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 .
Claim Objections
Claims 1, 19, and 21 are objected to because of the following informalities:
Claim 1: lines 7-9 should read “wherein the plurality of piezoelectric transducers is arranged electrically in parallel”.
Claim 19: in the last line, “comprising light absorption layer” should read “comprising a light absorption layer”.
Claim 21: since it is their first recitation, “CNP” and “PDMS” should be spelled out in claim 21 (as “carbon nanoparticles” and “polydimethylsiloxane” b). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 13, 16, and 23 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Visuri et al. (US 6,484,052). Visuri discloses a catheter-implemented transducer device for intravascular sonification comprising a catheter (20) defining a longitudinal axis and having a proximal end and a distal end, an optical fiber (24) configured to direct laser light along the longitudinal axis of the catheter, a laser generated focused ultrasound lens (“LGFU lens”) (41/45/50; figs. 3a-3c) on the distal end of the catheter (fig. 2), and a supply conduit arranged along the catheter, the supply conduit configured to supply contrast agents from the distal end of the catheter (note: “configured to supply…” is a recitation of intended use; because the conduit is capable of being used to supply contrast agents, it meets this functional limitation). The laser-generated focused ultrasound lens (41/45/50, noting the tip focuses the emitted acoustic wave and is thus considered a lens) is configured to absorb the laser light from the optical fiber, thermally expand, and generate a shock wave of pressure to cavitate contrast agents (see col. 4, ll. 6-32 and col. 6, ll. 13-39).
Regarding claim 16, the supply conduit is further configured to deliver a lytic agent, noting that the supply conduit is merely a hollow tube through which media may be introduced into the body.
Regarding claim 23, because the supply conduit of Visuri is capable of delivering contrast agents that comprise microbubble contrast agents, it meets this recitation of intended use.
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.
Claim(s) 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Visuri in view of Guo et al. (US 2014/0112107). Visuri discloses the invention substantially as stated above but does not expressly disclose that the LGFU is a plano optical lens, a concave optical lens, or that it includes a laser ultrasound transduction layer as claimed.
Guo discloses another device for cavitation-based ultrasound therapy, the device including an LGFU lens. According to Guo and regarding instant claims 17-19, the LGFU lens comprises a plano-concave fused silica lens with a laser ultrasound transduction layer which absorbs laser light and thus forms a light absorption layer ([0015], [0100], [0101]; abstract). Regarding claim 21, the laser ultrasound transduction layer comprising a composite film of CNP (carbon nano particle, carbon nanotubes in particular) and PDMS ([0015]). Regarding claim 20, the composite film thermally expands ([0009]) when the light energy is directed to the LGFU. Regarding claim 22, Guo further teaches that the LGFU lens has a focal spot of less than 2 mm in an axial direction and less than 1 mm in a lateral direction ([0012]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Visuri to include an LGFU lens that has a plano-concave fused silica lens with a laser ultrasound transduction layer comprising a composite film of CNP and PDMS, the lens having a focal spot of less than 2mm in an axial direction and less than 1mm in a lateral direction as taught by Guo, in order to provide a highly efficient transmitter that provides tightly focused ultrasound, thereby minimizing possible damage to the surrounding area ([0005], [0007], [0057])
Claim(s) 14, 15, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Visuri in view of Hossack et al. (US 2012/0209116). Visuri discloses the invention substantially as stated above including an LGFU lens, but fails to disclose that the device further comprises an ultrasonic transducer arrangement disposed about the distal end of the catheter.
Hossack discloses another catheter used to deliver acoustic energy to surrounding tissue. Hossack teaches that the catheter may comprise a plurality of ultrasonic transducer arrangements (1236, 1237, 1238; fig. 12a) disposed about the distal end of the catheter, at least one of which is configured to emit ultrasonic energy with a frequency of less than 3 MHz ([0175]; [0211]). Transducer arrangement 1236 allows for bursting of microbubbles, transducer arrangement 1237 allows for imaging, and transducer arrangement 1238 transports microbubbles downstream ([0211]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Visuri to include a plurality of ultrasonic transducer assemblies on the distal end of the catheter, at least one of which emits ultrasonic energy with a frequency of less than 3 MHz ([0175]) as taught by Hossack in order to provide a plurality of treatments including imaging, cavitation, and advancement of microbubbles as taught by Hossack.
Claim(s) 1, 4-5, and 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossack et al. (US 2012/0209116) in view of Dayton et al. (US 2015/0141833). Hossack discloses a catheter-implemented transducer device for intravascular sonification comprising a catheter defining a longitudinal axis and having opposed proximal and distal ends, an ultrasonic transducer arrangement (e.g., fig. 4; LF/HF) disposed about the distal end of the catheter, the ultrasonic transducer arrangement comprising a plurality of piezoelectric transducers ([0197]), and a supply conduit (433; fig. 4) arranged along the catheter, the supply conduit configured to supply contrast agents from the distal end of the catheter (fig. 4; [0120]), wherein the ultrasonic transducer arrangement is configured to generate pressure to cavitate the contrast agents (see fig. 4). Hossack fails to disclose that the plurality of piezoelectric transducers is arranged electrically in parallel and mechanically in series.
Dayton discloses another catheter having piezoelectric transducers used to produce ultrasonic vibrations. Dayton discloses that the multilayer piezoelectric transducers are stacked mechanically in series and electrically connected in parallel to increase capacitance thereof such that, in transmit mode, the power output may be maximized while the mechanical resistance is minimized ([0040]). It would have been obvious to have modified the prior art of Hossack to construct the piezoelectric transducers such that they are arranged mechanically in series and electrically in parallel as taught by Dayton in order to maximize power output while minimizing mechanical resistance.
Regarding claim 4, the ultrasonic transducer arrangement is configured to emit ultrasonic energy with a frequency of less than 1MHz (see [0321] of Hossack, where “about” 1MHz is considered to include values less than 1 MHz).
Regarding claim 5, the supply conduit is further configured to deliver a lytic agent (streptokinase – [0313] of Hossack).
Regarding claim 7, the device further comprises a multi-layer stacked longitudinal mode resonator. Consider any one of the LF/HF stacks in fig. 4, which are considered resonators, and vibrate in the longitudinal direction of the resonator itself, noting direction of wave propagation. See [0175] and fig. 4 of Hossack.
Regarding claim 9, the ultrasonic transducer arrangement has a resonance frequency of less than 1 MHz ([0175] of Hossack, noting “about” 1 MHz is considered to include values less than 1 MHz).
Regarding claim 10, the ultrasonic transducer arrangement is configured to operate at multiple frequencies simultaneously ([0119]; see also [0163], wherein arrangement comprises both a high frequency and low frequency transducer components; fig. 3c; [0175]).
Regarding claim 11, the contrast agents comprise microbubble contrast agents ([0178]-[0179] of Hossack).
Regarding claim 12, the device of Hossack further comprises a plurality of ultrasonic transducer arrangements on the distal end of the catheter (consider each arrangement of HF/LF in fig. 3c and 4; see also fig. 12A, noting transducer arrangements 1238, 1237, 1236 of Hossack).
Regarding claim 8, Hossack in view of Dayton does not expressly disclose that the ultrasonic transducer arrangement has a thickness greater than 0.5mm. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Hossack in view of Dayton to size the ultrasonic transducer arrangement such that it has a thickness greater than 0.5mm since it has 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 dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the prior art ultrasonic transducer arrangement of Hossack is capable of generating pressure to cavitate the contrast agents and thus a device having the claimed dimensions would not perform differently than that of Hossack as modified by Dayton.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossack in view of Dayton as applied to claim 1 above and further in view of Brisken (US 6,464,680). Hossack in view of Dayton discloses the invention substantially as stated above except for the ultrasonic transducer arrangement having an acoustic output with a mechanical index of greater than 0.3.
Brisken ‘680 discloses another catheter (42; fig. 3a) having an ultrasonic transducer (30) used to enhance cellular absorption of a substance delivered to a target region in a patient’s body. Brisken discloses that the transducer should have a mechanical index of greater than 0.3 (MI of 0.3 to 15 according to Brisken) in order to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents (col. 6, ll. 4-13). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Hossack to configured the ultrasonic transducer arrangement to have a mechanical index of greater than 0.3 as taught by Brisken ‘680 in order to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hossack in view of Dayton as applied to claim 1 above and further in view of Corl et al. (US 5,581,144). Hossack in view of Dayton discloses the invention substantially as stated above but fail to expressly disclose that, in each of a lateral and longitudinal mode, the transducer arrangement is configured to emit a forward viewing low-frequency ultrasonic energy that generates pressure.
Corl discloses another catheter that includes an ultrasonic transducer arrangement at its distal end. Corl discloses that the transducer arrangement is configured, in both a lateral and longitudinal mode, to emit a forward viewing (see fig. 5, noting beams 46 and 48) low frequency ultrasonic energy that generates pressure (col. 4, ll. 45-56; col 4, ll. 60-col. 5, ll. 7). Corl discloses that such a dual-mode transducer takes advantage of an unwanted mode by creating a low-frequency lateral mode to provide a transducer which has two strong modes (longitudinal mode, corresponding to “thickness resonance” by Corl, and lateral mode, corresponding to “lateral resonance”; note that Corl discloses that the two frequencies may be designed to be close to another). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Hossack to construct the ultrasonic arrangement such that it is configured, in a lateral mode, to emit a forward viewing low-frequency ultrasonic energy, and in a longitudinal mode, to emit a forward viewing low-frequency ultrasonic energy as taught by Corl in order to provide a transducer that has two strong modes and selectable beamwidth (see fig. 5 and abstract of Corl).
Conclusion
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KSH 4/27/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
