DETAILED ACTION
The applicant’s response, from 12 May 2026, has been fully considered.
Amendments to the claims, from 12 May 2026, were received and entered. The
following rejections and/or objections are either reiterated or newly applied. They
constitute the complete set presently being applied to the instant application.
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 Status
Claims 2-4 and 6-18 are cancelled.
Claims 1, 5, and 19-23 are currently pending and under examination herein.
Claims 1, 5, and 19-23 are rejected.
Priority
The instant application claims priority to JP2019-207348 filed on 15 November 2019 and JP2020-070309 filed on 09 April 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. In this action, claims 1, 5, and 19-23 are examined as though they had an effective filing date of 15 November 2019. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 May 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed 11 May 2022 are accepted.
Specification
The previously issued objections to the specification are withdrawn due to the amended specification overcoming the prior objections by defining a previously undefined acronym.
Claim Objections
The previously issued objections to the claims are withdrawn due to the amended claims overcoming the prior objections by canceling the claims that were objected to.
Claim Rejections - 35 USC § 112
The previously issued 35 USC 112 (b) rejections are withdrawn due to the amended claims overcoming the prior rejections.
Claim Rejections - 35 USC § 101
Arguments associated with the previously issued 35 USC 101 rejection are considered non-persuasive (see response to arguments below the rejection). The following rejection is reiterated and modified as has been necessitated by amendment.
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, 5, and 19-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. In accordance with MPEP 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea or natural law (Step 2A, Prong 1). Claims 1, 5, 19-21, and 23 are directed to systems and Claim 22 is directed to a method. In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recite the limitation - calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period; calculate a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74]; calculate a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero; and convert the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points. Based on the broadest reasonable interpretation, the calculations and conversion encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 5 recites the limitation - calculate, as a variance, a sum of squares of a deviation between a signal intensity of the OCT signal and a mean value of the signal intensity at a frame time within the predetermined period, calculate, as a covariance, a sum of a product of a deviation between a signal intensity of the OCT signal and a mean value of the signal intensity at a frame time within the predetermined period and another deviation between a time-shifted signal intensity of the OCT signal at a shift time shifted from the frame time by a time shift amount t and a mean value of the time-shifted signal intensity, calculate the correlation coefficient by dividing the covariance by the variance for each shift amount [Symbol font/0x74], and perform regression analysis using a predetermined decay function using the correlation coefficient for each time shift amount [Symbol font/0x74] and calculate a parameter of the decay function approximating the correlation coefficient, as the decay speed at each of the observation points. Based on the broadest reasonable interpretation, the calculations and regression encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 19 recites the limitation - calculate the temporal variation characteristic value in an observation period, the observation period being longer than the predetermined period. Based on the broadest reasonable interpretation, the calculation encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 20 recites the limitation - determine an evaluation value indicating an active state of the sample based on the temporal variation characteristic value. Based on the broadest reasonable interpretation, the determination of a value encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 22 recites the limitation - calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period; converting the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points; calculating a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74]; calculating a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero. Based on the broadest reasonable interpretation, the calculations and conversion encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 23 recites the limitation - calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period; calculating a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74]; calculating a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero; and converting the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points. Based on the broadest reasonable interpretation, the calculations and conversion encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
These limitations recite concepts of calculating, converting, and determining values and information that are so generically recited that they can be practically performed in the human mind as claimed, which falls under the “Mental processes” and “Mathematical concepts” grouping of abstract ideas. A mathematical concept need not be expressed in mathematical symbols, because words used in a claim operating on data to solve a problem can serve the same purpose as a formula (MPEP 2106.04(a)(2)). Additionally, both product claims and process claims may recite mental processes, which can include a claim that requires a computer (MPEP 2106.04(a)(2)). Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. As such, claims 1, 5, and 19-23 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). These judicial exceptions are not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology (MPEP § 2106.04(d)(1)). Rather, the claims provide insignificant extra-solution activity (MPEP § 2106.05(g)) and provide mere instructions to apply a judicial exception (MPEP § 2106.05(f)). Specifically, the claims recite the following additional elements:
Claim 1 recite a light source; a photodetector; a measurement circuitry configured to acquire an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample and to acquire a signal value based on the OCT signal at an observation point in the sample; an evaluation circuitry; an image processing circuitry; output image data indicating the pixel value to a display screen for displaying an image based on the output image data.
Claim 21 recites the image processing circuitry configured to generate the image data having the pixel value using a function to provide an output value monotonically changing with respect to a change in an input value.
Claim 22 recites generating light from a light source; detecting intensity of the generated light at a photodetector; acquiring, based on the detecting, an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample and acquiring a signal value based on the OCT signal at an observation point in the sample; outputting image data indicating the pixel value to a display screen for displaying an image based on the output image data.
Claim 23 recites a non-transitory computer readable medium storing instructions executable by a processor; generating light from a light source; detecting intensity of the generated light at a photodetector; acquiring, based on the detecting, an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample, and acquiring a signal value based on the OCT signal at an observation point in the sample; and outputting image data indicating the pixel value to a display screen for displaying an image based on the output image data.
There are no limitations that indicate that the claimed calculating, converting, and determining values and information require anything other than generic computing systems (i.e. the circuitry). As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible. There is no indication that these steps are affected by the judicial exception in any way and thus do not integrate the recited judicial exception into a practical application. As such, claims 1, 5, and 19-23 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite conventional additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The claims also recite conventional additional elements that represent insignificant extra-solution activities.
As discussed above, there are no additional limitations to indicate that the claimed calculating, converting, and determining values and information require anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. As specified in MPEP 2106.05(g), extra-solution activities can be understood as incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Insignificant extra-solution activities include mere data gathering, selecting a particular data source or type of data to be manipulated, and displaying information. Additionally, Podoleanu (2012, Journal of Microscopy, Vol. 247, No. 3: 1-11, previous office action) teaches lights, photodetectors, processing devices (Page 2, Figure 2), the acquisition of OTC signals (Page 8, Column 1, Paragraph 2: OCT is now regularly used in diagnosis of a variety of diseases), and displaying the results as an image (Page 6, Column 2, Paragraph 2: This represents the minimum time interval to acquire the data necessary to produce a C-scan image) are well understood, routine, and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, Claims 1, 5, and 19-23 are not patent eligible.
Response to arguments
Applicant disagrees with the Office's assertions that independent claims recite a judicial exception (Applicant Remarks Page 8).
Applicant asserts the claims do not recite a mathematical concept. The independent claims recite calculating and converting values, including those with known formulas such as a correlation coefficient and decay speed of the correlation coefficient. The claims rely on these calculations and are therefore directed to an abstract idea. MPEP 2106.04(a)(2) specifies a mathematical concept need not be expressed in mathematical symbols, because words used in a claim operating on data to solve a problem can serve the same purpose as a formula. Additionally, both product claims and process claims may recite mental processes, which include a claim that requires a computer (i.e. the recited evaluation and image processing circuitry) (MPEP 2106.04(a)(2)). Even though it is a physical device carrying out the calculations, the claims rely on these calculations and are therefore directed to an abstract idea. Therefore this argument is not persuasive.
Applicant asserts the claims do not recite a mental process. MPEP 2106.04(a)(2) specify both product claims and process claims may recite mental processes, which include a claim that requires a computer (i.e. the recited evaluation and image processing circuitry). Applicant further asserts "measurement circuitry configured to acquire an optical coherence tomography (OCT) signal" and "output image data indicating the pixel value to a display screen for displaying an image based on the output image data" require machine interactions and thus cannot be performed solely in the human mind. The examiner, agrees with the characterization of using circuitry to acquire OTC signal and display information, which is why these limitations are categorized as additional elements (see rejection above). The applicant has not presented evidence to refute that the claimed calculating and converting (the judicial exceptions) can be a mental process. Therefore this argument is not persuasive.
Applicant asserts the amended independent claims recite limitations that integrate the alleged judicial exceptions into a practical application and are therefore further patent eligible under Step 2A, Prong 2 (Applicant Remarks Page 9). MPEP 2106.04(d) sets forth limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application, such as an improvement to technology, a particular treatment/prophylaxis, or a particular machine. It is unclear how the additional elements recited integrate the judicial excepts into a particular practical application recited by the MPEP 2106.04(d). Furthermore, the applicant asserts the invention informs on the active state of biological tissue imaged by the OCT device. It is unclear from the applicant’s remarks and disclosure of the invention how determining the active state of biological tissue is a practical application relative to the guidance in MPEP MPEP 2106.04(d). Therefore this argument is not persuasive.
Overall, the applicant’s arguments are not considered to be persuasive. Therefore the rejection stands but is updated to reflect the amended claims.
Claim Rejections - 35 USC § 102
The previously issued 35 USC 102 rejection is withdrawn due to the amended claims overcoming the prior rejection. The amended claims combine limitations that were previously rejected with multiple pieces of art.
Claim Rejections - 35 USC § 103
Arguments associated with the previously issued 35 USC 103 rejection are considered non-persuasive (see response to arguments below the rejection). The following rejection is reiterated and modified as has been necessitated by amendment.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Makihira (US 20190130170 A1, previous office action), in view of Nadkarni (US 20140378845 A1, previous office action). Italicized text from reference art.
Applicable claims include:
Claim 1. An evaluation device comprising:(Claim 1.i) a light source; (Claim 1.ii) a photodetector; (Claim 1.iii) a measurement circuitry configured to acquire an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample and to acquire a signal value based on the OCT signal at an observation point in the sample; (Claim 1.iv) an evaluation circuitry configured to calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period, and an image processing circuitry; wherein: (Claim 1.v) the evaluation circuitry is configured to calculate a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74], and (Claim 1.vi) calculate a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero, (Claim 1.vii) the image processing circuitry is configured to convert the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points, and (Claim 1.viii) output image data indicating the pixel value to a display screen for displaying an image based on the output image data.
Claim 19. The evaluation device according to claim 1, wherein the evaluation circuitry is configured to calculate the temporal variation characteristic value in an observation period, the observation period being longer than the predetermined period.
Claim 20. The evaluation device according to claim 1, further comprising: an output processing circuitry configured to determine an evaluation value indicating an active state of the sample based on the temporal variation characteristic value.
Claim 21. The evaluation device according to claim 1, wherein: the image processing circuitry configured to generate the image data having the pixel value using a function to provide an output value monotonically changing with respect to a change in an input value.
Claim 22. An evaluation method for an evaluation device comprising: (Claim 22.i) generating light from a light source; (Claim 22.ii) detecting intensity of the generated light at a photodetector; (Claim 22.iii) acquiring, based on the detecting, an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample and acquiring a signal value based on the OCT signal at an observation point in the sample; (Claim 22.iv) calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period; (Claim 22.v) converting the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points, and (Claim 22.vi) outputting image data indicating the pixel value to a display screen for displaying an image based on the output image data; wherein the calculating the temporal variance characteristic value comprises: (Claim 22.vii) calculating a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74], and (Claim 22.viii) calculating a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero. Claim 23. A non-transitory computer readable medium storing instructions executable by a processor, wherein execution of the instructions causes the processor to perform: a measurement procedure comprising: (Claim 23.i) generating light from a light source; (Claim 23.ii) detecting intensity of the generated light at a photodetector; (Claim 23.iii) acquiring, based on the detecting, an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample, and acquiring a signal value based on the OCT signal at an observation point in the sample; (Claim 23.iv) an evaluation procedure of calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period and an image processing procedure; wherein: the evaluation procedure comprises: (Claim 23.v) calculating a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74], and (Claim 23.vi) calculating a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero, and the image processing procedure comprises:(Claim 23.vii) converting the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points, and (Claim 23.viii) outputting image data indicating the pixel value to a display screen for displaying an image based on the output image data.
Regarding Claims 1, 22 and 23, Makihira teach (Claim 1.i) a light source (Paragraph 0022: In FIG. 1A, a light source is a superluminescent diode). Makihira teach (Claim 1.ii) a photodetector (Paragraph 0023: The measurement light and the reference light returned to the coupler are combined by the coupler and guided to a detection system (or spectrometer)). The detection system detects lights so is therefore interpreted as a photodetector. Makihira teach (Claim 1.iii) a measurement circuitry configured to acquire an optical coherence tomography (OCT) signal indicating a state of a biological tissue provided as a sample and to acquire a signal value based on the OCT signal at an observation point in the sample (Paragraph 0003: information generation unit configured to generate motion contrast information about substantially a same region of an eye to be examined by using a plurality of pieces of tomographic information obtained by imaging substantially the same region at a predetermined time interval). Motion contrast information is interpreted as a state of the biological tissue (i.e. is the tissue moving). Tomographic information obtained by imaging substantially the same region is interpreted as equivalent to signal value based on the OCT signal at an observation point. Discerning information about the eye is interpreted as equivalent to the sample and tissue. Makihira teach (Claim 1.iv) an evaluation circuitry configured to calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period (Paragraph 0003: information acquisition unit configured to obtain information about a change in a motion contract value of at least part of substantially the same region by using a plurality of pieces of motion contrast information at different times). Information about a change in a motion contract value is interpreted as equivalent to a temporal variation characteristic value. The teachings of Makihira for claim 1.iii indicate the OTC signals are captured for a predetermined time interval. Makihira teaches (Claim 1.vi) the time shift amount [Symbol font/0x74] being non-zero (Paragraph 0027: OCTA needs a plurality of measurements performed at the same position at predetermined time intervals; Paragraph 0040: signal processing unit calls a stored plurality of OCTA images obtained in time series; Paragraph 0041: The signal processing unit which is an example of the information acquisition unit obtains information about a change in the MC values of at least part of substantially the same region by using a plurality of OCTA images at different times). Because the analysis is conducted on images taken a different times/using time intervals, the time shift amount must be greater than 0. Additionally, Makihira teaches a device to execute the methods. The device includes a computer with inherently has non transitory computer readable media and at least one processor (Paragraph 0062: Embodiment(s) of the present invention can also be realized by a computer of a system or apparatus that reads out and executes computer executable instructions recorded on a storage medium to perform the functions of one or more of the above-described embodiment(s) and/or that includes one or more circuits for performing the functions of one or more of the above-described embodiment(s)). Claim 22 recites the limitations of claim 1 drawn to a method. Claim 23 recites the limitations of claim 1 drawn to a non-transitory computer readable medium.
Regarding Claim 19, Makihira teaches the evaluation circuitry is configured to calculate the temporal variation characteristic value in an observation period, the observation period being longer than the predetermined period (Paragraph 0027: OCTA needs a plurality of measurements performed at the same position at predetermined time intervals to measure a blood flow-based temporal change in an OCT interference signal. This, however, leads to a prolonged scan time, causing a problem of occurrence of a motion artifact in the image due to eye movement. The number of repetitions m may be changed according to an A scan speed of the SDOCT apparatus and a motion analysis of a fundus surface image of the eye to be examined). This indicates that the overall time of the that the temporal variation characteristic value is calculated is variables and extends to longer than the predetermined period.
Regarding Claim 20, Makihira teaches an output processing circuitry configured to determine an evaluation value indicating an active state of the sample based on the temporal variation characteristic value (Paragraph 0031: OCTA is a technique for distinguishing contrast between flowing tissue and flowless tissue among the subject's tissues based on local correlation values between images. In other words, flowing tissue is extracted on the assumption that flowless tissue shows high correlation between images). The correlation values are related to the state of the tissue as flowing or not flowing. The change in correlation values based on a collection images (correlation between images) is interpreted as the temporal variation characteristic value.
Regarding Claim 21, Makihira teaches the image processing circuitry configured to generate the image data having the pixel value using a function to provide an output value monotonically changing with respect to a change in an input value (Paragraph 0013: Figure 9 illustrate display examples of MC value change images and MC value change amounts; Paragraph: 0047: The MC value change information can be drawn as an image by performing the foregoing analysis on all the pixels within the coordinates of the effective area of each OCTA image; Paragraph 0048: As described above, there are various possible patterns of parameters expressing a temporal change in the MC values. FIG. 8B which is formed by imaging the macular portion with the maximum values Imax of the MC values in the OCTA images). Makihira teaches that the values used to the set the pixel values for displaying the motion contrast image can be based on the maximum intensity. This is interpreted to indicate the pixel value will increase as a greater maximum is achieved (i.e. the values only go in one direction).
Makaira does not teach (Claim 1.v) the evaluation circuitry is configured to calculate a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74]. Makaira does not teach Nadkarni teach (Claim 1.vi) calculate a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero.
Regarding Claims 1, 22 and 23, Nadkarni teach (Claim 1.v) the evaluation circuitry is configured to calculate a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount [Symbol font/0x74], the time-shifted signal value being the signal value shifted by a time shift amount [Symbol font/0x74] (Paragraph 0210: The modulation of the transmitted speckles can then be evaluated by the correlation coefficient of the intensity patterns between reconstructed speckle patterns at different positions; Paragraph 0218: In order to characterize the rate of speckle temporal fluctuations and further map the viscoelastic properties of vessel walls, the temporal autocorrelation of the speckle intensities g2(Δt)). The published specification (US 20220390357 A1) for the instant application indicates a correlation coefficient corresponds to the autocorrelation function (Paragraph 0067). Δt of Nadkarni is interpreted as the time shift amount [Symbol font/0x74] (Paragraph 0218: where I(t) and I(t+Δt) can be the pixel intensities at times t and t+Δt). Nadkarni teach (Claim 1.vi) calculate a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] being non-zero, without using the time shift amount [Symbol font/0x74] being zero (Paragraph 0218: the fitting parameter [Symbol font/0x74] can be the decay rate of the speckle correlation functions). As explained for Claim 1.v, the speckle temporal fluctuations is described by the correlation coefficient. Therefore, the decay rate of the speckle correlation functions is equivalent to the decay speed of the correlation coefficient. Additionally, autocorrelation as used by the art indicates the time shift amount cannot be 0 (Paragraph 0218: the temporal autocorrelation of the speckle intensities g2(Δt) can be calculated as Equation 9 where I(t) and I(t+Δt) can be the pixel intensities at times t and t+Δt). Δt indicates a difference in time and it Δt was equal to 0, then I(t) and I(t+Δt) would be the same value which would not make sense for the given calculation. Nadkarni teaches (Claim 1.vii) the image processing circuitry is configured to convert the temporal variation characteristic value for each one of observation points into a pixel value for a pixel corresponding to each one of the observation points (Paragraph 0219: To construct 2D maps of the viscoelasticity of tissues, whole imaging area can be divided, as shown in FIG. 27A, into multiple small windows (e.g., 40 by 40 pixel windows); Paragraph 0223: At each position along the coronary, four [Symbol font/0x74] maps can be constructed. All the [Symbol font/0x74] maps can be stitched together and wrapped on the surface of a cylinder to create 2D cylindrical maps of viscoelasticity of the coronary. An example of wrapping 2D maps to form a cylindrical view of the maps is shown in FIG. 32). Nadkarni describes that [Symbol font/0x74] can be the decay rate of the speckle correlation functions (i.e. decay rate of the correlation coefficient, see claim 1.v and 1.vi). Therefore, [Symbol font/0x74] as used by Nadkarni is equivalent to the temporal variation characteristic value of the instant application (see Paragraph 0009 of the published specification of the instant application). The [Symbol font/0x74] maps as seen in Figure 32 of Nadkarni are equivalent to the temporal variation characteristic value for each one of observation points converted into a pixel value that be displayed as image data. Nadkarni (Claim 1.viii) output image data indicating the pixel value to a display screen for displaying an image based on the output image data (see Claim 1.vii for image data indicating pixel value; See figure 32 for a display of pixel values). Additionally, Figure 40 of Nadkarni teaches a display arrangement (Paragraph 0194: It can also be possible to display 2D maps of time constant by using spatial averaging, spatial filtering along with bilinear image interpolation techniques). Additionally, Nadkarni teaches a device to do the methods. The device includes a computer with inherently has non transitory computer readable media and at least one processor (Paragraph 0018: In another embodiment of the present disclosure, a system, method and computer-accessible medium can be provided). Claim 22 recites the limitations of claim 1 drawn to a method. Claim 23 recites the limitations of claim 1 drawn to a non-transitory computer readable medium.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine Makaira and Nadkarni. Both references use the same technology (OCT) to assess tissues. Makihira investigates blood vessels and blood flow in human tissues. Nadkarni is primarily concerned with integrating OTC imagery acquisition into catheters, for example to assess the tissues of the heart. The references study the implementation of OTC technology to assess human tissues. They also seek to use the information generated from OCT to assess the state of biological samples. Nadkarni teaches mathematical models used to evaluate changes in tissues over time which is obvious to apply Makihira because the method acquires additional information on the changes of tissue over time from the OTC technology when considering similar types of samples. Additionally, Nadkarni teaches their methods result in increased efficiency over other methods of processing OTC signals (Paragraph 0027: An advantage of utilizing the temporal-spatial behavior of the optical vortices can be that it may only a need few frames to obtain the adequate statistics of the mean squared displacement of the phase singularities. Therefore, it can greatly shorten the imaging time, while calculating the decorrelation of the speckle frames can require long imaging time that has to be few times longer than the decorrelation time of the speckles). Furthermore, one of ordinary skill in the art would predict that the methods could be readily combined with a reasonable expectation of success because both are within the same technical field – utilizing OCT technology to consider biological samples.
Claims 1, 5, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1 and 19-23 above, in view of Nadkarni, as applied to claims 1 and 19-23 above, and in further view of Grzywacz et al. (2010, IEEE Transactions on Medical Imaging, Vol. 29, No. 6: 1224-1237, previous office action). Italicized text from reference art.
Applicable claims include:
Claims 1 and 19-23 are presented above
Claim 5. The evaluation device according to claim 1, wherein the evaluation circuitry is configured to (Claim 5.i) calculate, as a variance, a sum of squares of a deviation between a signal intensity of the OCT signal and a mean value of the signal intensity at a frame time within the predetermined period, (Claim 5.ii) calculate, as a covariance, a sum of a product of a deviation between a signal intensity of the OCT signal and a mean value of the signal intensity at a frame time within the predetermined period and another deviation between a time-shifted signal intensity of the OCT signal at a shift time shifted from the frame time by a time shift amount t and a mean value of the time-shifted signal intensity, (Claim 5.iii) calculate the correlation coefficient by dividing the covariance by the variance for each shift amount [Symbol font/0x74], and (Claim 5.iv) perform regression analysis using a predetermined decay function using the correlation coefficient for each time shift amount [Symbol font/0x74] and calculate a parameter of the decay function approximating the correlation coefficient, as the decay speed at each of the observation points.
Regarding Claims 1 and 19-23, these limitations are taught by Makihira and Nadkarni as above
Makihira and Nadkarni do not teach using the calculated variance and covariance to calculate the correlation coefficient or using regression analyses (Claim 5).
Regarding Claim 5, Grzywacz et al. teach (Claim 5.i) calculate, as a variance, a sum of squares of a deviation between a signal intensity of the OCT signal and a mean value of the signal intensity at a frame time within the predetermined period (Page 1226, Column 1, Equation 7: Hence, in particular, the mean, second moment, variance, and coefficient of variation are). Grzywacz et al. teach (Claim 5.ii) calculate, as a covariance, a sum of a product of a deviation between a signal intensity of the OCT signal and a mean value of the signal intensity at a frame time within the predetermined period and another deviation between a time-shifted signal intensity of the OCT signal at a shift time shifted from the frame time by a time shift amount t and a mean value of the time-shifted signal intensity (Page 1228, Column 1, Equation 27: we obtain for the covariance). Grzywacz et al. teach (Claim 5.iii) calculate the correlation coefficient by dividing the covariance by the variance for each shift amount [Symbol font/0x74] (Page 1228, Equation 28: Dividing this equation (equation 27-covariance) by the product of the two standard deviations (equation 7-variance) gives the correlation coefficient shown in Equation 28 at the bottom of this page). Grzywacz et al. teach (Claim 5.iv) perform regression analysis using a predetermined decay function using the correlation coefficient for each time shift amount [Symbol font/0x74] and calculate a parameter of the decay function approximating the correlation coefficient, as the decay speed at each of the observation points (Page 1230, Figure 3: Fits of the data with the stretched exponential model; Page 1225, Column 2, Paragraph 1: We then normalized the histograms to obtain probability density functions, and combined the data from the various subregions to estimate the mean and standard errors of the functions). Fitting a negative line to the data is interpreted as equivalent to regression analysis using a predetermined decay function. Combining the data from the various subregions is considered equivalent to each of the observation points.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine Grzywacz et al. with Makaira and Nadkarni. All three references are focused on the same technology (OCT) to assess biological tissues. Makihira is concerned with blood vessels and blood flow in human tissues. Nadkarni is primarily concerned with integrating imagery techniques into catheters for use in organs such as the heart. Grzywacz et al. utilizes OTC to study retinal tissue. All refences attempt to implement the OTC technology is to assess characteristics of human tissues. They also all attempt to use the information generated from OCT to assess the state of a biological tissues. Grzywacz teaches specific ways to calculate changes in OTC signals which is obvious to apply because the calculations allow for information on the state of tissue to be extracted from the OTC signals when considering similar sample types. Additionally, Grzywacz et al. teach application of their methods to automatically determining the state of a sample (Page 1235, Column 1, Paragraph 4: The relative constancy of stretched exponential parameters, especially of, within individual retinal layers of normal subjects gives hope that one may use OCT to detect pathologies automatically), which is also a focus of by Makaira. Furthermore, one of ordinary skill in the art would predict that the methods could be readily combined with a reasonable expectation of success because all are within the same technical field – utilizing OCT technology to consider biological samples.
Response to arguments
Applicant argues that none of the cited prior art references, whether taken singularly or in any reasonable combination, discloses every feature of the amended independent claims (Applicant Remarks Page 11, Paragraph 2).
Applicant asserts the limitations "calculate a correlation coefficient of the signal value and a time-shifted signal value for each time shift amount T, the time-shifted signal value being the signal value shifted by a time shift amount T" and "calculate a decay speed of the correlation coefficient according to an increase in the time shift amount T being non-zero, without using the time shift amount T being zero" (amended claim 1, formerly claims 4 and 6) are not taught by Nadkarni. Applicant provides excerpts from the art where they assert the time shift amount is zero. This argument is not persuasive because, as explained in the updated rejection above, Nadkarni teaches the speckle temporal fluctuations is described by the correlation coefficient. Therefore, the decay rate of the speckle correlation functions is equivalent to the decay speed of the correlation coefficient. The, autocorrelation as used by Nadkarni indicates the time shift amount cannot be zero (Paragraph 0218: the temporal autocorrelation of the speckle intensities g2(Δt) can be calculated as Equation 9 where I(t) and I(t+Δt) can be the pixel intensities at times t and t+Δt). Δt indicates a difference in time and it Δt was equal to 0, then I(t) and I(t+Δt) would be the same value which would not make sense for the given calculation. Additionally, if the time shift amounts in Nadkarni were equal to zero, it would not make sense to describe the relationship between events of a sequence as autocorrelation because then it would be describing the relationship between identical events (i.e. occupy the same time).
Applicant also asserts Nadkarni teaches away from calculating the correlating coefficient without using the time shift amount being zero and cites figure 30B of the art. This argument is not persuasive. Figure 30B shows the x axis includes 0, but does not show that the calculation of decay incorporates Δt =0. Additionally, MPEP 2145 explains a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed. The applicant does not provide evidence that Nadkarni teaches away the time shift amount being zero. As explained above, the calculations would not make sense if Δt =0 because that it would just be comparing something to itself. This would also not represent a change in time, which is how Δt is interpreted. Therefore, Nadkarni does not criticize, discredit or otherwise discourage the time shift amount being a non-zero amount.
Overall, the applicant’s arguments are not considered persuasive. Therefore the rejection stands but is updated to reflect the amended claims.
Double Patenting
The previously issued double patenting rejection against US patent 8879070 is withdrawn due to the amended claims overcoming the prior rejection. The examiner agrees with applicant’s assertion that the amendments to the independent claims (calculating a correlation coefficient and decay speed of the correlation coefficient) are not recited by or obvious variants of the claims of US patent 8879070.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.H.E./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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