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).
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 2-15 and 17-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 16, 21-22, 32-33, 35-41, 43, 45, 47 and 50-52 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 2-15 and 17-21 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 they both claiming the same ultrasound system for sonodynamic therapy to treat patient with sonosensitizer.
Claims 2-15 and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,097,392. 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 2-15 and 17-21 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 system of the current application perform the method of the patented application.
Claims 2-15 and 17-21 are 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 2-15 and 17-21 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 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 2-15 and 17-21 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)); 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, a cooling system, an array of piezoelectric ultrasound transducer elements, wherein the array of piezoelectric ultrasound transducer elements is electronically 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 the frequency is in range of 650 kHz to 2 Mhz (see [0109]; 1 mhz),
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 (see abstract, Fig. 2A, [0046] and [0115]),
wherein the frequency is in range of 650 kHz to 2 Mhz (see [0109]; 1 mhz),
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]),
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 Fig. 14, sine wave).
Hynynen does not disclose sonosensitizer. Liu discloses activate sonosensitizer to treat tumor cells in a patient (see [0006], [0033, [0044] and [0059]; Liu also disclose ultrasound frequency of 1-2 mhz (see [0010])). 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 of up 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 of up 50 to 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 of up 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.
Drive transducer at high peak and low average intensity is a designer choice that only require routine skill in the art. Hynynen explicitly discloses a low temporal average acoustic intensity (see [0004] and [0047]; low duty cycle result in a low temporal average acoustic intensity; in ultrasound, a low duty cycle does produce a lower temporal average acoustic intensity). Hynynen is capable of drive transducer at high temporal peak since he controls the duty cycle. This is an obvious feature that only require routine skill in the art.
Addressing claims 3-5, 7-8, 10, 12, 14 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 via a fluid (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 (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, 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 less than or equal to 1 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 (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 [0004], [0047] and [0059]; drive transducer at high peak and low average intensity is a designer choice that only require routine skill in the art. Hynynen discloses a low temporal average acoustic intensity; low duty cycle result in a low temporal average acoustic intensity; in ultrasound, a low duty cycle does produce a lower temporal average acoustic intensity; Hynynen is capable of drive transducer at high temporal peak; this only require routine skill in the art).
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 05/18/65 have been fully considered but they are not persuasive. Applicant argues the references do not disclose high temporal peak, acoustic intensity of up to 50 W/cm2, frequency is in range of 650 kHz to 2 Mhz and signals comprises square wave. Applicant’s argument is not persuasive because Hynynen discloses 1 Mhz and signals of square wave, Lacoste discloses intensity of 18 W/cm2. Up to does not require the system to produce at 50 W/cm2. The claim is claiming a system that produce any intensity level up to 50 W/cm2. Regarding high temporal peak this is a designer choice that only require routine skill in the art. Hynynen system is capable of having high temporal peak and low temporal average acoustic intensity. Since Hynynen explicitly discloses low cycle, this would result in low temporal average acoustic intensity. As see in the prior art made of record and not relied upon is considered pertinent to applicant's disclosure below high temporal peak is well-known in the field and within one ordinary skill in the art. Also as see in applicant’s paragraph [0114], control the duty cycle to drive transducer at high temporal peak acoustic intensity of ultrasonic acoustic waves with low temporal average acoustic intensity.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2010/0092424 (see [0041]; spatial peak temporal peak intensities is a subset of high temporal peak).
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.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
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