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 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 1-6, & 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Raju et al (US20110301508A1 ;hereinafter referred to as Raju) in view of Zhao et al (CN209172680U; hereinafter referred to as Zhao).
Regarding Claim 1, Raja discloses a medical device (“A probe includes a shaft on which an ultrasound element is mounted.” [Abstract]) comprising:
an ultrasound applicator (“The present application provides a new and improved transurethral ultrasound probe for thermal ablation “ [0006]) comprising:
a shaft having proximal and distal ends (“The probe includes an axially rotatable ultrasonic element which is supported and rotates congruently with a shaft.” [0007];
a plurality of channels defined in the shaft and extending from the proximal end of the shaft (“The fluid and gas conduits continue through the probe into the shaft 52 as shown in FIG. 5, a cross section of the probe at line 5-5. At the proximal end of the probe, shown in FIG. 6, the additional fluid conduits terminate into luer adapaters 102 and 104. With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040], see Figure 5 for the plurality of channels), including:
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an ultrasound channel, and a cooling channel (“The transducer housing is affixed to a stiff shaft 52, e.g. with epoxy 54, to form a single rigid member. The cooling channels 56 and electrode leads 58 are bundled together and further enclosed in epoxy within the shaft.” [0031]);
one or more ultrasound transducers disposed in the ultrasound channel (“A transurethral probe 40 for delivering therapeutic ultrasound to prostate tissues is operated by the surgeon or clinician. The probe is localized using real-time MRI imaging. Continuing with reference to FIGS. 2, 7A, and 7B, therapeutic ultrasound energy is directed toward the prostate by energizing an ultrasound array 42 at the distal end of the probe 40. The ultrasound array may contain a single or a plurality of ultrasound transducers elements stacked on a transducer housing 44.” [0030]);
an ultrasound window defined in the shaft and aligned with the one or more ultrasound transducers (“A transurethral probe 40 for delivering therapeutic ultrasound to prostate tissues is operated by the surgeon or clinician. The probe is localized using real-time MRI imaging. Continuing with reference to FIGS. 2, 7A, and 7B, therapeutic ultrasound energy is directed toward the prostate by energizing an ultrasound array 42 at the distal end of the probe 40. The ultrasound array may contain a single or a plurality of ultrasound transducers elements stacked on a transducer housing 44.” [0030]);
and a handle attached to the proximal end of the shaft (“the plug housing 70 can be attached to a rotator housing 80 which includes mechanical means for rotating the ultrasound device 62. Optionally, the ultrasound device can be rotated manually by an operator.“ [0035], see Fig. 1 for system overview as well as plug housing 70);
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and a fluid-collection ring disposed on a distal side of the handle configured to direct fluid away from the handle (“ With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040], “the plug housing 70 can be detachable connected to the rotator housing 80. The attachment and/or detachment means can be an electric plug connector 110 (FIG. 10A-10C). In this manner, the probe can be positioned in the urethra without the rotator housing. Once the probe is positioned relative to the prostate, the rotator housing can be connected to the probe via the plug housing and therapy can commence.” [0044]).
Raja does not specifically disclose the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape.
However, in a similar field of endeavor, Zhao teaches a utility model related to the technical field of medical instruments, in particular to an external auditory canal irrigation device [Pg 1].
Zhao also teaches the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83… wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 2, Raja discloses the distal side of the fluid-collection ring is configured to conform to an entry point of a mammalian body (“the plug housing 70 can be detachable connected to the rotator housing 80. The attachment and/or detachment means can be an electric plug connector 110 (FIG. 10A-10C). In this manner, the probe can be positioned in the urethra without the rotator housing. Once the probe is positioned relative to the prostate, the rotator housing can be connected to the probe via the plug housing and therapy can commence.” [0044]).
Regarding Claim 3, Raja discloses the distal side of the fluid-collection ring is configured to conform to a tip of a penis (“the plug housing 70 can be detachable connected to the rotator housing 80. The attachment and/or detachment means can be an electric plug connector 110 (FIG. 10A-10C). In this manner, the probe can be positioned in the urethra without the rotator housing. Once the probe is positioned relative to the prostate, the rotator housing can be connected to the probe via the plug housing and therapy can commence.” [0044]).
Regarding Claim 4, Raja discloses a proximal side of the fluid-collection ring is attached to the distal side of the handle such that a rotational orientation of the fluid-collection ring remains stationary when the shaft is rotated (“The plug housing is attached to the outer sheath 64 so that the outer portion of the probe (the sheath 64 and acoustic membrane 66) can be held mechanically avoiding movement during rotation of the enclosed ultrasound device 62. The fluid conduits 56 terminate into luer adapters 72 made from plastic or similar material.” [0034], “With continuing reference to FIG. 1, the plug housing 70 can be attached to a rotator housing 80 which includes mechanical means for rotating the ultrasound device 62. Optionally, the ultrasound device can be rotated manually by an operator.” [0035]).
Regarding Claim 5, Raja discloses all limitations noted above except the inner edge and the shaft form a fluid-tight seal.
However, in a similar field of endeavor, Zhao teaches the inner edge and the shaft form a fluid-tight seal (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83, lower end of the ear 8 by a compression spring 82, liquid outlet is connected with the connecting hose 90 screw thread; the connecting hose 90 connected with the soiling solution collecting bag 9 bag opening at the other end. two sides of the soiling solution collecting bag 9 bag opening respectively 91 two ends fixedly connected with the fixing rope. wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the inner edge and the shaft form a fluid-tight seal as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 6, Raja discloses all limitations noted above except the inner edge and the shaft define a fluid-collection channel and the medical device further comprises a fluid-collection reservoir that is fluidly coupled to the fluid-collection channel.
However, in a similar field of endeavor, Zhao teaches the inner edge and the shaft define a fluid-collection channel and the medical device further comprises a fluid-collection reservoir that is fluidly coupled to the fluid-collection channel (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83, lower end of the ear 8 by a compression spring 82, liquid outlet is connected with the connecting hose 90 screw thread; the connecting hose 90 connected with the soiling solution collecting bag 9 bag opening at the other end. two sides of the soiling solution collecting bag 9 bag opening respectively 91 two ends fixedly connected with the fixing rope. wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the inner edge and the shaft define a fluid-collection channel and the medical device further comprises a fluid-collection reservoir that is fluidly coupled to the fluid-collection channel as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 8, Raja discloses further comprising complementary keyed projections disposed on a proximal side of the fluid-collection ring and the distal side of the handle, the complementary keyed projections configured to mechanically engage one another to limit a rotation of the fluid-collection ring with respect to the shaft (“the plug housing 70 can be detachable connected to the rotator housing 80. The attachment and/or detachment means can be an electric plug connector 110 (FIG. 10A-10C). In this manner, the probe can be positioned in the urethra without the rotator housing. Once the probe is positioned relative to the prostate, the rotator housing can be connected to the probe via the plug housing and therapy can commence.” [0044]).
Regarding Claim 9, Raja discloses the fluid-collection ring comprises a biocompatible polymer or a biocompatible plastic (“the proximal end of the probe terminates into a plug housing 70. The plug housing is attached to the outer sheath 64 so that the outer portion of the probe (the sheath 64 and acoustic membrane 66) can be held mechanically avoiding movement during rotation of the enclosed ultrasound device 62. The fluid conduits 56 terminate into luer adapters 72 made from plastic or similar material.” [0034]).
Regarding Claim 10, Raja discloses a drainage hole is defined through a proximal side and the distal side of the fluid-collection ring and the medical device further comprises a drainage tube fluidly coupled to the drainage hole on the proximal side of the fluid-collection ring (“With reference to FIGS. 4A and 4B, in one embodiment a positioning balloon 90 and a drainage system 92 are included adjacent the distal tip of the probe. Although illustrated closer to the distal end than the ultrasound array, it is to be appreciated that the ultrasonic array could be closer to the distal end. With appropriate acoustic materials, the balloon could surround the ultrasonic array. The positioning balloon is inflated, e.g. in the bladder, to fix the translational position of the probe in place. Optionally, the positioning balloon can fix the rotational position of the probe. Included with the positioning balloon, a catheter with a drain eye or aperture 94 to drain the urine from the bladder or other fluids that make up the drainage system. The catheter travels through the positioning balloon and includes an inflation eye 96 for supplying fluid to inflate the balloon. The drain eye and inflation eye are connected to a fluid drain conduit 98 and an inflation fluid conduit 100 respectively that are housed within the catheter. The fluid and gas conduits continue through the probe into the shaft 52 as shown in FIG. 5, a cross section of the probe at line 5-5. At the proximal end of the probe, shown in FIG. 6, the additional fluid conduits terminate into luer adapaters 102 and 104. With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040]).
Regarding Claim 11, Raja discloses all limitations noted above except the fluid-collection ring is elongated with respect to a first axis compared to with respect to a second axis, the shaft extending along a third axis, the first, second, and third axes mutually orthogonal.
However, in a similar field of endeavor, Zhao teaches the fluid-collection ring is elongated with respect to a first axis compared to with respect to a second axis, the shaft extending along a third axis, the first, second, and third axes mutually orthogonal (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83, lower end of the ear 8 by a compression spring 82, liquid outlet is connected with the connecting hose 90 screw thread; the connecting hose 90 connected with the soiling solution collecting bag 9 bag opening at the other end. two sides of the soiling solution collecting bag 9 bag opening respectively 91 two ends fixedly connected with the fixing rope. wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the fluid-collection ring is elongated with respect to a first axis compared to with respect to a second axis, the shaft extending along a third axis, the first, second, and third axes mutually orthogonal as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 12, Raja discloses a medical apparatus (“A probe includes a shaft on which an ultrasound element is mounted.” [Abstract]) comprising:
an ultrasound applicator (“The present application provides a new and improved transurethral ultrasound probe for thermal ablation “ [0006]) comprising:
a shaft having proximal and distal ends (“The probe includes an axially rotatable ultrasonic element which is supported and rotates congruently with a shaft.” [0007];
a plurality of channels defined in the shaft and extending from the proximal end of the shaft (“The fluid and gas conduits continue through the probe into the shaft 52 as shown in FIG. 5, a cross section of the probe at line 5-5. At the proximal end of the probe, shown in FIG. 6, the additional fluid conduits terminate into luer adapaters 102 and 104. With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040], see Figure 5 for the plurality of channels), including:
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an ultrasound channel, and a cooling channel (“The transducer housing is affixed to a stiff shaft 52, e.g. with epoxy 54, to form a single rigid member. The cooling channels 56 and electrode leads 58 are bundled together and further enclosed in epoxy within the shaft.” [0031]);
one or more ultrasound transducers disposed in the ultrasound channel (“A transurethral probe 40 for delivering therapeutic ultrasound to prostate tissues is operated by the surgeon or clinician. The probe is localized using real-time MRI imaging. Continuing with reference to FIGS. 2, 7A, and 7B, therapeutic ultrasound energy is directed toward the prostate by energizing an ultrasound array 42 at the distal end of the probe 40. The ultrasound array may contain a single or a plurality of ultrasound transducers elements stacked on a transducer housing 44.” [0030]);
an ultrasound window defined in the shaft and aligned with the one or more ultrasound transducers (“A transurethral probe 40 for delivering therapeutic ultrasound to prostate tissues is operated by the surgeon or clinician. The probe is localized using real-time MRI imaging. Continuing with reference to FIGS. 2, 7A, and 7B, therapeutic ultrasound energy is directed toward the prostate by energizing an ultrasound array 42 at the distal end of the probe 40. The ultrasound array may contain a single or a plurality of ultrasound transducers elements stacked on a transducer housing 44.” [0030]);
and a handle attached to the proximal end of the shaft (“the plug housing 70 can be attached to a rotator housing 80 which includes mechanical means for rotating the ultrasound device 62. Optionally, the ultrasound device can be rotated manually by an operator.“ [0035], see Fig. 1 for system overview as well as plug housing 70);
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and a fluid-collection ring disposed on a distal side of the handle (“ With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040], “the plug housing 70 can be detachable connected to the rotator housing 80. The attachment and/or detachment means can be an electric plug connector 110 (FIG. 10A-10C). In this manner, the probe can be positioned in the urethra without the rotator housing. Once the probe is positioned relative to the prostate, the rotator housing can be connected to the probe via the plug housing and therapy can commence.” [0044]).
Raja does not specifically disclose the fluid-collection ring having an inner edge, an outer edge, and a fluid-collection channel defined on a distal side of the fluid-collection ring, the inner edge defining a hole through which the shaft extends.
However, in a similar field of endeavor, Zhao teaches a utility model related to the technical field of medical instruments, in particular to an external auditory canal irrigation device [Pg 1].
Zhao also teaches the fluid-collection ring having an inner edge, an outer edge, and a fluid-collection channel defined on a distal side of the fluid-collection ring, the inner edge defining a hole through which the shaft extends (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83… wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4])
It would have been obvious to an ordinary skilled person in the art before the effective filing date of the claimed invention to modify the system of Raja as outlined above with the fluid-collection ring having an inner edge, an outer edge, and a fluid-collection channel defined on a distal side of the fluid-collection ring, the inner edge defining a hole through which the shaft extends as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 13, Raja discloses all limitations noted above except the fluid-collection channel is defined only on a distal surface of the fluid-collection ring.
However, in a similar field of endeavor, Zhao teaches the fluid-collection channel is defined only on a distal surface of the fluid-collection ring (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83… wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the fluid-collection channel is defined only on a distal surface of the fluid-collection ring as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 14, Raja discloses all limitations noted above except that the hole is a first hole, and the fluid-collection channel extends to a second hole defined in the outer edge of the fluid-collection ring.
However, in a similar field of endeavor, Zhao teaches the hole is a first hole, and the fluid-collection channel extends to a second hole defined in the outer edge of the fluid-collection ring (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83… wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above the hole is a first hole, and the fluid-collection channel extends to a second hole defined in the outer edge of the fluid-collection ring as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 15, Raja discloses all limitations noted above except the second hole is oriented at a bottom of the fluid- collection channel when the shaft is oriented parallel to a horizontal axis.
However, in a similar field of endeavor, Zhao teaches the second hole is oriented at a bottom of the fluid- collection channel when the shaft is oriented parallel to a horizontal axis (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83… wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the second hole is oriented at a bottom of the fluid- collection channel when the shaft is oriented parallel to a horizontal axis as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Regarding Claim 16, Raja discloses a medical apparatus (“A probe includes a shaft on which an ultrasound element is mounted.” [Abstract]) comprising:
an ultrasound applicator (“The present application provides a new and improved transurethral ultrasound probe for thermal ablation “ [0006]) comprising:
a shaft having proximal and distal ends (“The probe includes an axially rotatable ultrasonic element which is supported and rotates congruently with a shaft.” [0007];
a plurality of channels defined in the shaft and extending from the proximal end of the shaft (“The fluid and gas conduits continue through the probe into the shaft 52 as shown in FIG. 5, a cross section of the probe at line 5-5. At the proximal end of the probe, shown in FIG. 6, the additional fluid conduits terminate into luer adapaters 102 and 104. With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040], see Figure 5 for the plurality of channels), including:
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an ultrasound channel, and a cooling channel (“The transducer housing is affixed to a stiff shaft 52, e.g. with epoxy 54, to form a single rigid member. The cooling channels 56 and electrode leads 58 are bundled together and further enclosed in epoxy within the shaft.” [0031]);
one or more ultrasound transducers disposed in the ultrasound channel (“A transurethral probe 40 for delivering therapeutic ultrasound to prostate tissues is operated by the surgeon or clinician. The probe is localized using real-time MRI imaging. Continuing with reference to FIGS. 2, 7A, and 7B, therapeutic ultrasound energy is directed toward the prostate by energizing an ultrasound array 42 at the distal end of the probe 40. The ultrasound array may contain a single or a plurality of ultrasound transducers elements stacked on a transducer housing 44.” [0030]);
an ultrasound window defined in the shaft and aligned with the one or more ultrasound transducers (“A transurethral probe 40 for delivering therapeutic ultrasound to prostate tissues is operated by the surgeon or clinician. The probe is localized using real-time MRI imaging. Continuing with reference to FIGS. 2, 7A, and 7B, therapeutic ultrasound energy is directed toward the prostate by energizing an ultrasound array 42 at the distal end of the probe 40. The ultrasound array may contain a single or a plurality of ultrasound transducers elements stacked on a transducer housing 44.” [0030]);
and a handle attached to the proximal end of the shaft (“the plug housing 70 can be attached to a rotator housing 80 which includes mechanical means for rotating the ultrasound device 62. Optionally, the ultrasound device can be rotated manually by an operator.“ [0035], see Fig. 1 for system overview as well as plug housing 70);
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a fluid-collection ring disposed on a distal side of the handle configured to direct fluid away from the handle (“ With continuing reference to FIG. 1, luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder.” [0040], “the plug housing 70 can be detachable connected to the rotator housing 80. The attachment and/or detachment means can be an electric plug connector 110 (FIG. 10A-10C). In this manner, the probe can be positioned in the urethra without the rotator housing. Once the probe is positioned relative to the prostate, the rotator housing can be connected to the probe via the plug housing and therapy can commence.” [0044]).
and a power supply electrically coupled to the one or more ultrasound transducers (“The electrical leads 58 from the ultrasound array continue through the shaft 52, plug housing 70, and rotator housing 80 to an ultrasound generator 86. The ultrasound generator is made up of RF power amplifiers, an RF power monitoring system,” [0036]);
a reservoir configured to store a cooling fluid, the reservoir fluidly coupled to the cooling channel; and a pump that circulates the cooling fluid between the reservoir and the cooling channel (“The luer connectors 72 at the terminal end of the fluid conduits 56 attach to a cooling unit 88. The cooling unit is made up of a refrigeration unit for cooling the fluid and maintaining the cooled temperature; additionally, the cooling unit includes a recirculation pump configured to recirculate the fluid and optionally is capable of removing bubbles formed during the ultrasound therapy. A suitable cooling and coupling fluid is degassed water, but other fluids are contemplated.” [0037]).
Raja does not specifically disclose the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape.
However, in a similar field of endeavor, Zhao teaches a utility model related to the technical field of medical instruments, in particular to an external auditory canal irrigation device [Pg 1].
Zhao also teaches the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape (“the soiling solution collecting device comprises a fixed sleeve 83, a compression spring 82, ear 8, a connecting hose 90, soiling solution collecting bag 9, rope 91, the fixed sleeve 83 connected with the front screw thread of the gun body 1, cap 8 and right end of the sliding hole 80. the sliding hole 80 of the cleaning head 2 on the cap 8 the right end is opened with liquid outlet connected with the fixing sleeve 83… wherein, the ear 8 is bowl-shaped structure and the cross section is oval, the ear 8 is fixed with a silicon rubber gasket 81.” [Pg. 4])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape as taught by Zhao, because it allows for the collecting of dirty liquid to be simple to operate and convenient to use [Pg.2].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Raju in view of Zhao as applied to Claim 1 above, and further in view of Ergun et al (US20190076674A1; hereinafter referred to as Ergun)
Regarding Claim 7, Raja in view of Zhao discloses all limitations noted above except the fluid-collection reservoir is disposed in the handle.
However, in a similar field of endeavor, Ergun teaches a medical device includes a capacitive micromachined ultrasonic transducer (CMUT) array configured to emit ultrasound to target tissue [Abstract].
Ergun also teaches the fluid-collection reservoir is disposed in the handle (“Catheter sleeve 2900 may further include a fluid port 2930 at distal end 104 and a conduit 2932 that passes a fluid received from a part of body channel 392 via fluid port 2930, through catheter sleeve 2900, to proximate end 102, and out of catheter sleeve 2900.” [0175], “Handle 3860 may further include a fluid handler 3820 that receives and handles fluid passed through conduit 2932 from fluid port 2930.” [0211])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Raja as outlined above with the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape as taught by Zhao, because it allows passage of urine from bladder through catheter sleeve and out of urethra, while being pliable for patient comfort [0181]).
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
Regarding the U.S.C. 103 rejection of claims 16, & 8-16 the applicant argues the following:
The Office Action states that Raju discloses a fluid-collection ring disposed on a distal side of the handle and that the ear 8 of Zhao corresponds to the specific limitations of the fluid-collection ring.
With respect to Raju, the Office Action indicates that the plug housing 70 corresponds to the claimed handle and that the "luer adapter 102 is connected to a drain unit 110 which collects the urine drained from the bladder" (Raju [0040], quoted in Office Action) corresponds to "a fluid-collection ring disposed on a distal side of the handle configured to direct fluid away from the handle." Office Action, p. 4.
The luer adaptor 102 is not a fluid-collection ring (or even a ring). Moreover, it is located on the proximal side of the alleged handle (plug housing 70), as shown in Fig. 6 (below). Raju does not disclose or suggest that the luer adaptor 102 can be disposed on the distal side of the plug housing 70 (the alleged handle).
The alleged combination of Raju and Zhao fails because even if the ear 8 (Zhao) is placed on the distal side of the plug housing 70 (the alleged handle) (Raju), the shaft 52 (Raju) would not extend through the ear 8. Rather, the sheath 64 (Raju) would extend through the ear 8. In order for the shaft 52 to extend through the ear 8 in the alleged Raju-Zhao combination, the sheath 64 would need to be removed. However, removing the sheath 64 would render the modified transurethral ultrasound probe 40 unsatisfactory for its intended purpose.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is first noted that Applicants interpretation of Raju’s luer adaptor 102 is framed incorrectly, it is true that the luer adaptor 102 is positioned proximally; however, the purpose of the luer adaptor is to show there is a fluid collection system described within Raju. As described in paragraph [0040] from Raju’s specification, the fluid collection system first begins at the distal end of the probe system at aperture 94 which initiates the fluid collection and carries the fluid through fluid conduits 98,100,56 of the probe and finally into luer adaptor 102 which carries the fluids to a drain unit 110 (See Fig. 4 below).
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It is then noted that the fluid collection ring limitation is fully taught through combination with Zhao which teaches a fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape [Pg. 4]. Applicant notes that combination would fail because “even if the ear 8 (Zhao) is placed on the distal side of the plug housing 70 (the alleged handle) (Raju), the shaft 52 (Raju) would not extend through the ear 8.”. This is once again an incorrectly framed argument, at no point in the office action is the Sheath 64 removed from Raju in order to satisfy the combination. The combination is merely using the fluid collection system of Zhao in combination with the probe of Raju; as mentioned above Raju has a distal beginning of its fluid collection system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure (EP3508180B1).
THIS ACTION IS MADE FINAL. 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 STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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