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 .
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 Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-13 and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konofagou et al (2014/0114216).
Regarding claim 1, Konofagou et al disclose a system for opening a target tissue of a subject, comprising:
a navigation guidance device configured to locate and/or monitor the target tissue (system 100 – fig.1d), comprising:
a cavitation detector (cavitation detector 108 – [0010];[0041]); and
an arm having 4 degrees of freedom (3D positioning system – fig.1d) and configured for control by a controller (the positioning rod can be mounted on the manipulator – [0042]);
a single element transducer, coupled to the arm, for stimulating the target tissue with focused ultrasound (FUS) (single-element FUS transducer 102 – fig.1d;[0041]), wherein the single element transducer includes the FUS with a predetermined parameter to open the target tissue (the center frequency, focal depth, outer radius and inner radius parameters – [0041]); and
a processor configured to determine a cavitation mode (processor, coupled to the cavitation detector, configured to determine a cavitation spectrum – [0010]-[0014]).
Regarding claim 3, Konofagou et al disclose wherein the single element transducer is connected to a function generator (FUS transducer 102…drive by a function generator 104 – fig.1d).
Regarding claim 4, Konofagou et al disclose further comprises microbubbles configured to react to the FUS (transcranially acquiring acoustic emissions produced from an interaction between the one or more microbubbles and the tissue - abstract).
Regarding claim 5, Konofagou et al disclose wherein the microbubbles are configured to react to a predetermined pulse of the FUS and induce cavitation for opening the target tissue ([0079]).
Regarding claim 6, Konofagou et al disclose wherein a size of the microbubbles ranges from about 1 micron to about 10 microns ([0009]).
Regarding claim 7, Konofagou et al disclose wherein the microbubbles are configured to carry or be coated with an active agent (polydispersed Definity.RTM microbubbles – [0044]).
Regarding claim 8, Konofagou et al disclose wherein the cavitation detector is configured to detect microbubble cavitation ([0010]).
Regarding claim 9, Konofagou et al disclose wherein the cavitation detector is configured to capture a cavitation signal, wherein the cavitation signal is selected from the group consisting of a cavitation magnitude ([0097]), a cavitation duration ([0063]).
Regarding claim 10, Konofagou et al disclose wherein the processor is configured to determine a stable cavitation dose (SCD) and an inertial cavitation dose (ICD) based on the cavitation signal ([0054];[0069];[0104]).
Regarding claim 11, Konofagou et al disclose wherein the navigation guidance device is an image-based navigator device (MRI images - [0049]; The PCD with the hydrophone and the diagnostic B-mode imaging system can be used, to monitor sonification – [0073]).
Regarding claim 12, Konofagou et al disclose wherein the predetermined parameter to one the target tissue is selected from the group consisting of center frequency, an outer diameter, an inner diameter, and a combination thereof (the center frequency, focal depth, outer radius and inner radius parameters – [0041]), and wherein the processor is configured to determine a value of the predetermined parameter through numerical simulations (acquiring from a simulation – [0102]).
Regarding claim 13, Konofagou et al disclose wherein the center frequency ranges from about 0.2 MHz to about 0.35 MHz (the center frequency…200-900 kHz – [0041]).
Regarding claim 15, Konofagou et al disclose wherein the target tissue comprises a cortical brain structure ([0043]).
Regarding claim 16, Konofagou et al disclose a method for opening a target tissue of a subject, comprising:
locating the target tissue using a navigation guidance device (The PCD with the hydrophone and the diagnostic B-mode imaging system can be used, to monitor sonification – [0073]), wherein the navigation guidance device comprises a cavitation detector (3D positioning system – fig.1d) and an arm (cavitation detector 108 – [0010];[0041]), an arm having 4 degrees of freedom (3D positioning system – fig.1d) and configured for control by a controller (the positioning rod can be mounted on the manipulator – [0042]);
administering microbubbles into the target tissue (delivering one or more microbubbles to proximate the target region – claim 1); and
applying FUS using a single element transducer (single-element FUS transducer 102 – fig.1d;[0041], wherein the signal element transducer induces the FUS with a predetermined parameter to open the target tissue, the predetermined parameter to one the target tissue is selected from the group consisting of center frequency, an outer diameter, an inner diameter, and a combination thereof (the center frequency, focal depth, outer radius and inner radius parameters – [0041]).
Regarding claim 17, Konofagou et al disclose further comprising:
obtaining a cavitation signal using the cavitation detector, wherein the cavitation signal is selected from the group consisting of a cavitation magnitude ([0097]) and a cavitation duration ([0063]).
Regarding claim 18, Konofagou et al disclose further comprising:
determining a cavitation mode by calculating a stable cavitation dose (SCD) and an inertial cavitation dose (ICD) based on the cavitation signal ([0054];[0069];[0104]).
Regarding claim 19, Konofagou et al disclose further comprising:
determining the predetermined parameter through numerical simulations (acquiring from a simulation – [0102]).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 27 October 2025 have been fully considered but they are not persuasive.
Regarding claims 1 and 16, Applicant states the prior art does not disclose the amended limitation of “an arm having 4 degrees of freedom and configured for control by a controller”.
Specifically, Applicant states the present application is directed to a system for opening a target tissue of a subject with a robotic arm to enable an image-based navigation and real-time tracking. In contrast, Konofagou discloses a system for opening a target with a positioning rod, failing to disclose at least the features of “an arm having 4 degrees of freedom and configured for control by a controller”.
Applicant disagrees with the interpretation equating the “positioning rod” with the claimed “arm”. Compared to the positioning rod serves as a fixed alignment tool in Konofagou, the arm in claim 1 represents a significant advancement by providing active control and dynamic adjustability with multiple degrees of freedom.
Examiner’s position is Konofagou is directed to a system for opening a target tissue of a subject as disclosed in figure 1d and paragraph [0041]. Further, while claim 1 discloses a navigation guidance device configured to locate and/or monitor the target tissue, the navigation guidance device is defined as comprising a cavitation detector, an arm, a single element transducer and a processor. All of these elements are disclosed by Konofagou as set forth in the body of the rejection. Examiner notes claims 1 and 16 do not disclose image-based navigation and real-time tracking.
Examiner notes the body of the rejection never defines the arm as equating to the positioning rod. The body of the rejection explicitly defines the arm as corresponding to the 3D positioning system element of figure 1d. Examiner notes the claim defined the arm as being configured for control by a controller; however, the controller is not positively recited and is only generically disclosed. Examiner’s position is the arm having 4 degrees of freedom corresponds to the 3D positioning system element noted in figure 1d and the arm is configured for control by a controller (i.e. manipulator). Amended claim 16 includes similar recitations noted with respect to claim 1.
Applicant’s arguments, see page 5, filed 27 October 2025, with respect to claim 14 have been fully considered and are persuasive. The rejection of claim 14 has been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797