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 3-4 and 8-10 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 claims 3-4 and 9, the phrase "in particular" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of continued examination, “photodisruption and/or photoablation” are interpreted to be optional limitations.
Regarding claims 8-9, the phrase “configured to perform a respective method according to claim 1” renders the claim indefinite as it is unclear whether claim 8 requires, exactly, the method of claim 1. For the purpose of continued examination, the limitation will be interpreted to read, “configured to perform the method of claim 1”. Furthermore, claim 8 is interpreted to require a control device which is specifically programmed to perform the method of claim 1.
Regarding claim 10, the “medium configured for storing” is unclear. As written, it’s not entirely
clear whether medium actually stores the program (i.e. which is specifically programmed with the “computer program” of the claim), or if the claim requires a medium which is merely programable (i.e. a generic computer). For the purpose of continued examination, the claim will be interpreted to read, “A non-transitory computer-readable medium, storing a computer program, the program …”; which is understood to require the medium storing (i.e. being programmed with) the claimed “program”.
Claim Rejections - 35 USC § 101
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step (1)
The claimed invention in claims 1-10 are directed to a system or a method, and thus, the claims all fall under one of the four patent eligible categories.
Step (2a) Prong 1 (Judicial Exception)
Regarding claims 1-10, 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:
ascertaining visual disorder correction data…;
determining Zernike polynomials from the ascertained visual disorder correction data, which are adjusted based on a first reference center of the eye;
ascertaining an offset vector from the first reference center to a further second preset reference center of the eye;
calculating corrected Zernike polynomials, in which higher order aberrations are calculated by means of an adaptation of the corresponding Zernike polynomials by the offset vector;
providing the control data for the treatment apparatus.
Under the broadest reasonable interpretation, this limitation requires determining visual correction parameters, determining Zernike polynomials based on a first reference center, determining an offset vector based on a second reference center, calculating adjusted Zernike polynomials, and providing control data to a treatment apparatus. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgements and utilizing mathematical concepts. In particular, a person can determine visual correction parameters and associated Zernike polynomials based on a reference center, then determine an offset vector or shift based on an additional reference center, adjust the Zernike polynomials accordingly, and then the person can provide instructions to the treatment apparatus based on the adjusted/corrected Zernike polynomials. These are data gathering and processing steps (providing, ascertaining, determining, adjusting, calculating) that reflect mental processes and mathematical relationships/clinical decision rules.
Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas, specifically mental processes and mathematical concepts.
Independent claims 7-10 recite the corresponding apparatus associated with the method in claim 1, including an eye surgical laser of the treatment apparatus, a control device, a treatment apparatus with at least one eye surgical and at least one control device, and a non-transitory computer-readable medium. Under the broadest reasonable interpretation, this claim also recites a judicial exception including one or more abstract ideas under the mental processes and mathematical concepts buckets.
The dependent claims recite additional limitations for determining control data, including Zernike polynomial types, reference center definitions, other techniques for determination of Zernike polynomials, and threshold analysis. These limitations also fall within the judicial exceptions of one or more mental processes and/or mathematical calculations.
Step (2a) Prong 2 (Integration into a Practical Application)
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
For claims 1-10, the judicial exception is not integrated into a practical application.
Regarding claim 1, the additional element of “Providing control data for 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 correcting a cornea” 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 the control data for the treatment apparatus” 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 2-6 further limit the abstract ideas of claim 1 without introducing any additional elements.
Claims 7-10 also recite the additional elements of a “control device” and a “non-transitory computer-readable medium,” but these additional elements merely define the field of use of the current claim. These additional elements do not practically integrate the judicial exception because these elements do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the mental processes grouping.
Step (2b) (Inventive Concept)
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of a treatment apparatus, ophthalmological laser, control device, and non-transitory computer-readable medium in the field of laser eye surgery are well-understood, routine and conventional activities previously known in the industry as indicated in the following references:
Fabrikant (US 2013/0204237) teaches a treatment apparatus (10), Fig. 1A, [0072], laser (12), Fig. 1, [0070], control system (Fig. 4), and computer program [0015].
Peyman (US 2022/0240779) teaches a laser treatment apparatus (50) [0174], laser [0073], control system [0265], and computer program [0266].
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-10 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azar et al. (US Pre-Grant Publication 2006/0023162), hereinafter ‘Azar’.
Regarding claim 1, Azar teaches a method for providing control data for an ophthalmological laser of a treatment apparatus [0001, 0006], wherein the method comprises the following steps performed by a control device (Fig. 1):
ascertaining visual disorder correction data for correcting a cornea (210) of an eye (see wavefront mapping module, element 120) [0060];
determining Zernike polynomials from the ascertained visual disorder correction data [0061], which are adjusted based on a first reference center of the eye;
ascertaining an offset vector [0066, parameter di] from the first reference center to a further second reference center of the eye (Fig. 3);
calculating corrected Zernike polynomials (110) in which higher order aberrations are calculated (104) [0068] by means of an adaptation of the corresponding Zernike polynomials by the offset vector [0070-0071]; and
providing the control data for the treatment apparatus [0036], wherein the control data is generated by means of the corrected Zernike polynomials (110).
Regarding claim 3, Azar teaches the method according to claim 1, further comprising:
wherein the first reference center is a pupil center of the eye (106) and the Zernike polynomials are corrected towards the second reference center, in particular towards a corneal vertex, by the offset vector [0065] (Fig. 3).
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 2, 5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Azar et al. (US Pre-Grant Publication 2006/0023162) in view of Thompson et al. (US 2005/0134799), hereinafter ‘Thompson’.
Regarding claim 2, Azar teaches the method according to claim 1, but does not teach the limitations of claim 2.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), further comprising:
wherein at least the Zernike polynomials for defocus, astigmatism, coma, trefoil and/or spherical aberration are adapted by means of the offset vector [0108].
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 Azar to incorporate the teachings of Thompson to include various types of Zernike polynomials. Doing so would allow for greater accuracy in diagnosing and treating the visual system of a patient, as recognized by Thompson [0127].
Regarding claim 5, Azar teaches the method according to claim 1, but does not teach translating the Zernike polynomials in an opposite direction to the offset vector for higher order aberrations.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), further comprising:
wherein for calculating the corrected Zernike polynomials, the corresponding Zernike polynomials are adapted for higher order aberrations by a translation in opposite direction to the offset vector [0048, inverting wavefront data, higher order aberrations].
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 Azar to incorporate the teachings of Thompson to translate Zernike polynomials for higher order aberrations in an opposite direction. Doing so would allow for greater accuracy in diagnosing and treating the visual system of a patient, as recognized by Thompson [0127].
Regarding claim 7, Azar teaches the method according to claim 1, but does not teach an eye surgical laser of a treatment apparatus.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), further comprising:
transferring the provided control data to a respective eye surgical laser of the treatment apparatus [0139, laser used].
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 Azar to incorporate the teachings of Thompson to transfer the control data to a laser. Doing so would allow for treatment of the patient to reduce anomalies in their visual system, as recognized by Thompson [0140].
Regarding claim 8, Azar teaches the method according to claim 1, but does not teach a control device.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), further comprising:
A control device (Fig. 16), which is configured to perform a respective method according to claim 1 [0132].
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 Azar to incorporate the teachings of Thompson to include a control device. Doing so would allow for treatment of the patient to reduce anomalies in their visual system, as recognized by Thompson [0140].
Regarding claim 9, Azar teaches the method according to claim 1, but does not teach a treatment apparatus with at least one eye surgical laser and a control device.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), further comprising:
A treatment apparatus [0178, apparatus or device] with at least one eye surgical laser [0139, laser used] for separation of a corneal volume with predefined interfaces of a human or animal eye (110, Fig. 2) by means of optical breakthrough, in particular by means of photodisruption and/or photoablation [0140, types of treatments], and at least one control device (Fig. 16) according to claim 8 [0132].
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 Azar to incorporate the teachings of Thompson to include a treatment apparatus with a laser and control device. Doing so would allow for treatment of the patient to reduce anomalies in their visual system, as recognized by Thompson [0140].
Regarding claim 10, Azar teaches the method according to claim 1, but does not teach a non-transitory computer-readable medium.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), 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 a method according to claim 1 [0178].
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 Azar to incorporate the teachings of Thompson to include computer commands to execute the method via the treatment apparatus. Doing so would allow for treatment of the patient to reduce anomalies in their visual system, as recognized by Thompson [0140].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Azar et al. (US Pre-Grant Publication 2006/0023162) in view of Thompson et al. (US 2005/0134799), further in view of Fabrikant (US Pre-Grant Publication 2013/0204237), hereinafter ‘Fabrikant’.
Regarding claim 4, Azar teaches the method according to claim 1, but does not teach the first reference center being a corneal vertex and correcting Zernike polynomials determined based on subjective refraction data.
Thompson teaches a treatment method using obtained wavefront data (Fig. 17), further comprising:
wherein the first reference center is a visual axis of the eye, in particular a corneal vertex (920) (Fig. 9) [0092], and Zernike polynomials at least of the second order are determined based on a predetermined subjective refraction of a glasses correction [0101, subjectively modify Zernike function terms], wherein these Zernike polynomials are corrected by the offset vector [0048].
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 Azar to incorporate the teachings of Thompson to include the corneal vertex as a reference center and subjective Zernike polynomials. Doing so would allow for the incorporation of the subject’s own input/preferences, as recognized by Thompson [0101].
Regarding claim 4, Azar and Thompson teach the above method, but do not teach the subjective refraction data being obtained from a phoropter.
Fabrikant teaches a system and method for corneal topography or wavefront measurements of an eye (Fig. 4), the method further comprising Zernike polynomials [0140]:
which is in particular ascertained by means of a phoropter measurement [0065].
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 Azar and Thompson to incorporate the teachings of Fabrikant to include the use of a phoropter. Doing so would allow for the more accurate reflection of the various characteristics of an eye, as recognized by Fabrikant [0065].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Azar et al. (US Pre-Grant Publication 2006/0023162) in view of Peyman (US Pre-Grant Publication 2022/0240779), hereinafter ‘Peyman’.
Regarding claim 4, Azar teaches the method according to claim 1, but does not teach the tolerance threshold for correction of Zernike polynomials, and providing a warning message if the threshold is exceeded.
Peyman teaches a system and method for laser treatment of the eye [0003], the method further comprising:
wherein a difference of the Zernike polynomials [0478] to the corrected Zernike polynomials is examined for exceeding a tolerance threshold, wherein a warning message is provided if the difference is above the tolerance threshold [0256, safety threshold and warning message] [0280].
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 Azar to incorporate the teachings of Peyman to include a tolerance threshold and a warning message if it is exceeded. Doing so would allow for safe and effective operation of the system, as recognized by Peyman [0279].
Conclusion
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