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 Status
Claims 1-23 are currently pending and under examination herein.
Claims 1-23 are rejected.
Claims 4, 10, and 14 are objected to.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 for JP2019-207348 filed on 11/15/2019 and JP2020-070309 filed on 04/09/2020. Acknowledgment is made of applicant's claim for foreign priority based on JP2019-207348 with an effective filling date of the instant application set as 11/15/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/11/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The disclosure is objected to because of the following informalities:
The abbreviation “PS-OCT” is used in the specification (Page 13, Paragraph 0089) without being defined.
Appropriate correction is required.
Claim Objections
Claims 4, 10, and 14 are objected to because of the following informalities: Punctuation in these claims is insufficient to determine the relationships between some variables (see 112(b) rejections). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 3-6 and 10-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 recites the limitation "the number of frames". There is insufficient antecedent basis for this limitation in the claim. There is a prior reference to “a frame time” in claim 3, but not a number of frames.
Claim 4 recites the limitations: The evaluation device according to claim 1, wherein the evaluation circuitry
i. calculates a correlation coefficient of the signal value and a time-shifted signal value obtained by time-shifting the signal value by a time shift amount [Symbol font/0x74] for each time shift amount [Symbol font/0x74], and
ii. calculates a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] as the temporal variation characteristic value.
In limitation 4.i, it is unclear if “obtained by” is referring to “a correlation coefficient” or “a time-shifted signal value”. In limitation 4.ii, it is unclear if “a decay speed” or “the time shift amount” is functioning “as the temporal variation characteristic value”. Claims 5-6 are also rejected because they depend from claim 4, and thus contains the above issues due to said dependence.
Claim 10 recites the limitation - wherein the measurement circuitry determines a birefringence by dividing the local phase retardation by a wavenumber of incident light incident on the sample and a thickness between the first observation point and the second observation point. In claim 10, it is unclear if the “thickness between the first observation point and the second observation point” is being used in the denominator of the division. Claims 11-13 are also rejected because they depend from claim 10, and thus contains the above issues due to said dependence.
Claim 14 recites the limitation - wherein the measurement circuitry converts, as the polarization characteristic values, a first Jones vector based on the first measurement signal and the second measurement signal and a second Jones vector based on the third measurement signal and the fourth measurement signal into a first Stokes vector and a second Stokes vector, respectively. In claim 14, it is unclear which Jones vectors and measurement signals compose each Stokes vector. Claim 15 is also rejected because it depends from claim 14, and thus contains the above issues due to said dependence.
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 1-23 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 (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recites the limitation - an evaluation circuitry configured to calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period. Based on the broadest reasonable interpretation, calculating a temporal variation characteristic value could include an equation that 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 21 depends on claim 1, and thus contains the above issues due to said dependence.
Claim 2 recites the limitation - the evaluation circuitry calculates a variance of the signal value as the temporal variation characteristic value. Based on the broadest reasonable interpretation, calculating a variance could include an equation that 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 3 recites the limitation - the evaluation circuitry divides 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 by the number of frames in the predetermined period to calculate the variance at the observation point. This calculation includes an equation that 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 4 recites the limitations - the evaluation circuitry calculates a correlation coefficient of the signal value and a time-shifted signal value obtained by time-shifting the signal value by a time shift amount [Symbol font/0x74] for each time shift amount [Symbol font/0x74]; and calculates a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] as the temporal variation characteristic value. Based on the broadest reasonable interpretation, the calculations include an equation that 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 limitations - calculates, 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; and calculates, 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 [Symbol font/0x74] and a mean value of the time-shifted signal intensity; and calculates the correlation coefficient by dividing the covariance by the variance for each shift amount [Symbol font/0x74]; and performs regression analysis using a predetermined decay function using the correlation coefficient for each time shift amount [Symbol font/0x74] and calculates a parameter of the decay function approximating the correlation coefficient, as the decay speed at an observation point. Making these calculations include equations that could practically be done by the human mind. This draws the limitations to mathematical concepts and mental processes, which classify the limitations as abstract ideas.
Claim 6 recites the limitation - the evaluation circuitry calculates the decay speed using the correlation coefficient calculated with the time shift amount [Symbol font/0x74] being non-zero. Based on the broadest reasonable interpretation, the calculation could include an equation that 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 7 recites the limitations - the measurement circuitry determines a polarization characteristic value based on a polarization characteristic at an observation point in the sample, based on a first measurement signal of a first interferometric component in a first polarization state, the first interferometric component being obtained by causing a first incidence component incident on the sample in the first polarization state to interfere with a component obtained by reflection or scattering of the first incidence component from the sample, a second measurement signal in a second polarization state with respect to the first interferometric component, a third measurement signal of a second interferometric component in the first polarization state, the second interferometric component being obtained by causing a second incidence component incident on the sample in the second polarization state to interfere with a component obtained by reflection or scattering of the second incidence component from the sample, and a fourth measurement signal in the second polarization state with respect to the second interferometric component; and the evaluation circuitry determines the temporal variation characteristic value indicating a temporal variation characteristic of the polarization characteristic value. Based on the broadest reasonable interpretation, the determinations could include using equations that could practically be done by the human mind or making selections that could practically be done by the human mind. This draws the limitations to mathematical concepts and mental processes, which classify the limitations as abstract ideas. Claim 18 depends on claim 7, and thus contains the above issues due to said dependence.
Claim 8 recites the limitations - determines a Jones matrix at an observation point based on the first measurement signal, the second measurement signal, the third measurement signal, and the fourth measurement signal; and determines a cumulative Jones matrix at the observation point from a Jones matrix at the observation point in the sample and a Jones matrix on a surface of the sample; and determines, as the polarization characteristic value, a cumulative phase retardation index value that is a phase difference between eigenvalues of the cumulative Jones matrix. Based on the broadest reasonable interpretation, determining Jones matrixes and a cumulative phase retardation index value could include equations or formulas. This draws the limitations to mathematical concepts, which classify the limitations as abstract ideas.
Claim 9 recites the limitations - determines a Jones matrix at an observation point based on the first measurement signal, the second measurement signal, the third measurement signal, and the fourth measurement signal; and determines, from a Jones matrix at a first observation point in the sample and a Jones matrix at a second observation point in the sample, a local Jones matrix between the first observation point and the second observation point; and determines the polarization characteristic value based on a local phase retardation that is a phase difference between eigenvalues of the local Jones matrix. Based on the broadest reasonable interpretation, determining Jones matrixes and local phase retardation could include equations or formulas. This draws the limitations to mathematical concepts, which classify the limitations as abstract ideas.
Claim 10 recites the limitation - the measurement circuitry determines a birefringence by dividing the local phase retardation by a wavenumber of incident light incident on the sample and a thickness between the first observation point and the second observation point. This determination includes an equation that 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 11 recites the limitation - the evaluation circuitry calculates the temporal variation characteristic value based on a variance or a standard deviation of the polarization characteristic value. Based on the broadest reasonable interpretation, calculating a variance or standard deviation could include an equation that 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 12 recites the limitation - the evaluation circuitry calculates the temporal variation characteristic value based on a variance or a standard deviation of a logarithmic value of the polarization characteristic value. Based on the broadest reasonable interpretation, calculating a variance or standard deviation could include an equation that 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 13 recites the limitation - the evaluation circuitry calculates a dynamic contrast by dividing the standard deviation of the polarization characteristic value by a mean value of the birefringence. Based on the broadest reasonable interpretation, this calculation could include an equation that 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 14 recites the limitations - the measurement circuitry converts, as the polarization characteristic values, a first Jones vector based on the first measurement signal and the second measurement signal and a second Jones vector based on the third measurement signal and the fourth measurement signal into a first Stokes vector and a second Stokes vector, respectively, and the evaluation circuitry determines a temporal polarization uniformity based on a time average of the first Stokes vectors and a time average of the second Stokes vectors as the temporal variation characteristic value. Based on the broadest reasonable interpretation, the conversions could include equations that could practically be done by the human mind. Also, the determination could include making a selection that can practically be done by the human mind. This draws the limitation to mathematical concepts and mental processes, which classify the limitations as abstract ideas.
Claim 15 recites the limitation - the measurement circuitry determines a temporal polarization uniformity based on a time average of a corrected first Stokes vector obtained by subtracting a noise component from the first Stokes vector and a time average of a corrected second Stokes vector obtained by subtracting a noise component from the second Stokes vector. Based on the broadest reasonable interpretation, the determination could include equations that could practically be done by the human mind. This draws the limitations to a mathematical concept and a mental process, which classifies the limitations as abstract ideas.
Claim 16 recites the limitations - the measurement circuitry determines, as the polarization characteristic value, a Jones matrix at an observation point based on the first measurement signal, the second measurement signal, the third measurement signal, and the fourth measurement signal, and the evaluation unit calculates a von Neumann entropy of the Jones matrix as the temporal variation characteristic value. Based on the broadest reasonable interpretation, determining a Jones matrix and calculating a von Neumann entropy could include equations or formulas. This draws the limitations to mathematical concepts, which classifies the limitations as abstract ideas.
Claim 17 recites the limitations - the evaluation circuitry calculates an entropy of a noise component from a temporal polarization uniformity of a first Stokes vector and a temporal polarization uniformity of a second Stokes vector, the first Stokes vector and the second Stokes vector being obtained by conversion from a first Jones vector based on the first measurement signal and the second measurement signal and a second Jones vector based on the third measurement signal and the fourth measurement signal, respectively, and corrects the von Neumann entropy based on the entropy of the noise component. Based on the broadest reasonable interpretation, determining and correcting the entropy could include equations or formulas. Additionally, the correction of entropy could practically be done by the human mind. This draws the limitations to mathematical concepts and mental process, which classifies the limitations as abstract ideas.
Claim 19 recites the limitation - the evaluation circuitry calculates the temporal variation characteristic value on a per observation period interval basis, the observation period interval being longer than the predetermined period. Based on the broadest reasonable interpretation, the calculation could include an equation that 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 - an output processing circuitry configured to determine an evaluation value indicating an active state of the sample based on the temporal variation characteristic value. Based on the broadest reasonable interpretation, determining an evaluation value could include an equation or making a selection that 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 - an evaluation method for an evaluation device comprising calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period. Based on the broadest reasonable interpretation, calculating a temporal variation characteristic value could include an equation that 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 - a non-transitory computer readable medium storing instructions executable by a processor, wherein execution of the instructions causes the processor to perform an evaluation procedure of calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period. Based on the broadest reasonable interpretation, calculating a temporal variation characteristic value could include an equation that 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 18 is dependent on claim 7 and claim 21 is dependent on claim 1.
These limitations recite concepts of analyzing, organizing and identifying 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. These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. As such claims 1-23 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 recites an evaluation device comprising 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 18 recites the evaluation device wherein the first polarization state is horizontal polarization, and the second polarization state is vertical polarization, the first measurement signal is a first horizontally polarized spectral interferometric signal, the second measurement signal is a second horizontally polarized spectral interferometric signal, the third measurement signal is a first vertically polarized spectral interferometric signal, and the fourth measurement signal is a second vertically polarized spectral interferometric signal.
Clam 21 recites an image processing circuitry configured to generate image data having, as a signal value, an output value for the temporal variation characteristic value at the observation point using a function to provide the output value monotonically changing with respect to a change in an input value.
Claim 22 recites an evaluation method for an evaluation device comprising acquiring 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 recites 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 of acquiring 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.
There are no limitations that indicate that the claimed calculations and determinations require anything other than generic computing systems. 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 in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. 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 1-23 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. The instant claims recite the following additional elements:
Claim 1 recites an evaluation device comprising 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 18 recites the evaluation device wherein the first polarization state is horizontal polarization, and the second polarization state is vertical polarization, the first measurement signal is a first horizontally polarized spectral interferometric signal, the second measurement signal is a second horizontally polarized spectral interferometric signal, the third measurement signal is a first vertically polarized spectral interferometric signal, and the fourth measurement signal is a second vertically polarized spectral interferometric signal.
Claim 21 recites an image processing circuitry configured to generate image data having, as a signal value, an output value for the temporal variation characteristic value at the observation point using a function to provide the output value monotonically changing with respect to a change in an input value.
Claim 22 recites an evaluation method for an evaluation device comprising acquiring 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 recites 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 of acquiring 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.
As discussed above, there are no additional limitations to indicate that the claimed calculation and determinations 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. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. 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: 209-299) teaches that the acquisition of OTC signals is a conventional tool within the field of medicine (Page 8, Column 1, Paragraph 2: OCT is now regularly used in diagnosis of a variety of diseases).
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 1-23 are not patent eligible.
Claim Rejections - 35 USC § 102
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 1-2 and 19-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makihira (U.S. 2019/0130170 A1, IDS document 05/11/2022). Bold text corresponds to the instant claims.
Claim 1 is directed to an evaluation device comprising:
i. 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; and
ii. an evaluation circuitry configured to calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
Claim 2, which is dependent on claim 1, contains an additional limitation – wherein the evaluation circuitry calculates a variance of the signal value as the temporal variation characteristic value.
Claim 19, which is dependent on claim 1, contains an additional limitation – the evaluation circuitry calculates the temporal variation characteristic value on a per observation period interval basis, the observation period interval being longer than the predetermined period.
Claim 20, which is dependent on claim 1, contains an additional limitation – 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, which is dependent on claim 1, contains an additional limitation – an image processing circuitry configured to generate image data having, as a signal value, an output value for the temporal variation characteristic value at the observation point using a function to provide the output value monotonically changing with respect to a change in an input value.
Claim 22, which is independent, is directed to an evaluation method for an evaluation device comprising:
i. acquiring 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
ii. calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
Claim 23, which is independent, is directed to a non-transitory computer readable medium storing instructions executable by a processor, wherein execution of the instructions causes the processor to perform:
i. a measurement procedure of acquiring 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
ii. an evaluation procedure of calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
Makihira teaches an apparatus configured to generate motion contrast information about substantially a same region (observation point) of an eye (biological tissue) to be examined by using a plurality of pieces of tomographic information (OCT signals) obtained by imaging substantially the same region at a predetermined time interval (Page 1, Paragraph 0003) (Claim 1.i), and an 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 (temporal variation characteristic value) (Page 1, Paragraph 0003) (Claim 1.ii). The motion contract value is taken to be equivalent to the temporal variation characteristic value as both indicate the quantitative change in OCT value between observations over time. Makihira also teaches calculating the variance values for each pixel generated from the OTC signal and uses the variance values as the motion contrast values (temporal variation characteristic value) (Page 4, Paragraph 0034) (Claim 2). Makihira also teaches calculating the temporal variation characteristic value based on a period longer than the predetermined period. For example, Makihira discusses that despite setting a predetermined time interval, scans repeated at the same position increase the detection accuracy which can lead to a prolonged scan time (exceeding a predetermined period) (Page 2, Paragraph 0027) (Claim 19). Makihira also teaches a technique for distinguishing between flowing tissue (active state of the tissue) and flowless tissue (Page 4, Paragraph 0031) (Claim 20). Makihira also teaches generating a display of motion contrast value change (Page 1, Paragraph 0013, also see Figure 9) (Claim 21). Makihira also teaches a method of generating motion contrast information (temporal variation characteristic value) about an eye (biological tissues) to be examined by using a plurality of pieces of tomographic information (OTC signals) at a predetermined time interval; and obtaining information about a change in a motion contrast value by using a plurality of pieces of the motion contrast information at different times (Page 9-10, Claim 18) (Claim 22). Makihira also teaches a non-transitory computer-readable storage medium storing a program for causing a computer to execute an image processing method, the image processing method comprising the same limitations as reference claim 18 shown above (Page 10, Claim 19) (Claim 23). Therefore, claims 1-2 and 19-23 are rejected under 35 U.S.C. 102(a)(1).
Claim Rejections - 35 USC § 103
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 1-3 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Makihira (U.S. 2019/0130170 A1, IDS document 05/11/2022), as applied to claims 1-2 and 19-23 above in the 35 USC 102 Rejection, in view of Singla et al. (2018, Laser Physics Letters, 15: 1-5). Bold text corresponds to the instant claims.
Claim 1 is directed to an evaluation device comprising:
i. 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; and
ii. an evaluation circuitry configured to calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
Claim 2, which is dependent on claim 1, contains an additional limitation – wherein the evaluation circuitry calculates a variance of the signal value as the temporal variation characteristic value.
Claim 3, which is dependent on claim 2, contains an additional limitation – the evaluation circuitry divides 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 by the number of frames in the predetermined period to calculate the variance at the observation point.
Claim 19, which is dependent on claim 1, contains an additional limitation – the evaluation circuitry calculates the temporal variation characteristic value on a per observation period interval basis, the observation period interval being longer than the predetermined period.
Claim 20, which is dependent on claim 1, contains an additional limitation – 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, which is dependent on claim 1, contains an additional limitation – an image processing circuitry configured to generate image data having, as a signal value, an output value for the temporal variation characteristic value at the observation point using a function to provide the output value monotonically changing with respect to a change in an input value.
Claim 22, which is independent, is directed to an evaluation method for an evaluation device comprising:
i. acquiring 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
ii. calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
Claim 23, which is independent, is directed to a non-transitory computer readable medium storing instructions executable by a processor, wherein execution of the instructions causes the processor to perform:
i. a measurement procedure of acquiring 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
ii. an evaluation procedure of calculating a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
Makihira teaches an apparatus configured to generate motion contrast information about substantially a same region (observation point) of an eye (biological tissue) to be examined by using a plurality of pieces of tomographic information (OCT signals) obtained by imaging substantially the same region at a predetermined time interval (Page 1, Paragraph 0003) (Claim 1.i), and an 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 (temporal variation characteristic value) (Page 1, Paragraph 0003) (Claim 1.ii). The motion contract value is taken to be equivalent to the temporal variation characteristic value as both indicate the quantitative change in OCT value between observations over time. Makihira also teaches calculating the variance values for each pixel generated from the OTC signal and uses the variance values as the motion contrast values (temporal variation characteristic value) (Page 4, Paragraph 0034) (Claim 2). Makihira also teaches calculating the temporal variation characteristic value based on a period longer than the predetermined period. For example, Makihira discusses that despite setting a predetermined time interval, scans repeated at the same position increase the detection accuracy which can lead to a prolonged scan time (exceeding a predetermined period) (Page 2, Paragraph 0027) (Claim 19). Makihira also teaches a technique for distinguishing between flowing tissue (active state of the tissue) and flowless tissue (Page 4, Paragraph 0031) (Claim 20). Makihira also teaches generating a display of motion contrast value change (Page 1, Paragraph 0013, also see Figure 9) (Claim 21). Makihira also teaches a method of generating motion contrast information (temporal variation characteristic value) about an eye (biological tissues) to be examined by using a plurality of pieces of tomographic information (OTC signals) at a predetermined time interval; and obtaining information about a change in a motion contrast value by using a plurality of pieces of the motion contrast information at different times (Page 9-10, Claim 18) (Claim 22). Makihira also teaches a non-transitory computer-readable storage medium storing a program for causing a computer to execute an image processing method, the image processing method comprising the same limitations as reference claim 18 shown above (Page 10, Claim 19) (Claim 23).
Makihira does not teach the specific equation or variables used to calculate the variance (Claim 3).
Singla et al. teaches the formula used to calculate the variance (equation 3), which includes the sum of squares of the signal intensities over a number related to the number frames (Page 3, Column 2, Paragraph 1) (Claim 3).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. In the instant case, both references utilize the same technology (OCT) to assess biological tissue. Makihira is investigating blood vessels and blood flow in human tissues. Singla et al. is primarily concerned with assessing burn damage to skin. Both seek to implement the technology to assess human tissues. Both references also seek to quantify the variability of OTC signals. Singla et al. teaches a specific formula for variance which is obvious to apply because the variables of the equation are used in similar ways when considering similar types of samples. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Singla et al. could be readily added to the method of Makihira with a reasonable expectation of success because they utilize the same imaging technology and input variables to consider similar sample types. Accordingly, claims 1-3 and 19-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1-3 and 19-23 above, and view of Nadkarni (U.S. 2014/0378845 A1). Bold text corresponds to the instant claims.
Claim 4, which is dependent on claim 1, contains additional limitations:
i. the evaluation circuitry calculates a correlation coefficient of the signal value and a time-shifted signal value obtained by time-shifting the signal value by a time shift amount [Symbol font/0x74] for each time shift amount [Symbol font/0x74], and
ii. calculates a decay speed of the correlation coefficient according to an increase in the time shift amount [Symbol font/0x74] as the temporal variation characteristic value.
Claim 6, which is dependent on claim 4, contains an additional limitation - the evaluation circuitry calculates the decay speed using the correlation coefficient calculated with the time shift amount [Symbol font/0x74] being non-zero.
Makihira teaches claim 1 as applied above to claims 1-3 and 19-23. Makihira also teaches utilizing OTC signals separated by a non-zero amount of time (time shift amount [Symbol font/0x74]) (Claim 6). Some examples of time intervals discussed by Makihira include approximately 2.5 msec or the range of approximately 1 to 4 msec (Page 2, Paragraph 0027). These values are encompassed by the range (non-zero) described in instant claim 6 (see MPEP 2144.05).
However, Makihira does not teach calculating a correlation coefficient (Claim 4.i) or decay speed of the correlation coefficient (Claim 4.ii).
Nadkarni teaches calculating a correlation coefficient based on the intensity patterns (signal values) of different OTC signals (Page 16, Paragraph 0210) (Claim 4.i). Nadkarni also teaches calculating the decay rate of the correlation coefficients (functions) based on the parameter [Symbol font/0x74] (Page 18, Paragraph 0218) (Claim 4.ii).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. 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. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Nadkarni could be readily added to the methods of Makihira with a reasonable expectation of success because they utilize the same OCT technology to consider similar sample types. Accordingly, claims 1-2, 4, 6, and 19-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1-3, 4, 6, and 19-23 above, in view of Nadkarni, as applied to claims 4 and 6 above, and in further view of Grzywacz et al. (2010, IEEE Transactions on Medical Imaging, Vol. 29, No. 6: 1224-1237). Bold text corresponds to the instant claims.
Claim 5, which is dependent on claim 4, contains additional limitations:
i. calculates, 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,
ii. calculates, 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 [Symbol font/0x74] and a mean value of the time-shifted signal intensity,
iii. calculates the correlation coefficient by dividing the covariance by the variance for each shift amount [Symbol font/0x74], and
iv. performs regression analysis using a predetermined decay function using the correlation coefficient for each time shift amount [Symbol font/0x74] and calculates a parameter of the decay function approximating the correlation coefficient, as the decay speed at an observation point.
Makihira teaches claim 1 as applied above to claims 1-3, 4, 6, and 19-23. Nadkarni teaches claim 4 as applied above to claims 4 and 6.
Makihira and Nadkarni do not teach specific ways of calculating a variance of OCT time shifted signals (Claim 5.i), a covariance of OCT time shifted signals (Claim 5.ii), a correlation coefficient calculated by dividing the covariance by the variance (Claim 5.iii), or performs regression with the correlation coefficient (Claim 5.iv).
Grzywacz teaches a method calculating variance using modeled OTC signals (intensities) (Page 1226, Column 1, Equation 7) (Claim 5.i). Grzywacz also teaches a method of calculating a covariance using modeled OTC signals (Page 1228, Column 1, Equation 27) (Claim 5.ii). Grzywacz also teaches calculating the correlation coefficient by dividing the covariance by the variance (Page 1228, Equation 28) (Claim 5.iii). Grzywacz also teaches performing regressions (fitting) to demonstrate the decay function (Page 1230, Figure 3) (Claim 5.iv).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. 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 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. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Grzywacz could be readily added to the methods of Makihira and Nadkarni with a reasonable expectation of success because they utilize the same imaging technology to consider similar sample types. Accordingly, claims 1-2, 4-6, and 19-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Claims 7-10 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1-6, and 19-23 above, in view of Yamanari (U.S. 2018/0035894 A1). Bold text corresponds to the instant claims.
Claim 7, which is dependent on claim 1, contains additional limitations:
i. the measurement circuitry determines a polarization characteristic value based on a polarization characteristic at an observation point in the sample, based on a first measurement signal of a first interferometric component in a first polarization state, the first interferometric component being obtained by causing a first incidence component incident on the sample in the first polarization state to interfere with a component obtained by reflection or scattering of the first incidence component from the sample, a second measurement signal in a second polarization state with respect to the first interferometric component, a third measurement signal of a second interferometric component in the first polarization state, the second interferometric component being obtained by causing a second incidence component incident on the sample in the second polarization state to interfere with a component obtained by reflection or scattering of the second incidence component from the sample, and a fourth measurement signal in the second polarization state with respect to the second interferometric component, and
ii. the evaluation circuitry determines the temporal variation characteristic value
indicating a temporal variation characteristic of the polarization characteristic value.
Claim 8, which is dependent on claim 7, contains additional limitations:
i. determines a Jones matrix at an observation point based on the first measurement signal, the second measurement signal, the third measurement signal, and the fourth measurement signal, and
ii. determines a cumulative Jones matrix at the observation point from a Jones matrix at the observation point in the sample and a Jones matrix on a surface of the sample, and
iii. determines, as the polarization characteristic value, a cumulative phase retardation index value that is a phase difference between eigenvalues of the cumulative Jones matrix.
Claim 9, which is dependent on claim 7, contains additional limitations:
i. determines a Jones matrix at an observation point based on the first measurement signal, the second measurement signal, the third measurement signal, and the fourth measurement signal, and
ii. determines, from a Jones matrix at a first observation point in the sample and a Jones matrix at a second observation point in the sample, a local Jones matrix between the first observation point and the second observation point, and
iii. determines the polarization characteristic value based on a local phase retardation that is a phase difference between eigenvalues of the local Jones matrix.
Claim 10, which is dependent on claim 9, contains an additional limitation - wherein the measurement circuitry determines a birefringence by dividing the local phase retardation by a wavenumber of incident light incident on the sample and a thickness between the first observation point and the second observation point.
Claim 14, which is dependent on claim 7, contains additional limitations:
i. the measurement circuitry converts, as the polarization characteristic values, a first Jones vector based on the first measurement signal and the second measurement signal and a second Jones vector based on the third measurement signal and the fourth measurement signal into a first Stokes vector and a second Stokes vector, respectively, and
ii. the evaluation circuitry determines a temporal polarization uniformity based on a time average of the first Stokes vectors and a time average of the second Stokes vectors as the temporal variation characteristic value.
Claim 15, which is dependent on claim 14, contains an additional limitation - the measurement circuitry determines a temporal polarization uniformity based on a time average of a corrected first Stokes vector obtained by subtracting a noise component from the first Stokes vector and a time average of a corrected second Stokes vector obtained by subtracting a noise component from the second Stokes vector.
Claim 16, which is dependent on claim 7, contains additional limitations:
i. the measurement circuitry determines, as the polarization characteristic value, a Jones matrix at an observation point based on the first measurement signal, the second measurement signal, the third measurement signal, and the fourth measurement signal, and
ii. the evaluation unit calculates a von Neumann entropy of the Jones matrix as the temporal variation characteristic value.
Claim 17, which is dependent on claim 16, contains additional limitations:
i. the evaluation circuitry calculates an entropy of a noise component from a temporal polarization uniformity of a first Stokes vector and a temporal polarization uniformity of a second Stokes vector, the first Stokes vector and the second Stokes vector being obtained by conversion from a first Jones vector based on the first measurement signal and the second measurement signal and a second Jones vector based on the third measurement signal and the fourth measurement signal, respectively, and
ii. corrects the von Neumann entropy based on the entropy of the noise component.
Makihira teaches claim 1 as applied above to claims 1-6 and 19-23.
However, Makihira does not teach calculating a polarization characteristic value based on 4 signals at two different polarization states (Claim 7.i) or determining a temporal variation characteristic value based on the polarization characteristic value (Claim 7.ii). Makihira also does not teach determining a Jones matrix (Claim 8.i), a cumulative Jones matrix (Claim 8.ii), or a polarization characteristic value based on eigenvalues of the cumulative Jones matrix (Claim 8.iii). Makihira also does not teach determining a Jones matrix (Claim 9.i), a local Jones matrix (Claim 9.ii), or a polarization characteristic value based on eigenvalues of the local Jones matrix (Claim 9.iii). Makihira also does not teach determining a birefringence (Claim 10). Makihira also does not teach converting Jones vectors into Stokes vectors (Claim 14.i) and determining a temporal polarization uniformity based on the Stokes vectors (Claim 14.ii). Makihira also does not teach determining a temporal polarization uniformity based on noise corrected Stokes vectors (Claim 15). Makihira also does not teach determining a jones matrix based on 4 signals (Claim 16.i) or a von Neumann entropy of the Jones matrix (Claim 16.ii). Makihira also does not teach calculating an entropy of noise component (Claim 17.i) or a corrected von Neumann entropy based on the entropy of noise component (Claim 17.ii).
Yamanari teaches calculating a polarization characteristic value (polarization property) based on four spectral signals at two different polarization states (Page 1, Paragraph 0006) (Claim 7.i). Yamanari also teaches taking multiple signals (scans) over time to assess a temporal variation characteristic value (applied temporally) (Page 8, Paragraph 0084) (Claim 7.ii). Yamanari also teaches determining a Jones matrix (Page 4, Paragraph 0054) (Claim 8.i), a cumulative Jones matrix (Page 4, Paragraph 0055) (Claim 8.ii), and the utilization of eigenvalues related to the cumulative Jones matrix (Page 4, Paragraph 0053) (Claim 8.iii). Yamanari also teaches determining a Jones matrix (Page 4, Paragraph 0054) (Claim 9.i), a local Jones matrix (Page 4, Paragraph 0055) (Claim 9.ii), and a polarization characteristic value (polarization property) based on eigenvalues of the local Jones matrix (Page 4, Paragraph 0055) (Claim 9.iii). Yamanari also teaches determining a birefringence related to the local characteristics (including depth) (Page 6, Paragraph 0072) (Claim 10). Yamanari also teaches converting multiple Jones vectors into Stokes vectors (Page 4, Paragraph 0051) (Claim 14.i) and determining a temporal polarization uniformity based on Stokes vectors (Page 1, Paragraph 0008) (Claim 14.ii). Yamanari also teaches determining a temporal polarization uniformity based on noise (bias) corrected Stokes vectors (Page 1, Paragraph 0011) (Claim 15). Yamanari also teaches determining a Jones matrix (Page 2 Paragraph 0017) (Claim 16.i) and a von Neumann entropy of the Jones matrix (Page 2 Paragraph 0017) (Claim 16.ii). Yamanari also teaches calculating an entropy of noise component (Page 10, Reference Claims 3 and 4) (Claim 17.i) and a corrected von Neumann entropy based on the entropy of noise component (Page 10, Reference Claim 2) (Claim 17.ii).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Both references use the same technology (OCT) to assess tissues. Makihira utilizes OTC to investigate blood vessels and blood flow in human tissues. Yamanari is primarily concerned with utilizing the technology for assessing general biological tissues including from the retina. They both attempt to utilize the information generated from OCT scans to assess the state of a tissues. Yamanari teaches specific methods to evaluate changes in tissues over time, while quantifying and correcting for signal noise, which is obvious to apply because it is a way of getting higher quality information out of the OTC technology for considering similar types of samples. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Yamanari could be readily added to the method of Makihira with a reasonable expectation of success because they utilize the same OCT technology to consider similar sample types. Accordingly, claims 1-2, 7-10, 14-17, and 19-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1-6, 7-10, 14-17, and 19-23 above, in view of Yamanari, as applied to claims 7-10 and 14-17 above, and in further view of Motaghiannezam and Fraser (2012, Biomedical Optics Express, Vol. 3, No. 3: 503-521).
Claim 11, which is dependent on claim 10, contains an additional limitation - the evaluation circuitry calculates the temporal variation characteristic value based on a variance or a standard deviation of the polarization characteristic value.
Claim 12, which is dependent on claim 11, contains an additional limitation - the evaluation circuitry calculates the temporal variation characteristic value based on a variance or a standard deviation of a logarithmic value of the polarization characteristic value.
Makihira teaches claim 1 as applied above to claims 1-6, 7-10, 14-17, and 19-23. Yamanari teaches claims 7, 9, and 10 as applied above to claims 7-10 and 14-17.
Makihira and Yamanari do not teach calculating the temporal variation characteristic value based on a variance or a standard deviation of the polarization characteristic value (Claim 11). Makihira and Yamanari also do not teach calculating the temporal variation characteristic value based on a variance or a standard deviation of a logarithmic value of the polarization characteristic value (Claim 12).
Motaghiannezam and Fraser teaches using the standard deviation of the polarization characteristic (intensity and amplitude) (Claim 11) and logarithmic transformation of the polarization characteristic (Claim 12) to calculate a temporal variation characteristic value (speckle amplitude contrast (SACR)) (Page 514, Section 4.2, Paragraph 1).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. All three references use the same technology (OCT) to assess biological tissues. Makihira investigates blood vessels and blood flow in human tissues. Yamanari is primarily concerned with utilizing the technology for assessing general biological tissues, including the retina. Motaghiannezam and Fraser utilize the technology to assess tissues of the eye. They also all use the information generated from OCT to assess the state of a biological samples. Motaghiannezam and Fraser teach specific methods and calculations to evaluate changes in tissues over time which are obvious to apply because the methods allow the extractions of greater information when utilizing OTC for considering similar types of samples. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Motaghiannezam and Fraser by could be readily added to the methods Yamanari and Makihira with a reasonable expectation of success because they utilize the same OCT imaging technology to consider similar sample types. Accordingly, claims 1-2, 7-12, 14-17, and 19-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1-12, 14-17, and 19-23 above, in view of Yamanari, as applied to claims 7-12 and 14-17 above, and Motaghiannezam and Fraser, as applied to claims 11-12 above and in further view of Singla et al., as applied to claims 1-3 and 19-23 above.
Claim 13, which is dependent on claims 1, 7, 9, 10, and 11, contains an additional limitation - the evaluation circuitry calculates a dynamic contrast by dividing the standard deviation of the polarization characteristic value by a mean value of the birefringence.
Makihira teaches claim 1 as applied above to claims 1-6, 7-12, 14-17, and 19-23. Yamanari teaches claims 7, 9, and 10 as applied to claims 7-12 and 14-17. Motaghiannezam and Fraser teach claim 11 applied to claims 11-12.
However, Makihira, Yamanari, and Motaghiannezam and Fraser do not teach calculating a dynamic contrast based on dividing a standard deviation by a mean birefringence (Claim 13).
Singla et al. teaches calculating a dynamic contrast (speckle contrast) by dividing the standard deviation of the polarization characteristic value (pixel value of the OCT signal) by a mean value of the of the OCT signal (Page 3, Equation 3), which was shown to be indicative of birefringence of the sample (Page 4, Column 2, Paragraph 2) (Claim 13).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. All references use the same technology (OCT) to assess biological tissue. Makihira utilized OTC to investigate blood vessels and blood flow in human tissues. Yamanari utilizes the technology for assessing the general biological tissues, including the retina. Motaghiannezam and Fraser utilize the technology to assess tissues of the eye. Singla et al. uses OCT to evaluate human skin. All the references use information generated from OCT to assess the state of a biological samples. Singla et al. teach quantitative methods to evaluate changes in tissues over time which are obvious to apply because it aids in the extraction of information from the OTC when considering similar types of samples. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Singla et al. could be readily added to the methods Motaghiannezam and Fraser, Yamanari, and Makihira with a reasonable expectation of success because they utilize the same imaging technology to consider similar sample types. Accordingly, claims 1-3, 7-17 and 19-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Makihira, as applied to claims 1-17 and 19-23 above, in view of Yamanari, as applied to claims 7-17 above, and in further view of Kim et al. (U.S. 2019/0078872).
Claim 18, which is dependent on claim 7, contains additional limitations:
i. the first polarization state is horizontal polarization, and
ii. the second polarization state is vertical polarization,
iii. the first measurement signal is a first horizontally polarized spectral interferometric signal, the second measurement signal is a second horizontally polarized spectral interferometric signal, the third measurement signal is a first vertically polarized spectral interferometric signal, and the fourth measurement signal is a second vertically polarized spectral interferometric signal.
Makihira teaches claim 1 as applied to claims 1-17 and 19-23. Yamanari teaches claim 7 as applied to claims 7-17.
Makihira and Yamanari do not teach the first polarization state being horizontal (Claim 18.i), the second polarization state being vertical (Claim 18.ii), or four separate interferometric signals (Claim 18.iii).
Kim et al. teaches the first polarization state being horizontal (first horizontally polarized beam) (Page 2, Paragraph 0017) (Claim 18.i), the second polarization state being vertical (first vertically polarized beam) (Page 2, Paragraph 0017) (Claim 18.ii), and the utilization of four separate interferometric signals (reference and sample arm beams x 2 polarization states = 4 signals) (Page 2, Paragraph 0017) (Claim 18.iii).
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. All three references use the same technology (OCT) to assess tissues. Makihira investigates blood vessels and blood flow in human tissues. Yamanari and Kim et al. are primarily concerned with utilizing the technology for assessing general biological tissues, including the retina. All three references attempt to use information generated from OCT to assess the state of a biological samples. Kim et al. teaches the use of multiple polarized beams to assess tissues over time, which are obvious to apply because this method can extract more information from OTC when considering similar types of samples. Therefore, it would have been obvious to someone of ordinary skill in the art the time of the effective filling date to combine the methods from both of the references indicated above.
Furthermore, one of ordinary skill in the art would predict that the method taught by Kim et al. by could be readily added to the methods Yamanari and Makihira with a reasonable expectation of success because they utilize the same imaging technology to consider similar sample types. Accordingly, claims 1-2, 7-10, 14-23 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8879070 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 is directed to an evaluation device comprising:
i. 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; and
ii. an evaluation circuitry configured to calculate a temporal variation characteristic value indicating a temporal variation characteristic of the signal value within a predetermined period.
The reference patent (Patent No. 8879070) contains the following claim that anticipate the instant application claim:
Reference claim 1 is directed to a two-beam optical coherence tomography apparatus comprising a spectrometer comprising: a diffraction grating which converts the interference signal light into spectral interference signal light by means of spectroscopy; a polarized beam splitter which separates the spectral interference signal light into a vertically polarized component and a horizontally polarized component; and two optical detectors which simultaneously detect the vertically polarized component and the horizontally polarized component of the spectral interference signal light to obtain two tomography images (optical coherence tomography signals) of the same location (an observation point) at different times by one mechanical scan as mentioned above (Instant Claim 1.i), and the obtained two tomography images are used to measure the amount of temporal change (temporal variation characteristic value) in phase at the same location (Instant Claim 1.ii). All limitations of instant claim 1 are therefore anticipated by reference claim 1.
Conclusion
No claims are allowed.
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/B.H.E./ Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687