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
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1, 16, 21-22, 28, 32-33, 35-41, 43, 45, 47 and 50-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,491,353. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a device that perform the method in the patented application.
Claims 1, 16, 21-22, 28, 32-33, 35-41, 43, 45, 47 and 50-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,724,132. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a device that perform the method in the patented application.
Claims 1, 16, 21-22, 28, 32-33, 35-41, 43, 45, 47 and 50-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,980,777. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a device that perform the method in the patented application.
Claims 1, 16, 21-22, 28, 32-33, 35-41, 43, 45, 47 and 50-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,427,345. Although the claims at issue are not identical, they are not patentably distinct from each other because the current application is claiming a device that perform the method in the patented application.
Claim Rejections - 35 USC § 103
1. 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.
2. Claims 1, 6, 16, 21-22, 28, 32-33, 35-41, 43, 45, 47, 50-53 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Liu et al. (US 2018/0207447 (provided in the IDS)), further in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)) and Kajitani et al. (US 2010/0228523).
3. Addressing claim 1, Hynynen discloses an ultrasound transducer that generates an acoustic pressure field for providing sonodynamic therapy, the ultrasound transducer comprising:
a plurality of piezoelectric ultrasonic transducer elements arranged in an array configured to generate an acoustic pressure field with an energy profile for treating tissue of a patient (see abstract, Fig. 1A, 1C and 2A).
wherein the energy profile is driven at ultrasonic frequencies in a range of 250 kHz to 3 MHz (see [0044]).
temporal-average intensity between 1 and 20 W/cm2 (see [0004] and [0047]; Hynynen’s device is capable of output temporal average intensity between 1 and 20 W/cm2).
a cooling system configured to remove excess heat from the patient and wherein the ultrasound is administered non-invasively (see [0065] and Fig. 1A; coupling fluid also allow cooling; non-invasive ultrasound treatment of brain).
Hynynen does not disclose incoherent acoustic pressure field with modulated phase, sonosensitizer and planar emitting surface configured to emit a planar acoustic wave; wherein the cooling system comprises a flexible cavity for circulation of a cooling fluid and wherein the incoherent acoustic pressure field comprises a temporal-average intensity; wherein the sonosensitizer is selected from the group consisting of: 5-aminolevulinic acid (5-ALA) and protoporphyrin IX (PpIX). Liu discloses a sonosensitizer (protoporphyrin IX), activate protoporphyrin IX within a treatment tissue to treat cancer in the tumor cells of the patient (see [0006], [0033], [0044] and [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to use sonosensitizer at cancer treatment tissue as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
Lacoste discloses planar ultrasound wave emitted by planar and wherein the cooling system comprises a flexible cavity for circulation of a cooling fluid (see Fig. 21, [0041], [0056], [0128] and [0136]; Lacoste explicitly discloses circulation of a cooling fluid in balloon (flexible cavity)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to emit planar ultrasound wave using transducer with planar surface as taught by Lacoste because planar wave provides a uniform and deep diffusion of sound energy (see [0136]). Lacoste also explicitly discloses intensity output between 1 and 20 W/cm2 (see [0128] and [0136])
Kajitani discloses phase randomization (see [0018]; drive signal that is phase modulated by a random signal is a drive signal with phase randomization; modulate phase/random phase is incoherent acoustic signal/field). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have phase randomization/modulation as taught by Kajitani because this improves correlativity of a reception wave (see [0036]). Kajitani discloses phase randomization or incoherent and Hynynen’s device is capable of output temporal-average intensity. Hynynen discloses modulate duty cycle. Modulate duty cycle produces temporal-average intensity. Hynynen discloses an array. Array includes many transducer elements; each element is driven by a signal. Kajitani discloses a drive signal with phase randomization. Hynynen in view of Kajitani discloses transducer array with many transducer elements driven by many signals with phase randomization. This is randomized phased difference across the plurality of piezoelectric ultrasonic transducer elements.
Addressing claim 6, Hynynen discloses an ultrasound transducer for providing sonodynamic therapy, the ultrasound transducer comprising:
a plurality of ultrasonic transducer elements arranged in an array configured to
generate an acoustic pressure field with an energy profile for treating tissue of a patient (see abstract, Fig. 1A, 1C and 2A).
wherein an aperture size of the aperture is selected to be larger than a lesion size of a targeted lesion of cancer cells (see Figs. 1A and 1C; only 3 transducers to cover the whole skull so the aperture of the transducer is larger than a lesion size).
wherein the aperture is sized and configured with the energy profile to saturate a treatment volume to ensure treatment of the targeted lesion of cancer cells and extraneous cancer cells located within the tissue of the patient (see [0060], Figs. 1A and 1C; 3 transducers to cover the whole skull to saturate a treatment volume to ensure treatment of the targeted lesion of cancer cells and extraneous cancer cells located within the tissue of the patient; cover the target region 50 that contain cancer cell).
wherein the plurality of ultrasonic transducer elements is arranged in the array configured to couple to a head of the patient (see Fig. 1A, C and 3).
a modulated frequency across the plurality of ultrasonic transducer elements, and a modulated amplitude across the plurality of ultrasonic transducer elements (see [0081] and [0083]; modulate or using different frequencies).
Hynynen does not disclose sonosensitizer and incoherent acoustic pressure field and wherein the signal comprises: a modulated phase across the plurality of ultrasonic transducer elements; wherein each ultrasonic transducer element in the array comprises an emitting surface configured to emit planar or defocused acoustic waves; wherein the modulated phase comprises a randomized phase difference and wherein the array is driven by the signal to generate the incoherent acoustic pressure field. Liu discloses a sonosensitizer (protoporphyrin IX), ultrasound activate protoporphyrin IX within a treatment tissue of the patient to treat cancer in the tumor cells of the patient (see [0006], [0033], [0044], [0049] and [0059]); Liu also implicitly discloses wherein the aperture is sized and configured with the energy profile to saturate a treatment volume to ensure treatment of the targeted lesion of cancer cells and extraneous cancer cells located within the tissue of the patient (see [0044], claim 1, abstract; ultrasound target tumor cells and activate protoporphyrin IX at the tumor cells). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to use sonosensitizer at cancer treatment tissue as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
Kajitani discloses wherein the modulated phase comprises a randomized phase difference; wherein the plurality of ultrasonic transducer elements is configured to generate the incoherent acoustic pressure field (see [0018]; drive signal with modulated phase by a random signal is a drive signal with random phase different; modulate phase/random phase is incoherent acoustic signal/field; Kajitani discloses drive signal with random phase that create incoherent acoustic pressure field; Hynunen explicitly discloses transducer array) and wherein the array is driven by a signal, wherein the signal comprises one or more of the group consisting of: a modulated phase across the plurality of ultrasonic transducer elements, a modulated frequency across the plurality of ultrasonic transducer elements, and a modulated amplitude across the plurality of ultrasonic transducer elements (see [0018]; Hynynen explicitly disclose array of the plurality of ultrasonic transducer elements). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have phase randomization/modulation and wherein the array is driven by a signal as taught by Kajitani because this improves correlativity of a reception wave (see [0036]). Hynynen in view of Kajitani disclose wherein an aperture size of the aperture is selected to be larger than a lesion size of a targeted lesion of cancer cells, such that an aspect ratio of the aperture size to the lesion size enables initiation of the incoherent acoustic pressure field to treat the targeted lesion of cancer cells and extraneous cancer cells in the tissue. Hynynen discloses aperture size larger than a lesion size and Kajitani discloses incoherent pressure field. Hynynen discloses an array. Array includes many transducer elements; each element is driven by a signal. Kajitani discloses a drive signal with phase randomization. Hynynen in view of Kajitani discloses transducer array with many transducer elements driven by many signals with phase randomization. This is randomized phased difference across the plurality of piezoelectric ultrasonic transducer elements.
Lacoste discloses wherein each ultrasonic transducer element in the array comprises an emitting surface configured to emit planar or defocused acoustic waves (see Fig. 21, [0041], [0056], [0128] and [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to emit planar ultrasound wave using transducer with planar surface as taught by Lacoste because planar wave provides a uniform and deep diffusion of sound energy (see [0136]).
4. Addressing claims 16, 21-22, 28, 32-33, 35-39, 41, 45, 47, 50, 51, 53 and 57-58, Hynynen discloses:
addressing claim 16, wherein the ultrasonic transducer elements are arranged according to a predetermined element packing technique (see Fig. 2A and [0062]; specific patient arrangement of transducers).
addressing claim 21, wherein the ultrasound transducer defines a rectangular array geometry (Hynynen does not explicitly discloses rectangular array arrangement; however, this is a designer choice that only require routine skill in the art; Hynynen is capable of having rectangular arrangement).
addressing claim 22, wherein the rectangular array geometry defines a square (Hynynen does not explicitly discloses square array arrangement; however, this is a designer choice that only require routine skill in the art; Hynynen is capable of having square arrangement).
addressing claim 28, wherein the plurality of ultrasonic transducer elements are arranged in the array disposed on a helmet configured to couple to the a head of the patient (see Fig. 2A and [0063]; transducer are arranged on frame which is similar to helmet; helmet, cap or shell or frame are obvious designer choice).
addressing claim 32, wherein the plurality of ultrasonic transducer elements are arranged in a hemispherical array (see Figs. 1A, C and 3).
addressing claim 33, wherein the plurality of ultrasonic transducer elements are arranged in a curved linear array (see Figs. 1A, C, 2A and 3).
addressing claims 35-39, wherein a diameter of the array is in a range of 100mm to 200mm, 100 to 150mm, 120 to 165mm, 0.5mm to 20mm and 2mm to 10mm (this is a designer choice that depend on treatment application).
addressing claim 41, configured for treating cancerous tissue in a brain, spine, mouth, in a lung, breast, colorectal region, prostate or pancreas (see [0004] and [0060]; treat tumor/caner in the brain).
addressing claim 45, wherein the ultrasound transducer is minimally invasive (see Figs. 1A, C, 2A and 3; ultrasound transducer is outside of patient therefore that is minimum invasive or non-invasive).
addressing claim 47, wherein the plurality of ultrasonic transducer elements is acoustically coupled to the patient via a fluid filled cavity (see [0065]).
addressing claim 50, wherein the aperture is sized and configured with the energy profile to saturate a treatment volume to ensure treatment of the targeted lesion of cancer cells and extraneous cancer cells located within the tissue of the patient by activating the sonosensitizer located within the tissue of the patient, and wherein each of the ultrasonic transducer elements in the array comprises a dimension in a range of 0.5 mm to 20 mm (see Fig. 1A and C; broad ultrasound field to treat target site and surrounding tissue; Kajitani discloses phase randomization (see [0018]; Liu disclose sonosensitizer (see claim 1)).
addressing claim 51, wherein the array comprises a rectangular subarray geometry, wherein the plurality of ultrasonic transducer elements comprises between 128 to 1024 ultrasonic transducer elements, and wherein the plurality of ultrasonic transducer elements are driven at frequencies in a range of 20 kHz to 2 MHz (see [0042] and [0044]; rectangular or ring or annular or any shape is just an obvious designer choice that only require routine skill in the art; as see in applicant’s Figs. 6-8, rings and rectangular sub-array).
addressing claim 53, wherein the plurality of piezoelectric ultrasonic transducer elements generate the incoherent acoustic pressure field through a patient interface configured to acoustically couple the transducer to the patient, and wherein the patient interface comprises at least one of a cap and a flexible shell (see abstract and Fig. 2A; Hynunen discloses transducer array elements and flexible cap shell; Kajitani discloses drive signal with random phase that create incoherent acoustic pressure field (see [0018])).
addressing claim 57, wherein the plurality of piezoelectric ultrasonic transducer elements are driven by a plurality of signals to generate the incoherent acoustic pressure field, and wherein the plurality of signals comprises at least one selected from the group consisting of: a sine wave, a rectangular pulse, and a triangular pulse (see [0044]; drive signals are usually sinewave; sometime square/rectangular wave; Kajitani discloses drive signal with random phase that create incoherent acoustic pressure field (see [0018])).
addressing claim 58, wherein the plurality of signals comprises one or more frequencies in a range of 650 kHz to 1 MHz (see [0109]).
Addressing claims 43 and 56, Liu discloses:
addressing claim 43, wherein the sonosensitizer is configured for oral administration to the patient (see claim 1; Liu does not disclose administer sonosensitizer by oral or injection; however, this is just designer choice that only require routine skill in the art; Liu is capable of administer sonosensitizer orally).
addressing claim 56, wherein the sonosensitizer comprises a porphyrin IX (PpIX) (see [0006]).
Addressing claims 40 and 52, Lacoste discloses:
addressing claim 40, configured to activate a sonosensitizer without focusing ultrasound (see Fig. 21, [0041], [0056], [0128] and [0136]; planar wave is not focus; Liu discloses sonosensitizer (see [0006], [0033], [0044] and [0059])).
addressing claim 52, a cooling system configured to remove excess heat from the patient, wherein the cooling system comprises a flexible cavity for circulation of a cooling fluid, and wherein the incoherent acoustic pressure field is administered non-invasively (see Fig. 21, [0041], [0056], [0128] and [0136]; circulate cooling fluid in balloon which is a flexible cavity; Kajitani discloses phase randomization or incoherent (see [0018]).
5. Claims 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Hynynen et al. (US 2018/0177491 (provided in the IDS)), in view of Liu et al. (US 2018/0207447 (provided in the IDS)), further in view of Lacoste et al. (US 2005/0085726 (provided in the IDS)), Kajitani et al. (US 2010/0228523) and Vrba et al. (US 2019/0069949).
6. Addressing claims 54-55, Hynynen does not explicitly disclose a pump, valve and pressure sensor. Vrba explicitly discloses a pump, valve and pressure sensor (see [0294-0295], [0299], [0311], [0610] and [0683]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hynynen to have a pump because this allows the system to circulate cooling fluid to cool the transducer/electrode and tissue (see [0295]).
Response to Arguments
Applicant's arguments filed 08/24/26 have been fully considered but they are not persuasive. Applicant argues applicant does not acquiesce to the Examiner's rejections and/or characterization of the cited art. Applicant argues applicant traverses each of these claim rejections and maintains that the previously pending claims are in condition for allowance to expedite examination of this application, Applicant has amended independent claims 1 and 6 to further clarify the claimed subject matter. Applicant made minor amendment to the independent claims that does not change the scope of the claims. Applicant added new claims 53-58 are being addressed above. There is no new argument and examiner maintains the rejection. Examiner had previously addressed applicant’s argument in the previous rejection. Please see the previous rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
Prosecution Insights