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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, line 8 recites “determining a desired thermal profile for additional cooling times to be implemented” and line 11 recites “adding cooling time periods to one or more of the plurality of treatment volumes. It is unclear from these limitations if the desired thermal profile already has a predetermined cooling time period, and that there is additional period of cooling time that is added on to the predetermined amount of cooling of the desired thermal profile, or if the additional cooling time periods are simply just the cooling time periods, and they are added after the treatment pulses. For examination purposes, the second interpretation shall be used.
Further, it is unclear if the “additional cooling time periods” and the “adding cooling time periods” are the same or different cooling time periods. For examination purposes, they shall be considered the same.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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, 5, 7, 8, 10-12, 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata et al.,(US20200164231A1) in view of Coon et al., “HIFU treatment time reduction in superficial tumours through focal zone path selection” (2011) International Journal Hyperthermia, 27:6, 465-481, DOI 10.3109/02656736.2011.564597.
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 additional cooling time periods to be implemented in 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 one the plurality of treatment volumes of the digital treatment plan according to the desired thermal profile (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 added);
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, Coon teaches the cooling time periods varying as the treatment progresses thought the plurality of treatment volumes (pg.467 inter-pulse cooling periods are individually minimized at each of the focal zone positions)
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 varying cooling times as taught by Coon as this would reduce total treatment times (see Coon pg. 466).
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 the second value is larger than the first value (fig. 10 the second volume at the bottom, would have a longer cooling period time since it is deeper)
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata in view of Coon as applied to claim 1 above, and further in view of Vortman et al., (US20120101412A1).
Regarding claim 2, modified Cannata teaches the method of claim 1, but is silent regarding wherein the cooling time periods increase as the treatment progresses through the plurality of treatment volumes.
However in the same ultrasound treatment field of endeavor, Vortman teaches cooling time periods vary as the treatment progresses ([0005] variable cooling levels are adjusted according to specific anatomy; [0031] the system may specify sequencies of sonication and cooling periods that vary in time).
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 include varying cooling time periods as treatment progresses, as this would avoid excessive cooling of non-target tissues without increasing the risk to non-target tissues (see Vortman [0023]). One of ordinary skill would understand that this modification would result in the cooling periods of Cannata being varied according to specific anatomy. In addition, one of ordinary skill would understand that the deeper the anatomy the longer the cooling period, and Cannata teaches the treatment would inevitably go deeper as treatment goes on in fig. 7A/B. Therefore, Cannata in view of Vortman teaches the limitations of claim 2.
Regarding claim 3, modified Cannata teaches the method of claim 1 , wherein Cannata further teaches wherein the cooling time periods are between treatment pulses (fig. 13 [0223] Scheme 1303 the cooling time is between therapy), but is silent regarding wherein the cooling time periods are non-uniformly distributed throughout the volume of tissue to be treated.
In the same ultrasound treatment, Vortman teaches cooling time are non-uniform ([0005] variable cooling levels are adjusted according to specific anatomy; [0031] the system may specify sequencies of sonication and cooling periods that vary in time).
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 include varying cooling time periods as taught of Vortman, as this would avoid excessive cooling of non-target tissues without increasing the risk to non-target tissues (see Vortman [0023]). One of ordinary skill would understand that this modification would result in the cooling periods of Cannata being varied and non-uniform. In addition, one of ordinary skill would understand that the deeper the anatomy the longer the cooling period, and Cannata teaches the treatment would inevitably go deeper as treatment goes on in fig. 7A/B. Therefore, Cannata in view of Vortman teaches the limitations of claim 3.
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cannata in view of Coon 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 Coon 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 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the prior art teaches fixed cooling periods or cooling delays inserted between pulses of ultrasound therapy so as to allow a return to safe temperatures. However, none of the references teach or suggest a cooling plan wherein the total cooling time is based on a product of a cooling coefficient and a total number of plurality of treatment volumes, and is further split for each of the plurality of treatment volumes wherein each cooling time is based on a product of the cooling coefficient and a cooling weight for each treatment point.
Regarding claim 13, the prior art teaches inserting cooling periods between treatments or adjusting cooling based on the local thermal conditions, but fails to teach or even suggest a redistribution of cooling time across treatment as part of a treatment path planning, specifically wherein the desired thermal profile includes a range from a minimum cooling time to a maximum cooling time, wherein a number of segments in the treatment pathway is adjusted based on one or more of the minimum cooling time and maximum cooling time, wherein cooling time periods for the plurality of treatment volumes falling above the maximum cooling times or below the minimum cooling times are iteratively distributed across the plurality of treatment volumes to bring the cooling time period for each one of the plurality of treatment volumes within the range.
Claim 14 is rejected for the same reasons as above.
Regarding claim 16, the prior art teaches fixed, linearly adjusted, or feedback-based cooling times applied between ultrasound therapy pulses, but fails to teach or suggest cooling times that increase in an exponential way.
Conclusion
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798