a distal region ," Evans discloses at Paragraph [0052]: "the ultrasonic catheter 10 generally includes a multi-component, elongate flexible tubular body 12 having a proximal region 14 and a distal region 15." Regarding the limitation of "an inner lumen extending through the elongate catheter shaft ," Evans discloses at Paragraph [0059]: "In an exemplary embodiment, the central lumen 51 extends through the length of the tubular body 12." Regarding the limitation of "a drug delivery lumen extending adjacent to the inner lumen, " Evans discloses at Paragraph [0057]: "three fluid delivery lumens 30 are incorporated into the tubular body 12... the arrangement of the fluid delivery lumens 30 provides a hollow central lumen 51 passing through the tubular body 12." Regarding the limitation of "a plurality of drug delivery ports in fluid communication with the drug delivery lumen ," Evans discloses at Paragraph [0075]: "holes or slits are formed from the fluid delivery lumen 30 through the tubular body 12, thereby permitting fluid flow from the fluid delivery lumen 30 to the treatment site. A plurality of fluid delivery ports 58 can be positioned axially along the tubular body 12." Regarding the limitation of "an ultrasound catheter adapted to be disposed within the inner lumen ," Evans discloses at Paragraph [0060]: "The central lumen 51 is configured to receive an elongate inner core 34." Regarding the limitation of "the ultrasound catheter including a plurality of ultrasound transducers, " Evans discloses at Paragraph [0060]: "One or more ultrasound radiating members 40 are positioned within an inner core energy delivery section 41." Evans does not explicitly disclose that the inner lumen is adapted to allow a cooling media to pass therethrough, nor does it disclose a plurality of cooling media ports in fluid communication with the inner lumen . Evans discloses cooling fluid lumens at Paragraph [0079]: "placement of the inner core 34 within the tubular body 12 further defines cooling fluid lumens 44. Cooling fluid lumens 44 are formed between an outer surface 39 of the inner core 34 and an inner surface 16 of the tubular body 12." Evans does not disclose cooling media ports extending from the inner lumen through the side wall to the exterior . However, Tran discloses at Paragraph [0004]: "Ultrasound transducers may dissipate some energy as heat into the blood and surrounding tissue as well as causing the ultrasound transducers to become hot. This may result in blood damage, clotting, and/or protein fouling of the transducer among other undesirable side effects." Tran further discloses at Paragraph [0027]: "Ultrasound ablation catheters may also generate significant heat in the ultrasound transducers may cause clots to form on the transducers, damage to the blood, or damage to the transducers among other undesirable side effects. As the ablation transducers heat, the energy conversion efficiency of those devices is lowered, thus generating more heat... The efficiency of the ablation transducers may be enhanced using a cooling mechanism. One possible cooling mechanism is increasing the flow of blood past the transducers, providing passive cooling to the ablation transducers ." Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Evans to include cooling media ports in fluid communication with the inner lumen to allow cooling media to pass therethrough and exit the catheter , as taught by Tran. The motivation to combine is explicitly provided by Tran at Paragraph [0027], which teaches that cooling mechanisms are necessary to prevent overheating, blood damage, and clotting of ultrasound transducers. One of ordinary skill in the art would have been motivated to add cooling media ports to the inner lumen of Evans's catheter to provide the active cooling taught by Tran, with a reasonable expectation of success given that Evans already discloses a cooling fluid fitting hydraulically connected to the central lumen (Paragraph [0059]). Independent claim 13 recites a system for treating a vascular region, the system comprising : an ultrasound catheter including a plurality of ultrasound transducers; an elongate catheter shaft defining a central lumen and a plurality of peripheral lumens extending through the elongate catheter shaft, the central lumen adapted to accommodate the ultrasound catheter extending therethrough, the elongate catheter shaft including a side wall; a plurality of central lumen ports extending through the side wall and in fluid communication with the central lumen; a plurality of peripheral lumen ports extending through the side wall and in fluid communication with the plurality of peripheral lumens. In relation to independent claim 13 , the combination of Evans in view of Tran discloses: Regarding the limitation of "an ultrasound catheter including a plurality of ultrasound transducers ," Evans discloses at Paragraph [0060]: "One or more ultrasound radiating members 40 are positioned within an inner core energy delivery section 41." Regarding the limitation of "an elongate catheter shaft defining a central lumen and a plurality of peripheral lumens extending through the elongate catheter shaft ," Evans discloses at Paragraph [0057]: "three fluid delivery lumens 30 are incorporated into the tubular body 12... the arrangement of the fluid delivery lumens 30 provides a hollow central lumen 51 passing through the tubular body 12." Regarding the limitation of "the central lumen adapted to accommodate the ultrasound catheter extending therethrough ," Evans discloses at Paragraph [0060]: "The central lumen 51 is configured to receive an elongate inner core 34." Regarding the limitation of "a plurality of peripheral lumen ports extending through the side wall and in fluid communication with the plurality of peripheral lumens ," Evans discloses at Paragraph [0075]: "holes or slits are formed from the fluid delivery lumen 30 through the tubular body 12, thereby permitting fluid flow from the fluid delivery lumen 30 to the treatment site." Evans does not explicitly disclose a plurality of central lumen ports extending through the side wall and in fluid communication with the central lumen. However, Tran discloses at Paragraph [0027]: "The efficiency of the ablation transducers may be enhanced using a cooling mechanism. One possible cooling mechanism is increasing the flow of blood past the transducers , providing passive cooling to the ablation transducers." Based on the above teachings, it would have been obvious to provide ports extending from the central lumen (which carries cooling fluid in Evans, as stated at Paragraph [0059]: "the backend hub also includes a cooling fluid fitting 46, which is hydraulically connected to the central lumen 51") through the side wall to allow cooling fluid to exit laterally and cool the surrounding tissue and transducers, as taught by Tran at Paragraph [0027]. Independent claim 19 recites a system for treating a vascular region comprising : an ultrasound catheter including a plurality of ultrasound transducers; an elongate catheter shaft defining an inner lumen and a plurality of outer lumens extending through the elongate catheter shaft, the inner lumen adapted to accommodate the ultrasound catheter extending therethrough, the elongate catheter shaft including a treatment zone that corresponds to where the plurality of ultrasound transducers are when the ultrasound catheter is disposed within the inner lumen; a plurality of inner lumen ports extending through the side wall and in fluid communication with the inner lumen; and a plurality of outer lumen ports extending through the side wall and in fluid communication with the plurality of outer lumens. In relation to independent claim 19 , the limitations of claim 19 are substantially similar to those of claim 13, with the inner lumen corresponding to the central lumen, the outer lumens corresponding to the peripheral lumens, and the treatment zone corresponding to the energy delivery section. The rejection of claim 13 is incorporated herein by reference. Regarding the additional limitation of "a treatment zone that corresponds to where the plurality of ultrasound transducers are when the ultrasound catheter is disposed within the inner lumen, " Evans discloses at Paragraph [0052]: "The tubular body 12 includes a flexible energy delivery section 18 located in the distal region 15," and at Paragraph [0074]: "the inner core 34 can be slid within the central lumen 51 of the tubular body 12, thereby allowing the inner core energy delivery section 41 to be positioned within the tubular body energy delivery section 18." Thus, the energy delivery section 18 of Evans corresponds to the claimed treatment zone. Accordingly, in view of the conventionality of the claimed enhancements, their implementation in the invention would have been considered an obvious alternative in the design of the system. In relation to claim 2 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Regarding the limitation that the inner lumen allows cooling media to pass therethrough when the ultrasound catheter is disposed within the inner lumen, Evans discloses at Paragraph [0079]: "placement of the inner core 34 within the tubular body 12 further defines cooling fluid lumens 44. Cooling fluid lumens 44 are formed between an outer surface 39 of the inner core 34 and an inner surface 16 of the tubular body 12. In certain embodiments, a cooling fluid is introduced through the proximal access port 31 such that cooling fluid flows through cooling fluid lumens 44 and out of the catheter 10 through distal exit port 29." Thus, the inner lumen allows cooling media to pass therethrough when the ultrasound catheter (inner core 34) is disposed within it. Evans does not disclose cooling media ports extending from the inner lumen to the exterior. However, Tran discloses at Paragraph [0004]: "Ultrasound transducers may dissipate some energy as heat into the blood and surrounding tissue as well as causing the ultrasound transducers to become hot. This may result in blood damage, clotting, and/or protein fouling of the transducer among other undesirable side effects." Tran further discloses at Paragraph [0027]: "Ultrasound ablation catheters may also generate significant heat in the ultrasound transducers may cause clots to form on the transducers, damage to the blood, or damage to the transducers among other undesirable side effects. As the ablation transducers heat, the energy conversion efficiency of those devices is lowered, thus generating more heat... The efficiency of the ablation transducers may be enhanced using a cooling mechanism. One possible cooling mechanism is increasing the flow of blood past the transducers, providing passive cooling to the ablation transducers ." Based on the above teachings, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Evans to include cooling media ports in fluid communication with the inner lumen to allow cooling media to pass therethrough and exit the catheter, as taught by Tran. The motivation to combine is explicitly provided by Tran at Paragraph [0027], which teaches that cooling mechanisms are necessary to prevent overheating, blood damage, and clotting of ultrasound transducers. One of ordinary skill in the art would have been motivated to add cooling media ports to the inner lumen of Evans's catheter to provide the active cooling taught by Tran, with a reasonable expectation of success given that Evans already discloses a cooling fluid fitting hydraulically connected to the central lumen (Paragraph [0059]). In relation to claim 3 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Regarding the limitation that the cooling media ports are disposed within the distal region, Evans discloses at Paragraph [0075]: "FIG. 8 further illustrates placement of fluid delivery ports 58 within the tubular body energy delivery section 18." Evans further discloses at Paragraph [0052] that the energy delivery section is "located in the distal region 15." Based on the above teachings, it would have been obvious to locate the cooling media ports in the distal region as well, to provide cooling directly to the ultrasound transducers located in that region, as taught by Tran at Paragraph [0027]. In relation to claim 4 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Regarding the limitation that the cooling media ports extend through a side wall, Evans discloses at Paragraph [0075]: "holes or slits are formed from the fluid delivery lumen 30 through the tubular body 12." Accordingly, it would have been obvious to form the cooling media ports through the side wall of the tubular body in a similar manner to allow the cooling fluid to exit the catheter and cool the surrounding area and transducers. In relation to claim 5 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Regarding the limitation that the cooling media ports are axially spaced, Evans discloses at Paragraph [0075]: "A plurality of fluid delivery ports 58 can be positioned axially along the tubular body 12." Therefore, it would have been obvious to axially space the cooling media ports in a similar manner to provide uniform cooling along the length of the energy delivery section. In relation to claim 6 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Evans does not explicitly disclose cooling media ports axially aligned with the ultrasound transducers. Tran discloses at Paragraph [0027] that "The efficiency of the ablation transducers may be enhanced using a cooling mechanism." Accordingly, it would have been obvious to align the cooling media ports with the ultrasound transducers to maximize the cooling effect directly at the source of the heat generation, as suggested by the cooling goals of Tran. In relation to claim 8 , Evans discloses at Paragraph [0075]: "FIG. 8 further illustrates placement of fluid delivery ports 58 within the tubular body energy delivery section 18." Evans further discloses at Paragraph [0052] that the energy delivery section is "located in the distal region 15." Thus, Evans discloses the limitation that the drug delivery ports are disposed within the distal region of the elongate catheter shaft. Accordingly, in view of the conventionality of the claimed enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the system. In relation to claim 9 , Evans discloses at Paragraph [0075]: "holes or slits are formed from the fluid delivery lumen 30 through the tubular body 12, thereby permitting fluid flow from the fluid delivery lumen 30 to the treatment site." Thus, Evans discloses the limitation that the drug delivery ports extend through a side wall of the elongate catheter shaft. Accordingly, in view of the conventionality of the claimed enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the system. In relation to claim 11 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Evans discloses at Paragraph [0076]: "By spacing the fluid delivery lumens 30 around the circumference of the tubular body 12 substantially evenly, as illustrated in FIG. 8, a substantially uniform flow of therapeutic compound around the circumference of the tubular body 12 can be achieved." Accordingly, it would have been obvious to space the drug delivery ports and cooling media ports axially and/or circumferentially from each other to ensure even distribution of both fluids without interference. In relation to claim 12 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 1. Evans discloses a distal exit port where cooling fluid can pass into the vasculature, stating at Paragraph [0081]: "the fluid delivery lumens 30 and the cooling fluid lumens 44 are open at the distal end of the tubular body 12, thereby allowing the therapeutic compound and the cooling fluid to pass into the patient's vasculature at the distal exit port 29." Evans further discloses selective occlusion at Paragraph [0081]: "the fluid delivery lumens 30 can be selectively occluded at the distal end of the tubular body 12, thereby providing additional hydraulic pressure to drive the therapeutic compound out of the fluid delivery ports 58." Evans does not explicitly disclose the elongate catheter shaft and the ultrasound catheter adapted to selectively open or close the terminal cooling media port. Tran teaches at Paragraph [0027] the need for cooling mechanisms. Therefore, it would have been obvious to adapt the inner core and catheter shaft to selectively open or close the terminal port to control the hydraulic pressure and direct fluid flow either out the side ports or the terminal port, as Evans already teaches selective occlusion of lumens at the distal end. In relation to claim 14 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 13. It would have been obvious to axially space the central lumen ports to provide uniform cooling along the length of the catheter, similar to the axial spacing of the fluid delivery ports in Evans, which states at Paragraph [0075]: "A plurality of fluid delivery ports 58 can be positioned axially along the tubular body 12." In relation to claim 15 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 13. Evans does not explicitly disclose central lumen ports axially aligned with the ultrasound transducers. However, Tran discloses at Paragraph [0027] that cooling mechanisms are necessary to prevent overheating of ultrasound transducers. Therefore, it would have been obvious to align the central lumen ports with the transducers to provide direct cooling to the heat-generating elements. In relation to claim 18 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 13. Evans discloses at Paragraph [0076]: "By spacing the fluid delivery lumens 30 around the circumference of the tubular body 12 substantially evenly, as illustrated in FIG. 8, a substantially uniform flow of therapeutic compound around the circumference of the tubular body 12 can be achieved." Therefore, it would have been obvious to space the central and peripheral ports from each other to ensure even distribution of cooling fluid and therapeutic compounds without interference. In relation to claim 20 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran for the reasons set forth in the rejection of claim 19. Evans discloses that fluid delivery ports (outer lumen ports) are disposed within the energy delivery section (treatment zone), stating at Paragraph [0075]: "FIG. 8 further illustrates placement of fluid delivery ports 58 within the tubular body energy delivery section 18." Evans does not explicitly disclose inner lumen ports disposed within the treatment zone. However, Tran discloses at Paragraph [0027] that cooling mechanisms are necessary to prevent overheating of ultrasound transducers. Therefore, it would have been obvious to also locate the inner lumen ports in the treatment zone to provide cooling directly to the transducers located in that zone . 07-21-aia AIA Claim s 7, 10, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Evans (US 2005/0209578A1) in view of Tran (US 2014/0088630A1), as discussed above, and in further view of Wilson (US 2007/0112296A1) . In relation to claim 7 , Evans and Tran do not explicitly disclose a spiral configuration for the cooling media ports. However, Wilson discloses at Paragraph [0074]: "In a modified embodiment, such as illustrated in FIG. 7D, the common wire 108 is twisted to form a helical shape before being fixed within the inner core 34. In such embodiments, the ultrasound radiating members 40 are oriented in a plurality of radial directions, thus enhancing the radial uniformity of the resulting ultrasonic energy field." Therefore, it would have been obvious to arrange the cooling media ports in a corresponding spiral or helical configuration to match the helical transducer arrangement taught by Wilson, so as to provide uniform 360-degree cooling and fluid delivery corresponding to the radially distributed transducers. In relation to claim 10 , Evans does not explicitly disclose drug delivery ports arranged in a spiral configuration. However, Wilson discloses at Paragraph [0074]: "In a modified embodiment, such as illustrated in FIG. 7D, the common wire 108 is twisted to form a helical shape before being fixed within the inner core 34. In such embodiments, the ultrasound radiating members 40 are oriented in a plurality of radial directions, thus enhancing the radial uniformity of the resulting ultrasonic energy field." Therefore, it would have been obvious to arrange the drug delivery ports in a spiral configuration to provide uniform, 360-degree drug delivery to the vessel wall, corresponding to the helical transducer arrangement taught by Wilson, with a reasonable expectation of success. In relation to claim 16 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Tran and Wilson for the reasons set forth in the rejection of claim 7. Wilson discloses at Paragraph [0074]: "the common wire 108 is twisted to form a helical shape before being fixed within the inner core 34. In such embodiments, the ultrasound radiating members 40 are oriented in a plurality of radial directions, thus enhancing the radial uniformity of the resulting ultrasonic energy field." Therefore, it would have been obvious to arrange the central lumen ports in a corresponding spiral configuration to match the helical transducer arrangement for uniform cooling. In relation to claim 17 , this claim is rejected under 35 U.S.C. § 103 as being unpatentable over Evans in view of Wilson for the reasons set forth in the rejection of claim 10. Wilson discloses at Paragraph [0074]: "the common wire 108 is twisted to form a helical shape before being fixed within the inner core 34. In such embodiments, the ultrasound radiating members 40 are oriented in a plurality of radial directions." Therefore, it would have been obvious to arrange the peripheral (drug delivery) ports in a spiral configuration to provide uniform, 360-degree drug delivery corresponding to the helical transducer arrangement. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM. 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. Respectfully submitted, /MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783 Application/Control Number: 18/438,738 Page 2 Art Unit: 3783 Application/Control Number: 18/438,738 Page 4 Art Unit: 3783 Application/Control Number: 18/438,738 Page 5 Art Unit: 3783 Application/Control Number: 18/438,738 Page 6 Art Unit: 3783 Application/Control Number: 18/438,738 Page 7 Art Unit: 3783 Application/Control Number: 18/438,738 Page 8 Art Unit: 3783 Application/Control Number: 18/438,738 Page 9 Art Unit: 3783 Application/Control Number: 18/438,738 Page 10 Art Unit: 3783 Application/Control Number: 18/438,738 Page 11 Art Unit: 3783 Application/Control Number: 18/438,738 Page 12 Art Unit: 3783 Application/Control Number: 18/438,738 Page 13 Art Unit: 3783