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
Claims 2 and 11, 14 are objected to because of the following informalities: Claim 2 and 11 end in a semi-colon. Appropriate correction is required.
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.
Claim(s) 1, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adie et al. (US 2017/0241765 A1 – cited by Applicant), hereinafter Adie.
Regarding Claim 1, Adie teaches: A method for measuring corneal biomechanical properties (paragraph 0084-0090), the method comprising:
determining a plurality of optical coherence tomography (OCT) measurement locations in a region of a cornea (paragraph 0034);
for each OCT measurement location:
applying a mechanical excitation to the cornea at the OCT measurement location, and
measuring a response of the cornea to the mechanical excitation by acquiring temporal OCT data at the OCT measurement location (paragraph 0004; 0034);
generating temporal deformation data for the region of the cornea based on the temporal OCT data at each OCT measurement location (paragraph 0035); and
generating biomechanical data for the region of the cornea based on the temporal deformation data (paragraph 0004; 0034-0035).
Regarding Claim 13, Adie teaches: A system for measuring corneal biomechanical properties (figures 2-3), the system comprising:
a beam delivery system (BDS) defining a common optical path (figures 2-3; paragraph 0030-0035);
an excitation laser (figures 2-3; paragraph 0030-0035);
an optical coherence tomography (OCT) engine configured to:
send a command to the excitation laser to apply a mechanical excitation to a cornea at an OCT measurement location via the common optical path (figures 2-3; paragraph 0030-0035), and
measure a response of the cornea to the mechanical excitation by acquiring temporal OCT data at the OCT measurement location via the common optical path (figures 2-3; paragraph 0030-0035); and
a control computer, coupled to the OCT engine, the control computer comprising a processor configured to (claim 4; figures 2-3):
determine a plurality of OCT measurement locations in a region of the cornea (paragraph 0030-0035),
send the OCT measurement locations to the OCT engine (paragraph 0030-0035),
receive temporal OCT data for each OCT measurement location from the OCT engine (paragraph 0084),
generate temporal deformation data for the region of the cornea based on the temporal OCT data for each OCT measurement location (paragraph 0084), and
generate biomechanical data for the region of the cornea based on the temporal deformation data (paragraph 0084).
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.
Claim(s) 2, 3, 6-11, 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adie in view of Larin et al. (US 2019/0125185 A1 – cited by Applicant), hereinafter Larin.
Regarding Claim 2 and 14 Adie teaches: The method of claim 1, and system of claim 13, but does not explicitly mention wherein the biomechanical data for the region of the cornea comprise:
a largest deformation amplitude at each OCT measurement location; and
a hysteresis at each OCT measurement location (paragraph 0004; 0034-0035).
Larin teaches the generation of data related to a largest deformation and viscoelastic properties (paragraph 0025, 0035, 0043-0044). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method and system to include wherein the biomechanical data for the region of the cornea comprise:
a largest deformation amplitude at each OCT measurement location; and
a hysteresis at each OCT measurement location to obtain a more accurate assessment of biomechanical properties.
Regarding Claim 3, Adie in view of Larin teach: The method of claim 2, wherein the biomechanical data for the region of the cornea further comprise:
a natural frequency at each OCT measurement location (Larin – paragraph 0025; 0035).
Regarding Claim 6, Adie in view of Larin teach: The method of claim 2, wherein:
the applying the mechanical excitation to the cornea at the OCT measurement location comprises emitting, by an excitation laser, one or more excitation laser pulses that propagate along a common optical path to the OCT measurement location (Adie – paragraph 0034); and
a beam delivery system (BDS) defines the common optical path (Adie - figures 2-3).
Regarding Claim 7, Adie in view of Larin teach: The method of claim 6, wherein the acquiring temporal OCT data comprises:
emitting, by a low-coherence light source, light that propagates along the common optical path to the OCT measurement location (Adie - paragraph 0032-0034);
detecting, by a reflected light detector, reflected light that propagates along the common optical path from the OCT measurement location (Adie - figure 2-3); and
generating, by a processor or signal processing circuitry coupled to the reflected light detector, the temporal OCT data based on the reflected light (Adie - paragraph 0032-0034; figures 2-3).
Regarding Claim 8 and 16, Adie in view of Larin teaches: The method of claim 7 and system of claim 15, wherein the BDS comprises a dichroic mirror, a beam scanner, an alignment mirror, and a focusing lens that define the common optical path (Adie - figure 2-3; figure 18).
Regarding Claim 9 and 17, Adie in view of Larin teaches: The method of claim 8 and system of claim 16, wherein the dichroic mirror is configured to:
reflect the excitation laser pulses from the excitation laser into the common optical path;
pass the light from the low-coherence light source into the common optical path; and
pass the reflected light from the common optical path to the reflected light detector (Adie - paragraph 0024-0025; 0035).
Regarding Claim 10 and 18, Adie in view of Larin teach: The method of claim 9, and system of claim 17 wherein the excitation laser pulses and the light propagate coaxially along the common optical path to the OCT measurement location (Adie – figures 2-3).
Regarding Claim 11, Adie in view of Larin teaches: The method of claim 1, wherein the applying the mechanical excitation comprises:
directing an air puff to the OCT measurement location; or
directing one or more ultrasonic pulses to the OCT measurement location (Adie - paragraph 0030).
Regarding Claim 15, Adie in view of Larin teaches: The system of claim 14, wherein:
the OCT engine comprises a low-coherence light source, a reflected light detector, and a processor or signal processing circuitry configured to generate the temporal OCT data (figures 2-3; paragraph 0030-0035);
the excitation laser is configured to emit one or more excitation laser pulses that propagate along the common optical path to the OCT measurement location (figures 2-3; paragraph 0030-0035);
the low-coherence light source is configured to emit light that propagates along the common optical path to the OCT measurement location (figures 2-3; paragraph 0030-0035); and
the reflected light detector is configured to detect reflected light that propagates along the common optical path from the OCT measurement location (figures 2-3; paragraph 0030-0035).
Claim(s) 4-5, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adie in view of Larin, further in view of, Zhang et al. (CN 114587266 A), hereinafter Zhang.
Regarding Claim 4 and 19, Adie in view of Larin teach: The method of claim 2 and system of claim 14, but do not mention wherein:
the acquiring temporal OCT data comprises:
acquiring M-mode OCT data, and
generating complex OCT data based on the M-mode OCT data; and
the generating temporal deformation data for the region of the cornea comprises:
generating relative phase difference data between adjacent OCT measurement locations based on the complex OCT data, and
generating temporal deformation data for each OCT measurement location based on the relative phase difference data.
Zhang teaches the acquiring temporal OCT data comprises:
acquiring M-mode OCT data, and
generating complex OCT data based on the M-mode OCT data; and
the generating temporal deformation data for the region of the cornea comprises:
generating relative phase difference data between adjacent OCT measurement locations based on the complex OCT data, and
generating temporal deformation data for each OCT measurement location based on the relative phase difference data (Page 7, 13-14 of provided translation). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method and system to include the acquiring temporal OCT data comprises:
acquiring M-mode OCT data, and
generating complex OCT data based on the M-mode OCT data; and
the generating temporal deformation data for the region of the cornea comprises:
generating relative phase difference data between adjacent OCT measurement locations based on the complex OCT data, and
generating temporal deformation data for each OCT measurement location based on the relative phase difference data as the substitution of one data acquisition and data generation would have yielded predictable results to one of ordinary skill.
Regarding Claim 5 and 20, Adie in view of Larin in view of Zhang teach: The method of claim 4, system of claim 19 wherein the generating the complex OCT data comprises processing the M-mode OCT data based on a wavenumber remapping, a dispersion compensation, or a fast Fourier transform (FFT) (Zhang pages 7-8, 14 of provided translation).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adie in view of Frisken et al. (US 2021/0244278 A1 – cited by Applicant), hereinafter Frisken.
Regarding Claim 12, Adie teaches: The method of claim 1, but do not mention further comprising:
dividing the cornea into a plurality of regions;
measuring biomechanical properties of the cornea in each region; and
determining, based on the biomechanical properties of each region the cornea, a spatial map of the biomechanical properties of the cornea.
Frisken teaches dividing the cornea into a plurality of regions;
measuring biomechanical properties of the cornea in each region; and
determining, based on the biomechanical properties of each region the cornea, a spatial map of the biomechanical properties of the cornea (paragraph 0132; figure 8). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the method to include dividing the cornea into a plurality of regions;
measuring biomechanical properties of the cornea in each region; and
determining, based on the biomechanical properties of each region the cornea, a spatial map of the biomechanical properties of the cornea for a more comprehensive analysis of the cornea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prentasic et al. (US 2018/0012359 A1) – M-Mode analysis.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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