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
Applicant’s response filed 07/14/2026 has been entered. Currently claims 1, and 3-23 are pending.
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 1, 3, 5, 7, 8, 10-12, 15, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata et al.,(US20200164231A1) in view of Cosman et al., (US20150320479A1).
Regarding claim 1, Cannata teaches an ultrasound therapy method, comprising the steps of (Abstract Histotripsy therapy system):
receiving a digital treatment plan that includes a target tissue volume of a subject divided into a plurality of treatment volumes ([0093] a treatment plan is accepted by the user; figs 7A/B the target tissue volume is divided into a number of slices and are treated [0202]), and a treatment pathway through the plurality of treatment volumes ([0093] treatment plan includes acoustic pathway);
receiving a treatment depth of the target tissue volume ([0093] parameters also include depth);
receiving at least one driving voltage required for an ultrasound transducer to produce cavitation in at least one of the plurality of treatment volumes ([0093] parameters include drive voltage; [0213] test locations can be used to test cavitation thresholds to see what drive voltage results in cavitation; fig. 7A/B the target tissue volume is divided into a number of slices (such as 13) and are treated[0202]);
determining a desired thermal profile ([0246] the Cooling Treatability Matrix/lookup table of fig. 17D is used to determine the appropriate treatment and cooling parameters, which would be the thermal profile) for the digital treatment plan based on the treatment depth and at least one driving voltage (fig. 17D is the lookup table, and uses treatment depth and drive voltage to determine the ratio of treatment pulses to cooling time for the pulse parameters[0246]; [0247] for example, if therapy total treatment time is 30 minutes, then for a ratio of 1:1, the treatment time would 15 minutes and then 15 minutes of cooling time is be added);
adding cooling time periods to two the plurality of treatment volumes of the digital treatment plan according to the desired thermal profile ([0234]-[0235] table 2 shows that Cooling Scheme 2 is implemented point-by-point, and that in Scheme 2, the 24 minutes of cooling time was equally distributed after each treatment point);
commencing ultrasound treatment in the subject according to the digital treatment plan ([0192] the treatment plan is executed by the system).
However Cannata is silent regarding the cooling time periods varying as the treatment progresses
In the same ultrasound therapy field of endeavor, Cosman teaches a duration of the cooling time periods increasing as the treatment progresses thought the plurality of treatment volumes ([0159] the down time can increase in a predetermined schedule as an increasing function of one or more of the values selected from the following list: total elapsed time, number of up-time pulses, total elapsed up-time duration, and other parameter, including incrementing the downtown after every period; fig. 3D shows that initial down time is 20 seconds, and then later increases to 24 seconds [0152]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application, to modify the method of Cannata to have each of the plurality of treatment volumes have increasing cooling times as taught by Cosman, as a short up time can indicate that a longer cooling time is required before the next up time in order to more completely dissipate the bubble zone to allow for continued tissue heating (see Cosmon [0116]).
Regarding claim 3, modified Cannata teaches the method of claim 1, but fails to explicitly disclose wherein the cooling time periods are between treatment pulses, wherein the cooling time periods are non-uniformly distributed throughout the volume of tissue to be treated.
In the same ultrasound field of endeavor, Cosman teaches wherein the cooling time periods are between treatment pulses, wherein the cooling time periods are non-uniformly distributed throughout the volume of tissue to be treated ([0159] the down time can increase in a predetermined schedule as an increasing function of one or more of the values selected from the following list: total elapsed time, number of up-time pulses, total elapsed up-time duration, and other parameter, including incrementing the downtown after every period; fig. 3D shows that initial down time is 20 seconds, and then later increases to 24 seconds [0152]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application, to modify the method of Cannata to have each of the plurality of treatment volumes have increasing cooling times as taught by Cosman, as a short up time can indicate that a longer cooling time is required before the next up time in order to more completely dissipate the bubble zone to allow for continued tissue heating (see Cosmon [0116]).
Regarding claim 5, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the cooling time periods are off periods where no therapy is delivered ([0219] cooling time is in which no therapy pulses are delivered).
Regarding claim 7, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the treatment depth is automatically determined based on patient imaging ([0093] real time imaging is provided, which is used to determine depth; [0212] the depth from the imaging can be determined automatically with the system).
Regarding claim 8, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the driving voltage is determined based on a plurality of test pulses ([0093] test pulses are provided and are used to determined depth/drive voltage).
Regarding claim 10, modified Cannata teaches the method of claim 1, but fails to explicitly disclose wherein a last one of the plurality of treatment volumes to be treated is excluded from cooling.
However in the same ultrasound therapy field of endeavor, Coon teaches wherein a last one of the plurality of treatment volumes to be treated is excluded from cooling (page 46, the cooling period is inter-pulse, therefore cooling is only done between pulses, and since the last treatment volume would not have another pulse after it, there would not be any cooling done on it.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application, to modify the method of Cannata to exclude that last treatment volume from cooling as taught by Coon as this would reduce total treatment times (see Coon pg. 466).
Regarding claim 11, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the ultrasound treatment progresses in a pattern based on one or more of: a linear sequence (fig. 7A-7B the target tissue is treated using DZ pattern, and are treated in a top down/bottom up manner).
Regarding claim 12, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the plurality of treatment volumes are grouped and treated by size ([0244] the system determines the treatment time and set of parameters based on the determined size of the target tissue volume).
Regarding claim 15, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the cooling time periods increases linearly ([0248] the cooling ratio depends on the treatability matrix of 17D; the first cooling ratio is 1:1, then goes to 1:2, 1:3, etc. Therefore when therapy time is fixed, the cooling time increases linearly).
Regarding claim 17, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the cooling time periods increases in a stepwise manner [0248] the cooling ratio increases from 1:1 to 1:2 to 1:3 which is a stepwise increase).
Regarding claim 18, modified Cannata teaches the method of claim 1, wherein Cannata further teaches wherein the cooling time periods have a first value in a first region of the target tissue volume (fig.10 there are multiple volumes and a first volume at the top most would have a first value of a cooling time) and a second value in a second region of the target tissue volume (fig.10 there are multiple volumes (slices) and a second volume at the bottom would have a second value of a cooling time).
Regarding claim 19, modified Cannata teaches the method 18, wherein Cannata is silent regarding the second value is larger than the first value.
In the same ultrasound field endeavor, Shina teaches the second value is larger than the first value ([0159] the down time can increase in a predetermined schedule as an increasing function of one or more of the values selected from the following list: total elapsed time, number of up-time pulses, total elapsed up-time duration, and other parameter, including incrementing the downtown after every period; fig. 3D shows that initial down time is 20 seconds, and then later increases to 24 seconds [0152]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application, to modify the method of Cannata to have each of the plurality of treatment volumes have increasing cooling times as taught by Cosman, as a short up time can indicate that a longer cooling time is required before the next up time in order to more completely dissipate the bubble zone to allow for continued tissue heating (see Cosmon [0116]).
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata in view of Cosmon as applied to claim 1 and 18 (respectively) above, and further in view of Brasset et al., (US20150112235A1).
Regarding claim 4, modified Cannata teaches the method of claim 1, but fails to explicitly disclose wherein the treatment pathway starts at a distal-most region of the target tissue volume relative to a transducer configured to carry out the ultrasound treatment and moves towards a proximal-most region of the target tissue volume relative to the transducer.
However in the same ultrasound field of endeavor, Brasset teaches wherein the treatment pathway starts at a distal-most region of the target tissue volume relative to a transducer configured to carry out the ultrasound treatment and moves towards a proximal-most region of the target tissue volume relative to the transducer ([0049] probe movement 7 goes from a distal point of the treatment zone to a proximal point of the treatment zone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Cannata with the pathway of Brasset, as this would allow for more uniform treatment without over-treatment (see Brasset [0054]).
Regarding claim 20, modified Cannata teaches the method of claim 18, but is silent regarding wherein the first region is further from the ultrasound transducer than second region.
In the same ultrasound therapy field of endeavor, Brasset teaches wherein the first region is further from the ultrasound transducer than second region (fig. 2 there are four regions, and the top region is further away from the probe 2 than the bottom region).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Cannata to have regions that are different distances from the transducer as taught by Brasset, as this allow for more uniform treatment without over-treatment (see Brasset [0054]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cannata in view of Cosmon as applied to claim 1 above, and further in view of Shields (US20090254008A1).
Regarding claim 6, modified Cannata teaches the method of claim 1, but is silent regarding wherein the treatment depth is received via a user input.
However in the same ultrasound treatment field of endeavor, Shields teaches wherein the treatment depth is received via a user input ([0062] lesion depth may be inputted).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the known technique of a user inputting the treatment depth to the base method of Cannata, as both inventions relate to ultrasound treatment, and would yield the predictable results of an ultrasound treatment method that comprises a user inputting the treatment depth to one of ordinary skill in the art. One of ordinary art in the skill would be able to perform such an application, and the results of the method of Cannata including the step of a user inputting the treatment depth are reasonably predictable. Providing a step in which the user inputs treatment depth improves flexibility by allowing the operator to select a desired depth based on imaging, diagnosis, or treatment goals.
Allowable Subject Matter
Claims 21-23 are allowed.
Claims 9, 13, 14, and 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 9, 13, 14, and 16 contain allowable subject matter for the same reasons set forth in the Non-Final Rejection filed 01/14/2026.
Claims 21-23 are allowable for the same reasons set forth in the Non-Final Rejection filed 01/14/2026 for claims 9, 13, and 16.
Further, a reference that may be relevant, Wang et al., “AN EFFICIENT TREATMENT STRATEGY FOR HISTOTRIPSY BY REMOVING CAVITATION MEMORY” Ultrasound Med Biol. 2012 May;38(5):753-66. doi: 10.1016/j.ultrasmedbio.2012.01.013. Epub 2012 Mar 6. PMID: 22402025; PMCID: PMC3462164 teaches of several cooling periods from 2-200ms, but does not apply cooling periods that are exponentially increasing to the different plurality of treatment volumes as treatment progresses.
Response to Arguments
Applicant’s arguments filed 07/14/2026 with respect to claims 1, 3-8, 10-12, 15, and 17-20 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. Coon and Vortman have not been used to teach the increasing cooling times, and instead Cosman has been used to teach such limitations.
The remaining claims 3-8, 10-12, 15, and 17-20 are rejected for substantially the same reasons.
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.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
