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 .
Notice of Amendment
The Amendment filed 6/18/2025 has been entered. Claims 21-25, 27-34, 36-38 are pending in the application with claims 21, 27, 32, 34, 36 amended, claims 37, 38 withdrawn, claims 1-20, 26, 35, 39, 40 cancelled.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-23, 27-29 and 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Molnar (US Patent Application Publication No. 2019/0059710).
In regard to claim 21, Molnar discloses a method of using an endoscope assembly (140, Fig. 9A), the endoscope assembly including:
a) a shaft assembly (12), the shaft assembly comprising a flexible outer shaft defining a lumen (via central lumen of shaft (12)), a working channel (142), and a first fluid communication line (14);
b) an endoscopic camera assembly (16) associated with the shaft assembly, the endoscopic camera assembly defining a field of view (Par. 89); and
c) an anatomy elevation assembly (13) comprising an inflatable member coupled to the flexible outer shaft, the inflatable member comprising an interior surface, the first fluid communication line being in fluid communication with the inflatable member (Fig. 9A); and
the method including:
a) inserting a distal end of the endoscope assembly into an ear, nose, or throat (via insertion into throat);
b) positioning a portion of the distal end of the endoscope assembly adjacent to a deformable internal anatomical structure, while the distal end of the endoscope assembly is disposed in the ear, nose, or throat (the distal end would be positioned within the throat of a patient);
c) transitioning the inflatable member from a deflated configuration to an inflated configuration with fluid communicated via the first fluid communication line to thereby elevate the deformable internal anatomical structure away from the endoscope camera assembly (the balloon is inflated to radially press the trachea of a patient), the inflatable member being outside of the field of view of the camera when in the inflated configuration (the camera is positioned distal to the inflatable member, Fig. 9A); and
d) capturing an image of an anatomical cavity or passageway within a head or the throat via the endoscope assembly, while the deformable anatomical structure is elevated by the inflatable member (Par. 89);
e) sliding a surgical instrument (124) through the working channel (Fig. 9B); and
f) manipulating an anatomical structure in the anatomical cavity or passageway with the surgical instrument (Par. 89, the tool (124) is used to manipulate tissue while in the field of view of the camera).
In regard to claim 22, Molnar teaches further including selectively engaging and moving the deformable internal anatomical structure so as to not obstruct the endoscopic camera (via selectively inflating/deflating the cuff (13)).
In regard to claim 23, Molnar teaches the endoscopic camera including an illumination component, the method further including lighting the ear, nose, or throat with the illumination component (Par. 75).
In regard to claim 27, Molnar teaches the surgical instrument including a forceps (124) or a swab, the method including advancing the forceps or swab beyond the inflatable member and into the anatomical cavity or passageway to thereby manipulate the anatomical structure in the anatomical cavity or passageway (Par.89).
In regard to claim 28, Molnar teaches the deformable internal anatomical structure defining a passage axis, the shaft assembly defining a longitudinal axis, the method further including axially aligning the passage axis and the longitudinal axis (via positioning within a trachea of a patient).
In regard to claim 29, Molnar teaches the camera defining a field of view, the transitioning of the inflatable member from the deflated configuration to the inflated configuration resulting in the interior surface being outside of the field of view (the camera is positioned distal to the inflatable member and therefore the interior surface of the inflatable member is outside the field of view of the camera).
In regard to claim 31, Molnar teaches the method further including inserting the endoscope assembly transnasally or transorally to thereby position the portion of the endoscope assembly adjacent to the structure (via insertion through a mouth of the patient to position the endoscope assembly adjacent the trachea of a patient).
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 24 is rejected under 35 U.S.C. 103 as being unpatentable over Molnar (US Patent Application Publication No. 2019/0059710) in view of Wood et al. (US Patent Application Publication No. 2012/0167882, hereinafter Wood).
In regard to claim 24, Molnar is silent with respect to forming a frusto-conical shape with the interior surface when the inflatable member is in the inflated configuration.
Wood teaches an analogous trachea tube comprising an inflatable cuff (34), wherein the inflatable cuff can have a tapered configuration (shown in Fig. 1) or non-tapered configuration in order to seal against the walls of the trachea (Par. 17).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the cuff of Molnar to have a tapered or frustoconical configuration as taught by Wood as a matter of design choice since Wood illustrates the shape of the balloon is not particularly important since both tapered and non-tapered cuffs can provide a seal about the walls of the trachea (Par. 17). There being no unexpected results in modifying the cuff of Molnar to have a tapered or frustoconical shape as taught by Wood.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Molnar (US Patent Application Publication No. 2019/0059710) in view of Molnar (US Patent Application Publication No. 2016/0038014, hereinafter Molnar2).
In regard to claim 30, Molnar does not expressly teach the deformable internal anatomical structure being a passage of a paranasal sinus.
Molnar2 teaches an analogous device (580) in which a tubal body (582) having a camera tube (12) can be inserted through the nasal passage of a patient and a cuff of the tubal body is inflated to occlude the nasal septum.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the method of Molnar with the teaches of providing the tubal body to occlude the nasal septum as taught by Molnar2 in order to maintain direct and continuous visualization of the endotracheal tube and the vocal cords (Par.187).
Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Molnar (US Patent Application Publication No. 2019/0059710) in view of Makower et al. (US Patent Application Publication No. 2015/0165176, hereinafter Makower).
In regard to claim 21, Molnar discloses a method of using an endoscope assembly (140, Fig. 9A), the endoscope assembly including:
a) a shaft assembly (12), the shaft assembly comprising a flexible outer shaft defining a lumen (via central lumen of shaft (12)), a working channel (142), and a first fluid communication line (14);
b) an endoscopic camera assembly (16) associated with the shaft assembly, the endoscopic camera assembly defining a field of view (Par. 89); and
c) an anatomy elevation assembly (13) comprising an inflatable member coupled to the flexible outer shaft, the inflatable member comprising an interior surface, the first fluid communication line being in fluid communication with the inflatable member (Fig. 9A);
the method including:
a) inserting a distal end of the endoscope assembly into an ear, nose, or throat (via insertion into throat);
b) positioning a portion of the distal end of the endoscope assembly adjacent to a deformable internal anatomical structure, while the distal end of the endoscope assembly is disposed in the ear, nose, or throat (the distal end would be positioned within the throat of a patient);
c) transitioning the inflatable member from a deflated configuration to an inflated configuration with fluid communicated via the first fluid communication line to thereby elevate the deformable internal anatomical structure away from the endoscope camera assembly (the balloon is inflated to radially press the trachea of a patient), the inflatable member being outside of the field of view of the camera when in the inflated configuration (the camera is positioned distal to the inflatable member, Fig. 9A); and
d) capturing an image of an anatomical cavity or passageway within a head or the throat via the endoscope assembly, while the deformable anatomical structure is elevated by the inflatable member (Par. 89).
Molnar does not expressly teach a position sensor and a processor operable to provide video in real time via a display screen, using the processor to display on the display screen a position of the position sensor in relation to at least one of: a) an image of the structure, b) a computerized tomography scan of the structure, and c) a three-dimensional model of the structure.
Makower teaches a device for treating disorders related to the ear, nose and throat which can be aided by image guided surgery. During surgery, sensors mounted on the surgical instruments send data to the computer indicating the position of each surgical instrument. The computer correlates the data received from the instrument-mounted sensors with the digital map that was created from the preoperative tomographic scan. One or more image(s) is/are then displayed on a monitor showing the tomographic scan along with an indicator (e.g., cross hairs or an illuminated dot) of the real time position of each surgical instrument. In this manner, the surgeon is able to view the precise position of each sensor-equipped instrument relative to the surrounding anatomical structures shown on the tomographic scan. Various embodiments of adapter devices comprising image guidance sensors are disclosed herein. Such adapter devices are adapted to be fitted to one or more devices that are being introduced in the anatomy. This enables a user to view the real time position of the one or more devices that are being introduced in the anatomy (Par. 225).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the device of Molnar to include the positions sensors and computer of Makower enabling a position of the device to be visualized on a digital map formed by preoperative tomographic scans. In this manner, the surgeon is able to view the precise position of each sensor-equipped instrument relative to the surrounding anatomical structures shown on the tomographic scan (Par. 225).
In regard to claim 33, Molnar teaches the endoscope assembly including a light source, the method further including illuminating the anatomical cavity or passageway with the light source (Par. 75).
Response to Arguments
Applicant’s arguments with respect to claims 21-25, 27-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 34 and 36 allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 September 13, 2025