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.
(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.
Claim(s) 1-5, 7-8, 10-13, 23-24, 27-28, and 30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Herda et al. (US 20230123867 A1).
Regarding claim 1, Herda teaches a camera module for installation on an elongated interventional device (110 and 400 of figs. 2A-2B and 4A to 4MM, [0051], [0052], [0060], and [0099] a camera or image sensor 410 at tip 116 of the shaft, any panning mechanism, illumination, power and signal connectors, and fluid flow channels may be in the disposable shaft 110) comprising:
a. a base comprising a body (400, 412, and 414 of figs. 4A-4C; [0099], [0100], and [0104] endoscope tip 400 may be formed of top brace 412, bottom brace 414, and flexible circuit board 416. Camera 410 may be mounted on one side of flexible circuit board 416, and an illumination LED on the other side);
b. at least one camera flexible printed circuit board (camera FCB) attached to said base (414 and 416 of figs. 4A-4C, [0099] and [0100] the flexible circuit board 416 is attached to the base 414, see fig. 4B for example, [0100] then bottom brace 414 may be brought into place, which holds top brace 412, bottom brace 414, circuit board 416, LED, and camera 410 in their positions of mutual alignment);
c. one or more cameras positioned on said at least one camera FCB and said body (412, 414, and 416 of figs. 4A-4C, [0099] and [0100] FIGS. 4A-4C, endoscope tip 400 may be formed of top brace 412, bottom brace 414, and flexible circuit board 416. Camera 410 may be mounted on one side of flexible circuit board 416. Then bottom brace 414 may be brought into place, which holds top brace 412, bottom brace 414, circuit board 416, LED, and camera 410 in their positions of mutual alignment).
Regarding claim 2, Herda teaches the camera module according to claim 1, Herda teaches further comprising at least one protrusion positioned on said body of said base ([0067] Referring to FIGS. 2F and 2G, the camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable; [0185] The distal bendable portion is extendable from and retractable into a solid sheath; [0126] protrusion).
Regarding claim 3, Herda teaches the camera module according to claim 2, Herda further teaches wherein said one or more cameras are positioned on said at least one protrusion (410 of fig. 4A and 4B, 410 of fig. 6C).
Regarding claim 4, Herda teaches the camera module according to claim 1, Herda further teaches wherein said base further comprises at last one channel sized and shaped to match a working channel of said elongated interventional device (400 of fig. 4L, [0107] and [0108]).
Regarding claim 5, Herda teaches the camera module according to claim 1, Herda further teaches wherein said at least one protrusion comprises a distal surface and a proximal surface (400, 410, and 430 of fig. 4L, endoscope tip has a distal surface and proximal surface, [0005] and ); and wherein said one or more cameras are positioned on said distal surface of said protrusion (410 of fig. 4L, and 410 of fig. 6C for more cameras).
Regarding claim 7, Herda teaches the camera module according to claim 1, Herda further teaches at least one first sensor and at least one sensor flexible printed circuit board (sensor FCB) ([0068] A camera, illumination LED, pressure sensor, temperature sensor, or other sensors may be affixed to substrate 220. Referring to FIG. 2L, substrate 220 may be folded into three sides of a parallelogram, and a fourth side may be formed by a linkage connected to hinge points; [0090] proximal handle 114 may hold power transformers, signal amplifiers, controls for the illumination LED and camera, a mechanical control for panning camera 410, rotation sensors for righting of an image from camera 410, and the like).
Regarding claim 8, Herda teaches the camera module according to claim 7, Herda further teaches wherein said at least one first sensor is one or more of: amounted on said sensor FCB; b. positioned on said proximal surface of said protrusion ([0068] A camera, illumination LED, pressure sensor, temperature sensor, or other sensors may be affixed to substrate 220).
Regarding claim 10, Herda teaches the camera module according to claim 7, Herda further teaches at least one second sensor positioned on said sensor FCB ([0068] A camera, illumination LED, pressure sensor, temperature sensor, or other sensors may be affixed to substrate 220).
Regarding claim 11, Herda teaches the camera module according to claim 1, Herda further teaches at least one second sensor positioned on said camera FCB ([0068] referring to FIG. 2K, a flex circuit 232 may be laminated onto the substrate, and control tension cables 228 attached to the two ends. A camera, illumination LED, pressure sensor, temperature sensor, or other sensors may be affixed to substrate 220).
Regarding claim 12, Herda teaches the camera module according to claim 1, Herda further teaches wherein said camera FCB comprises one or more of:
a. a distal head configuration (410, 412, 414, and 416 of figs. 4A and 4B; [0097]-[0099] endoscope tip has a distal head configuration);
b. a neck configuration (416 of figs. 4A and 4B), attached to said distal head configuration (414 of fig. 4A and 4B); and
c. an elongated tail (416 of fig. 4B), attached to said neck configuration ([0099]).
Regarding claim 13, Herda teaches the camera module according to claim 12,
wherein at least one of the following it true:
a. said distal head configuration and said neck configuration together comprise a geometry that conforms a geometry of said base (412, 414, and 416 of figs. 4A and 4B, [0099] and [0100]);
b. said elongated tail is wound along a longitudinal axis of said base, which matches a longitudinal axis of said elongated interventional device; wherein a winding of said elongated tail is either clockwise or counter-clockwise; and
c. said neck is configured to be wrapped around said base on a plane perpendicular to the longitudinal axis of said base (414 and 416 of fig. 4A).
Regarding claim 23, Herda teaches the camera module according to claim 1, Herda further teaches one or more lights positioned on said base ([0100] and [0101] LED mount therein).
Regarding claim 24, Herda teaches the camera module according to claim 23, Herda further teaches wherein said one or more lights are mounted on one or more of: a. said distal face of said protrusion; b. adjacent to said one or more cameras; c. said camera FCB ([0108] and [0149].
Regarding claim 27, Herda teaches the camera module according to claim 1, Herda further teaches wherein said base further comprises at least one connection element for at least one steering mechanism ([0072] to [0073], [0081] and [0084]).
Regarding claim 28, Herda teaches the camera module according to claim 27, Herda further teaches wherein said at least one steering mechanism is at least one steering wire ([0071]; and/or wherein said at least one connection element is one or more of a slit (200 of fig. 2F, [0075]), a protrusion and an anchor ([0067] the camera tip 202 may be slideable within cannula shaft 132, to be extendable and retractable. When extended, the distal portion of camera stalk 202 may be bendable, for example, as rigid segments 210 joined at articulation joints. In FIGS. 2F and 2G, cone 204 shows the field of view of camera 410. The extendable/bendable portion of shaft 202 may be formed of a series of elements that are each essentially rigid in the longitudinal dimension, but articulated at each joint to permit bending or flexure).
Regarding claim 30, Herda teaches the camera module according to claim 1, Herda further teaches a mold enclosing a distal end of said camera module; and wherein said mold is configured for holding a plurality of components in said base of said camera module (412 and 414 of figs. 4A, 4B, 4C, and 4D, [0100] Then bottom brace 414 may be brought into place, which holds top brace 412, bottom brace 414, circuit board 416, LED, and camera 410 in their positions of mutual alignment. A locking notch and clip, or ultrasonic welding may hold this assembly together for a time. Then an overmolding step may lock everything together).
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) 17-18 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herda et al. (US 20230123867 A1) in view of Lund et al. (US 20230165436 A1).
Regarding claim 17, Herda teaches the camera module according to claim 10, but Herda is silent about wherein said sensor FCB is wound along a longitudinal axis of said base, which matches a longitudinal axis of said elongated interventional device.
Lund teaches wherein said sensor FCB is wound along a longitudinal axis of said base (30 of fig. 6, and 40 of fig. 9, [0041] and [0042]), which matches a longitudinal axis of said elongated interventional device (30 of fig. 6, [0041]).
Taking the teachings of Herda and Lund together as a whole, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wound helical member of Lund into the flexible print circuit board of Herda to improve the bendable endoscope during the operation.
Regarding claim 18, Herda and Lund teach the camera module according to claim 17, Lund further teaches wherein at least one of the following is true: a said elongated tail and said sensor FCB are both wound along a longitudinal axis of said base, which matches a longitudinal axis of said elongated interventional device; b. said winding of said elongated tail and said winding of said sensor FCB have a same winding orientation; c. said winding of said elongated tail and said winding of said sensor FCB do not overlap; d. said winding of said elongated tail and said winding of said sensor FCB have a different winding orientation; e. said winding of said elongated tail and said winding of said sensor FCB overlap (30 of fig. 6, [0041] and [0042]).
Regarding claim 32, Herda discloses a camera module for installation on an elongated interventional device configured to be inserted and navigated in a body lumen (110 and 400 of fig. 2A), the camera module comprising:
a. a fixture having a body and a protrusion (200 of fig. 2F, extendable and retractable, 400 of fig. 2A), said body is configured to be connected to steering wires of the elongated device (228 of fig. H, 430 of fig. 4L, [0072], [0080], and [0081]);
b. a flexible PCB having a frontal plate ([0080]), a frontal folding mark (416 of figs. 4A and 4B, [0080], [0099], [0010] and [0105], there is a front folding mark),
wherein the frontal plate includes a camera and illumination components ([0097] camera sensor and one or more LEDs), and
wherein the flexible PCB is foldable in a close fit about the fixture and about the elongated device ([0068], [0080], [0099] and [0100]); and
c. a mold to hold the fixture and the flexible PCB together (412 and 414 of figs. 4A and 5B, [0099] and [0100]).
It is noted that Herda is silent about a wounding starter folding mark, and a PCB woundable tail.
Lund discloses a wounding starter folding mark ([0041] Towards the distal end 22 the coupling member 19 comprises a cylindrical or preferably frusto-conical part (a first sector of the coupling member 19) 29 which is provided with an external thread 26a-26f adapted to engage between the windings of a wound helical member forming part of the wall of the insertion tube 2. Using the external thread 26a-26f the coupling member 19 may be screwed into the proximal end of the wall of the insertion tube 2 to form a sub-assembly 40 including the insertion tube 2 and a camera 42, as seen in FIG. 9), and a PCB woundable tail (40 of fig. 9, [0013] where said first sector is closer to the distal end than said second sector, and where said first sector is provided with a thread adapted to engage the inside of a wound helical member of an insertion tube; [0041] Using the external thread 26a-26f the coupling member 19 may be screwed into the proximal end of the wall of the insertion tube 2 to form a sub-assembly 40 including the insertion tube 2 and a camera 42, as seen in FIG. 9 and [0042] the rotational orientation of the sub-assembly with respect to the first handle housing part 6 may then be checked and adjusted. This is preferably done using the camera 42 in the distal end of the sub-assembly).
Taking the teachings of Herda and Lund together as a whole, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wound helical member of Lund into the flexible print circuit board of Herda to improve the bendable endoscope during the operation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Morishima et al. (US 20200100655 A1) discloses a single use endoscope device which is inserted inside a subject includes: a distal end portion which includes at least an imaging element; an operation unit which operates an operation of the endoscope device; a curved portion which can be curved inside the subject by operating the operation unit.
Wagner et al. (US 20140005480 A1) discloses an endoscope sheath including an elongate flexible hose, which encloses a main lumen, for receiving at least one portion of a shank of a flexible endoscope, and at least one working channel, for receiving at least one portion of a flexible endoscopic working instrument, wherein the endoscope sheath has a transparent distal end portion. Further provided is an endoscope arrangement, and a method for providing an endoscope arrangement.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUNG T VO whose telephone number is (571)272-7340. The examiner can normally be reached Monday-Friday 6:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Pendleton can be reached at 571-272-7527. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TUNG T. VO
Primary Examiner
Art Unit 2425
/TUNG T VO/Primary Examiner, Art Unit 2425
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