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
Examiner notes the claimed subject matter is not supported in the 15/011156, 15/229804 and 18/344758 applications. Accordingly, the effective filing date of the claims is considered to be 04/21/2025.
This application repeats a substantial portion of prior Application No. 15/011156, filed 01/09/2015, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the ultrasound images of structures of a brain and the graphical image of the brain must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 22-25, 27-32 and 34-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0160309 to Ebbini et al. “Ebbini” in view of U.S. Publication No. 2012/0016239 to Barthe et al. “Barthe”.
As for Claims 22, 27, 30, 35 and 38, Ebbini discloses a dual mode ultrasound system and method that provides real time imaging and therapy delivery using a transducer array (Abstract). Ebbini discloses at least one imaging transducer and at least one treatment transducer configured to transmit different frequencies for imaging and treatment/therapy (Paragraphs [0007]-[0008]; [0049]-[0051]) and a control system (e.g. one or more processing apparatuses; Paragraph [0059]). Ebbini explains the ultrasound image may be evaluated for feedback in order to generate an optimized therapy/treatment focus (Paragraphs [0045], [0067] and [0070]). Ebbini discloses where the system is useful for various medical applications such as imaging or therapy of brain tissue, vasculature, nerve structure, cardiac tissue, and drug delivery including transcranial focused ultrasound (Paragraph [0039]) and opening the blood-brain barrier (Paragraph [0006]).
While the transducer array would be housed in an “applicator” in order to position the array on the various body parts, Ebbini does not expressly disclose nor depict an applicator to house the imaging and treatment array.
Barthe teaches from within a similar field of endeavor with respect to dual mode ultrasound systems and methods (Paragraph [0154]) where system components are arranged in a hand wand applicator (Figs. 1 and 10 and corresponding descriptions)
Accordingly, one skilled in the art would have been motivated to have modified the ultrasound system and method described by Ebbini with an applicator as described by Barthe in order to efficiently house system components for a variety of applications. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claims 23, 31 and 39, Ebbini discloses where the system is useful for various medical applications such as imaging or therapy of brain tissue, vasculature, nerve structure, cardiac tissue, and drug delivery including transcranial focused ultrasound (Paragraph [0039]) and opening the blood-brain barrier (Paragraph [0006]). Such a system would include a drug delivery system configured to deliver the aforementioned drug in its broadest reasonable interpretation.
As for Claims 24, 32 and 40, Ebbini explains the drug may benefit cancer patients (Paragraph [0046]) and Barthe explains a combined ultrasound system can be used with a pharmaceutical agent (Paragraph [0075]).
With respect to Claims 26 and 34, Barthe explains where additional imaging systems can be used to visualize, localize or monitor the ROI including MRI, CT, PET, x-ray, (Paragraph [0215]).
Regarding Claims 28-29 and 36-37, Ebbini discloses where the ultrasound images can be evaluated for instant feedback and control of reconfiguring the arrays (Paragraphs [0198]-[0200]) in order to reach a target volume in the brain (Paragraphs [0094]-[0099]). Furthermore, Ebbini depicts the geometric distances to the target point (Paragraphs [0121] and [0267]). In addition, the image produced is considered to be a graphical image of the brain (e.g. at least a portion) in its broadest reasonable interpretation.
Claim(s) 23-25, 31-33 and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebbini and Barthe as applied to claims 22, 30 and 39 above, and further in view of U.S. Publication No. 2012/0179073 to Nita.
As for Claims 23-25, 31-33 and 39-40, Ebbini and Barthe disclose a dual mode ultrasound system and method as explained above. However, the art of record does not expressly disclose delivering microbubbles into the subject as claimed.
Nita teaches from within a similar field of endeavor with respect to systems and methods for delivering ultrasound energy to a patient’s intracranial space (Abstract) where microbubbles are delivered into the patient to help detect structures and to assist in therapeutic lyses of a clot (Abstract; Paragraphs [0041] and [0046]). Examiner notes the delivered microbubbles would create the acoustic mismatch and enhance therapeutic action in its broadest reasonable interpretation.
Accordingly, one skilled in the art would have been motivated to have modified the dual mode system and method described by Ebbini and Barthe to deliver microbubbles as described by Nita in order to improve the therapeutic action of the delivered treatment. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Alternate Rejection:
Claim(s) 22-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0000493 to Seip et al. “Seip” in view of U.S. Publication No. 2014/0276055 to Barthe et al. hereinafter “Barthe 2”.
As for Claim 22, 27, 30, 35 and 38, Seip discloses an ultrasound system and method for treatment (Paragraphs [0001]-[0004]) comprising at least one imaging transducer (Paragraphs [0017]-[0019]) and at least one treatment transducer (Paragraphs [0017]-[0019]) and a controller, processor and memory (Paragraph [0042]) configured to operate the imaging transducer to transmit and receive ultrasound energy in a first frequency range to generate one or more ultrasound images of a brain of the subject to determine a treatment target (Paragraphs [0017]-[0022]). Subsequently, Seip’s system transmits a treatment beam to the center of the target (Paragraph [0021]). Seip makes it clear where treatment ultrasound frequencies can be different than ultrasound imaging frequencies (Paragraphs [0009]- [0010], [0024]) and where the treatment can include enhancing the transport of drugs across the blood brain barrier using the targeted and defined ultrasound exposures (Paragraph [0037]).
While the combined imaging and therapy transducer array would be housed in an “applicator” in order to position the array on the various body parts, Seip’s disclosed embodiment of a second probe (Paragraph [0017]) does not expressly disclose where the separate arrays are housed in an applicator.
Barthe 2 teaches from within a similar field of endeavor with respect to dual mode ultrasound systems and methods (Paragraph [0187]) where system components are arranged in a hand wand applicator (Figs. 1 and 10 and corresponding descriptions). Barthe 2 makes it clear where the ultrasound therapy/treatment can be delivered to the brain (Paragraph [0348]).
Accordingly, one skilled in the art would have been motivated to have modified the ultrasound system and method described by Seip with an applicator as described by Barthe in order to efficiently house system components for a variety of applications. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claims 23, 31 and 39, Seip discloses where the treatments may include introducing microbubbles into the blood stream (Paragraph [0003]) and utilizing injected agents or nanoparticles across the blood brain barrier (Paragraph [0037]). Such a system would include a drug delivery system configured to deliver the aforementioned drug in its broadest reasonable interpretation.
As for Claims 24-25, 32-33 and 40, Seip discloses where the treatments may include introducing microbubbles into the blood stream (Paragraph [0003]) and utilizing injected agents or nanoparticles across the blood brain barrier (Paragraph [0037]) and Barthe explains a combined ultrasound system can be used with a pharmaceutical agent (Paragraph [0112]).
With respect to Claims 26 and 34, Barthe explains where additional imaging systems can be used to visualize, localize or monitor the ROI including MRI, CT, PET, x-ray, (Paragraph [0249]). Seip also discloses CT imaging to evaluate targeting parameters (Paragraph [0020]).
Regarding Claims 28-29 and 36-37, Seip discloses where the ultrasound images can be evaluated for treatment targeting (Paragraph [0022]). In addition, the image produced is considered to be a graphical image of the brain (e.g. at least a portion) in its broadest reasonable interpretation.
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive. Alternate 35 U.S.C. 103 rejections necessitated by amendments. Examiner respectfully disagrees the claimed subject matter is disclosed in the ‘804 application. For example, Applicant asserts Paragraphs [0078]-[0079] and [0131] support the claimed step of “operate at least one imaging ultrasound transducer to transmit and receive ultrasound signals in a first frequency range to generate one or more images of a brain of a subject”. However, the cited paragraphs fail to disclose actually imaging the brain. The drawings fail to depict any brain image. The disclosure that ultrasound can be used to enhance delivery of a therapeutic agent across the blood brain barrier is not sufficient support to image the brain in order to determine a treatment site. Accordingly, the effective filing date of the claims should be 04/21/2025.
Drawings remain objected to despite Applicant’s argument that they are not necessary. The claims require use of the generated image to determine proper treatment transducer position. The drawings must show every feature of the invention specified in the claims as described above.
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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