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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/26 has been entered.
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 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kvale et al. (GB 2,595,513 (provide in the IDS)) and in view of Park et al. (US 2021/0169515).
Addressing claim 19, Kvale discloses a method of treatment enhanced by ultrasound insonation comprising:
creating at least one bubble proximate to a target region by: administering a cluster composition, comprising a microbubble component and a microdroplet component, to a subject, wherein the cluster composition comprises at least one cluster (see page 11, lines 8-20);
activating a phase-shift transition of the microdroplet component of the at least one cluster by ultrasound insonation to create the at least one bubble (see page 11, lines 8-20);
wherein an expansion from the transition of the least one cluster to the at least one bubble provides a mechanical stress on the target region (see page 11, lines 8-20).
Kvale does not disclose using bubble to assist ablation and providing an ablating energy to the at least one ablation-assisting bubble. Using bubble to assist ablation and drug delivery by mechanical stress is well-known. Park explicitly discloses using bubble to assist ablation and providing an ablating energy to the at least one ablation-assisting bubble (see [0009], [0011], [0076] and claims 10-11; ablation tissue using mechanical stress cause by bubble; mechanical ablation instead of thermal ablation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kvale to use bubble to assist ablation and providing an ablating energy to the at least one ablation-assisting bubble as taught by Park because this allows for physician to perform another type of treatment such as ablation treatment (see Park’s paragraph [0076]; Kvale discloses interest in non-thermal, mechanical destruction ablation (see page 26, lines 14-15). Kvale discloses treatment by drug delivery and he also interested in ablation treatment therefore combine Kvale with Park provide more treatments.
Addressing claims 20-23, Kvale discloses:
addressing claim 20, bubble has a diameter of at least 10 micrometer (see page 24, lines 32-33).
addressing claim 21, insonating the at least one ablation-assisting bubble with ultrasound at a predetermined intensity to induce at least one of energy absorption, deposition, oscillation and cavitation of the ablation-assisting bubble to provide an additional mechanical and/or thermal stress on the target region, to aid ablation on the target tissue in the target region (see page 15, line 18 – page 16, line 5 (cause oscillation; also see Zhang’s abstract and introduction pages 1-2, energy absorption and cavitation).
addressing claim 22, wherein the predetermined intensity of the ultrasound for insonating the ablation-assisting bubble is equal to an intensity for non-bubble assisted ultrasound ablation divided by a factor of between 12 and 24 (this would have been obvious to one of ordinary skill in the art because bubble enhance ablation therefore the intensity can be lower; “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)).
addressing claim 23, wherein the enhanced ultrasound ablation is configured to provide a resultant temperature in the target region of 30 to 70 degrees Celsius, for a continuous exposure time of at least 30 seconds (treatment time duration and treatment temperature depend on physician desire or goal and treatment parameters (intensity, frequency, etc.) and this only require routine in the art).
Claims 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kvale et al. (GB 2,595,513 (provide in the IDS)), in view of Park et al. (US 2021/0169515) and further in view of Levy (US 2020/0323515 (provided in the IDS)).
Addressing claims 25-30, Kvale does not disclose using the at least one ablation-assisting bubble for real-time imaging of the target region by insonating the at least one ablation-assisting bubble with imaging ultrasound and wherein the at least one ablation-assisting bubble is induced as a hyperechoic spot; a further step of ultrasound planning comprising using unique subject and application specific information to plan a specific ultrasound exposure regime wherein ultrasound planning comprises at least one of a passive ultrasound planning and an active ultrasound planning; wherein passive ultrasound planning is based on one or more of: physiological information, anatomical structures in an ablation zone, cross-modality imaging and co-registration, and data defining subject anatomy retrieved from a software; wherein active ultrasound planning comprises: monitoring the ablation zone for real-time feedback of the ablation zone; and adjusting the specific ultrasound exposure regime to achieve predetermined parameters in the bastion zone; wherein the steps of monitoring and adjusting are performed on a continuous basis for a predetermined duration; wherein monitoring the ablation zone for real-time feedback of ablation zone comprises at least one of: real-time temperature feedback, real-time mechanical feedback; real-time monitoring of ablation assisting bubble dynamics; wherein monitoring the target region, including an ablation zone, further comprises imaging via image guidance modalities, wherein the image guidance modalities comprise at least on of: magnetic resonance guided, ultrasound guided and concentration and co-administration of a therapeutic agent configured to assist ablation efficacy. Levy discloses using the at least one ablation-assisting bubble for real-time imaging of the target region by insonating the at least one ablation-assisting bubble with imaging ultrasound and wherein the at least one ablation-assisting bubble is induced as a hyperechoic spot (see [0033] and Fig. 1A; 122 is ultrasound imaging and the bubble shows as hyperechoic spot); a further step of ultrasound planning comprising using unique subject and application specific information to plan a specific ultrasound exposure regime wherein ultrasound planning comprises at least one of a passive ultrasound planning and an active ultrasound planning (see Figs. 3, 6, [0006-0008], [0037], [0042] and [0051-0055]; passive treatment planning with tissue-sensitivity map gets from specific subject images; monitor real-time treatment and adjust is active planning); wherein passive ultrasound planning is based on one or more of: physiological information, anatomical structures in an ablation zone, cross-modality imaging and co-registration, and data defining subject anatomy retrieved from a software (see Figs. 3, 6, [0006-0008], [0037-0038], [0042] and [0051-0055]; anatomical structure such as tissue type is consider in passive planning); wherein active ultrasound planning comprises: monitoring the ablation zone during the enhancement step for real-time feedback of the ablation zone; and adjusting the specific ultrasound exposure regime to achieve predetermined parameters in the bastion zone; wherein the steps of monitoring and adjusting are performed on a continuous basis for a predetermined duration (see Figs. 3, 6, [0006-0008], [0037-0038], [0042] and [0051-0055]; monitor cavitation bubbles with real-time imaging and adjust ultrasound parameters to control ultrasound cavitation bubbles); wherein monitoring the ablation zone during the enhancement step for real-time feedback of ablation zone comprises at least one of: real-time temperature feedback, real-time mechanical feedback; real-time monitoring of ablation assisting bubble dynamics and concentration (see [0013], [0055] and [0059]; monitor bubble movement and concentration) wherein monitoring the target region, including an ablation zone, further comprises imaging via image guidance modalities, wherein the image guidance modalities comprise at least on of: magnetic resonance guided, ultrasound guided (see [0033]) and co-administration of a therapeutic agent configured to assist ablation efficacy (see [0033]; imager 122 monitor target using mri or ultrasound). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kvale to have a further step of ultrasound planning comprising using unique subject and application specific information to plan a specific ultrasound exposure regime wherein ultrasound planning comprises at least one of a passive ultrasound planning and an active ultrasound planning; wherein passive ultrasound planning is based on one or more of: physiological information, anatomical structures in an ablation zone, cross-modality imaging and co-registration, and data defining subject anatomy retrieved from a software; wherein active ultrasound planning comprises: monitoring the ablation zone during the enhancement step for real-time feedback of the ablation zone; and adjusting the specific ultrasound exposure regime to achieve predetermined parameters in the bastion zone; wherein the steps of monitoring and adjusting are performed on a continuous basis for a predetermined duration; wherein monitoring the ablation zone during the enhancement step for real-time feedback of ablation zone comprises at least one of: real-time temperature feedback, real-time mechanical feedback; real-time monitoring of ablation assisting bubble dynamics and concentration; wherein monitoring the target region, including an ablation zone, further comprises imaging via image guidance modalities, wherein the image guidance modalities comprise at least on of: magnetic resonance guided, ultrasound guided and co-administration of a therapeutic agent configured to assist ablation efficacy as taught by Levy because this allow physician to plan for treatment and improve treatment efficiency and effectively (see [0037]; direct ultrasound treatment more effectively).
Response to Arguments
Applicant’s arguments with respect to claim(s) 19-30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2006/0025756 (see [0073]; treatment duration of 60 second depending on desired lesion size and/or ablative effect); US 6,165,440 (see col. 3, lines 10-13; enhance drug delivery by producing hot cavitation also result in heating tissue); US 2003/0204141 (see [0010] and [0040]; drug delivery by heating tissue to cavitation); US 2008/0242979 (see [0010]; ablating tissue and using microbubbles to facilitate drug delivery); US 2015/0273061 (see [0008]; perform ablation by cavitation that enhance drug delivery); US 2015/0258353 (see [0004]; collapsing or oscillating bubbles lead to induced stress and high energy release; larger bubbles release more energy that open tissue for drug delivery); 2018/0360420 (see [0061-0062]; cavitation cause mechanical stress that assist ablation) and Acoustic Droplet Vaporiation for Enhancement of Thermal Ablation by High Intensity Focused Ultrasound).
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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