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 .
Terminal Disclaimer
The Terminal Disclaimer filed on 05/19/2026 has been reviewed and is accepted. The double patenting rejection set forth in the previous Office Action has been withdrawn.
Response to Amendment
The amendment filed 05/19/2026 has been entered. Claims 3-4, 10-11, and 19-20 have been canceled. Claims 1-2, 5-9, and 12-18 remain pending in the application. Applicant’s amendments to the claims and specification have overcome each and every objection previously set forth in the Non-Final Office Action mailed 02/25/2026.
Response to Arguments
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive.
Applicant argues, on pages 12-13 and 18 of Remarks filed 05/19/2026, that Chen and all the references cited fail to disclose “a silicone layer having a first flat surface, a convex surface, and a first thickness between the first flat surface and the convex surface; and a cross-linked polystyrene plastic layer having a second flat surface, a concaved surface, and a second thickness between the second flat surface and the concaved surface, wherein the concaved surface of the cross-linked polystyrene plastic layer is directly on and mated to the convex surface of the silicone layer, wherein each of the convex surface of the silicone layer and the concaved surface of the cross-linked polystyrene plastic layer is curved with a first radius of curvature where the convex surface of the silicone layer mates with the concaved surface of the cross-linked polystyrene plastic layer for the compound acoustic lens to focus acoustic waves generated by the ultrasound probe at a first focal length, wherein the first radius of curvature is greater than a second radius of curvature of a single material lens consisting of one of the cross-linked polystyrene plastic layer or the silicone layer having a second focal length that is the same as the first focal length, and wherein the first thickness is at a center of the silicone layer and the second thickness is at a center of the cross-linked polystyrene plastic layer, and wherein an overall thickness of the compound acoustic lens determined as a sum of the first thickness and the second thickness is less than the thickness at a center of a single material lens of one of the cross-linked polystyrene plastic layer or the silicone layer having the same focal length as the compound acoustic lens, and wherein the overall thickness of the compound acoustic lens is less than 380 micrometers to increase a range of operating frequencies of the ultrasound probe” as recited in claim 1.
Examiner respectfully disagrees. Chen teaches a compound acoustic lens for an ultrasound probe ([0051], “such as when the CMUT apparatus is part of a medical probe or other instrument”, [0097], “In this example, the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”), the compound acoustic lens comprising:
A silicone layer (1720) having a first flat surface, a convex surface, and a first thickness between the first flat surface and the convex surface (Fig. 17, [0097], “an outer surface 1724 may be flat…the curvature of the inside surface 1722 of the acoustic window 1720 may be designed to be either convex as shown in FIG. 17”, [0004], “A commonly used acoustic lens material for a PZT-based ultrasonic transducer in medical imaging is RTV silicone rubber (RTV)”, [0052], “suitable materials for the acoustic window 120 include, but are not limited to, plastics and rubber material”, [0053], “Additionally, in some examples, an acoustic lens (e.g., made of RTV or made from other material listed above)”; the acoustic window 1720 functions as an acoustic lens element in conjunction with coupling medium 130 and therefore it would be obvious that the acoustic window 1720 may be made of silicone because Chen states that silicone is a commonly used for acoustic lenses and wherein acoustic lens may be made of RTV (silicone rubber))
A cross-linked polystyrene plastic layer (130) having a second flat surface, a concaved surface, and a second thickness between the second flat surface and the concave surface, wherein the concaved surface of the cross-linked polystyrene plastic layer is directly on and mated to the convex surface of the silicone layer (Fig. 17, [0056], “Some example solid-based materials suitable for the coupling medium 130 include…cross-linked polystyrene microwave plastic”, [0097], wherein figure 17 shows the flat surface, concaved surface, second thickness, and direct mating with the convex surface 1722 of the silicone layer 1720)
Wherein each of the convex surface (1722) of the silicone layer (1720) and the concave surface of the cross-linked polystyrene plastic layer (130) is curved with a first radius of curvature where the convex surface of the silicone layer mates with the concaved surface of the cross-linked polystyrene plastic layer (130) for the compound acoustic lens to focus acoustic waves generated by the ultrasound probe at a first focal length (Fig. 17, Abstract, “the acoustic window or the coupling medium may include a focusing capability for focusing acoustic energy to or from the CMUT”, [0097], “In this example, the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”)
Wherein the first radius of curvature is greater than a second radius of curvature of a single material lens consisting of one of the cross-linked polystyrene plastic layer or the silicone layer having a second focal length that is the same as the first focal length (Chen discloses the same or identical compound acoustic lens structure as claimed; same materials, same concave-convex mating, same focusing function. The claimed radius relationship is a necessary consequence of the structure; it is inherent in the structure. Therefore the disclosed compound lens structure of Chen has the same property as it is inherent to the structure. The ratio of sound speeds across the silicone/cross-linked polystyrene interface (~2.34) is substantially greater than ratio between either material and tissue (~1.5), allowing more refraction, thus allowing for the compound lens to have a greater radius of curvature than a single material lens to reach the same focal length; a strongly refracting interface (silicone-to-cross-linked polystyrene) only needs a gentle curve to focus the beam. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada).
Wherein the first thickness is at a center of the silicone layer and the second thickness is at a center of the cross-linked polystyrene plastic layer, and wherein an overall thickness of the compound acoustic lens determined as a sum of the first thickness and the second thickness is less than the thickness at a center of a single material lens of one of the cross-linked polystyrene plastic layer or the silicone layer having the same focal length as the compound acoustic lens (Similar to above; Chen discloses the same or identical compound acoustic lens structure as claimed. The thickness relationship is related to the radius of curvature; a greater radius of curvature allows for a thinner lens whereas a smaller, e.g. tighter, radius of curvature physically requires a greater thickness. Because the compound acoustic lens taught by Chen has a greater radius of curvature, the overall required thickness of the compound acoustic lens is lesser than that of a single material lens having the same focal length; the thickness relationship is a necessary geometric consequence of the radius relationship already shown. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada).
However, Chen fails to teach wherein the overall thickness of the compound acoustic lens is less than 380 micrometers to increase a range of operating frequencies of the ultrasound probe.
While Chen fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the invention of Chen to have the overall thickness of the compound acoustic lens be less than 380 micrometers. Chen teaches a convex-concave compound acoustic lens (1720, 130) comprised of a silicone layer (1720) and a cross-linked polystyrene layer (130) having an overall thickness (Fig. 17, [0097]). Chen therefore teaches structurally the same invention as claimed except for an optimized parameter being the overall thickness being less than 380 micrometers. The optimized parameter is a result-effective variable because the thicker the lens, the more sound (acoustic waves) is attenuated as the sound has to travel through the lens. Moreover, the thickness of the lens also affects the size of the ultrasound probe it is in; a thinner lens may result in a smaller or more ultrasound probe. Therefore, it would have been obvious to optimize the claimed parameter, the overall thickness of the compound acoustic lens, to be less than 380 micrometers because it is a result-effective variable as explained above. An ordinarily skilled artisan may want to optimize for probe size or sound attenuation and thus adjust and optimize the overall thickness to be less than 380 micrometers as a result of routine optimization. Moreover, the claimed range comprising the overall thickness being less than 380 micrometers is merely a workable range as there is no evidence this range is critically important. In addition, because high frequencies are attenuated more per unit thickness, a thinner lens meaning less attenuation predictably allows for higher operating frequencies to be used. See MPEP §2144.05 (II), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
For the reasons above regarding amended independent claim 1, Chen similarly teaches amended independent claim 8 and 17.
Claim Objections
Claims 1, 8, and 17 are objected to because of the following informalities:
“the thickness at a center of a single material lens” should be corrected to:
“a thickness at a center of a single material lens”
“single material lens of one of the cross-linked” should be corrected to:
“single material lens consisting of one of the cross-linked”
Claim 8 is objected to because of the following informalities:
“a second flat surface a concaved surface and a second thickness” to:
“a second flat surface, a concaved surface, and a second thickness”
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5-8, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20130301394).
Regarding claim 1, Chen teaches a compound acoustic lens for an ultrasound probe ([0051], “such as when the CMUT apparatus is part of a medical probe or other instrument”, [0097], “In this example, the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”), the compound acoustic lens comprising:
an acoustic window (1720) having a first flat surface (1724), a convex surface (1722), and a first thickness between the first flat surface (1724) and the convex surface (1722) (Fig. 17, [0097], “an outer surface 1724 may be flat…the curvature of the inside surface 1722 of the acoustic window 1720 may be designed to be either convex as shown in FIG. 17”).
However, Chen fails to expressly disclose wherein the acoustic window (1720) is a silicone layer.
Chen discloses a commonly used acoustic lens material for an ultrasound transducer in medical imaging is RTV silicone rubber (RTV) ([0004]). Chen discloses that in some examples, an acoustic lens may be made of RTV (silicone rubber) ([0053]). Chen further discloses that the acoustic window (1720) may form a compound lens in conjunction with a coupling medium (130), therefore teaching that the acoustic window (1720) functions as and is structurally an acoustic lens (Fig. 17, [0097]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the acoustic window (1720) be formed of an RTV silicone rubber layer as taught by Chen ([0004], [0053], [0097]). Chen discloses that silicone is a known and common material for acoustic lenses ([0004], [0053]), expressly discloses using silicone as material for an acoustic lens ([0053]), and discloses wherein the acoustic window (1720) functions as an acoustic lens ([0097]). Therefore, it would be obvious to have the acoustic window (1720) be formed of silicone and thus result in a silicone layer because doing so would have been a simple substitution of one known acoustic lens material for another (silicone) to obtain the predictably results of an acoustic lens which focuses acoustic energy. One of ordinary skill would therefore have had a reasonable expectation of success in substituting the acoustic window (1720) material with silicone since the substituted material performs the same function in the same manner. See MPEP § 2143 (I)(B), “Simple substitution of one known element for another to obtain predictable results”.
Chen therefore further teaches wherein the compound acoustic lens comprises:
a cross-linked polystyrene plastic layer (130) having a second flat surface, a concaved surface, and a second thickness between the second flat surface and the concaved surface, wherein the concaved surface of the cross-linked polystyrene plastic layer is directly on and mated to the convex surface (1722) of the silicone layer (1720) (Fig. 17, [0056], “Some example solid-based materials suitable for the coupling medium 130 include…cross-linked polystyrene microwave plastic”, [0097], wherein figure 17 shows the flat surface, concaved surface, second thickness, and direct mating with the convex surface 1722 of the silicone layer 1720),
wherein each of the convex surface (1722) of the silicone layer (1720) and the concaved surface of the cross-linked polystyrene plastic layer (130) is curved with a first radius of curvature where the convex surface (1722) of the silicone layer (1720) mates with the concaved surface of the cross-linked polystyrene plastic layer (130) for the compound acoustic lens to focus acoustic waves generated by the ultrasound probe at a first focal length (Fig. 17, Abstract, “the acoustic window or the coupling medium may include a focusing capability for focusing acoustic energy to or from the CMUT”, [0097], “In this example, the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”)
wherein the first radius of curvature is greater than a second radius of curvature of a single material lens consisting of one of the cross-linked polystyrene plastic layer (130) or the silicone layer (1720) having a second focal length that is the same as the first focal length (Chen discloses the same or identical compound acoustic lens structure as claimed; same materials, same concave-convex mating, same focusing function. The claimed radius relationship is a necessary consequence of the structure; it is inherent in the structure. Therefore the disclosed compound lens structure of Chen has the same property as it is inherent to the structure. The ratio of sound speeds across the silicone/cross-linked polystyrene interface (~2.34) is substantially greater than ratio between either material and tissue (~1.5), allowing more refraction, thus allowing for the compound lens to have a greater radius of curvature than a single material lens to reach the same focal length; a strongly refracting interface (silicone-to-cross-linked polystyrene) only needs a gentle curve to focus the beam. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada), and
wherein the first thickness is at a center of the silicone layer (1720) and the second thickness is at a center of the cross-linked polystyrene plastic layer (130), and wherein an overall thickness of the compound acoustic lens determined as a sum of the first thickness and the second thickness is less than the thickness at a center of a single material lens of one of the cross-linked polystyrene plastic layer (130) or the silicone layer (1720) having the same focal length as the compound acoustic lens (Similar to above; Chen discloses the same or identical compound acoustic lens structure as claimed. The thickness relationship is related to the radius of curvature; a greater radius of curvature allows for a thinner lens whereas a smaller, e.g. tighter, radius of curvature physically requires a greater thickness. Because the compound acoustic lens taught by Chen has a greater radius of curvature, the overall required thickness of the compound acoustic lens is lesser than that of a single material lens having the same focal length; the thickness relationship is a necessary geometric consequence of the radius relationship already shown. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada).
However, Chen fails to teach wherein the overall thickness of the compound acoustic lens is less than 380 micrometers to increase a range of operating frequencies of the ultrasound probe.
While Chen fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the invention of Chen to have the overall thickness of the compound acoustic lens be less than 380 micrometers. Chen teaches a convex-concave compound acoustic lens (1720, 130) comprised of a silicone layer (1720) and a cross-linked polystyrene layer (130) having an overall thickness (Fig. 17, [0097]). Chen therefore teaches structurally the same invention as claimed except for an optimized parameter being the overall thickness being less than 380 micrometers. The optimized parameter is a result-effective variable because the thicker the lens, the more sound (acoustic waves) is attenuated as the sound has to travel through the lens. Moreover, the thickness of the lens also affects the size of the ultrasound probe it is in; a thinner lens may result in a smaller or more ultrasound probe. Therefore, it would have been obvious to optimize the claimed parameter, the overall thickness of the compound acoustic lens, to be less than 380 micrometers because it is a result-effective variable as explained above. An ordinarily skilled artisan may want to optimize for probe size or sound attenuation and thus adjust and optimize the overall thickness to be less than 380 micrometers as a result of routine optimization. Moreover, the claimed range comprising the overall thickness being less than 380 micrometers is merely a workable range as there is no evidence this range is critically important. In addition, because high frequencies are attenuated more per unit thickness, a thinner lens meaning less attenuation predictably allows for higher operating frequencies to be used. See MPEP §2144.05 (II), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
Regarding claim 5, Chen teaches the invention as claimed above in claim 1.
Chen further teaches wherein a speed of sound in the silicone layer (1720) is less than a speed of sound in the cross-linked polystyrene plastic layer (130) to prevent divergence of the acoustic waves generated by the ultrasound probe ([0004], [0053], [0056], the speed of sound in RTV silicone rubber (960-1110 m/s) is less than the speed of sound in cross-linked polystyrene plastic (~2300 m/s)).
Regarding claim 6, Chen teaches the invention as claimed above in claim 1.
However, Chen fails to teach wherein the first thickness is no greater than 125 micrometers and the second thickness is no greater than 255 micrometers, the first thickness measured along a first side edge of the silicone layer and the second thickness measured along a second side edge of the cross-linked polystyrene plastic layer.
While Chen fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the first thickness be no greater than 125 micrometers and the second thickness be no greater than 255 micrometers. Chen teaches a silicone layer (1720) and a cross-linked polystyrene plastic layer (130) having first and second thicknesses respectively (Fig. 17). Chen therefore teaches structurally the same invention as claimed except for an optimized parameter comprising the thicknesses of the silicone and cross-linked polystyrene plastic layer being no greater than 125 and 255 micrometers respectively. The optimized parameter is a result-effective parameter as the thicknesses affect the amount of sound attenuated by the lens and predictably the size of the lens. Thus, it would have been obvious to optimize the claimed parameter, the first and second thicknesses, to be no greater than 125 and 255 micrometers respectively because it is a result-effective variable as explained above. An ordinarily skilled artisan may want to optimize for probe size/thickness or sound attenuation and thus adjust and optimize the first and second thicknesses to be less than 125 and 255 micrometers respectively as a result of routine optimization. Moreover, the claimed range comprising the thicknesses being no greater than 125 and 255 micrometers is merely a workable range as there is no evidence this range is critically important. See MPEP §2144.05 (II), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
Regarding claim 7, Chen teaches the invention as claimed above in claim 1.
Chen further teaches wherein the first flat surface (1724) of the silicone layer (1720) is for patient contact, and the second flat surface of the cross-linked polystyrene plastic layer (130) is to couple to a transducer array (110) (Fig. 17, [0052], wherein the target medium is human tissue, i.e. a patient, [0097], “The CMUT apparatus 1700 may include a CMUT (or a CMUT array), such as the CMUTs 110 or 210 discussed above”, [0118], “For example, the acoustic window may be constructed of a material suitable to contact a target medium”).
Regarding claim 8, Chen teaches an ultrasound probe ([0051], “…such as when the CMUT apparatus is part of a medical probe or other instrument”, [0097], “CMUT apparatus 1700”) comprising:
a transducer array (110) (Fig. 17, [0044], [0097]); and
a compound acoustic lens (1720, 130) coupled to the transducer array (110) (Fig. 17, [0097], “the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”), the compound acoustic lens including:
an acoustic window (1720) having a first flat surface (1724), a convex surface (1722) and a first thickness between the first flat surface (1724) and the convex surface (1722) (Fig. 17, [0097], “an outer surface 1724 may be flat…the curvature of the inside surface 1722 of the acoustic window 1720 may be designed to be either convex as shown in FIG. 17”).
However, Chen fails to expressly disclose wherein the acoustic window (1720) is a silicone layer.
Chen discloses a commonly used acoustic lens material for an ultrasound transducer in medical imaging is RTV silicone rubber (RTV) ([0004]). Chen discloses that in some examples, an acoustic lens may be made of RTV (silicone rubber) ([0053]). Chen further discloses that the acoustic window (1720) may form a compound lens in conjunction with a coupling medium (130), therefore teaching that the acoustic window (1720) functions as and is structurally an acoustic lens (Fig. 17, [0097]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the acoustic window (1720) be formed of an RTV silicone rubber layer as taught by Chen ([0004], [0053], [0097]). Chen discloses that silicone is a known and common material for acoustic lenses ([0004], [0053]), expressly discloses using silicone as material for an acoustic lens ([0053]), and discloses wherein the acoustic window (1720) functions as an acoustic lens ([0097]). Therefore, it would be obvious to have the acoustic window (1720) be formed of silicone and thus result in a silicone layer because doing so would have been a simple substitution of one known acoustic lens material for another (silicone) to obtain the predictably results of an acoustic lens which focuses acoustic energy. One of ordinary skill would therefore have had a reasonable expectation of success in substituting the acoustic window (1720) material with silicone since the substituted material performs the same function in the same manner. See MPEP § 2143 (I)(B), “Simple substitution of one known element for another to obtain predictable results”.
Chen therefore further teaches wherein the compound acoustic lens includes:
a cross-linked polystyrene plastic layer (130) having a second flat surface a concaved surface and a second thickness between the second flat surface and the concaved surface, wherein the concaved surface of the cross-linked polystyrene plastic layer is directly on and mated to the convex surface (1722) of the silicone layer (1720) (Fig. 17, [0056], “Some example solid-based materials suitable for the coupling medium 130 include…cross-linked polystyrene microwave plastic”, [0097], wherein figure 17 shows the flat surface, concaved surface, second thickness, and direct mating with the convex surface 1722 of the silicone layer 1720),
wherein each of the convex surface (1722) of the silicone layer (1720) and the concaved surface of the cross-linked polystyrene plastic layer (130) is curved with a first radius of curvature where the convex surface (1722) of the silicone layer (1720) mates with the concaved surface of the cross-linked polystyrene plastic layer (130) for the compound acoustic lens to focus acoustic waves generated by the ultrasound probe at a first focal length (Fig. 17, Abstract, “the acoustic window or the coupling medium may include a focusing capability for focusing acoustic energy to or from the CMUT”, [0097], “In this example, the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”)
wherein the first radius of curvature is greater than a second radius of curvature of a single material lens consisting of one of the cross-linked polystyrene plastic layer (130) or the silicone layer (1720) having a second focal length that is the same as the first focal length (Chen discloses the same or identical compound acoustic lens structure as claimed; same materials, same concave-convex mating, same focusing function. The claimed radius relationship is a necessary consequence of the structure; it is inherent in the structure. Therefore the disclosed compound lens structure of Chen has the same property as it is inherent to the structure. The ratio of sound speeds across the silicone/cross-linked polystyrene interface (~2.34) is substantially greater than ratio between either material and tissue (~1.5), allowing more refraction, thus allowing for the compound lens to have a greater radius of curvature than a single material lens to reach the same focal length; a strongly refracting interface (silicone-to-cross-linked polystyrene) only needs a gentle curve to focus the beam. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada), and
wherein the first thickness is at a center of the silicone layer (1720) and the second thickness is at a center of the cross-linked polystyrene plastic layer (130), wherein an overall thickness of the compound acoustic lens determined as a sum of the first thickness and the second thickness is less than the thickness at a center of a single material lens of one of the cross-linked polystyrene plastic layer (130) or the silicone layer (1720) having the same focal length as the compound acoustic lens (Similar to above; Chen discloses the same or identical compound acoustic lens structure as claimed. The thickness relationship is related to the radius of curvature; a greater radius of curvature allows for a thinner lens whereas a smaller, e.g. tighter, radius of curvature physically requires a greater thickness. Because the compound acoustic lens taught by Chen has a greater radius of curvature, the overall required thickness of the compound acoustic lens is lesser than that of a single material lens having the same focal length; the thickness relationship is a necessary geometric consequence of the radius relationship already shown. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada).
However, Chen fails to teach wherein the overall thickness of the compound acoustic lens is less than 380 micrometers to increase a range of operating frequencies of the ultrasound probe.
While Chen fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the invention of Chen to have the overall thickness of the compound acoustic lens be less than 380 micrometers. Chen teaches a convex-concave compound acoustic lens (1720, 130) comprised of a silicone layer (1720) and a cross-linked polystyrene layer (130) having an overall thickness (Fig. 17, [0097]). Chen therefore teaches structurally the same invention as claimed except for an optimized parameter being the overall thickness being less than 380 micrometers. The optimized parameter is a result-effective variable because the thicker the lens, the more sound (acoustic waves) is attenuated as the sound has to travel through the lens. Moreover, the thickness of the lens also affects the size of the ultrasound probe it is in; a thinner lens may result in a smaller or more ultrasound probe. Therefore, it would have been obvious to optimize the claimed parameter, the overall thickness of the compound acoustic lens, to be less than 380 micrometers because it is a result-effective variable as explained above. An ordinarily skilled artisan may want to optimize for probe size or sound attenuation and thus adjust and optimize the overall thickness to be less than 380 micrometers as a result of routine optimization. Moreover, the claimed range comprising the overall thickness being less than 380 micrometers is merely a workable range as there is no evidence this range is critically important. In addition, because high frequencies are attenuated more per unit thickness, a thinner lens meaning less attenuation predictably allows for higher operating frequencies to be used. See MPEP §2144.05 (II), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
Regarding claim 14, Chen teaches the invention as claimed above in claim 8.
Chen further teaches wherein a speed of sound in the silicone layer (1720) is less than a speed of sound in the cross-linked polystyrene plastic layer (130) to prevent divergence of the acoustic waves generated by the ultrasound probe ([0004], [0053], [0056], the speed of sound in RTV silicone rubber (960-1110 m/s) is less than the speed of sound in cross-linked polystyrene plastic (~2300 m/s)).
Regarding claim 15, Chen teaches the invention as claimed above in claim 8.
However, Chen fails to teach wherein the first thickness is no greater than 125 micrometers and the second thickness is no greater than 255 micrometers, the first thickness measured along a first side edge of the silicone layer and the second thickness measured along a second side edge of the cross-linked polystyrene plastic layer.
While Chen fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the first thickness be no greater than 125 micrometers and the second thickness be no greater than 255 micrometers. Chen teaches a silicone layer (1720) and a cross-linked polystyrene plastic layer (130) having first and second thicknesses respectively (Fig. 17). Chen therefore teaches structurally the same invention as claimed except for an optimized parameter comprising the thicknesses of the silicone and cross-linked polystyrene plastic layer being no greater than 125 and 255 micrometers respectively. The optimized parameter is a result-effective parameter as the thicknesses affect the amount of sound attenuated by the lens and predictably the size of the lens. Thus, it would have been obvious to optimize the claimed parameter, the first and second thicknesses, to be no greater than 125 and 255 micrometers respectively because it is a result-effective variable as explained above. An ordinarily skilled artisan may want to optimize for probe size/thickness or sound attenuation and thus adjust and optimize the first and second thicknesses to be less than 125 and 255 micrometers respectively as a result of routine optimization. Moreover, the claimed range comprising the thicknesses being no greater than 125 and 255 micrometers is merely a workable range as there is no evidence this range is critically important. See MPEP §2144.05 (II), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20130301394) in view of Tyler (US20160038770).
Regarding claim 2, Chen teaches the invention as claimed above in claim 1.
However, Chen fails to teach wherein the first radius of curvature is at least 10 millimeters.
In an analogous ultrasound device field of endeavor, Tyler teaches such a feature. Tyler teaches an ultrasound system incorporating a compound convex-concave lens and an ultrasound probe (104) (Fig. 1, [0066]). Tyler teaches an ultrasound transducer (201) including a compound lens (Figs. 2A-2D, [0067]). Tyler teaches the compound lens comprises a convex acoustic lens (202) as a top layer and a concave acoustic lens (203) as a bottom layer (Figs. 2A-2D, [0067]). Tyler teaches wherein the radius of curvature of the compound acoustic lens is estimated to be about 21.75 mm ([0067]). Tyler therefore teaches wherein a radius of curvature of a convex-concave lens interface is at least 10 millimeters.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the radius of curvature be about 21.75 mm as taught by Tyler ([0067]). The selected radius of curvature may achieve a particular focus as recognized by Tyler ([0067]). Moreover, a greater radius of curvature may reduce the required size (thickness) of the compound lens and thus reduce the size of the ultrasound device.
Regarding claim 9, Chen teaches the invention as claimed above in claim 8.
However, Chen fails to teach wherein the first radius of curvature is at least 10 millimeters.
In an analogous ultrasound device field of endeavor, Tyler teaches such a feature. Tyler teaches an ultrasound system incorporating a compound convex-concave lens and an ultrasound probe (104) (Fig. 1, [0066]). Tyler teaches an ultrasound transducer (201) including a compound lens (Figs. 2A-2D, [0067]). Tyler teaches the compound lens comprises a convex acoustic lens (202) as a top layer and a concave acoustic lens (203) as a bottom layer (Figs. 2A-2D, [0067]). Tyler teaches wherein the radius of curvature of the compound acoustic lens is estimated to be about 21.75 mm ([0067]). Tyler therefore teaches wherein a radius of curvature of a convex-concave lens interface is at least 10 millimeters.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the radius of curvature be about 21.75 mm as taught by Tyler ([0067]). The selected radius of curvature may achieve a particular focus as recognized by Tyler ([0067]). Moreover, a greater radius of curvature may reduce the required size (thickness) of the compound lens and thus reduce the size of the ultrasound device.
Claims 12-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20130301394) in view of Snyder (US5577507).
Regarding claim 12, Chen teaches the invention as claimed above in claim 8.
However, Chen fails to teach wherein the second flat surface of the cross-linked polystyrene plastic layer is coupled to the transducer array via one or more matching layers.
In an analogous ultrasound probe field of endeavor, Snyder teaches such a feature. Snyder teaches a compound lens (22, 24) for an ultrasound probe (2) having an array (4) of piezoelectric transducer elements (Fig. 3, Abstract, Column 3 line 50 – Column 4 line 10). Snyder teaches wherein a second flat surface of a second layer (22) of the compound lens is coupled to the transducer array (4) via one or more matching layers (12, 14) (Fig. 3, Column 3 line 55 – Column 4 line 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to include matching layers between the transducer array and compound lens as taught by Snyder (Fig. 3, Column 3 line 55 – Column 4 line 4). The matching layers may predictably help lower acoustic impedance mismatch between the transducer array and the human body, thereby improving coupling with a medium in which ultrasound waves will propagate as recognized by Snyder (Column 2 lines 19-29).
Regarding claim 13, Chen teaches the invention as claimed above in claim 8.
However, Chen fails to teach wherein the transducer array includes a piezoelectric transducer.
In an analogous ultrasound probe field of endeavor, Snyder teaches such a feature. Snyder teaches a compound lens (22, 24) for an ultrasound probe (2) having an array (4) of piezoelectric transducer elements (Fig. 3, Abstract, Column 2 lines 58-65, Column 3 line 50 – Column 4 line 10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the transducer array include piezoelectric transducer elements as taught by Snyder (Abstract, Column 2 lines 58-65). The piezoelectric transducer elements may similarly emit and receive ultrasound waves for ultrasonic imaging as recognized by Snyder (Column 1 lines 5-10 and 32-42).
Regarding claim 16, Chen teaches the invention as claimed above in claim 8.
Chen further teaches wherein the first flat surface (1724) of the silicone layer (1720) is for a patient contact (Fig. 17, [0052], wherein the target medium is human tissue, i.e. a patient, [0097], [0118], “For example, the acoustic window may be constructed of a material suitable to contact a target medium”, wherein the target medium may comprise a patient).
However, Chen fails to teach wherein the second flat surface of the cross-linked polystyrene plastic layer is on one or more matching layers of the transducer array.
In an analogous ultrasound probe field of endeavor, Snyder teaches such a feature. Snyder teaches a compound lens (22, 24) for an ultrasound probe (2) having an array (4) of piezoelectric transducer elements (Fig. 3, Abstract, Column 3 line 50 – Column 4 line 10). Snyder teaches wherein a second flat surface of a second layer (22) of the compound lens is coupled to the transducer array (4) via one or more matching layers (12, 14) (Fig. 3, Column 3 line 55 – Column 4 line 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to include matching layers between the transducer array and compound lens as taught by Snyder (Fig. 3, Column 3 line 55 – Column 4 line 4). The matching layers may predictably help lower acoustic impedance mismatch between the transducer array and the human body, thereby improving coupling with a medium in which ultrasound waves will propagate as recognized by Snyder (Column 2 lines 19-29).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20130301394) in view of Samset (US20170112473). Samset is cited in the IDS filed 02/13/2025.
Regarding claim 17, Chen teaches an ultrasound probe having a compound acoustic lens (1720, 130) ([0051], “…such as when the CMUT apparatus is part of a medical probe or other instrument”, [0097], “CMUT apparatus 1700”);
the compound acoustic lens (1720, 130) having (Fig. 17, [0097]):
an acoustic window (1720) having a first flat surface (1724), a convex surface (1722), and a first thickness between the first flat surface (1724) and the convex surface (1722) (Fig. 17, [0097], “an outer surface 1724 may be flat…the curvature of the inside surface 1722 of the acoustic window 1720 may be designed to be either convex as shown in FIG. 17”).
However, Chen fails to expressly disclose wherein the acoustic window (1720) is a silicone layer.
Chen discloses a commonly used acoustic lens material for an ultrasound transducer in medical imaging is RTV silicone rubber (RTV) ([0004]). Chen discloses that in some examples, an acoustic lens may be made of RTV (silicone rubber) ([0053]). Chen further discloses that the acoustic window (1720) may form a compound lens in conjunction with a coupling medium (130), therefore teaching that the acoustic window (1720) functions as and is structurally an acoustic lens (Fig. 17, [0097]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the acoustic window (1720) be formed of an RTV silicone rubber layer as taught by Chen ([0004], [0053], [0097]). Chen discloses that silicone is a known and common material for acoustic lenses ([0004], [0053]), expressly discloses using silicone as material for an acoustic lens ([0053]), and discloses wherein the acoustic window (1720) functions as an acoustic lens ([0097]). Therefore, it would be obvious to have the acoustic window (1720) be formed of silicone and thus result in a silicone layer because doing so would have been a simple substitution of one known acoustic lens material for another (silicone) to obtain the predictably results of an acoustic lens which focuses acoustic energy. One of ordinary skill would therefore have had a reasonable expectation of success in substituting the acoustic window (1720) material with silicone since the substituted material performs the same function in the same manner. See MPEP § 2143 (I)(B), “Simple substitution of one known element for another to obtain predictable results”.
Chen therefore further teaches wherein the compound acoustic lens has:
a cross-linked polystyrene plastic layer (130) having a second flat surface, a concaved surface, and a second thickness between the second flat surface and the concaved surface, wherein the concaved surface of the cross-linked polystyrene plastic layer is directly on and mated to the convex surface (1722) of the silicone layer (1720) (Fig. 17, [0056], “Some example solid-based materials suitable for the coupling medium 130 include…cross-linked polystyrene microwave plastic”, [0097], wherein figure 17 shows the flat surface, concaved surface, second thickness, and direct mating with the convex surface 1722 of the silicone layer 1720),
wherein each of the convex surface (1722) of the silicone layer (1720) and the concaved surface of the cross-linked polystyrene plastic layer (130) is curved with a first radius of curvature where the convex surface (1722) of the silicone layer (1720) mates with the concaved surface of the cross-linked polystyrene plastic layer (130) for the compound acoustic lens to focus acoustic waves generated by the ultrasound probe at a first focal length (Fig. 17, Abstract, “the acoustic window or the coupling medium may include a focusing capability for focusing acoustic energy to or from the CMUT”, [0097], “In this example, the coupling medium 130 may serve, at least in part, as an acoustic lens by forming a compound lens in conjunction with the acoustic window 1720”)
wherein the first radius of curvature is greater than a second radius of curvature of a single material lens consisting of one of the cross-linked polystyrene plastic layer (130) or the silicone layer (1720) having a second focal length that is the same as the first focal length (Chen discloses the same or identical compound acoustic lens structure as claimed; same materials, same concave-convex mating, same focusing function. The claimed radius relationship is a necessary consequence of the structure; it is inherent in the structure. Therefore the disclosed compound lens structure of Chen has the same property as it is inherent to the structure. The ratio of sound speeds across the silicone/cross-linked polystyrene interface (~2.34) is substantially greater than ratio between either material and tissue (~1.5), allowing more refraction, thus allowing for the compound lens to have a greater radius of curvature than a single material lens to reach the same focal length; a strongly refracting interface (silicone-to-cross-linked polystyrene) only needs a gentle curve to focus the beam. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada), and
wherein the first thickness is at a center of the silicone layer (1720) and the second thickness is at a center of the cross-linked polystyrene plastic layer (130), and wherein an overall thickness of the compound acoustic lens determined as a sum of the first thickness and the second thickness is less than the thickness at a center of a single material lens of one of the cross-linked polystyrene plastic layer (130) or the silicone layer (1720) having the same focal length as the compound acoustic lens (Similar to above; Chen discloses the same or identical compound acoustic lens structure as claimed. The thickness relationship is related to the radius of curvature; a greater radius of curvature allows for a thinner lens whereas a smaller, e.g. tighter, radius of curvature physically requires a greater thickness. Because the compound acoustic lens taught by Chen has a greater radius of curvature, the overall required thickness of the compound acoustic lens is lesser than that of a single material lens having the same focal length; the thickness relationship is a necessary geometric consequence of the radius relationship already shown. Where the prior art structure is identical or substantially identical, the burden is on applicant to show the claimed property is not present. See MPEP § 2112 V, § 2112.01 I., In re Best, In re Spada).
However, Chen fails to teach wherein the overall thickness of the compound acoustic lens is less than 380 micrometers to increase a range of operating frequencies of the ultrasound probe.
While Chen fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the invention of Chen to have the overall thickness of the compound acoustic lens be less than 380 micrometers. Chen teaches a convex-concave compound acoustic lens (1720, 130) comprised of a silicone layer (1720) and a cross-linked polystyrene layer (130) having an overall thickness (Fig. 17, [0097]). Chen therefore teaches structurally the same invention as claimed except for an optimized parameter being the overall thickness being less than 380 micrometers. The optimized parameter is a result-effective variable because the thicker the lens, the more sound (acoustic waves) is attenuated as the sound has to travel through the lens. Moreover, the thickness of the lens also affects the size of the ultrasound probe it is in; a thinner lens may result in a smaller or more ultrasound probe. Therefore, it would have been obvious to optimize the claimed parameter, the overall thickness of the compound acoustic lens, to be less than 380 micrometers because it is a result-effective variable as explained above. An ordinarily skilled artisan may want to optimize for probe size or sound attenuation and thus adjust and optimize the overall thickness to be less than 380 micrometers as a result of routine optimization. Moreover, the claimed range comprising the overall thickness being less than 380 micrometers is merely a workable range as there is no evidence this range is critically important. In addition, because high frequencies are attenuated more per unit thickness, a thinner lens meaning less attenuation predictably allows for higher operating frequencies to be used. See MPEP §2144.05 (II), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
However, Chen fails to teach a medical device comprising the ultrasound probe having the compound acoustic lens; a memory storing instructions; and a processor system coupled to the memory and the ultrasound probe that, upon execution of the instructions, is configured to: cause the ultrasound probe to transmit an ultrasound beam through the compound acoustic lens that focuses the ultrasound beam.
In an analogous ultrasound imaging with an ultrasound probe field of endeavor, Samset teaches such a feature. Samset teaches an ultrasound image system or device (100) including an ultrasound probe (126) (Fig. 1, [0022]). Samset teaches the ultrasound probe is coupled to a controller circuit (136) via a transmit circuit (122) which drives the ultrasound probe (126) to emit ultrasonic signals into a patient ([0022]). Samset teaches the controller circuit (136) includes a processor and may execute instructions stored on a memory (140) ([0031]). Samset further teaches wherein the controller circuit (136) may instruct the ultrasound probe (126) to transmit pulses via the transmit circuit (122) ([0050-0051]). Samset further teaches wherein the controller circuit (136) focuses the pulses emitted by the transducer elements (124) at one or more desired focal positions ([0051]). Samset therefore teaches a medical device (100) comprising an ultrasound probe (126), a memory (140) storing instructions, and a processor system (136) coupled to the memory (140) and the ultrasound probe (126) that, upon execution of the instructions, is configured to cause the ultrasound probe (126) to transmit an ultrasound beam. Chen above teaches wherein the ultrasound probe includes the compound acoustic lens which focuses the ultrasound beam.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to include a medical device comprising the ultrasound probe and a memory and corresponding processor to execute instructions therefrom to cause the ultrasound probe to transmit ultrasound as taught by Samset (Fig. 1, [0022], [0031], [0050-0051]). By including the processor and memory, the processor may execute programmed instructions to perform multiple operations such as acquiring and storing ultrasound images as recognized by Samset ([0004], [0033-0034]). Moreover the ultrasound system or device may predictably house the processor, memory, and may further include a display for displaying the ultrasound images acquired by the ultrasound probe as recognized by Samset (Fig. 1).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (US20130301394) in view of Samset (US20170112473) as applied to claim 17 above, and further in view of Tyler (US20160038770). Samset is cited in the IDS filed 02/13/2025.
Regarding claim 18, Chen in view of Samset teaches the invention as claimed above in claim 17.
However, Chen fails to teach wherein the first radius of curvature is at least 10 millimeters.
In an analogous ultrasound device field of endeavor, Tyler teaches such a feature. Tyler teaches an ultrasound system incorporating a compound convex-concave lens and an ultrasound probe (104) (Fig. 1, [0066]). Tyler teaches an ultrasound transducer (201) including a compound lens (Figs. 2A-2D, [0067]). Tyler teaches the compound lens comprises a convex acoustic lens (202) as a top layer and a concave acoustic lens (203) as a bottom layer (Figs. 2A-2D, [0067]). Tyler teaches wherein the radius of curvature of the compound acoustic lens is estimated to be about 21.75 mm ([0067]). Tyler therefore teaches wherein a radius of curvature of a convex-concave lens interface is at least 10 millimeters.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Chen to have the radius of curvature be about 21.75 mm as taught by Tyler ([0067]). The selected radius of curvature may achieve a particular focus as recognized by Tyler ([0067]). Moreover, a greater radius of curvature may reduce the required size (thickness) of the compound lens and thus reduce the size of the ultrasound device.
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 TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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