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 Objections
Claim 13 is objected to because of the following informalities: in line 2, the first word “according” seems to have been inadvertently left in the claim instead of being removed in the most recent amendment (it now reads “… program according is stored” which seems to be a mistake). Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement filed April 4, 2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language (specifically the DE Office Action, cited as NPL1, has no English translation or explanation). It has been placed in the application file, but the information referred to therein has not been considered.
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 9-11 and 13 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.
Concerning all of claims 9-11 and 13, these claims refer to “a” method according to claim 1. Claim 10 refers to “a respective” method according to claim 1. To be in proper antecedent form, these claims should refer to “the” method of claim 1, to make clear that all of claim 1 is being incorporated. As currently written, it is unclear whether all of claim 1 is being incorporated into these later claims. In other words, it is unclear whether “a” method according to claim 1 is the same as “the” method according to claim 1.
Concerning claim 11, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “optical breakthrough”, and the claim also recites “in particular by photodisruption and/or ablation” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 101
Claims 1-11 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mathematical concept and/or mental process without significantly more.
Step 1: All of claims 1-11 and 13 are directed either to a method/process or to a form of a system/machine/apparatus.
Step 2A, Prong One: The claims recite a mathematical concept and/or a mental process including the steps of “ascertaining … calculating … ascertaining …” in claim 1 which (1) are mathematical concept steps since they are calculations, and/or (2) could be calculated manually by the human mind with a basic physical aid such as pen and paper. It is noted that the “ascertaining topographic data …” step could alternatively be considered insignificant pre-solution activity of mere data gathering (i.e., instead of being part of the judicial exception itself), as seen in the next step.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the step of “ascertaining topographic data …” is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process using a generic and well known modality; the step of “providing the control data … for the ophthalmological laser …” is considered insignificant post-solution activity since it merely outputs the result of the mental process using a generic output modality, and does not meet the requirements of a particular treatment or prophylaxis since the treatment step is not particular and does not actually require the treatment to be performed. Furthermore, merely carrying out mental steps using generic computing technology such as “control device” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection and output components and the generic ophthalmological laser. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 8-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0096273 A1 to Mosquera et al. (hereinafter “Mosquera”) in view of US 2010/0274234 A1 to Liang (hereinafter “Liang”) and/or US 2013/0190736 A1 to Fabrikant et al. (hereinafter “Fabrikant ‘736”).
Regarding Claims 1, 9-11 and 13, Mosquera teaches a method for providing control data for an ophthalmological laser of a treatment apparatus for correcting a cornea (see e.g. the abstract, Paras. 3, , wherein the method comprises the following steps performed by a control device:
ascertaining topographic data of the preoperative cornea from predetermined examination data (see e.g. Para. 17: “it is provided that the predetermined examination data for the corneal geometry is measured by means of corneal topography” and Para. 36: “In a step S10 of the method, a corneal geometry of the cornea 22 of the eye 16 is ascertained from predetermined examination data. The corneal geometry can for example have been measured by means of corneal topography.”);
calculating wavefront aberration data of the preoperative cornea by the topographic data (see e.g. Para. 37: “In a step S12, a corneal wavefront 28 can then be determined from the corneal geometry of the cornea 22 by means of a physical model”), wherein a passage of light beams through the cornea, which has the topographic data, is determined by a beam passage model for calculating the wavefront aberration data (see e.g. Para. 37: “The physical model can describe a change of an input wavefront (not illustrated in FIG. 3) upon a passage through the cornea 22, wherein the input wavefront becomes the corneal wavefront 28 after passage through the cornea 22. Preferably, the physical model can be based on the Fermat's principle, which indicates in simplified manner that light takes the fastest and not the shortest path.” Also generally see Paras. 35-45);
ascertaining an (“target” wavefront and/or “target” corneal geometry in Paras. 42-43; see generally Paras. 35-45) is adapted depending on the ascertained wavefront aberration data for ascertaining the (see Paras. 42-44); and
providing the control data for correcting the cornea for the ophthalmological laser, which includes the (see e.g. Para. 45: “In a step S24, control data for controlling the eye surgical laser 12 can finally be provided, wherein the control data uses the tissue geometry to be removed for removing the tissue 14.” Also see e.g. Paras. 1 and 20-21).
Mosquera fails to teach that the correction profile is aberration neutral, by which higher order aberrations of the preoperative cornea are preserved for a postoperative cornea. Another reference, Liang, teaches an analogous refractive correction of the cornea which specifically preserves high-order aberrations of the pre-operative eye (see e.g. claim 34 and Para. 11: “step of preserving or reducing high-order aberrations in the periphery pupil section that are present prior to treatment”). Similarly, Fabrikant ‘736 teaches that preserving the total high order aberrations between preoperative and postoperative eyes is useful “to inhibit an increase in high order aberrations post-operatively” (see e.g. Para. 260; also see Paras. 14, 23, 135). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Mosquera to preserve high-order aberrations present in the pre-operative eye because Liang teaches that failing to do so has various disadvantages (discussed in the background Paras. 3-9) and/or because Fabrikant ‘736 teaches that doing so is useful to avoid increasing high order aberrations post-operatively.
Regarding Claims 2-4 and 8, see Paras. 13, 37-42 of Mosquera.
Regarding Claim 5, see e.g. Paras. 40-44 of Mosquera (the “target corneal geometry” is the virtual post-operative cornea).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mosquera in view of Liang and/or Fabrikant ‘736 as applied to claim 1 above, and further in view of US 2013/0204237 A1 to Fabrikant (hereinafter “Fabrikant ‘423”).
Regarding Claim 6, Mosquera as modified above teaches claim 1 but fails to specify a reference center for the topographic data being a point of intersection of the visual axis with the corneal surface. Another reference, Fabrikant ‘423, teaches that “surgery and an optical tissue surface measurement are centered about a pupil of an eye as illustrated in FIG. 9. The center of the pupil 5A of the eye has an associated line of sight passing through the cornea of the eye as a patient looks at a fixation target … A topography system generally has a central coordinate reference near an apex of the cornea 5B. A topography system may use any reference point as a coordinate center” (see Para. 92). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Mosquera to select a suitable reference center for the topographic data as the intersection of the visual axis and the corneal surface since Fabrikant ‘423 teaches that any reference point can be used, and acknowledges that such systems are known to be centered about the visual axis but that a topography system also generally uses a reference center near the apex of the cornea. As such, this would be one of the obvious selections that one skilled in the art would consider as the reference center for the topography system.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mosquera in view of Liang and/or Fabrikant ‘736 as applied to claim 1 above, and further in view of US 2011/0224657 A1 to Stevens et al. (hereinafter “Stevens”).
Regarding Claim 7, Mosquera as modified above teaches claim 1 but fails to specify that predetermined corneal tomography data is additionally used for the calculation of the wavefront aberration data. Stevens teaches that it was known to collect multi-model aberration measurements including topography and tomography (see Para. 66). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Mosquera to also include corneal tomography data since it would predictably increase the total useful information gathered of the patient’s cornea, and thus predictably help ensure a more accurate correction is calculated and carried out.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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, NIKETA PATEL can be reached at (571)-272-4156. 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.
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792