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 .
Response to Arguments
Applicant's arguments with respect to the claim(s) 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.
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) 1, 3-6, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 5,329,496) and Corl (US 2014/0180128). Smith discloses a multi-pillar piezoelectric stack ultrasound transducer (figs. 1-2), the ultrasound transducer comprising N pillars (e.g., 11, 12), each formed of a stack of M piezoelectric elements (e.g., 24, 26, 28), N and M being integers of at least two, and N being no greater than four (see col. 4, ll. 45-54: transducer is not restricted to arrays of 3 x 3, but may include any two dimensional transducer array N x M, wherein N and M are each at least two as understood by the word “plurality”; this range covers the claimed values of N being 2, 3, or 4), a bonding layer (electrodes 34, 36, 38 or 40) between each pair of the M piezoelectric elements, wherein the pillars are laterally spaced apart from one another for form an inter-pillar gap (kerfs 13, 15; see fig.1 and 2), and at least one electrical interconnect (e.g., 54 and 46) for connecting the ultrasound transducer to a signal source. The M piezoelectric elements have a combined thickness smaller than a lateral dimension of the ultrasonic transducer. In particular, the thickness of each piezoelectric element can be as small as 0.01 mm such that the combined thickness of M piezoelectric elements (5 in figures) may be as small as 0.05 mm, while the lateral dimension of the ultrasonic transducer (2x2 array) is larger than 2mm (each square transducer element in the array can have a width of 1.0mm; see claim 1).
Smith discloses that the inter-pillar gap (defined by kerfs) separates each layer of the N pillars from each corresponding layer of each of the other N pillars (see fig. 1), and is filled with an epoxy or polymer (col. 4, ll. 57-60), but does not expressly disclose that the gap is filled with a polydimethylsiloxane (PDMS) material for realizing extensional vibration of the pillars.
Corl discloses another multi-pillar piezoelectric stack ultrasound transducer (figs. 2, 3) wherein the pillars (320) are laterally spaced from each other to form an interpillar gap, wherein the interpillar gap (330) is filled with a polydimethylsiloxane (PDMS) material ([0034]). Corl discloses PDMS as a suitable silicone material for filling the interpillar gap, and further discloses PDMS as an alternative to an epoxy ([0034]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Smith to use PDMS as the inter gap filler of Smith since Corl discloses that such a material is known in the art as suitable for filling the interpillar gap of a multi-pillar piezoelectric stack ultrasound transducer, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416). The limitation “for realizing extensional vibration of the pillars” is considered a functional limitation. Because the prior art of Smith in view of Corl discloses an ultrasound transducer having all of the claimed structure of claim 1, including an interpillar gap filled with PDMS, the PDMS is considered capable of realizing extensional vibration of the pillars in the same manner as the invention of the instant application.
Regarding claim 3, each pillar is greater in axial length (i.e. height) than in lateral dimensions (height of pillar can be 1.3mm while width is 0.05 to 1mm; col. 8, ll. 1-5 and claim 1 of Smith).
Regarding claim 4, the bonding layer comprises an electrically conductive material (electrodes 34, 36, 38, 40) and the at least one electrical interconnect (46 or 54) is connected to the bonding layer.
Regarding claim 5, the at least one electrical interconnect comprises a plurality of electrical interconnects (46 and 54; fig. 1 of Smith) on lateral faces of the pillars.
Regarding claim 6, the piezoelectric elements each have a lateral dimension of more than one wavelength of an ultrasound signal produced at an operating frequency of the ultrasound transducer, noting that the wavelength of the ultrasound signal produced at an operating frequency is dependent on the medium in which the transducer is placed (air vs. water vs. tissue of a patient, etc.) and the frequency supplied to the transducer, and may be chosen by the user such that the wavelength of the ultrasound signal at the operating frequency is less than less than 1.0mm. It is further noted that the piezoelectric elements have a lateral dimension similar to that of the instant invention (Smith: length/width: 1.0mm, height 1.3mm; instant application as per. [0026]: width/length 0.85mm, height 1mm, noting five 0.2mm layers) and thus appear to have a lateral dimension of more than one wavelength of an ultrasound signal produced at a certain frequency in the same manner as the instant invention).
Regarding claim 8, the piezoelectric elements comprise a lead zirconate titanate material (PZT; col. 8, ll. 1-5).
Regarding claim 14, each pillar formed of stacked piezoelectric elements of the ultrasound transducer of Smith has dimensions similar to the dimensions disclosed by the instant application (Smith: length/width: 1.0mm, height 1.3mm; instant application as per. [0026]: width/length 0.85mm, height 1mm, noting five 0.2mm layers), and is made of the same piezoelectric materials as the instant application (e.g., PZT). Thus, it is the examiner’s position that the ultrasound transducer of Smith is capable of achieving a -6dB focal zone ranging from about zero wavelengths to about two wavelengths from an aperture (noting that “aperture” is a term of art meaning the active area of a transducer that transmits acoustic waves at a certain moment) of the transducer, wherein a wavelength is a wavelength of an ultrasound signal defined at an operating frequency of the ultrasound transducer, noting that the claim is not limited to any particular operating frequency and does not require a particular medium (air, water, blood, tissue, etc.) in which the ultrasonic energy is being applied.
Claim(s) 9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Corl as applied to claim 1 above and further in view of Flesch et al. (US 6,656,124). Smith in view of Corl discloses the invention substantially as stated above except for an acoustic impedance matching layer and backing layer as claimed.
Flesch discloses another multi-pillar piezoelectric stack ultrasound transducer (abstract), the ultrasound transducer comprising N pillars (14), each formed of a stack of M piezoelectric elements (30; fig. 5), N and M being integers of at least two, a bonding layer (electrode 28, 30; figs. 6, 7) between each pair of the M piezoelectric elements, wherein the pillars are laterally spaced apart from one another for form an inter-pillar gap (groove 52/58, filled with resin 60; col. 11, ll. 12-20). Flesch further discloses an acoustic impedance matching layer (46) connected to the pillars that has an acoustic impedance between an acoustic impedance of the piezoelectric elements and an acoustic impedance of an operating medium of the ultrasound transducer (col. 9, ll. 50-64). Flesch discloses that the matching layer is conventionally a part of a standard transducer array (col. 9, ll. 25-34) and enhances the performance of the transducer array (col. 9, ll. 50-60). The pillars are connected to a backing layer (50; fig. 9) that comprises a polymer (col. 10, ll. 26-40), the backing material serving to acoustically dampen the rear face of the transducer to shorten impulse response. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Smith to include an acoustic impedance matching layer and backing layer having the claimed features as taught by Flesch in order to enhance the performance of the transducer array and acoustically dampen the rear face of the transducer to shorten impulse response.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Corl as applied to claim 1 above, and further in view of Suwaki et al. (US 4,375,818). Smith in view of Corl discloses the invention substantially as stated above except for an acoustic impedance matching layer as claimed.
Suwaki discloses another piezoelectric transducer, wherein the transducer includes an acoustic impedance matching layer (24; fig. 5) connected to the ultrasonic energy emitting surface of the transducer (21/22/23) in order to provide a matching of an acoustical impedance with an ultrasonic wave transmitting medium and to provide electrical insulation (col. 7, ll. 35-48). Suwaki further discloses that the acoustic impedance matching layer comprises an acoustic lens (33), the lens comprising a cylinder (note transducer has circular cross-section as understood in view of circular distal face of transducer assembly 123 of fig. 24) having a concave axially facing surface in order to achieve convergence of the ultrasonic beam emitted by the ultrasonic transducer (fig. 5; col. 8, ll. 36-46). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Smith to have an acoustic impedance matching layer that includes an acoustic lens comprising a cylinder having a concave axially facing surface as taught by Suwaki in order to match the acoustical impedance with an ultrasonic wave transmitting medium, to provide electrical insulation, and to achieve convergence of the ultrasonic beam emitted by the transducer of Smith.
Claim(s) 15, 21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2004/0251784) in view of Corl and Crowley et al. (US 4,951,677).
Smith discloses a multi-pillar piezoelectric stack ultrasound transducer (figs. 1-2), the ultrasound transducer comprising N pillars (e.g., 11, 12), each formed of a stack of M piezoelectric elements (e.g., 24, 26, 28), N and M being integers of at least two, and N being no greater than four (see col. 4, ll. 45-54: transducer is not restricted to arrays of 3 x 3, but may include any two dimensional transducer array N x M, wherein N and M are each at least two as understood by the word “plurality”; this range covers the claimed values of N being 2, 3, or 4), a bonding layer (electrodes 34, 36, 38 or 40) between each pair of the M piezoelectric elements, wherein the pillars are laterally spaced apart from one another to form an inter-pillar gap (kerfs 13, 15; see fig.1 and 2), and at least one electrical interconnect (e.g., 54 and 46) for connecting the ultrasound transducer to a signal source. The M piezoelectric elements have a combined thickness smaller than a lateral dimension of the ultrasonic transducer. In particular, the thickness of each piezoelectric element can be as small as 0.01 mm such that the combined thickness of M piezoelectric elements (5 in figures) may be as small as 0.05 mm, while the lateral dimension of the ultrasonic transducer (2x2 array) is larger than 2mm (each square transducer element in the array can have a width of 1.0mm; see claim 1).
Smith discloses that the inter-pillar gap (defined by kerfs) separates each layer of the N pillars from each corresponding layer of each of the other N pillars (see fig. 1), and is filled with an epoxy or polymer (col. 4, ll. 57-60), but does not expressly disclose that the gap is filled with a polydimethylsiloxane (PDMS) material for realizing extensional vibration of the pillars.
Corl discloses another multi-pillar piezoelectric stack ultrasound transducer (figs. 2, 3) wherein the pillars (320) are laterally spaced from each other to form an interpillar gap, wherein the interpillar gap (330) is filled with a polydimethylsiloxane (PDMS) material ([0034]). Corl discloses PDMS as a suitable silicone material for filling the interpillar gap, and further discloses PDMS as an alternative to an epoxy ([0034]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Smith to use PDMS as the inter gap filler of Smith since Corl discloses that such a material is known in the art as suitable for filling the interpillar gap of a multi-pillar piezoelectric stack ultrasound transducer, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416). The limitation “for realizing extensional vibration of the pillars” is considered a functional limitation. Because the prior art of Smith in view of Corl discloses an ultrasound transducer having all of the claimed structure of claim 1, including an interpillar gap filled with PDMS, the PDMS is considered capable of realizing extensional vibration of the pillars in the same manner as the invention of the instant application.
Smith also fails to disclose a catheter from which the ultrasonic transducer is deployable to deliver ultrasound energy from within the body of a subject, though Smith disclose that the transducer may be applied in medical ultrasound applications.
Crowley teaches that acoustic imaging via piezoelectric ultrasound transducers can be carried out within the body of a subject in order to facilitate medical procedures. Crowley further teaches that the piezoelectric ultrasound transducer (10) can be mounted at the end of a probe (6), the probe advanced through a catheter (introducer sheath 13) that is insertable into the body of the subject (fig. 1) in order to facilitate acoustic imaging of structures internal to the subject’s body (col. 5, ll. 49-66). The probe is deployable from within the catheter (i.e., out the distal end of the sheath 13) to deliver ultrasound energy from within the body of the subject. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Smith to mount the transducer to a distal end portion of a probe and to include a catheter from which the transducer can be deployed as taught by Crowley in order to facilitate delivery of ultrasound energy within a patient’s body, thus allowing imaging of structures internal to the patient’s body.
Regarding claim 21, the piezoelectric elements each have a lateral dimension (0.05 to 1.0mm) of more than one wavelength of an ultrasound signal produced at an operating frequency of the ultrasound transducer, noting that the wavelength of the ultrasound signal produced at an operating frequency is dependent on the medium in which the transducer is placed (air vs. water vs. tissue of a patient, etc.) and the frequency supplied to the transducer, and may be chosen by the user such that the wavelength of the ultrasound signal at the operating frequency is less than 1.0mm. It is further noted that the piezoelectric elements of Smith have a lateral dimension similar to that of the instant invention (Smith: length/width: 0.05-1.0mm, height 1.3 mm; instant application as per. [0026]: width/length 0.85mm, height 1mm, noting five 0.2mm layers) and thus appear to have a lateral dimension of more than one wavelength of an ultrasound signal produced at a certain frequency in the same manner as the instant invention).
Regarding claim 23, each pillar formed of stacked piezoelectric elements of the ultrasound transducer of Smith has dimensions falling within the dimensions disclosed by the instant application (Smith: length/width: 0.05-1.0mm, height 1.3 mm; instant application as per. [0026]: width/length 0.85mm, height 1mm, noting five 0.2mm layers), and is made of the same piezoelectric materials as the instant application (e.g., PZT). Thus, it is the examiner’s position that the ultrasound transducer of Smith is capable of achieving a -6dB focal zone ranging from about zero wavelengths to about two wavelengths from an aperture (noting that “aperture” is a term of art meaning the active area of a transducer that transmits acoustic waves at a certain moment) of the transducer, wherein a wavelength is a wavelength of an ultrasound signal defined at an operating frequency of the ultrasound transducer, noting that the claim is not limited to any particular operating frequency and does not require a particular medium (air, water, blood, tissue, etc.) in which the ultrasonic energy is being applied.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Corl and Crowley as applied to claim 15 above, and further in view of Suwaki et al. (US 4,375,818). Smith in view of Corl and Crowley discloses the invention substantially as stated above except for an acoustic impedance matching layer as claimed.
Suwaki discloses another piezoelectric transducer, wherein the transducer includes an acoustic impedance matching layer (24; fig. 5) connected to the ultrasonic energy emitting surface of the transducer (21/22/23) in order to provide a matching of an acoustical impedance with an ultrasonic wave transmitting medium and to provide electrical insulation (col. 7, ll. 35-48). Suwaki further discloses that the acoustic impedance matching layer comprises an acoustic lens (33), the lens comprising a cylinder (note transducer has circular cross-section as understood in view of circular distal face of transducer assembly 123 of fig. 24) having a concave axially facing surface in order to achieve convergence of the ultrasonic beam emitted by the ultrasonic transducer (fig. 5; col. 8, ll. 36-46). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Smith to have an acoustic impedance matching layer including an acoustic lens comprising a cylinder having a concave axially facing surface as taught by Suwaki in order to match the acoustical impedance with an ultrasonic wave transmitting medium, to provide electrical insulation, and to achieve convergence of the ultrasonic beam emitted by the transducer of Smith.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Corl and Crowley as applied to claim 15 above, and further in view of Visuri (US 6,484,052). Smith in view of Corl and Crowley discloses the invention substantially as stated above except for a microbubble/nanodroplet injection tube as claimed.
Visuri discloses another catheter (20) having an ultrasonic transducer (24) deployable therefrom, the catheter further including an injection tube (28; fig. 2) extending along the catheter and terminating at a distal end of the catheter in order to deliver drugs (30) distal of the catheter in the vicinity of the ultrasonic transducer and its acoustic energy field (fig. 2). The ultrasonic transducer increases diffusion of the drug, delivered via the injection tube, into cells by temporarily increasing the permeability of the membranes of local cells (col. 4, ll. 26-33). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Smith/Corl/Crowley to include an injection tube extending along the longitudinal axis of the catheter and terminating at the distal end of the catheter, in order to provide drug delivery via the catheter, which is enhanced by the increased permeability of the membranes of local cells caused by the ultrasonic energy from the ultrasonic transducer. The injection tube taught by Visuri can be considered a “microbubble/nanodroplet” injection tube since it is capable of delivering microbubbles and phase change nanodroplets within the body of the subject (i.e., tube 28 has a lumen through which microbubbles and nanodroplets can be delivered) simultaneously with the delivery, within the body of the subject, of ultrasound energy by the ultrasonic transducer, noting this is a recitation of intended use.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 1/29/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771