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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claim 1 – 9) in the reply filed on 02/18/2026 is acknowledged.
Claim 1 – 13 remain pending in the application;
Claim 9 – 13 are withdrawn from consideration.
Claim Objections
Claim 1 and 3 – 6 are objected to because of the following informalities:
Claim 1 line 3 – 4, limitation "wherein both sonication of the body and positioning of the catheter adjacent thereto" should read "wherein both the sonication of the body and positioning of the catheter adjacent thereto".
Claim 3 line 1 – 2, limitation "prior to sonicating the hematoma" should read "prior to the sonication of the hematoma".
Claim 3 line 2 – 3, limitation "during sonication thereof" should read "during the sonication thereof".
Claim 4 line 1 – 2, limitation "wherein both sonication of the hematoma and positioning the catheter adjacent thereto" should read "wherein both the sonication of the hematoma and the positioning of the catheter adjacent thereto".
Claim 5 line 2, limitation "prior to sonicating the body" should read "prior to the sonication of the body".
Claim 5 line 2, limitation "during sonication" should read "during the sonication".
Claim 6 line 1, limitation "during sonication" should read "during the sonication".
Appropriate correction is required.
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)(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.
Claim 1 – 5, 8 and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stopek (US 2023/0061534 A1; filed on 03/08/2021).
Regarding claim 1, Stopek discloses a method of treatment ("A method of treating tissue of a patient with a robotic surgical system is provided …" [0007]) comprising sonicating a body within an organ of a patient with ultrasound energy ("... and delivering histotripsy therapy to the prepared target tissue location with a histotripsy sub-system of the robotic surgical system." [0007]; "Histotripsy may be performed in multiple ways and under different parameters. It may be performed totally non-invasively by acoustically coupling a focused ultrasound transducer over the skin of a patient and transmitting acoustic pulses transcutaneously through overlying (and intervening) tissue to the focal zone (treatment zone and site)." [0075]) thereby liquefying the body to produce liquified material ("... delivering histotripsy therapy further comprises lysing or liquefying the target tissue location." [0012]), and aspirating the liquified material via a catheter positioned adjacent to the body ("… wherein a catheter based, bed/table based (integral to table side and/or next to table) robotic drive system, in combination with a non-invasive transcranial histotripsy system approach (bed/table side), are used to liquefy and aspirate hemorrhage, clot or thrombus." [0189]), wherein both sonication of the body and positioning of the catheter adjacent thereto are assisted via image guidance ("… this multi-approach configuration may be conducted within a cone beam CT, and as one integrated system approach." [0189]; "… the method further comprises performing the accessing, fluidizing, and delivering steps under real-time imaging guidance." [0043]).
Regarding claim 2, Stopek discloses all claim limitations, as applied in claim 1, and further discloses said body being a deep-brain hematoma ("… of treating hemorrhage or clot in the brain …" [0189]; "Examples similar to Examples 16-19, but wherein the treatment locations are sub-dural ... subdural hematoma ..." [0192]).
Regarding claim 3, Stopek discloses all claim limitations, as applied in claim 2, and further discloses wherein the catheter is positioned adjacent to the hematoma prior to sonicating the hematoma ("… accessing a target hollow organ location with an endoscopic robotic system of the robotic surgical system, fluidizing the target hollow organ location to create an acoustic window within the target hollow organ location, and delivering histotripsy therapy ..." [0040]; here the accessing step is prior to the fluidizing and histotripsy delivering steps) and wherein the catheter is adjacent to the hematoma during sonication thereof ("… of treating hemorrhage or clot in the brain, and wherein a catheter based, bed/table based (integral to table side and/or next to table) robotic drive system, in combination with a non-invasive transcranial histotripsy system approach (bed/table side), are used to liquefy and aspirate hemorrhage, clot or thrombus." [0189]).
Regarding claim 4, Stopek discloses all claim limitations, as applied in claim 2, and further discloses wherein both sonication of the hematoma and positioning the catheter adjacent thereto are assisted via MRI-image guidance ("Systems may also be configured to comprise, communicate or integrate with … magnetic resonance imaging (MRI) … to afford the ability to visualize the patient, procedure approach, device/treatment trajectory … the dynamic real-time treatment effect(s), and pre/peri/post-procedure treatment verification ..." [0165]).
Regarding claim 5, Stopek discloses all claim limitations, as applied in claim 1, and further discloses wherein the catheter is positioned adjacent to the body using CT imaging prior to sonicating the body, and wherein during sonication, MRI imaging is used to monitor the aspiration of the liquified material ("Systems may also be configured to comprise, communicate or integrate with … computed tomography (CT) … magnetic resonance imaging (MRI) … to afford the ability to visualize the patient, procedure approach, device/treatment trajectory … the dynamic real-time treatment effect(s), and pre/peri/post-procedure treatment verification ..." [0165]: "Imaging modalities may comprise various ... CT, MRI ... and/or various combinations of." [0095]; both CT and MRI are used).
Regarding claim 8, Stopek discloses all claim limitations, as applied in claim 1, and further discloses wherein high intensity focused ultrasound energy is used to produce the liquified material ("Histotripsy comprises short, high amplitude, focused ultrasound pulses to generate a dense, energetic, “bubble cloud”, capable of the targeted fractionation and destruction of tissue." [0072]).
Regarding claim 9, Stopek discloses all claim limitations, as applied in claim 1, and further discloses wherein low intensity focused ultrasound energy is used to produce the liquified material ("The method also can provide feedback permitting the histotripsy process to be initiated at a higher intensity and maintained at a much lower intensity." [0099]).
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.
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.
Claim 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Stopek, as applied in claim 1, and further in view of Nita (US 2012/0330196 A1; published on 12/27/2012).
Regarding claim 6, Stopek teaches all claim limitations, as applied in claim 1, except wherein real-time image guidance is used during sonication to reposition the catheter adjacent the liquified material as the liquified material is aspirated.
However, in the same field of endeavor, Nita teaches wherein real-time image guidance is used during sonication ("... intraoperative computed tomography (CT) imaging may be used to help guide placement of the catheter … Such image guided systems are provided, for example, by Medtronic, Inc. (StealthStation S7), or BrainLAB, Inc. (VectorVision System)." [0080]; both StealthStation S7 and VectorVision System are commercially avaible real-time image guidance system) to reposition the catheter adjacent the liquified material as the liquified material is aspirated ("The drainage catheter 90 may be repositioned within the blood clots BC, or it may be repositioned into blood clots located in different areas of the brain ..." [0091]).
It would have been prima facie obvious to one skilled in the art before the effective filing date of present invention to modify the catheter positioning as taught by Stopek with the additional catheter repositioning as taught by Nita. Doing so would make it possible to "provide appropriate visualization of the blood clots and ability to remove them without a need for craniotomy" (see Nita; [0022]).
Regarding claim 7, Stopek teaches all claim limitations, as applied in claim 1, except delivering a cavitation nucleation agent to the body to enhance liquification of the body.
However, in the same field of endeavor, Nita teaches delivering a cavitation nucleation agent to the body ("Alternative methods optionally involve delivering microbubbles or nanobubbles into the patient's bloodstream, in conjunction with the delivered ultrasound energy." [0030]; microbubble is a known cavitation nucleation agent) to enhance liquification of the body ("U.S. Pat. No. RE36,939, issued to Tachiba a et al., describes the use of microbubbles to enhance the effects of ultrasound delivery, with or without a pharmacological composition." [0024]; the effect of microbubble is known in the art as recited by Tachiba).
It would have been prima facie obvious to one skilled in the art before the effective filing date of present invention to modify the ultrasound energy delivery as taught by Stopek with the additional microbubbles in combination with ultrasound energy as taught by Nita. Doing so would make it possible to "enhance the effects of ultrasound delivery," (see Nita; [0024]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Xu et al. (US 2018/0154186 A1; published on 06/07/2018) teach a histotripsy method for brain hematoma. The method uses image guidance and a drainage catheter.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797