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
This action is in response to the remarks filed on 04/28/2025.
The amendments filed on 04/28/2025 have been entered. Accordingly claims 1-21 remain pending. Claim 21 was previously withdrawn from consideration. Claims 1, 11-14, 16, and 19-20 are presently amended.
The previous objections to claims 11, 13, 14, and 1 have been withdrawn in light of applicant's amendments to claims 11, 13, 14, and 1. However there are two remaining objections that were not addressed with the amendments that are detailed below.
Response to Arguments
Applicant's arguments filed 04/28/2025 regarding the 35 U.S.C. 112(b) rejection of the claims have been fully considered but they are not persuasive. Although some of the issues raised in the 112(b) rejection have been addressed by applicant’s amendments, there are still some remaining issues that were nor amended or argued. The indefiniteness of the limitation “operational speed” in claim 11 has not been resolved. Additionally, the indefiniteness of the plurality of ablation probes of claims 1 and 9 has not been resolved. Therefore these particular rejections have been maintained below.
Applicant’s arguments, with respect to the prior art rejection of the claims have been fully considered and are persuasive, in part. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly discovered prior art Razzaque.
Claim Objections
Claim 11 is objected to because of the following informalities:
Regarding claim 11, each instance of the limitation “the ablation” should be changed to –the ablation process—in order to have proper antecedent basis.
Further regarding claim 11, the recitation “and/or” in the limitation “relating to the adjustment of the probe positioning and/or energy provided” makes it unclear exactly what is being claimed. It is suggested instead to recite e.g., --relating to at least one or more of the probe positioning and energy provided--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Amended claim 12 recites “the ablation system is [...] a reversible electroporation system”. However, neither the original claims, original drawings, nor the specification as originally filed provides support for this limitation. Applicant has not indicated where support for this amendment can be found. The specification and original claims merely provide support for an irreversible electroporation ablation system not a reversible electroporation system. As such claim 12 contains new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation “wherein the simulation and display steps are conducted at an operational speed allowing for an interactive update [...]” which renders the claim indefinite because it is unclear what operational speed refers to. It is unclear to which particular operation this limitation refers to. Further clarification is required.
Claim 1 recites the limitation “a plurality of ablation probes” which renders the claim indefinite because it is unclear whether these are the same or different from the at least two multi-active probes recited in claim 11. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required. This also applied to the recitation of “the ablation probes” in claim 9.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
Claims 11-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mansi et al. (US 2014/0296842, October 2, 2014, hereinafter “Mansi) in view of Razzaque (US 2018/0286287, October 4, 2018).
Regarding claim 11, as best understood in light of the 35 U.S.C 112(b) rejection stated above, Mansi discloses a method of ablating a target tissue volume in a subject (“methods, computer readable media and systems for patient specific computation of temperature distribution under ablation therapy” [0006]; also see [0019]), comprising:
identifying a position (“a user indication of a placement position of the ablation device is received” [0022]; also see “the position is selected based on image data, such as identifying a center of the tumor” [0025]) of the at least two multi-active probes (“the user indicates multiple placements for simulating ablation using multiple devices at a same time” [0024]) in the tissue volume of the subject (“data representing an organ or other tissue and vessels in the tissue or organ of a patient is acquired. A preoperative volume is acquired. The data represents locations distributed in three dimensions. The volume is a frame or set of data representing part or the entire tissue region of interest, such as the liver or part of the liver. The data may represent other portions of the patient, such as part of an adjacent organ, bone, fluid, or other structure in the patient.” [0027]);
simulating (“In act 24, the ablation procedure is simulated.” [0036]) for the at least two multi-active probes, an ablation process for said multi-active probes as positioned in the tissue volume (“the user indicates multiple placements for simulating ablation using multiple devices at a same time” [0024]) with a computing device (“The computing components of the system, such as the preoperative system 11 and/or the processor 12 are configured by hardware, software, and/or design to perform calculations or other acts. The computing components operate independently or in conjunction with each other to perform any given act. The act is performed by one of the computer components, another of the computing components, or a combination of the computing components. Other components may be used by the computing components to scan or perform other functions.” [0092]; also see [0018]) to predict an ablation volume that would be necrotized when the ablation process is performed (“In act 28, tissue damage is modeled. As heat (or cold) is applied, tissue is damaged. Cells die. Tissue necrosis occurs. The result may alter temperature diffusion. Dead or treated tissue may not conduct heat in the same way or rate as in healthy tissue. One or more aspects of heat transfer may be different due to the change in the tissue.” [0040]);
obtaining a visual display of the ablation volume, said ablation volume encompassing tissue that would be necrotized if the ablation were performed with the at least two multi-active probes positioned in the tissue volume (“In act 36, the diffusion of temperature is indicated. An image of the map of temperature is displayed or output. The image represents the tissue region of interest, such as the liver or part of the liver having a tumor. The image is formed at any resolution. Temperature may be interpolated to the display grid or greater resolution. Alternatively, the temperature is indicated by a value, graph, or chart.” [0081]; also see act 36, ‘Indicate Diffusion/Necrosis area’ in Fig. 1, reproduced below, and corresponding description, e.g., [0082]-[0087]);
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adjusting at least one of the position of, and energy provided by, at least one of the at least two multi-active probes such that (i) the displayed ablation volume encompasses the target tissue volume to be ablated, and (ii) the visual display of the ablation volume does not encompass more than a predetermined volume of non-target tissue (“In act 38, the optimal, better, or sufficient probe location is determined. An optimal solution for probe location, power, application sequence, or other variance in ablation is automatically sought. Rather than rely on user feed back, the temperature diffusion and corresponding necrosis associated with different locations and/or other variance in ablation is compared to the region to be treated. For example, the position, power level, and sequence of application resulting in the greatest, sufficient, or complete coverage of the tumor and least necrosis of healthy tissue is found by simulating different combinations [...] The thermal dose coverage may be measured as the area defined by temperatures higher than a threshold (e.g., 70 degrees Celsius). Other measures may be used, such as a weighted measure that most strongly weights necrosis of the tumor while considering avoidance of necrosis outside the tumor. ” [0088]);
repeating the identifying, simulating and obtaining the visual display steps until the ablation volume encompasses the targeted tissue volume and does not encompass more than a predetermined volume of non-target tissue (“By successively [repeating] computing the thermal dose for a number of needle placements, the placement with maximum coverage on the tumor is found. In a successive optimization loop to solve for the probe location, orientation, and/or other characteristic, the combination for maximum tumor thermal dose coverage is found. The thermal dose coverage may be measured as the area defined by temperatures higher than a threshold (e.g., 70 degrees Celsius). Other measures may be used, such as a weighted measure that most strongly weights necrosis of the tumor while considering avoidance of necrosis outside the tumor.” [0088]), wherein the simulation and display steps are conducted at an operational speed allowing for an interactive update of the visual display of the ablation volume relating to the adjustment of the probe positioning and/or energy provided (“simulating ablation using data acquired by a separate system or systems in real-time” [0091]; also see [0104]); and
performing the ablation (“the ablation device 18 is one to be used, such as a radio frequency ablation device. A probe, such as a catheter, with electrodes at a tip is used to ablate. The electrodes are used to create heat conducted into the surrounding tissue, causing coagulative necrosis at temperatures between 50.degree. C. and 100.degree. C.” [0093]).
Although Mansi discloses integrating the simulation with on-going ablation (e.g., see [0089]) and using at least two multi-active probes, as stated above, Mansi fails to explicitly disclose inserting at least two multi-active probes into the anatomy of the subject such that the at least two multi-active probes are disposed in a tissue volume inside the anatomy of the subject; identifying a position of the at least two multi-active probes while the multi-active probes are disposed in the anatomy of the subject; and moving at least one of the at least two multi-active probes.
However, Razzaque teaches, in the same field of endeavor, inserting at least two multi-active probes into the anatomy of the subject such that the at least two multi-active probes are disposed in a tissue volume inside the anatomy of the subject (“the clinician begins the simulated surgical procedure by advancing the simulated ablation probe 112 toward the first tumor along the predetermined trajectory during a navigation phase of the simulated surgical procedure” [0068]); identifying a position of the at least two multi-active probes while the multi-active probes are disposed in the anatomy of the subject (“the workstation receives position information from the simulated ablation probe 112, the simulated ultrasound probe 11, and, optionally, the surface of the phantom 110” [0069]); and moving at least one of the at least two multi-active probes (“If any tumors are determined to remain (block 616), process 600 continues to block 608, navigating toward the next tumor to perform ablation.” [0069]; also see Figs. 3, 6, and corresponding descriptions).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Mansi with disclose inserting at least two multi-active probes into the anatomy of the subject such that the at least two multi-active probes are disposed in a tissue volume inside the anatomy of the subject; identifying a position of the at least two multi-active probes while the multi-active probes are disposed in the anatomy of the subject; and moving at least one of the at least two multi-active probes as taught by Razzaque in order to provide updated position information and navigation aids to a display ([0069] of Razzaque).
Regarding claim 12, Mansi further discloses wherein the at least two multi-active probes are elements of an ablation system, and further wherein the ablation system is a radiofrequency ablation system, a microwave ablation system, a cryoablation system, an irreversible electroporation ablation system, or a reversible electroporation system (“A variety of methods have been employed to locally ablate tissue. Radiofrequency ablation (RFA) is the most commonly used, but other techniques are also used, including ethanol injection, cryo-therapy, irreversible electroporation, and microwave ablation.” [0003]; also see [0016], [0039]).
Regarding claim 13, Mansi modified by Razzaque discloses the limitations of claim 11 as stated above. Mansi fails to disclose wherein the position of the at least two multi-active probes are identified with a surgical tool tracking system.
However, Razzaque teaches, in the same field of endeavor, wherein the position of the at least two multi-active probes are identified with a surgical tool tracking system (“the simulator has an electromagnetic (EM) field generator forming part of an EM tracking system 109 which tracks the position and orientation (also commonly referred to as the “pose”) of EM sensors disposed on the simulated ablation probe and the simulated ultrasound wand. The simulator then transmits the information received by the EM tracking system 109 to the workstation which determines the pose of the instruments in three-dimensional space relative to the phantom.” [0037]; also see [0038]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Mansi with wherein the position of the at least two multi-active probes are identified with a surgical tool tracking system as taught by Razzque in order to provide faster execution of the ablation plan and better accuracy in positioning a probe.
Regarding claim 14, Mansi further discloses wherein the position of the at least two multi-active probes are identified by acquiring an image of the tissue volume of the patient comprising the at least two multi-active probes, and retrieving and processing the image with the computing device. (“the position is selected based on image data, such as identifying a center of the tumor. Various possible placements may be automatically identified and tested with separate simulations. Other automatic approaches may be used.” [0025]).
Regarding claim 15, Mansi further discloses wherein the visual display is displayed by a screen or monitor (“display screen” [0083]; also see “The display 16 is a CRT, LCD, plasma, projector, printer, or other output device for showing an image.” [0105]).
Regarding claim 16, Mansi further discloses further comprising: obtaining an image of the target tissue volume; and superimposing the image on the visual display of the ablation volume (“The image may be separate but share the display screen with an image generated from the preoperative data. The temperature may be overlaid on the anatomy image, such as rendering the temperature with a different color, brightness or other characteristic. The rendered model is added to the CT image. FIG. 3 shows temperature mapped to CT cross-section images. The temperature overlay is a modulation, such as color modulation.” [0083]; also see [0084], [0086]).
Regarding claim 17, Mansi further discloses further comprising conducting additional simulating and displaying steps simultaneously with the ablation step (“The simulation may be integrated with on-going ablation or temperature measurements from a previous ablation. Temperature readings from thermistors or temperature MRI are used to validate the simulation.” [0089]).
Regarding claim 18, Mansi further discloses wherein the target tissue volume is a solid cancer or tumor (“ablation of one or more liver tumors is planned. Planning for liver cancer or other treatment of other organs (e.g., lung, kidneys, breast and bones) may be provided.” [0019]).
Regarding claim 20, Mansi further discloses wherein the simulating step uses electrical and thermal characteristics of the tissue volume of the subject (“Computer models of heat diffusion in biological tissues, tissue thermal properties and reaction to the heat, and the effect of nearby vessels, which act as heat sinks, are included in the simulation.” [0017]; also see “The flow rate may be an average over a heart cycle or may include variation in flow rate through one or more heart cycles.” [0048]), the identified position of the at least two multi-active probes (“the user indicates multiple placements for simulating ablation using multiple devices at a same time. The aggregated thermal dose is computed based on a single simulation run.” [0024]), a geometry of the at least two multi-active probes (“probe orientation” [0085]; also see “the simulation of ablation also simulates probe insertion prior to ablation. The insertion may move vessels relative to the tumor, cause flow differences, or result in spatial distortion in the region of interest. Biomechanical properties of the liver may be considered to predict the local deformations of the tissue due to the insertion of the probe.” [0090]) and electrical and thermal characteristics of the at least two multi-active probes to predict the ablation volume (“In one embodiment for radio frequency ablation, the ablation device is modeled as a function of resistance, current, and time. The heat generation by the ablation device is simulated using a resistance of the particular ablation device, the current indicated by the user or processor, and time of application. The input is the electrical power delivered to the probe. How the electrical current at the probe is transformed to the heat source at the surface of the probe is modeled to have a virtual radio frequency ablation engine that closely reproduces the actual protocol.” [0038).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mansi in view of Razzaque as applied to claim 11 above and further in view of Kulstad et al. (US 2021/0145334, corresponding PCT filed April 3, 2019, hereinafter “Kulstad”).
Regarding claim 19, Mansi modified by Razzaque discloses the limitations of claim 1 as stated above but fails to disclose wherein the target tissue volume is the atrium of the heart.
However, Kulstad teaches, in the same field of endeavor, wherein the target tissue volume is the atrium of the heart (“This example describes a simulation of the process of RF ablation of left atrium” [0280]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Mansi with wherein the target tissue volume is the atrium of the heart as taught by Kulstad in order to treat atrial fibrillation ([0004] of Kulstad).
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mansi in view of Razzaque as applied to claim 11 above and further in view of Borsic (US 2017/0224402, August 10, 2017).
Regarding claim 1, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Mansi discloses the limitations of claim 11 as stated above and Mansi further discloses further comprising: providing a tissue ablation system (“FIG. 4 shows a system for patient specific temperature mapping” [0091]; also see Fig. 4, reproduced below and corresponding description) comprising: a plurality of ablation probes connected to an energy source (ablation device 18 in Fig. 4 and corresponding description; also see [0024], [0093] “RF generator” in Fig. 2 and corresponding description); an imaging device (“medical diagnostic imaging system” [0018]; also see preoperative system 11 in Fig. 4 and corresponding description); a screen for displaying computer generated information and/or medical images (display 16 in Fig. 4 and corresponding description); a computing system for executing programming code and algorithms (processor 12 in Fig. 4 and corresponding description); and a facility picture, archiving and communication (PACS) network, with which the computing system interfaces (“PACS station” [0018]; also see [0030]).
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Mansi fails to explicitly disclose a multi-active probe controller; and the plurality of ablation probes being controlled by the multi-active probe controller.
However, Borsic teaches, in the same field of endeavor, a multi-active probe controller; and the plurality of ablation probes being controlled by the multi-active probe controller (“an ablation device (1); this device can comprise a single or multiple RFA electrodes acting in monopolar or multipolar fashion, a single or multiple NWA antennas, a single or multiple IRE electrodes, a single or multiple cryo-probes, or a single or multiple devices able to ablate tissues thermally or by other means. The system comprises also an ablation device controller (2) which controls the ablation effect of to the ablation device (1) (e.g. by providing RF or microwave energy, by providing electric pulses for IRE, or by providing refrigeration for cryoablation probes).” [0048]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Mansi with a multi-active probe controller; and the plurality of ablation probes being controlled by the multi-active probe controller as taught by Borsic in order to provide a desired ablation effect to the plurality of ablation probes ([0048] of Borsic).
Regarding claim 2, Mansi further discloses wherein the imaging device comprises a CT, MRI, PET, or ultrasound scanner device (“he preoperative system 11 is a CT, MR, x-ray, fluoroscopy, PET, SPECT, or ultrasound system” [0096]).
Regarding claim 3, Mansi further discloses wherein the screen is stand-alone component or comprises a part of at least one of a Personal Computer (PC), the ablation controller, or the imaging device (“The processor 12, user input 10, display 16, and the memory 14 are shown separate, such associated with being a computer or workstation apart from the preoperative system 11. In other embodiments, the processor 12, user input 10, display 16, and/or memory 14 are part of the preoperative system 11. In alternative embodiments, the system is a workstation, computer, or server for simulating ablation using data acquired by a separate system or systems in real-time or using previously acquired patient-specific data stored in a memory.” [0091]).
Regarding claim 4, Mansi further discloses wherein the computing system comprises a PC, an embedded system, a virtual machine, or a docker (“The processor 12 is a general processor, digital signal processor, three-dimensional data processor, graphics processing unit, application specific integrated circuit, field programmable gate array, digital circuit, analog circuit, combinations thereof, or other now known or later developed device for processing medical data. The processor 12 is a single device, a plurality of devices, or a network. For more than one device, parallel or sequential division of processing may be used. Different devices making up the processor 12 may perform different functions, such as a segmentor as one device and a separate device for simulating ablation. The processor 12 operates pursuant to stored instructions to perform various acts described herein.” [0101]).
Regarding claim 5, Mansi further discloses wherein the computing system is directly or virtually connected to the screen (see processor 12 and display 16 in Fig. 4 and corresponding description; also see “The processor 12 is configured to output an image of the predicted ablation results to the display 16.” [0104]).
Regarding claim 6, Mansi further discloses wherein the computing system interfaces with the controller, or to at least one ablation probe (see processor 12 and ablation device 18 in Fig. 4 and corresponding description).
Regarding claim 7, Mansi further discloses wherein the computing system interfaces locally or remotely to the facility PACS network. (“the preoperative volume is acquired by loading from memory. Data from a previously performed scan of the patient is stored in a memory, such as a picture archiving and communications system (PACS) database.” [0030]; also see processor 12 and memory 14 in Fig. 4 and corresponding description).
Regarding claim 8, Mansi further discloses wherein the computing system interfaces locally or remotely to the imaging device (see processor 12 and preoperative system 11 in Fig. 4 and corresponding description).
Regarding claim 9, Mansi modified by Razzaque and Borsic discloses the limitations of claim 11 as stated above. Mansi fails to disclose further comprising a surgical tool tracking sub-system for tracking an intracorporeal position of the ablation probes.
However, Razzaque teaches, in the same field of endeavor, a surgical tool tracking sub-system for tracking an intracorporeal position of the ablation probes (“the simulator has an electromagnetic (EM) field generator forming part of an EM tracking system 109 which tracks the position and orientation (also commonly referred to as the “pose”) of EM sensors disposed on the simulated ablation probe and the simulated ultrasound wand. The simulator then transmits the information received by the EM tracking system 109 to the workstation which determines the pose of the instruments in three-dimensional space relative to the phantom.” [0037]; also see [0038]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Mansi with a surgical tool tracking sub-system for tracking an intracorporeal position of the ablation probes as taught by Razzque in order to provide faster execution of the ablation plan and better accuracy in positioning a probe.
Regarding claim 10, Mansi further discloses wherein the visual display is a 2D or 3D display (“FIG. 3 shows temperature mapped to CT cross-section images. The temperature overlay is a modulation, such as color modulation.” [0083]; also see Fig. 3 reproduced below and corresponding description).
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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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797