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 .
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
In claim 1, in line 12, “ultrasound” should be deleted and replaced with --- plurality of ---. Claim 12 is similarly objected to.
In claim 1, in line 15, --- of the plurality of transducer array elements --- should be inserted after “element”. Claim 12 is similarly objected.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With regards to claim 1, lines 12-17 recite “wherein each of the ultrasound transducer array elements has a plurality of transducer cells of multiple diameters with varied spacing therebetween integrated into each transducer array element to provide a wide bandwidth of an individual focused beam”. However, the specification makes no mention of the ultrasound transducer array having any type of varied spacing between the transducer cells of multiple diameters and thus does not appear to support the above limitations. Applicant’s Figure 7 does depict a plurality of transducer array cells (704) wherein there does appear to be transducer cells of different diameters, but there appears to be consistent spacing between transducer cells (704) of multiple/different diameters (see the below annotated copy of Applicant’s Figure 7). Figure 7 is further disclosed as being an illustration and there is no disclosure that the drawings are drawn in scale such that Figure 7 can be viewed as providing support for the relative spacing between the transducer cells of multiple diameters, and thus do not provide support for the claimed varied spacing between the transducer cells of multiple diameters. Examiner further notes that paragraph [0046] of Applicant’s PG-Pub 2024/0206979 specification does disclose that the one or more ultrasonic transducer arrays (3808) may be constructed from a pMUT based array containing individual elements of different diameters, but is silent with regards to the spacing between the individual elements. Claim 12 is similarly rejected. The claims therefore fail to comply with the written description requirement.
Annotated Copy of Figure 7:
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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.
Claim(s) 1-4, 6-7, 9, 10, 12-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waters et al. (US Pub No. 2020/0178788) in view of Hajati et al. (US Pub No. 2013/0293065), alone, or alternatively, further in view of Saarinen et al. (US Pub No. 2018/0206819).
With regards to claims 1 and 12, Waters et al. disclose a piezoelectric Micromachined Ultrasonic Transducer (pMUT) guided ultrasound bronchoscope (100) (paragraphs [0020]-[0022], [0031], referring to the endobronchial ultrasound bronchoscope which can include a piezoelectric micromachined ultrasound transducer (pMUT); Figures 1-2), comprising:
an insertion tube (104) having a proximal section (202) and a distal section (204) paragraphs [0021]-[0022], Figures 1-2); and
a handle (102) connected to the proximal section (202), and a distal tip (106) connected to the distal section (204) of the insertion tube (104) (paragraphs [0021]-[0022]; Figures 1-2), wherein the handle comprises:
a working channel entry port (206) for inserting fluids and biopsy tools into a working channel (302) extending through the insertion tube and exiting near the distal tip (paragraphs [0022]-[0024], referring to the working channel entry port (206) being used for inserting fluids or tools into the working channel (302) which extends through the insertion tube and exits near the distal tip; Figures 1-3); and
a suction button (214) configured to control a valve disposed adjacent to the suction port for controlling suction when connected to a suction device (paragraph [0022], referring to the suction button (214) controlling a valve adjacent to the suction port for purposes of controlling suction when suction port (212) is connected to a suction device; Figure 2); and
an ultrasound transducer array (310, 602) having a transmit and receiver circuitry (606) and the ultrasound transducer array comprising a plurality of transducer array elements (704) arranged toward the distal tip, wherein each of the ultrasound transducer array elements (704) has a plurality of transducer cells (610) (paragraph [0026], referring to the transducer assembly (310) including a MEMS-based ultrasound transducer with integrated electronics installed at distal tip (106); paragraphs [0031]-[0033], referring to the signal-processing electronics/ASIC (606) being used to provide transmit-and-receive circuitry for the ultrasound transducer array (602) within distal tip (106), further referring to the transducer array (602) including multiple elements (704), wherein each element (704) includes one or more MEMS drums (610) and an electrode (702), wherein the MEMS drums (610) act as transducer elements that transmit ultrasound energy and receive acoustic reflection or echoes); paragraphs [0030], [0034]-[0035], referring got the flexible interconnection (608) which provides wired connections between the transducer array (602) and ASIC (606); Figures 3-9, in particular, see Figures 6-7).
Further, with regards to claim 12, Waters et al. further discloses that their bronchoscope further comprises an ultrasound transducer array (310, 602) having a transmit and receive circuitry (606) disposed onto the distal tip towards the distal section of the insertion tube, where the ultrasound transducer array is configured to communicate via the transmit and receive circuitry (paragraph [0026], referring to the transducer assembly (310) including a MEMS-based ultrasound transducer with integrated electronics installed at distal tip (106); paragraphs [0031], [0033], referring to the signal-processing electronics/ASIC (606) being used to provide transmit-and-receive circuitry for the ultrasound transducer array (602) within distal tip (106); paragraphs [0030], [0034]-[0035], referring got the flexible interconnection (608) which provides wired connections between the transducer array (602) and ASIC (606); Figures 3-9).
However, Waters et al. do not specifically disclose that the plurality of transducer cells is of multiple diameters with varied spacing therebetween integrated into each transducer array element to provide a wide bandwidth of an individual focused beam.
Hajati et al. disclose pMUT arrays and systems comprising pMUT arrays, wherein the pMUT array (700) can comprise transducer elements of different sizes (Abstract; paragraphs [0062]-[0063]; Figure 7). Differing membrane sizes within a population of transducer elements provides differing frequency response for wide bandwidth total response while layout of the differing membrane sizes between adjacent element populations provides adequately low crosstalk between the element populations (Abstract). Electrically coupled to one drive/sense electrode (e.g., 110) are transducer elements having 2-20 different membrane sizes (e.g., diameters), or more (paragraphs [0063]-[0064]; Figure 7A). The range of diameters will generally depend on the desired frequency range as a function of membrane stiffness and mass (paragraph [0063]). Membranes of the same size (e.g., 711A, 711B) are spaced apart by at least one intervening element having a membrane of different size, wherein this has the advantage of reducing crosstalk because nearest neighboring elements which generally induces the most crosstalk will be off resonance with resepct to each other (paragraph [0064]; Figure 7A). As depicted in Figure 7A, each of the transducer elements have a plurality of transducer cells of multiple diameters (i.e. 711A, 712A, 713A…713B, 714B…716B) with varied spacing therebetween integrated into each transducer array element (see Figure 7A, wherein there exists varied spacing between transducer cells (i.e. 711A-716B) of multiple diameters).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the plurality of transducer cells of Waters et al. comprise of multiple diameters with varied spacing therebetween integrated into each transducer array element to provide a wide bandwidth of an individual focused beam, as taught by Hajati et al., in order to provide differing frequency response for wide bandwidth total response while layout of the differing membrane sizes between adjacent element populations provides adequately low crosstalk between the element populations (Abstract).
With regards to the limitation directed to the transducer cells of the multiple diameters being with “varied spacing therebetween integrated into each transducer element”, if Applicant does not view Figure 7A of Hajati et al. as depicting the claimed varied space, alternatively, Saarinen et al. disclose a transducer array device and system, wherein the transducer portion has an array of piezoelectric transducers mounted to an inner concave surface of a semi-rigid surface, wherein each array contains multiple piezoelectric crystals that both emit and receive ultrasound waves. The distance between crystals can be irregular causing crystal density to vary or, in other examples, each crystal of the array has uniform spacing between the crystals throughout the array (Abstract; paragraph [0023], note that this irregular spacing between the crystals throughout the array would correspond to the ultrasound transducer array having transducer cells/crystals having varied spacing; Figure 1). Each transducer array may be equally spaced from the array next to it, or the array spacing may vary to cause higher density in certain imaging regions (paragraph [0223], note that the spacing between the transducer elements would thus vary in a lateral or longitudinal direction, depending on along which direction the array is considered to be extending; Figure 1).
Therefore, alternatively, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the transducer cells of the multiple diameters of the above combined references have varied spacing therebetween integrated into each transducer element, as taught by Saarinen et al., in order to cause the transducer array element density to vary, such as providing higher density of the elements in certain imaging regions and thereby providing the ability to focus in certain regions (paragraph [0023]).
With regards to claims 2 and 13, Waters et al. disclose that the insertion tube (104) is inserted into a patient and directed towards a region of interest (paragraph [0021], referring to the insertion tube (104) being inserted into the patient and directed to a region of interest; Figure 1B).
With regards to claim 3, Waters et al. disclose that the handle comprises a flexion extension lever (210) to adjust location and orientation of the distal tip when directed toward a region of interest (paragraphs [0022], [0027], referring to the flexion/extension lever (210) controlling wires within the insertion tube (104) for steering the distal tip (106) during insertion to a patient, thereby adjusting location/orientation of the distal tip; Figure 2).
With regards to claims 4 and 14, Waters et al. disclose that the biopsy tools include a biopsy needle (504) extending through the insertion tube and exiting near the distal tip, wherein the biopsy needle is located above the ultrasound transducer array (see Figure 5) (paragraphs [0022]-[0024], referring to the biopsy needle (504) which is inserted at working channel entry port (206) and pushed through the working channel lumen (302) and exits through working channel exit port (306) which is near the distal tip (106); Figures 1-3, 5).
With regards to claims 6 and 15, Waters et al. disclose that the ultrasound transducer array includes a flexible interconnection (608) between the transmit and receiver circuity (606) and the ultrasound transducer array (602) (paragraphs [0030], [0034]-[0035], referring got the flexible interconnection (608) which provides wired connections between the transducer array (602) and ASIC (606); Figures 6).
With regards to claims 7 and 16, Waters et al. disclose that the ultrasonic transducer array corresponds to a micro-electromechanical (MEMS) based Piezoelectric Micromachined Ultrasonic Transducer (pMUT) (paragraph [0031], referring to the transducer array (602) being a piezoelectric micromachined ultrasound transducer (PMUT)).
With regards to claims 9 and 18, Waters et al. disclose the ultrasonic transducer array is coupled to an imaging device (i.e. 20, 1210, 22 or Beamformer (804) in Interface Module (1210) in Figure. 12B) using a custom dongle (linking interface (1320)/1310 or 1302a), and the custom dongle is configured to communicate ultrasound transmit pulses and ultrasound receive waveforms (paragraphs [0020], [0034], [0039]-[0044], referring to the beamformer (804) may provide input to the analog front end (AFE) for controlling the phase and relative amplitude of signals to provide directional signal transmission or reception, wherein the beamformer may be located in interface module (1210) [Figure 12B] and the linking interface (1320) allows handle segment (1302b) to be attached to handle segment (1302a) for a procedure, and thus communication signals for transmission/reception from the beamformer would necessarily be transmitted through 1302a, and/or referring to the linking interface (1320) including a communication interface to connect the communication wires to wires in handle segment 1302a that lead to control logic (1214); Figures 1, 12-13).
With regards to claims 10 and 19, Hajati et al. disclose that the transducer cells are of multiple diameters to achieve the wide bandwidth (Abstract; paragraphs [0050]). Though the above combined references do not specifically disclose that the wide bandwidth is of greater than 55%, it would have been obvious to one of ordinary skill in the art, through routine optimization, to modify the diameters to achieve the claimed wide bandwidth of greater than 55%, in order to determine the optimal bandwidth that would provide a desired image.
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waters et al. in view of Hajati et al., alone, or further in view of Saarinen et al. as applied to claims 1 and 12 above, and further in view of Sverdlik et al. (US Pub No. 2019/0105520).
With regards to claim 8 and 17, as discussed above, the above combined references meet the limitations of claims 1 and 12. However, they do not specifically disclose that the distal tip is coated with a material to provide electrical isolation and transmission of ultrasound signals.
Sverdlik et al. disclose an applicator for applying ultrasound energy to a tissue volume, wherein a thin coating is disposed on the transducer, wherein the coating may reduce interference with ultrasonic energy transmission, yet provides an electrical isolation between the transducer and the tissue surface (Abstract; paragraph [0133]). The thickness of the coating is selected in accordance with a working frequency of the tissue surface (paragraph [0133]).
Before the effective filing date of the clamed invention, it would have been obvious to one of ordinary skill in the art to have the distal tip of the above combined references be coated with a material to provide electrical isolation and transmission of ultrasound signals, as taught by Sverdlik et al., in order to provide a selective reduction of interference with ultrasonic energy transmission, yet provide an electrical isolation between the transducer and the tissue surface (paragraph [0133]).
Claim(s) 11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waters et al. in view of Hajati et al., alone, or further in view of Saarinen et al. as applied to claims 10 and 19 above, and further in view of Hajati’202 (US Pub No. 2013/0294202).
With regards to claims 11 and 20, as discussed above, the above combined references meet the limitations of claims 10 and 19.
However, the above combined references do not specifically disclose that each of the plurality of transducer array elements is a linear phased array, and the plurality of transducer array elements creates an individual focused beam.
Hajati’202 discloses pMUT arrays and techniques for frequency shaping in pMUT arrays to achieve both high frequency and low frequency operation in a same device, thereby eliminating a need to change transducers while imaging a patient (Abstract; paragraphs [0005]-[0007]). Each of the plurality of piezoelectric transducer element populations includes a first and second transducer element having piezoelectric membranes of differing size, wherein an ultra wide bandwidth mode can be achieved (paragraphs [0006], [0038], [0045]-[0046], Figure 1, wherein the transducer elements (A,B,C,D) are of multiple diameters). Th transducer element population (180) forms a linear array with all transducer elements centered about a longitudinal population axis (151) with drive/sense electrode rails having a parallel longitudinal axis (151) (paragraph [0039]). Phase of first and second electrical drive signals are modulated relative to each other to control a penetration depth of a pMUT array and respective time delays can be added to the individual drive voltage signals by a programmable time-delay controller (610) to beam steer, create a desired beam shape, focus and direction, etc., (paragraphs [0044], [0052], note that controlling the phase as such for a linear array provides a “linear phased array” which can be steered to provide a desired focus (i.e. “individual focused beam”).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the transducer cells of the above combined references comprise of multiple diameters to achieve a wide bandwidth and further have each of the plurality of transducer array elements of the above combined references comprise a linear phased array, and the plurality of transducer array elements create an individual focused beam, as taught by Hajati’202, in order to achieve both high and low frequency operation in a same device, thereby eliminating a need to change transducers while imaging a patient (paragraphs [0005]-[0007]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4 and 6-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Hajati’065 has been introduced to teach a plurality of transducer cells of multiple diameters with varied spacing therebetween integrated into each transducer array element to provide a wide bandwidth of an individual focused beam. With regards to the limitation concerning the “varied spacing therebetween integrated into each transducer array element”, if Hajati’065 is not viewed as teaching this limitation, previously applied Saarinen has been applied in an alternative rejection of claims 1 and 12.
With regards to Applicant’s arguments concerning Hajati’202, Examiner notes that Hajati’202 is not used in the above rejection of claims 1 and 12. However, a related reference Hajati’065 has been used, wherein Hajati’065 discloses the similar disclosure of it being advantageous “to space out elements of a same size by a same amount…” which Applicant refers to in their arguments with respect to Hajati’202. Applicant argues that modifying Hajati to incorporate Saarinen’s irregular spacing would contradict Hajati’s express design principle and would render Hajati unsuitable for its intended purpose of maintaining comparable resolution across frequencies.
Examiner respectfully disagrees and notes that the above disclosure of Hajati’065 is directed to “elements of a same size” being spaced out by a same amount. As depicted in Figure 7A, elements of the “same size”, such as elements 711A, 711B of rail (110) are separated by the same amount in the neighboring rail (130). However, the above disclosure is not directed to the spacing between elements of different/multiple diameters. As depicted in Figure 7A of Hajati’065, there exists varied spacing between the transducer cells of multiple/different diameters. For example, the spacing between elements 711A and 712A appears different from the spacing between elements 714A and 715A. As such, it does not appear that modifying Hajati to incorporate Saainent’s irregular spacing, as set forth in the above alternative rejection, would contradict Hajati’s express design principle or render Hajati unsuitable for its intended purpose as the desired for elements to be separated by the same amount appears to be directed to elements of the “same size” rather than elements of multiple/different diameters.
The claims therefore remain rejected.
Conclusion
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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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798