The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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.
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Talbot et al. (US Patent Pub. No. 2021/0038309).
Talbot discloses an endoscopic laser system with a laser interlock (see Title). Specifically, Talbot teaches a system for a surgical laser console (see Figure 1), the system comprising:
a processor (see numeral 54 of Figure 1);
a light detector (see at least paragraph 6, “an endoscope including an optical detector configured to detect an amount of light reflected from a target in response to illumination of the target from a distal end of the endoscope”); and
memory (see numeral 56 in Figure 1) comprising instructions, which when executed by the processor cause the processor to:
receive, from the light detector, an electrical signal comprising an indication of a power of light received at a distal end of an optical fiber (see paragraph 25, “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber… A lack of optical detection of a reflected signal back through the surgical laser fiber (or optical detection less than a predetermined value) causes a determination that the surgical laser fiber is within the working channel of the endoscope. Optical detection of a reflected signal greater than a predetermined value back through the surgical laser fiber causes a determination that the surgical laser fiber has been advanced enough through the working channel to have exited the endoscope”),
wherein the light corresponds to light generated by one or more illumination lights of an endoscope (see paragraph 25 again, “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber. The reflected light comes from the light source used in the endoscopic procedure”).
Regarding claims 2-4, it is re-iterated that paragraph 25 teaches that “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber… A lack of optical detection of a reflected signal back through the surgical laser fiber (or optical detection less than a predetermined value) causes a determination that the surgical laser fiber is within the working channel of the endoscope. Optical detection of a reflected signal greater than a predetermined value back through the surgical laser fiber causes a determination that the surgical laser fiber has been advanced enough through the working channel to have exited the endoscope.” Additionally, paragraph 42 teaches that “In some embodiments, the feedback analyzer 50 may make a determination that the surgical laser fiber 22 is located fully in the working channel 36 and may, for example, indicate such to the user via a red light (or similar signal). Based on the feedback, the feedback analyzer 50 may interface with the laser interlock 42 to prevent the laser 40 from firing, even when in emission mode and the user makes an intentional attempt to fire the laser. The laser interlock 42 would also prevent the unintentional firing of the laser 40. Until the surgical laser fiber 22 has left the endoscope 20 by protruding from the sheath 34, based on the reflectance of the light source 24 delivered back through the surgical laser fiber 22, the laser 40 will remain restricted from firing.”
Regarding claim 5, it is noted that paragraph 42 states that “Based on the feedback, the feedback analyzer 50 may interface with the laser interlock 42 to prevent the laser 40 from firing, even when in emission mode and the user makes an intentional attempt to fire the laser.” Therefore, this reads on interrupting an activation signal, since it explicitly teaches that laser firing is prevented even when the user intentionally attempts to fire the laser.
Regarding claim 6, it is noted that paragraph 42 states that “Based on the feedback, the feedback analyzer 50 may interface with the laser interlock 42 to prevent the laser 40 from firing, even when in emission mode and the user makes an intentional attempt to fire the laser. The laser interlock 42 would also prevent the unintentional firing of the laser 40. Until the surgical laser fiber 22 has left the endoscope 20 by protruding from the sheath 34, based on the reflectance of the light source 24 delivered back through the surgical laser fiber 22, the laser 40 will remain restricted from firing.” In other words, this teaches that when a signal is sent from the feedback analyzer 50 that prevents the laser from firing, then an intentional attempt to fire the laser by the user is prevented. However, once a signal is sent from the feedback analyzer 50 that the surgical laser fiber 22 has left the endoscope 20, then the laser will be enabled to fire and the user may then cause the laser to fire if/when the user makes an intentional attempt to fire the laser, which would inherently require a device that allows for intentional firing (i.e., an activation device).
Regarding claim 7, it is re-iterated that paragraph 25 teaches that “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber. The reflected light comes from the light source used in the endoscopic procedure.” Also, Figure 1 illustrates light source 24 at the distal end of the endoscope.
Regarding claim 8, it is clear from the disclosure, particularly paragraph 25, that the laser fiber can move back and forth within the working channel of the endoscope (i.e., “A lack of optical detection of a reflected signal back through the surgical laser fiber (or optical detection less than a predetermined value) causes a determination that the surgical laser fiber is within the working channel of the endoscope. Optical detection of a reflected signal greater than a predetermined value back through the surgical laser fiber causes a determination that the surgical laser fiber has been advanced enough through the working channel to have exited the endoscope” – emphasis added).
Regarding claim 9, Figure 1 illustrates that the endoscope and all aspects contained therein are coupled to a laser console which includes elements 40 and 50 as shown in Figure 1.
Regarding claims 11 and 16, Talbot teaches a system that includes a controller having a processor and memory, and an analyzer that is configured to receive, from a light detector, an electrical signal comprising an indication of a power of light received at a distal end of an optical fiber (see paragraph 25, “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber… A lack of optical detection of a reflected signal back through the surgical laser fiber (or optical detection less than a predetermined value) causes a determination that the surgical laser fiber is within the working channel of the endoscope. Optical detection of a reflected signal greater than a predetermined value back through the surgical laser fiber causes a determination that the surgical laser fiber has been advanced enough through the working channel to have exited the endoscope”), wherein the light corresponds to light generated by one or more illumination lights of an endoscope (see paragraph 25 again, “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber. The reflected light comes from the light source used in the endoscopic procedure”).
Regarding claims 12-13 and 17-18, it is re-iterated that paragraph 25 teaches that “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber… A lack of optical detection of a reflected signal back through the surgical laser fiber (or optical detection less than a predetermined value) causes a determination that the surgical laser fiber is within the working channel of the endoscope. Optical detection of a reflected signal greater than a predetermined value back through the surgical laser fiber causes a determination that the surgical laser fiber has been advanced enough through the working channel to have exited the endoscope.” Additionally, paragraph 42 teaches that “In some embodiments, the feedback analyzer 50 may make a determination that the surgical laser fiber 22 is located fully in the working channel 36 and may, for example, indicate such to the user via a red light (or similar signal). Based on the feedback, the feedback analyzer 50 may interface with the laser interlock 42 to prevent the laser 40 from firing, even when in emission mode and the user makes an intentional attempt to fire the laser. The laser interlock 42 would also prevent the unintentional firing of the laser 40. Until the surgical laser fiber 22 has left the endoscope 20 by protruding from the sheath 34, based on the reflectance of the light source 24 delivered back through the surgical laser fiber 22, the laser 40 will remain restricted from firing.”
Regarding claims 14 and 19, it is noted that paragraph 42 states that “Based on the feedback, the feedback analyzer 50 may interface with the laser interlock 42 to prevent the laser 40 from firing, even when in emission mode and the user makes an intentional attempt to fire the laser.” Therefore, this reads on interrupting an activation signal, since it explicitly teaches that laser firing is prevented even when the user intentionally attempts to fire the laser.
Regarding claims 15 and 20, it is noted that paragraph 42 states that “Based on the feedback, the feedback analyzer 50 may interface with the laser interlock 42 to prevent the laser 40 from firing, even when in emission mode and the user makes an intentional attempt to fire the laser. The laser interlock 42 would also prevent the unintentional firing of the laser 40. Until the surgical laser fiber 22 has left the endoscope 20 by protruding from the sheath 34, based on the reflectance of the light source 24 delivered back through the surgical laser fiber 22, the laser 40 will remain restricted from firing.” In other words, this teaches that when a signal is sent from the feedback analyzer 50 that prevents the laser from firing, then an intentional attempt to fire the laser by the user is prevented. However, once a signal is sent from the feedback analyzer 50 that the surgical laser fiber 22 has left the endoscope 20, then the laser will be enabled to fire and the user may then cause the laser to fire if/when the user makes an intentional attempt to fire the laser, which would inherently require a device that allows for intentional firing (i.e., an activation device).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Talbot in view of Cook et al. (US Patent Pub. No. 2022/0354578).
Talbot is described above with respect to claim 9. It is re-iterated that Talbot teaches that “The methods may be carried out by measuring optically detected reflectance back through the surgical laser fiber. The reflected light comes from the light source used in the endoscopic procedure.… A lack of optical detection of a reflected signal back through the surgical laser fiber (or optical detection less than a predetermined value) causes a determination that the surgical laser fiber is within the working channel of the endoscope. Optical detection of a reflected signal greater than a predetermined value back through the surgical laser fiber causes a determination that the surgical laser fiber has been advanced enough through the working channel to have exited the endoscope” (see paragraph 25). However, Talbot fails to teach how laser light would be transmitted from the proximal end to the distal end of this fiber, while endoscopic illumination light would be transmitted from the distal end to the proximal end and impinge upon an optical detector.
Cook teaches an optical analyzer assembly with a safety shutdown system for intravascular lithotripsy devices (see Title). In Cook, Figure 2A illustrates how light from the laser 224 is sent through a beamsplitter 264 in order to provide treatment, while light returning through the optical fiber is reflected and directed to photodetector(s) 272 and/or 280 for detection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a beam splitter, as taught by Cook, within the system and methods of Talbot in order to properly direct the optical energy, whether it be the laser treatment beam or the illumination light to be detected, in the necessary direction to allow both treatment and detection through the same optical fiber, because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Conclusion
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
Zappia et al. (US Patent Pub. No. 2013/0072753)
“A system for preventing inadvertent actuation of a medical device. The system includes an elongate tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The lumen is configured to receive a medical device configured to transition between an actuated state and an inactive state. The device further includes a detection system configured to determine a position of a distal end of the medical device relative to the distal end of the elongate tube. The detection system includes a transmitting element and a receiving element” (see Abstract).
Olesen et al. (WO 2024/223506)
“It will generally be appreciated that the term enabling output of a laser radiation does not mean that laser radiation is necessarily emitted. Actual emission may further depend on the operator activating the output, e.g. by pressing a foot pedal or the like. Hence enabling output of the laser radiation is intended to mean that the operator may cause the laser radiation to be emitted. When the output is not enabled, the user is prevented from initiating emission of the laser radiation. In other words, enabling output of the treatment laser radiation is intended to refer to enabling a user to control the apparatus to output the treatment laser radiation.”
Batchelor et al. (DE 102024106134, filed on March 16, 2023)
“A reflected intensity of the reflected light signal 122 that falls below the lower threshold (or the absence of a reflected signal) may indicate that no target or object is detected, for example, when the light signal from the aiming beam 104 and/or an endoscopic light source (not shown) is reflected by water or tissue with low reflection intensity. In such a case, one or more laser emission sources (e.g., a green light laser emitter or a blue light laser emitter, or the emitter of any laser that emits a signal at a wavelength that is not or poorly absorbed by water) 118 may be disabled, deactivated, turned off, or the like by the system until the laser fiber 120 and/or the surgical fiber 108 can be repositioned.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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