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 .
Priority
This application is the national stage entry under 35 USC 371 of PCT/IL2022/050595 field 3 June 2022, which claims the benefit of domestic priority from US Provisional Application no. 63/196,251 filed 3 June 2021.
Election/Restrictions
Applicant's election with traverse of Invention I, pertaining to claims 1-19, and 27 in the reply filed on 28 November 2025 is acknowledged. The traversal is on the ground(s) that there was no evidentiary showing to demonstrate that a shared technical feature was not a contribution over the prior art. Additionally, Applicant amended claims in a manner that caused both inventions share the special technical feature. This is found persuasive.
The requirement was found to be in error and is therefore WITHDRAWN. Claims 1-19, 27, and 29 are examined.
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.
Claims 1-5, 10, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canady et al. (US Publication no. 2020/0275979 – disclosed by Applicant).
In regard to claim 1, Canady et al. discloses system for providing a controlled plasma dosage to a target region of tissue of a subject (para 10, a fully Robotic Optical Navigational System will be integrated optical imaging, navigational and deliver a plasma beam, or electrical charge to ablate or kill the tumor or any identify biological tissue which requires ablation), the system comprising: a plasma delivery probe 480;
a motion controller 210 (motion control module 210 for controlling motor 210) configured to move a plasma plume produced from the plasma delivery probe 480 (para 27-28); and
a processor and a memory storing processor instructions which instruct the processor to (para 22):
access a specification of a total specific dosage specifying a targeted range of effective plasma dose per unit of tissue to be delivered by the plasma delivery probe to sub-regions of the target region of the tissue (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage),
calculate a plan for operation of the plasma delivery probe, including rate of plasma delivery and movements to deliver the total specific dosage to the target region (para 22, dosage module 240; para 11, dosage parameters may be set based on the type of cancer being addressed and stored genomic plasma results; para 23, Preoperative information may include, for example, information regarding location and type of cancerous tissue and appropriate dosage or treatment settings information for the type of cancerous tissue to be treated, wherein the “preoperative information and treatment setting construed as comprising a plan; para 24, in the context of cold atmospheric plasma, the “dosage” may include application time, power setting, gas flow rate setting and waveform or type of treatment), and
instruct the motion controller 210 to move the plasma plume (i.e., plasma beam) according to the movements while the plasma delivery probe operates to provide plasma (see para 24 wherein the probe seeks out regions for treatment);
wherein, for each of at least one of the sub-regions (para 24, sub-regions here include a first region of cancerous tissue and a second region of cancerous tissue):
the movements together with the rate of plasma delivery are calculated to deliver a delivered total specific dosage to the sub- region corresponding to the specified target range of effective plasma dose per unit tissue (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage; para 24, the dosage delivered includes the application time (i.e., considered to imply how long the plasma beam lingers in one region before moving) and the flow rate and the power level), and the
delivered total specific dosage of the sub-region includes delivery to the whole sub-region from each of a plurality of positions of the plasma plume during the movements (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage, wherein completion of delivery at a region implies that the total specific dosage was delivered); and
for each of said at least one of the sub-regions, the processor instructions further instruct the processor to:
receive an indication of a rate of actual plasma delivery to the sub- region (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage; sensor array 490 assists in providing indications of the plasma delivery to target locations)
determine that the indicated rate, together with the movements to position the plasma plume at the plurality of positions, may not produce the specified total specific dosage of plasma for the sub-region (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage. If necessary, the application can be repeated precisely (this implies that the system may move to the regions again in the event that an insufficient plasma dose was not delivered; further the system uses sensors to determine presence of cancers cells which serve as proxy for determining if the plasma dosage was sufficient),
adjust the plan for operation of the plasma delivery probe so that actually delivered total specific dosage of plasma in the sub-region satisfies the specification of the total specific dosage of effective plasma (para 26, if necessary, the application can be repeated precisely (this implies that the system may move to the regions again in the event that an insufficient plasma dose was not delivered in) wherein the need to repeat of the process to construed to imply a plan adjustment), and
operate the plasma delivery probe according to the adjusted plan, while still providing the specified total specific dosage to the rest of the target region (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage. If necessary, the application can be repeated precisely).
Although Canady et al. does not expressly disclose acquiring an indication of the actual plasma dosage delivered to the target region, the reference teaches delivering plasma to a target region with controlled and precise dosage and coverage. A person of ordinary skill in the art would recognize that achieving such controlled dosage necessarily involves determining whether the desired plasma exposure has been delivered. Additionally, the disclosure that the treatment process may be repeated if necessary implies evaluating the adequacy of the delivered plasma treatment. Therefore, determining or acquiring an indication of the actual plasma dosage and adjusting the treatment accordingly would have been obvious to one of ordinary skill in the art as feedback for process optimization.
In regard to claim 2, Canady et al. is considered to suggest that the processor adjusts the plan for operation of the plasma delivery probe by a modification to the planned movements (para 26, if necessary the process repeats, which is considered to suggest that a change in planned movements. If the process was successful, the original planned movement was to cease. If the repeat is necessary, revisiting either each region or certain regions is a change from the planned cease operation). Modification of the movement of the robotic arm 400 carrying the plasma beam is considered to have been obvious to one of ordinary skill as optimization of a result effective variable to provide precise dosage to the target region.
In regard to claim 3, Canady et al. is considered to suggest that the modification to the planned movements comprises changing a speed of movement of the plasma delivery probe (para 24, dosage includes flow rate). Modification of the flow rate is considered to have been obvious to one of ordinary skill as optimization of a result effective variable to provide precise dosage to the target region.
In regard to claim 4, Canady et al. is considered to suggest that the modification to the planned movements comprises changing a planned position of the plasma delivery probe (para 27, robotic arm further may have structural means for moving the disposable tip or tool, for example, to rotate the tip, which is considered to suggest capability to a change in position). Modification of the plasma probe position is considered to have been obvious to one of ordinary skill as optimization of a result effective variable to provide precise dosage to the target region.
In regard to claim 5, Canady et al. teaches at least one sensor configured to measure the rate of plasma delivery, and wherein the processor receives the indication of the rate of actual plasma delivery from the at least one sensor (para 26, and para 29 teach use of sensor array 490 comprising a variety of sensors).
In regard to claim 10, Canady et al. teaches the movements include a plurality of locations within the target region at which movement of the plasma delivery probe pauses while the plasma delivery probe delivers plasma (para 24, after completion of treating a first region of cancerous tissue, the system moves the plasma beam to a second region of cancerous tissue for treatment; the dosage at each site pertains to the application time, wherein when the beam reaches each section is considered a pause for a the specific application time).
In regard to claim 29, Canady et al. discloses system for providing a controlled plasma dosage to a target region of tissue of a subject (para 10, a fully Robotic Optical Navigational System will be integrated optical imaging, navigational and deliver a plasma beam, or electrical charge to ablate or kill the tumor or any identify biological tissue which requires ablation), the system comprising:
a plasma delivery probe 480;
a motion controller 210 (motion control module 210 for controlling motor 210) configured to move a plasma plume produced from the plasma delivery probe 480 (para 27-28); and
a processor and a memory storing processor instructions which instruct the processor to (para 22):
access a specification of a total specific dosage specifying a targeted range of effective plasma dose per unit of tissue to be delivered by the plasma delivery probe to sub-regions of the target region of the tissue (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage), and
for each of at least one of the sub-regions:
the delivered total specific dosage of the sub-region includes delivery to the whole sub-region from each of a plurality of positions of the plasma plume during the movements (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage, wherein completion of delivery at a region implies that the total specific dosage was delivered); and
for each of said at least one of the sub-regions, the processor instructions further instruct the processor to:
receive an indication of a rate of actual plasma delivery to the sub-region (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage; sensor array 490 assists in providing indications of the plasma delivery to target locations),
determine that the indicated rate of actual plasma delivery, together with the detected movements, may not produce the specified total specific dosage of plasma for the sub-region (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage. If necessary, the application can be repeated precisely (this implies that the system may move to the regions again in the event that an insufficient plasma dose was not delivered; further the system uses sensors to determine presence of cancers cells which serve as proxy for determining if the plasma dosage was sufficient),
adjust operation of the plasma delivery probe so that actually delivered total specific dosage of plasma in the sub-region satisfies the specification of the total specific dosage of effective plasma (para 26, the surgical application of treatments such as cold plasma will be precise with respect to region of interest coverage and dosage. If necessary, the application can be repeated precisely),
wherein the adjusted operation modifies one or both of movement of the probe and plasma delivery from the probe, while still providing the specified total specific dosage to the rest of the target region.
Although Canady et al. does not expressly disclose acquiring an indication of the actual plasma dosage delivered to the target region or detecting the movement of the plasma plume, the reference teaches delivering plasma to a target region with controlled and precise dosage and coverage. A person of ordinary skill in the art would recognize that achieving such controlled dosage necessarily involves determining whether the desired plasma exposure has been delivered either by the settings of the application time (considered an aspect of movement), flow rate, power setting etc (para 24 of Canady et al.). Additionally, the disclosure that the treatment process may be repeated if necessary implies evaluating the adequacy of the delivered plasma treatment. Therefore, determining or acquiring an indication of the actual plasma dosage and detecting the plume movement to adjust the treatment accordingly would have been obvious to one of ordinary skill in the art as feedback for process optimization.
Claim(s) 9, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canady et al. (US Publication no. 2020/0275979 – disclosed by Applicant) in view of Hicks (US Patent no. 8,267,884 – disclosed by Applicant).
In regard to claim 9, Canady et al. substantially suggests the invention as claimed including a sensor array 490 that includes photoresistor sensors, visible or IR cameras, a URF sensor, or other sensors (para 28). Canady et al. does not teach specific sensors for power, temperature, or spectral emission. Hicks describes a plasma treatment device. In figure 5, the plasma treatment device is mounted to a robotic arm 26 and motion control unit 28 to cause the arm to scan plasma probe 28 over the affected region in a precise manner (col 9 lines 27-50). Hicks expressly teaches that the device 28 may be equipped with sensors that automatically adjust the apparatus's position above the wound through a feedback control system (col 9 lines 41-44; these sensors necessarily comprising position sensors). Therefore incorporating a position sensor is considered to have been obvious to one of ordinary skill in the art since this specific sensor is expressly taught and suggested by Hicks provide feedback information automatically optimize placement of the plasma probe.
In regard to claims 13 and 14, Canady et al. substantially suggests the invention as claimed, however does not expressly teach that the movements comprise a contiguous pathway along which the plasma delivery probe continuously moves while delivering the plasma, wherein the delivery of the plasma is onto successive contiguous surface regions along the contiguous pathway. While Canady et al. does move from region to region for treatment, it is not clear if the movements are continuous onto successive contiguous regions. Hicks describes a plasma treatment device. In figure 5, the plasma treatment device is mounted to a robotic arm 26 and motion control unit 28 to cause the arm to scan plasma probe 28 over the affected region in a precise manner (col 9 lines 27-50). The “Scan” technique is considered to comprise continuously movement onto successive contiguous surface regions along the contiguous pathway. Modificaiton to direct the movement across regions in Canady et al. is considered to have been obvious to one of ordinary skill in the art since Hicks demonstrates that the plasma delivery may be scanned over a region of interest in a precise manner, wherein the application of the scanning technique to Canady et al. is considered motivated by Hicks to optimize therapeutic effect.
Claims 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canady et al. (US Publication no. 2020/0275979 – disclosed by Applicant) in view of Roman et al. (US Publication no. 2023/0093858).
In regard to claim 11, Canady et al. substantially suggests the invention as claimed except does not teach a rigid introducer having a lumen sized to introduce the plasma delivery probe through the lumen to the target tissue region, internal to the subject. Roman et al. disclose an electrosurgical apparatus for generating a plasma probe (para 10 and 63). In one embodiment of the plasma probe shown in figure 4A and 4b, the electrosurgical apparatus 200 includes a rigid introducer (para 96). The introducer is disposed about the apparatus 200 and stabilizes the tip in proper position approximate the desired surgical site. Therefore modification to include an introducer is considered obvious to one of ordinary skill in the art since Roman et al. shows that the introducer serves to stabilize and guide the plasma probe tip (e.g., tip 480 of Canady et al.) at the desired target site.
In regard to claim 12, Canady et al. is considered to suggest that the invention as claimed, however does not expressly teach that the movements across regions include at least one of inserting and withdrawing the introducer while plasma is delivered continuously from the plasma delivery probe. The robotic arm of Canady et al. is structured in a manner that it considered capable of this motion (para 27, the robotic arm further may have structural means for moving the disposable tip or tool 480, for example, to rotate the tip which is considered to demonstrate that the robotic arm of Canady et al. is capable of movement in the claimed direction). Roman et al. teaches that the introducer maybe be slid linearly along the electrosurgical tool 200 toward a distal top in an manner that comprises inserting and withdrawing of the introducer (para 96). Modification to insert the tip of the plasma probe of Canady et al. through an introducer in a inserting and withdrawing is considered obvious to one of ordinary skill in the art since Roman et al. expressly teach this motion for inserting the electrosurgical tip through an introducer to the target treatment site.
Claim(s) 6-8, 18, 19, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canady et al. (US Publication no. 2020/0275979 – disclosed by Applicant) in view of Krasik et al. (US Publication no. 2021/0338304 – disclosed by Applicant).
In regard to claims 6-8, Canady et al. substantially suggests the invention as claimed including a sensor array 490 that includes photoresistor sensors, visible or IR cameras, a URF sensor, or other sensors (para 28). Canady et al. does not teach specific sensors for power, temperature, or spectral emission. Krasik et al. is directed to a cold plasma generating system and expressly teaches one or more sensors located at the distal end of the plasma probe. The sensors include temperature sensor (e.g. thermocouple type or any other thermal sensor), a spectrometry sensor (e.g. photo-spectrometer), electric and or magnetic field sensors or any other type of sensor. the thermal sensor and/or spectrometry sensor may be used to characterize properties of the generated plasma such as temperature, ionic composition etc. The use of such additional one or more sensors may provide feedback information to an operator and or be used in a feedback loop of the system to prevent over increase in plasma temperature and thus reduce repetition rate of peak voltage. Additionally, Krasik et al. teach that the technique and system of the invention provide controlled plasma generation with desired power and temperature enabling selective treatment of cancer and additional abnormal cells in-vivo and in-vitro (para 167). The suggestion of “desired power” implies that some form of sensor for feedback to indicate a desired power level must necessarily be incorporated. Therefore incorporating sensors of power, temperature and spectral emissions is considered to have been obvious to one of ordinary skill in the art since these specific sensors are expressly taught and suggested by Krasik et al. for provide feedback information to an operator and or be used in a feedback loop of the system to keep parameters within desired ranges to prevent harm to a patient.
In regard to claims 18, 19, and 27, Canady et al. teach that the dosage calculated specific to the region of interest includes the gas flow setting (para 24). Krasik et al. in a similar field of endeavor teaches that the technique for applying plasma therapy requires control of plasma flow rate and temperature, wherein flow meter is incorporated to measure the plasma flow (para 44, 136, 139-145). These teachings together are considered to suggest that the indication of the rate of actual plasma delivery comprises a measurement of a flow of ionization gas to the plasma plume; and the operation of the plasma delivery probe is adjusted by slowing movement of the plasma delivery probe in response to a decrease in the flow, the indication of the rate of actual plasma delivery comprises a measurement of a flow of ionization gas to the plasma plume; and the operation of the plasma delivery probe is adjusted by withdrawing the plasma delivery probe in response to a decrease in the flow, and the indication of the rate of actual plasma delivery is an indication of a pattern of gaseous flow near the target region of tissue; and operation of the plasma delivery probe is adjusted to modify said pattern of gaseous flow are merely steps of monitoring flow rate as feedback for adjusting the output of plasma within desired ranges to optimize therapeutic effect and minimize harm.
Although Canady et al. does not expressly disclose acquiring an indication of the flow rate of the plasma dosage delivered to the target region or adjusting the movement of the plasma plume, the reference teaches delivering plasma to a target region with controlled and precise dosage and coverage. A person of ordinary skill in the art would recognize that achieving such controlled dosage necessarily involves determining whether the desired plasma exposure has been delivered either by the settings of the application time (considered an aspect of movement), flow rate, power setting etc (para 24 of Canady et al.). Additionally, the disclosure by Krasick et al. pertaining to control of plasma flow is suggestive of using these measurements as feedback to adjust therapy. Therefore, the claimed features would have been obvious to one of ordinary skill in the art as feedback for process optimization.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canady et al. (US Publication no. 2020/0275979 – disclosed by Applicant) in view of Krasik et al. (US Publication no. 2021/0338304 – disclosed by Applicant), further in view of Hicks (US Patent no. 8,267,884 – disclosed by Applicant).
In regard to claims 15-17, Canady et al. teach that the dosage of plasma includes the power setting and flow rate. Krasik et al. teach that sensors for temperature, spectrometry, and power (para 28 and 167) are used in a feedback loop of the system to ensure that the desired power level and temperature of the applied plasma are properly controlled. Hicks includes a position sensor automatically adjust the apparatus's position above the wound through a feedback control system (col 9 lines 41-44; these sensors necessarily comprising position sensors). These structural features are considered to suggest that the system of Canady et al. as modified in view of the functions attributed to the structural features of Krasik et al. and Hicks is configured to measure a reduction in the power dissipated by plasma generation, and the operation of the plasma probe is adjusted by moving the plasma delivery probe towards the target region, wherein the processor selects a distance of the movement towards the target region according to the magnitude of an increase in measured power as the plasma probe is moved toward the target region. Moreover, Canady et al. is considered to suggest that the processor halts movement of the probe towards the target region upon the measured feedback (para 26, this would indicate that the precise application with respect to the region of coverage was successful thereby ending further application; thus negating need for repeat application).
Although Canady et al. does not expressly disclose acquiring an indication of the power level of the plasma dosage delivered to the target region or adjusting the movement of the plasma plume, the reference teaches delivering plasma to a target region with controlled and precise dosage and coverage. A person of ordinary skill in the art would recognize that achieving such controlled dosage necessarily involves determining whether the desired plasma exposure has been delivered either by the settings of the application time (considered an aspect of movement), flow rate, power setting etc (para 24 of Canady et al.). Additionally, the disclosures by Krasik et al. and Hicks pertaining to sensing temperature, power and position are suggestive of using these measurements as feedback to adjust therapy. Therefore, the claimed features would have been obvious to one of ordinary skill in the art as feedback for process optimization.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 5 March 2026