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 . In the event the determination of the status of the application as subject to 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.
Status of Claims
Claims 1-10 are currently pending and are being hereby examined herein.
Joint Inventors
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.
Response to Amendment / Remarks
Any reference to the prior office action refers to the nonfinal rejection dated 5 May 2025.
All drawing objection from the prior office action are withdrawn.
Examiner has updated the specification objections (see below), any specification objection not listed in this office action is withdrawn.
Examiner has updated the claim objections to reflect the current claim language (see below), any claim objection not listed in this office action is withdrawn.
All rejection under 35 U.S.C. 112(a) from the prior office are withdrawn.
All rejections under 35 U.S.C. 112(b) from the prior office are withdrawn.
Applicant cites the text of 35 U.S.C. 102(b)(2) as a reason WIPO Pub. No. 2019/126636 is not prior art and should not be valid for rejections from the prior office action under 35 U.S.C. 103. This argument is not persuasive because 35 U.S.C. 102(b)(2) only provides exceptions to prior art under 35 U.S.C. 102(a)(2). WIPO Pub. No. 2019/126636 is prior art under 35 U.S.C. 102(a)(1), regardless of if it is prior art under 35 U.S.C. 102(a)(2), and therefore the rejections under 35 U.S.C. 103 are proper and are maintained. The earliest possible effective filing date of the present application is 4 March 2021 which is the filing date of provisional application 63/156,787 (note: as addressed in the prior office action, the the provisional applications do not provide support for every claim limitation, but this point will be disregarded here as it is a moot point to the current argument). All exceptions to prior art under 35 U.S.C. 102(a)(1), which addresses a disclosure with a prior public availability date, are found in 35 U.S.C. 102(b)(1), these exceptions all reference a one year grace period. Therefore, any disclosure with a prior public availability date before 4 March 2020 is prior art for this application regardless of the inventor and ownership (and without even considering if there was support in the provisional application with that filing date). WIPO Pub. No. 2019/126636 has a public availability date of 27 June 2019 (i.e., was described in a printed publication on that date), which means it is not within the grace period specified in 35 U.S.C. 102(b)(1) for exceptions prior art under 35 U.S.C. 102(a)(1), and should be considered prior art with a prior public availability date (see MPEP 2152 and 2153).
Specification
The amendment filed 5 November 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: paragraph [0036] has been amended to state “The processor then defines a depth map in the robot coordinate system”, no support for “the processor” completing this was found in the original disclosure. Applicant is required to cancel the new matter in the reply to this Office Action.
Additionally, the disclosure is objected to because of the following informalities:
In paragraph [0014], “moving the robotic arm with the processor in accordance with the instructions” should be “moving the robotic arm
In paragraphs [0031] and [0040], there is punctuation (i.e., a comma or a period) after some bullet points and not others, use of punctuation should be consistent among all bullet points.
In paragraph [0032], “mater control 610” should be “master[[mater]] control 610”.
In paragraph [0032], “under interface 636” should be “user[[under]] interface 636”.
In paragraph [0040], “Position&” should be “Position &”.
In the case that there are additional issues within the specification that Examiner did not specifically point out above, it is requested of the Applicant to review the specification in its entirety to ensure no further objectionable language exists. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
“the defined tissue area” should be “the [[defined]] tissue area to be treated”.
“said defined tissue area” should be “said [[defined]] tissue area to be treated”.
Claim 3 is objected to because of the following informality:
“said passive positioning arm” should be “said at least one passive positioning arm”.
Claim 8 is objected to because of the following informality:
“comprises” should be “comprising [[comprises]]”.
Claim 10 is objected to because of the following informality:
“A method…according to claim 1” should be “The [[A]] method…according to claim 1”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over WIPO Pub. No. 2019/126636 (Canady et al., hereinafter, Canady) in view of U.S. Pub. No. 2005/0276377 (hereinafter, Carol).
Regarding Claim 1, Canady discloses A method for robotic controlled cold atmospheric plasma surgery comprising (see at least [0011]-[0012]: a method for uniform application of Cold Atmospheric Plasma using an automated robotic arm is described):
defining a tissue area to be treated (see at least [0022]: preoperative planning and review may to be performed to identify a target region or regions or interest in the patient),
inputting cold atmospheric plasma settings into a cold atmospheric plasma surgical system(see at least [0012] and [0021]-[0023]: cold atmospheric plasma dosage and treatment settings are determined, and a robotic management system is programmed to locate and apply cold atmospheric plasma of said dosage and treatment settings to the cancerous tissue);
calculating with a processor a robot movement plan to move a cold atmospheric plasma probe over the defined tissue area at said cold atmospheric plasma settings and storing said robot movement plan in memory (see at least [0012] and [0021]-[0023]: cold atmospheric plasma dosage and treatment settings are determined, and a robotic management system is programmed to locate and apply cold atmospheric plasma of said dosage and treatment settings to the cancerous tissue; the surgical management system has processors and memory for storing and running software to control the system and run various functions; In FIG. 2, there is a disposable tip shown on the end of the robot arm), wherein said robot movement plan comprises robotically moving said cold atmospheric plasma probe connected to a robotic arm end-effector over the tissue area to be treated in accordance with the robot movement plan (see at least [0021]-[0023] and FIG. 2: the surgical management system controls movement of the robotic arm; In FIG. 2, there is a disposable tip shown on the end of the robot arm);
robotically moving said cold atmospheric plasma probe over said defined tissue area according to said calculated robot movement plan…(see at least [0021]-[0023] and FIG. 2: the surgical management system controls movement of the robotic arm; In FIG. 2, there is a disposable tip shown on the end of the robot arm); and
activating said robot movement plan to move said cold atmospheric plasma probe over said tissue area to be treated according to said robot movement plan while activating said cold atmospheric plasma to treat the defined tissue area with said cold atmospheric plasma (see at least [0021], [0023], and FIG. 2: surgical management system controls movement of the robotic arm; in FIG. 2, there is a disposable tip shown on the end of the robot arm; the surgical management system can be programmed to seek out regions of cancerous tissue and apply cold atmospheric plasma to that region).
Canady does not explicitly disclose that robotically moving said cold atmospheric plasma probe over said defined tissue area according to said robot movement plan should occur without activating cold atmospheric plasma. However, Carol, solving the same problem of cancer treatment, within the same field of robotically controlled medical devices, and therefore analogous art, teaches robotically moving a cancer treating probe over said defined tissue area according to said robot movement plan without activating the treatment (see at least [0142]-[0143]: the robot can retrace treatment the region before treatment begins (i.e., without activating); the system can continue the treatment while compensating for movement by determining the vector and amount of movement and changing the delivery instructions for the delivery device such as a robot so that it positions the delivery arm correctly for the new position of the patient).
In the case of Carol, the treatment is radiation as opposed to cold plasma treatment in Canady; however, it would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one of ordinary skill in the art, to have combined the cold plasma method of Canady with the additional step of operating without activating the treatment of Carol because the theoretical goal of a cancer treatment is to eliminate malignant cells without effecting normal tissue; an incorrect dose might be delivered to the treatment region if the patient moves; retracing data determines if the patient has moved; if the patient has moved, the treatment can be shutdown (see at least Canady [0030], [0138], and [0142]-[0143]).
Regarding Claim 2, the Canady and Carol combination teaches all the limitations of Claim 1. Carol further teaches wherein said step of defining a tissue area to be treated comprises detecting at least three points inputted by a user (see at least [0134]: the region to be treated is acquired directly off the patient’s body; the user guides the robot around the contour of the region to be treated as if painting it with a paint brush; defining a region requires detecting at least three points), and said step of detecting at least three points comprises:
detecting a manual force applied to said robotic arm end-effector with at least one sensor (see at least [0134]: a camera system (i.e., at least one sensor) can detect the location of active or passive markers placed on the robot arm that is used by the user to trace the area of interest (i.e., a manual force is applied to the robot arm by the user to trace and the camera is detecting a manual force by detecting movement of the arm));
converting the manual force into robot instructions with said processor (see at least [0134]: the control system is put in “data acquisition” mode; the control system records the movement of the arm);
moving a robotic arm in accordance with the robot instructions (see at least [0134]: the arm is moving as the control system records the movement of the arm); and
recording the movement path (see at least [0134]: the control system is put in “data acquisition” mode; the control system records the movement of the arm).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have combined the cold plasma method of Canady with the additional steps related to defining a tissue area to be treated of Carol to create high doses of treatment for unhealthy tissue, such as tumors, while maintaining low doses in all other healthy tissue (see at least Carol [0054]).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Canady in view of U.S. Pub. No. 2020/0281676 (Rohs et al., hereinafter Rohs).
Regarding Claim 3, Canady discloses A system for robotic controlled cold atmospheric plasma surgery comprising (see at least FIG. 2 and [0026]: a system for application of Cold Atmospheric Plasma using an automated robotic arm is described):
a robotic end effector (see at least FIG. 1 and FIG. 2: surgical tool 480 is a component of robotic arm 400)
a cold atmospheric plasma generator (see at least [0028])
a cold atmospheric plasma accessory (see least claim 4).
Canady does not explicitly disclose
a passive positioning system comprising:
a positioning system base;
at least one passive positioning arm
a robotic end effector connected to said at least one passive positioning arm, said robotic end effector having three degrees of freedom and a connector for connecting a cold atmospheric plasma accessory to said robotic end effector;
a master control module in said base positioning system for controlling robotic movement of said robotic end effector.
However, Rohs, in the same field of surgical robot controls, and therefore analogous art, teaches
a passive positioning system comprising (see at least [0072]: a passive positioning system is described):
a positioning system base (see at least FIG. 1: manipulator cart 17);
at least one passive positioning arm extending from said positioning system base(see at least [0072] and FIG. 1: the system may operate in manual mode; the user physically contacts the tool 20 to cause movement of the tool 20 in manual mode; In one version, the manipulator 14 (i.e., passive positioning arm) monitors forces and torques placed on the tool 20 by the user in order to position the tool 20; in FIG.1, manipulator 14 is shown attached to tool 20), said passive positioning arm having five degrees of freedom (see at least [0042]: the manipulator 14 has at least six-degrees of freedom (i.e., with six degrees of freedom there would also be five degrees of freedom));
a robotic end effector connected to said at least one passive positioning arm (see at least [0046] and FIG. 1: the tool 20 is or forms part of an end effector 22 supported by the manipulator 14), said robotic end effector having three degrees of freedom (see at least [0042] and [0046]: the tool 20 couples to the manipulator and therefore has at least as many degrees of freedom as the manipulator 14; the manipulator 14 has at least six-degrees of freedom (i.e., with six degrees of freedom there would also be three degrees of freedom)) and a connector for connecting an energy applicator to said robotic end effector (see at least [0047]: the tool 20 includes an energy applicator 24);
a master control module in said positioning system base for controlling robotic movement of said robotic end effector (see at least [0045] and FIG. 1: the manipulator cart 17 can house a manipulator controller 26, other type of control unit).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have modified the disclosure of Canady with the teachings of Rohs in order to provide manual and semi-autonomous modes for a robotic surgical system (see at least Rohs [0004]).
Regarding Claim 8, the Canady and Rohs combination teaches all the limitations of Claim 3.
Furthermore, Rohs teaches wherein said system has three degrees of freedom comprises two rotational degrees of freedom and one translational degree of freedom (see at least [0079]: the inputs to the path handler 82 may comprise components of force along the x, y, z axes and torque about the x, y, z axes; this can be transformed to the coordinate system of the tool)).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have modified the disclosure of Canady with the information provided by Rohs so that the robotic surgical system generally positions the surgical tool in accordance with the user's intentions (see at least Rohs [0004).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Canady in view of U.S. Pub. Rohs in further view of U.S. Pub. No. 2017/0334067 (Swarup et al., hereinafter, Swarup).
Regarding Claim 4, the Canady and Rohs combination teaches all the limitations of Claim 3.
Neither Canady nor Rohs teaches wherein said passive positioning system further comprises a levelling stage.
Swarup, in the same field of computer-assisted medical devices, and therefore analogous art, teaches wherein said passive positioning system further comprises a levelling stage (see at least [0036] and FIG. 2: the shoulder joint 223 can be moved up and down along an axis 232).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have modified the teachings of Canady and Rohs with the teachings of Swarup so the corresponding manipulators and instruments have sufficient range of motion to perform a surgical procedure on the patient (see at least Swarup [0037]).
Claims 5, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Canady in view of Carol in further view of U.S. Pub. No. 2021/0007786 (Konesky et al., hereinafter, Konesky).
Regarding Claim 5, the Canady and Carol combination teaches all the limitations of Claim 1. Canady nor Carol teach wherein said robot movement plan comprises maintaining a constant distance between a tip end of said cold atmospheric plasma probe and the tissue.
Konesky, in the same field of applying cold plasma to an operative site, and therefore analogous art, teaches moving a cold plasma probe while maintaining a constant distance between a tip end of said cold atmospheric plasma probe and the tissue (see at least [0150]: the applicator nozzle tip is placed 5 millimeters above the test tissue and scanned across the tissue surface).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have further combined the combination of Canady and Carol with the additional step of maintaining a constant distance between a tip end of said cold atmospheric plasma probe and the tissue to ensure the energy density to the operative site remains within a beneficial range that achieves a desired physiological effect to the operative site since relatively small changes in applicator distance can have significant effects in applied power density (see at least Konesky [0009] and [0093]).
Regarding Claim 6, the Canady and Carol combination teaches all the limitations of Claim 1. Canady nor Carol teach wherein said robot movement plan comprises moving said cold atmospheric plasma probe at a constant speed.
Konesky, in the same field of applying cold plasma to an operative site, and therefore analogous art, teaches moving said cold atmospheric plasma probe at a constant speed (see at least [0150]: the applicator nozzle is scanned across the tissue surface at a constant speed of 4 millimeters per second).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have further combined the combination of Canady and Carol with the additional step of moving said cold atmospheric plasma probe at a constant speed since a small change in the applicator scanning speed can result in undesirable physiological effects to the operative site (see at least Konesky [0095]).
Regarding Claim 7, the Canady, Carol, and Konesky combination teaches all the limitations of Claim 5. Canady nor Carol nor Konesky teach wherein said constant distance between said tip end of said cold atmospheric plasma probe and the tissue area to be treated is in the range of 1.5-2.5 mm.
However, it would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have said constant distance between said tip end of said cold atmospheric plasma probe and the tissue area to be treated is in the range of 1.5-2.5 mm, since it has been held that discovering an optimum value of a result effective variable involved only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). There is no unexpected result or particular advantage for the constant distance to be in the range of 1.5-2.5 mm provided in Applicant’s specification.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Canady in view of Carol in further view of U.S. Pub. No. 2010/0130986 (Mailloux et al., hereinafter, Mailloux).
Regarding Claim 9, the Canady and Carol combination teaches all the limitations of Claim 1. Additionally, Carol teaches wherein said step of defining a tissue area to be treated comprises:
detecting an area inputted by a user manually moving a cold atmospheric probe connected to a robotic end-effector…(see at least [0134]: the robot is used in a passive data acquisition mode whereby the control system for the robot records the position of the tip of the arm in the coordinate system of the robot as the user guides the robot arm around the contour of the region to be treated).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have combined the disclosure of Canady with the teachings of Carol to create high doses of treatment for unhealthy tissue, such as tumors, while maintaining low doses in all other healthy tissue (see at least Carol [0054]).
Neither Canady nor Carol explicitly disclose or teach detecting…by counting a number of steps of a robotic motor in a direction.
However, Mailloux, in the same field of surgical robots, and therefore analogous art, teaches detecting…by counting a number of steps of a robotic motor in a direction (see at least [0041] and [0044]: the motors 610, 620 are preferably brushless motors with hall sensors being used for communication, and the encoders 630 being used for position measurements; the hall sensors can also serve as a redundant position measuring system).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have further combined the combination of Canady and Carol and with the additional teachings of Mailloux because many surgical procedures require a high precision in the surgical gesture (see at least Mailloux [0004]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Canady in view of Carol in further view of U.S. Pub. No. 2018/0014851 (Hansen et al., hereinafter, Hansen).
Regarding Claim 10, the Canady and Carol combination teaches all the limitations of Claim 1. Canady further discloses wherein said step of defining a tissue area to be treated comprises:
inputting boundaries of the tissue area to be treated (see at least [0012] and [0022]: dye marks the areas of operation and imagery allow the user to define target areas).
Neither Canady nor Carol explicitly disclose or teach wherein said step of defining a tissue area to be treated comprises:
detecting with a camera a projected surface shape of the tissue area to be treated;
calculating with said processor a deformation of the projected surface shape; and defining a depth map of said tissue area to be treated.
However, Hansen, in the same field of surgery including a robot, and therefore analogous art, teaches
detecting with a camera a projected surface shape of the tissue area to be treated (see at least [0282] and Fig. 17a: a projector projects a light pattern; a camera captures images of the reflected pattern and transmits image data to the computer system);
calculating with said processor a deformation of the projected surface shape; and defining a depth map of said tissue area to be treated (see at least [0282] and Fig. 17b: the image data is processed by the computer system using software algorithms for determining spatial position and orientation of the projector relative to the surgical surface e.g. distance).
It would have been obvious, before the effective filing date of the invention, with a reasonable expectation of success, to one having ordinary skill in the art, to have further modified the combination of Canady and Carol with the additional teachings of Hansen in order to improve vision for the surgeon (see at least Hansen [0006]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/A.R.M./Examiner, Art Unit 3658 /JASON HOLLOWAY/ Primary Examiner, Art Unit 3658