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 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.
Claim(s) 1, 3, 4, 6-8, 10, 11, 14, 15, 18, and 20-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berrada et al. (WO 2021/178696).
Regarding claim 1, Berrada et al. discloses a method of estimating progress of a thrombectomy procedure (abstract discloses thrombus removal wherein [0025] “the imaging element 108 can generate image data before, during, and/or after the thrombectomy procedure so the clinician can evaluate whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial, etc”), comprising: performing pre-operative medical imaging of one or more clots (“T”) in a patient (Use of imaging element 108, [0025]); determining a pre-operative parameter of the one or more clots based on the pre-operative medical imaging (camera 108 can generate an image or data representative of the vasculature and thrombus. Imagining data is used to assist the clinician in positioning the distal end of the device and can be used to determine the type of thrombus, which affects the choice of treatment tool, [0025]. The “preoperative parameter” is interpreted to be an image of the clot); removing at least a portion of the one or more clots with a thrombectomy device (wherein 102 is the thrombectomy device, FIG 1A-1B, [0027, 0032-0035]); determining a parameter of the removed portion of the one or more clots ([0025] discloses the imaging can be done during and after the procedure, therefore these parameters determined by the imaging are considered parameters of the removed portion); and displaying the parameter of the removed portion of the one or more clots to a user ([0025] the imaging can be “displayed to assist the clinician”).
Regarding claim 3, 4, and 6, Berrada et al. discloses the pre-operative parameter comprises a volume, dimension, and morphology of the one or more clots ([0025]; imaging that can determine the type of thrombus and how much has been removed is indicative of a volume, dimension, and morphology of the clot).
Regarding claim 7, 8, and 10, Berrada et al. discloses the parameter of the removed portion comprises a volume, dimension, and morphology of the one or more clots removed ([0025]; imaging that can determine the type of thrombus and how much has been removed is indicative of a volume, dimension, and morphology of the clot).
Regarding claim 11, Berrada et al. discloses determining the pre-operative parameter comprises performing image processing to estimate the parameter of the one or more clots ([0025] discloses image processing).
Regarding claim 14, Berrada et al. discloses determining the parameter of the removed portion comprises evaluating one or more images of the one or more clots after removal ([0025] discloses “the imaging element 108 can generate image data during and/or after the thrombectomy procedure so the clinician can evaluate whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial”).
Regarding claim 15, Berrada et al. discloses comparing the pre-operative parameter to the parameter of the removed portion of the one or more clots ([0025]; the imaging element 108 can generate image data before, during, and/or after the thrombectomy procedure so the clinician can evaluate whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial).
Regarding claim 18, Berrada et al. discloses comprising filtering blood and/or saline from the one or more removed clots ([0035 and 0040-0041]).
Regarding claim 20-21, Berrada et al. discloses comparing a pre-operative dimension and volume of the one or more clots to a dimension of the one or more clots removed ([0025] “the imaging element 108 can generate image data before, during, and/or after the thrombectomy procedure so the clinician can evaluate whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial” is interpreted as comparing the pre and post operative clot properties to determine if the procedure is complete or should be continued).
Regarding claim 22, Berrada et al. discloses removing at least a portion of the one or more clots comprises: directing one or more fluid streams towards the one or more clots to break up the one or more clots (using fluid delivery mechanism 114 od 124, [0035-0038]); and aspirating the one or more clots with the thrombectomy device (using aspiration mechanism 140, [0040-0041]).
Regarding claim 23, Berrada et al. discloses calculating a volume of saline delivered with the one or more fluid streams ([0032 and 0035]; monitoring, via the sensors 113, the volume of fluids in the body constitutes calculating a volume of saline since the fluid streams being applied to macerate the thrombus can be saline).
Regarding claim 24, Berrada et al. discloses separating fluid from the removed portion of the one or more clots ([0040]; “The aspiration mechanism 140 can be configured to aspirate the fragmented thrombus… The pump fluid and aspirated materials can be collected in the container 142. Optionally, collected fluids can be filtered and reused to continue running the pump”).
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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (WO 2021/178696) in view of Mintz (US 2022/0061872).
Regarding claim 2, Berrada discloses the invention substantially as claimed, as set forth above for claim 1.
Berrada is silent regarding the pre-operative medical imaging comprises CT imaging.
However, Mintz discloses in the same filed of endeavor of thrombectomy procedures ([0003, 0030-0031]) a step of obtaining pre-operative medical imaging using CT ([0114]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select CT as the imaging modality used to obtain the pre-operative images in Berrada, for the purpose of utilizing a technique commonly known in the are for pre- and intra-operative medical imaging.
Claim(s) 5, 9, 12, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (WO 2021/178696) in view of Hamilton (WO 2013/119662).
Regarding claims 5, 9, 12, 13, and 19, Berrada discloses the invention substantially as claimed, as set forth above for claim 1. Berrada further discloses the removed clots being received within a clot capture container (142, [0040]).
Berrada is silent regarding the pre-operative parameter and a parameter of the removed portion comprises a weight of the one or more clots, wherein determining the parameter of the removed portion comprises sensing a weight of the one or more clots after removal, and further comprising comparing a pre-operative weight of the one or more clots to a weight of the one or more clots removed.
However, Hamilton teaches in the same field of endeavor of thrombus removal ([0025]) a process for determine the efficacy to the treatment by weighting the clots before and after treatment to determine loss of mass ([0054], wherein determining the loss of mass is understood as comparing the before and after weights).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method to use weight as a pre-operative parameter and a parameter of the removed portion and to compare the before and after weights of the clot, as taught by Hamilton, for the purpose of utilizing a parameter commonly known in the art for determining if the treatment ahs been effective in removing the clot, thereby assisting the clinician in determining whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial.
Claim(s) 16 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (WO 2021/178696).
Regarding claim 16, Berrada discloses the invention substantially as claimed, as set forth above for claim 15.
Berrada is silent regarding displaying a percentage of the one or more clots removed.
However, since Berrada discloses using imaging to determine an amount of clot prior to the thrombectomy procedure, and after the procedure ([0025]), it would have been obvious to one of ordinary skill in the art at the time of filing to include a step of calculating a percentage based off of these images to display a percentage of the one of more clots removed, for the purpose of assisting the clinician in evaluating whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial. Such a modification would require only routine skill in the art.
Regarding claim 25, Berrada discloses the invention substantially as claimed, as set forth above for claim 24. Berrade teaches the use of blood volume sensors ([0032]) and that the pump fluid and aspirated materials can be collected in the container 142 and collected fluids can be filtered and reused to continue running the pump ([0040]) meaning that the clot material is separated from the saline.
Berrada is silent regarding calculating a volume of blood removed from the patient by subtracting the volume of saline delivered from a volume of the separated fluid.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method to comprise a step of calculating volume of blood removed from the patient by subtracting the volume of saline delivered from a volume of the separated fluid, for the purpose of providing a metric of how much volume of clot has been retrieved from the procedure and aiding the clinician in determining whether the thrombus has been completely removed, whether there are any portions or other thrombi remaining in the blood vessel, whether other treatment procedures would be beneficial. Such a modification would require only routine skill in the art.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Berrada et al. (WO 2021/178696) in view of Takehiro et al (JP 2007117384).
Regarding claim 17, Berrada discloses the invention substantially as claimed, as set forth above for claim 1.
Berrada is silent regarding overlaying a graphic of portions of the one or more clots removed on top of a graphic of the pre-operative medical imaging of the one or more clots.
However, Takehiro teaches in the field of imagine diagnosis and treatment a step of overlaying a graphic on top of a pre-operative image (FIG 8 which shows Doppler mode 3D imaging showing before and after imaging superimposed and being used to determine when a procedure on the blood vessel is complete, [0067-0069]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing modify the method of Berrada such that the pre-operative image and the image taken after removal are overlayed, as taught by Takehiro, for the purpose of using image data obtained before treatment and after treatment to determine effectiveness of the treatment (Takehiro: [0015]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
