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 2 is objected to because of the following informalities: A claim must begin with a capital letter and end with a period. See MPEP 608.01(m). Appropriate correction is required.
Claims 8-9 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 7. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rollins et al. (US 20180211383) cited in IDS.
Regarding claim 1, Rollins discloses a method for corneal cross-linking with real-time monitoring (Fig. 1, section 0018, 0043-0044), the method comprising:
determining a plurality of optical coherence tomography (OCT) measurement locations in a region of a cornea (section 0048);
applying a corneal cross-linking treatment to the region of the cornea (Section 0043, 0048); and
during the applying of the corneal cross-linking treatment: acquiring a temporal OCT interferogram at each OCT measurement location (Section 0043), generating temporal complex OCT data based on the temporal OCT interferogram (Section 0045), determining biomechanical data based on the temporal complex OCT data, and adjusting the corneal cross-linking treatment based on the biomechanical data (Section 0048).
Regarding claim 2, Rollins discloses the method of claim 1, wherein the applying the corneal cross-linking treatment comprises:
irradiating, by a corneal cross-linking radiation source, a photosensitizer that has been applied to the region of the cornea (section 0043).
Regarding claim 3, Rollins discloses the method of claim 2, wherein the adjusting the corneal cross-linking treatment comprises:
increasing or decreasing an illumination intensity emitted by the corneal cross-linking radiation source based on the biomechanical data (Section 0044).
Regarding claim 4, Rollins discloses the method of claim 3, further comprising:
during the applying of the corneal cross-linking treatment: displaying a corneal structure at each OCT measurement location (Section 0022).
Regarding claim 5, Rollins discloses the method of claim 1, wherein the biomechanical data comprise:
a collagen confinement (Section 0014, 0017-0018, 0045); and a corneal stiffness (Section 0014, 0018).
Regarding claim 7, Rollins discloses the method of claim 6, wherein:
the complex OCT data includes amplitude data and phase data (section 0021); and
the determining the biomechanical data comprises: determining a signal change rate based on the phase data of the temporal complex OCT data, determining the collagen confinement based on the signal change rate (Section 0014, 0017-0018, 0045), and determining the corneal stiffness (Section 0014, 0018) based on the collagen confinement.
Regarding claim 8, Rollins discloses the method of claim 6, wherein:
the complex OCT data includes amplitude data and phase data (Section 0021); and
the determining the biomechanical data comprises: determining a signal change rate based on the phase data of the temporal complex OCT data, determining the collagen confinement based on the signal change rate (Section 0014, 0017-0018, 0045), and determining the corneal stiffness (Section 0014, 0018) based on the collagen confinement.
Regarding claim 9, Rollins discloses the method of claim 6, wherein:
the complex OCT data includes amplitude data and phase data (Section 0021); and
the determining the biomechanical data comprises: determining a signal change rate based on the phase data of the temporal complex OCT data, determining the collagen confinement based on the signal change rate (Section 0014, 0017-0018, 0045), and determining the corneal stiffness (Section 0014, 0018) based on the collagen confinement.
Regarding claim 10, Rollins discloses the method of claim 2, wherein:
the corneal cross-linking radiation source is configured to emit ultraviolet (UV) light that propagates along a common optical path to the cornea (Section 0043); and
the common optical path is defined by a beam delivery system (BDS) (section 0038).
Regarding claim 15, Rollins discloses a system for corneal cross-linking with real-time monitoring (Fig. 1, section 0018, 0043-0044), the system comprising:
a beam delivery system (BDS) defining a common optical path (Section 003812);
a corneal cross-linking radiation source configured to apply a corneal cross-linking treatment to a region of a cornea (Section 0043);
an optical coherence tomography (OCT) engine 12 (section 0019) configured to: acquire temporal OCT interferogram at each of a plurality of OCT measurement locations in the region via the common optical path (section 0020), and generate temporal complex OCT data based on the temporal OCT interferogram (Section 0020); and
a control computer 16, coupled to the OCT engine (section 0019, 0048-0049), the control computer comprising a processor configured to: determine the plurality of OCT measurement locations in the region of the cornea (Section 0048), send the OCT measurement locations to the OCT engine (Section 0019), and during the corneal cross-linking treatment application: receive temporal complex OCT data for each OCT measurement location from the OCT engine (section 0043), determine biomechanical data for the region of the cornea based on the temporal complex OCT data (Section 0045, 0048), and adjust the corneal cross-linking radiation source based on the biomechanical data for the region of the cornea (Section 0018).
Regarding claim 17, Rollins discloses the system of claim 16, wherein:
the complex OCT data includes amplitude data and phase data (Section 0021);
the biomechanical data for the region of the cornea comprise a collagen confinement (Section 0014, 0017-0018, 0045) and a corneal stiffness (Section 0014, 0018); and
the processor being configured to determine the biomechanical data comprises the processor being configured to: determine a signal change rate based on the phase data of the temporal complex OCT data (Section 0014, 0017-0018, 0045);
determine the collagen confinement based on the signal change rate (Section 0014, 0017-0018, 0045); and
determine the corneal stiffness based on the collagen confinement (Section 0014, 0018).
Regarding claim 18, Rollins discloses the system of claim 17, wherein:
the processor being configured to apply the corneal cross-linking treatment comprises the processor being configured to emit ultraviolet light (UV) that propagates along the common optical path to the cornea (Section 0043); and
the processor being configured to adjust the corneal cross-linking radiation source comprises the processor being configured to increase or decrease a UV light illumination intensity emitted by the corneal cross-linking radiation source based on the biomechanical data (section 0018, Section 0045, 0048).
Regarding claim 19, Rollins discloses
Regarding claim 20, Rollins discloses
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.
Claim(s) 6, 11-14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rollins et al. (US 20180211383) in view of Boppart et al. (US 20160367146), both cited in IDS.
Regarding claims 6 and 16, Rollins discloses the method of claim 5, wherein:
the acquiring temporal OCT interferogram comprises acquiring M-mode OCT data at each OCT measurement location (Section 0020); and
However Rollins does not disclose generating temporal complex OCT data comprises processing the temporal OCT interferogram based on a wavenumber remapping, a dispersion compensation, or a fast Fourier transform (FFT). Boppart discloses generating temporal complex OCT data comprises processing the temporal OCT interferogram based on a wavenumber remapping, a dispersion compensation, or a fast Fourier transform (FFT) (section 0085). This allows for proper generation of temporal complex OCT data for a specific location. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device and method of Rollins by adding generating temporal complex OCT data comprises processing the temporal OCT interferogram based on a wavenumber remapping, a dispersion compensation, or a fast Fourier transform (FFT) as taught by Boppart in order to facilitate proper generation of temporal complex OCT data for a specific location.
Regarding claim 11, Rollins in view of Boppart, specfically Boppart discloses the method of claim 10, wherein the acquiring temporal OCT interferogram comprises:
emitting, by a low-coherence (LC) light source, LC light that propagates along the common optical path to the OCT measurement location (section 0038, 0063);
detecting, by a reflected LC light detector, reflected LC light that propagates along the common optical path from the OCT measurement location (section 0079); and
generating, by a processor or signal processing circuitry coupled to the reflected LC light detector, the temporal OCT interferogram based on the reflected LC light (section 0079).
This allows for proper light to be radiated and measured by the device.
Regarding claim 12, Rollins in view of Boppart, specfically Boppart discloses the method of claim 11, wherein
the BDS comprises a dichroic mirror 154, a beam scanner 116, and a focusing lens 118 that define the common optical path (Fig. 1, Section 0080-0081).
This allows for proper light to be radiated and measured by the device.
Regarding claim 13, Rollins discloses the method of claim 12, wherein the dichroic mirror is configured to:
pass the UV light from the corneal cross-linking radiation source into the common optical path (Section 0043);
However, Rollins does not disclose reflect the LC light from the LC light source into the common optical path; and reflect the reflected LC light from the common optical path to the reflected LC light detector. Boppart discloses reflect the LC light from the LC light source into the common optical path; and reflect the reflected LC light from the common optical path to the reflected LC light detector (section 0038, 0063, 0079). This allows for proper generation of temporal complex OCT data for a specific location.
Regarding claim 14, Rollins in view of Boppart, specfically Boppart discloses the method of claim 13, wherein
the UV light and the LC light propagate coaxially along the common optical path to the OCT measurement location (section 0038, 0063, 0079).
This allows for proper generation of temporal complex OCT data for a specific location.
Regarding claim 19, Rollins in view of Boppart, specfically Boppart discloses the system of claim 18, wherein:
the OCT engine comprises a low-coherence (LC) light source, a reflected LC light detector, and a processor or signal processing circuitry configured to generate the temporal OCT interferogram and the temporal complex OCT data (section 0038, 0063);
the LC light source is configured to emit LC light that propagates along the common optical path to the OCT measurement location (section 0079); and
the reflected LC light detector is configured to detect reflected LC light that propagates along the common optical path from the OCT measurement location (section 0038, 0063, 0079).
This allows for proper generation of temporal complex OCT data for a specific location.
Regarding claim 20, Rollins in view of Boppart, specfically Boppart discloses the method of claim 19, wherein
the BDS comprises a dichroic mirror 154, a beam scanner 116, and a focusing lens 118 that define the common optical path (Fig. 1, Section 0080-0081).
This allows for proper light to be radiated and measured by the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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