Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 –
(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.
(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.
Claims 1, 4-9, 11, 14-19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Knight et al. (US20090234231, hereafter Knight).
Regarding claims 1 and 11, Knight discloses in Figures 2 and 7 a system and a method for microbubble-enhanced treatment of target tissue (Knight, Para 7; “Described herein are systems and methods that integrate the injection of contrast agents with imaging catheters”) (Knight, Para 11; “drug-filled microbubbles in combination with ultrasound imaging are used to deliver a controlled drug dose to a specific treatment site. In this embodiment, the drug-filled microbubbles are delivered to the treatment site and subjected to high-level ultrasound energy to burst the microbubbles and release the drug into the treatment site. The amount of microbubbles that are ruptured, and hence the amount of the drug released into the treatment site, is determined by examining images taken before and after the microbubble bursting. This cycle of bursting microbubbles and determining the amount of the drug released can be repeated until a desired drug dose has been delivered to the treatment site”), the system comprising:
an ultrasound transducer (ultrasound imager 125) (Knight, Para 22; “The catheter 105 further comprises an ultrasound imager 125. The ultrasound imager 125 may comprise one or more ultrasound transducers, e.g., piezoelectric transducers or capacitive micromachined transducers (CMUTs)”);
an administration device (contrast agent lumen 115) for administering an exogenous agent (Knight Para 45; “In step 710, microbubbles containing the drug or pharmaceutical agent is injected into the blood vessel near the treatment site 305. Preferably, the drug-filled microbubbles are released upstream of the treatment site 305. The drug-filled microbubbles perfuse into the treatment site 305, increasing the echocentricity of the treatment site 305.”);
a monitoring system for measuring at least one parameter value associated with at least one of the ultrasound transducer, the exogenous agent, the target tissue, or non-target tissue (Knight, Para 46; “In step 715, the catheter is used to image the treatment site 305 as the microbubbles perfuse into the treatment site 305. The perfusion of the microbubbles into the treatment site 305 causes the image brightness of the treatment site 305 to increase. The image brightness can be used to estimate the concentration of the unreleased drug in the treatment site 305. This is because the image brightness is a function of the concentration of microbubbles in the treatment site 305. The greater the image brightness, the higher the concentration of microbubbles, and hence the drug contained in the microbubbles. Preferably, the treatment site 305 is imaged using low-level ultrasound energy that is insufficient to burst the microbubbles. The image brightness of the treatment site 305 is monitored to determine when a desired concentration of the microbubbles containing the drug has been reached.”);
computer memory storing a treatment plan; and at least one controller (controller 160) configured to (Knight, Para 34; “The catheter apparatus 107 further comprises a synchronizing controller 160 that electronically controls the ultrasound system 150 and the pump 156 to synchronize the injection of contrast agent with imaging. The synchronizing controller 160 may comprise a processor that executes instructions for performing the synchronization and may be integrated in the ultrasound system 150”):
(a) cause administration of the exogenous agent based at least in part on a size and a shape of the target tissue (Knight, Para 49; “the drug dose released in the treatment site 305 by the bursting of the microbubbles is estimated. This may be done by subtracting the post-energizing microbubble concentration from the pre-energizing microbubble concentration to determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”);
(b) cause the ultrasound transducer to transmit ultrasound waves to the target tissue and generate a focus therein in the presence of administered exogenous agent (Knight, Para 48; “In step 725, the treatment site 305 is imaged after the imager 125 has been energized to determine the post-energizing microbubble concentration. Since additional microbubbles may perfuse into the treatment site 305 between the time the microbubbles burst and the time the post-energizing image is acquired, the post-energizing microbubble concentration may be adjusted to take this into account, e.g., based on the perfusion rate of microbubbles into the treatment site 305”) (Knight, Para 47; “In step 720, when the desired concentration has been reached, the imager 125 is energized to an energy level sufficient to burst the microbubbles in the treatment site 305, thereby releasing the drug contained in the microbubbles into the treatment site 305. The imager 125 may be pulled back as the imager 125 is energized to burst the microbubbles along the entire length of the treatment site 305.”);
(c) receive, from the monitoring system, the measured at least one parameter value indicating a treatment condition in response to administration of the exogenous agent and transmission of the ultrasound waves during treatment (Knight, Para 49; “In step 730, the drug dose released in the treatment site 305 by the bursting of the microbubbles is estimated. This may be done by subtracting the post-energizing microbubble concentration from the pre-energizing microbubble concentration to determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”) (Knight, Para 46; “The perfusion of the microbubbles into the treatment site 305 causes the image brightness of the treatment site 305 to increase. The image brightness can be used to estimate the concentration of the unreleased drug in the treatment site 305. This is because the image brightness is a function of the concentration of microbubbles in the treatment site 305. The greater the image brightness, the higher the concentration of microbubbles, and hence the drug contained in the microbubbles. Preferably, the treatment site 305 is imaged using low-level ultrasound energy that is insufficient to burst the microbubbles. The image brightness of the treatment site 305 is monitored to determine when a desired concentration of the microbubbles containing the drug has been reached”); and
(d) adjust the treatment plan based at least in part on the measured at least one parameter value (Knight, Para 50; “In step 735, the dose of the released drug is recorded and compared to the desired total dose to be delivered to the treatment site 305. If the desired total dose has not been reached, then steps 705 through 735 may be repeated until the desired amount of drug has been delivered to the treatment site 305.”).
Regarding claims 4 and 14, Knight discloses all of the limitations of claims 1 and 11 as discussed above.
Knight further discloses wherein the administration device is further configured to administer the exogenous agent carrying microbubbles, and the treatment plan specifies a microbubble characteristic comprising at least one of a diameter, a size distribution, a shell composition, a gas composition and/or a liquid core composition (Knight, Para 28;” the contrast agent may comprise microbubbles containing the drug that burst and release the drug when subjected to sufficiently high ultrasound energy. Methods of delivering a drug in a patient using drug-filled microbubbles are discussed further below”) (Knight, Para 47; “In step 720, when the desired concentration has been reached, the imager 125 is energized to an energy level sufficient to burst the microbubbles in the treatment site 305, thereby releasing the drug contained in the microbubbles into the treatment site 305. The imager 125 may be pulled back as the imager 125 is energized to burst the microbubbles along the entire length of the treatment site 305”).
Regarding claims 5 and 15, Knight discloses all of the limitations of claims 1 and 11 as discussed above.
Knight further discloses wherein the monitoring system comprises an imager, and the measured at least one parameter value comprises a tissue characteristic of at least one of the target tissue or the non-target tissue, wherein the tissue characteristic comprises at least one of a temperature, a structure, a size, a shape, or a location of the target tissue (Knight, Para 49; “the drug dose released in the treatment site 305 by the bursting of the microbubbles is estimated. This may be done by subtracting the post-energizing microbubble concentration from the pre-energizing microbubble concentration to determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”) (Knight, Para 46; “The perfusion of the microbubbles into the treatment site 305 causes the image brightness of the treatment site 305 to increase. The image brightness can be used to estimate the concentration of the unreleased drug in the treatment site 305. This is because the image brightness is a function of the concentration of microbubbles in the treatment site 305. The greater the image brightness, the higher the concentration of microbubbles, and hence the drug contained in the microbubbles. Preferably, the treatment site 305 is imaged using low-level ultrasound energy that is insufficient to burst the microbubbles. The image brightness of the treatment site 305 is monitored to determine when a desired concentration of the microbubbles containing the drug has been reached”).
Regarding claims 6 and 16, Knight discloses all of the limitations of claims 5 and 15 as discussed above.
Knight further discloses wherein the treatment plan specifies a characteristic of the exogenous agent, and the at least one controller is further configured to adjust the characteristic of the exogenous agent based at least in part on the measured tissue characteristic of at least one of the target tissue or the non-target tissue (Knight, Para 49; “determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”) (Knight, Para 50; “In step 735, the dose of the released drug is recorded and compared to the desired total dose to be delivered to the treatment site 305. If the desired total dose has not been reached, then steps 705 through 735 may be repeated until the desired amount of drug has been delivered to the treatment site 305.”).
Regarding claims 7 and 17, Knight discloses all of the limitations of claims 1 and 11 as discussed above.
Knight further discloses wherein the monitoring system comprises an acoustic-signal detector, and the measured at least one parameter value comprises at least one of ultrasound reflections or emissions from at least one of the target tissue or the non-target tissue (Knight, Para 52; “The drug delivery method is based on the principle that the concentration of contrast agent microbubbles can be determined analytically by comparing the reflected ultrasound energy before and after administration of the contrast agent. By knowing the microbubble concentration, an estimation of the number of microbubbles and, therefore, the volume of the drug or pharmaceutical agent contained within the microbubbles can be calculated”).
Regarding claims 8 and 18, Knight discloses all of the limitations of claims 8 and 18 as discussed above.
Knight further discloses wherein: the treatment plan specifies a characteristic of the exogenous agent, and the at least one controller is further configured to adjust the characteristic of the exogenous agent based at least in part on the measured ultrasound reflections and/or emission (Knight, Para 49; “determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”) (Knight, Para 50; “In step 735, the dose of the released drug is recorded and compared to the desired total dose to be delivered to the treatment site 305. If the desired total dose has not been reached, then steps 705 through 735 may be repeated until the desired amount of drug has been delivered to the treatment site 305.”); and the treatment plan specifies an acoustic power profile associated with the ultrasound transducer, and the at least one controller is further configured to adjust the acoustic power profile based at least in part on the adjusted characteristic of the exogenous agent or the measured ultrasound reflections and/or emissions (Knight, Para 53; “Further, the drug-filled microbubbles may comprise microbubbles that have a frequency-generated non-linear response. This allows ultrasound waves reflected from the microbubbles to be isolated from ultrasound waves reflected from surrounding tissue, e.g. using a filter that filters out ultrasound waves at the fundamental frequency (i.e., frequency of the transmit signal). For example, the microbubbles may comprise harmonic microbubbles, sub-harmonic microbubbles, et”).
Regarding claims 9 and 19, Knight discloses all of the limitations of claims 1 and 11 as discussed above.
Knight further discloses a second administration device for administering a therapeutic agent to the target tissue, wherein the treatment plan specifies a characteristic of the therapeutic agent (Knight, Para 32; “Although FIG. 1 shows the imaging catheter 105 comprising one contrast lumen 115, the imaging catheter 105 may comprise multiple contrast lumens. For example, the imaging catheter 105 may comprise multiple contrast lumens to inject different types of contrast agents into the blood vessel. For example, one contrast lumen may be used to inject non-drug-filled microbubbles into the blood vessel to image the blood vessel and identify an area for treatment, e.g., atherosclerotic lesion. Another contrast lumen may then be used to inject drug-filled microbubbles into the blood vessel to deliver a drug to the treatment area. In these embodiments, the catheter apparatus may comprise multiple contrast injection ports 130, one for each contrast lumen”), and the at least one controller is configured to adjust the characteristic of the therapeutic agent based at least in part on the measured at least one parameter value, wherein the characteristic of the therapeutic agent comprises at least one of a type, a dose, a concentration profile, a temperature, an administration rate, an administration timing, or an administration pressure of the therapeutic agent (Knight, Para 35; “he pull back procedure can last several minutes depending on the rate of pullback and the length of blood vessel being imaged. During the pullback procedure, the synchronizing controller 160 may control the pump 156 to inject contrast agent into the blood vessel at a uniform rate. The uniform injection of contrast agent during pullback provides a more uniform concentration of contrast agent in the blood. This results in more uniform contrast imaging along the entire length of the pullback. In this embodiment, the exit port 120 may be located far enough toward the proximal end of the catheter so that the exit port 120 remains proximal to the imager 125 throughout the pullback”).
Regarding claim 21, Knight discloses in Figures 2 and 7 a system for microbubble-enhanced focused ultrasound treatment of target tissue (Knight, Para 7; “Described herein are systems and methods that integrate the injection of contrast agents with imaging catheters”) (Knight, Para 11; “drug-filled microbubbles in combination with ultrasound imaging are used to deliver a controlled drug dose to a specific treatment site. In this embodiment, the drug-filled microbubbles are delivered to the treatment site and subjected to high-level ultrasound energy to burst the microbubbles and release the drug into the treatment site. The amount of microbubbles that are ruptured, and hence the amount of the drug released into the treatment site, is determined by examining images taken before and after the microbubble bursting. This cycle of bursting microbubbles and determining the amount of the drug released can be repeated until a desired drug dose has been delivered to the treatment site”), the system comprising:
an ultrasound transducer (ultrasound imager 125) (Knight, Para 22; “The catheter 105 further comprises an ultrasound imager 125. The ultrasound imager 125 may comprise one or more ultrasound transducers, e.g., piezoelectric transducers or capacitive micromachined transducers (CMUTs)”);
an administration device (contrast agent lumen 115) for administering at least one of an exogenous agent or a therapeutic agent (Knight Para 45; “In step 710, microbubbles containing the drug or pharmaceutical agent is injected into the blood vessel near the treatment site 305. Preferably, the drug-filled microbubbles are released upstream of the treatment site 305. The drug-filled microbubbles perfuse into the treatment site 305, increasing the echocentricity of the treatment site 305.”);
computer memory storing a treatment plan specifying a series of operations of the ultrasound transducer and the administration device so as to achieve as a desired treatment effect on the target tissue, the treatment plan being based at least in part on a size and shape of the target tissue (Knight, Para 49; “the drug dose released in the treatment site 305 by the bursting of the microbubbles is estimated. This may be done by subtracting the post-energizing microbubble concentration from the pre-energizing microbubble concentration to determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”); and at least one controller (controller 160) configured to (Knight, Para 34; “The catheter apparatus 107 further comprises a synchronizing controller 160 that electronically controls the ultrasound system 150 and the pump 156 to synchronize the injection of contrast agent with imaging. The synchronizing controller 160 may comprise a processor that executes instructions for performing the synchronization and may be integrated in the ultrasound system 150”) drive the ultrasound transducer and the administration device based at least in part on the treatment plan (Knight, Para 48; “In step 725, the treatment site 305 is imaged after the imager 125 has been energized to determine the post-energizing microbubble concentration. Since additional microbubbles may perfuse into the treatment site 305 between the time the microbubbles burst and the time the post-energizing image is acquired, the post-energizing microbubble concentration may be adjusted to take this into account, e.g., based on the perfusion rate of microbubbles into the treatment site 305”) (Knight, Para 47; “In step 720, when the desired concentration has been reached, the imager 125 is energized to an energy level sufficient to burst the microbubbles in the treatment site 305, thereby releasing the drug contained in the microbubbles into the treatment site 305. The imager 125 may be pulled back as the imager 125 is energized to burst the microbubbles along the entire length of the treatment site 305.”) (Knight, Para 49; “In step 730, the drug dose released in the treatment site 305 by the bursting of the microbubbles is estimated. This may be done by subtracting the post-energizing microbubble concentration from the pre-energizing microbubble concentration to determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”) (Knight, Para 46; “The perfusion of the microbubbles into the treatment site 305 causes the image brightness of the treatment site 305 to increase. The image brightness can be used to estimate the concentration of the unreleased drug in the treatment site 305. This is because the image brightness is a function of the concentration of microbubbles in the treatment site 305. The greater the image brightness, the higher the concentration of microbubbles, and hence the drug contained in the microbubbles. Preferably, the treatment site 305 is imaged using low-level ultrasound energy that is insufficient to burst the microbubbles. The image brightness of the treatment site 305 is monitored to determine when a desired concentration of the microbubbles containing the drug has been reached”) (Knight, Para 50; “In step 735, the dose of the released drug is recorded and compared to the desired total dose to be delivered to the treatment site 305. If the desired total dose has not been reached, then steps 705 through 735 may be repeated until the desired amount of drug has been delivered to the treatment site 305.”).
Regarding claim 22, Knight discloses all of the limitations of claim 21 as discussed above.
Knight further discloses a monitoring system for measuring at least one parameter value associated with at least one of the ultrasound transducer, the exogenous agent, the therapeutic agent, the target tissue, or non-target tissue (Knight, Para 46; “In step 715, the catheter is used to image the treatment site 305 as the microbubbles perfuse into the treatment site 305. The perfusion of the microbubbles into the treatment site 305 causes the image brightness of the treatment site 305 to increase. The image brightness can be used to estimate the concentration of the unreleased drug in the treatment site 305. This is because the image brightness is a function of the concentration of microbubbles in the treatment site 305. The greater the image brightness, the higher the concentration of microbubbles, and hence the drug contained in the microbubbles. Preferably, the treatment site 305 is imaged using low-level ultrasound energy that is insufficient to burst the microbubbles. The image brightness of the treatment site 305 is monitored to determine when a desired concentration of the microbubbles containing the drug has been reached.”), wherein the controller is further configured to adjust the treatment plan based at least in part on the measured at least one parameter value (Knight, Para 49; “In step 730, the drug dose released in the treatment site 305 by the bursting of the microbubbles is estimated. This may be done by subtracting the post-energizing microbubble concentration from the pre-energizing microbubble concentration to determine the drug concentration released into the treatment site 305 and using the volume of the treatment site 305 to determine the drug dose. The volume of the treatment site 305 may be estimated based on a three-dimensional ultrasound image of the treatments site 305.”) (Knight, Para 46; “The perfusion of the microbubbles into the treatment site 305 causes the image brightness of the treatment site 305 to increase. The image brightness can be used to estimate the concentration of the unreleased drug in the treatment site 305. This is because the image brightness is a function of the concentration of microbubbles in the treatment site 305. The greater the image brightness, the higher the concentration of microbubbles, and hence the drug contained in the microbubbles. Preferably, the treatment site 305 is imaged using low-level ultrasound energy that is insufficient to burst the microbubbles. The image brightness of the treatment site 305 is monitored to determine when a desired concentration of the microbubbles containing the drug has been reached”) (Knight, Para 50; “In step 735, the dose of the released drug is recorded and compared to the desired total dose to be delivered to the treatment site 305. If the desired total dose has not been reached, then steps 705 through 735 may be repeated until the desired amount of drug has been delivered to the treatment site 305.”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Knight and Hoffmann et al. (US20130281897A1, hereafter Hoffmann).
Regarding claims 2 and 12, Knight discloses all of the limitations of claims 1 and 11 as discussed above.
Knight does not clearly and explicitly disclose wherein the monitoring system comprises a biosensor, and the measured at least one parameter value comprises a physiological parameter value, wherein the physiological parameter value comprises at least one of a blood pressure, a blood circulation rate, a blood perfusion rate, a blood oxygen level, or a heart rate.
In an analogous localized delivery of drugs via microbubbles field of endeavor (Hoffmann, Para 33; “The kit is optionally portable to meet the needs of first line emergency treatment in the field or emergency room, employable with drugs (and most preferably thrombolytic drugs, with or without acoustically active micro-bubbles), complete with instructions, and adaptable to meet the needs of differing operators with varying levels of training and skill”) Hoffmann discloses wherein a monitoring system comprises a biosensor, and measuring at least one parameter value comprises a physiological parameter value, wherein the physiological parameter value comprises at least one of a blood pressure, a blood circulation rate, a blood perfusion rate, a blood oxygen level, or a heart rate (Hoffmann, Para 101; "an operator of the thrombolytic and/or microbubble, and/or vibrator, and would convey all the methods and apparatus described within this present disclosure (including use of feedback sensors enabling detection of arterial vessel deformations or resultant blood flow or pressure fluctuations to enable optimized vibrator positioning), to enable many levels of assisted drug effectiveness or drug delivery, depending on the skill or comfort level of an operator ") (Hoffmann, Para 122; “bio-feedback monitoring sensor enabling detection of and degree of percussion or oscillation induced target artery deformations with resultant propagating blood pressure fluctuations (to ensure optimized positioning, engagement or compression force, stroke amplitude emissions, and optionally wave-shape and wave pattern emissions) of a non-invasive vibrator positioned over a target artery”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Knight wherein the monitoring system comprises a biosensor, and the measured at least one parameter value comprises a physiological parameter value, wherein the physiological parameter value comprises at least one of a blood pressure, a blood circulation rate, a blood perfusion rate, a blood oxygen level, or a heart rate in order to optimize drug delivery and effectiveness as taught by Hoffmann.
Regarding claims 3 and 13, Knight discloses all of the limitations of claim 2 and 12 as discussed above.
Knight further discloses wherein the treatment plan specifies a characteristic of the exogenous agent, and the at least one controller is further configured to adjust the characteristic of the exogenous agent based at least in part on the physiological parameter value, wherein the characteristic of the exogenous agent comprises at least one of a type, a dose, a concentration profile, a temperature, or an administration profile of the exogenous agent; the treatment plan specifies a disruption rate profile of the target tissue, and the controller is further configured to adjust the characteristic of the exogenous agent based at least in part on the disruption rate profile; and/or the treatment plan specifies an acoustic power profile associated with the ultrasound transducer, the at least one controller being further configured to adjust the acoustic power profile based at least in part on an adjusted characteristic of the exogenous agent (Knight, Para 50; “In step 735, the dose of the released drug is recorded and compared to the desired total dose to be delivered to the treatment site 305. If the desired total dose has not been reached, then steps 705 through 735 may be repeated until the desired amount of drug has been delivered to the treatment site 305.”).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Knight and Mohan et al. (US20130072854A1, hereafter Mohan).
Regarding claims 10 and 20, Knight discloses all of the limitations of claim 9 and 19 as discussed above.
Knight does not clearly and explicitly disclose wherein the therapeutic agent comprises at least one of Busulfan, Thiotepa, CCNU (lomustine), BCNU (carmustine), ACNU (nimustine), Temozolomide, Methotrexate, Topotecan, Cisplatin, Etoposide, Irinotecan/SN-38, Carboplatin, Doxorubicin, Vinblastine, Vincristine, Procarbazine, Paclitaxel, Fotemustine, Ifosfamide/4-Hydroxyifosfamide/aldoifosfamide, Bevacizumab, 5-Fluorouracil, Bleomycin, Hydroxyurea, Docetaxel, or Cytarabine (cytosine arabinoside, ara-C)/ara-U.
In an analogous microbubble drug delivery field of endeavor Mohan discloses wherein a therapeutic agent comprises at least one of Busulfan, Thiotepa, CCNU (lomustine), BCNU (carmustine), ACNU (nimustine), Temozolomide, Methotrexate, Topotecan, Cisplatin, Etoposide, Irinotecan/SN-38, Carboplatin, Doxorubicin, Vinblastine, Vincristine, Procarbazine, Paclitaxel, Fotemustine, Ifosfamide/4-Hydroxyifosfamide/aldoifosfamide, Bevacizumab, 5-Fluorouracil, Bleomycin, Hydroxyurea, Docetaxel, or Cytarabine (cytosine arabinoside, ara-C)/ara-U (Mohan, Para 27; “Examples of cytotoxic agents are listed in Goodman and Gilman's “The Pharmacological Basis of Therapeutics,” Tenth Edition, McGraw-Hill, New York, 2001. These include taxol; nitrogen mustards, such as mechlorethamine, cyclophosphamide, melphalan, uracil mustard and chlorambucil; ethylenimine derivatives, such as thiotepa; alkyl sulfonates, such as busulfan; nitrosoureas, such as carmustine, lomustine, semustine and streptozocin; triazenes, such as dacarbazine; folic acid analogs, such as methotrexate; pyrimidine analogs, such as fluorouracil, cytarabine and azaribine; purine analogs, such as mercaptopurine and thioguanine; vinca alkaloids, such as vinblastine and vincristine; antibiotics, such as dactinomycin, daunorubicin, doxorubicin, bleomycin, mithramycin and mitomycin; enzymes, such as L-asparaginase; platinum coordination complexes, such as cisplatin; substituted urea, such as hydroxyurea; methyl hydrazine derivatives, such as procarbazine; adrenocortical suppressants, such as mitotane; hormones and antagonists, such as adrenocortisteroids (prednisone), progestins (hydroxyprogesterone caproate, medroprogesterone acetate and megestrol acetate), estrogens (diethylstilbestrol and ethinyl estradiol), antiestrogens (tamoxifen), and androgens (testosterone propionate and fluoxymesterone).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Knight wherein the therapeutic agent comprises at least one of Busulfan, Thiotepa, CCNU (lomustine), BCNU (carmustine), ACNU (nimustine), Temozolomide, Methotrexate, Topotecan, Cisplatin, Etoposide, Irinotecan/SN-38, Carboplatin, Doxorubicin, Vinblastine, Vincristine, Procarbazine, Paclitaxel, Fotemustine, Ifosfamide/4-Hydroxyifosfamide/aldoifosfamide, Bevacizumab, 5-Fluorouracil, Bleomycin, Hydroxyurea, Docetaxel, or Cytarabine (cytosine arabinoside, ara-C)/ara-U in order to effectively treat diseases as needed as taught by Mohan (Mohan, Para 50).
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798
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