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 .
Specification
The disclosure is objected to because of the following informalities:
The specification uses reference character 150 for multiple different labels (communication interface, retrieving device) e.g. page 7, 8. The full specification should be checked for additional such errors.
Appropriate correction is required.
Claim Objections
Claims 27 and 39 is/are objected to because of the following informalities:
Claim 27 recites “The method of claims 23, further”.
Claim 39 recites “The method of any of claim 18, wherein …”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 3, 8, 12, 23, 24-26, 28, 31, 33, 37 and dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 24-26, 28 recite “a distal end region”, “a proximal end region”, and “an interior region”, but it is unclear the delineation and scope of these elements. It is unclear where one region ends and another starts as this has not been clearly explained. It will be interpreted as provided in the prior art rejection below.
These claims also recite “a first portion of a working channel” and “a second portion of the working channel” but is it unclear the delineation and scope of these elements. It is unclear where one portion ends and another starts. It will be interpreted as provided in the prior art rejection below.
Claim 2 recites “a cable port” but parent claim 1 also recites “a cable port”. It is therefore unclear the relationship between these elements.
Claim 3 and others recite both “the distal end of the catheter” and “the distal end”. It is unclear if the recitation of the “distal end” is to mean “of the catheter” or of some other structure. The terms should be clarified to define of what structure the distal end refers.
Claims 8, 12, 23-26, 28, 31, 33, 37 require “at least one sensor positioned proximate to the working channel port”, but this is not what appears to be depicted in applicant’s fig 2, where sensor 209 is positioned distal to the port 118. The claims also require a positional relationship between the sensor and the first portion of the working channel, but since it has been deemed that the scope of the first and second portions is indefinite, this relationship requirement is also considered indefinite. It will be interpreted as provided in the prior art rejection.
Claims 24-26 recite the limitation "interior region". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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) 1-6, 17-22 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Ogasawara US 20150265134.
Ogasawara discloses for claim 1, “A ureteroscope system (fig 1), comprising:
a handpiece having a distal end region, a proximal end region, an interior region (block diagram of fig 1 showing the endoscope components including the operation portion 22 and the proximal portion of endoscope 2 containing the laser port), a working channel port (port of the insertion channel for laser probe 5; fig 1), a first portion of a working channel in fluid communication with the working channel port (fig 1 showing the working channel and the corresponding port), and a cable port (the control cabling with corresponding housing components connecting the operation portion 22 with the system control apparatus 2; fig 1);
a catheter (insertion portion 21; fig 1) extending from the distal end region of the handpiece, the catheter including a second portion of the working channel in fluid communication with the working channel port and the first portion of the working channel (middle continuation of the working channel extending from the working channel port and the proximal portion of the working channel; fig 1), a distal end defining a working channel opening in fluid communication with the working channel (distal portion of the working channel opening up to the exit opening; fig 1);
one or more sensors (image pickup portion 25; fig 1; 0034) positioned and configured to detect a position of at least a portion of a laser fiber (0035 describes the image pickup portion 25 as an image sensor which is used to detect the laser probe 5 in an image as image portion 5i via the image analysis portion 33; fig 1, 3); and
a processor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) in communication with the one or more sensors and configured to determine if an emitting end of the laser fiber configured to emit laser light is outside the working channel and spaced at least a predetermined distance from the distal end of the catheter such that laser light emitting from the emitting of the laser fiber does not damage the catheter and/or the handpiece,
wherein the one or more sensors include at least an image sensor (image pickup portion 25; fig 1; 0034) positioned at the distal end of the catheter that is configured to detect at least a portion of the laser fiber has exited the working channel through the working channel opening in the distal end of the catheter with the processor being configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end by determining an amount of the laser fiber visible on a display (monitor 6; fig 1) displaying in real time the images (fig 3) collected from the image sensor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Ogasawara discloses for claim 2, “The ureteroscope system of claim 1, wherein the handpiece includes a cable port (the control cabling with corresponding housing components connecting the operation portion 22 with the system control apparatus 2; fig 1) and the ureteroscope system includes a cable connected or connectable to the handpiece at the cable port and configured to provide power to the one or more sensors and communicate with one or more electronic devices including the processor (components of the system control apparatus 3, including monitor 6; fig 1; 0037)”.
Ogasawara discloses for claim 3, “The ureteroscope system of claim 2, wherein the one or more sensors include at least the image sensor positioned at the distal end of the catheter that is configured to detect at least the portion of the laser fiber has exited the working channel through the working channel opening in the distal end of the catheter, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end based on data from the image sensor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Ogasawara discloses for claim 4, “The ureteroscope system of claim 3, wherein the one or more electronic devices include at least the display configured to display in real time the images collected from the image sensor (fig 3) and the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end by determining the amount of the laser fiber visible on the display displaying in real time the images collected from the image sensor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Ogasawara discloses for claim 5, “The ureteroscope system of claim 4, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end by determining a number or ratio of pixels on the display displaying a color of the laser fiber (0050-0053 describes determining the protrusion condition based on a number of pixels)”.
Ogasawara discloses for claim 6, “The ureteroscope system of claim 5, wherein the processor is configured to coordinate an alert on the display if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not outside the working channel and/or not spaced at least the predetermined distance from the distal end of the catheter (condition alerts are provided as seen in fig 3, i.e. probe detection result, logical value, logical product value and laser output)”.
Ogasawara discloses for claim 17, “A method of using a laser fiber with an ureteroscope (0010 describes applications involving the urethra), the method comprising:
inserting a catheter (endoscope 2; fig 1) of the ureteroscope into a urethra of a subject to a selected position;
feeding the laser fiber (laser probe 5; fig 1) into a working channel port (port of the insertion channel for laser probe 5; fig 1) on a handpiece (block diagram of fig 1 showing the endoscope components including the operation portion 22 and the proximal portion of endoscope 2 containing the laser port) of the ureteroscope and through a working channel positioned at least partially in the handpiece and the catheter and in fluid communication with the working channel port (fig 1 showing the working channel and the corresponding port);
determining if an emitting end on the laser fiber is outside the working channel and spaced at least a predetermined distance from a working channel opening in a distal end of the catheter distal to the handpiece using one or more sensors (image pickup portion 25; fig 1; 0034) and a processor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) in communication with the one or more sensors, wherein determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from the working channel includes at least determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from the working channel opening using the processor and data from an image sensor positioned at the distal end of the catheter that detects at least a portion of the laser fiber has exited the working channel through the working channel opening by determining an amount of the laser fiber (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) visible on a display (monitor 6; fig 1) displaying in real time the images collected from the image sensor (fig 3); and
emitting a laser light from the emitting end of the laser fiber if the emitting end on the laser fiber is determined to be outside the working channel and spaced at least the predetermined distance from the working channel (fig 4 shows the flow diagram of the laser operation)”.
Ogasawara discloses for claim 18, “The method of claim 17, further comprising feeding the laser fiber further through the working channel if the emitting end of the laser fiber is not outside the working channel and/or is not spaced at least the predetermined distance from the working channel (fig 3 shows the laser fiber in multiples stages of insertion)”.
Ogasawara discloses for claim 19, “The method of claim 18, wherein determining if an emitting end on the laser fiber is outside the working channel and spaced at least a predetermined distance from a working channel opening using one or more sensors (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) and a processor in communication with the one or more sensors includes:
determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from the working channel opening using the processor and data from the image sensor positioned at the distal end of the catheter that detects at least the portion of the laser fiber has exited the working channel through the working channel opening (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Ogasawara discloses for claim 20, “The method of claim 19, further comprising: displaying in real time images collected from the image sensor on the display in communication with the processor (fig 3)”.
Ogasawara discloses for claim 21, “The method of claim 20, wherein determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from the working channel opening by determining an amount of the laser fiber visible (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) on the display displaying in real time the images (fig 3) collected from the image sensor includes:
determining, with the processor, if the emitting end of the laser fiber is spaced at least the predetermined distance from the distal end by determining a number or ratio of pixels on the display displaying a color of the laser fiber (0050-0053 describes determining the protrusion condition based on a number of pixels)“.
Ogasawara discloses for claim 22, “The method of claim 21, further comprising coordinating, with the processor, an alert on the display if the emitting end of the laser fiber is outside the working channel spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not outside the working channel and/or spaced at least the predetermined distance from the distal end of the catheter (condition alerts are provided as seen in fig 3, i.e. probe detection result, logical value, logical product value and laser output)“.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7, 11-13, 15, 23, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogasawara and further in view of Takemoto US 20170071450 A1.
Ogasawara does not disclose for claim 7, “The ureteroscope system of claim 1, wherein the one or more sensors include at least one sensor positioned to detect the laser fiber or a jacket on the laser fiber entering the working channel and/or passing through the working channel”. Takemoto teaches in the same field of endeavor, detecting the insertion of a tool into a working channel 35 of an endoscope (fig 1) with a sensor (photo interrupter/second detection part 55; fig 1; 0060). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Takemoto into the invention of Ogasawara in order to configure the ureteroscope system e.g. as claimed because it allows detection of both enter status and exit status of the tool with respect to a working channel.
Modified Ogasawara discloses for claim 11, “The ureteroscope system of claim 7, further comprising an image sensor (image pickup portion 25; fig 1; 0034) positioned at the distal end of the catheter, wherein the one or more electronic devices include at least a display (monitor 6; fig 1) configured to display in real time images (fig 3) collected from the image sensor and the processor is configured to coordinate an alert on the display if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not outside the working channel and/or not spaced at least the predetermined distance from the distal end of the catheter (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Modified Ogasawara discloses for claim 12, “The ureteroscope system of claim 7, wherein the at least one sensor is positioned on the handpiece (Takemoto: photo interrupter/second detection part 55; fig 1; 0060) proximate to the working channel port, the at least one sensor being configured to detect the laser fiber or the jacket on the laser fiber entering the working channel through the working channel port (Takemoto: 0060)”.
Modified Ogasawara discloses for claim 13, “The ureteroscope system of claim 12, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on the at least one sensor detecting the emitting end and a predetermined length of the laser fiber or the jacket on the laser fiber entering the working channel through the working channel port (Ogasawara: image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Modified Ogasawara discloses for claim 15, “The ureteroscope system of claim 12, further comprising the image sensor (image pickup portion 25; fig 1; 0034) positioned at the distal end of the catheter, wherein the one or more electronic devices include at least a display (monitor 6; fig 1) configured to display in real time images collected from the image sensor and the processor is configured to coordinate an alert on the display if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not spaced at least the predetermined distance from the distal end of the catheter (condition alerts are provided as seen in fig 3, i.e. probe detection result, logical value, logical product value and laser output)”.
Ogasawara does not disclose for claim 23, “The method of claim 17, wherein determining if an emitting end on the laser fiber is outside the working channel and spaced at least a predetermined distance from a working channel opening using one or more sensors and a processor in communication with the one or more sensors includes: detecting the laser fiber or a jacket on the laser fiber entering the working channel port and/or passing through the working channel with at least one sensor positioned proximate to the working channel port and/or the working channel; and determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from a working channel opening using the processor and the data from the at least one sensor detecting the laser fiber or the jacket on the laser fiber”.
Takemoto teaches in the same field of endeavor, detecting the insertion of a tool into a working channel 35 of an endoscope (fig 1) with a sensor (photo interrupter/second detection part 55; fig 1; 0060). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Takemoto into the invention of Ogasawara in order to configure the ureteroscope system e.g. as claimed because it allows detection of both enter status and exit status of the tool with respect to a working channel.
Ogasawara discloses for claim 27, “The method of claim 23, further comprising coordinating, with the processor, an alert on a display if the emitting end of the laser fiber is outside the working channel spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not outside the working channel and/or spaced at least the predetermined distance from the distal end of the catheter (condition alerts are provided as seen in fig 3, i.e. probe detection result, logical value, logical product value and laser output)”.
Claim(s) 8, 9, 24, 25, 28-30, 32-34, 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogasawara and Takemoto and further in view of Pacey US 20170071450.
Ogasawara does not disclose for claim 8, “The ureteroscope system of claim 7, wherein:
at least some of the first portion of the working channel passing through the interior region of the handpiece and is translucent or transparent; and
the at least one sensor is positioned in the interior region of the handpiece at least proximate to the first portion of the working channel that is translucent or transparent, the at least one sensor being configured to detect the laser fiber or the jacket on the laser fiber passing through the first portion of the working channel that is translucent or transparent”. Pacey teaches in the same field of endeavor, providing a transparent laryngoscope with working channels which can be visible to the operator so that the operator can visually confirm routing instruments into and through the channels within the laryngoscope (0024). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Pacey into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it allows the operator to visually confirm the location of the inserted instrument.
Modified Ogasawara discloses for claim 9, “The ureteroscope system of claim 8, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on the at least one sensor detecting the emitting end and a predetermined length of the laser fiber or the jacket on the laser fiber passing through the first portion of the working channel (Ogasawara: image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) that is translucent or transparent (Pacey: 0024)”.
Ogasawara does not disclose for claim 24, “The method of claim 23, wherein detecting the laser fiber or the jacket on the laser fiber entering the working channel port and/or passing through the working channel with the at least one sensor positioned proximate to the working channel port and/or the working channel includes: detecting the laser fiber or the jacket on the laser fiber passing through a portion of the working channel that is translucent or transparent with the at least one sensor that is positioned in the interior region of the handpiece at least proximate to the portion of the working channel that is translucent or transparent”. Pacey teaches in the same field of endeavor, providing a transparent laryngoscope with working channels which can be visible to the operator so that the operator can visually confirm routing instruments into and through the channels within the laryngoscope (0024). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Pacey into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it allows the operator to visually confirm the location of the inserted instrument.
Modified Ogasawara discloses for claim 25, “The method of claim 24, wherein:
detecting the laser fiber or the jacket on the laser fiber passing through a portion of the working channel that is translucent or transparent (Pacey: 0024) with the at least one sensor that is positioned in the interior region of the handpiece (Takemoto: photo interrupter/second detection part 55; fig 1; 0060) at least proximate to the portion of the working channel that is translucent or transparent (Pacey: 0024) includes:
detecting the emitting end and a predetermined length of the laser fiber or the jacket on the laser fiber passing through the portion of the working channel (Ogasawara: image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) that is translucent or transparent (Pacey: 0024) with the at least one sensor that is positioned in the interior region of the handpiece (Takemoto: photo interrupter/second detection part 55; fig 1; 0060) at least proximate to the portion of the working channel that is translucent or transparent; and
determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from a working channel opening using the processor and data from the at least one sensor detecting the laser fiber or the jacket on the laser fiber (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) includes:
determining, using the processor, if the emitting end of the laser fiber is spaced at least the predetermined distance from the distal end of the catheter based on data form the at least one sensor detecting the emitting end and the predetermined length of the laser fiber or the jacket on the laser fiber passing through the portion of the working channel (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) that is translucent or transparent (Pacey: 0024)”.
Modified Ogasawara discloses for claim 28, “A ureteroscope system (fig 1), comprising:
a handpiece having a distal end region, a proximal end region, an interior region (block diagram of fig 1 showing the endoscope components including the operation portion 22 and the proximal portion of endoscope 2 containing the laser port), a working channel port (port of the insertion channel for laser probe 5; fig 1), a first portion of a working channel in fluid communication with the working channel port (fig 1 showing the working channel and the corresponding port), and a cable port (the control cabling with corresponding housing components connecting the operation portion 22 with the system control apparatus 2; fig 1);
a catheter (insertion portion 21; fig 1) extending from the distal end region of the handpiece, the catheter including a second portion of the working channel in fluid communication with the working channel port and the first portion of the working channel (middle continuation of the working channel extending from the working channel port and the proximal portion of the working channel; fig 1), a distal end defining a working channel opening in fluid communication with the working channel (distal portion of the working channel opening up to the exit opening; fig 1);
one or more sensors (image pickup portion 25; fig 1; 0034) positioned and configured to detect a position of at least a portion of a laser fiber (0035 describes the image pickup portion 25 as an image sensor which is used to detect the laser probe 5 in an image as image portion 5i via the image analysis portion 33; fig 1, 3); and
a processor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) in communication with the one or more sensors and configured to determine if an emitting end of the laser fiber configured to emit laser light is outside the working channel and spaced at least a predetermined distance from the distal end of the catheter such that laser light emitting from the emitting of the laser fiber does not damage the catheter and/or the handpiece,
wherein the one or more sensors include at least one sensor positioned to detect the laser fiber or a jacket on the laser fiber entering the working channel (Takemoto: photo interrupter/second detection part 55; fig 1; 0060) and/or passing through the working channel with at least some of the first portion of the working channel passing through the interior region of the handpiece and being translucent or transparent (Pacey: 0024), and with the at least one sensor being positioned in the interior region of the handpiece (Takemoto: photo interrupter/second detection part 55; fig 1; 0060) at least proximate to the first portion of the working channel that is translucent or transparent, the at least one sensor being configured to detect the laser fiber or the jacket on the laser fiber passing through the first portion of the working channel (Takemoto: photo interrupter/second detection part 55; fig 1; 0060) that is translucent or transparent (Pacey: 0024)”.
Ogasawara discloses for claim 29, “The ureteroscope system of claim 28, wherein the one or more sensors include at least an image sensor positioned at the distal end of the catheter that is configured to detect at least a portion of the laser fiber has exited the working channel through the working channel opening in the distal end of the catheter, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end based on data from the image sensor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Modified Ogasawara discloses for claim 30, “The ureteroscope system of claim 28, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on the at least one sensor detecting the emitting end and a predetermined length of the laser fiber or the jacket on the laser fiber passing through the first portion of the working channel that is translucent or transparent (Pacey: 0024)”.
Ogasawara discloses for claim 32, “The ureteroscope system of claim 30, further comprising an image sensor positioned at the distal end of the catheter, wherein the one or more electronic devices include at least a display (monitor 6; fig 1) configured to display in real time images collected from the image sensor and the processor is configured to coordinate an alert (condition alerts are provided as seen in fig 3, i.e. probe detection result, logical value, logical product value and laser output) on the display if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not outside the working channel and/or not spaced at least the predetermined distance from the distal end of the catheter (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Modified Ogasawara discloses for claim 33, “The ureteroscope system of claim 30, wherein the at least one sensor is positioned on the handpiece proximate to the working channel port, the at least one sensor being configured to detect the laser fiber or the jacket on the laser fiber entering the working channel through the working channel port (Takemoto: photo interrupter/second detection part 55; fig 1; 0060)”.
Ogasawara discloses for claim 34, “The ureteroscope system of claim 33, wherein the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on the at least one sensor detecting the emitting end and a predetermined length of the laser fiber or the jacket on the laser fiber entering the working channel through the working channel port (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Ogasawara discloses for claim 36, “The ureteroscope system of claim 33, further comprising an image sensor (image pickup portion 25; fig 1; 0034) positioned at the distal end of the catheter, wherein the one or more electronic devices include at least a display (monitor 6; fig 1) configured to display in real time images collected from the image sensor and the processor is configured to coordinate an alert on the display if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter or if the emitting end of the laser fiber is not spaced at least the predetermined distance from the distal end of the catheter (condition alerts are provided as seen in fig 3, i.e. probe detection result, logical value, logical product value and laser output)”.
Modified Ogasawara discloses for claim 37, “A method of using a laser fiber with an ureteroscope (0010 describes applications involving the urethra), the method comprising:
inserting a catheter (endoscope 2; fig 1) of the ureteroscope into a urethra of a subject to a selected position;
feeding the laser fiber (laser probe 5; fig 1) into a working channel port (port of the insertion channel for laser probe 5; fig 1) on a handpiece (block diagram of fig 1 showing the endoscope components including the operation portion 22 and the proximal portion of endoscope 2 containing the laser port) of the ureteroscope and through a working channel positioned at least partially in the handpiece and the catheter and in fluid communication with the working channel port (fig 1 showing the working channel and the corresponding port);
determining if an emitting end on the laser fiber is outside the working channel and spaced at least a predetermined distance from a working channel opening in a distal end of the catheter distal to the handpiece using one or more sensors (image pickup portion 25; fig 1; 0034) and a processor (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) in communication with the one or more sensors, wherein determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from the working channel includes at least detecting the laser fiber or a jacket on the laser fiber entering the working channel port and/or passing through the working channel with at least one sensor positioned proximate to the working channel port and/or the working channel and determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from a working channel opening (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value) using the processor and data from the at least one sensor detecting the laser fiber or the jacket on the laser fiber; and
emitting a laser light from the emitting end of the laser fiber if the emitting end on the laser fiber is determined to be outside the working channel and spaced at least the predetermined distance from the working channel (fig 4 shows the flow diagram of the laser operation)”.
Ogasawara discloses for claim 38, “The method of claim 37, further comprising feeding the laser fiber further through the working channel if the emitting end of the laser fiber is not outside the working channel and/or is not spaced at least the predetermined distance from the working channel (fig 3)”.
Ogasawara discloses for claim 39, “The method of any of claim 18, wherein determining if an emitting end on the laser fiber is outside the working channel and spaced at least a predetermined distance from a working channel opening using one or more sensors and a processor in communication with the one or more sensors includes:
determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from the working channel opening using the processor and data from an image sensor positioned at the distal end of the catheter that detects at least a portion of the laser fiber has exited the working channel through the working channel opening (image processing portion 32; fig 1; 0035-0037 in particular 0037 describes the detection of the laser protruding a certain predetermined condition in order to operate the laser, e.g. a distance as depicted by fig 3 frame number n+1 and n+2 switching from a false logic value to a true logic value)”.
Claim(s) 10, 14, 26, 31, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogasawara, Takemoto, and Pacey as applied to claim 8 above, and further in view of Devries US 20160166328.
Ogasawara does not disclose for claim 10, “The ureteroscope system of claim 8, further comprising the laser fiber having a plurality of markers on the laser fiber or the jacket on the laser fiber, wherein the at least one sensor is configured to detect the plurality of markers and the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on at least a predetermined number of markers of the plurality of markers passing the at least one sensor”.
Devries teaches in the same field of endeavor, tracking inserted instruments via reference markers position on the instruments (fig 2; 0017, 0045). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Devries into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it provides a physical and visible reference located on the instrument which can be observed by the operator to gauge distances.
Ogasawara does not disclose for claim 14, “The ureteroscope system of claim 12, further comprising the laser fiber having a plurality of markers on the laser fiber or the jacket on the laser fiber, wherein the at least one sensor is configured to detect the plurality of markers and the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on at least a predetermined number of markers of the plurality of markers entering the working channel through the working channel port”.
Devries teaches in the same field of endeavor, tracking inserted instruments via reference markers position on the instruments (fig 2; 0017, 0045). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Devries into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it provides a physical and visible reference located on the instrument which can be observed by the operator to gauge distances.
Ogasawara does not disclose for claim 26, “The method of claim 24, wherein: detecting the laser fiber or the jacket on the laser fiber passing through a portion of the working channel that is translucent or transparent with the at least one sensor that is positioned in the interior region of the handpiece at least proximate to the portion of the working channel that is translucent or transparent includes: detecting a predetermined number of markers of a plurality of markers on the laser fiber or the jacket on the laser fiber passing through a portion of the working channel that is translucent or transparent with the at least one sensor that is positioned in the interior region of the handpiece at least proximate to the portion of the working channel that is translucent or transparent; and determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from a working channel opening using the processor and data from the at least one sensor detecting the laser fiber or the jacket on the laser fiber includes: determining if the emitting end on the laser fiber is outside the working channel and spaced at least the predetermined distance from a working channel opening using the processor and data from the at least one sensor of the predetermined number of markers of the plurality of markers on the laser fiber or the jacket on the laser fiber passing through a portion of the working channel”, i.e. the claimed marker aspects of the claim.
Devries teaches in the same field of endeavor, tracking inserted instruments via reference markers position on the instruments (fig 2; 0017, 0045). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Devries into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it provides a physical and visible reference located on the instrument which can be observed by the operator to gauge distances.
Ogasawara does not disclose for claim 31, “The ureteroscope system of claim 30, further comprising the laser fiber having a plurality of markers on the laser fiber or the jacket on the laser fiber, wherein the at least one sensor is configured to detect the plurality of markers and the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on at least a predetermined number of markers of the plurality of markers passing the at least one sensor”.
Devries teaches in the same field of endeavor, tracking inserted instruments via reference markers position on the instruments (fig 2; 0017, 0045). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Devries into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it provides a physical and visible reference located on the instrument which can be observed by the operator to gauge distances.
Ogasawara does not disclose for claim 35, “The ureteroscope system of claim 33, further comprising the laser fiber having a plurality of markers on the laser fiber or the jacket on the laser fiber, wherein the at least one sensor is configured to detect the plurality of markers and the processor is configured to determine if the emitting end of the laser fiber is outside the working channel and spaced at least the predetermined distance from the distal end of the catheter based on at least a predetermined number of markers of the plurality of markers entering the working channel through the working channel port”.
Devries teaches in the same field of endeavor, tracking inserted instruments via reference markers position on the instruments (fig 2; 0017, 0045). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Devries into the invention of Ogasawara in order to configure the ureteroscope e.g. as claimed because it provides a physical and visible reference located on the instrument which can be observed by the operator to gauge distances.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ogasawara as applied to claim 1 above, and further in view of Brown US 20020188285.
Ogasawara does not disclose for claim 16, “The ureteroscope system of claim 1, wherein the predetermined distance is about 3 mm to about 8 mm”. Brown teaches in the same field of endeavor, a laser delivery fiber tip 13 must protrude some distance beyond the end of the shaft 1, typically several millimeters and up to about 5mm (0017). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Brown into the invention of Ogasawara in order to configure the system e.g. as claimed because it allow proper functioning of the laser fiber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/17/26
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