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 Objections
Claims 10 and 12 are objected to because of the following informalities: claim 10 states “pressure at least 50 MPa” should state “pressure is at least 50 MPa” and claim 12 states “is comprised of a only” which should state “is comprised of . Appropriate correction is required.
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) 1-8, 10-17, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al (2015/0258352).
Regarding claim 1, Lin et al disclose a method of delivering histotripsy therapy to a target tissue, comprising:
positioning a focus of an ultrasound therapy transducer at a focal location in the target tissue (a multi-element dual-frequency transducer array can be used to generate parametric Histotripsy pulses – [0007]); and
delivering histotripsy waveform to the focal location to generate a bubble cloud at the focal location (dense bubble clouds (and resulting lesions) can be generated – [0007]), wherein the histotripsy waveform comprises a leading peak positive half-cycle (P+), followed by a peak negative half-cycle (P-), and further followed by a trailing positive half-cycle (P2) (the waveform comprising a half-cycle high peak positive phase preceding and following peak negative half cycles – [0061];[0102]), and wherein a ratio between the leading peak positive half-cycle (P+) and the negative half-cycle (P-) is maximized for a given peak negative half-cycle (the ratio of half cycle P+ to half cycle P- for peak negative pressure decreases slightly (i.e., maximized) – fig.17a, [0116]), and wherein the peak positive half-cycle is delivered to the focal location prior to the peak negative half-cycle (the half cycle high peak positive phase precedes the peak negative half cycle of the waveform transmitted to the tissue – [0061];[0102]).
Regarding claim 2, Lin et al disclose wherein the histotripsy waveform is therapeutic (system for performing Histotripsy therapy – abstract; [0003]).
Regarding claim 3, Lin et al disclose wherein the peak negative pressure is at least 15 MPa (the P- pressure is typically 26-30 MPa – [0006]).
Regarding claim 4, Lin et al disclose wherein the peak negative pressure is at least 20 MPa (the P- pressure is typically 26-30 MPa – [0006]).
Regarding claim 5, Lin et al disclose wherein the peak negative pressure is at least 25 MPa (the P- pressure is typically 26-30 MPa – [0006]).
Regarding claim 6, Lin et al disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 4:1 (the ratio of the half cycle P+ to half cycle P- for peak negative pressure is 6:1 – [0116]; fig. 17c).
Regarding claim 7, Lin et al disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 5:1 (the ratio of the half cycle P+ to half cycle P- for peak negative pressure is 6:1 – [0116]; fig. 17c).
Regarding claim 8, Lin et al disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 6:1 (the ratio of the half cycle P+ to half cycle P- for peak negative pressure is 6:1 – [0116]; fig. 17c).
Regarding claim 10, Lin et al disclose wherein the leading peak positive pressure is at least 50 MPa (P+ ranging from 30 to 50 MPa – [0118]).
Regarding claim 11, Lin et al disclose wherein the histotripsy waveform comprises a single peak negative half-cycle (a single bubble generated from a peak negative half cycle – [0051]).
Regarding claim 12, Lin et al disclose wherein the histotripsy waveform is comprised of a only the leading peak positive half-cycle, the peak negative half-cycle, and the secondary positive half-cycle (each frequency component of the transducer can be capable of generating pulses with only one high amplitude negative half-cycle with the preceding and following peak positive phases – [0008];[0061];[0102]).
Regarding claim 13, Lin et al disclose wherein the histotripsy waveform is a shock scattering waveform (the histotripsy waveform is a shock-scattering mechanism – [0061]).
Regarding claim 14, Lin et al disclose a histotripsy therapy system, comprising:
a therapy transducer array comprising a plurality of transducer elements (a multi-element dual-frequency transducer array can be used to generate parametric Histotripsy pulses – [0007]);
driving electronics configured to produce a histotripsy waveform (an electronic controller coupled to the pulse generator and the ultrasound therapy transducer – [0032]); and
an electronic controller configured to control delivery of the histotripsy waveform to the therapy transducer array to generate a bubble cloud in tissue (the electronic controller controls transmission of histotripsy ultrasound pulses – [0032]);
the electronic controller, therapy transducer, and driving electronics being configured to produce the histotripsy waveform to include a leading peak positive half-cycle (P+), followed by a peak negative half-cycle (P-), and further followed by a trailing positive half-cycle (P2) (the waveform comprising a half-cycle high peak positive phase preceding and following peak negative half cycles – [0061];[0102]), and wherein a ratio between the secondary positive half-cycle (P2) and the peak negative half-cycle (P-) is at or below a pressure ratio optimization threshold (the low frequency ultrasound pulse has a peak pressure below an intrinsic threshold; the ratio of P- and P+ values are minimal – [0121];[0128]; fig.17).
Regarding claim 15, Lin et al disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 4:1 (the ratio of the half cycle P+ to half cycle P- for peak negative pressure is 6:1 – [0116]; fig. 17c).
Regarding claim 16, Lin et al disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 5:1 (the ratio of the half cycle P+ to half cycle P- for peak negative pressure is 6:1 – [0116]; fig. 17c).
Regarding claim 17, Lin et al disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 6:1 (the ratio of the half cycle P+ to half cycle P- for peak negative pressure is 6:1 – [0116]; fig. 17c).
Regarding claim 19, Lin et al disclose wherein the leading peak positive half-cycle has a higher amplitude than the trailing positive half-cycle (the positive phases preceding and following the negative phase are “smeared out” positive phases (leading has a higher amplitude) – [0102]).
Regarding claim 20, Lin et al disclose wherein the histotripsy waveform comprises only the leading peak positive half-cycle, the peak negative half-cycle, and the trailing positive half-cycle (the waveform comprising a half-cycle high peak positive phase preceding and following peak negative half cycles – [0061];[0102]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (2015/0258352) in view of Rosenzweig et al (2020/0305842).
Regarding claims 9 and 18, Lin et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the ratio of the leading peak positive half-cycle to the peak negative half-cycle is at least 7:1.
However, Rosenzweig et al teach in the same medical field of endeavor, wherein a ratio of a leading peak positive half-cycle to a peak negative half-cycle is at least 7:1 (the ratio is provided for half of the cycles of the positive peak amplitude to the negative peak amplitude is 10 – [0026];[0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ratio of the leading peak positive half-cycle to a peak negative half-cycle of Lin et al with being at least 7:1 as it would provide greater acoustic power.
Conclusion
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797
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