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 .
Response to Amendment
The amendment filed on 07/26/2026 has been entered:
Claim 1 – 4 remain pending in the application;
Claim 1 – 4 are amended.
Applicant’s amendments to claim overcome each and every claim objection as set forth in the Non-Final Office Action mailed on 01/29/2026. The corresponding claim objections are withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1 – 4 under 35 U.S.C. 103 have been fully considered but they are not persuasive and are moot in view of new grounds of rejection.
Regarding the rejection of independent claim 1, applicant amend claim 1 to include limitation “with a robotic surgical system having a processor, a memory, a robotic control arm, a surgical tool connected to said robotic control arm, wherein said surgical tool comprises an accessory for delivering cold atmospheric plasma”; “scanning a patient for cancerous tissue in a plurality of regions in said patient based on parameters set by said processor;” “locate cancerous tissue in said first region by comparing stored images of said first region to real time images of said first region,” “locate the cancerous tissue in the second region by comparing stored images of said second region to real time images of said first region”. Applicant submitted on p.4 that “Applicant has amended the claims to more clearly define the steps being performed by the robotic surgical system. The surgical systems disclosed in the cited prior art do not perform nor render obvious these steps performed by the robotic surgical system.”
Applicant’s arguments have been fully considered but they are not persuasive and are moot in view of new grounds of rejection for the following reasons.
First, Buske does teach a robotic system (Fig.10) with processor (control device 138; see [0153]), memory (storage means; see [0137]), robotic arm (robot arm 132; [0153]), and surgical tool delivering cold atmospheric plasma (the plasma nozzle 134; see [0153]), and corresponding controlled robotic movement (see [0153]).
Second, since applicant’s amendment changed the scope of claim, reference Schadewaldt, previously recited in the rejection of dependent claim 2, is introduced in new grounds of rejection to teach the amended features in combination with other cited references. See detail in later 103 rejection.
Thus, applicant’s arguments regarding the rejection of independent claim 1 have been fully considered but they are not persuasive and are moot for the reasons detailed above.
Regarding the rejection of all other corresponding dependent claims, applicant’s remarks submitted on p.4 rely on supposed deficiencies with the rejection of parent claim 1. Applicant’s arguments are not persuasive and are moot for the same reasons detailed above.
Overall, applicant’s remarks submitted on p.4 have been fully considered, but they are not persuasive and are moot in view of new grounds of rejection. The amendments result in new grounds of rejection. THIS ACTION IS MADE FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 21 – 22, limitation “locate the cancerous tissue in the second region by comparing stored images of said second region to real time images of said first region” should read “locate the cancerous tissue in the second region by comparing stored images of said second region to real time images of said second region”, to avoid potential 112 issue.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites limitation “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.” However, the parent claim 1 recites similar limitations “locate cancerous tissue in said first region by comparing stored images of said first region to real time images of said first region,” “locate the cancerous tissue in the second region by comparing stored images of said second region to real time images of said first region”. Claim 2 does not include any other limitations to further limit the subject matter of parent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 – 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 Schadewaldt et al. (US 2020/0038683 A1; published on 02/06/2020) (hereinafter "Schadewaldt"), 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]) with a robotic surgical system (“FIG. 10 shows a further alternative for the design of a device according to the invention …” [0153]) having a processor (“For the control of the device a control device 138 is provided for.” [0153]; processor or equivalent is inherent element of robot control device), a memory (“… with the help of storage means” [0137]), a robotic control arm (“… in which a movement device 130 with a robot arm 132 is used.” [0153]), a surgical tool connected to said robotic control arm (“The robot arm 132 allows six degrees of freedom in the movement of the plasma nozzle 134 …” [0153]; see Fig.10), wherein said surgical tool comprises an accessory for delivering cold atmospheric plasma (“… for plasma treatment of living tissue each have a plasma source 52, 72 or 134.” [0154]), comprising:
scanning a patient for cancerous tissue in a plurality of regions in said patient based on parameters set by said processor ("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 with settings);
storing in a memory images of first and second regions of cancerous tissue 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 said robotic surgical system to move said surgical tool (“The robot arm 132 allows six degrees of freedom in the movement of the plasma nozzle 134 relative to a body to be treated … For the control of the device a control device 138 is provided for.” [0153]) to the first region of cancerous tissue, locate cancerous tissue in said first region, and apply cold atmospheric plasma of said first specific dosage and treatment settings to the first region of 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 of cancerous tissue, locate the cancerous tissue in the second region and apply cold atmospheric plasma of said second specific dosage and settings to the cancerous tissue in the second region ("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).
Buske does not explicitly teach programing said robotic surgical system to locate cancerous tissue in said first region by comparing stored images of said first region to real time images of said first region, and to locate the cancerous tissue in the second region by comparing stored images of said second region to real time images of said first region.
However, in the same field of endeavor, Schadewaldt teaches programing said robotic surgical system to locate cancerous tissue in said first region by comparing stored images of said first region to real time images of said first region, and to locate the cancerous tissue in the second region by comparing stored images of said second region to real time images of said first 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]).
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 2, Buske in view of Schadewaldt, Hashimshony and Canady teaches all claim limitations, as applied in claim 1, and Schadewaldt teaches 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 (see 112d rejection; "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]).
Regarding claim 3, Buske in view of Schadewaldt, 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 Schadewaldt, 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]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ye et al. (US 2021/0196398 A1; priority date on 12/31/2019) teach methods of targeting anatomical feature by comparing real-time images with prior acquired image.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
