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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/25 has been entered.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-8, 12-16, 18 and 20 of copending Application No. 18/215,525. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claiming the same ultrasound system for sonodynamic therapy to treat patient with sonosensitizer.
Claims 2-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 9, 16, 21-22, 28, 32-33, 35-41, 45, 47 and 49-52 of copending Application No. 18/215,515. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claiming the same ultrasound system for sonodynamic therapy to treat patient with sonosensitizer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,097,393. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claiming the same ultrasound system for sonodynamic therapy to treat patient with sonosensitizer.
Claims 2-21 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 system of the current application perform the method of the patented application.
Claims 2-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,872,414. Although the claims at issue are not identical, they are not patentably distinct from each other because the system of the current application perform the method of the patented application.
Claims 2-21 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 system of the current application perform the method of the patented application.
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 2-8, 9-13 and 14-21 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 (provided in the IDS)).
Addressing claims 2 and 17, Hynynen discloses an ultrasound system for non-invasive sonodynamic therapy with acoustic waves to treat cells, the ultrasound system comprising:
a controller, a patient interface, and a cooling system, wherein the patient interface comprises an array of piezoelectric ultrasound transducer elements, wherein the array of piezoelectric ultrasound transducer elements is coupled to the controller (see [0011], [0063-0064] and [0136]; operating processor),
wherein the array of piezoelectric ultrasound transducer elements is configured to be driven by the controller with a signal at a frequency to produce acoustic waves to produce an acoustic intensity (see abstract, Fig. 2A, [0046] and [0115]),
wherein each of the piezoelectric ultrasound transducer elements is configured to emit the acoustic waves through a skin surface of the patient (see Figs. 1C and 2A),
wherein the patient interface is configured to acoustically couple the array of piezoelectric ultrasound transducers to the skin surface (see [0063], Figs. 2A and 3),
wherein the patient interface is configured for conforming to the skin surface (see [0067]),
wherein the patient interface is configured to acoustically couple the array of piezoelectric ultrasound transducers to the skin surface (see [0063], [0067] and Figs. 2A),
an ultrasound system for non-invasive sonodynamic therapy with acoustic waves to treat cells, the ultrasound system comprising: a patient interface, an array of piezoelectric ultrasound transducer elements, and a controller (see [0011], [0063-0064] and [0136]; operating processor),
wherein each of the piezoelectric ultrasound transducer elements comprises an emitting surface configured to emit ultrasound waves, wherein the array of piezoelectric ultrasound transducer elements is coupled to the controller (see Fig. 1C, [0011], [0063-0064] and [0136]),
wherein the array of piezoelectric ultrasound transducer elements is configured to be driven by the controller with a signal at a frequency to produce acoustic waves to produce an acoustic intensity intensity (see abstract, Fig. 2A, [0046] and [0115]),
wherein each of the piezoelectric ultrasound transducer elements is configured to emit the acoustic waves through a skin surface of the patient (see Figs. 1C and 2A),
wherein the patient interface is configured to acoustically couple the array of piezoelectric ultrasound transducers to the skin surface (see [0063], [0067] and Figs. 2A),
wherein the patient interface is configured for conforming to the patient at the skin surface (see [0067]).
Hynynen does not disclose sonosensitizer. Liu discloses activate sonosensitizer to treat tumor cells in a 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 to treat tumor cells in a patient as taught by Liu because this provides effective treatment against cancer cells (see [0044] and [0059]).
Hynynen does not disclose intensity in a range of 0.1 W/cm2 to 50 W/cm2 and wherein the acoustic waves are planar or defocused, wherein the acoustic waves are planar or defocused, wherein the cooling system is configured to circulate a fluid to reduce heat at the patient interface and wherein the cooling system comprises one or more cooling channels connected to an inlet and an outlet configured to remove heat from the skin surface. Lacoste discloses intensity in a range of 0.1 W/cm2 to 50 W/cm2 and wherein the acoustic waves are planar or defocused, wherein the cooling system is configured to circulate a fluid to reduce heat at the patient interface and wherein the cooling system comprises one or more cooling channels connected to an inlet and an outlet configured to remove heat from the skin surface (see abstract, [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 have intensity in a range of 0.1 W/cm2 to 50 W/cm2 and wherein the acoustic waves are planar or defocused, wherein the acoustic waves are planar or defocused, wherein the cooling system is configured to circulate a fluid to reduce heat at the patient interface and wherein the cooling system comprises one or more cooling channels connected to an inlet and an outlet configured to remove heat from the skin surface as taught by Lacoste because planar wave provides a uniform and deep diffusion of sound energy (see [0136]).
Hynynen does not disclose phase randomization acoustic wave for the array different elements. Kajitani discloses phase randomization acoustic wave (see [0018]; can only be intra or inter pulse; randomization of acoustic wave provides broad treatment). 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 acoustic wave as taught by Kajitani because this improves treatment by improve correlativity (see [0036]). Hynynen discloses array of different transducer elements and each signal control one transducer element and Kajitani disclose a signal that control a transducer element to produce phase randomization therefore Hynynen in view of Kajitani discloses signals that control each transducer elements in the array to produce phase randomization. Each signal control each transducer element in the array. The specification does not disclose randomized phases over different piezoelectric ultrasound transducer elements. Specification paragraph [0126] discloses “the processing unit 1102 may be configured to control phased randomization of acoustical signals”. Examiner interpreted the claim limitation as having a transducer array with many different elements and each transducer element is control by a signal then configured each signal to produce phase randomization.
Addressing claims 3-5, 7-8, 10, 12, 14, 16 and 20-21, Hynynen discloses:
addressing claim 3, patient interface comprises a flexible membrane, wherein the flexible membrane is configured to be placed between the array of piezoelectric ultrasound transducer elements and the skin surface, wherein the flexible membrane is configured for conforming to the skin surface of the patient, and wherein the flexible membrane is configured to acoustically couple the array of piezoelectric ultrasound transducer elements to the skin surface of the patient (see [0065]).
addressing claim 4, wherein the cooling system comprises a cap configured to remove heat from the patient with the one or more cooling channels (see [0065]; elastic membrane is the cap with coupling fluid that could also serve as cooling system; see Lacoste’s abstract and [0029]; inlet and outlet opening for channels; Lacoste discloses coupling fluid serve as cooling fluid).
addressing claim 5, the patient interface further comprises a shell, wherein the array of piezoelectric ultrasound transducer elements is fixed to the shell, and wherein the shell is made of a rigid material or a flexible material (see Fig. 2A; element 110).
addressing claim 7, wherein the signal is a duty cycle modulated drive signal configured to drive each of the piezoelectric ultrasound transducer elements of the array of piezoelectric ultrasound transducer elements with one or more duty cycles to produce a duty cycle modulated acoustic wave (see [0047] and [0141]).
addressing claim 8, wherein the signal is a frequency modulated drive signal configured to drive each of the piezoelectric ultrasound transducer elements of the array of piezoelectric ultrasound transducer elements with one or more frequencies to produce a frequency modulated acoustic wave (see [0100] and [0109]).
addressing claim 10, wherein the non-invasive sonodynamic therapy lasts for 30 minutes to an hour, or wherein the frequency is in a range of 650 kHz to 2 MHz (see [0109] and Liu’s paragraphs [0010-0012]).
addressing claim 12, wherein the array of piezoelectric ultrasound transducer elements comprises a grid of elements, wherein the acoustic intensity is in a range of 0.2 W/cm2 to 20 W/cm2 to activate the sonosensitizer, and wherein the sonosensitizer becomes cytotoxic upon exposure to the acoustic waves (see Fig. 2A and [0105]; array of transducer arrange on the shell 110 for simulation with grid method involve grid transducer elements; In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice); sonosensitizer becomes cytotoxic is a result of ultrasound treatment and not a structure; Liu discloses treat sonosensitizer with ultrasound (see Liu’s paragraph [0006] and [0024])).
addressing claim 14, wherein the signal is a packet comprising a predetermined number of cycles per packet to produce a packet of acoustic waves, and wherein the packet is made of a repeating signal comprising at least one selected from the group consisting of: a sine wave, a rectangular pulse, and a triangular pulse (see Fig. 14, sine wave).
addressing claim 16, wherein the signal is configured to generate a high temporal peak acoustic intensity with a low temporal average acoustic intensity to activate the sonosensitizer with the acoustic waves (see [0004] and [0047]; low duty cycle which result in a low temporal average acoustic intensity; Liu disclose sonosensitizer).
addressing claim 20, wherein the frequency is in a range of 20 kHz to 2 MHz, and the patient interface comprises at least one of a cap, a rigid shell, or a flexible shell (see Fig. 2A and [0109]; element 110).
addressing claim 21, wherein the signal is selected from the group consisting of: a phase modulated drive signal to produce phase modulated acoustic waves, a pulse signal to produce pulsed acoustic waves, a duty cycle modulated drive signal to produce duty cycle modulated acoustic waves, and a frequency modulated drive signal to produce frequency modulated acoustic waves (see [0047], [0100], [0109] and [0141]).
Addressing claims 6 and 18-19, Lacoste discloses:
addressing 6, wherein the signal is configured to minimize a spatial variation of the acoustic intensity in a brain with the tumor cells of the patient (see Fig. 21, [0041], [0056], [0128] and [0136]; planar wave minimize a spatial variation of an acoustic intensity in the treatment region).
addressing claim 18, wherein the signal is configured to minimize a spatial variation of the acoustic intensity in the tumor cells of the patient with a modulated wave parameter configured to emit a plurality of the ultrasound waves at the acoustic intensity in a range of 0.1 W/cm2 to 50 W/cm2 (see Fig. 21, [0041], [0056], [0128] and [0136]; planar wave minimize a spatial variation of an acoustic intensity in the treatment region; Hynynen discloses modulating frequency and duty cycle).
addressing claim 19, wherein the signal is modulated by a duty cycle modulated drive signal configured to produce a duty cycle modulated pulses sequence, wherein the duty cycle modulated drive signal comprises a phase configured to drive each of the piezoelectric ultrasound transducer elements to produce a high temporal peak acoustic intensity with a low temporal average acoustic intensity when activating the sonosensitizer (see [0128] and [0136]; high intensity therefore the temporal peak is high acoustic intensity; Hynynen discloses vary and low duty cycle which result in a low temporal average acoustic intensity (see [0004], [0047] and [0059]).
Addressing claims 11 and 15, Liu discloses:
addressing claim 11, wherein the sonosensitizer comprises 5-aminolevulinic acid and/or protoporphyrin IX (see [0006], [0033] and [0044]).
addressing claim 15, wherein the acoustic waves produce a sonomechanical or sonoluminescence effect, which in turn activates protoporphyrin IX to produce reactive oxygen species (ROS) to thereby cause tumor cell death, wherein said sonomechanical or sonoluminescence effect is optionally caused through bubble formation and collapse (see [0030] and [0044-0045]; ultrasound causing bubble formation and collapse (see Hynynen’s paragraph [0100]; cavitation)).
Addressing claims 9 and 13, Hynynen does not disclose phase randomization acoustic wave. Kajitani discloses phase randomization acoustic wave (see [0018]; can only be intra or inter pulse; randomization of acoustic wave provides broad treatment). Hynynen discloses array with many driving signals to drive many transducer elements. Kajitani discloses a random phase driving signal. Hynynen in view of Kajitani disclose randomized phases over different piezoelectric transducer element.
Response to Arguments
Applicant's arguments filed 11/24/25 have been fully considered but they are not persuasive. Applicant argues it would not be obvious to combine Kajitani with Hynynen because Hynynen teaches away from randomizing the phases of the ultrasound waves. Applicant argues the drive signal taught by Kajitani renders the system of Hynynen inoperable with respect to its intended mode of operation. Applicant’s argument is not persuasive because Hynynen does not teaches away from randomizing the phases of the ultrasound waves. Hynynen teaches the timing of the pulses (and/or phase) emitted by each transcranial ultrasound transducer array element 100 is controlled in order to generate constructive interference at or within a target region residing within the brain. This is not teaching away from randomizing the phases of the ultrasound waves. It is possible to randomize ultrasound phase to have ultrasound beams focused within the skull (focus range or treatment region) and diverging with the brain (see abstract, [0022], Fig. 1A and 1C). As see in applicant’s specification paragraph [0115] random phase constructive interference at random location within the treatment region. The drive signal taught by Kajitani does not renders the system of Hynynen inoperable with respect to its intended mode of operation. Applicant argues examiner statement “It is possible to randomize ultrasound phase to focus on a target” contradicts with the explanation that focusing is achieved “by manipulating [controlling] the phase of these individual elements”. Applicant’s argument is not persuasive because Hynynen teaches control the timing of pulses or phase, but he does not teach don’t modulate the ultrasound waves with randomized phases. Hynynen disclose nothing about randomization of phase. Hight intense focus and constructive interference can not happen at a specific target using randomize phase; however, focusing range (treatment region) can be achieve with randomize phase which would produce constructive interference at random location within treatment region (see Hynynen’s Fig. 1A; treatment region 50; see applicant’s specification paragraph [0115]). Hynynen focus range in Fig. 1A is wide, one can have random phase and produce overlap and constructive region within that range. Teaching away mean not to do a certain way, but Hynynen never disclose not to use random phase. Hynynen teaches the timing of the pulses (and/or phase) emitted by each transcranial ultrasound transducer array element 100 is controlled in order to generate constructive interference at or within a target region residing within the brain. Constructive interference can happen with random phase at random location within the target region. Hynynen also teaches each transducer element emit individual defocus beam (see [0022]). Hynynen is not just focus on control and focus the beams at one specific target. There are many embodiments discloses by Hynynen. Applicant argues Hynynen in view of Kajitani would still provide the same randomized signal to all transducers of the transcranial ultrasound transducer array by Hynynen, which is different from plurality of signals with randomized phases over different piezoelectric element. Applicant’s argument is not persuasive because this is not in the specification. The specification does not disclose that each signal is randomize and different from each other. Kajitani discloses a randomize signal because he does not disclose an array which has many signals to control many elements. Hynynen discloses an array with many driving signals therefore Hynynen in view of Kajitani would have many randomize driving signals and not the same randomized signal to all transducer elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. A random phased array device for delivery of high intensity focused ultrasound (see abstract, random phase array can focus on a target).
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