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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto et. al. (U.S. 20210169312, June 10, 2021)(hereinafter, “Morimoto”) in view of Sabado et. al. (U.S. 10335233, July 2, 2019)(hereinafter, “Sabado”) and Spero (U.S. 20190133696, May 9, 2019)(hereinafter, “Spero”).
Regarding Claim 1, Morimoto teaches: An interventional endoscope (Fig.1 , element 10, ultrasonic endoscope, [0039]) comprising:
a cannula (Fig. 1, element 20, insertion section, [0039]) having a distal end, a proximal end, and a longitudinal axis therebetween (“The insertion section 20 has a distal end, a proximal end, and a longitudinal axis; and has a distal end portion 50, a bending portion 52, and a soft portion 54 that are arranged in order from the distal end side toward the proximal end side.” [0046]. See Fig. 1)
an optical imaging element at the distal end of the cannula (“The endoscope observation portion 80 has the observation window 88 provided in the first inclined surface 86A…in a region in the outer case 72 and behind the observation window 88, an observation optical system (an objective lens and the like) that constitutes the endoscope observation portion 80, an imaging device such as a CCD (Charge Coupled Device) or a CMOS (Complementary Metal Oxide Semiconductor) device, and the like are disposed.” [0068]. See Figs. 3-4);
an ultrasonic imaging element at the distal end of the cannula, said ultrasonic imaging element being configured to image along an image path (“As illustrated in FIG. 1, the ultrasonic inspection system 2 includes an ultrasonic endoscope 10 that captures an image of the inside of a lumen 154 (also called a body cavity, see FIG. 12) of a subject to be examined, an ultrasonic processor device 12 that generates an ultrasound image, an endoscopic processor device 14 that generates an endoscopic image…” [0038]. See Fig. 1);
a treatment element configured to be deployed from the cannula along a treatment path (“In the outer case 72, from the outer case distal end side toward the outer case proximal end side, an ultrasonic observation portion 60 that acquires an ultrasonic detection signal, the treatment tool lead-out port 94 for a treatment tool, a first inclined surface 86A, a second inclined surface 86B, and an endoscope observation portion 80 that acquires an image pick-up signal are provided…” [0061]. See Figs. 1 and 3), wherein the treatment element does not comprise the ultrasonic imaging element ([0038][0061],See Figs. 1 and 3), and wherein the imaging path and the treatment path intersect at an intersectional location spaced away from the cannula (“FIG. 3, a direction perpendicular to both of the longitudinal axis LA and the normal direction NV of the opening surface of the treatment tool lead-out port 94 will be referred to as the “width direction WD” of the treatment tool lead-out port 94, one side in the width direction WD will be referred to as the “L side”, and the other side opposite to the one side in the width direction WD will be referred to as the “R side”.” [0062]. See Figs. 1 and 3);
and a display configured to present both an optical image from the optical imaging element and an ultrasonic image from the ultrasonic imaging element (“…a monitor 18 that displays the ultrasound image and the endoscopic image…” [0038]; “It is possible to selectively display only one of the ultrasound image and the endoscopic image or to display both of these images.” [0044]. See Fig. 1).
Morimoto does not explicitly teach: a hysteroscope and wherein the display is further configured to present a marker on the ultrasonic image at a location corresponding to the intersectional location.
Sabado in the field of endoscope systems teaches: “…A hysteroscope is an endoscope that carries optical and light channels or fibers.” (column 3, lines 26-28); “System 100 comprises an endoscope capable of accessing the uterus through the cervix (hysteroscope 102). Management of hysteroscope 102 is monitored on a video monitor 104.” (column 5, lines 38-41).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the endoscope of Morimoto to be a hysteroscope as taught in Sabado for “…treatment of gynecological conditions and in particular for minimally invasive laser treatment of uterine growths, including myopias, polyps and adhesions…” (Sabado, column 1, lines 16-19).
The combination of references does not teach: the display is further configured to present a marker on the ultrasonic image at a location corresponding to the intersectional location.
Spero in the field of ultrasound imaging systems visualization teaches: “A second GUI 350′ may show a two-dimensional representation (e.g., avatar) of the ultrasound transducer 228 and the ablation device 16 in real time as they are being positioned within the abdominal cavity. It places the image from the ultrasound machine onto a virtual ultrasound transducer plane 352 and displays a “Target Zone” with, e.g., purple lines, as an indicator of where the ablation device 16 shaft will intersect the ultrasound transducer plane 352.” [0086].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the display of the combination of references to include an intersectional location where the display presents a marker corresponding to the intersectional location as taught in Spero to enhance operational performance with more precise procedures that has increased amount of information available to the user reducing “…collateral damage and shorten recovery time as well as enhance survival rates.” (Spero, [0003][0008]).
Regarding Claim 2, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
Morimoto further teaches: further comprising a display disposed on a handle attached to the proximal end of the cannula (“…an ultrasonic processor device 12 that generates an ultrasound image, an endoscopic processor device 14 that generates an endoscopic image, a light source device 16 that supplies to the ultrasonic endoscope 10 illumination light for illuminating the inside of the lumen 154, and a monitor 18 that displays the ultrasound image and the endoscopic image.” [0038]; “The insertion section 20 is inserted into the lumen 154…of various types. The operation section 22 is joined to the proximal end side of the insertion section 20 and receives an operation by an operator.” [0040]. See Figs. 1-2).
Regarding Claim 3, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
Morimoto does not teach: wherein the cannula comprises one or more lumens for one or more of an endoscope, an ultrasound source, a guide channel for directing the treatment element into the intersection, fluid irrigation and fluid evacuation channels, and a working channel for an additional operating instrument.
Sabado in the field of endoscope systems teaches: “Management of hysteroscope 102 is monitored on a video monitor 104. Hysteroscope 102 also accepts insertion of optical fiber 106 through fiber channel 108 conveying energy from laser source 110, and other channels such as an illumination channel (not shown) or irrigation channels 112 for clearing the surface of substances that prevent good vision. Irrigation channel 112 is also good for inserting a fluid to spread uterus open for easier access.” (column 5, lines 40-47). See Fig. 1.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the in the combination of references to comprise one or more lumens for one or more of an endoscope, an ultrasound source, a guide channel for directing the treatment element into the intersection, fluid irrigation and fluid evacuation channels, and a working channel for an additional operating instrument as taught in Sabado for “…treatment of gynecological conditions and in particular for minimally invasive laser treatment of uterine growths, including myopias, polyps and adhesions…” (Sabado, column 1, lines 16-19).
Regarding Claim 4, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
Morimoto further teaches: wherein the endoscope comprises a CMOS chip and a transparent or semi-transparent tip at a distal end of the endoscope, wherein the distal end of the endoscope comprises the optical imaging element (“The endoscope observation portion 80 has the observation window 88 provided in the first inclined surface 86A…in a region in the outer case 72 and behind the observation window 88, an observation optical system (an objective lens and the like) that constitutes the endoscope observation portion 80, an imaging device such as a…CMOS (Complementary Metal Oxide Semiconductor) device, and the like are disposed.” [0068]. See Figs. 3-4).
Regarding Claim 5, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
Morimoto further teaches: wherein the transparent or semi-transparent tip is configured to preserve a visual image upon contact with a tissue (“The endoscope observation portion 80 has the observation window 88 provided in the first inclined surface 86A…in a region in the outer case 72 and behind the observation window 88, an observation optical system (an objective lens and the like) that constitutes the endoscope observation portion 80, an imaging device such as a…CMOS (Complementary Metal Oxide Semiconductor) device, and the like are disposed.” [0068]; “…the first illumination window 90A and the second illumination window 90B each emit illumination light in the forward direction thereof. In a region in the outer case 72 and behind the illumination windows 90A and 90B, the emission ends of the aforementioned light guides 128 are disposed.” [0069] See Figs. 3-4).
Regarding Claim 6, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
Morimoto further teaches: wherein the endoscope and the ultrasound source are configured to be disposed in a single lumen in the cannula (“…the ultrasonic inspection system 2 includes an ultrasonic endoscope 10 that captures an image of the inside of a lumen 154 (also called a body cavity, see FIG. 12) of a subject to be examined, an ultrasonic processor device 12 that generates an ultrasound image, an endoscopic processor device 14 that generates an endoscopic image, a light source device 16 that supplies to the ultrasonic endoscope 10 illumination light for illuminating the inside of the lumen 154, and a monitor 18 that displays the ultrasound image and the endoscopic image.” [0038]; “…a treatment tool inserted into the treatment tool insertion port 44 is led into the lumen 154 (see FIG. 12) from the treatment tool lead-out port 94 via the treatment tool insertion channel 100…” [0077]).
Regarding Claim 10, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
Morimoto further teaches: wherein the imaging path and the treatment path are laterally oriented such that an angle between the imaging path and the treatment path is between 0 degrees and 45 degrees ([0038][0061-0062]. See Figs. 1 and 3-4).
Claims 7-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto, Sabado and Spero as applied to claim 1, and further in view Sharma et. al. (U.S. 20210059749, March 4, 2021)(hereinafter, “Sharma”).
Regarding Claim 7, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
wherein the treatment element comprises a superelastic needle, wherein a distal end on the superelastic needle comprises a diverging array of needle segments.
Morimoto teaches a treatment element: (“In the outer case 72, from the outer case distal end side toward the outer case proximal end side, an ultrasonic observation portion 60 that acquires an ultrasonic detection signal, the treatment tool lead-out port 94 for a treatment tool, a first inclined surface 86A, a second inclined surface 86B, and an endoscope observation portion 80 that acquires an image pick-up signal are provided…” [0061]. See Figs. 1 and 3).
The combination of references does not teach: wherein the treatment element comprises a superelastic needle.
Sharma in the field of prostate and uterine treatment systems teaches: “…inserting a hysteroscope through the cervix and into a uterus of a patient. …a hollow shaft through which an ablative agent can travel, a puncturing tip at its distal end, at least one positioning element, and a plurality of needles on a distal end of the catheter and configured to deliver ablative agent to said uterine fibroid.” [0451].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the treatment element in the combination of references to comprise a superelastic needle as taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]).
Regarding Claim 8, the combination of Morimoto, Sabado, Spero and Sharma teach the claim limitations as noted above.
The combination of references Morimoto, Sabado and Spero does not teach: further comprising a needle lumen having a laterally deflected distal portion relative to the longitudinal axis of the cannula, wherein the superelastic needle is slidably mounted in the lumen so that a distal portion of the needle deflects laterally relative to the longitudinal axis of the cannula as the needle is advanced longitudinally through the lumen.
Sharma in the field of prostate and uterine treatment systems teaches: “… a handle 29104 having actuators 29106, 29108 for extending at least one needle or a plurality of needles 29110 from a distal end of the catheter 29112 and expanding a positioning element 29114 at the distal end of the catheter 29112….actuators 29106 and 29108 may be…a slide…to enable extending of at least one needle from the plurality of needles 29110.” [0463]. See Figs. 1A and 29.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the needle in the combination of references to include a needle lumen having a laterally deflected distal portion relative to the longitudinal axis of the shaft, wherein the superelastic needle is slidably mounted in the lumen so that a distal portion of the needle deflects laterally relative to the longitudinal axis of the shaft as the needle is advanced longitudinally through the lumen as taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]).
Regarding Claim 11, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
The combination of references does not teach: further comprising one or more electrodes disposed in one or more channels in the cannula, wherein the one or more electrodes are configured to supply power to the optical imaging element and the ultrasonic imaging element.
Sharma in the field of prostate and uterine treatment systems teaches: “ FIG. 1C illustrates a transverse cross-section view 122a and a longitudinal cross-section view 122b of a first array of electrodes 136 along with a transverse cross-section view 123a and a longitudinal cross-section view 123b of a second array of electrodes 138 of a flexible heating chamber for a catheter…FIGS. 1D and 1E are, respectively, transverse and longitudinal cross-section views 124, 125 of the heating chamber 130 including assembled first and second electrodes 136, 138.” [0281]; “…the heating chamber 130 comprises an outer covering 132 and a coaxial inner core, channel, or lumen 134. A plurality of electrodes, configured as first and second arrays of electrodes 136, 138, is disposed between the outer covering 132 and the inner lumen 134.” [0282].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the combination of references to include one or more electrodes disposed in one or more channels in the cannula, wherein the one or more electrodes are configured to supply power to the optical imaging element and the ultrasonic imaging element as taught in Sharma “…to prevent users from being burned while manipulating the catheter, including insulation, and optionally, cool air flush, cool water flush, and alarms/tones to indicate start and stop of treatment.” (Sharma, [0280]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Morimoto, Sabado and Spero as applied to claims 1, and further in view of Morita (U.S. 5596989, January 28, 1997)(hereinafter, “Morita”).
Regarding Claim 9, the combination of Morimoto, Sabado and Spero teach the claim limitations as noted above.
The combination of references does not teach: further comprising a rotating mirror at the distal end of the cannula, wherein the ultrasonic imaging element faces proximally into the rotating mirror, wherein the rotating mirror reflects outgoing and incoming ultrasound energy laterally relative to the longitudinal axis of the cannula.
Morita in the field of ultrasound endoscope systems teaches: “The ultrasonic probe 10 is a mechanical ultrasonic probe capable of scanning it by rotating a mirror, and comprises the ultrasonic transducer 1 displaced in such a manner that the oscillating direction of the piezo-electric element is directed to the axial direction of the ultrasonic probe, the concave acoustic lens 2 provided to connect to the ultrasonic transducer 1, and the convex acoustic mirror 31. In case of adding the concave acoustic lens 2 to the ultrasonic transducer 1 as a focusing element, and the convex ultrasonic mirror 31 is used as the ultrasonic mirror 3, the ultrasonic generating unit and the ultrasonic mirror are so arranged and set that the distance between the convex mirror 31 and the concave acoustic lens 2 on the acoustic axial is made shorter than the focal length of the concave acoustic lens 2.” (column 4-5, lines 63-9)
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to further comprising a rotating mirror at the distal end of the cannula, wherein the ultrasonic imaging element faces proximally into the rotating mirror, wherein the rotating mirror reflects outgoing and incoming ultrasound energy laterally relative to the longitudinal axis of the cannula as taught in Morita to obtain 360 degrees ultrasound scanning and forming of an image (Morita, column 5, lines 17-20).
Claims 12-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto in view of Spero and Sharma.
Regarding Claim 12, A method for deploying at least one needle in tissue (“The endoscope observation portion 80 has the observation window 88 provided in the first inclined surface 86A…in a region in the outer case 72 and behind the observation window 88, an observation optical system (an objective lens and the like) that constitutes the endoscope observation portion 80, an imaging device such as a CCD (Charge Coupled Device) or a CMOS (Complementary Metal Oxide Semiconductor) device, and the like are disposed.” [0068]. See Figs. 3-4), the method comprising:
capturing an optical image of a surface of the tissue with an optical imaging element disposed at a distal end of a device (“As illustrated in FIG. 1, the ultrasonic inspection system 2 includes an ultrasonic endoscope 10 that captures an image of the inside of a lumen 154 (also called a body cavity, see FIG. 12) of a subject to be examined, an ultrasonic processor device 12 that generates an ultrasound image, an endoscopic processor device 14 that generates an endoscopic image…” [0038]; “The endoscope observation portion 80 has the observation window 88 provided in the first inclined surface 86A…in a region in the outer case 72 and behind the observation window 88, an observation optical system (an objective lens and the like) that constitutes the endoscope observation portion 80, an imaging device such as a CCD (Charge Coupled Device) or a CMOS (Complementary Metal Oxide Semiconductor) device, and the like are disposed.” [0068]. See Figs. 1 and 3-4)
capturing an ultrasound image of the tissue with an ultrasonic imaging element disposed at the distal end of the device and configured to image along an imaging path (“As illustrated in FIG. 1, the ultrasonic inspection system 2 includes an ultrasonic endoscope 10 that captures an image of the inside of a lumen 154 (also called a body cavity, see FIG. 12) of a subject to be examined, an ultrasonic processor device 12 that generates an ultrasound image, an endoscopic processor device 14 that generates an endoscopic image…” [0038]. See Fig. 1);
extending a treatment element from the distal end of the device along a treatment path (“In the outer case 72, from the outer case distal end side toward the outer case proximal end side, an ultrasonic observation portion 60 that acquires an ultrasonic detection signal, the treatment tool lead-out port 94 for a treatment tool, a first inclined surface 86A, a second inclined surface 86B, and an endoscope observation portion 80 that acquires an image pick-up signal are provided…” [0061]. See Figs. 1 and 3), wherein the treatment element does not comprise the ultrasonic imaging element ([0038][0061],See Figs. 1 and 3), and wherein the imaging path and the treatment path intersect at an intersectional location spaced away from the cannula (“FIG. 3, a direction perpendicular to both of the longitudinal axis LA and the normal direction NV of the opening surface of the treatment tool lead-out port 94 will be referred to as the “width direction WD” of the treatment tool lead-out port 94, one side in the width direction WD will be referred to as the “L side”, and the other side opposite to the one side in the width direction WD will be referred to as the “R side”.” [0062]. See Figs. 1 and 3),
wherein the treatment element is separate from the ultrasonic imaging element (“As illustrated in FIG. 1, the ultrasonic inspection system 2 includes an ultrasonic endoscope 10 that captures an image of the inside of a lumen 154 (also called a body cavity, see FIG. 12) of a subject to be examined, an ultrasonic processor device 12 that generates an ultrasound image, an endoscopic processor device 14 that generates an endoscopic image…” [0038]. See Fig. 1), and wherein the imaging path and the treatment path intersect at an intersectional location spaced away from the device;
displaying a real time optical image of the surface of the tissue (“…a monitor 18 that displays the ultrasound image and the endoscopic image…” [0038]; “It is possible to selectively display only one of the ultrasound image and the endoscopic image or to display both of these images.” [0044]. See Fig. 1);
displaying a real time ultrasonic image of the tissue including an anatomical feature to be treated (“…while acquiring an ultrasound image of a treatment target area (including an observation target area, an inspection area, and the like) by using the ultrasonic transducer, cells are sampled by inserting a puncture treatment tool, which has been led out to the inside of a body through a treatment tool insertion channel and a treatment tool lead-out port, into the treatment target area.” [0003];“…a monitor 18 that displays the ultrasound image and the endoscopic image…” [0038].See Fig. 1);
and applying energy through the treatment element to treat the anatomical feature (“…the first illumination window 90A can illuminate a treatment tool led out from the treatment tool lead-out port 94 and a treatment target area thereof constantly from one side…” [0113]. Claim 1).
Morimoto is silent regarding the treatment element comprises at least one needle and the specifics regarding the guidance for limitations: presenting a marker on the ultrasonic image at a location corresponding to the intersectional location; aligning the marker with the displayed anatomical feature to be treated.
Spero in the field of ultrasound imaging systems visualization teaches: “A second GUI 350′ may show a two-dimensional representation (e.g., avatar) of the ultrasound transducer 228 and the ablation device 16 in real time as they are being positioned within the abdominal cavity. It places the image from the ultrasound machine onto a virtual ultrasound transducer plane 352 and displays a “Target Zone” with, e.g., purple lines, as an indicator of where the ablation device 16 shaft will intersect the ultrasound transducer plane 352.” [0086].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Morimoto to present a marker on the ultrasonic image at a location corresponding to the intersectional location and align the marker with the displayed anatomical feature to be treated as taught in Spero to enhance operational performance with more precise procedures that has increased amount of information available to the user reducing “…collateral damage and shorten recovery time as well as enhance survival rates.” (Spero, [0003][0008]).
The combination of references does not explicitly teach the treatment element comprises at least one needle.
Sharma in the field of prostate and uterine treatment systems teaches: “…inserting a hysteroscope through the cervix and into a uterus of a patient. …a hollow shaft through which an ablative agent can travel, a puncturing tip at its distal end, at least one positioning element, and a plurality of needles on a distal end of the catheter and configured to deliver ablative agent to said uterine fibroid.” [0451].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the treatment element in the combination of references to comprise a needle as taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]).
Regarding Claim 13, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Claim 13 further recites limitations: wherein the imaging path and the treatment path are laterally oriented such that an angle between the imaging path and the treatment path is between 0 degrees and 45 degrees. These limitations are present in claim 10 and is therefore, rejected under the same rationale.
Regarding Claim 15, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Morimoto does not explicitly teach: wherein the anatomical feature comprises a uterine fibroid.
Sharma in the field of prostate and uterine treatment systems teaches: “…inserting a hysteroscope through the cervix and into a uterus of a patient. …a hollow shaft through which an ablative agent can travel, a puncturing tip at its distal end, at least one positioning element, and a plurality of needles on a distal end of the catheter and configured to deliver ablative agent to said uterine fibroid.” [0451].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the anatomical feature in the combination of references to comprise a uterine fibroid as taught in Sharma for “…the treatment of genitourinary structures…” (Sharma, [0265]).
Regarding Claim 16, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Morimoto does not teach: wherein applying the energy through the treatment element to treat the anatomical feature comprises ablating the anatomical feature.
Sharma in the field of prostate and uterine treatment systems teaches: “Ablation, as it pertains to the present specification, relates to the removal or destruction of a body tissue, via the introduction of a destructive agent, such as radiofrequency energy…” [0016]; “Optional topographic mapping using multiple infrared, electromagnetic, acoustic or radiofrequency energy emitters and sensors can be used to define cavity size and shape in patients with an irregular or deformed uterine cavity due to conditions such as fibroids. Additionally, data from diagnostic testing can be used to ascertain the uterine cavity size, shape, or other characteristics.” [0427].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that applying the energy through the treatment element to treat the anatomical feature comprises ablating the anatomical feature as taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]) for “…the treatment of genitourinary structures…” (Sharma, [0265]).
Regarding Claim 17, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Morimoto does not teach: wherein the anatomical feature is ablated with radiofrequency energy.
Sharma in the field of prostate and uterine treatment systems teaches: “Ablation, as it pertains to the present specification, relates to the removal or destruction of a body tissue, via the introduction of a destructive agent, such as radiofrequency energy…” [0016]; “Optional topographic mapping using multiple infrared, electromagnetic, acoustic or radiofrequency energy emitters and sensors can be used to define cavity size and shape in patients with an irregular or deformed uterine cavity due to conditions such as fibroids. Additionally, data from diagnostic testing can be used to ascertain the uterine cavity size, shape, or other characteristics.” [0427].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that the anatomical feature is ablated with radiofrequency energy as taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]) for “…the treatment of genitourinary structures…” (Sharma, [0265]).
Regarding Claim 18, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Morimoto does not teach: wherein the anatomical feature is ablated using the at least one needle.
Sharma in the field of prostate and uterine treatment systems teaches: “…inserting a hysteroscope through the cervix and into a uterus of a patient. …a hollow shaft through which an ablative agent can travel, a puncturing tip at its distal end, at least one positioning element, and a plurality of needles on a distal end of the catheter and configured to deliver ablative agent to said uterine fibroid.” [0451].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to such that the anatomical feature is ablated using the at least one needle taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]).
Regarding Claim 19, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Morimoto does not teach: wherein the anatomical feature is ablated using at least one diverging needle segment of the at least one needle.
Sharma in the field of prostate and uterine treatment systems teaches: “… a handle 29104 having actuators 29106, 29108 for extending at least one needle or a plurality of needles 29110 from a distal end of the catheter 29112 and expanding a positioning element 29114 at the distal end of the catheter 29112….actuators 29106 and 29108 may be…a slide…to enable extending of at least one needle from the plurality of needles 29110.” [0463].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the combination of references such that the anatomical feature is ablated using at least one diverging needle segment of the at least one needle as taught in Sharma “…to allow delivery of an ablative agent, such as steam or vapor, through the needles…when the needles…are extended and deployed through the plurality of openings…” (Sharma, [0295]).
Regarding Claim 20, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Morimoto does not teach: wherein extending the treatment element comprises advancing the at least one needle laterally relative to a longitudinal axis of the device.
Sharma in the field of prostate and uterine treatment systems teaches: “… a handle 29104 having actuators 29106, 29108 for extending at least one needle or a plurality of needles 29110 from a distal end of the catheter 29112 and expanding a positioning element 29114 at the distal end of the catheter 29112….actuators 29106 and 29108 may be…a slide…to enable extending of at least one needle from the plurality of needles 29110.” [0463]. See Figs. 1A and 29.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the treatment element extension in the combination of references comprises advancing the at least one needle laterally relative to a longitudinal axis of the device as taught in Sharma to deliver ablative treatment to ablate the target tissue while avoiding structures in regions near the target tissue (Sharma, Abstract and [0064]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Morimoto, Sabado and Spero as applied to claim 12, and further in view of Morita.
Regarding Claim 14, the combination of Morimoto, Spero and Sharma teach the claim limitations as noted above.
Claim 14 further recites limitations: further comprising reflecting outgoing and incoming ultrasound energy laterally relative to a longitudinal axis of the device via a rotating mirror, wherein the rotating mirror is disposed at the distal end of the device and the ultrasonic imaging element faces proximally into the rotating mirror. These limitations are present in claim 9 and is therefore, rejected under the same rationale.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2,7-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-10, 12 and 16-20 of U.S. Patent No. 12318252. Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to an interventional hysteroscope and method for deploying at least one needle in tissue. The ‘524 application anticipates the limitations of the ‘252 patent.
Conclusion
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798