DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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 6-7, 9-10, and 12 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.
Regarding claim 6, the limitation of “K is a tissue factor” renders the claim indefinite. Since no value is provided for K is unclear as to whether K is a measured value or a predetermined constant. The instant disclosure teaches that K “can in particular be predetermined for the cornea” [0019]. Dependent claims inherit the same deficiencies.
Regarding claims 9 and 12, the phrase “in particular” renders the claim indefinite because it is unclear as to whether or not the limitations following the phrase are required by the current claim language. Dependent claims inherit the same deficiencies.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of adjusting optimized irradiation parameters) without significantly more.
Step 1
The claimed invention in claims 1-13 are directed to statutory subject matter as the claims recite a method/system for adjusting optimized irradiation parameters.
Step 2A, Prong One
Regarding claims 1-13, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claim 1, the limitations of “ascertaining a threshold value…”, “providing at least one energy window…”, “selecting a laser pulse energy…”, “providing at least one spatial pulse distance range…”, and “selecting at least one spatial laser pulse distance” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation but for the recitation of generic computing components.
Step 2A, Prong Two
For claims 1-13, the judicial exception is not integrated into a practical application. For claims 1, 11, and 13, the additional limitation of “a control device”, “a non-transitory computer-readable medium”, and “a computer program”, are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of “ascertaining a threshold value” amount to nothing more than the pre-solution activity of data gathering.
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitation of “ascertaining a threshold value” is directed to nothing more than the pre-solution activity of data gathering, which does not amount to an inventive concept. In addition, “a treatment apparatus” is recited at a high level of generality and considered to be well known, routine, and conventional in the art. For examples, please see Volger et al (US 2012/0150160) [0026] and Abba Mosquera (US 2021/0361487) [0029].
Dependent claim 2 is directed towards the insignificant extra-solution activity of data gathering (MPEP 2106.05(g)). The above mentioned claim does not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 3-10 and 13 are further directed towards the abstract idea of adjusting optimized irradiation parameters and amount to nothing more than instructions to execute the abstract idea using generic computing components. The above mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claim 12 is directed towards executing the abstract idea using a generic treatment apparatus, which is considered to be well-known, routine, and conventional in the art as discussed above. The above mentioned claim does not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
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) 1-3, 5, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Volger et al (US 2012/0150160) hereinafter Volger in view of Sumiya (US 5,800,424).
Regarding claim 1, Volger discloses a method for adjusting optimized irradiation parameters of laser pulses (pulsed laser radiation) for an ophthalmological laser (working laser 110) of a treatment apparatus (apparatus 100, [0026]), comprising the steps:
ascertaining a threshold value for a laser-induced optical breakthrough ([0014] LIOB threshold (LIOB=laser-induced optical breakdown)), wherein the threshold value is preset to a control device (control unit 120) of the treatment apparatus (apparatus 100; [0026]);
providing at least one energy window including a selection of laser pulse energies (first and second operating modes) depending on the ascertained threshold value by the control device ([0018-0019] the second operating mode has to lie below the LIOB threshold; first operating mode is designed for placing incisions); and
selecting a laser pulse energy from the provided energy window ([0028] the apparatus 100 is set to the second operating mode).
Volger fails to disclose providing at least one spatial pulse distance range including a selection of laser pulse distances of the laser pulses depending on the selected laser pulse energy by the control device, wherein the pulse distance range is determined by means of a pulse distance model based on the selected laser pulse energy; and selecting at least one spatial laser pulse distance from the provided pulse distance range.
However, Sumiya discloses providing at least one spatial pulse distance range (Figure 9) including a selection of laser pulse distances (shifting positions a-i) of the laser pulses (Col. 6, ln 44: number of pulses) depending on the selected laser pulse energy by the control device (Col. 7, ln 34: fixed condition of irradiation),
wherein the pulse distance range (Figure 9) is determined by means of a pulse distance model based on the selected laser pulse energy (Col. 6, ln 36-39: the shifting distance is determined in nine grades (a) through (i) so as to change every step of 1.4 mm; Col. 7, ln 34: fixed condition of irradiation); and
selecting at least one spatial laser pulse distance (Figures 10a-10b, 11c-11e, 12f-12h, and 13) from the provided pulse distance range (Col. 6, ln 41: irradiated by the laser beam for 30 seconds at each shifting position).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Volger with providing at least one spatial pulse distance range including a selection of laser pulse distances of the laser pulses depending on the selected laser pulse energy by the control device, wherein the pulse distance range is determined by means of a pulse distance model based on the selected laser pulse energy; and selecting at least one spatial laser pulse distance from the provided pulse distance range as taught by Sumiya. Such a modification would provide the predictable results of ablating the cornea circularly (Sumiya abstract).
Regarding claim 2, Volger discloses herein the threshold value ([0014] LIOB threshold) of the laser-induced optical breakthrough is measured ([0017] this threshold amounts to 0.3 Joule/cm.sup.2 to 1 Joule/cm.sup.2).
Regarding claim 3, Volger discloses wherein the threshold value ([0014] LIOB threshold) of the laser-induced optical breakthrough is calculated by the control device ([0026] control unit 120 has been set up to vary the beam parameters of the pulsed laser radiation).
Regarding claim 5, Volger discloses herein the laser pulse energies (first and second operating mode), which are given for selection for the energy window, are additionally provided by a preset incision criterion ([0018-0019] the second operating mode has to lie below the LIOB threshold; first operating mode is designed for placing incisions).
Regarding claim 8, the modified Volger discloses the method of claim 1 as discussed above, but fails to disclose wherein the spatial pulse distance range includes a distance between adjacent laser pulses on a laser pulse path and/or a distance of laser pulse paths.
However, Sumiya discloses wherein the spatial pulse distance range includes a distance between adjacent laser pulses on a laser pulse path and/or a distance of laser pulse paths (Col. 6, ln40-42: irradiated by the laser beam for 30 seconds at each shifting position (distance)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Volger with the spatial pulse distance range includes a distance between adjacent laser pulses on a laser pulse path and/or a distance of laser pulse paths as taught by Sumiya. Such a modification would provide the predictable results of ablating the cornea circularly (Sumiya abstract).
Regarding claim 9, the modified Volger discloses the method of claim 1 as discussed above, but fails to disclose wherein pulse distances are provided for the spatial pulse distance range, for which a ratio between the distance of adjacent laser pulses on a laser pulse path and the distance of adjacent laser pulse paths is within predetermined limit values, in particular between 0.1 and 10, preferably between 0.2 and 5.
However, Sumiya discloses wherein pulse distances (Figure 9: shifting positions a-i) are provided for the spatial pulse distance range (shifting distance of 1.4mm to 12.6 mm), for which a ratio between the distance of adjacent laser pulses (Col. 6, ln 40-42) on a laser pulse path and the distance of adjacent laser pulse paths (Col. 6, ln 38: every step of 1.4mm) is within predetermined limit values, in particular between 0.1 and 10, preferably between 0.2 and 5 (Col 6, ln 38-42; Examiner notes a change of 1.4mm at each shifting position of the adjacent laser pulses would result in a ratio of 1).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Volger with pulse distances are provided for the spatial pulse distance range, for which a ratio between the distance of adjacent laser pulses on a laser pulse path and the distance of adjacent laser pulse paths is within predetermined limit values, in particular between 0.1 and 10, preferably between 0.2 and 5 as taught by Sumiya. Such a modification would provide the predictable results of ablating the cornea circularly (Sumiya abstract).
Regarding claim 10, the modified Volger discloses the method of claim 9 as discussed above, but fails to disclose wherein the limit values are set depending on the energy window. However, Sumiya discloses wherein the limit values are set depending on the energy window (Col. 6, ln 41: irradiated by the laser beam for 30 seconds at each shifting position; Col. 7, ln 34: fixed condition of irradiation).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Volger with the limit values are set depending on the energy window as taught by Sumiya. Such a modification would provide the predictable results of ablating the cornea circularly (Sumiya abstract).
Regarding claim 11, Volger discloses A control device (control unit 120), which is configured to perform a respective method according to claim 1 [0026].
Regarding claim 12, Volger discloses A treatment apparatus (apparatus 100) with at least one eye surgical laser (working laser 110) for separation of a corneal volume (cornea 210) with predefined interfaces of a human or animal eye (eye 200) by means of optical breakthrough, in particular by means of photodisruption and/or photoablation ([0027]photodisruptive application of an incision), and at least one control device (control unit 120) according to claim 11 [0026-0027].
Claim(s) 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Volger (US 2012/0150160) in view of Sumiya (US 5,800,424) and further in view of Abba Mosquera (US 2021/0361487).
Regarding claim 4, the modified Volger discloses the method of claim 1 as discussed above, but fails to disclose wherein the energy window of the laser pulse energy is calculated by multiplication or division of the range from 1.2 to 4 by the ascertained threshold value.
However, Abba Mosquera discloses wherein the energy window of the laser pulse energy (refractive power) is calculated by multiplication or division by the ascertained threshold value ([0014] the deformation refractive power value is calculated in that the refractive power value to be corrected is divided by the correction value).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Volger with the energy window of the laser pulse energy is calculated by multiplication or division by the ascertained threshold value as taught by Abba Mosquera. Such a modification would provide the predictable results of calculating a deformation diameter that is used by the controller during separation of the lenticule (Sumiya abstract).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by the modified Volger with the range from 1.2 to 4, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding claim 13, the modified Volger discloses the method of claim 1 as discussed above, but fails to disclose a non-transitory computer-readable medium configured for storing a computer program, the computer program including commands which cause a treatment apparatus to execute the method according to claim 1.
However, Abba Mosquera discloses a non-transitory computer-readable medium configured for storing a computer program (Claim 14), the computer program including commands which cause a treatment apparatus to execute the method according to claim 1 (Claim 13).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Volger with a non-transitory computer-readable medium configured for storing a computer program, the computer program including commands which cause a treatment apparatus to execute the method according to claim 1 as taught by Abba Mosquera. Such a modification would provide the predictable results of storing the program including instructions for controlling a surgical laser.
Examiner’s Note
Examiner notes that claims 6-7 are rejected under 35 UC 112, however no prior art rejections have been made. Examiner has not found any references that teach or suggest in combination the limitations recited in claim 6. Specifically, Examiner has not found any references that teach the equation: d = K*(Epulse-LIOBth)^(1/3).
Claims 6-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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, Benjamin Klein can be reached at 571-270-5213. 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.
/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792