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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Claim 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 11-16 and 25-29 of U.S. Patent No. 11,806,553. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are just a different order, mixing and broader of claims 1-6, 8, 11-16 and 25-29 of patent US 11,806,553. Claims 1-6, 8, 11-16 and 25-29 of patent US 11,806,553 has all the limitations in the current claims 2-21.
Current Application US 11,806,553
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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 2-3 and 5-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa et al. (US 2008/0195003), in view of Nagasaki (US 4,945,915), further in view of Nakamura et al. (US 2017/0263846) and Maxwell et al. (US 2016/0287909).
3. Addressing claim 2, Sliwa discloses an ultrasound system for generating focused ultrasound and performing histotripsy, the ultrasound system comprising:
an ultrasound transducer assembly comprising: a piezoelectric layer (see [0053]);
an acoustic lens having a proximal surface and a curved distal surface, wherein the proximal surface is attached to the piezoelectric layer (see Figs. 1, 5 and [0050]).
Sliwa does not disclose wherein an intermediate layer is provided between the acoustic lens and the piezoelectric layer, wherein an acoustic impedance of the intermediate layer is less than the acoustic impedance of the acoustic lens and the acoustic impedance of the piezoelectric layer. In the same field as endeavor, Nakamura discloses wherein an intermediate layer is provided between the acoustic lens and the piezoelectric layer, wherein an acoustic impedance of the intermediate layer is less than the acoustic impedance of the acoustic lens and the acoustic impedance of the piezoelectric layer (see [0018]; intermediate layer impedance less than lens therefore also less than emitter). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sliwa to have wherein an intermediate layer is provided between the acoustic lens and the piezoelectric layer, wherein an acoustic impedance of the intermediate layer is less than the acoustic impedance of the acoustic lens and the acoustic impedance of the piezoelectric layer as taught by Nakamura because this improve the device by improving ultrasound transmission (see [0020]).
Sliwa discloses layers coating the curved distal surface of the acoustic lens (see Fig. 4, elements 22 and 34) that help provide transmission of ultrasound to tissue which is impedance matching. However, Sliwa does not disclose the term impedance matching for these layers. In the same field of endeavor, which is ultrasound Nagasaki explicitly discloses an acoustic impedance matching layer coating the curved distal surface of the acoustic lens (see Fig. 1 and col. 3, lines 20-25; impedance 5a coated on lens 5; Nagasaki explicitly discloses the term “acoustic impedance matching layer”). Examiner only relies on Nagasaki to explicitly disclose the layer label as “acoustic impedance matching layer”. Water and coupling gel act as an impedance matching layer but are not called impedance matching layer. Element 22 act as an impedance matching layer. Examiner only provide Nagasaki as evidence that having an acoustic impedance matching layer on a lens is well-known and older than Sliwa. Also, Nagasaki impedance matching layer perform the same function as element 22 discloses by Sliwa which is improve transmission of ultrasound. Nagasaki provides evidence for an explanation that element 22 is a form of impedance matching layer.
Sliwa does not disclose driver circuitry operably connected with the ultrasound transducer assembly, wherein the driver circuitry is configured to deliver electrical pulses with a voltage and operating frequency configured to generate ultrasound pulses capable of producing cavitation within water. In the same field of endeavor, Maxwell discloses driver circuitry operably connected with the ultrasound transducer assembly, wherein the driver circuitry is configured to deliver electrical pulses with a voltage and operating frequency configured to generate ultrasound pulses capable of producing cavitation within water (see Fig. 9, [0084] and [0086-0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sliwa to have driver circuitry operably connected with the ultrasound transducer assembly, wherein the driver circuitry is configured to deliver electrical pulses with a voltage and operating frequency configured to generate ultrasound pulses capable of producing cavitation within water as taught by Maxwell because this allow the device to perform therapy/treatment on tissue (see abstract).
4. Addressing claims 3, 5-12 and 16, Sliwa discloses:
addressing claim 3, wherein an acoustic impedance of the piezoelectric layer resides within plus or minus 40% of an acoustic impedance of the acoustic lens (see claims 20-21; 1.5 mrayl different out of 12-35 mrayl is within plus or minus 40% different).
addressing claim 5, wherein the acoustic lens comprises aluminum (see [0115]).
addressing claim 6, wherein the acoustic lens is formed from an aluminum alloy (see [0115]).
addressing claim 7, wherein the acoustic lens comprises at least 85% aluminum by weight (see [0018] and [0115]; acoustic lens of 85% aluminum is a designer choice for a specific application; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and only require routine skill in the art).
addressing claim 8, wherein the curved distal surface of the acoustic lens is non-spherical (see Fig. 1).
addressing claim 9, wherein the curved distal surface of the acoustic lens is elliptical (see Fig. 1).
addressing claim 10, wherein the acoustic impedance matching layer is formed from a polymer compatible with chemical vapor deposition (see [0084]).
addressing claim 11, wherein the acoustic impedance matching layer comprises polyimide (see [0081]; Sliwa does not disclose a specific polymer; however, using any polymer is a designer choice that only require routine skill in the art).
addressing claim 12, wherein the acoustic impedance matching layer comprises a fluoropolymer (see [0081]; Sliwa does not disclose a specific polymer; however, using any polymer is a designer choice that only require routine skill in the art).
addressing claim 16, wherein the intermediate layer is an adhesive layer bonding the acoustic lens to the piezoelectric layer (see [0016] and [0027]; 28 is intermediate layer; Nakamura also discloses intermediate layer).
Addressing claims 13-15, Maxwell discloses:
addressing claim 13, an integrated ultrasound imaging transducer (see Figs. 1, 3-4, [0045] and [0049]; 135 is imaging transducer).
addressing claim 14, wherein the integrated ultrasound imaging transducer is coaxially supported relative to an axis of the acoustic lens within an aperture defined within the acoustic lens (see Figs. 1, 3-4, [0045] and [0049]).
addressing claim 15, wherein a distal end of the integrated ultrasound imaging transducer is recessed within an aperture defined within the acoustic lens (see Figs. 1, 3-4, [0045] and [0049]).
Addressing claims 17-21, Nakamura discloses:
addressing claim 17, wherein a thickness of the intermediate layer is configured to effect an increase in peak emitted acoustic power in an acoustic power spectrum of the ultrasound system by a factor ranging between two and three relative to an equivalent ultrasound system absent of the intermediate layer (see 0018-0019] and [0140]; the frequency; power spectrum peak, intensity peak depend on the thickness of intermediate layer is a natural function of the intermediate layer and not an additional structure to the claim; the thickness of intermediate layer is a designer choice; Nakamura discloses the thickness of intermediate layer could be adjusted (see [0140]); the intermediate layer effect frequency, power, intensity depend of its size and thickness; size and thickness is adjustable as disclose by Nakamura and it is designer choice depend on user need for power, frequency, intensity, etc.).
addressing claim 18, wherein a thickness of the intermediate layer is configured to effect an increase in peak efficiency in an acoustic efficiency spectrum of the ultrasound system between 20% and 40% relative to an equivalent ultrasound system absent of the intermediate layer (see 0018-0019] and [0140]; the frequency; power spectrum peak, intensity peak depend on the thickness of intermediate layer is a natural function of the intermediate layer and not an additional structure to the claim; the thickness of intermediate layer is a designer choice; Nakamura discloses the thickness of intermediate layer could be adjusted (see [0140]); the intermediate layer effect frequency, power, intensity depend of its size and thickness; size and thickness is adjustable as disclose by Nakamura and it is designer choice depend on user need for power, frequency, intensity, etc.).
addressing claim 19, wherein the operating frequency corresponds to a frequency associated with a peak in an acoustic power spectrum of the ultrasound transducer assembly (see [0018-0019] and [0140]; the frequency; power spectrum peak, intensity peak depend on the thickness of intermediate layer is a natural function of the intermediate layer and not an additional structure to the claim; the thickness of intermediate layer is a designer choice; Nakamura discloses the thickness of intermediate layer could be adjusted (see [0140]); the intermediate layer effect frequency, power, intensity depend of its size and thickness; size and thickness is adjustable as disclose by Nakamura and it is designer choice depend on user need for power, frequency, intensity, etc.).
addressing claim 20, wherein an intensity of a peak is also dependent on the thickness of the intermediate layer (see [0140]; this is an inherent nature of the intermediate layer; the frequency; power spectrum peak, intensity peak depend on the thickness of intermediate layer is a function of the intermediate layer and not a structure; the thickness of intermediate layer is a designer choice; Nakamura discloses the thickness of intermediate layer could be adjusted (see [0140]); the intermediate layer effect frequency, power, intensity depend of its size and thickness; size and thickness is adjustable as disclose by Nakamura and it is designer choice depend on user need for power, frequency, intensity, etc.).
addressing claim 21, wherein the acoustic impedance matching layer is a quarter wave matching layer corresponding to the frequency associated with a peak in the acoustic power spectrum (see 0018-0019] and [0140]; λ/4 is quarter wave matching; the frequency; power spectrum peak, intensity peak depend on the thickness of intermediate layer is natural function of the intermediate layer and not an additional structure to the claim; the thickness of intermediate layer is a designer choice; Nakamura discloses the thickness of intermediate layer could be adjusted (see [0140]); the intermediate layer effect frequency, power, intensity depend of its size and thickness; its size and thickness is adjustable as disclose by Nakamura and it is designer choice depend on user need for power, frequency, intensity, etc.)).
5. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sliwa et al. (US 2008/0195003), in view of Nagasaki (US 4,945,915), further in view of Nakamura et al. (US 2017/0263846), Maxwell et al. (US 2016/0287909) and Stearns (US 10,325,768).
6. Addressing claims 8-9, Sliwa does not disclose wherein an f-number of the acoustic lens is less than two. However, this is a designer choice that only require routine skill in the art. In the same field of endeavor, Stearns explicitly discloses wherein an f-number of the acoustic lens is less than two (see col. 7, lines 27-30). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sliwa to have wherein an f-number of the acoustic lens is less than two as taught by Stearn because this provide good focus (see col. 7, lines 27-30).
Conclusion
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797
