DETAILED ACTION
Claims 1-20 are hereby the present claims under consideration.
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 § 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 1-20 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 1-20 are directed to a method of processing PS-OCT signals using a computational algorithm, which is an abstract idea. Claims 1-20 do not include additional elements that integrate the exception into a practical application 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, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] determine birefringent information for the measurement location based on the PS-OCT data
[B1] determine biomechanics information for the measurement location based on the PS-OCT data
[C1] determine a correlation between at least a portion of the biomechanics information and at least a portion of the birefringent information
These elements [A1]-[C1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. In particular the determination of birefringent and biometric data from the gathered PS-OCT data is not particularly limited and may be performed in the human mind. The human mind is further readily capable of making correlations between values based on observed patterns.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a polarization sensitive optical coherence tomography (PS-OCT) device
[B2] a memory
[C2] a processor in communication with the memory
[D2] emit polarized light to a measurement location on eye tissue of a patient
[E2] generate PS-OCT data based on the polarized light
These elements [A2]-[E2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2] and [D2]-[E2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [B2]-[C2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations of a PS-OCT device and using said device to emit light and receive data is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a polarization sensitive optical coherence tomography (PS-OCT) device performing typical measurement operations (that is emitting light and receiving data from the reflected light). Such PS-OCT sensors are conventional as evidenced by:
U.S. Patent Application Publication No. US 20110028967 A1 (Rollins) discloses that OCT systems are conventional and can detect signals differences in multiple polarizations using different channels of a polarization sensitive OCT (paragraph 0032 of Rollins);
U.S. Patent Application Publication No. US 20020196446 A1 (Roth) discloses that polarization sensitive OCT (PS-OCT) systems are known in the art (paragraph 0003 of Roth);
U.S. Patent Application Publication No. US 20140115022 A1 (Yasuno) discloses that PS-OCT systems are conventional (paragraph 0023 of Yasuno); and
U.S. Patent Application Publication No. US 20090247862 A1 (Meyer) discloses that PS-OCT system are typical and comprise at least two detection channels to evaluate the polarization state of the returned light (paragraph 0011 of Meyer).
U.S. Patent Application Publication No. US 20120327423 A1 (Hanebuchi) discloses that PS-OCT systems are conventional (paragraph 0011 of Hanebuchi).
Further, the elements [B2]-[C2] do not qualify as significantly more because this limitation is 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 (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-10 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 2: receive an indication of a stimulus applied to the eye tissue, wherein the emission of polarized light to the PS-OCT device is in response to the received indication;
Claim 3: PS-OCT device comprises a vertical polarization sensitive detector and a horizontal polarization sensitive detector; the PS-OCT data comprises first PS-OCT data from the vertical polarization sensitive detector; and
Claim 9: at least one of record or display data related to the correlation.
Each of these claim limitations does not integrate the exception into a practical application. In particular, the limitations of claim 2 are mere extrasolution activity as they merely limit the timing of the collected data. The claim does not incorporate the application of a stimulus into the claimed invention, merely limits the timing of when the data gathering occurs. Additionally, the elements of claim 3 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). In particular, conventional PS-OCT devices are known to include multiple measurement channels for different polarizations of light as evidenced by Rollins and Meyers above. Finally, the limitations of claim 9 are drawn towards mere extrasolution activity and/or a recitation to implement the abstract idea onto a computer. Claim 9 requires nothing more than the generic storage or display of data and does not amount to significantly more than the abstract idea itself.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 11-20 recite the same abstract idea as claims 1-10 and do not recite any additional elements not already addressed above. Thus, claims 11-20 are rejected on the same basis as claims 1-10 as presented above.
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, 6-7, 9-11, 16-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Qaisi US Patent Application Publication Number US 20180214309 A1 hereinafter Al-Qaisi
Regarding claim 1, Al-Qaisi discloses an ophthalmic diagnostics system (Abstract; Paragraph 0037: PS-OCT is of significant value in the diagnosis of ocular diseases), comprising:
a polarization sensitive optical coherence tomography (PS-OCT) device (Fig. 1; Paragraphs 0039-0040: the PS-OCT system);
a memory comprising executable instructions (Paragraph 0065: a memory);
a processor in communication with the memory and configured to execute the instructions (Paragraphs 0025, 0056, and 0065: the processor in communication with the memory for controlling the PC-OCT system) to:
cause the PS-OCT device to: emit polarized light to a measurement location on eye tissue of a patient (Paragraphs 0039-0043: the emission of polarized light including vertically and horizontally polarized light; Paragraphs 0033 and 0048: the cornea); and
generate PS-OCT data based on the polarized light (Paragraphs 0046-0048: the data generated by the reflected polarized light hitting the detector(s));
determine birefringent information for the measurement location based on the PS-OCT data (Paragraphs 0028 and 0047: the PS-OCT may be used to measure tissue birefringence such as phase retardation);
determine biomechanics information for the measurement location based on the PS-OCT data (Paragraphs 0047-0048, 0060, and 0063: determine fiber alignment, orientation, and density; Paragraph 0028: fiber orientation is directly relevant to the biomechanical integrity and stability of the cornea); and
determine a correlation between at least a portion of the biomechanics information and at least a portion of the birefringent information (Paragraphs 0047, 0060, and 0063: the phase retardation may be determined as a function of tissue depth. The data relating to the phase retardation of the reflected sample beam, in relation to the phase retardation of the reflected reference beam, provides information directly related to the fiber orientation and density of the tissue that the sample beam passed through. Birefringence of tissue increases as fiber alignment, orientation, and density increases. Thus phase retardation is directly related to, or correlated with, fiber alignment, orientation, and density).
Regarding claim 11 Al-Qaisi discloses a method of operating an ophthalmic diagnostics system comprising a polarization sensitive optical coherence tomography device (PS-OCT) device (Abstract; Paragraph 0037: PS-OCT is of significant value in the diagnosis of ocular diseases), the method comprising:
emitting, by the ophthalmic diagnostics system, polarized light to a measurement location on eye tissue of a patient (Paragraphs 0039-0043: the emission of polarized light including vertically and horizontally polarized light; Paragraphs 0033 and 0048: the cornea);
generating, by the ophthalmic diagnostics system, PS-OCT data for the measurement location based on the polarized light (Paragraphs 0046-0048: the data generated by the reflected polarized light hitting the detector(s));
determining, by the ophthalmic diagnostics system, birefringent information for the measurement location based on the PS-OCT data (Paragraphs 0028 and 0047: the PS-OCT may be used to measure tissue birefringence such as phase retardation);
determining, by the ophthalmic diagnostics system, biomechanics information for the measurement location based on the PS-OCT data (Paragraphs 0047-0048, 0060, and 0063: determine fiber alignment, orientation, and density; Paragraph 0028: fiber orientation is directly relevant to the biomechanical integrity and stability of the cornea); and
determining, by the ophthalmic diagnostics system, a correlation between at least a portion of the biomechanics information and at least a portion of the birefringent information (Paragraphs 0047, 0060, and 0063: the phase retardation may be determined as a function of tissue depth. The data relating to the phase retardation of the reflected sample beam, in relation to the phase retardation of the reflected reference beam, provides information directly related to the fiber orientation and density of the tissue that the sample beam passed through. Birefringence of tissue increases as fiber alignment, orientation, and density increases. Thus phase retardation is directly related to, or correlated with, fiber alignment, orientation, and density).
Regarding claims 6 and 16, Al-Qaisi discloses the ophthalmic diagnostics system and method of claims 1 and 11 respectively. Al-Qaisi further discloses the system and method wherein the birefringent information comprises at least one of phase retardance, degree of polarization uniformity, or birefringent axial orientation (Paragraphs 0028 and 0047: the PS-OCT may be used to measure tissue birefringence such as phase retardation).
Regarding claims 7 and 17, Al-Qaisi discloses the ophthalmic diagnostics system and method of claims 1 and 11 respectively. Al-Qaisi further discloses the system and method wherein at least a portion of the biomechanics information is determined based on at least a portion of the birefringent information (Paragraphs 0047, 0060, and 0063: the phase retardation may be determined as a function of tissue depth. The data relating to the phase retardation of the reflected sample beam, in relation to the phase retardation of the reflected reference beam, provides information directly related to the fiber orientation and density of the tissue that the sample beam passed through. Birefringence of tissue increases as fiber alignment, orientation, and density increases).
Regarding claims 9 and 19, Al-Qaisi discloses the ophthalmic diagnostics system and method of claims 1 and 11 respectively. Al-Qaisi further discloses the system and method wherein the processor is further configured to execute the instructions to at least one of record or display data related to the correlation (Paragraphs 0048: the pictorial representations of the tissue indicating relative fiber orientation and fiber density based on birefringence properties of the corneal tissue).
Regarding claims 10 and 20, Al-Qaisi discloses the ophthalmic diagnostics system and method of claims 1 and 11 respectively. Al-Qaisi further discloses the system and method wherein the eye tissue comprises a cornea of the patient (Paragraph 0048: the patient’s cornea).
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 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qaisi US Patent Application Publication Number US 20180214309 A1 hereinafter Al-Qaisi as applied to claim 1 above and further in view of Larin US Patent Application Publication Number US 20200077881 A1 hereinafter Larin.
Regarding claims 2 and 12, Al-Qaisi discloses the ophthalmic diagnostics system and method of claims 1 and 11 respectively. Al-Qaisi fails to further disclose the system and method wherein the processor is further configured to execute the instructions to receive an indication of a stimulus applied to the eye tissue, wherein the emission of polarized light to the PS-OCT device is in response to the received indication.
Larin teaches an excitation force (internal or external) and phase-sensitive optical coherence elastography (OCE) system, used in conjunction with a data analyzing algorithm, is capable of measuring and quantifying biomechanical parameters of tissues in situ and in vivo (Abstract). Thus, Larin falls within the same field of endeavor as Applicant’s invention.
Larin teaches the application of an external force through a variety of possible stimulation means including air puffs or ultrasound and the recording of tissue displacement using phase-sensitive OCT in response thereto (Paragraphs 0014 and 0017). The OCT system measures the displacement profile generated by the stimulation. The generated data is used to quantify the mechanical parameters of the tissue including displacement amplitude, natural frequency Young’s modulus, and shear viscosity (Paragraph 0034). The system may measure the cornea (Paragraph 0029). The initiation of the OCT imaging is synchronized with the application of acoustic radiation force (Paragraph 0048).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the stimulation system and measurement of the response thereto as taught by Larin into the system and method of Al-Qaisi because Larin teaches that performing such stimulation allows the OCT system to measure and quantify biomechanical properties of the tissue (Larin: Paragraphs 0015 and 0034) and Al-Qaisi discloses that it is desirable to preserve the biomechanical integrity and stability of the eye (Al-Qaisi: paragraphs 0028-0030) so such a quantification may allow modified Al-Qaisi to better determine what the biomechanical properties are and how they might be preserved.
Regarding claims 3 and 13, Al-Qaisi in view of Larin teaches the ophthalmic diagnostics system and method of claims 2 and 12 respectively. Modified Al-Qaisi further teaches the system and method wherein: the PS-OCT device comprises a vertical polarization sensitive detector and a horizontal polarization sensitive detector (Paragraph 0046: the vertical polarization sensitive detector and the horizontal polarization sensitive detector);
the PS-OCT data comprises first PS-OCT data from the vertical polarization sensitive detector and second PS-OCT data from the horizontal polarization sensitive detector (Paragraphs 0046-0047: each detector may detect and generate data. Thus the “first data” is considered to be from the vertical detector and the “second data” is considered to be from the horizontal detector); and
the biomechanics information comprises first biomechanics information determined based on the first PS-OCT data and second biomechanics information determined based on the second PS-OCT data (Paragraph 0047-0048: the data from each detector is compared to its reference to generate information about the tissue including fiber orientation and density. Thus the fiber orientation and density determined using the vertical data is considered “first biomechanics information” and the fiber orientation and density data determined using the horizontal data is considered “second biomechanics information”).
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qaisi US Patent Application Publication Number US 20180214309 A1 hereinafter Al-Qaisi in view of Larin US Patent Application Publication Number US 20200077881 A1 hereinafter Larin as applied to claims 3 and 13 above and further evidenced by Whitford “Biomechanical model of the human cornea: Considering shear stiffness and regional variation of collagen anisotropy and density” published by ScienceDirect February 2015, pages 1-12 hereinafter Whitford and further in view of Mission “Birefringent Properties of the Human Cornea in vivo: Towards a New Model of Corneal Structure” published by University of Warwick, September 2012, pages 1-310 hereinafter Mission.
Regarding claims 4-5 and 14-15, Al-Qaisi in view of Larin teaches the ophthalmic diagnostics system and method of claims 3 and 13 respectively. Modified Al-Qaisi fails to further teach the system and method wherein the first biomechanics information comprises a first vibration amplitude and the second biomechanics information comprises a second vibration amplitude; and/or wherein the first biomechanics information comprises a first quantification of tissue stiffness and the second biomechanics information comprises a second quantification of tissue stiffness.
Larin teaches that the velocity and amplitude of the induced waves are measured. The velocity of the waves are used to determine a stiffness of the tissue by calculating Young’s modulus from the measured waves and the amplitude data is used to determine an amplitude attenuation rate which provides insight into both the tissue viscosity and stiffness (Paragraphs 0029-0031).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the amplitude measurement and quantification of tissue stiffness as taught by Larin into the system and method of Modified Al-Qaisi such that these quantifications occur for each of the vertical and horizontal polarization data because the amplitude and tissue stiffness parameters provide additional insight into the biomechanics of the tissue being measured by modified Al-Qaisi which may improve the ability of modified Al-Qaisi to preserve the biomechanical integrity and stability of the tissue (Al-Qaisi: Paragraphs 0028-0030). Furthermore, it would have been obvious to one of ordinary skill in the art to correlate the birefringent properties (such as phase retardation) measured by Al-Qaisi (Al-Qaisi: Paragraph’s 0028 and 0047) with the biomechanical properties measured by Larin (such as stiffness, amplitude, and viscosity; Larin paragraphs 0029-0031) because Al-Qaisi teaches that the fibril fiber alignment, orientation and density which affect phase retardation (Al-Qaisi: paragraphs 0028 and 0047) are also directly related to the biomechanical properties of the cornea (Al-Qaisi: Paragraphs 0028 and 0070: The fiber orientation of corneal tissue is directly relevant to the biomechanical integrity and stability of the cornea; choosing to cut the tissue in areas of low fiber density to preserve the biomechanical stability of the cornea). Such a relationship between corneal fibers orientation, alignment, and density with the biomechanical properties of tissue such as stiffness is known in the art as further evidenced by Whitford page 2 left column paragraph 2 and page 10 left column which teaches that the arrangement and the density of collagen fibrils in the stroma (a layer of the cornea) are the primary contributors to the biomechanical stiffness of corneal tissue and that stiffness can be directly correlated with fibril density .
Al-Qaisi in view of Larin and evidenced by Whitford fail to explicitly contemplate a correlation between the birefringent parameters and the biomechanics information of amplitude and stiffness.
Mission is directed towards an analysis of mechanical corneal properties and birefringent data (Abstract). Thus Mission is reasonably pertinent to the problem at hand.
Mission teaches that correlations between birefringent data and mechanical properties has been contemplated as both parameters are based on collagen fiber arrangements (Page 2-25: many authors has hypothesized that birefringence might be a useful tool in determining structural and biomechanical properties of the cornea; and Page 13-227 the close link between birefringence and mechanical properties is well known referencing pages 2-18 – 2-20 section 2.3 Biomechanical properties).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to correlate the tissue birefringent properties measured by Al-Qaisi with the biomechanical properties measured by Larin because both of these properties are primarily affected by the same underlying structure as taught by Al-Qaisi paragraphs 0028 and 0047 in view of Whitford page 2 left column paragraph 2 and correlating these parameters has been contemplated in the art as taught by Mission pages 2-25 and 13-227. The correlation of these parameters would provide the benefit of allowing modified Al-Qaisi to better understand the relationship between fiber configuration and the biomechanical properties of the cornea such that modified Al-Qaisi may be able to choose flap cutting sites that better maintain biomechanical stability and integrity which is a goal contemplated by Al-Qaisi in paragraphs 0028-0031 and 0033.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qaisi US Patent Application Publication Number US 20180214309 A1 hereinafter Al-Qaisi as applied to claims 7 and 17 above and further in view of Larin US Patent Application Publication Number US 20200077881 A1 hereinafter Larin and evidenced by Fingler US Patent Application Publication Number US 20080025570 A1 hereinafter Fingler and Ambrozinski US Patent Application Publication Number US 20200315570 A1 hereinafter Ambrozinski.
Regarding claims 8 and 18, Al-Qaisi discloses the ophthalmic diagnostics system and method of claims 7 and 17 respectively. Al-Qaisi fails to further disclose the system and method wherein the determination of the biomechanics information comprises a determination of change in a reflectance property with time via at least one of phase decorrelation or intensity variance.
Larin teaches the application of an external force through a variety of possible stimulation means including air puffs or ultrasound and the recording of tissue displacement using phase-sensitive OCT in response thereto (Paragraphs 0014 and 0017). The OCT system measures the displacement profile generated by the stimulation though phase sensitive OCT. The generated data is used to quantify the mechanical parameters of the tissue including displacement amplitude, natural frequency Young’s modulus, and shear viscosity (Paragraphs 0032-0034). The system may measure the cornea (Paragraph 0029). The initiation of the OCT imaging is synchronized with the application of acoustic radiation force and a plurality of A-scans are rapidly repeated at the same location (Paragraph 0048).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the stimulation system and measurement of the response thereto as taught by Larin into the system of Al-Qaisi because Larin teaches that performing such stimulation allows the OCT system to measure and quantify biomechanical properties of the tissue (Larin: Paragraphs 0015 and 0034) and Al-Qaisi discloses that it is desirable to preserve the biomechanical integrity and stability of the eye (Al-Qaisi: paragraphs 0028-0030) so such a quantification may allow modified Al-Qaisi to better determine what the biomechanical properties are and how they might be preserved. It is noted that the plurality of A-scans performed by Larin are considered to render obvious the determination of “a change in a reflectance property with time via at least one of phase decorrelation or intensity variance” because A-scans are a measurement of signal intensity and phase to generate a reflectivity, or reflectance, map of the tissue. Thus the plurality of A-scans used to measure displacement are also a measure of variations in reflectivity caused by the displacement of the tissue. This is evidenced by Fingler which teaches that A-scans are reflectivity measurements which involve intensity and phase samples (Fingler: Paragraph 0015), and Ambrozinski which teaches that phase sensitive OCT measures the amplitude of displacement waves by measuring a phase difference between a reference and sample signal, or the measurement of phase decorrelation (Ambrozinski: Paragraphs 0021, 0060, 0084, and 0102). Thus the A-scans taken by Larin are measures of changes in the reflectivity of the tissue as measured by variations in intensity and phase correlation which are caused by displacements, these changes are transformed into the actual displacement values used to determine biomechanical properties as taught by Larin.
Conclusion
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