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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
Regarding claim 1, the examiner has interpreted “commonly shifted” to mean shifted together.
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 2, 6, and 9-10 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 2, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 2, the conversion of corneal and/or ocular wavefront measurements to “new positions based on the first vector portion” renders the claim indefinite because it is unclear when or if wavefront measurements were taken, or what the “new positions” entail.
Regarding claim 6, the phrase “inclination components” renders the claim indefinite because it is unclear what components are referred to.
Regarding claims 9-10, the phrases “a control device” and “at least one control device” render the claims indefinite because it is unclear whether the said control device is the same control device as in claim 1.
Regarding claim 11, the “medium configured for storing” is unclear. As written, it’s not entirely clear whether medium actually stores the program, or if the claim requires a medium which is merely programmable (i.e. a generic computer).
In order to address the objections and rejections under 112(b), and for the purpose of continued examination, claims 9-11 will be interpreted to read:
9. A control device , which is configured to perform
10. A treatment apparatus comprising at least one eye surgical laser for separation of a corneal volume with predefined interfaces of a human or animal eye by means of photoablation and/or photodisruption, and the control device according to claim 9.
11. A non-transitory computer readable medium storing a computer program, the computer program including commands which cause a treatment apparatus according to claim 10 to execute the method according to claim 1.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mathematical calculations and the mental process of adjusting a parameter) without significantly more.
Step 1
The claimed invention in claims 1-11 are directed to statutory subject matter as the claims recite a method/system for performing mathematical calculations and adjusting parameters.
Step 2A, Prong One (Judicial Exception)
Regarding claims 1-11, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and utilizing mathematical concepts (See MPEP 2106.05(a)(2) subsections (I) and (III)).
Independent claim 1 recites operations including: providing control data, determining a correction profile and offset vector, adjusting the optical zone/axis, and shifting various parameters based on the offset vector. These are data gathering and processing steps (providing, determining, adjusting, shifting) that reflect mental processes and mathematical relationships/clinical decision rules (e.g., shifting and adjusting parameters based on the offset vector composed of three vector portions).
Claims 9-11 recite the corresponding apparatus associated with the method steps, likewise mental processes and mathematical concepts.
Step 2A, Prong Two (Integration into a Practical Application)
For claims 1-11, the judicial exception is not integrated into a practical application.
Regarding claim 1, the additional element of “providing control data … for the treatment of a cornea … by an ophthalmological laser of a treatment apparatus” amounts to recitation of a generic “treatment apparatus” and “ophthalmological laser.” Merely stating that the mathematical results will be “for the treatment” or “by a laser” is an instruction to apply the abstract idea in a particular technological environment. As in Alice Corp. v. CLS Bank, 573 U.S. 208, 223 (2014), limiting an abstract idea to a field of use or adding generic hardware does not integrate the exception into a practical application.
The additional element of “Providing … control data … which includes the correction profile adapted by the offset vector” is directed to outputting data to a generic laser control system. Merely outputting the result of the mathematical processing to generic hardware is “post-solution activity” and does not integrate the abstract idea. See Parker v. Flook, 437 U.S. 584, 590 (1978) (updating alarm limits after calculation is still abstract).
Claims 2-8 further limit the abstract ideas of claim 1
Claim 9 recites a control device configured to perform the method according to claim 1. This limitation is recited at a high level of generality and amounts to nothing more than parts of a generic computer.
Claim 11 recites a non-transitory computer readable medium for storing a computer program for executing the method according to claim 1. This limitation is recited at a high level of generality and amounts to nothing more than parts of a generic computer.
Step 2B (Inventive Concept)
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 limitations in claim 1 of providing control data, determining a correction profile and offset vector, adjusting the optical zone/axis, and shifting various parameters based on the offset vector are directed to nothing more than the pre-solution activity of mere data gathering/post-solution activity of adjusting a parameter, which does not amount to an inventive concept.
In addition, the treatment apparatus and at least one eye surgical laser in claims 9-11 are recited at a high level of generality and considered to be well known, routine, and conventional in the art. For examples, see Steinlechner et al. (European Patent No. 3928752) and Bischoff et al. (German Patent No. 102010012616).
Dependent claims 2-8 are further directed towards insignificant extra-solution activities (MPEP 2106.05(g)) and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Claims 9-11 fail to recite significantly more as they amount to nothing more than parts of a generic computer, as discussed above.
Accordingly, the claims, considered individually and as an ordered combination, do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Steinlechner et al. (European Patent No. 3928752), hereinafter ‘Steinlechner’, in view of Bischoff et al. (German Patent No. 102010012616), hereinafter ‘Bischoff’. Paragraph numbers correspond to the paragraphs in the original documents, and are followed by the English translation.
Regarding claim 1, Steinlechner teaches a method for providing control data with a centered correction profile (Fig. 5, C’) for treatment of a cornea of an eye (60) by an ophthalmological laser (3) of a treatment apparatus (1) [0001, “The present invention relates to an ophthalmological device for processing eye tissue by means of a pulsed laser beam.”], the method further comprising the following steps performed by a control device (2):
Ascertaining a correction based on a first reference center from predetermined visual disorder data [0024, “In one embodiment, the circuit is set up to control the scanner system for cutting a lenticle in the eye tissue that is symmetrical to the center axis of the patient interface and is formed by two cut surfaces”];
Determining an offset vector (Figs. 2, 5, or 7, axis o) for the ascertained correction profile, wherein;
The optical zone of the correction profile (C’) is adjusted to the first reference center and an optical axis (Figs. 2, 5, or 7, axis m) of the correction profile is adjusted to a second reference center (S’) by the offset vector, wherein;
The correction profile is commonly shifted by the offset vector (Fig. 7, t’), wherein;
The optical axis is displaced within the optical zone (Figs. 10, 11); and
Providing the control data for the ophthalmological laser of the treatment apparatus, which includes the correction profile adapted by the offset vector [0015, “to control the scanner system in such a way that the pulsed laser beam is directed to machining points on the transformed second curved machining path”].
Steinlechner fails to teach the correction profile including a transition zone, an offset vector composed of three vector portions, and the optical zone being shifted within the transition zone.
Bischoff teaches an ophthalmic laser treatment device and method of operation (Fig. 1A), the method further comprising:
Ascertaining a correction profile including an optical zone and a transition zone adjoining thereto [0016, “The enlargement of the processing area (in the example: the actual correction zone within the lenticular diameter) with respect to the optical zone (in particular the maximum pupil diameter)”], wherein;
The offset vector is composed of three vector portions (Figs. 3A, 3B), wherein;
The optical zone is shifted within the transition zone by the second vector portion (Figs. 3A, 3B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner to incorporate the teachings of Bischoff to include a transition/buffer zone in the correction profile, use an offset vector comprised of three portions, and shift the optical zone within the transition zone. Doing so would allow for a more sufficient coverage of the optical zone by the surgical structure, as recognized by Bischoff [0016, “In order to allow a sufficient coverage of the optical zone by the surgical structure”].
Regarding claim 2, Steinlechner and Bischoff teach the method according to claim 1, further comprising:
The correction profile is shifted from the first reference center towards the second reference center, in particular towards an optical axis of the eye or a corneal vertex, by the first vector portion (Steinlechner, Fig. 7).
Steinlechner and Bischoff do not teach a method where corneal and/or ocular wavefront measurements are converted to new positions based on the first vector portion.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner and Bischoff to adjust the positions/topography mapping measurements based on the determined shift factor/vector. Doing so would provide appropriate patient treatment.
Regarding claim 3, Steinlechner and Bischoff teach the method according to claim 1, further comprising:
The transition zone is kept concentric to the first reference center (Steinlechner, Fig. 11) and the optical zone is shifted towards the second reference center by the second vector portion [Steinlechner, 0050, “If the cut surface C or the tilted cut surface C 'and the eye 6 have equidistant surfaces, the vertex S' of the tilted cut surface C 'and the vertex S of the untilted cut surface C have the same position”].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner to incorporate the teachings of Bischoff to include a transition/buffer zone in the correction profile, use an offset vector comprised of three portions, and shift the optical zone within the transition zone. Doing so would allow for a more sufficient coverage of the optical zone by the surgical structure, as recognized by Bischoff [0016, “In order to allow a sufficient coverage of the optical zone by the surgical structure”].
Regarding claim 4, Steinlechner and Bischoff teach the method according to claim 1, but do not teach asymmetrically deforming the correction profile for displacing the optical axis by the third vector portion.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner and Bischoff to asymmetrically deform the correction profile, as it is an inherent result of claim 1. Further, an asymmetric eye would lead to asymmetric deformation of the correction profile.
Regarding claim 9, Steinlechner and Bischoff teach the method according to claim 1, further comprising a control device configured to perform the method (Steinlechner, 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner to incorporate the teachings of Bischoff to include a transition/buffer zone in the correction profile, use an offset vector comprised of three portions, and shift the optical zone within the transition zone. Doing so would allow for a more sufficient coverage of the optical zone by the surgical structure, as recognized by Bischoff [0016, “In order to allow a sufficient coverage of the optical zone by the surgical structure”].
Regarding claim 10, Steinlechner and Bischoff teach the method according to claim 1, further comprising:
At least one eye surgical laser (Steinlechner, 3);
A treatment apparatus for the separation of a corneal volume with predefined interfaces of a human or animal eye by means of photoablation and/or photodisruption (Steinlechner, Fig. 2), and;
A control device configured to perform the method.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner to incorporate the teachings of Bischoff to include a transition/buffer zone in the correction profile, use an offset vector comprised of three portions, and shift the optical zone within the transition zone. Doing so would allow for a more sufficient coverage of the optical zone by the surgical structure, as recognized by Bischoff [0016, “In order to allow a sufficient coverage of the optical zone by the surgical structure”].
Regarding claim 11, Steinlechner and Bischoff teach the method according to claim 1, further comprising:
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 (Bischoff, 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Steinlechner to incorporate the teachings of Bischoff to include a transition/buffer zone in the correction profile, use an offset vector comprised of three portions, and shift the optical zone within the transition zone. Doing so would allow for a more sufficient coverage of the optical zone by the surgical structure, as recognized by Bischoff [0016, “In order to allow a sufficient coverage of the optical zone by the surgical structure”].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weyhausen et al. (US Pre Grant Publication 2023/0372149) teaches a method for centering a contact glass on a patient’s eye and a surgical laser system.
Lörner et al. (US Pre Grant Publication 2023/0338191) teaches an ophthalmic laser surgical system capable of docking an eye.
Kang Sung et al. (Korean Patent No. 10-1893926) teaches a marking system for centering a patient’s eye during ophthalmologic surgery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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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.
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/E.L.O./
Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792