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
Claims 5 and 10 are objected to because of the following informalities:
In claim 5, line 3, “adjacent the tissue” should read “adjacent to the tissue”
In claim 10, line 7, “insertion of needles” should read “insertion of brachytherapy needles”
In claim 10, line 8, “placement of needles” should read “placement of brachytherapy needles”
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.
Claim(s) 1-4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merzouki et al. (WO 2017/009572), citing to attached document, in view of Koutrouvelis et al. (WO 9614880), citing to attached document, further in view of Pitman (US 2014/0309525).
Regarding claim 1, Merzouki et al. teaches a method for automated brachytherapy (page 2, para. 6, “The present invention relates more specifically to a robotic system for the autonomous guidance of a needle holder or syringe holder for internal treatment (brachytherapy and / or biopsy) of at least one tumor located on an organ”), comprising:
activating a controller for brachytherapy (Fig. 10, wherein the computer processing module 30 comprises a modeling circuit 31, image processing circuit 32, computer 33, dosimetry circuit 34, detection means 35, calibration module 36; Claim 22);
loading a treatment plan for a patient into the controller (Abstract, “treatment plan (P)”; Fig. 9; page 12, para. 8, “From this information provided by the digital model M, the circuit 32 then generates a processing schedule P during a step S4”), the patient;
automatically moving, under control of the controller in response to the treatment plan for the patient (page 12, para. 13, “this transformation of the coordinates of the processing targets t1, t2 and t3 and the exclusion zones Z into the reference system of the robot 20 makes it possible to generate the guidance instructions ORD of the robot 20 for guiding the head of the needle 11 and reaching each of the treatment targets t1, t2 and t3”; page 12, paras. 9-10, “This schedule P is characteristic of the present invention. The processing schedule includes the Cartesian coordinates of each of the processing targets t1, t2 and t3 and the exclusion zones Z in the reference frame of the imaging probe 41”), a robotic arm (Fig. 2A, articulated arm 21) to a position close to a tissue of the patient being treated using brachytherapy (Claim 1; Fig. 4a, wherein the needle-carrying equipment 10, which is mounted on a multidirectional guiding robot 20, abuts the patient’s prostate (PR)”; page 11, para. 1, “The system 100…makes it possible to practice on the prostate of a patient the brachytherapy technique in an automated and intelligent way”) the robotic arm having an imager (Fig. 2a, imaging probe 41) and a needle connector (Fig. 2b, needle-carrying equipment 10) connected to a radioactive source needle (Fig. 2b, needle 11) containing one or more radioactive sources to be implanted into the tissue of the patient (page 16, para. 7, “the functionalities of the insertion of the brachytherapy needle, the automatic loading of the radioactive seeds and the injection with a precise deposit under a guidance by medical imaging”; page 8, para. 5, “the charger comprises a step-by-step actuator configured to charge the needle with a radioactive grain”; Fig. 4a, wherein the needle 11 comprises a plurality of radioactive seeds, for example of the 1125 type; the needle 11 is configured to be inserted into the prostate ‘PR’);
scanning, using the imager, the tissue of the patient to determine a needle insertion site (Fig. 7c, digital model M of the prostate PR and treatment targets t1, t2, and t3; page 11, para. 17, “an imaging probe 41 is thus provided, such as an ultrasound probe which provides at least one image I of the prostate PR of the patient P”; page 12, para. 1, “the image I representing the prostate is processed by a modeling circuit 31 which generates…a digital model M of the prostate PR”; page 12, para. 6, “the circuit 32 determines in the model M the treatment targets to reach t1, t2 and t3, and exclusion zones Z on which the treatment is prohibited”); and
inserting, using the needle connector that is moved by the robotic arm (Figs. 3-4b; page 14, para. 18, “the deposition of the grains on each target is done rectilinearly, thanks to two synchronized movements: the tip of the needle 11, using the robot 20 towards the outside of the prostate and the mandrel 13 translation inside the prostate from the linear motor. During this rectilinear movement, the robot can advantageously rotate the needle 11 about its longitudinal axis: such a rotation during insertion has the advantage of minimizing the effect of static friction on the longitudinal axis of the needle”), at least one radioactive source from the radioactive source needle into a position in the tissue according to the treatment plan (page 13, para. 14, “P further comprises the doses to be injected for each target…the doses d1, d2, and d3, of the radioactive seeds to be injected”; page 14, para. 12, “the insertion of a single needle 11 into the body of the patient. This needle will then inject a product on the different treatment targets t1, t2 and t3 according to the treatment schedule P”).
Merzouki et al. fails to specifically teach a position adjacent; and wherein the needle is one of a fiducial needle for fixating the brachytherapy treatment to a surgery table; and inserting, using the needle connector that is moved by the robotic arm, at least one fiducial needle into the tissue at the needle insertion site.
In the same field of endeavor, Koutrouvelis et al. teaches wherein an analogous stereotactic assembly is positioned adjacent to a patent’s tissue (Fig. 2; page 3, para. 8, “the stereotactic assembly 26 is adjusted to match the tilt of the gantry 24 and is positioned adjacent the gluteal region of the patient 10”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Merzouki et al. with the adjacent positioning of Koutrouvelis et al. Doing so facilitates the insertion of radioactive seeds into the gluteal region of the patient, thereby forming a three-dimensional array of seeds encompassing the entire prostate gland (Koutrouvelis et al., page 2, para. 9, “obtaining regularly spaced two- dimensional images of the prostate gland, placing a needle guiding device adjacent the gluteal region of the patient at an angle substantially identical to an angle of the imaging device, successively placing radioactive seeds within the patient through the gluteal region so as to form a three-dimensional array of seeds encompassing the entire prostate gland”).
While Merzouki et al. in view of Koutrouvelis et al. teaches the adjacent positioning, the combination of Merzouki et al. and Koutrouvelis et al. fails to teach wherein the needle is one of a fiducial needle for fixating the brachytherapy treatment to a surgery table; and inserting, using the needle connector that is moved by the robotic arm, at least one fiducial needle into the tissue at the needle insertion site.
In the same field of endeavor, Pitman teaches wherein the needle is one of a fiducial needle (Fig. 3, fiducial needle 74) for fixating the brachytherapy treatment to a surgery table (Fig. 1b; paras. 0027-0028, 0030, and 0032-0033; Claim 1); and inserting at least one fiducial needle into the tissue at the needle insertion site (Claim 1, “ inserting, guided by medical imaging, one or more fiducial fixation needles into a lumpectomy site”; para. 0032).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Merzouki et al. in view of Koutrouvelis et al. with the fiducial needles of Pitman. Inserting fiducial needles into the target tissue facilitates the precise placement of one or more radioactive source into the tumor cavity (Pitman, para. 0028).
Regarding claim 2, Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman teaches the method according to claim 1 as stated above. The combination of Merzouki et al. and Pitman fails to teach verifying, by the imager, the position of the at least one radioactive source in the tissue.
Koutrouvelis et al. further teaches verifying, by the imager, the position of the at least one radioactive source in the tissue (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman, with the radioactive source verification of Koutrouvelis et al. Verifying the placement of the radioactive seeds confirms they are within and enveloping the prostate gland in a three dimensional array averaging one centimeter from center to center (Koutrouvelis et al., page 2, para. 8, “successively placing radioactive seeds within the patient through the gluteal region so as to form a three-dimensional array of seeds encompassing the entire prostate gland, and verifying seed placement using the imaging device”).
Regarding claim 3, Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman, teaches the method according to claim 2 as stated above wherein inserting the at least one radioactive source in the tissue further comprising inserting, by the needle connection (Merzouki et al., page 11, para. 11, “the [needle-carrying] equipment 10 is mounted on a multidirectional guidance robot 20”) of the robotic arm based on the treatment plan (Merzouki et al., Fig. 9, wherein the treatment/processing schedule (p) includes the cartesian coordinates of each of the processing targes t1, t2, and t3 and the does d1, d2, and d3 of radioactive seeds to be injected into the target tissue; page 14, para. 17, “The treatment schedule P makes it possible to calculate the dose dl of radiation associated with this target tl. The needle 11 is thus loaded from the grain magazine 12, by inserting one grain at a time into the needle 11 using the mandrel 13”), a radioactive source needle into the tissue (Merzouki et al., page 14, para. 18, “the deposition of the grains on each target is done rectilinearly, thanks to two synchronized movements: the tip of the needle 11, using the robot 20 towards the outside of the prostate”), moving at least one radioactive source from the radioactive source needle into the tissue (Merzouki et al., page 14, para. 18 and page 15, para. 1, “and the mandrel 13 translation inside the prostate from the linear motor. During this rectilinear movement, the robot can advantageously rotate the needle 11 about its longitudinal axis: such a rotation during insertion has the advantage of minimizing the effect of static friction on the longitudinal axis of the needle”) and removing the radioactive source needle from the tissue (Merzouki et al., page 15, para. 2, “Once the deposit is finished, the needle 11 is removed from the prostate but not from the body”).
Regarding claim 4, Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman teaches the method according to claim 3 as stated above. The combination of Merzouki et al. and Pitman fails to teach lying the patient in a prone position on the table.
Koutrouvelis et al. further teaches lying the patient in a prone position on the table (Abstract; Fig. 1, patient 10 and CAT-scan table 12).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the method of Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman with the patient’s prone positioning of Koutrouvelis et al. With the patient lying in a prone position, transgluteal prostate brachytherapy may be performed (Koutrouvelis et al., page 2, para. 10, “FIG. 1 is a side view of a patient positioned for transgluteal prostate brachytherapy according to an embodiment of the invention”; page 3, para. 6, “The brachytherapy method of the present invention (See FIG. 1) includes identifying a patient in need of treatment for prostate carcinoma. A metastatic work-up is then performed including computer-aided tomography (CAT) or magnetic resonance imaging (MRI) of the pelvis and a bone scan. Transgluteal tomographic cuts (5 mm thickness) are obtained by placing the patient 10 in a prone position on the CAT scan table 12”).
Regarding claim 10, Merzouki et al. teaches an apparatus (Abstract; Fig. 2a), comprising:
an imaging component (Fig. 2a, imaging probe 41); one or more robotic arms (Fig. 2a, articulated arm 21), wherein one end of the arm is capable of holding and inserting a brachytherapy needle (page 4, para. 17, “The robot is configured to fix and guide a brachytherapy needle”; Fig. 2a, needle-carrying equipment 10; page 11, para. 10, “This [needle-carrying] equipment 10 serves as a gripper for the needle 11”; Fig. 4a, wherein the needle-carrying equipment 10 is configured to insert the needle 11 into the patient’s prostate PR); and
a system control component so that the user can operate the one or more robotic arms and an imaging component (Fig. 10, computer processing module 30; page 11, para. 16, “It requires, in the preoperative phase, a succession of specific technical steps by the treatment module 30” – page 12, para. 12, “the module 30 further comprises a computer 33 which calculates, in a step S7, the coordinates of the processing targets t1, t2 and t3 and the exclusion zones Z in the reference frame of the robot”); the system control component guiding the insertion of the brachytherapy needle (page 14, para. 18, “The insertion is done under ultrasound guidance, up to the target tl…the deposition of the grains on each target is done rectilinearly, thanks to two synchronized movements: the tip of the needle 11, using the robot 20 towards the outside of the prostate and the mandrel 13 translation inside the prostate from the linear motor”) and verifying the placement of the brachytherapy needle (page 15, para. 11, “In order to manage the guidance of the needle 11 in the event of PR prostate movements, it is provided with…specific detection means 35 comprising an internal geolocation network 35a with a plurality tags for example RFID chips”); and wherein the system control component is capable of adjusting the placement of the radioactive sources (page 15, paras. 3-4, “A second target t2 is chosen on the virtual grid G with an angle of incidence different from the first target tl. The robot 20 is then oriented to perform a second insertion i2 from ccO by tilting the needle 11 according to the angle of inclination defined in the planning P”; page 15, para. 6, “that the ORD guidance instructions are such that the location of the new grains is recalculated so that the grains deposited during the second insertion do not overlap with the grains deposited during the first insertion”) from the treatment plan based on input from the imaging component (Figs. 7a-7c, wherein the processing computer module 30 determines the schedule/treatment plan (p), which includes the cartesian coordinates of the processing targets t1, t2 and t3 and doses d1, d2, and d3, based on the image I of the patient’s prostate).
Merzouki et al. fails to teach verifying the placement of radioactive sources and multiple brachytherapy needles.
In the same field of endeavor, Koutrouvelis et al. teaches verifying the placement of radioactive sources (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the apparatus of Merzouki et al. with the placement verification of the radioactive sources of Koutrouvelis et al. Verifying the placement of the radioactive seeds confirms they are within and enveloping the prostate gland in a three dimensional array averaging one centimeter from center to center (Koutrouvelis et al., page 2, para. 8, “successively placing radioactive seeds within the patient through the gluteal region so as to form a three-dimensional array of seeds encompassing the entire prostate gland, and verifying seed placement using the imaging device”).
While Merzouki et al. in view of Koutrouvelis et al. teaches verifying the placement of radioactive sources, the combination of Merzouki et al. and Koutrouvelis et al. fails to teach multiple brachytherapy needles.
In the same field of endeavor, Pitman teaches multiple brachytherapy needles (para. 0042).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the apparatus of Merzouki et al. in view of Koutrouvelis et al. with the brachytherapy needles of Pitman. Doing so may permit the concurrent insertion of radioactive seeds into the patient per defined and distinct tissue coordinate locations (Pitman, paras. 0003-0008, 0029, and 0042).
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Merzouki et al. in view of Koutrouvelis et al. and Pitman, further in view of Glossop (US 10,265,137).
Regarding claim 5, Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman, teaches the method according to claim 1 as stated above. Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman, fails to teach automatically positioning, using a second robotic arm connected to the controller and based on the treatment plan, a template adjacent to the tissue of the patient.
Glossop teaches an analogous method further comprising automatically positioning, using a second robotic arm (Col. 21, lines 53-57; Col. 27, lines 40-43; Col. 31, lines 11-20) connected to the controller and based on the treatment plan (Col. 7, lines 4-32), a template adjacent to the tissue of the patient (Col. 3, lines 61-63).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the apparatus of Merzouki et al. in view of Koutrouvelis et al., further in view of Pitman, with the second robotic arm and attached template of Glossop. Doing so creates an automated, robotic mechanism configured to support and align the template into a fixed orientation without manual manipulation (Glossop, Col. 14, lines 49-61; Col. 31, lines 1-62).
Regarding claim 6, Merzouki et al. in view of Koutrouvelis et al. and Pitman, further in view of Glossop teaches the method according to claim 5 as stated above further comprising lying the patient in a supine position on the table (Merzouki et al., Fig. 2a, wherein the patient (P) is in a supine position with their legs abducted – this specific position is commonly referred to as the lithotomy position; page 11, para. 7, “support 40 for receiving the patient P in an extended position”).
Regarding claim 7, Merzouki et al. in view of Koutrouvelis et al. and Pitman, further in view of Glossop, teaches the method according to claim 6 as stated above wherein automatically positioning the template further comprises automatically moving the template in a horizontal and vertical direction (Glossop, Col. 31, lines 31-62).
Regarding claim 8, Merzouki et al. in view of Koutrouvelis et al. and Pitman, further in view of Glossop, teaches the method according to claim 5 as stated above further comprising verifying, by the imager, the position of the at least one radioactive source in the tissue (Koutrouvelis et al., Abstract).
Regarding claim 9, Merzouki et al. in view of Koutrouvelis et al. and Pitman, further in view of Glossop, teaches the method according to claim 8 as stated above wherein inserting the at least one radioactive source in the tissue further comprising inserting, by the needle connection (Merzouki et al., page 11, para. 11, “the [needle-carrying] equipment 10 is mounted on a multidirectional guidance robot 20”) of the robotic arm based on the treatment plan (Merzouki et al., Fig. 9, wherein the treatment/processing schedule (p) includes the cartesian coordinates of each of the processing targes t1, t2, and t3 and the does d1, d2, and d3 of radioactive seeds to be injected into the target tissue; page 14, para. 17, “The treatment schedule P makes it possible to calculate the dose dl of radiation associated with this target tl. The needle 11 is thus loaded from the grain magazine 12, by inserting one grain at a time into the needle 11 using the mandrel 13”), a radioactive source needle into the tissue (Merzouki et al., page 14, para. 18, “the deposition of the grains on each target is done rectilinearly, thanks to two synchronized movements: the tip of the needle 11, using the robot 20 towards the outside of the prostate”), moving at least one radioactive source from the radioactive source needle into the tissue (Merzouki et al., page 14, para. 18 and page 15, para. 1, “and the mandrel 13 translation inside the prostate from the linear motor. During this rectilinear movement, the robot can advantageously rotate the needle 11 about its longitudinal axis: such a rotation during insertion has the advantage of minimizing the effect of static friction on the longitudinal axis of the needle”) and removing the radioactive source needle from the tissue (Merzouki et al., page 15, para. 2, “Once the deposit is finished, the needle 11 is removed from the prostate but not from the body”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nesvacil et al. (WO 2015/181632) teaches methods for brachytherapy planning using ultrasound and CT images. Image data is analyzed manually or automatically to determine the location and boundary of the target tissue. Fenster et al. (WO 2005/092197) discloses an apparatus for performing brachytherapy comprising a robotic assembly having a needle guide for insertion of a brachytherapy needle into a patient wherein the robotic assembly is controlled by a computing device and the needle guide permits manual longitudinal movement. Berkey et al. (WO 0237934) discloses an automated implantation system wherein radioactive seeds are deposited into a tissue and the needle assembly is controlled by an automated motion control system.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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