DETAILED ACTION
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 Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 2, “the steps” should read “steps”.
In claim 2, line 4, “the patient” should read “the human patient”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12220602 in view of Behar et al (US 20140200489), hereinafter Behar.
Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 2 of the instant application corresponds to the parent claim 5. Specifically, claim 1 of U.S. Patent No. 12220602 recites the “method of transmitting ultrasound energy into a brain of a human patient, comprising the steps of: positioning a plurality of transducer elements of a therapy transducer outside a skullcap of the patient; positioning a focus of the therapy transducer within a target region of the brain of the patient; positioning a drainage catheter in the target region of the brain; transmitting histotripsy pulses from each of the plurality of transducer elements into the target region through the skullcap to form a non-thermal bubble cloud in the target region; measuring the histotripsy pulses with a piezoelectric sensor disposed on a guidewire portion of the drainage catheter; adjusting transmission of subsequent histotripsy pulses from the plurality of transducer elements with an aberration correction algorithm based on the measured histotripsy pulses to automatically correct for an aberration effect caused by the histotripsy pulses passing through the skullcap, liquefying the target region with the histotripsy pulses; and draining the liquified target region from the brain with a sheath portion of the drainage catheter.” Claim 5 of U.S. Patent No. 12220602 additionally recites “electronically steering the focus to fully liquefy the target tissue”.
2. (New) A method of providing histotripsy therapy to a brain of a human patient, comprising the steps of:
positioning a plurality of transducer elements of a therapy transducer outside a skullcap of the patient;
US12220602
1. A method of transmitting ultrasound energy into a brain of a human patient, comprising the steps of:
positioning a plurality of transducer elements of a therapy transducer outside a skullcap of the patient;
positioning a focus of the therapy transducer at a first treatment location within a target treatment volume of the brain;
US12220602
positioning a focus of the therapy transducer within a target region of the brain of the patient;
transmitting histotripsy pulses from the plurality of transducer elements into the first treatment location of the target treatment volume through the skullcap to form a non-thermal bubble cloud in the target treatment volume;
US12220602
transmitting histotripsy pulses from each of the plurality of transducer elements into the target region through the skullcap to form a non-thermal bubble cloud in the target region;
adjusting transmission of subsequent histotripsy pulses from the plurality of transducer elements to the first treatment location with an aberration correction algorithm based on the time of flight to automatically correct for an aberration effect caused by the histotripsy pulses passing through the skullcap;
US12220602
adjusting transmission of subsequent histotripsy pulses from the plurality of transducer elements with an aberration correction algorithm based on the measured histotripsy pulses to automatically correct for an aberration effect caused by the histotripsy pulses passing through the skullcap,
electronically steering the focus of the therapy transducer to a subsequent treatment location within the target treatment volume;
US12220602
5. The method of claim 1, further comprising electronically steering the focus to fully liquefy the target tissue.
and
repeating the transmitting and adjusting steps for the subsequent treatment location.
US12220602
electronically steering the focus to fully liquefy the target tissue
It is clear from claim 5 of US12220602 that the transmitting and adjusting steps are repeated in order to fully liquefy the target tissue.
The ‘210 patent does not teach identifying a time of flight of the histotripsy pulses from the transducer elements to the target treatment volume; the adjusting based on the time of flight and repeating the identifying step.
However, in the ultrasound treatments field of endeavor, Behar discloses a method and system for tissue modulation, Behar teaches identifying a time of flight (“measurements of time of flight” [0353]) of the histotripsy pulses (“the energy beams” [0353]) from the transducer elements (604) to the target treatment volume (“the method employs ultrasound at frequency of from about 400 kHz to about 4 MHz." [0203]; “modulating tissue of an internal organ in vivo" [0247]; “emitter 604 emits ultrasound" [0263]; “emitter 604 may be a phased array 1604, for example a HIFU phased array 3604." [0305]; Fig. 6A) and the adjusting based on the time of flight (“An additional advantage of some methods described herein is that they provide means to overcome distortions due to inhomogeneous tissues on the path of the energy beam: since each element or small subset of elements is measured separately, measurements of time of flight and received intensities are sensitive to differences in the speed of sound in tissues through which the energy beams must pass, so that calculations of the timing and phase and intensities to be used at the various elements during the treatment phase automatically take transmission differences imposed by tissues intervening between transmitters and target into account. This method is specifically beneficial for aiming beams where obstruction and aberration are high, like brain treatment (aberration by skull)” [0353]).
Therefore, based on Behar’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the method of U.S. Patent No. 12220602 employ the steps of identifying a time of flight of the histotripsy pulses from the transducer elements to the target treatment volume and the adjusting based on the time of flight, as taught by Behar, in order to facilitate treatment of tissue by applying ultrasound energy to the region. Additionally, the repeating of the identifying step naturally follows from the combination of claim 5 of U.S. Patent No. 12220602 and Behar because, when steering the focus, measurements of time of flight are performed to automatically take transmission differences imposed by tissues intervening between transmitters and target into account.
Other clams correspond to each other as follows.
Claim 3 of the instant application corresponds to claim 5 of U.S. Patent No. 12220602.
Claims 4-5 and 7 of the instant application correspond to claim 1 of U.S. Patent No. 12220602.
Claims 8 of the instant application correspond to claim 2 of U.S. Patent No. 12220602.
Claim 9 of the instant application correspond to claim 3 of U.S. Patent No. 12220602.
Claim 10 of the instant application corresponds to claim 4 of U.S. Patent No. 12220602.
Claim Rejections - 35 USC § 112
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.
Claim 3 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the "all subsequent treatment locations” in line 2. The relationship between this limitation and the “a subsequent treatment location” in claim 2 is unclear. For examination purposes, Examiner of record takes this to be “all additional treatment locations”.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 6 are rejected under 35 U.S.C. 103 as being unpatentable over Cain et al (US 20070083120), hereinafter Cain, in view of Behar et al (US 20140200489), hereinafter Behar.
Regarding claim 2, Cain teaches a method (Abstract. Claims 1-17) of providing histotripsy therapy (“the histotripsy process” [0028]) to a brain of a human patient (“Methods described herein seek to use cavitation,...By assembling a known, and/or optimally sized distribution of microbubbles in the therapy volume, one can use an effecter frequency low enough to avoid tissue heating and low enough for the sound to propagate through intervening bone, such as … skull " [0063], comprising the steps of:
positioning a plurality of transducer elements (18) of a therapy transducer (148) (The … transducers can be … phased arrays where the focus can be scanned in 1, 2, or 3-dimensions.” [0085]) outside a skullcap of the patient (“the sound to propagate through intervening bone, such as … skull " [0063]; “Ultrasound Generation: FIG. 9 illustrates the experimental apparatus 146. Ultrasound pulses are generated by an 18 element array 148, which is used to generate the bubble cloud 150 (where the tissue sample would be placed for therapy). Coupled to the array 148 is a 5 MHz transducer 152” [0181]);
positioning a focus of the therapy transducer at a first treatment location within a target treatment volume of the brain (“The therapy process is the interaction of ultrasound on existing cavitation nuclei to produce sufficiently vigorous cavitation to mechanically subdivide tissue within the therapy volume. Therapy energy in the histotripsy process can be acoustic (e.g., ultrasonic). The transducer or transducers can be either single focus, or multi-focus, or phased arrays where the focus can be scanned in 1, 2, or 3-dimensions.” [0085]);
transmitting histotripsy pulses (“The pulsed cavitational ultrasound therapy (i.e., the histotripsy process) coupled with the ability to monitor and adjust the process based on feedback provides a significant advantage over previous methods.” [0028] “Therapy can comprise a therapy pulse sequence," [0085]) from the plurality of transducer elements into the first treatment location of the target treatment volume through the skullcap to form a non-thermal bubble cloud (150) in the target treatment volume (“Methods described herein seek to use cavitation, not avoid it, by making the cavitation thresholds in the therapy volume much lower than in surrounding or intervening tissue at or adjacent to transport barriers. By assembling a known, and/or optimally sized distribution of microbubbles in the therapy volume, one can use an effecter frequency low enough to avoid tissue heating and low enough for the sound to propagate through intervening bone, such as … skull.” [0063]. “Ultrasound pulses are generated by an 18 element array 148, which is used to generate the bubble cloud 150 (where the tissue sample would be placed for therapy). Coupled to the array 148 is a 5 MHz transducer 152” [0181], Fig. 9);
adjusting transmission of subsequent histotripsy pulses from the plurality of transducer elements to the first treatment location (“monitoring and receiving feedback of pulsed cavitational ultrasound therapies during the procedure would inform a clinician whether the treatment procedure is progressing adequately according to plan and when it can be ended. As such, the ability to monitor and adjust the ultrasound therapy concomitant with treatment would provide significant advantages over prior ultrasound therapies." [0013]. “By measuring feedback for the therapy transducer, an accessory transducer can send out interrogation pulses. Moreover, the nature of the feedback received can be used to adjust acoustic parameters (and associated system parameters) to optimize … tissue erosion process." [0093]),
electronically steering the focus of the therapy transducer to a subsequent treatment location within the target treatment volume (“Ultrasound treatment consisted of scanning the therapeutic transducer focus electronically over 42 locations to define a one centimeter square grid 186, as shown in FIG. 23, perpendicular to the imaging axis. In each location, one high intensity (>18 MPa peak negative pressure) 25 cycle burst was delivered before moving to the next location.” [0240]); and
repeating the transmitting and adjusting steps for the subsequent treatment location (“The feedback and monitoring step allows for various parameters of the pulsed cavitational ultrasound process to be varied in real time or in stages, …, permitting controlled administration of the ultrasound therapy." [0074] “In each location, one high intensity (>18 MPa peak negative pressure) 25 cycle burst was delivered” [0240]).
While teaching adjusting transmission of subsequent histotripsy pulses from the plurality of transducer elements to the first treatment location (“monitoring and receiving feedback of pulsed cavitational ultrasound therapies during the procedure would inform a clinician whether the treatment procedure is progressing adequately according to plan and when it can be ended. As such, the ability to monitor and adjust the ultrasound therapy concomitant with treatment would provide significant advantages over prior ultrasound therapies." [0013]), Cain does not explicitly teach identifying a time of flight of the histotripsy pulses from the transducer elements to the target treatment volume; the adjusting with an aberration correction algorithm based on the time of flight to automatically correct for an aberration effect caused by the histotripsy pulses passing through the skullcap; and repeating the identifying step.
However, in the ultrasound treatments field of endeavor, Behar discloses a method and system for tissue modulation, Behar teaches identifying a time of flight (“measurements of time of flight” [0353]) of the histotripsy pulses (“the energy beams” [0353]) from the transducer elements (604) to the target treatment volume (“emitter 604 emits ultrasound" [0263]; “emitter 604 may be a phased array 1604, for example a HIFU phased array 3604." [0305]; Fig. 6A) and the adjusting with an aberration correction algorithm (“This method takes into account beam aberrations that may behave differently from one transmitting element to another.” [0260]) based on the time of flight to automatically correct for an aberration effect (“automatically take transmission differences imposed by tissues intervening between transmitters and target into account.” [0353]) caused by the histotripsy pulses passing through the skullcap (“An additional advantage of some methods described herein is that they provide means to overcome distortions due to inhomogeneous tissues on the path of the energy beam: since each element or small subset of elements is measured separately, measurements of time of flight and received intensities are sensitive to differences in the speed of sound in tissues through which the energy beams must pass, so that calculations of the timing and phase and intensities to be used at the various elements during the treatment phase automatically take transmission differences imposed by tissues intervening between transmitters and target into account. This method is specifically beneficial for aiming beams where obstruction and aberration are high, like brain treatment (aberration by skull)” [0353]).
Therefore, based on Behar’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Cain to employ the steps of identifying a time of flight of the histotripsy pulses from the transducer elements to the target treatment volume and the adjusting with an aberration correction algorithm based on the time of flight to automatically correct for an aberration effect caused by the histotripsy pulses passing through the skullcap, as taught by Behar, in order to facilitate treatment of tissue by applying ultrasound energy to the region. In invention of Cain and Behar, the steps include repeating the identifying step because, when steering the focus, measurements of time of flight are repeatedly performed to automatically take transmission differences imposed by tissues intervening between transmitters and target into account.
Regarding claim 3, Cain modified by Behar teaches the method of claim 2.
Cain teaches repeating the electronically steering, transmitting (“focus electronically over 42 locations … moving to the next location.” [0240]), and adjusting steps (“By measuring feedback for the therapy transducer, an accessory transducer can send out interrogation pulses. Moreover, the nature of the feedback received can be used to adjust acoustic parameters (and associated system parameters) to optimize … tissue erosion process." [0093]) for all subsequent treatment locations within the target treatment volume (“The feedback and monitoring step allows for various parameters of the pulsed cavitational ultrasound process to be varied in real time or in stages, …, permitting controlled administration of the ultrasound therapy." [0074] “Ultrasound treatment consisted of scanning the therapeutic transducer focus electronically over 42 locations to define a one centimeter square grid 186, as shown in FIG. 23, perpendicular to the imaging axis. In each location, one high intensity (>18 MPa peak negative pressure) 25 cycle burst was delivered before moving to the next location.” [0240]) until the target treatment volume is liquified (“Pulsed ultrasound at high intensities and low duty cycle is effective at creating precise regions consisting of liquefied tissue.” [0243]).
Cain does not explicitly teach repeating the identifying step for all subsequent treatment locations within the target treatment volume.
However, in the ultrasound treatments field of endeavor, Behar discloses a method and system for tissue modulation, Behar teaches the identifying step (“measurements of time of flight” [0353]) (“An additional advantage of some methods described herein is that they provide means to overcome distortions due to inhomogeneous tissues on the path of the energy beam: since each element or small subset of elements is measured separately, measurements of time of flight and received intensities are sensitive to differences in the speed of sound in tissues through which the energy beams must pass, so that calculations of the timing and phase and intensities to be used at the various elements during the treatment phase automatically take transmission differences imposed by tissues intervening between transmitters and target into account. This method is specifically beneficial for aiming beams where obstruction and aberration are high, like brain treatment (aberration by skull)” [0353]).
Therefore, based on Behar’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Cain to employ the step of repeating the identifying step for all subsequent treatment locations within the target treatment volume, as taught by Behar, in order to facilitate treatment of tissue by applying ultrasound energy to the region. In invention of Cain and Behar, the steps include repeating the identifying step because, when steering the focus, measurements of time of flight are repeatedly performed to automatically take transmission differences imposed by tissues intervening between transmitters and target into account.
Regarding claim 6, Cain modified by Behar teaches the method of claim 2, wherein Cain teaches that forming the non-thermal bubble cloud (150) in the target tissue volume liquefies the target tissue volume (“Methods described herein seek to use cavitation, not avoid it, by making the cavitation thresholds in the therapy volume much lower than in surrounding or intervening tissue at or adjacent to transport barriers. By assembling a known, and/or optimally sized distribution of microbubbles in the therapy volume, one can use an effecter frequency low enough to avoid tissue heating and low enough for the sound to propagate through intervening bone, such as … skull.” [0063]. “Ultrasound pulses are generated by an 18 element array 148, which is used to generate the bubble cloud 150 (where the tissue sample would be placed for therapy).” [0181]. “Pulsed ultrasound at high intensities and low duty cycle is effective at creating precise regions consisting of liquefied tissue.” [0243]; Fig. 9).
Claims 4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cain and Behar as applied to claims 2 and 6, and further in view of Wilcox et al (US 20130211316), hereinafter Wilcox.
Regarding claim 4, Cain modified by Behar teaches the method of claim 2.
Cain modified by Behar does not teach positioning a drainage catheter in the target treatment volume of the brain.
However, in the intracranial treatments field of endeavor, Wilcox discloses a method and apparatus for treatment of intracranial hemorrhages, which is analogous art. Wilcox teaches positioning a drainage catheter (422) in the target treatment volume of the brain (424) (“As illustrated in FIG. 15, … the ultrasound catheter 400 can be used with an external ventricular drain or drainage catheter (EVD) 422 which can be inserted to the blood clot 424 via the burr-hole or drill hole 426 that is formed in the patient's skull as described above. In some embodiments, before the EVD 422 is inserted into the brain, an introducer sheath is inserted through the burr-hole 426 and through brain tissue until it reaches the blood clot 424, which can be located in the ventricles 428 of the brain. [0130]).
Therefore, based on Wilcox’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Cain and Behar to have the step of positioning a drainage catheter in the target treatment volume of the brain, as taught by Wilcox, in order to facilitate intracranial treatments.
Regarding claim 7, Cain modified by Behar teaches the method of claim 6.
Cain modified by Behar does not teach draining the liquified target tissue volume from the brain with a sheath portion of the drainage catheter.
However, in the intracranial treatments field of endeavor, Wilcox discloses a method and apparatus for treatment of intracranial hemorrhages, which is analogous art. Wilcox teaches draining the liquified target tissue volume from the brain with a sheath portion (“Because the blood clot may be under compression by brain tissue surrounding the clot, by continuously or periodically draining fluid from the blood clot, the remaining unlysed portions of the clot tends to be pushed towards the catheter 400, thereby enhancing ultrasound and drug mediated clot lysis. In addition, removal of the lysed portions of the clot removes toxic blood components that can be harmful to brain tissue." [0129]; “an introducer sheath” [0130]) of the drainage catheter (422) (“As illustrated in FIG. 15, … the ultrasound catheter 400 can be used with an external ventricular drain or drainage catheter (EVD) 422 which can be inserted to the blood clot 424 via the burr-hole or drill hole 426 that is formed in the patient's skull as described above. In some embodiments, before the EVD 422 is inserted into the brain, an introducer sheath is inserted through the burr-hole 426 and through brain tissue until it reaches the blood clot 424, which can be located in the ventricles 428 of the brain. [0130]).
Therefore, based on Wilcox’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Cain and Behar to have the step of draining the liquified target tissue volume from the brain with a sheath portion of the drainage catheter, as taught by Wilcox, in order to facilitate intracranial treatments.
Regarding claim 8, Cain modified by Behar teaches the method of claim 2.
Cain modified by Behar does not teach that the target region comprises a clot or hemorrhage.
However, in the intracranial treatments field of endeavor, Wilcox discloses a method and apparatus for treatment of intracranial hemorrhages, which is analogous art. Wilcox teaches that the target region comprises a clot (424) or hemorrhage (“As illustrated in FIG. 15, … the ultrasound catheter 400 can be used with an external ventricular drain or drainage catheter (EVD) 422 which can be inserted to the blood clot 424 via the burr-hole or drill hole 426 that is formed in the patient's skull as described above. In some embodiments, before the EVD 422 is inserted into the brain, an introducer sheath is inserted through the burr-hole 426 and through brain tissue until it reaches the blood clot 424, which can be located in the ventricles 428 of the brain. [0130]).
Therefore, based on Wilcox’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Cain and Behar to have the target region that comprises a clot or hemorrhage, as taught by Wilcox, in order to facilitate intracranial treatments.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cain and Behar as applied to claim 2, and further in view of Hynynen et al (US 7175599), hereinafter Hynynen.
Regarding claim 9, Cain modified by Behar teaches the method of claim 2.
Cain modified by Behar does not teach that the target region comprises a brain tumor.
However, in the diagnostic ultrasound field of endeavor, Hynynen discloses a shear mode diagnostic ultrasound, which is analogous art. Hynynen teaches that the target region comprises a brain tumor (“Coherent noninvasive focusing of ultrasound through the human skull has been suggested for a number of therapeutic and diagnostic implications in the brain. For example, ultrasound has been considered as a tool for the transskull treatment of brain tumors, targeted drug delivery, improved thrombolytic stroke treatment, blood flow imaging, detecting internal bleeding, and tomographic brain imaging. Although the human skull has been the barrier to clinical realization of many of these applications, studies have demonstrated both minimally invasive and noninvasive aberration correction methods for transskull focusing.” Col. 1, l. 49-59).
Therefore, based on Hynynen’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Cain and Behar to have the target region that comprises a brain tumor, as taught by Hynynen, in order to facilitate intracranial treatments.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Cain, Behar, and Wilcox as applied to claim 4, and further in view of Hansmann et al. (US 20060173387), hereinafter Hansmann.
Regarding claim 10, Cain modified by Behar and Wilcox teaches the method of claim 4.
Cain modified by Behar and Wilcox does not teach positioning the drainage catheter through a hole of the therapy transducer.
However, Hansmann discloses externally enhanced ultrasonic therapy, which is analogous art. Hansmann teaches positioning the catheter (110) through a hole of the therapy transducer (124)(“In the example embodiment illustrated in FIGS. 5A and 5B, the ultrasound radiating member 124 is configured as a hollow cylinder. As such, the inner core 110 extends through the hollow core of the ultrasound radiating member 124.” [0047]).
Therefore, based on Hansmann’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Cain, Behar, and Wilcox to have the step of positioning the catheter through a hole of the therapy transducer, as taught by Hansmann, in order to facilitate the flow of fluids (Hansmann: [0044]). In the combined invention of Cain, Behar, Wilcox, and Hansmann, the catheter is the drainage catheter
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798