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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
Response to Amendment
Applicant’s amendments and remarks filed on 6/9/2026 are entered. The previous objections and 112(b) rejections are withdrawn in light of Applicant’s amendments and remarks. The previous 35 U.S.C. 103 rejections for claims 16-27 are withdrawn in light of Applicant’s amendments.
Claim Objections
Claim 16 is objected to because of the following informalities: limitation “…wherein each probe is in constant communication with the control unit on one hand and with the at least one tracker fixed to the micro-device on the other hand…” should be recited as: “wherein each probe is in constant communication with the control unit [[on one hand]] and with the at least one tracker fixed to the micro-device [[on the other hand]]…” to avoid misinterpretations to the limitation. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 16-27 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 16 limitation “…the transducer of the at least one probe sending ultrasounds to the tracker inside the target body part, the tracker being configured to scatter the ultrasounds and sending the ultrasounds back to the at least one probe, the at least one tracker inside the target body part within the internal referential defined with regards to the at least one probe, the at least one tracker inside the target body part within the internal referential defined with regards to the at least one probe…”, implies the human body is part of the invention. Thus, claim 16 its dependent claims are rejected under U.S.C. 101.
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 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (U.S. 20200281661, September 10, 2020)(hereinafter, “Govari”) in view of Vesely et. al. (U.S. 6246898, June 12, 2001)(hereinafter, “Vesely”) and Govari et. al. (U.S. 20080125646, May 29, 2008)(hereinafter, “Govari’08) and Errico et. al. (“Ultrafast ultrasound localization microscopy for deep super-resolution vascular imaging.” 2015)(hereinafter,“Errico”).
Regarding Claim 28, Govari teaches: A micro-device tracking and localization method implemented by means of a tracking system comprising (Fig. 1A, catheter-based cerebrovascular tracking system, [0048]):
a micro-device designed to be remotely steered and controlled from outside a target body part (Fig. 1A, element 28, brain catheter, “Physician 54, operating system 20a, holds a brain catheter controller handle 29, which is connected to the proximal end of brain catheter 28. Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32.” [0051]. See reproduced Fig 1A above),
at least one probe comprising at least one ultrasound transducer and configured to be brought in contact with a patient (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]),
a control unit comprising a memory, the memory being configured to store at least one ultrasound image of the target body part (“Processing circuitry 40 uses software stored in the memory 42 to operate system 20a. In practice, some or all of the functions of the processing circuitry 40 may be combined in a single physical component or, alternatively, implemented using multiple physical components.” [0053]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]),
at least one tracker configured to be connected to the micro-device (“The position of the distal end of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part (e.g. the brain). This signal is processed by the tracking subsystem 33 to track the locations of the distal end of the brain catheter 28 over time…” [0049]),
at least a screen (“The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56.” [0049]),
wherein the at least one probe and the at least one tracker communicate by means of ultrasound technology, the control unit being thus able to localize, in real time, the at least one tracker inside the target body part within an internal referential defined with regards to the at least one probe (“…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem…an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]; “…physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051]),
wherein the control unit is further designed to display, on the screen, the at least one ultrasound image stored inside the memory of the control unit, and to display, in real time, the localization of the micro-device on said at least one ultrasound image (“The processing circuitry 40 uses the images to present, for example, a brain section image 59 on a display 56.” [0049]; “Console 50 receives the position signals via a cable 19 that connects to brain catheter 28 via handle 29.” [0051]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]);
wherein the ultrasound tracking of the tracker is co-registered with an acquisition of the at least one ultrasound image acquisition within the internal referential (“…during the disclosed catheterization, systems 20a and 20b register a position of a distal end of a brain catheter 28 inside the patient's brain, with frames of reference of brain images of the patient 32. The position of the brain catheter 28 may be tracked using a tracking subsystem 33, which tracks position and orientation coordinates of a location tracking transducer fitted at the distal end. The location tracking transducer is configured to output a signal that is indicative of a location of the transducer in the body-part…” [0049]);
wherein the method enables, at the same time: the real time tracking of the micro-device, the real time localization of the micro-device within the internal referential (Fig. 1A, element 28, brain catheter, “Physician 54, operating system 20a, holds a brain catheter controller handle 29, which is connected to the proximal end of brain catheter 28. Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32.” [0051]. See reproduced Fig 1A below),
the real time localization of said micro-device inside the target body structure, the method further enables, at the same time: the visualization, on a screen, of an ultrasound image of a target body part of a patient, the ultrasound image being aligned with the internal referential, the real time display, on the screen, within the displayed ultrasound image of said micro device localization (“…the rendering includes rendering the length of the shaft so that the respective positions along the length of the shaft are located in the image responsively to the respective tracked locations a temporal order of the tracked locations in the movement log with one of the positions of the length of the shaft closest to a distal tip of the catheter corresponding with a most recent one of the tracked locations in the movement log.” [0015]; “Controller handle 29 allows the physician 54 to advance and navigate brain catheter 28 in the brain, for example, through an entry point 22 at an artery at a thigh of patient 32. As noted above and described below, physician 54 navigates the distal end of brain catheter 28 with the aid of real-time images rendered based on position and orientation signals from the location tracking transducer fitted at the distal end of brain catheter 28.” [0051]; “Console 50 receives the position signals via a cable 19 that connects to brain catheter 28 via handle 29.” [0051]; “The processing circuitry 40 is configured to render (block 142) to the display 56 (FIG. 1) the image 108 (FIGS. 9-11) of at least part of the brain of the living subject with the representation 100 of a length of the shaft of the brain catheter 28 in at least one blood vessel of the blood vessels 76 (FIGS. 5-11) of the brain with respective positions along the length of the shaft being located in the image 108 responsively to respective ones of the tracked locations from the movement log 98, which has been amended to add one or more tracked locations and optionally amended to remove one or more tracked locations as described in the step of block 134.” [0091]).
Govari does not teach the micro-device being steered and controlled in a contactless manner; a securing body part of the probe where the securing part surrounds at least partially the target body part.
Vesely in the field of instrument tracking and imaging systems teaches a 3D tracking system where a plurality of ultrasonic transducers are mounted on various positions of a cap that is mounted to the head of an individual, see Fig. 20 (column 34, lines 13-34).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the probe of Govari to include a securing body part where the securing part surrounds at least partially the target body part as taught in Vesely to mount and secure the transducer(s) to the head for effective transmission/receiving through the head and target(s).
The combination of references does not teach the micro-device being steered and controlled in a contactless manner.
Govari’08 in the field of tracking-based systems teaches: “FIG. 1 is a schematic, pictorial illustration of a system 20 for position tracking and steering of intrabody objects…” [0030]; “System 20 can be used for performing a variety of intra-cardiac surgical and diagnostic procedures in which navigation and steering of the catheter is performed automatically or semi-automatically by the system, and not manually by the physician.” [0031].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the micro-device in the combination of references to be steered and controlled in a contactless manner as taught in Govari’08 for automatic or semi-automatic performance of various intra-surgical and diagnostic procedures (Govari’08, [0031]).
The combination of references does not teach usage of ultrasound localization microscopy (ULM) technology.
Errico in the field of image-based systems teaches: “Here, we demonstrate ultrafast ultrasound localization microscopy (uULM), which combines deep penetration and super-resolution imaging at unprecedented spatiotemporal resolution, by using clinically approved contrast agents: inert gas microbubbles. uULM is implemented in vivo…”(pg. 499, column 2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to use ultrasound localization microscopy as taught in Errico to allow “…reconstruction of entire organs within tens of seconds…” (Errico, pg. 500, column 1).
Regarding Claim 29, the combination of Govari, Vesely, Govari’08 and Errico teach the claim limitations as noted above.
Govari further teaches: wherein the at least one probe displays two working modes: an acquisition mode, during which the at least one probe acquires the ultrasound image, and a tracking mode during which the at least one probe communicates with the at least one tracker, the at least one probe is switched from the acquisition mode to the tracking mode at least one time (“An image of at least part of the brain of the living subject, based on a pre-registered image, is rendered to a display…” [0040]; “…the tracking subsystem 33 may be an electrically-based tracking subsystem using multiple head surface electrodes…to track the position of the brain catheter 28 based on a signal emitted by at least one electrode (comprised in the location tracking transducer) of the brain catheter 28. The tracking subsystem 33 may be implemented using any suitable location tracking subsystem, for example, but not limited to, an ultrasound-based tracking system where the location tracking transducer includes at least one ultrasound transducer. Using tracking subsystem 33, a physician 54 advances the distal end of the brain catheter 28 through blood vessels…” [0049]; “…further compensation of head motion is provided by attaching a reference sensor 21 to the patient's forehead. Console 50 is configured to receive signals from reference sensor 21 via a cable 27.” [0050]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Vesely, Govari’08 and Errico as applied to claim 28 above, and further in view of Quaid et. al. (U.S. 20040106916, June 3, 2004)(hereinafter, “Quaid”).
Regarding Claim 30, the combination of Govari, Vesely, Govari’08 and Errico teach the claim limitations as noted above.
The combination of references does not teach: wherein the at least one ultrasound image is used to: plan at least one micro-device path, monitor, in real time, the micro-device path following, determine, in real time, if an obstacle is situated on the planned path, plan, if needed, a new micro-device path in order to avoid said obstacle.
Quaid in the field of image guided systems teaches: “FIG. 3C is a flowchart of an exemplary method 140 for intra-operative haptic planning of a surgical procedure.” [0064]; “In step 146, anatomical obstacles to be avoided are defined. The anatomical obstacles comprise features to be avoided during surgery, such as major blood vessels, tendons, nerves, critical areas of the brain, organs, healthy bones or other tissues, and/or the like.” [0066]; “In step 152, a determination is made as to whether the virtual tool is intersecting any anatomical obstacles. If the virtual tool is not intersecting any anatomical obstacles, then the process starting at step 162 is executed. Otherwise, the process starting at step 154 is executed. In step 154, haptic cues are provided by haptic device 113 to the user.” [0068]; “In step 158, haptic device 113 is moved, preferably by the surgeon. Haptic device 113 is preferably moved based at least in part on the haptic cues provided by haptic device 113 to the surgeon. The position of surgical tool 112 had it been coupled to haptic device 113 is tracked by the virtual tool and displayed on display device 30. Preferably, the user moves haptic device 113 until an equilibrium pose is found. In the equilibrium position, the cues created by the attractive haptic objects are active and those created by the repulsive haptic objects are inactive.” [0070].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that wherein the ultrasound image is used to: plan at least one micro-device path, monitor, in real time, the micro-device path following, determine, in real time, if an obstacle is situated on the planned path, plan, if needed, a new micro-device path in order to avoid said obstacle as taught in Quaid to “…provides for tighter coupling of the planning and execution phases of the surgical procedure. Planning for the surgical procedure is preferably performed intra-operatively with respect to the patient.” (Quaid, [0074]).
Response to Arguments
In response to Applicant’s remarks against references Govari and Vesely individually with respect to the points identified in the remarks, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With regards to Applicant’s arguments regarding the amended preamble of claim 28 that includes “…by implementing ultrasound localization microscopy (ULM) technology…” is broad and not tied to the recited limitations of the body of the claim and thus the modification of Errico is sufficient for the disclosed recited amended claim limitations. Further, regarding Applicant’s argument that “…combininjg the teachings of Govari with any ultrasound related technology would result in a very high-risk technology…”, arguments of counsel cannot take the place of factually supported objective evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).”. The combination of references are all in the field of ultrasound imaging systems.
Applicant has made arguments to limitations not disclosed in recited cited claim 28. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant’s arguments also appear to a narrower interpretation of the recited limitations in claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cormier et. al. EP4192357 teaches a cardiac ultrasound imaging system in the presence of relative motion.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798
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