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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
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 8 and 18 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.
Claims 8 and 18 are indefinite because they recite “generating, within each ultrasound pulse, at least one μm-scale vapor bubble”. It is unclear how a bubble may be generated inside (i.e., “within”) an ultrasound pulse, as an ultrasound pulse is a mechanical wave that is not understood to be capable of including a bubble therewithin.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 8 and 18 recite limitations directed towards the boiling histotripsy being induced by generating a μm-scale vapor bubble and growing the bubble to a mm-scale bubble. These limitations fail to further limit the subject matter of claims 1 and 14 because the limitations merely describe implicit characteristics of the boiling histotripsy process. For example, any process of ‘inducing a boiling histotripsy in a target tissue of a patient by causing mechanical disintegration of the target tissue through interactions between at least one mm-scale bubble and the shock waves’, as recited in claims 1 and 18, would be understood by those in the art to already include a step of ‘generating a μm-scale vapor bubble and growing the bubble’, as these steps are fundamental to achieving boiling histotripsy. It is noted that Kreider et al. (“Rectified growth of histotripsy bubbles. Proc Meet Acoust. 2013: 19(1), of record) was cited during the prosecution of the parent application to provide evidence1 that such the boiling histotripsy process is understood in the art to entail such features as recited in claims 8 and 18.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3 - 7, 10 - 14, 16 - 17, 20 - 21, and 23 - 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2017/0072228, of record) in view of Hynynen et. al (US 2006/0052706, of record), Chaussy et al. (“Transrectal High-Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer: Current Role,” Journal of Cancer Therapy, 2013, 4, 59-73, of record), and Martin et al. (US 2003/0018255, of record).
Regarding claim 1, Wang shows an apparatus comprising:
an ultrasound probe having a therapy transducer (“ultrasound source 102 … ultrasound transducer”, [0014] and fig. 1); and
a controller (“controller 108 … computer…”, [0017] and fig. 1) having controller-executable instructions that, when executed, cause the therapy transducer to emit ultrasound pulses including ultrasound waves (“ … pulsing protocol to generate shock waves, [0022]) having a frequency between 1 MHz and 2.8 MHz (1.1 MHz, [0016]), such that the ultrasound waves emitted by the therapy transducer are configured to generate shock waves at a focal depth (“… induce boiling bubbles … proximate to the focus 120 to mechanically damage the tissue…”, [0014] and fig. 1) that induce a boiling histotripsy in a target tissue of a patient by causing mechanical disintegration of the target tissue through interactions between at least one mm-scale bubble and the shock waves (“boiling histotripsy that mechanically fractionates the tissue,” [0022]; “boiling activity and interaction of the ultrasound shock waves with the boiling bubbles emulsifies the tissue 112 at the target site,” [0024]. Note that the “mm-scale” is implicit), wherein the interactions take place within a duration of an ultrasound pulse (“… time-to-boil … during each pulse …”, [0024]) without thermally damaging a surrounding tissue (“surrounding tissue shows minimal to no evidence of thermal denature,” [0025]; [0038]),
wherein the ultrasound probe is configured for insertion into a body lumen of the patient and be positionable proximate to the target tissue (“ultrasound source 102 … intracavitary device”, [0015]; “emulsify malignant or benign tumors in a volume of tissue … prostate”, [0031]), and
wherein the therapy transducer includes a plurality of transducer elements (“ultrasound source 102 … multi-element device”, [0015]), the plurality of transducer elements including multiple groups of transducer elements that are individually controllable (implicit - any subset of the elements is a “group”, and is at least capable of being controlled individually) to generate the shock waves.2
Wang is silent as to the surface intensity of the therapy transducer being 10 - 80 W/cm2. In addition, although Wang provides that the target tissue is a prostate tumor ([0031]), Wang does not explicitly state that the focal depth is 2.5 - 5.5 cm. Further, Wang fails to show that the transducer elements of the therapy transducer are arranged around a centrally disposed opening.
Hynynen discloses medical applications of ultrasound ([0002]). Hynynen teaches a surface intensity of a therapy transducer that is 10-80 W/cm2 (“acoustic intensity on an array surface is high when thermal lesions are to be produced rapidly … acoustic intensities of about 63, 13, 10 W/cm2 on the transducer surface … acoustic intensity on the transducer surface about 22 … W/cm2,” [0076]).
Chaussy discloses transrectal HIFU devices for the treatment of prostate cancer. Chaussy teaches a target tissue that is at a range of focal depth of 2.5 - 5.5 cm (“treatment transducer focused at a maximum of 45 mm,” pg. 61, 1st paragraph in section 2.4.1; “25 mm or 45 mm focal-length probes… 30, 35 or 40 mm focal-length probes,” pg. 62, 1st paragraph in section 2.4.2).
Martin discloses applications of high-intensity focused ultrasound (focused high intensity ultrasound energy, abstract) for prostate therapies ([0110]; [0112]). Martin teaches transducer elements of a therapy transducer (“array 806 … region 809 shows a sectional view of dicing pitch of the transducer elements 807”, [0110] and figs. 8D - 8E) that are arranged around a centrally disposed opening (“central rectangular opening for an imaging array,” [0132], and figs. 8D - 8E).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Wang to have the surface intensity of the therapy transducer be 10-80 W/cm2, as taught by Hynynen in order to select desired tradeoffs between the sonication duration and acoustic power, since the surface intensity is related to the lesion production speed, as explained by Hynynen ([0076]).
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the target tissue be at a focal depth of 2.5 - 5.5 cm, as taught by Chaussy, in order to effectively treat prostate tissue located at the claimed focal depths, as envisaged by Wang (Wang: [0031]), which is well-understood and conventional in the art.
In addition, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, and Chaussy to have the transducer elements of the therapy transducer be arranged around a centrally disposed opening, as taught by Martin, in order to provide an opening for an imaging transducer, as suggested by Martin ([0132]), and is conventional in prostate therapies.
Regarding claim 3, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang fails to show that the probe includes an imaging transducer that is used to emit ultrasound waves in a frequency range of 7 MHz to 15 MHz for imaging the target tissue.
Chaussy teaches a probe that includes an imaging transducer that is used to emit ultrasound waves in a frequency range of 7 MHz to 15 MHz for imaging the target tissue (“imaging probe working at 7.5 MHz,” pg. 61, 1st paragraph in section 2.4.1.).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the probe include an imaging transducer that is used to emit ultrasound waves in a frequency range of 7 MHz to 15 MHz for imaging the target tissue, as taught by Chaussy, in order to facilitate target localization during treatment, as suggested by Chaussy (pg. 61, 2nd full paragraph in left column).
Regarding claims 4 - 6, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang fails to show that the imaging transducer is disposed within the centrally disposed opening, wherein the centrally disposed opening is rectangular, wherein the centrally disposed opening has dimensions between 13 mm and 16 mm.
Martin teaches an imaging transducer (imaging transducer 803, [0109]) that is disposed within the centrally disposed opening, wherein the centrally disposed opening is rectangular (“central rectangular opening for an imaging array,” [0132], and figs. 8D - 8E).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, and Chaussy to have the imaging transducer be disposed within the centrally disposed opening, wherein the centrally disposed opening is rectangular, as taught by Martin, in order to perform the imaging using a combined imaging and treatment probe that facilitates localizing the target relative to the treatment device.
Further, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, Chaussy, and Martin to have the centrally disposed opening have dimensions between 13 mm and 16 mm, in order to optimize the size of the imaging transducer, and corresponding opening to receive the transducer, to accommodate a doctor’s preference and/or a patient’s treatment needs. See MPEP 2144.04.IV.A, explaining that it has previously been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Examiner notes that a device having the relative dimensions recited in the instant claims would not perform differently than the prior art device.
Regarding claim 7, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang fails to show that the therapy transducer has dimensions between 35 mm and 50 mm.
Chaussy teaches a therapy transducer that has dimensions between 35 mm and close to 50 mm (fig. 5 and text within stating that the transducer is 57 x 35 x 25 mm).
It therefore would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the therapy transducer have dimensions between 35 mm and 50 mm, in order to optimize the size of therapy transducer for the patient’s body size and/or the doctor’s preference, particularly since Chaussy demonstrates that it is conventional in the art to employ similar dimensions for therapy transducers. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.I.
Regarding claim 10, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above. Wang further shows that the shock waves have an amplitude of between about 60 MPa and 140 MPa (“shock wave amplitudes may be … 95 MPa, 100 MPa, 105 MPa…, and/or values therebetween,” [0022]) at the focus depth. In the combined invention of the prior art, the focus depth is at distance of about 35 and 55 mm away from the therapy transducer, as explained in the art rejections of the independent claims.
Regarding claim 11, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Although Wang provides that the target tissue is a prostate tumor ([0031]), Wang does not explicitly state that the ultrasound probe is a transrectal probe configured to be inserted into a rectum of the patient.
Chaussy teaches an ultrasound probe that is a transrectal probe configured to be inserted into a rectum of the patient (title).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the ultrasound probe be a transrectal probe configured to be inserted into a rectum of the patient, as taught by Chaussy, in order to effectively treat prostate tissue, as envisaged by Wang (Wang: [0031]), using conventional probe form factors.
Regarding claim 12, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang is silent as to the plurality of transducer elements being disposed on a curved surface.
Martin teaches a plurality of transducer elements disposed on a curved surface ([0110] and curved surface in fig. 8D; [0112] - [0113] and fig. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, and Chaussy to have the plurality of transducer elements being disposed on a curved surface, as taught by Martin, in order to provide the therapy transducer with a conventional and well-understood distribution of the transducer elements, to thereby simplify probe design and control of the therapy.
Regarding claim 13, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang is silent as to the therapy transducer having a curved edge.
Chaussy teaches a therapy transducer having a curved edge (see curved edges in figs. 2 - 3).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the therapy transducer have a curved edge, as taught by Chaussy, in order to effectively treat prostate tissue, as envisaged by Wang (Wang: [0031]), using conventional probe form factors.
Regarding claim 14, Wang shows an apparatus comprising:
an ultrasound probe having a therapy transducer (“ultrasound source 102 … ultrasound transducer”, [0014] and fig. 1) including a plurality of transducer elements (“ultrasound source 102 … multi-element device”, [0015]); and
a controller (“controller 108 … computer…”, [0017] and fig. 1) having controller-executable instructions that, when executed, cause the therapy transducer to emit ultrasound pulses including ultrasound waves (“ … pulsing protocol to generate shock waves, [0022]) having a frequency between 1 MHz and 2.8 MHz (1.1 MHz, [0016]), such that the ultrasound waves emitted by the therapy transducer are configured to generate shock waves at a focal depth (“… induce boiling bubbles … proximate to the focus 120 to mechanically damage the tissue…”, [0014] and fig. 1) that induce a boiling histotripsy in a target tissue of a patient by causing mechanical disintegration of the target tissue through interactions between at least one mm-scale bubble and the shock waves (“boiling histotripsy that mechanically fractionates the tissue,” [0022]; “boiling activity and interaction of the ultrasound shock waves with the boiling bubbles emulsifies the tissue 112 at the target site,” [0024]. Note that the “mm-scale” is implicit), wherein the interactions take place within a duration of an ultrasound pulse (“… time-to-boil … during each pulse …”, [0024]) without thermally damaging a surrounding tissue (“surrounding tissue shows minimal to no evidence of thermal denature,” [0025]; [0038]),
wherein the ultrasound probe is configured for insertion into a body lumen of the patient and be positionable proximate to the target tissue (“ultrasound source 102 … intracavitary device”, [0015]; “emulsify malignant or benign tumors in a volume of tissue … prostate”, [0031]).
Wang fails to show that the transducer elements of the therapy transducer are arranged around a rectangular opening having an imaging transducer disposed therewithin, wherein the controller is configured to cause the imaging transducer to emit ultrasound waves having a frequency between 7 MHz and 15 MHz. In addition, Wang is silent as to the surface intensity of the therapy transducer being 10 - 80 W/cm2. Further, although Wang provides that the target tissue is a prostate tumor ([0031]), Wang does not explicitly state that the focal depth is 2.5 - 5.5 cm.
Hynynen discloses medical applications of ultrasound ([0002]). Hynynen teaches a surface intensity of a therapy transducer that is 10-80 W/cm2 (“acoustic intensity on an array surface is high when thermal lesions are to be produced rapidly … acoustic intensities of about 63, 13, 10 W/cm2 on the transducer surface … acoustic intensity on the transducer surface about 22 … W/cm2,” [0076]).
Chaussy discloses transrectal HIFU devices for the treatment of prostate cancer. Chaussy teaches a controller that is configured to cause an imaging transducer to emit ultrasound waves having a frequency between 7 MHz and 15 MHz (“imaging probe working at 7.5 MHz,” pg. 61, 1st paragraph in section 2.4.1.). Chaussy also teaches a target tissue that is at a range of focal depth of 2.5 - 5.5 cm (“treatment transducer focused at a maximum of 45 mm,” pg. 61, 1st paragraph in section 2.4.1; “25 mm or 45 mm focal-length probes… 30, 35 or 40 mm focal-length probes,” pg. 62, 1st paragraph in section 2.4.2).
Martin discloses applications of high-intensity focused ultrasound (focused high intensity ultrasound energy, abstract) for prostate therapies ([0110]; [0112]). Martin teaches transducer elements of a therapy transducer (“array 806 … region 809 shows a sectional view of dicing pitch of the transducer elements 807”, [0110] and figs. 8D - 8E) that are arranged around a rectangular opening having an imaging transducer disposed therewithin (“central rectangular opening for an imaging array,” [0132], and figs. 8D - 8E).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Wang to have the surface intensity of the therapy transducer be 10-80 W/cm2, as taught by Hynynen in order to select desired tradeoffs between the sonication duration and acoustic power, since the surface intensity is related to the lesion production speed, as explained by Hynynen ([0076]).
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the probe include an imaging transducer configured to generate imaging ultrasound in a frequency range of 7 MHz to 15 MHz, as taught by Chaussy, in order to facilitate target localization during treatment, as suggested by Chaussy (pg. 61, 2nd full paragraph in left column).
It would further have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the target tissue be at a focal depth of 2.5 - 5.5 cm, as taught by Chaussy, in order to effectively treat prostate tissue located at the claimed focal depths, as envisaged by Wang (Wang: [0031]), which is well-understood and conventional in the art.
In addition, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, and Chaussy to have the transducer elements of the therapy transducer be arranged around a rectangular opening having an imaging transducer disposed therewithin, as taught by Martin, in order to perform the imaging using a combined imaging and treatment probe that facilitates localizing the target relative to the treatment device, as is conventional in prostate therapies.
Regarding claim 16, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang fails to show that the rectangular opening has dimensions between 13 mm and 16 mm.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, Chaussy, and Martin to have the centrally disposed opening have dimensions between 13 mm and 16 mm, in order to optimize the size of the imaging transducer, and corresponding opening to receive the transducer, to accommodate a doctor’s preference and/or a patient’s treatment needs. See MPEP 2144.04.IV.A, explaining that it has previously been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Examiner notes that a device having the relative dimensions recited in the instant claims would not perform differently than the prior art device.
Regarding claim 17, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang fails to show that the therapy transducer has dimensions between 35 mm and 50 mm.
Chaussy teaches a therapy transducer that has dimensions between 35 mm and close to 50 mm (fig. 5 and text within stating that the transducer is 57 x 35 x 25 mm).
It therefore would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the therapy transducer have dimensions between 35 mm and 50 mm, in order to optimize the size of therapy transducer for the patient’s body size and/or the doctor’s preference, particularly since Chaussy demonstrates that it is conventional in the art to employ similar dimensions for therapy transducers. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.I.
Regarding claim 20, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above. Wang further shows that the shock waves have an amplitude of between about 60 MPa and 140 MPa (“shock wave amplitudes may be … 95 MPa, 100 MPa, 105 MPa…, and/or values therebetween,” [0022]) at the focus depth. In the combined invention of the prior art, the focus depth is at distance of about 35 and 55 mm away from the therapy transducer, as explained in the art rejections of the independent claims.
Regarding claim 21, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Although Wang provides that the target tissue is a prostate tumor ([0031]), Wang does not explicitly state that the ultrasound probe is a transrectal probe configured to be inserted into a rectum of the patient.
Chaussy teaches an ultrasound probe that is a transrectal probe configured to be inserted into a rectum of the patient (title).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the ultrasound probe be a transrectal probe configured to be inserted into a rectum of the patient, as taught by Chaussy, in order to effectively treat prostate tissue, as envisaged by Wang (Wang: [0031]), using conventional probe form factors.
Regarding claim 23, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above. Further, in the combined invention of the prior art, the plurality of transducer elements include multiple groups of transducer elements that are individually controllable (implicit - any subset of the elements is a “group”, and is at least capable of being controlled individually) to generate the shock waves.3
Regarding claim 24, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang is silent as to the plurality of transducer elements being disposed on a curved surface.
Martin teaches a plurality of transducer elements disposed on a curved surface ([0110] and curved surface in fig. 8D; [0112] - [0113] and fig. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, and Chaussy to have the plurality of transducer elements being disposed on a curved surface, as taught by Martin, in order to provide the therapy transducer with a conventional and well-understood distribution of the transducer elements, to thereby simplify probe design and control of the therapy.
Regarding claim 25, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang is silent as to the therapy transducer having a curved edge.
Chaussy teaches a therapy transducer having a curved edge (see curved edges in figs. 2 - 3).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang and Hynynen to have the therapy transducer have a curved edge, as taught by Chaussy, in order to effectively treat prostate tissue, as envisaged by Wang (Wang: [0031]), using conventional probe form factors.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, Hynynen, Chaussy, and Martin, as applied to claims 1 and 14 above, and as evidenced by Kreider et al. (“Rectified growth of histotripsy bubbles. Proc Meet Acoust. 2013: 19(1), of record).
Regarding claims 8 and 18, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang does not explicitly state that the µm-scale vapor bubble is grown to the mm-scale bubble. However, Kreider discloses rectified growth of histotripsy bubbles, and demonstrates that it is understood in the art that boiling histotripsy processes include a step of growing µm-scale vapor bubbles to mm-scale bubbles (“boiling bubbles excited for milliseconds ... need for bubble growth … boiling bubbles grow to about 1 mm,” abstract; “millimeter-sized bubbles are generated by boiling,” pg. 1, last paragraph). Therefore, even though Wang does not explicitly discuss that the µm-scale vapor bubble is grown to the mm-scale bubble, the prior art nonetheless meets the limitations directed towards growing the bubble because Wang’s boiling histotripsy steps ([0022] - [0024]) are understood in the art to include the step of growing the bubbles from µm-scale to mm-scale dimensions, as evidenced by Kreider.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable Wang, Hynynen, Chaussy, and Martin, as applied to claims 1 and 14 above, and further in view of Hwang et al. (US 2007/0041961, of record).
Regarding claims 9 and 19, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang fails to show that a focal region the therapeutic ultrasound at the target tissue is 0.1 mm to 1 mm wide and 2 mm to 10 mm long.
Hwang discloses applications of high-intensity focused ultrasound (abstract). Hwang teaches a focal region for the therapeutic ultrasound at target tissue is 0.1 - 1 mm wide and 2 - 10 mm long (1 mm by 9 mm, [0046]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, Chaussy, and Martin to have the focal region for the therapeutic ultrasound at the target tissue be 0.1 mm to 1 mm wide and 2 mm to 10 mm long, as taught by Hwang, in order to effectively treat cancerous tissue (e.g., prostate cancer) lesions of the claimed dimensions, as is well-understood and conventional in the art.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable Wang, Hynynen, Chaussy, and Martin, as applied to claim 14 above, and further in view of Vaezy et al. (US 2006/0235303).
Regarding claim 22, the combined invention of Wang, Hynynen, Chaussy, and Martin discloses the claimed invention substantially as noted above.
Wang is silent as to the each of the plurality of transducer elements having an equal area.
Vaezy discloses applications of high-intensity focused ultrasound ([0004]). Vaezy teaches each of a plurality of transducer elements having an equal area (“… discrete emitter elements, all equal in area …”, [0053] and fig. 4B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Wang, Hynynen, Chaussy, and Martin to have each of the plurality of transducer elements having an equal area, as taught by Vaezy, in order to optimize the transducer dimensions to provide desired therapeutic effects, as is well-understood and conventional in the art.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 Kreider et al. disclose rectified growth of histotripsy bubbles, and demonstrate that it is understood in the art that BH processes include a step of growing µm-scale vapor bubbles to mm-scale bubbles (“boiling bubbles excited for milliseconds ... need for bubble growth … boiling bubbles grow to about 1 mm,” abstract; “millimeter-sized bubbles are generated by boiling,” pg. 1, last paragraph).
2 In the interest of compact prosecution, it is noted that both Chaussy teaches phased arrays (section 2.1.2, last sentence), as does Martin ([0109] - [0110]).
3 In the interest of compact prosecution, it is noted that both Chaussy teaches phased arrays (section 2.1.2, last sentence), as does Martin ([0109] - [0110]).