CTNF 18/969,841 CTNF 101393 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112(b) 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 Claim 7 is 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 7 recites, “wherein the top layer is free from a therapeutic agent.” It is not clear, based on the language of the claim, what “free from a therapeutic agent” means. Free from could mean that the layer does not comprise a therapeutic agent. Or, it could also mean that it is a separate layer that is disposed away from the therapeutic agent in the coating. For examination purposes, it is interpreted that “free from a therapeutic agent” means the layer is disposed away from the drug eluting coating, and that it does not comprise a therapeutic agent. 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) 1 is rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by Hanson et al. (US 20190275224 A1, “Hanson”) . Regarding claim 1, Hanson teaches a percutaneous circulatory support device (Abstract: "Devices and methods for assisting blood flow are provided") comprising: a flexible elongate shaft (catheter shaft 115) ; a percutaneous blood pump ("blood assist device" 110) coupled to a distal end region of the flexible elongate shaft (115) at a junction, the percutaneous blood pump (110) configured to pump blood through a housing ("housing" 120) of the percutaneous blood pump during use; and a drug eluting coating (para. [0091]: "the device 110, 210 (and variations, systems or components thereof disclosed herein) may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents … ") disposed on at least a portion of a surface of the percutaneous blood pump (110) . 07-15 AIA Claim s 1, 9, 12, and 13 are rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by Gong (US 20230115631 A1) . Regarding claim 1 , Gong teaches a percutaneous circulatory support device (Fig. 1A; catheter pump 100A) comprising: a flexible elongate shaft (Fig. 1B; elongate body 174A) ; a percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") coupled to a distal end region of the flexible elongate shaft (Fig. 1B; 174A) at a junction, the percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") configured to pump blood through a housing (para. [0052]: "As explained above, the impeller assembly 116A can include an expandable cannula or housing and an impeller with one or more blades.") of the percutaneous blood pump (100A) during use; and a drug eluting coating ( para. [0104]: "] In some embodiments, a semi-durable coating (e.g., a thin film) having a time-release matrix of nanosphere particles, as described herein, may be applied to any surface of catheter pump 100A.") disposed on at least a portion of a surface of the percutaneous blood pump (100A). Regarding claim 9 , Gong teaches the percutaneous circulatory support device of claim 1 (see 102 rejection above) , wherein the percutaneous blood pump comprises: a flexible cannula (Fig. 1B; para. [0052]: "As explained above, the impeller assembly 116A can include an expandable cannula"); an impeller housing (Fig. 1A-C; para. [0055]: " The funnel may be gently curved such that relative proximal movement of the impeller housing causes the impeller housing to be collapsed by the funnel 1415. During or after the impeller housing has been fully collapsed, the distal end 170A"); and a motor housing (Fig. 1A-C; para. [0059]: " the motor housing and the motor are disposable components. However, in other implementations, the coupling between the motor housing and the catheter assembly 101 is disengageable, such that the motor and motor housing can be decoupled from the catheter assembly 101 after use."). Regarding claim 12, Gong teaches the percutaneous circulatory support device of claim 9 (see 102 rejection above), wherein the drug eluting coating is disposed on an inner surface of the flexible cannula (para. [0104]: "In some embodiments, a semi-durable coating (e.g., a thin film) having a time-release matrix of nanosphere particles, as described herein, may be applied to any surface of catheter pump 100A. For example, in some embodiments, the nanosphere coating may include lubricant nanospheres, anticoagulant nanospheres, anti-foaming nanospheres, hydrophilic nanospheres, thrombin inhibitors (e.g., bivalirudin, argatroban, and the like) and/or any combination of these."; para. [0106]: "Moreover, although any desired surface of catheter pump 100A may be coated, in at least some embodiments, example surfaces that may be coated include seals, thrust bearings, journal bearings, ball bearings, corners and other angled surfaces, “dead” spaces in which fluid flow may tend to stagnate or pool, and the like."). Regarding claim 13, Gong teaches the percutaneous circulatory support device of claim 9 (see rejection above) , wherein the drug eluting coating is disposed on a portion of the impeller housing. (para. [0104]: "In some embodiments, a semi-durable coating (e.g., a thin film) having a time-release matrix of nanosphere particles, as described herein, may be applied to any surface of catheter pump 100A. For example, in some embodiments, the nanosphere coating may include lubricant nanospheres, anticoagulant nanospheres, anti-foaming nanospheres, hydrophilic nanospheres, thrombin inhibitors (e.g., bivalirudin, argatroban, and the like) and/or any combination of these."; para.[0106]: "Moreover, although any desired surface of catheter pump 100A may be coated, in at least some embodiments, example surfaces that may be coated include seals, thrust bearings, journal bearings, ball bearings, corners and other angled surfaces, “dead” spaces in which fluid flow may tend to stagnate or pool, and the like.") . 07-15 AIA Claim 1 is rejected under 35 U.S.C. 102( a)(1)/(a)(2 ) as being anticipated by Alexander et al. (US 20230381492 A1, “Alexander”) . Regarding claim 1, Alexander teaches a percutaneous circulatory support device (abstract: "A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers.") comprising: a flexible elongate shaft (Fig. 157A; "flexible shaft 1704"); a percutaneous blood pump (Fig. 157A and B; para. [0667]: ". Then, the motors and shafts are held in place with the catheter pulled towards the motors, so that the contra-rotating blades of impellers 1710, 1712 and the hourglass frame 1714 are expanded in the vasculature for use as a blood pump.") coupled to a distal end region of the flexible elongate shaft at a junction (para. [0667]: " The contra-rotating impellers 1710, 1712 and the hourglass frame 1714 are held by the flexible shaft 1704"), the percutaneous blood pump configured to pump blood through a housing (para. [0667]: "hourglass frame 1714"; para. [0760]: "In some embodiments, the waist of the hourglass frame, or the waist and the diffuser, is covered with a biocompatible material. In some embodiments, the biocompatible material acts as a housing to the at least two contra-rotating non-magnetic impellers.") of the percutaneous blood pump during use; and a drug eluting coating disposed on at least a portion of a surface of the percutaneous blood pump. (para. [0593]: "The holes or openings 1776 in the biocompatible coating or material 1774 of the membrane…The material 1774 can be coated with antithrombotic anticoagulant coating."; para. [0760]: " In some embodiments, the material comprises antithrombotic and/or anticoagulant and/or drug-eluting coating.") . 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 2, 3, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gong (US 20230115631 A1) in view of Mazur (US 20100209263 A1) . Regarding claim 2 , Gong teaches the percutaneous circulatory support device of claim 1 (see 102 rejection above) , wherein the drug eluting coating comprises: a direct oral anticoagulant (DOAC). (para. [0104]: "argatroban”). However, Gong does not expressly teach wherein the drug eluting coating comprises an excipient. Mazur, in the same field of endeavor of circulatory assist pumps, discloses a drug eluting coating. Mazur discloses wherein a drug eluting coating comprises an excipient (Fig. 4A and 5A; para. [0022]: "The fluid conduit 160 is preferably made of medical-grade polyurethane, and more preferably from a profile extrusion of thermoplastic polyurethane for durability and greater strength and toughness than other thermoset materials…The fluid conduit 160 may be further treated to include an internal coating of heparin, an anticoagulant, to reduce the tendency of blood clots as blood passes through the fluid pump."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1, as disclosed by Gong, to include an excipient, as disclosed by Mazur. An excipient, as disclosed in para. [0022] of Mazur, would provide the advantage of preventing blood clots when using an excipient with an anticoagulant. Therefore, it would have been obvious to implement an excipient into the device of Gong, who is also in the same field of circulatory assist pumps and is concerned with preventing blood clots. Regarding claim 3, Gong, in combination with Mazur, discloses the percutaneous circulatory support device of claim 2 (see above). Mazur further discloses wherein the excipient comprises a thermoplastic polyurethane. (Fig. 4A and 5A; para. [0022]: "The fluid conduit 160 is preferably made of medical-grade polyurethane, and more preferably from a profile extrusion of thermoplastic polyurethane for durability and greater strength and toughness than other thermoset materials…The fluid conduit 160 may be further treated to include an internal coating of heparin, an anticoagulant, to reduce the tendency of blood clots as blood passes through the fluid pump."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 2, as disclosed by Gong in combination with Mazur, to include thermoplastic polyurethane, as disclosed by Mazur. An excipient, as disclosed in para. [0022] of Mazur, would provide the advantage of preventing blood clots when using an excipient with an anticoagulant. One of ordinary skill would recognize that thermoplastic polyurethane would yield a reasonable expectation of success as an excipient for preventing blood clots. Therefore, it would have been obvious to implement an excipient into the device of Gong, who is also in the same field of circulatory assist pumps and is concerned with preventing blood clots. Regarding claim 16, Gong teaches a percutaneous circulatory support device (Fig. 1A; catheter pump 100A) comprising: a flexible elongate shaft (Fig. 1B; elongate body 174A) ; a percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") coupled to a distal end region of the flexible elongate shaft (Fig. 1B; 174A) at a junction, the percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") configured to pump blood through a housing (para. [0052]: "As explained above, the impeller assembly 116A can include an expandable cannula or housing and an impeller with one or more blades.") of the percutaneous blood pump (100A) during use; and a drug eluting coating (para. [0104]: "] In some embodiments, a semi-durable coating (e.g., a thin film) having a time-release matrix of nanosphere particles, as described herein, may be applied to any surface of catheter pump 100A.") disposed on at least a portion of a surface of the percutaneous blood pump (100A), wherein the drug eluting coating comprises: a direct oral anticoagulant (DOAC). (para. [0104]: "argatroban”). However, Gong does not expressly teach wherein the drug eluting coating comprises an excipient. Mazur, in the same field of endeavor of circulatory assist pumps, discloses a drug eluting coating. Mazur discloses wherein a drug eluting coating comprises an excipient (Fig. 4A and 5A; para. [0022]: "The fluid conduit 160 is preferably made of medical-grade polyurethane, and more preferably from a profile extrusion of thermoplastic polyurethane for durability and greater strength and toughness than other thermoset materials…The fluid conduit 160 may be further treated to include an internal coating of heparin, an anticoagulant, to reduce the tendency of blood clots as blood passes through the fluid pump."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1, as disclosed by Gong, to include an excipient, as disclosed by Mazur. An excipient, as disclosed in para. [0022] of Mazur, would provide the advantage of preventing blood clots when using an excipient with an anticoagulant. Therefore, it would have been obvious to implement an excipient into the device of Gong, who is also in the same field of circulatory assist pumps and is concerned with preventing blood clots. Regarding claim 20 , Gong teaches a percutaneous circulatory support device (Fig. 1A; catheter pump 100A) comprising: a flexible elongate shaft (Fig. 1B; elongate body 174A) ; a percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") including a flexible cannula (Fig. 1B; para. [0052]: "As explained above, the impeller assembly 116A can include an expandable cannula"); an impeller housing (Fig. 1A-C; para. [0055]: " The funnel may be gently curved such that relative proximal movement of the impeller housing causes the impeller housing to be collapsed by the funnel 1415. During or after the impeller housing has been fully collapsed, the distal end 170A"); and a motor housing (Fig. 1A-C; para. [0059]: " the motor housing and the motor are disposable components. However, in other implementations, the coupling between the motor housing and the catheter assembly 101 is disengageable, such that the motor and motor housing can be decoupled from the catheter assembly 101 after use."). the percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") coupled to a distal end region of the flexible elongate shaft (Fig. 1B; 174A) at a junction, the percutaneous blood pump (para. [0044]: "motor assembly 1" and para. [0045]: "impeller assembly 116A") configured to pump blood through a housing (para. [0052]: "As explained above, the impeller assembly 116A can include an expandable cannula or housing and an impeller with one or more blades.") of the percutaneous blood pump (100A) during use; and a drug eluting coating ( para. [0104]: "] In some embodiments, a semi-durable coating (e.g., a thin film) having a time-release matrix of nanosphere particles, as described herein, may be applied to any surface of catheter pump 100A.") disposed on at least a portion of a surface of the percutaneous blood pump (100A) , wherein the drug eluting coating comprises: a direct oral anticoagulant (DOAC). (para. [0104]: "argatroban”). However, Gong does not expressly teach wherein the drug eluting coating comprises an excipient. Mazur, in the same field of endeavor of circulatory assist pumps, discloses a drug eluting coating. Mazur discloses wherein a drug eluting coating comprises an excipient (Fig. 4A and 5A; para. [0022]: "The fluid conduit 160 is preferably made of medical-grade polyurethane, and more preferably from a profile extrusion of thermoplastic polyurethane for durability and greater strength and toughness than other thermoset materials…The fluid conduit 160 may be further treated to include an internal coating of heparin, an anticoagulant, to reduce the tendency of blood clots as blood passes through the fluid pump."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1, as disclosed by Gong, to include an excipient, as disclosed by Mazur. An excipient, as disclosed in para. [0022] of Mazur, would provide the advantage of preventing blood clots when using an excipient with an anticoagulant. Therefore, it would have been obvious to implement an excipient into the device of Gong, who is also in the same field of circulatory assist pumps and is concerned with preventing blood clots . 07-21-aia AIA Claim s 4, 5, 8, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gong (US 20230115631 A1), Mazur (US 20100209263 A1), and Kangas et al. (US 20230011767 A1, “Kangas”) . Regarding claim 4 and 5, Gong, in combination with Mazur, discloses the percutaneous circulatory support device of claim 2 (see rejection above). However, neither reference discloses wherein an excipient comprises in the range of about 60 to 95 weight percent of the drug eluting coating and the DOAC comprises in the range of about 5 to 40 weight percent of the drug eluting coating (claim 4); or wherein the excipient comprises in the range of about 50 to 70 weight percent of the drug eluting coating and the DOAC comprises in the range of about 30 to 50 weight percent of the drug eluting coating. (claim 5). Kangas, concerned with the same problem of blood clots, discloses a direct oral anticoagulant-eluting medical device. Kangas discloses wherein the excipient comprises in the range of about 60 to 95 weight percent of the drug eluting coating and the DOAC comprises in the range of about 5 to 40 weight percent of the drug eluting coating. (para. [0057]: "The polymer to drug ratio may be, for example, 50/50 to 90/10 (weight/weight). Some examples include a polymer to drug ration of 60/40, 70/30, or 80/20 (weight/weight)."); and wherein the excipient comprises in the range of about 50 to 70 weight percent of the drug eluting coating and the DOAC comprises in the range of about 30 to 50 weight percent of the drug eluting coating. (para/ [0057]: "The polymer to drug ratio may be, for example, 50/50 to 90/10 (weight/weight). Some examples include a polymer to drug ration of 60/40, 70/30, or 80/20 (weight/weight)."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 2, as disclosed by Gong in combination with Mazur, to include the ratios of anticoagulant to excipient, as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that this ratio of excipient to anticoagulant is effective to prevent blood clots when used as the coating on a medical device. Further, one of ordinary skill would recognize that a polymer, as disclosed by Kangas, could be used as an excipient. Therefore, to limit blood clots effectively, it would have been an obvious improvement to include this ratio of anticoagulant to excipient in the device of Gong. Regarding claim 8, Gong, in combination with Mazur, discloses the percutaneous circulatory support device of claim 2 (see above). However, neither reference discloses wherein the DOAC is present in the drug eluting coating in an amount of between 1-40 micrograms per square millimeter. Kangas discloses wherein the DOAC is present in the drug eluting coating in an amount of between 1-40 micrograms per square millimeter. (para. [0057]: " The spray coating may be performed on the membrane before the membrane is attached to the support structure, or it may be performed after the membrane is attached to the support structure. The polymer coating may be applied to achieve a coat density of between 100-50,000 ng drug/mm.sup.2 on the membrane. In some examples, the polymer coating may be applied to achieve a coat density of 10,000 ng drug/mm.sup.2 on the membrane. The polymer to drug ratio may be, for example, 50/50 to 90/10 (weight/weight). Some examples include a polymer to drug ration of 60/40, 70/30, or 80/20 (weight/weight)"; In the disclosed ratios of polymer (excipient) to drug, the drug would be within the disclosed range of 1-40 micrograms/square mm). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 2, as disclosed by Gong in combination with Mazur, to include the amount of DOAC present in the drug eluting coating, as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that this ratio of excipient to anticoagulant is effective to prevent blood clots when used as the coating on a medical device. Further, one of ordinary skill would recognize that a polymer, as disclosed by Kangas, could be used as an excipient. Therefore, to limit blood clots effectively, it would have been an obvious improvement to include this amount of DOAC in the device of Gong. Regarding claim 14, Gong, in combination with Mazur, discloses the percutaneous circulatory support device of claim 2 (see above). However, neither reference discloses wherein the DOAC is apixaban, rivaroxaban, or edoxaban. Kangas discloses wherein the DOAC is apixaban, rivaroxaban, or edoxaban. (para. [0005]: "Alternatively or additionally to the embodiment above, the DOAC is apixaban, rivaroxaban, or edoxaban."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 2, as disclosed by Gong in combination with Mazur, to include where the DOAC is apixaban, rivaroxaban, or edoxaban, as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that the disclosed DOACs are effective at preventing blood clots. Therefore, it would have been an obvious improvement to include the specific DOAC types in the device of Gong. Regarding claim 19 , Gong, in combination with Mazur, discloses the percutaneous circulatory support device of claim 16 (see 103 rejection above). However, the references do not disclose a top layer disposed over the drug eluting coating. Kangas discloses a top layer disposed over the drug eluting coating. (para. [0020]: "Alternatively or additionally to any of the embodiments above, the film includes a base layer with the DOAC and a top layer with a modulating compound."; para. [0063]: "For example, the thin film 160 may include a base layer of polymer and anticoagulant and a top layer including a modulating compound."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 16, as disclosed by Gong and Mazur, to include the top layer as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that a top layer disposed over the drug eluting coating is effective to prevent blood clots when used as the coating on a medical device. Therefore, to limit blood clots effectively, it would have been an obvious improvement to the device of Gong to include the top layer of coating, as disclosed by Kangas . 07-21-aia AIA Claim s 6, 7, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gong (US 20230115631 A1) in view of Kangas et al. (US 20230011767 A1, “Kangas”) . Regarding claims 6 and 7, Gong discloses the percutaneous circulatory support device of claim 1 (see 102 rejection above). However, Gong does not expressly teach a top layer disposed over the drug eluting coating (claim 6); and wherein the top layer is free from a therapeutic agent (claim 7). Kangas, concerned with the same problem of blood clots, discloses a direct oral anticoagulant-eluting medical device. Kangas discloses a top layer disposed over the drug eluting coating. (para. [0020]: "Alternatively or additionally to any of the embodiments above, the film includes a base layer with the DOAC and a top layer with a modulating compound."; para. [0063]: "For example, the thin film 160 may include a base layer of polymer and anticoagulant and a top layer including a modulating compound."); and wherein the top layer is free from a therapeutic agent (para. [0020]: "Alternatively or additionally to any of the embodiments above, the film includes a base layer with the DOAC and a top layer with a modulating compound."; para. [0063]: "For example, the thin film 160 may include a base layer of polymer and anticoagulant and a top layer including a modulating compound."; The modulating compound is not a therapeutic agent). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1, as disclosed by Gong, to include the top layer that is also free of therapeutic agent, as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that a top layer that is free of therapeutic agent is effective to prevent blood clots when used as the coating on a medical device. Therefore, to limit blood clots effectively, it would have been an obvious improvement to include the top layer that is free of therapeutic agent in the device of Gong. Regarding claim 15, Gong discloses the percutaneous circulatory support device of claim 1 (see 102 rejection above). However, Gong does not expressly teach, wherein the drug eluting coating has a thickness in the range of about 1 to 50 micrometers. Kangas discloses wherein the drug eluting coating has a thickness in the range of about 1 to 50 micrometers. (para. [0057]: "The average coating thickness on the membrane may be about 10-30 μm."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1, as disclosed by Gong, to include the thickness of about 1-50 micrometers, as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that the disclosed thickness has proven effective in preventing blood clots when used as the coating on a medical device. Therefore, it would have been an obvious improvement to include this thickness of coating in the device of Gong . 07-21-aia AIA Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gong (US 20230115631 A1), Mazur (US 20100209263 A1), and Hunter et al. (US 20070197957 A1, “Hunter”) . Regarding claim 17 , Gong, in combination with Mazur, discloses the percutaneous circulatory support device of claim 16 (see 103 rejection above). However, neither reference discloses wherein the anticoagulant comprises a factor Xa inhibitor. Hunter, concerned with the same problem of preventing blood clots, discloses wherein an anticoagulant comprises a factor Xa inhibitor (para. [1314]: "Implantable pump and sensor devices and compositions for use with implantable pump and sensor devices may further include an anti-thrombotic agent and/or antiplatelet agent and/or a thrombolytic agent, which reduces the likelihood of thrombotic events upon implantation of a medical implant…Representative examples of anti-thrombotic and/or antiplatelet and/or thrombolytic agents include…Xa inhibitors"). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 16, as disclosed by Gong and Mazur, with the Xa inhibitor anticoagulant for preventing blood clots, as disclosed by Hunter. Both Hunter and Gong are concerned with the common problem of blood clots. One of ordinary skill would recognize that Xa inhibitors are effective in reducing blood clot occurrences. Therefore, it would have been an obvious improvement to include Xa inhibitors as the anticoagulant in the device of Gong . 07-21-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gong (US 20230115631 A1), Mazur (US 20100209263 A1), Hunter et al. (US 20070197957 A1, “Hunter”), and Kangas et al. (US 20230011767 A1, “Kangas”) . Regarding claim 18, Gong, in combination with Mazur and Hunter, discloses the percutaneous circulatory support device of claim 17 (see above). However, the references do not disclose wherein the excipient comprises in the range of about 60 to 95 weight percent of the drug eluting coating and the anticoagulant comprises in the range of about 5 to 40 weight percent of the drug eluting coating. Kangas, concerned with the same problem of blood clots, discloses a direct oral anticoagulant-eluting medical device. Kangas discloses wherein the excipient comprises in the range of about 60 to 95 weight percent of the drug eluting coating and the DOAC comprises in the range of about 5 to 40 weight percent of the drug eluting coating. (para. [0057]: "The polymer to drug ratio may be, for example, 50/50 to 90/10 (weight/weight). Some examples include a polymer to drug ration of 60/40, 70/30, or 80/20 (weight/weight)."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gong, to include the ratios of anticoagulant to excipient, as disclosed by Kangas. Kangas is also concerned with preventing blood clots. One of ordinary skill would recognize that this ratio of excipient to anticoagulant is effective to prevent blood clots when used as the coating on a medical device. Further, one of ordinary skill would recognize that a polymer, as disclosed by Kangas, could be used as an excipient. Therefore, to limit blood clots effectively, it would have been an obvious improvement to include this ratio of anticoagulant to excipient in the device of Gong . 07-21-aia AIA Claim s 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gong (US 20230115631 A1) in view of Rajaram et al. (US 20230364393 A1, “Rajaram”) . Regarding claim 10, Gong teaches the percutaneous circulatory support device of claim 9 (see 102 rejection above). However, Gong does not expressly teach wherein the flexible cannula comprises a slotted hypotube covered with a polyurethane sheath. Rajaram, in the same field of endeavor of blood pumps and cardiac assisting devices, discloses a catheter sheath for introducing a blood pump assembly. Rajaram discloses wherein the flexible cannula (Abstract: “An expandable sheath body for a sheath assembly. The sheath body has a tubular frame having a lumen therein…”) comprises a slotted hypotube covered with a polyurethane sheath (para. [0010]: "In a further aspect, the frame may be made from either braided Nitinol tube or a laser-cut hypotube. In a further aspect, the inner liner may be made of expanded polytetrafluoroethylene. In a further aspect, the expandable sheath may have an outer liner is made of thermoplastic polyurethane or expanded polytetrafluoroethylene and may be multilayer."). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gong to include a hypotube covered with a thermoplastic polyurethane sheath, as disclosed by Rajaram. One of ordinary skill in the art would recognize the benefit of using a hypotube covered in thermoplastic polyurethane for the flexible cannula since this would allow the pump assembly to advance through demanding cardiac anatomy (see Rajaram para. [0004]). Therefore, it would have been an obvious improvement to the device of Gong to include a slotted hypotube covered with a polyurethane sheath. Regarding claim 11 , Gong, in combination with Rajaram, discloses the percutaneous circulatory support device of claim 10 (see above). Further discloses wherein the drug eluting coating can be disposed anywhere on the catheter pump (para. [0104]: "In some embodiments, a semi-durable coating (e.g., a thin film) having a time-release matrix of nanosphere particles, as described herein, may be applied to any surface of catheter pump 100A. For example, in some embodiments, the nanosphere coating may include lubricant nanospheres, anticoagulant nanospheres, anti-foaming nanospheres, hydrophilic nanospheres, thrombin inhibitors (e.g., bivalirudin, argatroban, and the like) and/or any combination of these."; para. [0106]: "Moreover, although any desired surface of catheter pump 100A may be coated, in at least some embodiments, example surfaces that may be coated include seals, thrust bearings, journal bearings, ball bearings, corners and other angled surfaces, “dead” spaces in which fluid flow may tend to stagnate or pool, and the like."). However, Gong does not expressly disclose wherein the drug eluting coating is disposed between the slotted hypotube and the polyurethane sheath. Rajaram discloses reducing a risk of clot formation on the inner sheath using ePTFE (para. [0035]: “Characteristics of ePTFE provide the inner liner 204, 304, 404 with a smooth, soft, and flexible inner surface for the sheath body 200, 300, 400 that reduces the risk of clot formation.”). Although Rajaram does not disclose a drug eluting coating, Rajaram discloses using a material with antithrombotic characteristics for blood clot prevention on the surface of the inner sheath. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gong with a slotted hypotube and polyurethane sheath and to dispose drug eluting coating between the sheath. One of ordinary skill in the art would recognize that it would be desirable to include drug eluting coating on the sheath to prevent blood clots since Rajaram discloses using antithrombotic materials for the sheath. Therefore, it would have been obvious to include a drug eluting coating that accomplishes the same function between the sheath and the hypotube. Further, Gong discloses that it is desirable to use drug eluting material for blood clot prevention anywhere that blood may stagnate (see para. [0106]). Therefore, it would have been obvious to use drug eluting coating between the sheath and hypotube. In doing so, it would be an obvious improvement to the device of Gong that would prevent blood clot formation. Conclusion 60. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F). 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, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Additionally, SPE Carl Layno may be reached at (571) 272-4949. 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. /O.L.M./ Examiner, Art Unit 3796 /CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796 Application/Control Number: 18/969,841 Page 2 Art Unit: 3796 Application/Control Number: 18/969,841 Page 3 Art Unit: 3796 Application/Control Number: 18/969,841 Page 4 Art Unit: 3796
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