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
1. Applicant’s arguments, filed 06/25/2025 with respect to the rejection(s) of the claim(s) under U.S.C. 103 have been fully considered /but are not persuasive.
The Applicant argues that the art of Rathjen lets the user determine the 3D cut pattern rather than the control device. The Examiner respectfully disagrees. Par. 0047 of Rathjen discloses “The diagnosis data is stored in the database 82 and supplied to the computer system 1 for generating a three-dimensional cut pattern. The cut pattern is generated according to instructions from the medical practitioner 84, which are based on a (three-dimensional) model of the eye 83.” Rathjen does allow the user to make edits the cut pattern or change things about it [Par. 0071]; however, the cut pattern is still initially generated by a control/computer system based on the 3D model of the eye and the desired target to be removed. Par. 0047 further goes on to teach “For the actual treatment of an eye 2 (from a donor or on the patient 80), the cut pattern is supplied to the laser device 3 from the computer system 1.” Par. 098 further supports this, stating “If the user indicates to the control module 10 via the user interface 171 that the definition of the three-dimensional cut pattern in step SM has been completed,
the cut pattern generator 117 generates a three-dimensional cut pattern based thereon in step S10. The three-dimensional cut pattern basically defines one or more tissue cuts through one or more cut surfaces positioned in relation to at least one geometric reference in the non-deformed or deformed model of the eye, which cut surfaces have an execution sequence assigned thereto or are ordered according to the execution sequence. The cut surfaces are defined in the three-dimensional cut pattern in the form of e.g. macroinstructions … Along with the cut pattern data of a defined cut pattern, the (manually or automatically) defined geometric references are also transferred to the laser device 3.”
The Applicant further argues that it would not be obvious to combine the teachings of Rathjen and Zheleznyak since Zheleznyak teaches using crosslinking and LRIC. The Examiner respectfully disagrees. Zheleznyak teaches that both crosslinking and LRIC methods can be used, not that it is exclusively tied to crosslinking. Ultimately, Zheleznyak is used to teach that using a fiber laser and oscillator for laser induced refractive changes is known.
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.
2. Claim(s) 16-19, 21-23, 25-29, 31-34, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rathjen (US 20100256965 A1) in view of Zheleznyak (US 20190343683 A1).
In regards to claim 16, Rathjen discloses a treatment apparatus for a correction of an eye tissue (Abstract and Par. 0047discloses a treatment for correcting eye tissue) comprising:
at least one laser device (Abstract discloses a laser device); and
a control device (Par. 0051 discloses a control module [10]]) configured to
receive data corresponding to an actual morphology of a tissue of a correction area of a human or animal eye to be corrected from a data server (Par. 0045 teaches a data sever/storage for receiving and storing eye data; i.e. morphology, see also Par. 0065 that teaches using current eye data), wherein said actual morphology comprising a keratoconus and/or a shape of a keratoconus (Par. 0070 and 0074 teaches the system is used to take in data and correct for keratoconus);
ascertain a three-dimensional model of a cornea of said eye and/or the tissue of said correction area of said human or animal eye based on said data (Par. 0057 teaches using the eye data to make a 3D model of the eye),
ascertain a desired geometry of said cornea of said eye and/or the tissue of said correction area of said human or animal eye based on ascertained three-dimensional model of said cornea of said eye and/or the tissue of said correction area of said human or animal eye wherein the desired geometry corrects said keratoconus (Par. 0047 teaches the system ascertains a planned treatment module and Par. 0074 discloses that the system is used to correct keratoconus),
generate control data comprising position data and focusing data of individual laser pulses by determining an area of the eye to be irradiated to reduce the keratoconus based on a comparison of the ascertained three-dimensional model and the ascertained desired geometry (Par. 0061 teaches the control module can use the 3D model of the eye to generate references for where the target is/where it should be removed in order to treat keratoconus; see also Par. 0052 which discloses laser parameters like focus and distance)
provide control data to the at least one laser device that describes an operation of the at least one laser device for cut-free transfer of the tissue of the correction area from the actual morphology into the ascertained desired state geometry of the tissue (Par. 0043 teaches the diagnosis data is stored in the database 82 and supplied to the computer system 1 for generating a three-dimensional cut pattern; the cut pattern is generated according to instructions from the medical practitioner 84, which are based on a (three-dimensional) model of the eye 83. See also Par. 0098).
Rathjen des not disclose wherein the laser is a fiber laser and the system includes an oscillator/amplifier OR wherein the operation described by the control data utilizes a laser-induced change of a refractive index (LIRIC). However, in the same field of endeavor Zheleznyak teaches a vision correction apparatus (Abstract) with a fiber laser and oscillator (Par. 0057 and 0092) wherein cross-linking and LIRIC methods are used (Par. 0039-0040 and Par. 0083) in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rathjen and modified them by utilizing a laser-induced change of a refractive index (LIRIC), as taught and suggested by Zheleznyak, in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye
In regards to claim 17, the combined teachings of Rathjen and Zheleznyak disclose the treatment apparatus according to claim 15, wherein the fiber laser device is suitable to emit laser pulses in a wavelength range between 300 nm and 1400 nm, or between 700 nm and 1200 nm (Par. 0091-0082 of Zheleznyak disclose a wavelength at 800nm) at a respective pulse duration between 1 fs and 1 ns, or between 10 fs and 10 ps (Par 0050 of Zheleznyak disclose using a pulse width of 10-300 fs), and a repetition frequency of greater than 10 kHz, or between 100 kHz and 100 MHz (Par. 0048 of Zheleznyak discloses using a repetition rate of 100 MHz).
In regards to claim 18, the combined teachings of Rathjen and Zheleznyak the treatment apparatus according to claim 16, wherein the control device comprises:
at least one storage device for at least temporary storage of at least one control dataset (Par. 0051 of Rathjen teaches a storage [18]),
wherein the at least one control dataset includes control data for positioning and/or for focusing individual laser pulses in a cornea of the human or animal eye (Par. 0065 of Rathjen teaches means for positioning) and at least one beam device for beam guidance and/or beam shaping and/or beam deflection and/or beam focusing of a laser beam of the at least one fiber laser device (Par. 0041 of Rathjen teaches focusing the laser).
In regards to claim 19, the combined teachings of Rathjen and Zheleznyak the treatment apparatus according to claim 16, wherein the control device is configured to determine visual disorder data of the human or animal eye, which describes a visual disorder, wherein the ascertained desired geometry of the tissue satisfies a preset visual disorder reduction criterion, which presets that the human or animal eye with the tissue in the desired geometry has a visual disorder reduced compared to the actual morphology of the tissue (Par. 0074 of Rathjen discloses the device is for diagnosing and treating corneal diseases/disorders).
In regards to claim 21, the combined teachings of Rathjen and Zheleznyak the treatment apparatus according to claim 16, wherein the control device transmits the control data to the at least one fiber laser device of the treatment apparatus (Par. 0047 of Rathjen teaches the cut information is delivered to the laser from the computer/control system).
In regards to claim 22, Rathjen discloses the method for providing control data, via a control device, to a fiber laser device for a correction of an eye tissue (Abstract and Par. 0047discloses a treatment for correcting eye tissue) comprising, the laser device (Abstract discloses a laser device), the method comprising:
receive data corresponding to an actual morphology of a tissue of a correction area of a human or animal eye to be corrected from a data server (Par. 0045 teaches a data sever/storage for receiving and storing eye data; i.e. morphology, see also Par. 0065 that teaches using current eye data), wherein said actual morphology comprising a keratoconus and/or a shape of a keratoconus (Par. 0070 and 0074 teaches the system is used to take in data and correct for keratoconus);
ascertain a three-dimensional model of a cornea of said eye and/or the tissue of said correction area of said human or animal eye based on said data (Par. 0057 teaches using the eye data to make a 3D model of the eye),
ascertain a desired geometry of said cornea of said eye and/or the tissue of said correction area of said human or animal eye based on ascertained three-dimensional model of said cornea of said eye and/or the tissue of said correction area of said human or animal eye wherein the desired geometry corrects said keratoconus (Par. 0047 teaches the system ascertains a planned treatment module and Par. 0074 discloses that the system is used to correct keratoconus) and
provide control data, based on the ascertained three-dimensional model and desired geometry, to the at least one fiber laser device that describes an operation of the at least one fiber laser device for cut-free transfer of the tissue of the correction area from the actual morphology into the ascertained desired state geometry of the tissue ((Par. 0073 and 0081-0082 teaches taking in the 3D model of the eye and then planning and executing a cut pattern for the tissue correction).
Rathjen des not disclose wherein the laser is a fiber laser and the system includes an oscillator/amplifier OR wherein the operation described by the control data utilizes a laser-induced change of a refractive index (LIRIC). However, in the same field of endeavor Zheleznyak teaches a vision correction apparatus (Abstract) with a fiber laser and oscillator (Par. 0057 and 0092) wherein cross-linking and LIRIC methods are used (Par. 0039-0040 and Par. 0083) in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rathjen and modified them by utilizing a laser-induced change of a refractive index (LIRIC), as taught and suggested by Zheleznyak, in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye
In regards to claim 23, the combined teachings of Rathjen and Zheleznyak the method according to claim 22, wherein the method further comprises: determining visual disorder data of the human or animal eye, which describes the visual disorder, wherein the ascertained desired geometry of the tissue satisfies a preset visual disorder reduction criterion, which presets that the human or animal eye with the tissue in the desired geometry has a visual disorder reduced compared to the actual morphology of the tissue (Par. 0074 of Rathjen discloses the device is for diagnosing and treating corneal diseases/disorders).
In regards to claim 25, the combined teachings of Rathjen and Zheleznyak the method according to claim 22, further comprising emitting via the fiber laser device, laser pulses in a wavelength range between 300 nm and 1400 nm, or between 700 nm and 1200 nm (Par. 0091-0082 of Zheleznyak disclose a wavelength at 800nm) at a respective pulse duration between 1 fs and 1 ns, or between 10 fs and 10 ps (Par 0050 of Zheleznyak disclose using a pulse width of 10-300 fs), and a repetition frequency of greater than 10 kHz, or between 100 kHz and 100 MHz (Par. 0048 of Zheleznyak discloses using a repetition rate of 100 MHz).
In regards to claim 26, the combined teachings of Rathjen and Zheleznyak the method according to claim 22, wherein the control device transmits the control data to the fiber laser device (Par. 0047 of Rathjen teaches the cut information is delivered to the laser from the computer/control system).
In regards to claim 27, the combined teachings of Rathjen and Zheleznyak a non-transitory computer-readable medium for storing a computer program, the computer program including instructions that cause a control device of a treatment apparatus, having a fiber oscillator and/or a fiber amplifier, to execute a method according to claim 22 (Par. 0057 and 0095 of Zheleznyak).
In regards to claim 28, Rathjen discloses a control device for providing control data to a fiber laser device for a correction of an eye tissue (Abstract and Par. 0047discloses a treatment for correcting eye tissue) comprising, the laser device (Abstract discloses a laser device), and a control device (Par. 0050 teaches a control module) configured to:
receive data corresponding to an actual morphology of a tissue of a correction area of a human or animal eye to be corrected from a data server (Par. 0045 teaches a data sever/storage for receiving and storing eye data; i.e. morphology, see also Par. 0065 that teaches using current eye data), wherein said actual morphology comprising a keratoconus and/or a shape of a keratoconus (Par. 0070 and 0074 teaches the system is used to take in data and correct for keratoconus);
ascertain a three-dimensional model of a cornea of said eye and/or the tissue of said correction area of said human or animal eye based on said data (Par. 0057 teaches using the eye data to make a 3D model of the eye),
ascertain a desired geometry of said cornea of said eye and/or the tissue of said correction area of said human or animal eye based on ascertained three-dimensional model of said cornea of said eye and/or the tissue of said correction area of said human or animal eye wherein the desired geometry corrects said keratoconus (Par. 0047 teaches the system ascertains a planned treatment module and Par. 0074 discloses that the system is used to correct keratoconus) and
provide control data, based on the ascertained three-dimensional model and desired geometry, to the at least one fiber laser device that describes an operation of the at least one fiber laser device for cut-free transfer of the tissue of the correction area from the actual morphology into the ascertained desired state geometry of the tissue ((Par. 0073 and 0081-0082 teaches taking in the 3D model of the eye and then planning and executing a cut pattern for the tissue correction).
Rathjen des not disclose wherein the laser is a fiber laser and the system includes an oscillator/amplifier OR wherein the operation described by the control data utilizes a laser-induced change of a refractive index (LIRIC). However, in the same field of endeavor Zheleznyak teaches a vision correction apparatus (Abstract) with a fiber laser and oscillator (Par. 0057 and 0092) wherein cross-linking and LIRIC methods are used (Par. 0039-0040 and Par. 0083) in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rathjen and modified them by utilizing a laser-induced change of a refractive index (LIRIC), as taught and suggested by Zheleznyak, in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye
In regards to claim 29, the combined teachings of Rathjen and Zheleznyak the control device according to claim 28, wherein the control device is configured to determine visual disorder data of the human or animal eye, which describes a visual disorder, wherein the ascertained desired geometry of the tissue satisfies a preset visual disorder reduction criterion, which presets that the eye with the tissue in the desired geometry has a reduced visual disorder compared to the actual morphology of the tissue (Par. 0074 of Rathjen discloses the device is for diagnosing and treating corneal diseases/disorders).
In regards to claim 31, the combined teachings of Rathjen and Zheleznyak the control device according to claim 28, wherein the control device is configured to cause the fiber laser device to emit laser pulses in a wavelength range between 300 nm and 1400 nm (Par. 0091-0082 of Zheleznyak disclose a wavelength at 800nm) at a respective pulse duration between 1 fs and 1 ns, or between 10 fs and 10 ps (Par 0050 of Zheleznyak disclose using a pulse width of 10-300 fs), and a repetition frequency of greater than 10 kHz, or between 100 kHz and 100 MHz (Par. 0048 of Zheleznyak discloses using a repetition rate of 100 MHz).
In regards to claim 32, the combined teachings of Rathjen and Zheleznyak the control device according to claim 28, wherein the control device transmits the control data to the fiber laser device (Par. 0047 of Rathjen teaches the cut information is delivered to the laser from the computer/control system).
In regards to claim 33, Rathjen discloses a non-transitory computer readable storage medium storing one or more programs configured to be executed by a processor, the one or more programs comprising instructions for providing control data to a laser device for a correction of an eye tissue (Abstract and Par. 0047 discloses a treatment laser system for correcting eye tissue), instructions comprising
receive data corresponding to an actual morphology of a tissue of a correction area of a human or animal eye to be corrected from a data server (Par. 0045 teaches a data sever/storage for receiving and storing eye data; i.e. morphology, see also Par. 0065 that teaches using current eye data), wherein said actual morphology comprising a keratoconus and/or a shape of a keratoconus (Par. 0070 and 0074 teaches the system is used to take in data and correct for keratoconus);
ascertain a three-dimensional model of a cornea of said eye and/or the tissue of said correction area of said human or animal eye based on said data (Par. 0057 teaches using the eye data to make a 3D model of the eye),
ascertain a desired geometry of said cornea of said eye and/or the tissue of said correction area of said human or animal eye based on ascertained three-dimensional model of said cornea of said eye and/or the tissue of said correction area of said human or animal eye wherein the desired geometry corrects said keratoconus (Par. 0047 teaches the system ascertains a planned treatment module and Par. 0074 discloses that the system is used to correct keratoconus) and
provide control data, based on the ascertained three-dimensional model and desired geometry, to the at least one fiber laser device that describes an operation of the at least one fiber laser device for cut-free transfer of the tissue of the correction area from the actual morphology into the ascertained desired state geometry of the tissue ((Par. 0073 and 0081-0082 teaches taking in the 3D model of the eye and then planning and executing a cut pattern for the tissue correction).
Rathjen des not disclose wherein the laser is a fiber laser and the system includes an oscillator/amplifier OR wherein the operation described by the control data utilizes a laser-induced change of a refractive index (LIRIC). However, in the same field of endeavor Zheleznyak teaches a vision correction apparatus (Abstract) with a fiber laser and oscillator (Par. 0057 and 0092) wherein cross-linking and LIRIC methods are used (Par. 0039-0040 and Par. 0083) in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Rathjen and modified them by utilizing a laser-induced change of a refractive index (LIRIC), as taught and suggested by Zheleznyak, in order to deliver laser pulses in the desired wavelength and address various types of vision correction, as a known way to reshape the eye and change the curvature of the eye
In regards to claim 34, the combined teachings of Rathjen and Zheleznyak the non-transitory computer readable storage medium according to claim 33, wherein the one or more programs comprise instructions for determining visual disorder data of the human or animal eye, which describes a visual disorder, wherein the ascertained desired state of the tissue satisfies a preset visual disorder reduction criterion, which presets that the human or animal eye with the tissue in the desired morphology has a visual disorder reduced compared to the determined actual morphology of the tissue (Par. 0074 of Rathjen discloses the device is for diagnosing and treating corneal diseases/disorders).
In regards to claim 36, the combined teachings of Rathjjen and Zheleznyak the non-transitory computer readable storage medium according to claim 33, wherein the one or more programs comprise instructions for causing the fiber laser device to emit laser pulses in a wavelength range between 300 nm and 1400 nm, o between 700 nm and 1200 nm (Par. 0091-0082 of Zheleznyak disclose a wavelength at 800nm) at a respective pulse duration between 1 fs and 1 ns, or between 10 fs and 10 ps (Par 0050 of Zheleznyak disclose using a pulse width of 10-300 fs), and a repetition frequency of greater than 10 kHz, or between 100 kHz and 100 MHz (Par. 0048 of Zheleznyak discloses using a repetition rate of 100 MHz).
In regards to claim 37, the combined teachings of Rathjen and Zheleznyak the non-transitory computer readable storage medium according to claim 33, wherein the one or more programs further comprise instructions for transmitting the provided control data to the fiber laser device (Par. 0047 of Rathjen teaches the cut information is delivered to the laser from the computer/control system).
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.
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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792