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 .
Response to Arguments
Applicant’s amendments merit new grounds for rejection in view of Islam (U.S. Patent Application Publication No. 2015/0250542).
The Islam reference teaches adjusting laser output power by adjusting the power of a laser source (¶[0101] power ranges from 10-40W at the source).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser source of Kittrell to use an adjustable laser source, as taught by Islam, because they are considered particularly useful when significant power is desired in a relatively narrow bandwidth, such as therapeutic applications (Islam ¶[0100]).
Applicant’s remarks filed 12/23/2025 are limited to the amended claim limitations and are therefore considered moot in light of the new grounds for rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5, 7-8, 10, 14, 16-17, 19-22, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kittrell et al. (U.S. Patent Application Publication No. 2002/0045811); in view of Yamada (U.S. Patent Application Publication No. 2020/0337535) hereinafter referred to as Yamada; in view of Chen et al. (U.S. Patent Application Publication No. 2018/0000337) hereinafter referred to as Chen; in view of Islam (U.S. Patent Application Publication No. 2015/0250542) hereinafter referred to as Islam.
Regarding claim 1, Kittrell teaches a laser system comprising:
a laser configured to emit pulsed electromagnetic radiation (¶[0061] laser source, pulsed ¶¶[0127-0128]);
at least one optical fiber (elements 20, optical fibers) having a proximal end and a distal end, the proximal end of the optical fiber configured to receive pulsed electromagnetic radiation from the laser (¶[0067] accept radiation at their proximal ends, ¶[0110] input ends) and to transmit pulsed electromagnetic radiation from the proximal end to the distal end and out of the distal end of the optical fiber (¶[0062] distal end, ¶[0068] through the optical fibers out the distal end to treat tissue); and
a back-reflection monitoring sensor positioned to detect back-reflected pulsed electromagnetic radiation reflected back from the at least one optical fiber (¶[0110] photodiode… mounted near the input ends of the optical fibers, ¶[0111] photodiode…can monitor scattered return light at the laser wavelength);
a beam splitter positioned between the laser and the proximal end of the at least one optical fiber (¶[0117] return light is separated by the beam splitter);
wherein the beam splitter is adapted to permit pulsed electromagnetic radiation that is transmitted from the laser to pass through the beam splitter to the at least one optical fiber, and wherein the beam splitter is adapted to direct pulsed electromagnetic radiation that is reflected back from the at least one optical fiber to the back-reflection monitoring sensor (Fig. 21, the originating light is transmitted through the beam splitter, element 52, and reflected light is directed to the spectrum analyzer, ¶[0129] states that a beam splitter can be used in this fashion for systems that use intense laser light and collect returning light for analysis);
wherein the back-reflection monitoring sensor is a photodiode (¶[0111] photodiode…can monitor scattered return light at the laser wavelength);
wherein the back-reflection monitoring sensor is adapted to detect back-reflected electromagnetic radiation while the laser system is in use (¶[0110] in use for detecting positional corrections serving as a continuous monitor during operation);
wherein the laser system is further configured to continuously calibrate an output power of the system by automatically adjusting the output power of the laser system based upon the detected back reflection (¶[0110] the signal from the photodiode can be coupled to the computer to cause the computer…to serve as a continuous monitor during operation, providing feedback to computer...the computer adjust the input ends for maximum power transmission, see also claim 43, e.g. “extra optical fibers are provided for monitoring output powers, ¶[0155] controlled by attenuator 47).
wherein the back-reflection monitoring sensor detects back-reflected electromagnetic radiation while the laser system is in use (¶[0110]);
Kittrell does teach infrared lasers can be used with the invention of Kittrell but does not explicitly teach an infrared laser source, teaching that the configuration of the invention for an infrared laser is a matter of ordinary skill in the art (Kittrell ¶[0061]).
Kittrell does not teach adjusting the output power by adjusting the power of the laser source, or informing the user of information relating to the detected back reflection including an amount of back reflection, whether a threshold has been crossed, and whether mis-alignment or defects are suspected or detected. Kittrell further does not teach an output optical fiber each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber, nor that the laser is light in a mid-infrared range.
Attention is brought to the Yamada reference, which teaches a laser generating in the mid-infrared range (¶[0069]), a display (¶[0023], ¶[0075]) for informing the user of information relating to the detected back reflection including an amount of back reflection (¶[0065], Fig. 9), whether a threshold has been crossed (¶[0066], Fig. 9), and whether mis-alignment or defects are suspected or detected (Fig. 9, ¶[0067], ¶[0089] all of the disclosed laser sources are used with the console and user display of Fig. 9).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Kittrell to include informational display, as taught by Yamada, because detecting proper optical fiber connection prevents unsafe irradiation (Yamada ¶[0010]) and to use infrared range laser light to use other imaging wavelengths (Yamada ¶[0003]).
Kittrell as modified does not teach adjusting the output power by adjusting the power of the laser source; or an output optical fiber each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber, nor that the laser is light in a mid-infrared range.
Attention is drawn to the Chen reference, which teaches a delivery optical fiber (Fig. 29, element 161) and an output optical fiber (¶[0093] length of fiber between the male and female connectors) each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber (¶[0119-0120], ¶[0017] in summary makes it clear that the removable tip also contains an optical fiber).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser delivery of Kittrell as modified to include a removable and replaceable delivery device, as taught by Chen, for “sterilization and other clinical needs,” (Chen ¶[0093]).
Kittrell as modified does not teach adjusting the output power by adjusting the power of the laser source.
Attention is brought to the Islam reference, which teaches adjusting laser output power by adjusting the power of a laser source (¶[0101] power ranges from 10-40W at the source).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser source of Kittrell to use an adjustable laser source, as taught by Islam, because they are considered particularly useful when significant power is desired in a relatively narrow bandwidth, such as therapeutic applications (Islam ¶[0100]).
Regarding claim 5, Kittrell as modified teaches the laser system as recited in claim 1.
Kittrell further teaches wherein the beam splitter is adapted to direct electromagnetic radiation that is transmitted from the laser to the at least one optical fiber, and wherein the beam splitter is adapted to permit electromagnetic radiation that is reflected back from the at least one optical fiber to pass through the beam splitter to the back-reflection monitoring sensor (Fig. 21, the originating light is transmitted through the beam splitter, element 52, and reflected light is directed to the spectrum analyzer), ¶[0129] states that a beam splitter can be used in this fashion for systems that use intense laser light and collect returning light for analysis).
Regarding claim 7, Kittrell as modified teaches the laser system as recited in claim 1.
Kittrell does not make explicit a laser housing, wherein the laser source is located inside the laser housing, and wherein the at least one optical fiber is adapted to be removably connected to the laser housing.
Attention is drawn to the Chen reference, which teaches a laser housing, wherein the laser source is located inside the laser housing (¶[0075] within the device handle), and wherein the at least one optical fiber is adapted to be removably connected to the laser housing (¶[0119-0120]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser delivery of Kittrell as modified to include a removable and replaceable delivery device, as taught by Chen, for “sterilization and other clinical needs,” (Chen ¶[0093]).
Regarding claim 8, Kittrell as modified teaches the laser system as recited in claim 7.
Kittrell teaches wherein the back-reflection monitoring sensor is located at the proximal end of the device (Fig. 24, the sensor is located where the other system elements are, away from the delivery end of the device).
Attention is drawn to the Chen reference, which teaches a laser housing, wherein the laser is located inside the laser housing (¶[0075] within the device handle), and wherein the at least one optical fiber is adapted to be removably connected to the laser housing (¶[0119-0120]). Notably, Chen also teaches a photodiode that detects reflected light in order to monitor laser output power in the housing (¶[0098]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the proximal laser system of Kittrell as modified to include a housing encasing the system, as taught by Chen, for a self-contained handheld treatment device, operatable independently of an AC power source (Chen ¶[0075]).
Regarding claim 10, Kittrell as modified teaches the laser system as recited in claim 1.
Kittrell further teaches wherein the laser system further comprises a computing system adapted to calculate an output power of the system based upon the back-reflected electromagnetic radiation detected by the back-reflection monitoring sensor (¶[0110] the signal from the photodiode can be coupled to the computer to cause the computer…to serve as a continuous monitor during operation, providing feedback to computer...the computer adjust the input ends for maximum power transmission, see also claim 43, e.g. “extra optical fibers are provided for monitoring output powers).
Regarding claims 14/19, 16, and 20, the claims are directed to a method comprising substantially the same subject matter as claims 1 and 10, respectively, and are rejected under substantially the same sections of Kittrell, Yamada, Chen, and Islam.
Regarding claim 17, Kittrell as modified teaches the method of monitoring a laser system using detection of back reflection as recited in claim 14.
Kittrell does not teach informing the user of the output power of the laser system computed from the detected back reflection.
Attention is brought to the Chen reference, which teaches informing a user of an output power of a laser system computed from detected back reflection (¶[0098]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Kittrell as modified to include informational display of the detected output power of the system, as taught by Chen, for adjusting parameters of the therapeutic light with a self-contained handheld treatment device, operatable independently of an AC power source (Chen ¶[0075]).
Regarding claim 21, Kittrell as modified teaches the laser system of claim 1.
Kittrell does not teach informing the user of the output power of the laser system computed from the detected back reflection.
Attention is brought to the Chen reference, which teaches informing a user of an output power of a laser system computed from detected back reflection (¶[0098]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Kittrell as modified to include informational display of the detected output power of the system, as taught by Chen, for adjusting parameters of the therapeutic light with a self-contained handheld treatment device, operatable independently of an AC power source (Chen ¶[0075]).
Regarding claim 22, Kittrell as modified teaches the laser system of claim 1.
Yamada further teaches wherein the laser system is further configured to detect a misalignment between the delivery optical fiber and the output optical fiber based on the detected back reflection (Fig. 9, ¶[0067], ¶[0089] all of the disclosed laser sources are used with the console and user display of Fig. 9, a disconnected probe is misaligned).
Regarding claim 26, Kitrell as modified teaches the method of claim 19.
Yamada teaches further comprising: detecting a misalignment between the delivery optical fiber and the output optical fiber based on the detected back reflection (Fig. 9, ¶[0067], ¶[0089] all of the disclosed laser sources are used with the console and user display of Fig. 9, a disconnected probe is misaligned).
Claim(s) 11-13 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chassange et al. (U.S. Patent Application Publication No. 2018/0214306) hereinafter referred to as Chassange; in view of Kittrell et al. (U.S. Patent Application Publication No. 2002/0045811); in view of Yamada (U.S. Patent Application Publication No. 2020/0337535) hereinafter referred to as Yamada; in view of Chen et al. (U.S. Patent Application Publication No. 2018/0000337) hereinafter referred to as Chen; in view of Islam (U.S. Patent Application Publication No. 2015/0250542) hereinafter referred to as Islam.
Regarding claim 11, Chassange teaches a laser system (Fig. 1) for performing an ophthalmic procedure (Fig. 1, target is an eye, and ¶[0048] lists some intended procedures), the laser system comprising:
a laser configured to emit pulsed electromagnetic radiation (Fig. 1, element 1 laser source, ¶[0018] pulsed laser beam);
at least one optical fiber having a proximal end and a distal end (Fig. 1, element 15 optical fiber), the proximal end of the optical fiber configured to receive pulsed electromagnetic radiation from the laser (¶[0018] pulsed laser beam) and to transmit pulsed electromagnetic radiation from the proximal end to the distal end and out of the distal end of the optical fiber (Fig. 1, element 15, light travels from laser source to optical system, ¶[0018] pulsed laser beam); and
the laser system is configured for use during the ophthalmic procedure (¶[0048] intended procedures).
Chassange does not teach a back-reflection monitoring sensor positioned to detect back-reflected electromagnetic radiation reflected back from the at least one optical fiber; a beam splitter positioned between the laser and the proximal end of the at least one optical fiber; wherein the back-reflection monitoring sensor is a photodiode; wherein the laser system is configured to inform a user of information relating to the detected back reflection including an amount of back reflection, whether a threshold has been crossed, and whether mis-alignment or defects are suspected or detected; wherein the laser system is further configured to automatically adjust an output power of the laser based upon the detected back reflection; wherein the back-reflection monitoring sensor is adapted to detect back-reflected electromagnetic radiation while the laser system is in use. Chassange further does not teach an output optical fiber each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber, nor that the laser is light in a mid-infrared range.
Attention is brought to the Kittrell reference, which teaches a back-reflection monitoring sensor positioned to detect back-reflected pulsed electromagnetic radiation reflected back from the at least one optical fiber (¶[0110] photodiode… mounted near the input ends of the optical fibers, ¶[0111] photodiode…can monitor scattered return light at the laser wavelength);
a beam splitter positioned between the laser and the proximal end of the at least one optical fiber (¶[0117] return light is separated by the beam splitter);
wherein the beam splitter is adapted to permit pulsed electromagnetic radiation that is transmitted from the laser to pass through the beam splitter to the at least one optical fiber, and wherein the beam splitter is adapted to direct electromagnetic radiation that is reflected back from the at least one optical fiber to the back-reflection monitoring sensor (Fig. 21, the originating light is transmitted through the beam splitter, element 52, and reflected light is directed to the spectrum analyzer, ¶[0129] states that a beam splitter can be used in this fashion for systems that use intense laser light and collect returning light for analysis);
wherein the back-reflection monitoring sensor is a photodiode (¶[0111] photodiode…can monitor scattered return light at the laser wavelength);
wherein the back-reflection monitoring sensor is adapted to detect back-reflected electromagnetic radiation while the laser system is in use (¶[0110] in use for detecting positional corrections serving as a continuous monitor during operation);
wherein the laser system is further configured to continuously calibrate an output power of the system by automatically adjusting the output power of the laser system based upon the detected back reflection (¶[0110] the signal from the photodiode can be coupled to the computer to cause the computer…to serve as a continuous monitor during operation, providing feedback to computer...the computer adjust the input ends for maximum power transmission, see also claim 43, e.g. “extra optical fibers are provided for monitoring output powers).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the ophthalmic laser system of Chassange to include back-reflected light monitoring, as taught by Kittrell, because Kittrell teaches using back-reflected light to optimize a fiber connection for maximum power transmission (Kittrell ¶[0110]).
Chassange as modified does not teach informing the user of information relating to the detected back reflection including an amount of back reflection, whether a threshold has been crossed, and whether mis-alignment or defects are suspected or detected. Chassange as modified further does not teach an output optical fiber each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber, nor that the laser is light in a mid-infrared range.
Attention is brought to the Yamada reference, which teaches a display (¶[0023]) for informing the user of information relating to the detected back reflection including an amount of back reflection (¶[0065]), whether a threshold has been crossed (¶[0066]), and whether mis-alignment or defects are suspected or detected (¶[0089]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Kittrell to include informational display, as taught by Yamada, because detecting proper optical fiber connection prevents unsafe irradiation (Yamada ¶[0010]).
Chassange as modified does not teach an output optical fiber each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber, nor that the laser is light in a mid-infrared range.
Attention is drawn to the Chen reference, which teaches a delivery optical fiber (Fig. 29, element 161) and an output optical fiber (¶[0093] length of fiber between the male and female connectors) each having a proximal end and a distal end, wherein the output optical fiber is positioned distal to the delivery optical fiber, and wherein the proximal end of the output optical fiber is configured to receive electromagnetic radiation from the distal end of the delivery optical fiber (¶[0119-0120], ¶[0017] in summary makes it clear that the removable tip also contains an optical fiber).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser delivery of Kittrell as modified to include a removable and replaceable delivery device, as taught by Chen, for “sterilization and other clinical needs,” (Chen ¶[0093]).
Kittrell as modified does not teach adjusting the output power by adjusting the power of the laser source.
Attention is brought to the Islam reference, which teaches adjusting laser output power by adjusting the power of a laser source (¶[0101] power ranges from 10-40W at the source).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser source of Kittrell to use an adjustable laser source, as taught by Islam, because they are considered particularly useful when significant power is desired in a relatively narrow bandwidth, such as therapeutic applications (Islam ¶[0100]).
Regarding claim 12, Chassange as modified teaches the laser system as recited in claim 11.
Chassange further teaches wherein the laser system is adapted for fragmenting a cataractous lens (¶[0016], ¶[0048] FLAC).
Regarding claim 13, Chassange as modified teaches the laser system as recited in claim 11.
Chassange further teaches wherein the electromagnetic radiation is in a mid-infrared range (¶[0033]).
Regarding claim 23, Chassange as modified teaches the laser system of claim 11.
Chassange does not teach informing the user of the output power of the laser system computed from the detected back reflection.
Attention is brought to the Chen reference, which teaches informing a user of an output power of a laser system computed from detected back reflection (¶[0098]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Kittrell as modified to include informational display of the detected output power of the system, as taught by Chen, for adjusting parameters of the therapeutic light with a self-contained handheld treatment device, operatable independently of an AC power source (Chen ¶[0075]).
Regarding claim 24, Chassange as modified teaches the laser system of claim 11.
Yamada further teaches wherein the laser system is further configured to detect a misalignment between the delivery optical fiber and the output optical fiber based on the detected back reflection (Fig. 9, ¶[0067], ¶[0089] all of the disclosed laser sources are used with the console and user display of Fig. 9, a disconnected probe is misaligned).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kittrell, Yamada, Chen, and Islam as applied to claim 14 above, and further in view of Chassange et al. (U.S. Patent Application Publication No. 2018/0214306) hereinafter referred to as Chassange.
Regarding claim 25, Kittrell as modified teaches the method of claim 14.
Kittrell does teach infrared lasers can be used with the invention of Kittrell but does not explicitly teach an infrared laser source, teaching that the configuration of the invention for an infrared laser is a matter of ordinary skill in the art (Kittrell ¶[0061]).
Kittrell does not teach transmitted laser light in a mid-infrared range for fragmenting a cataractous lens.
Attention is brought to the Chassange reference, which teaches wherein the transmitted pulsed electromagnetic radiation is in a mid-infrared range (¶[0033]) for fragmenting a cataractous lens (¶[0016], ¶[0048] FLAC.)
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Kittrell as modified to include mid-infrared range light for fragmenting cataractous lenses, as taught by Chassange, because cataractous eye surgery is the most practiced microsurgery in the world, (Chassange ¶[0003]) and because Chassange teaches that there is a long felt need to apply safe laser systems to ophthalmic surgery (Chassange ¶[0016]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Kish can be reached at (571) 272-5554. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA L STEINBERG/ Examiner, Art Unit 3792