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.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-11 and 13 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Step 1: Claim 1 is drawn to a method.
Step 2A – Prong 1: Claim 1 is drawn to an abstract idea, that under its broadest reasonable interpretation, covers a mental process but for the recitation of generic computer components to perform the methods and steps for selecting particular data. In particular, claim 1 recites the following abstract limitations:
determining geometric irregularities of the eye from predetermined examination data, which generate higher order aberrations;
determining a treatment profile with a preset optical zone depending on the geometric irregularities,
wherein an optimization function, which includes
a term for reducing the higher order aberrations and
an opposing tissue removal term,
is optimized up to an optimization range for determining the treatment profile; and
providing the control data, which includes at least the treatment profile.
These limitations of claim 1 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps merely comprised of mental processes. Determining geometric irregularities and determining a treatment profile utilizing an optimization function is regarded as a mental process and, as such, an abstract idea.
Step 2A – Prong Two: Claim 1 recites the following emphasized (indicated in bold) additional elements that are beyond the judicial exception:
A method for providing control data for an ophthalmological laser of a treatment apparatus for reducing geometric irregularities of an eye, wherein the method comprises the following steps performed by a control device.
The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to mere instructions to apply an exception and insignificant extra-solution activity. The control device is a computer that carries out the abstract steps described in claim 1 (see 2106.05(g) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field. The alleged improvement made by the claimed invention as argued by the application above sets forth the improvement in a conclusory manner and the claim does not include the components or steps of the invention that the improvement described.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Determining and calculating data on a control device is well understood, routine, and conventional in the art. The additional elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry.
Claims 2-9 depend on claim 1 and/or depend on a claim depending on claim 1 and recite the same abstract idea as claim 1 for which they depend. Furthermore, these claims only contain recitations that further limit the abstract idea.
In re claim 10, see above 35 U.S.C. 101 analysis for claim 1. Claim 9 recites the same abstract idea as in claim 1 by referencing the limitations in claim 1, with no additional limitations.
In re claim 11, see above 35 U.S.C. 101 analysis for claims 1 and 10. Claim 10 recites the same abstract idea as in claim 1, by referencing the limitations in claim 1, with no additional limitations.
In re claim 12, see above 35 U.S.C. 101 analysis for claim 1. Claim 12 recites the same abstract idea as in claim 1, by referencing the limitations in claim 1, with the additional limitation of “a non-transitory computer-readable medium”, subject to the same analysis of the control device discussed above in re claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In re claim 1:
The limitation “an optimization function… is optimized up to an optimization range” fails to comply with the written description requirement because the specification does not provide an explanation of the optimization function or the optimization range. While the optimization function can be a cost function that includes a term for reducing the higher order aberrations and an opposing tissue removal term, this does not provide enough information as to the purpose, the input, the output, or the calculation of the optimization function. The range could be defined as 10% around an optimum value [0012], but there is no further information as to the optimum value.
The limitation “a term for reducing the higher order aberrations” fails to comply with the written description requirement because the specification does not provide an explanation of what the term for reducing the higher order aberrations is. The term could be the “geometric irregularities” in the previous limitation, but there is not enough information on how these are measured. The higher order aberrations to be corrected can be varied between the originally determined value and zero [0010], how the originally determined value was determined or the meaning of the value is not specified.
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 1-11 and 13 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.
In re claim 1,
The limitation “an optimization function… is optimized up to an optimization range” is unclear. See above 35 U.S.C 112(a) section regarding the limitations “an optimization function… is optimized up to an optimization range”. For purposes of examination, the limitation will be interpreted to the best degree possible in light of the specification as wherein the optimization function is the optimization of a treatment profile.
The limitation “a term for reducing the higher order aberrations” is unclear. See above 35 U.S.C 112(a) section regarding the limitation “a term for reducing the higher order aberrations”. For example, the term could refer to the amount of tissue intended to be removed, which would overlap with the “opposing tissue removal term” or could refer to the previously determined “geometric irregularities”. For purposes of examination, the limitation will be interpreted to the best degree possible in light of the specification as wherein the term for reducing the higher order aberrations as including the state of a patient’s higher order aberrations or geometric irregularities as a factor in the optimizing of a treatment profile.
In re claim 2, the limitation “wherein the geometric irregularities are determined by a wavefront measurement of the eye” is unclear. In claim 1, from which claim 2 depends, the geometric irregularities of the eye are determined from predetermined examination data which contradicts with this limitation. For purposes of examination, the limitation will be interpreted to the best degree possible as wherein the geometric irregularities are determined from predetermined examination data which is determined by a wavefront measurement of the eye.
In re claim 3, the limitation “wherein the geometric irregularities are provided by a corneal profile from a tomography and/or topography measurement of a cornea of the eye” is unclear. In claim 1, from which claim 3 depends, the geometric irregularities of the eye are determined from predetermined examination data which contradicts with this limitation. For purposes of examination, the limitation will be interpreted to the best degree possible as wherein the geometric irregularities are determined from predetermined examination data which is provided by a corneal profile from a tomography and/or topography measurement of a cornea of the eye.
In re claim 4, the limitation: “those areas of the corneal profile”, line 4, has insufficient antecedent basis.
Claims 5 and 6 recite the same limitation as in claim 4, on line 4 of each claim, with insufficient antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim 1, 3-4, 6, 8, 10-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by d’Ippolito (US 12414690).
In re claim 1, d’Ippolito discloses a method for providing control data (Col. 7, ln. 20-21: “correction information” for an ophthalmological laser (Fig. 1A: 106) of a treatment apparatus (Col. 15, ln. 43-51) for reducing geometric irregularities (Fig. 3: 303 and 304; col. 2, ln. 62-65: “irregular shapes”) of an eye, wherein the method comprises the following steps performed by a control device (105):
determining geometric irregularities of the eye from predetermined examination data (Col. 2, ln: 34-37: “refractive aberration information”), which generate higher order aberrations (Col. 21, ln. 12-16);
determining a treatment profile (Col. 7, ln. 20-23” “target profile”) with a preset optical zone (Fig. 2b: 201b) depending on the geometric irregularities (Col. 2, ln. 62-65),
wherein an optimization function (Col. 23, ln. 64-67, and col 24, ln. 1-5), which includes
a term for reducing the higher order aberrations (Col. 23, ln. 64-67, and col 24, ln. 1-5: “take into account topographic information… improved vision correction”) and
an opposing tissue removal (Col. 24 ln 1-5: “minimize ablation volume”)
is optimized up to an optimization range for determining the treatment profile (Col 24, ln. 1-5); and
providing the control data, which includes at least the treatment profile (Col. 7, ln. 20-21).
In re claim 3, d’Ippolito discloses:
wherein the geometric irregularities are provided by a corneal profile (Col. 15, ln. 52-62: “a profile… of the anterior and the posterior surfaces of the cornea”) from a tomography and/or topography measurement of a cornea of the eye (Col. 15, ln. 52-62),
wherein a corneal ideal profile (Fig. 5C: 470) is defined which does not have geometric irregularities and higher order aberrations (Col. 9, ln. 59-67),
wherein the optimization function is optimized depending on the corneal ideal profile (Col. 23, ln 40-50).
In re claim 4, d’Ippolito discloses:
wherein the corneal ideal profile is superimposed with the corneal profile (Fig. 5c) and shifted along a vertical axis of the corneal profile for optimizing the optimization function, until the optimization function reaches the optimization range (Col. 23, ln. 31-56),
wherein only those areas (Fig. 5c, between 470 and 401b) of the corneal profile (Fig. 5c: 401b), which are above the treatment profile in a direction of the vertical axis (420, optical axis can be determined as the vertical axis depending on the orientation of the eye), are set to be removed (Col. 18, ln. 65; col. 19, ln 1-2).
In re claim 6, d’Ippolito discloses:
wherein the corneal ideal profile is superimposed with the corneal profile and a curvature of the corneal ideal profile is changed (Col. 25: ln. 30-42; note: in determining multiple local target slopes the curvature of the corneal ideal profile is changed) until the optimization function reaches the optimization range (Col. 23: ln. 46-50),
wherein only those areas (Fig. 5c, between 470 and 401b) of the corneal profile (Fig. 5c: 401b), which are above the treatment profile in a direction of the vertical axis (420, optical axis can be determined as the vertical axis depending on the orientation of the eye), are set to be removed (Col. 18, ln. 65; col. 19, ln 1-2).
In re claim 8, d’Ippolito discloses wherein the predetermined examination data includes a wavefront measurement and/or a tomography measurement and/or a topography measurement of a cornea, by which the geometric irregularities of the eye are determined (Col. 2, ln. 36-46; abstract).
In re claim 10, d’Ippolito discloses control device (Fig. 1A: 105), which is configured to perform a method according to claim 1 (Col. 17, ln. 37-67).
In re claim 11, d’Ippolito discloses a treatment apparatus with at least one ophthalmological laser (Fig. 1A: 106) for removing a corneal volume of a human or animal eye by optical breakdown and at least one control device (Fig. 1A: 105) according to claim 10 (Col. 15, ln. 43-51).
In re claim 13, d’Ippolito discloses non-transitory, computer-readable medium for storing a computer program, the computer program comprising commands which cause a treatment apparatus to execute the method according to claim 1 (Col. 13, ln. 18-25)
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over d’Ippolito (US 12414690) in view of Chernyak (US 20150066466).
In re claim 2, d’Ippolito discloses:
wherein the geometric irregularities are determined by a wavefront measurement of the eye (Col. 2, ln. 36-38),
wherein a there exists a corneal ideal profile (Fig. 5C: 470), which does not have geometric irregularities and higher order aberrations (Col. 9, ln. 42-67)
wherein the optimization function is optimized depending on a corneal ideal profile (Col. 23, ln 40-50).
D’ippolito lacks:
wherein a corneal ideal profile is defined by a wavefront ideal profile.
Chernyak discloses a method to obtain ablation target profiles wherein a corneal ideal profile is determined (Fig. 18: 1800) by a wavefront ideal profile (Fig. 18: 1830).
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 for developing a treatment profile taught by d’Ippolito by determining the corneal ideal profile based on a wavefront ideal profile as taught by Chernyak as it is a known method and allows the treatment profile to target super sharp vision (Chernyak [0225]) utilizing the wavefront measurement in d’Ippolito.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over d’Ippolito (US 12414690) in view of Hohla (US 20130190735)
In re claim 5, d’Ippolito discloses
wherein the corneal ideal profile is transformed (Col. 23, ln. 31-39, Col. 25: ln. 30-42) until the optimization function reaches the optimization range (Col. 23: ln. 46-50)
wherein only those areas (Fig. 5c, between 470 and 401b) of the corneal profile (Fig. 5c: 401b), which are above the treatment profile in a direction of the vertical axis (420, optical axis can be determined as the vertical axis depending on the orientation of the eye), are set to be removed (Col. 18, ln. 65; col. 19, ln 1-2).
D’Ippolito lacks:
wherein the corneal ideal profile is superimposed with the corneal profile and tilted against a vertical axis of the corneal profile until the optimization function reaches the optimization range.
Hohla discloses a method for determining a corneal ablation profile wherein a standard ablation profile is modified to best correct higher order aberrations to optimize distance visual acuity and near visual acuity [0023] and wherein the central region of the corneal is elliptic [0026].
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to provide wherein there is a standard ablation profile with a standard shape for the corneal central region as taught by Hohla to the method of determining the treatment profile as taught by d’Ippolito. The standard ablation profile can be used to evaluate the post-operative profile, allowing for an optimal standard ablation profile to be determined (Hohla [0025]).
Further, it would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to try rotating the corneal ideal profile of the proposed system against a vertical axis as d’Ippolito discloses transforming the corneal ideal profile by translating and modifying the curvature of the corneal ideal profile (see above Claim Rejections – 35 U.S.C. 102 on claims 4 and 6). Rotating the corneal ideal profile would provide an additional method of transforming the profile to provide the best optical correction, while reducing the amount of tissue being removed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over d’Ippolito (US 12414690) in view of d’Ippolito (US 20240090996).
In re claim 7, d’Ippolito (‘690) lacks:
wherein the geometric irregularities include a keratoconus, a keratoglobus, a pellucid marginal degeneration of a cornea of the eye, a herpes simplex keratitis and/or improper treatments of the cornea.
D’Ippolito (‘996) discloses a method for optimizing the vision of an eye comprising an irregular corneal surface [0046] including keratoconus [0066].
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 for developing a treatment profile for higher order aberrations taught by d’Ippolito (‘690) by utilizing the method to treat keratoconus as taught by d’Ippolito (‘996) as it is an irregular disorder which leads to higher order aberrations which the method of d’Ippolito (‘690) is capable of doing.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over d’Ippolito (US 12414690) in view of Kanellopoulos (Kanellopoulos, Anastasios John. “Comparison of sequential vs same-day simultaneous collagen cross-linking and topography-guided PRK for treatment of keratoconus.” Journal of refractive surgery (Thorofare, N.J. : 1995) vol. 25,9 (2009): S812-8. doi:10.3928/1081597X-20090813-10).
In re claim 9, d’Ippolito lacks:
wherein a maximum depth of tissue to be removed is limited to below 50 µm.
Kanellopoulos discloses wherein a maximum depth of tissue to be removed is limited to below 50 µm (Pg. S816, col. 1, ln. 6-10).
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 taught by d’Ippolito by limiting the depth of tissue to be removed to below 50 µm as taught by Kanellopoulos as it is a known limit that allows for the tissue to be safely removed without altering the cornea’s biomechanical integrity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 7:30 am to 5:00 pm.
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796