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 1 – 4 are objected to because of the following informalities:
Claim 1 line 5, limitation "first and second regions of cancerous" should read "first and second regions of cancerous tissue".
Claim 1 line 17, limitation "that region" should read "the first region".
Claim 1 line 21 – 22, limitation "apply cold atmospheric plasma to that second cancerous tissue of the second specific dosage and settings" should read "apply cold atmospheric plasma of said second specific dosage and treatment settings to the second cancerous tissue".
Claim 2 line 1, preamble "A method" should read "The method".
Claim 2 line 2 – 3, limitation "wherein said robotic surgical system locates cancerous tissue in a region by comparing stored images of said region to real-time images of said region" should read "wherein said robotic surgical system locates cancerous tissue in the first and second regions by comparing stored images of the first and second regions to real-time images of the first and second regions".
Claim 3 line 1, preamble "A method" should read "The method".
Claim 4 line 1, preamble "A method" should read "The method".
Appropriate correction is required.
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 1, 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Buske (US 2013/0199540 A1; published on 08/08/2013) in view of Hashimshony (US 2012/0238867 A1; published on 09/20/2012) and Canady (US 2020/0237422 A1; filed on 01/28/2020).
Regarding claim 1, Buske teaches a method for performing robotic surgical treatments ("The technical problem for the invention is therefore to provide a device and a method which allow a more reliable and more rapid plasma treatment of living tissue." [0011]; "… it is also possible for the movement device to have a robot arm to which the plasma source is secured." [0069]) comprising:
scanning a patient for cancerous tissue in a plurality of regions in said patient ("Prior to performing the plasma treatment … The determination of the area to be treated and possibly its topography can be performed with optical means … within the camera image captured selection of the area can be performed by the treating person." [0081]; "If for the different treatment of various types of tissue ... The control device will then operate the plasma source and the movement device as a function of the setting." [0074]; here it is implied different treatment at different regions);
storing in a memory images of first and second regions of cancerous in said patient ("The measured data are stored in the control device and then used as a basis for control of the plasma source during the plasma treatment." [0075]; memory is inherent component for any computer based device);
determining a first specific cold atmospheric plasma dosage and treatment settings for cancerous tissue in said first region of cancerous tissue ("... can control the operating parameters of the plasma source and the movement device as a function of at least one of the preset parameters of plasma output, distance, temperature, tissue type and desired effect." [0064]; "If for the different treatment of various types of tissue different plasma outputs and intensities of the plasma treatment are necessary, then in particular on the control device a corresponding selection possibility for different plasma treatments is provided for." [0074]);
determining a second specific cold atmospheric plasma dosage and treatment settings for cancerous tissue in said second region of cancerous tissue ("... can control the operating parameters of the plasma source and the movement device as a function of at least one of the preset parameters of plasma output, distance, temperature, tissue type and desired effect." [0064]; "If for the different treatment of various types of tissue different plasma outputs and intensities of the plasma treatment are necessary, then in particular on the control device a corresponding selection possibility for different plasma treatments is provided for." [0074]);
programming a robotic surgical system to move to the first region of cancerous tissue, locate cancerous tissue in that region, and apply cold atmospheric plasma of said first specific dosage and treatment settings to the first cancerous tissue ("The control device will then operate the plasma source and the movement device as a function of the setting. It can similarly be provided that individual parameters for influencing the plasma treatment can be adjusted separately. This makes individualised plasma treatment possible." [0074]), after completion of treatment of the first region move to the second region, locate the cancerous tissue in the second region and apply cold atmospheric plasma to that second cancerous tissue of the second specific dosage and settings ("The control device will then operate the plasma source and the movement device as a function of the setting. It can similarly be provided that individual parameters for influencing the plasma treatment can be adjusted separately." [0074]; here the treatment is in a moving manner from one site to another site).
Although Buske does not explicitly teach the analyzing of cancerous tissue, it is a well-known diagnostic technology to detect tissue type and to plan treatment parameter according to target tissue/cell type.
Further, in the same field of endeavor, Hashimshony teaches analyzing cancerous tissue in each of said first and second regions of cancerous tissue to identify a type of cancerous tissue in each of the first and second regions of cancerous tissue ("... detecting the reflections of the laser pulses from the examined tissue; comparing an optical characteristic of the laser pulses applied to the examined tissue with that of the laser reflections from the examined tissue; and utilizing the comparison of optical characteristics for determining the presence of cancerous cells in the examined tissue." [0016]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the target body imaging as taught by Buske with the imaging based cancerous cell detection as taught by Hashimshony. Doing so would make it possible to provide the surgeon with useful information "which are capable of more accurately determining the extent of the presence of cancerous cells in a real-time manner" (see Hashimshony; [0006]).
In addition, in the same field of endeavor, Canady teaches determining a first specific cold atmospheric plasma dosage and treatment settings for cancerous tissue in said first region of cancerous tissue; determining a second specific cold atmospheric plasma dosage and treatment settings for cancerous tissue in said second region of cancerous tissue ("… the database comprising cell lines identifying data and cold atmospheric plasma settings associated with the cell line identifying data. The graphical user interface has input means for a surgeon to enter cell line identifier data and in response to the entry of cell line identifier data the electrosurgical generator automatically accesses the database in the data storage or memory and adopts cold atmospheric plasma settings associated with the entered cell line identifier data in the database and displays the adopted cold atmospheric plasma settings on the display." [0015]; "Additional cancer cell line data and associate settings or dosage data can be added to the database as new cell lines are tested and new data is developed." [0042]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the plasma therapy of various tissue types as taught by Buske with the preprogrammed CAP treatment setting database as taught by Canady. Doing so would make it possible that the user can "perform a CAP treatment of target cancer cells at those predicted optimum settings" (see Canady; [0041]).
Regarding claim 3, Buske in view of Hashimshony and Canady teaches all claim limitations, as applied in claim 1, and Buske further teaches detecting with a sensor array in said robotic surgical system a distance between an accessory attached to said robotic surgical system and target tissue ("In FIG. 14 and FIG. 15 a camera 370 is also shown, wherein by means of imaging the distance a between the front end of the outlet opening 316 and the surface of the object 320 is monitored." [0186]; the imaging chip of camera is in the form of pixel array; see Fig.10, the housing of plasma device is held by robot arm 132).
Regarding claim 4, Buske in view of Hashimshony and Canady teaches all claim limitations, as applied in claim 3, and Buske further teaches controlling movement of said accessory with said robotic surgical system to maintain a constant distance from said accessory to target tissue ("Similarly the movement device 58 is operated in such a way that the plasma source 52 is moved over the body 56, while the movement takes place in such a way that a predetermined distance range between the plasma source 52 and the surface of the body 56 is maintained." [0136]) based upon results of said detecting and a 3-D map of an area of target tissue ("Similarly, the topography, that is to say the three-dimensional surface form, can be determined." [0081]; "Then, during the plasma treatment, the distance between the plasma source and the tissue can be adjusted, preferably continuously, within a specified range, possibly also on the basis of the measured topography of the area." [0082]; "... wherein by means of imaging the distance a between the front end of the outlet opening 316 and the surface of the object 320 is monitored." [0186]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Buske in view of Hashimshony and Canady, as applied in claim 1, and further in view of Schadewaldt et al. (US 2020/0038683 A1; published on 02/06/2020) (hereinafter "Schadewaldt").
Regarding claim 2, Buske in view of Hashimshony and Canady teaches all claim limitations, as applied in claim 1, except wherein said robotic surgical system locates cancerous tissue in a region by comparing stored images of said region to real-time images of said region.
However, in the same field of endeavor, Schadewaldt teaches wherein said robotic surgical system locates cancerous tissue in a region by comparing stored images of said region to real-time images of said region ("Upon acquisition of a real-time image by the imaging unit 7, the evaluation unit 6 compares the acquired images with the navigation images included in the received series of navigation images … Using an appropriate matching criterion, the navigation image can be selected such that it essentially shows the target structure and/or the OARs in essentially the same phase of their motion as the acquired real-time image." [0082]; here the navigation images is pre-acquired and stored).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the robotic movement system as taught by Buske with image-guided therapy as taught by Schadewaldt. Doing so would make it possible "to improve the planning of the continuation of the treatment during the delivery of a radiation therapy treatment on the basis of real-time images acquired during the delivery of the treatment" (see Schadewaldt; [0012]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797