DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/13/2023 and 02/27/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites the limitation "the ¼ λ acoustic matching layer" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 101-104, 109, and 115 are rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (NPL: Ultrasound in Med. & Bio. Vol. 15, No. 7, pp. 649-659, 1989) in view of Corl (Pub. No.: US 2014/0180128).
Consider claim 101, Foster discloses an ultrasonic transducer (page 654-655, Figs. 7, 8, ultrasound transducer), comprising:
a piezoelectric composite disc having resonant properties (pages 649, 655, spherical PZT (piezoelectric disk) crystal);
at least one electrode in electrical contact with the piezoelectric composite disc (page 655, electrodes on each surface of the spherical PZT crystal); and
an annular apodizing backing structure in acoustic contact with the piezoelectric composite disc (page 655, Fig. 7, backing molded formed of a puck with a concave surface complementary to the spherical PZT crystal for contact therewith wherein holes 0.25 mm in diameter were drilled for electrical leads to each of the 12 annuli of the PZT (see page 649) and transmitted pulses apodized (see page 654, Table 1), the annular apodizing backing structure having:
an inner perimeter (page 653, Table 1, Inner rad) and a corresponding inner thickness (page 657, annuli height);
an outer perimeter (page 653, Table 1, Outer rad) and a corresponding outer thickness (page 657, annuli height); and
an inclined surface forming a substantially continuous slope extending from the inner perimeter to the outer perimeter, the inner thickness being smaller than the outer thickness (page 655, Fig. 7, backing molded in the form of a puck with a concave with changing width to height (w/h) ratios), wherein the annular apodizing backing structure is configured to change an apparent thickness of the piezoelectric composite disc with respect to the resonant properties of the piezoelectric composite disc (page 657, Fig. 11, pulse degradation due to lateral modes in thin annuli), thereby allowing the ultrasonic transducer to generate an acoustic field comprising at least one substantially uniform near field portion (page 657, Fig. 12, when these waveforms are summed to produce the effective focused pulse, the result is really quite acceptable).
Foster does not specifically disclose the piezoelectric composite disc being of low-volume fraction.
Corl discloses the piezoelectric composite disc being of low-volume fraction (paragraph [0043], values for volume fraction of piezoelectric in single crystal composite range from 20% to 80% wherein a volume fraction of approximately 50% is commonly chosen).
Therefore, in order to provide for a good compromise in terms of performance, flexibility, and manufacturability, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the same technique as suggested by Corl wherein the piezoelectric composite disc being of low-volume fraction, see teaching found in Corl, paragraph [0043].
Consider claim 102, the combination of Foster and Corl discloses wherein the low-volume fraction piezoelectric composite disc is in a 1 3 configuration (Corl, paragraph [0034], Fig. 3, transducer 150 includes a single crystal composite material (SCC) 301 commonly referred to as 1-3 composite).
Consider claim 103, the combination of Foster and Corl does not specifically discloses wherein the low-volume fraction piezoelectric composite disc comprises 280 µm by 280 µm pillars distributed in a 2D matrix pattern having a pitch of about 480 µm in both lateral axes.
However, the combination of Foster and Corl discloses a single crystal composite material (SCC) 301 having pillars 320 of a single crystal piezoelectric material (Corl, paragraph [0034], Fig. 3) with lateral dimension of a single pillar of 18 µm and a thickness of 30 µm providing an aspect ratio of width to height of 0.6 (or less as Corl suggest) (Corl, paragraph [0037], Fig. 3); therefore, matching the aspect ratio of the claimed invention (280/480 = 0.58) and providing a matter of design choice wherein the arrangement would not modify the device operation, see MPEP 2144.04, VI., C.).
Therefore, in order to ensure that the efficient pillar mode of vibration predominates, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the same technique as suggested by Corl wherein the low-volume fraction piezoelectric composite disc comprises 280 µm by 280 µm pillars distributed in a 2D matrix pattern having a pitch of about 480 µm in both lateral axes, see teaching found in Corl, paragraph [0037].
Consider claim 104, the combination of Foster and Corl discloses wherein the low-volume fraction piezoelectric composite disc has an acoustic impedance included in a range extending from about 9 MR to about 13 MR (Corl, paragraph [0041], acoustic impedance as low as 5 MRayls or as high as 20 MRayls).
Consider claim 109, the combination of Foster and Corl discloses an inductor connected in parallel with a piezocomposite of the low-volume fraction piezoelectric composite disc, the inductor being configured to resonate with the low-volume fraction piezoelectric composite disc, the annular apodizing backing structure, and the 1/4 λ acoustic matching layer, such that an impedance maximum is produced at about 1.5 MHz when a distal face of the transducer is air loaded (page 656, annular array tuned with a shunt inductor such that its phase was approximately zero at 4.5 MHz; thus, about 1.5 MHz as claimed. See Fig. 7 for piezoelectric composite disc, the annular apodizing backing structure, and the ¼ λ acoustic matching layer).
Consider claim 115, the combination of Foster and Corl discloses a matching layer, the matching layer having a thickness of about ¼ λ (page 655, matching layer having a thickness of λ/4).
Claim(s) is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Foster and Corl in view of Lukacs et al. (Pat. No.: 7,230,368).
Consider claim 105, the combination of Foster and Corl does not specifically disclose wherein the low-volume fraction piezoelectric composite disc has a thickness of about λ/2 at 1.5 MHz.
Lukacs discloses wherein the low-volume fraction piezoelectric composite disc has a thickness of about λ/2 at 1.5 MHz (col. 7, lines 40-62, thickness of the piezoelectric layer is most commonly based on a thickness that ranges from λ /4 to λ/2 wherein metalized surfaces of the electrode layers having lower resistance at 1-100 MHz, see col. 7, line 63 thru col. 8, line 14).
Therefore, in order to based on the choice of backing layer and matching layer(s) and their respective acoustic impedance values that dictate the final thickness of the piezoelectric layer, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the same technique as suggested by Lukacs wherein the low-volume fraction piezoelectric composite disc has a thickness of about λ/2 at 1.5 MHz, see teaching found in Lukacs, col. 7, lines 40-62.
Claim 106 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Foster and Corl in view of Inventor Unknown (Pub. No.: JP 2005537062 A).
Consider claim 106, the combination of Foster and Corl does not specifically disclose a ring-shaped printed circuit board having an inner diameter, wherein: the low-volume fraction piezoelectric composite disc has an outer diameter, the inner diameter of the ring- shaped printed circuit board being larger than the outside diameter of the low-volume fraction piezoelectric composite disc.
Inventor Unknown discloses a ring-shaped printed circuit board having an inner diameter (paragraph [0044], Fig. 6, flex circuit 32 forming an annular ring with inner diameter), wherein: the low-volume fraction piezoelectric composite disc has an outer diameter (paragraphs [0044], [0045], Fig. 6, piezoelectric material 52 used to form transducer array 28 forming an annular ring with outer diameter), the inner diameter of the ring-shaped printed circuit board being larger than the outside diameter of the low-volume fraction piezoelectric composite disc (paragraph [0044], Fig. 6).
Therefore, in order to provide for a transducer element for use with a catheter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the same technique as suggested by Inventor Unknown in providing a ring-shaped printed circuit board having an inner diameter, wherein: the low-volume fraction piezoelectric composite disc has an outer diameter, the inner diameter of the ring- shaped printed circuit board being larger than the outside diameter of the low-volume fraction piezoelectric composite disc, see teaching found in Inventor Unknown, paragraph [0045].
Claim 111 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Foster and Corl in view of Johnson et al. (Pub. No.: US 2019/0357882).
Consider claim 111, the combination of Foster and Corl does not specifically disclose wherein the annular apodizing backing structure has an acoustic impedance of about 2.8 MR.
Johnson discloses wherein the annular apodizing backing structure has an acoustic impedance of about 2.8 MR (paragraph [0074], in the case of the transducer array comprising piezoelectric transducers, the electroactive material layer (i.e., backing structure) may have an acoustic impedance ranging from 1.3-3.0 MRayls).
Therefore, in order to that the material is acoustically matched to the acoustic impedance of the transducer array, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the same technique as suggested by Johnson wherein the annular apodizing backing structure has an acoustic impedance of about 2.8 MR, see teaching found in Johnson, paragraph [0074].
Claim 113 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Foster and Corl in view of Hall et al. (Pub. No.: US 2014/0276248).
Consider claim 113, the combination of Foster and Corl does not specifically disclose wherein the ultrasonic transducer has a beam non- uniformity ratio of less than 3.5.
Hall discloses wherein the ultrasonic transducer has a beam non-uniformity ratio of less than 3.5 (paragraph [0029], ultrasonic transducer has a beam non-uniformity ratio of 3 or lower (e.g., about 3, 2.8, 2.6, 2.4, 2.2, 2, 1.8, 1.6, 1.4, 1.2, 1 or lower)).
Therefore, in order to provide decreasing hot spots on the surface of a patient's skin to provide a safer delivery to the patient, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the same technique as suggested by Hall wherein the ultrasonic transducer has a beam non- uniformity ratio of less than 3.5, see teaching found in Hall, paragraph [0029].
Allowable Subject Matter
Claims 107, and 112 and 114 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797