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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-5, 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Juan et al (Pub. No.: US 2021/0228849)
Regarding claim 1, de Juan et al disclose a medical device comprising:
a platform (insertion tool 200) [see 0050-0051, fig 4];
a probe holder (stabilizer device 100/1100) affixed to the platform (insertion tool 200), wherein the probe holder is configured to hold a probe (tool/instruments/cannula 1106) in a vertical (by disclosing vertical scissors with angle of 120 degrees) direction [see 0050-0055, 0060-0067] by disclosing the instruments inserted through the working channel 110 of the one or more stabilizer device 100 can include vertical scissors, the cutting angle of the vertical scissors (i.e., angle of the blade relative to the shaft) can be between 45-120 degrees [see 0055];
a plurality of spatially adjustable members (proximal anchor 1105, see fig 6) arranged to form an opening (working channel 1110) therebetween such that a probe (cannula 1106) when situated in the probe holder (stabilizer device 1100), extends through the opening (1110) and beyond the plurality of spatially adjustable members [see figs 5-6, 0060-0067];
a stabilizer (fixation device and/or rings 1116) coupled to the platform and positioned behind the plurality of spatially adjustable members and configured to secure the platform [see 0066-0067, figs 7A-7B].
Regarding claim 4, de Juan et al disclose wherein the probe holder (stabilizer device 1100) is further comprised of a gimbal assembly that allows for adjustment of the angle of entry of the probe along the x and y axes [see 0070] by disclosing the working channel 1110 can be coaxial with the longitudinal axis A of the device 1100 or can be offset from the axis A [see 0067, 0070-0071]
A gimbal is a pivoted support that permits rotation of an object about an axis, de Juan et al disclose stabilizer device is provided with fulcrum point (which relied on as the gimbal assembly, emphasis added) around which the instruments would rotate [see 0065, 0067].
The ball and socket type coupling of stabilizer device can also be used as a gimbal assembly that that allows for adjustment of the angle of entry of the probe along the x and y axes (due to multiple degrees of freedom, emphasis added) [see 0071].
Regarding claim 5, de Juan et al disclose wherein the probe holder is further comprised of
cantilever structures (legs, 0071 and fig 7B) that allow a probe to be secured based on friction with the stabilizer [see 0051] by disclosing proximal anchor 1105 can safely engage the surrounding canal 40 with sufficient force and/or friction to inhibit movement of the stabilizer device 1100 or instruments inserted through the stabilizer device 1100 [see 0061].
A cantilever is a structural element that is firmly attached to a fixed structure at one end and is unsupported at the other end and as shown in fig 7B; the legs 1200 are cantilever structures [see fig 7B].
Regarding claim 7, de Juan et al disclose wherein the opening formed by the distal portion of
the spatially adjustable members (1105) forms a circular or semi-circular shape (due to its cup-shaped) [see 0067-0068, fig 8A-8B]
Regarding claim 8, de Juan et al disclose wherein the distal portion of the spatially adjustable
Members (1105) is angled 93° (between 45-120 degrees) from the x-axis for optimal opening of the ear canal of the subject [see 0055].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Reed (Pub. No.: US 2012/0253267).
Regarding claim 2, de Juan et al don’t disclose a turret that secures the stabilizer.
de Juan et al don’t disclose wherein the platform comprises a turret that secures the stabilizer.
Nonetheless, Reed discloses wherein the platform (36) comprises a turret (38) that secures the stabilizer (needle assembly behaves as a stabilizer; therefore, the assembly is relied on as the stabilizer, emphasis added) [see 0050].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Reed by using a turret that secures the stabilizer; to provide stability to the medical device.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Kraitzer et al (Pub. No.: US 2016/0302973)
Regarding claim 3, de Juan et al disclose wherein the platform is further comprised of a lead screw (anchor 1105) adjusted by a rotatable knob, the screw controlling the opening between the spatially adjustable members so that a probe can be inserted through the opening [see 0067-0068] by disclosing the proximal anchor 1105 can be in the shape of a conical, adjustable speculum or cone fitted to the ear canal 40. The proximal anchor 1105 can be threaded or otherwise telescope to allow for adjustment in close proximity to the tympanic membrane 5. Instruments can be passed the interior of the proximal anchor 1105 and through one or more small rings 1116 (e.g., 0.5 mm to 1.0 mm in diameter) located on a distal face of the proximal anchor 1105 [see 0067].
de Juan et al don’t disclose the screw is adjusted by a rotatable knob.
Nonetheless, Kraitzer et al disclose the screw is adjusted by a rotatable knob [see 0142-0145, 0223-0225 and figs 6A, 6D].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Kraitzer et al by having the screw adjusted by a rotatable knob; so that a user may adjust the screw as desired.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Gill (US Pat: 6, 355, 049).
Regarding claim 6, de Juan et al don’t disclose wherein the probe holder is further comprised of a laterally adjustable slider to allow for varying distances from the cheek to the ear canal.
Nonetheless, Gill discloses wherein the probe holder is further comprised of a laterally adjustable slider to allow for varying distances from the cheek to the ear canal [see figs 2, 8 and column 8 lines 16-23] by disclosing the frame member 3 is attached to the frame holder 59 by means of sliding blocks 62 and 63 which are slidably mounted on the support arms 60 and 61 to allow relative movement between the frame holder 59 and the frame member 3 in the forward/rearward direction, or along an axis "X" relative to the head [see column 8 lines 16-33].
Figs 2, 8 show a probe holder (frame member 3) that receives adjustable support 78 that is adjustable in a forward/rearward direction, or along the axis "X" and in height relative to the frame member 3 aligned with an axis "Z" and also for adjustment of the depth of insertion of the ear plug [see column 8 lines 51-60].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Gill by using a laterally adjustable slider to allow for varying distances from the cheek to the ear canal; to allow relative movement between the frame holder 59 and the frame member 3 in the forward/rearward direction, or along an axis "X" relative to the head [see column 8 lines 16-23].
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Hock (US Pat: 5, 190, 042)
Regarding claim 9, de Juan et al don’t disclose a ball joint attached to a cheek rest that lies on the cheek bone of the subject, and which is adjustable with a rotatable knob.
Nonetheless, Hock discloses a ball joint attached to a cheek rest (cheek supports 40, 41) that lies on the cheek bone of the subject, and which is adjustable with a rotatable knob [see figs 13, 15, column 10 lines 29-39].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Hock by using a ball joint attached to a cheek rest that lies on the cheek bone of the subject, and which is adjustable with a rotatable knob; to adjust into an angle which makes it possible to find the right position.
Claim(s) 10, 24 are rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Vamanrao (Pub. No.: US 2006/0241728).
Regarding claim 10, de Juan et al disclose a kit [see 0053] comprising:
the medical device according to claim 1;
a probe [see 0073] configured to be situated in the probe holder (stabilizer device 100/1100) [see 0050-0055, 0060-0067, figs 4-7B].
de Juan et al disclose don’t disclose the probe comprising a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted.
Nonetheless, Vamanrao discloses the probe comprising a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted [see 0055-0061, 0067-0072, 0090-0091] by disclosing a control equipment, for holding a probe and precisely positioning the tip of said probe in its operative configuration within a body cavity [see 0055] by disclosing the probe forward/reward and upward/downward [see fig 2, 0090-0091].
Since the control equipment can move the probe in multiple directions such forward/reward and upward/downward, therefore, the control equipment can have a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted (emphasis added).
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao by having a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted; to accurately position the viewing tip of said probe at a desired point within said body cavity [see 0072, Vamanrao].
Regarding claim 24, de Juan et al disclose a method of viewing the ear during ear surgery, the method comprising:
mounting a probe to a medical device for stabilizing the probe [se claim 1]
the medical device comprising:
a platform (insertion tool 200) [see 0050-0055, fig 4];
a probe holder (stabilizer device 100) affixed to the platform (insertion tool 200) [see claim 1, 0050-0055, figs 2-4] by disclosing the stabilizer device 100 can be mounted on an insertion tool 200 (see FIG. 4) [see 0050, fig 4];
wherein the probe holder (stabilizer device 100) holds the mounted probe in a vertical direction (due to varying angle such as 45-120 degrees) [se 0055];
a plurality of spatially adjustable members (proximal anchor 1105, see fig 6) arranged to form an opening (working channel 1110) therebetween such that a probe (cannula 1106) when situated in the probe holder (stabilizer device 1100), extends through the opening (1110) and beyond the plurality of spatially adjustable members [see figs 5-6, 0060-0067];
a stabilizer (fixation device and/or rings 1116) coupled to the platform and positioned behind the plurality of spatially adjustable members and configured to secure the platform [see 0066-0067, figs 7A-7B];
viewing the surgical site using the probe [see 0073].
de Juan et al don’t disclose lowering the probe downwards along the vertical direction towards the ear canal.
Nonetheless, Vamanrao discloses lowering (due to downward motion, emphasis added) the probe downwards along the vertical direction towards (a body cavity) the ear canal [see 0055-0061, 0067-0072, 0090-0091] by disclosing a control equipment, for holding a probe and precisely positioning the tip of said probe in its operative configuration within a body cavity [see 0055] by disclosing the probe forward/reward and upward/downward [see fig 2, 0090-0091].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and by lowering the probe downwards along the vertical direction towards the ear canal; to accurately position the viewing tip of said probe at a desired point within said body cavity [see 0072, Vamanrao].
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Rebella et al (Pub. No.: US 2021/0220179)
Regarding claim 16, de Juan et al don’t disclose a speculum comprising two arms, wherein the two arms when separated from one another apply pressure to the walls of the ear.
Nonetheless, Rebella et al disclose a speculum comprising two arms, wherein the two arms when separated from one another apply pressure to the walls of the ear [see 0076]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Rebella et al by using a speculum comprising two arms, wherein the two arms when separated from one another apply pressure to the walls of the ear; because the speculum features a smooth one-handed operation for easier insertion and a self-locking feature that speeds up the examination process.
Claim(s) 11-15, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over de Juan et al (Pub. No.: US 2021/0228849) in view of Vamanrao (Pub. No.: US 2006/0241728) and further in view of Ruppersberg et al (Pub. No.: US 2015/0374208)
Regarding claim 11, de Juan et al and Vamanrao don’t disclose a video camera rotatably mounted to the distal end of the probe.
Nonetheless, Ruppersberg et al disclose wherein the probe (otoscope 10) comprises a video camera rotatably mounted to the distal end of the probe [see 0046, 0080, 0148, 0153, 0157 and figs 5-8, 12] by disclosing electronic imaging unit may comprise a video camera defining an optical axis, preferable a wide angle color video camera [see 0046]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao and Ruppersberg et al by using a video camera rotatably mounted to the distal end of the probe; so that the curved ear canal can thus be recorded in a desired fashion and in order to capture a larger area of interest or the entire ear structure, or in order to obtain measurements of occluded surfaces of the ear structure
Regarding claim 12, de Juan et al and Vamanrao don’t disclose wherein the video camera is rotatable 180° along the central axis of the probe.
Nonetheless, Ruppersberg et al disclose wherein the video camera (color video camera 40.1) is rotatable 180° along the central axis of the probe [see 0046, 0080, 0148, 0157 and figs 5-8, 12] by disclosing a rotation of at least 90°, more preferably of at least 120°, even more preferably of 180° or even more degrees around the axis may be realized [see 0080].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao and Ruppersberg et al by using video camera that is rotatable 180° along the central axis of the probe; in order to capture a larger area of interest or the entire ear structure, or in order to obtain measurements of occluded surfaces of the ear structure
Regarding claim 13, de Juan et al and Vamanrao don’t disclose a housing unit that can house a light emitting diode, a heat sink for that diode, optical fibers that extend to the distal end of the probe to illuminate the field captured by the video camera, and a data wire that extends to both the proximal and distal ends of the probe.
Nonetheless, Ruppersberg et al disclose a housing unit (bore 36, see 0154) that can house a light emitting diode (LEDs 46) [see 0067]; a heat sink (a printed circuit board) for that diode [see 0069]; optical fibers (light guides 42) that extend to the distal end of the probe to illuminate the field captured by the video camera [see 0153-0155, figs 5-8, 12];
a data wire (cable) that extends to both the proximal and distal ends of the probe [see 0153-0155] by disclosing cable, e.g. a ribbon cable, extends through the bore 36 and into the handle portion 12 of the otoscope 10. A distal end of the cable is connected to a logic unit 44, such as a microprocessor [see 0154].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao and Ruppersberg et al by a housing unit that can house a light emitting diode, a heat sink for that diode, optical fibers that extend to the distal end of the probe to illuminate the field captured by the video camera, and a data wire that extends to both the proximal and distal ends of the probe; because LED can ensure illumination with low energy consumption and minimum generation of heat [see 0067, Ruppersberg et al]; Effective heat dissipation reduces the impact of the otoscope on the tissue confining the ear canal, avoiding thermal irritation of the tissue [see 0069, Ruppersberg et al].
Regarding claim 14, de Juan et al and Vamanrao don’t disclose wherein the proximal end of the probe comprises a plurality of optical fibers that illuminate the field captured by the video camera, wherein the fibers are arranged in a bias configuration.
Nonetheless, Ruppersberg et al disclose wherein the proximal end of the probe comprises a plurality of optical fibers (light guides 42) that illuminate the field captured by the video camera, wherein the fibers are arranged in a bias configuration [see figs 5-8, 12, 0069, 0153-0155]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao and Ruppersberg et al by using a plurality of optical fibers that illuminate the field captured by the video camera, wherein the fibers are arranged in a bias configuration; In order to obtain images having a satisfying resolution.
Regarding claim 15, de Juan et al don’t disclose wherein the probe is further comprised of a wire that passes from the proximal end of the probe through past the distal end of the probe for communication of the camera's transmissions.
Nonetheless, Ruppersberg et al disclose a wire (cable 42) that passes from the proximal end of the probe through past the distal end of the probe for communication of the camera's transmissions [see figs 5-8, 0153-0157] by disclosing the video camera 40.1 of the electronic imaging unit 40 is connected to a distal end of a cable (not shown). The cable, e.g. a ribbon cable, extends through the bore 36 and into the handle portion 12 of the otoscope 10. A distal end of the cable is connected to a logic unit 44, such as a microprocessor [see 0154].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Ruppersberg et al by using a wire that passes from the proximal end of the probe through past the distal end of the probe for communication of the camera's transmissions; to facilitate signal transmission.
Regarding claim 17, de Juan et al disclose a medical system comprising:
the medical device according to claim 1;
a probe [see 0073] configured to be situated in the probe holder (stabilizer device 100/1100) [see 0050-0055, 0060-0067, figs 4-7B].
de Juan et al disclose don’t disclose the probe comprising a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted.
Nonetheless, Vamanrao discloses the probe comprising a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted [see 0055-0061, 0067-0072, 0090-0091] by disclosing a control equipment, for holding a probe and precisely positioning the tip of said probe in its operative configuration within a body cavity [see 0055] by disclosing the probe forward/reward and upward/downward [see fig 2, 0090-0091].
Since the control equipment can move the probe in multiple directions such forward/reward and upward/downward, therefore, the control equipment can have a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted (emphasis added).
de Juan et al and Vamanrao don’t disclose a user interface comprising a display, the user interface configured to be operably connected to the proximal end of the probe and display video from the camera mounted to the probe.
Nonetheless, Ruppersberg et al disclose a user interface (handle portion 12) comprising a display, the user interface configured to be operably connected to the proximal end of the probe (head portion 14) and display video from the camera (40.1, figs 5-8, 12) mounted to the probe (otoscope)[see 0154] by disclosing handle portion 12 may further comprise a display for displaying the images taken by the electronic imaging unit 40 or camera 40.1 to the user [see 0154].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao Ruppersberg et al by having a distal end facing the downward end of the probe along the vertical direction and a proximal end facing the upward end of the probe along the vertical direction when mounted; to accurately position the viewing tip of said probe at a desired point within said body cavity [see 0072, Vamanrao] and by using a user interface comprising a display, the user interface configured to be operably connected to the proximal end of the probe and display video from the camera mounted to the probe; to increase visualization.
Regarding claim 18, de Juan et al and Vamanrao don’t disclose wherein the user interface is configured to control the rotation of the video camera.
Nonetheless, Ruppersberg et al disclose wherein the user interface (handle portion 12) is configured to control the rotation of the video camera [see 0080, 0157] by disclosing motion mechanism 24 comprising a servo motor 26 is positioned within the handle portion 12 and is coupled to the rotatable portion 20 of the head portion 14, so as to rotate the rotatable portion 20 about its axis of rotation R [see 0148]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao and Ruppersberg et al by controlling the rotation of the video camera; in order to capture a larger area of interest or the entire ear structure.
Regarding claim 19, de Juan et al and Vamanrao don’t disclose wherein the user interface is configured to control the brightness of the LED of the probe.
Nonetheless, Ruppersberg et al disclose the user interface is configured to control the brightness of the LED of the probe [see 0070, 0154] by disclosing LEDs 46 can be individually switched on and off [see 0070-0071, 0154] by disclosing reducing e.g. shadowing and by sequentially switching on and off the individual light sources [see 0070]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine de Juan et al and Vamanrao and Ruppersberg et al by controlling the brightness of the LED of the probe; the ear canal can be illuminated from a favorable eccentric illumination point, reducing e.g. shadowing [see 0070, Ruppersberg et al].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798