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 .
Response to Amendment
The amendment filed on 01/23/2026 has been entered. Claims 1-10, 13 and 16-18 have been amended. Claims 1-11 and 13-18 remain pending.
The previously raised objection for Claim 16 is withdrawn because the issue has been properly corrected.
The previously raised rejections under 35 U.S.C. 112(b) for Claims 6-9 and 13 are withdrawn because the issues have been properly corrected.
Response to Arguments
Rejections under 35 USC § 101
On Pages 15 and 16 of Remarks, Applicant argues that amended Claims 1, 10 and 18 include a list of steps or elements (Page 15, last paragraph) that “cannot be performed mentally and are not merely mathematical abstractions” and “require real-world interaction with biological tissue, mid-infrared radiation, and imaging hardware …”, and therefore the claims are not directed to an abstract idea. Examiner respectfully disagrees. Among the listed steps of elements, irradiating tissue with light and acquiring an image are recited at a high level of generality, and can also be regarded as extra-solution activities; determining absorption or reflection at different portions can be performed in mind, e.g. a radiologist viewing an image and estimating for different portions in the image; determining a difference between different portions is a mathematical calculation; calculating focusing measures by edge analysis and according to the difference is also mathematical calculation; finally, identifying tissue based on the measures can be performed in mind, e.g. mentally evaluating the magnitude of the measures and estimate what type the tissue is classified to.
On Pages 16 and 17 of Remarks, Applicant argues that the amended Claims 1, 10 and 18 “departs from … conventional approach by” using “a single specific mid-infrared wavelength” and using such “single measurement image as diagnostic signal”, and therefore “improves efficiency” and “reduces system complexity”, which represents concrete or significant technological improvement. Examiner respectfully disagrees. To one of ordinary skill in the art, while hyperspectral imaging is popular, imaging using light of single wavelength or a narrow band is widely used as well. Nowadays, computation power has been dramatically improved to such a level that processing high-dimensional image data such as hyperspectral images is not time consuming anymore. Therefore, to simply acquire less data to save time or reduce complexity, particularly for clinically significant needs such as cancer diagnosis, seem not enough to be regarded as significant technological improvement.
On Page 17 of Remarks, Applicant argues that by requiring a list of limitations, including using a mid-infrared wavelength range, determining absorption or reflection differences between tissue portions, measures that vary according to absorption or reflection differences, and identification of tissue based on such measures, the amended Claims 1, 10 and 18 recite significantly more than an abstract idea. Examiner respectfully disagrees. The above listed limitations either have issues with 35 USC § 112(a) or 112(b), and/or are recited at a high level of generality. For example, for the limitation of “A specific physical wavelength in the mid-infrared range”, what is the “specific” wavelength? How such wavelength is to be determined? Neither the claims nor Specification specifies such details.
Rejections under 35 USC § 103
On Pages 11 and 12 of Remarks, Applicant argues that, in amended Claim 1, the measurement light has a specific wavelength (Page 11, Para 3), which when compared to conventional techniques reduces measurement time (Page 12, Para 2), and a mid-infrared absorption or mid-infrared reflection is determined for two portions of tissue and further a difference is determined between the absorption or reflection of the two portions (Page 11, Para 4). On Page 12 of Remarks, Applicant further argues that, in contrast, Kroeger does not teach “acquiring only a single wavelength image for tissue identification” (Page 12, Para 3), and Kroeger’s disclosure at column 11 is merely disclosing “acquiring multiple images at one wavelength only as a way to reduce the phase shift”, but not “acquiring images at the single wavelength to perform diagnostics for tissue identification”. Examiner respectfully disagrees. First, as an issue of 35 USC 112(a), the newly added limitations of “determining a mid-infrared absorption or mid-infrared reflection …” and “determining a difference …” as mentioned above in Page 11 of Remarks are not supported by Specification. With regard to the issue of “a single wavelength image”, amended Claim 1 recites “the method comprising: irradiating … with a mid-infrared measurement light having a specific wavelength …; acquiring a measurement image …” (Lines 1-9). For comparison, Kroeger uses the same light source as Application, i.e. quantum cascade laser (QCL), and a similar range of wavelength as Application. For spectroscopic analysis, one preferred embodiment of Kroeger does acquire multiple images using light of different wavelength, which is NOT contradicted with the Application’s claim of a method “comprising: irradiating … with a mid-infrared measurement light having a specific wavelength …; acquiring a measurement image …”. In addition, Kroeger emphasized multiple times that image of single wavelength contains much useful information and is worthy to be analyzed, by disclosing “Measurements can also be carried out with tunable lasers at individual selected wavelengths, wherein the number of images to be recorded is greatly reduced in relation to a wider spectrum and the analysis is accordingly accelerated.” (Column 8, Lines 9-13), “The analysis of a single wavelength was already sufficient to obtain a first impression of the quality of the imaging obtained.” (Column 22, Lines 31-33), and “Despite the astonishingly extensive information which could already be obtained from the recordings of a single wavelength, complete spectrums according to step 2 of the data analysis (k-means) were used for the additional examinations.” (Column 22, Lines 38-42). Furthermore, Kroeger also emphasized multiple times that reducing number of acquired images would reduce measurement time, such as “Depending on the bandwidth, one or two QCLs can be used therefor, whereby a relatively rapid measurement can be carried out.” (Column 7, Lines 7-9), “… wherein the number of images to be recorded is greatly reduced in relation to a wider spectrum and the analysis is accordingly accelerated” (Column 8, Lines 11-13) and “it is possible to record images of a few individual wavelengths, whereby the recording time is significantly reduced” (Column 16, Lines 19-21). With these disclosures of Kroeger, one of ordinary skill in the art would be motived to analyze an individual single-wavelength image for potential physiologic or diagnostic information.
On Pages 12-14 of Remarks, Applicant argues that the claimed “focusing measures” are “calculated from an edge analysis”, “characterize optical focus quality and image clarity, not geometric convergence of gradient vectors” (Page 13, Para 2 and 3), and in contrast Takeo discloses “a degree of convergence of gradient vectors using an iris filter”, used to detect tumor patterns (Page 13, Para 4-6), so “addresses a different problem” (Page 14, Para 2). Examiner respectfully disagrees. The claimed method of calculating focusing measures is recited as “an edge analysis of the measured image”, which according to Specification is based on “differentiation filter” (Para 0052, 0054, 0064, 0065 and 0066), and to one of ordinary skill in the field of medical image processing, such “edge analysis” is also widely used in image segmentation with edge detection, which essentially identifies pixels with high gradient magnitude or “edge” in an image. For comparison, Takeo discloses an “index value” for detecting a malignant tumor, and one approach for computing such index value is via Iris filtering processing (Para 0066-0078), “The iris filter calculates the gradients of image signal values … as gradient vectors and feeds out the information representing the degree of convergence of the gradient vectors. With the iris filtering processing a tumor pattern is detected in accordance with the degree of convergence of the gradient vectors” (Para 0069). Specifically, the disclosed processing of Takeo includes calculating gradient vector for each pixel (determines whether gradient exists around the pixel and the orientation of such gradient), and calculating the degree of convergence of gradient vectors for each pixel (Para 0077). Para 0078 discusses how the processing would discriminate patterns with linear vs tumor (or round) contour of edges. Further, Takeo concludes that “the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns” (Para 0078). Based on these disclosures of Takeo, it can be concluded that Takeo’s disclosed method can be interpreted as calculating a measure by an edge analysis of an image. Furthermore, both Application and Takeo aim to address a same problem, which is to identify cancer tissue in a medical image.
On Page 14 (Para 3) of Remarks, Applicant argues that (a) Takeo does not teach to apply its metric to mid-infrared hyperspectral microscopy images, (b) does not teach the claimed limitations of “determining a mid-infrared absorption or mid-infrared reflection”, “determining a difference” and “calculating focusing measures”, and (c) “applying Takeo’s analysis to Kroeger’s hyperspectral data would increase analytical complexity”. Examiner respectfully disagrees. With regard to the argument (a) above, Takeo discloses a method for identifying abnormal or malignant tumor in a medical image, so to one of ordinary skill in the art, the method can be readily applied to analyze individual single-wavelength images of Kroeger, which is one type of medical image. With regard to the argument (b) above, as discussed above, Takeo’s method can be interpreted to be a method of calculating a measure by an edge analysis of an image. The limitations of “determining a mid-infrared absorption or mid-infrared reflection” and “determining a difference” are not supported by Specification. With regard to the argument (c) above, Kroeger discloses much diagnostic information being contained in single-wavelength images, as “The analysis of a single wavelength was already sufficient to obtain a first impression of the quality of the imaging obtained.” (Column 22, Lines 31-33) and “Despite the astonishingly extensive information which could already be obtained from the recordings of a single wavelength, complete spectrums according to step 2 of the data analysis (k-means) were used for the additional examinations.” (Column 22, Lines 38-42). So applying Takeo’s analysis to Kroeger’s single-wavelength images, to a person of ordinary skill in the art, would make full use of the acquired images and further improve diagnostic precision.
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 1-11 and 13-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With regard to Claims 1-9 and 18:
Step 1: the claims are drawn to a method/process, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “determining a mid-infrared absorption or mid-infrared reflection …”, “determining a difference …”, “calculating focusing measures … by an edge analysis” and “identifying the biological tissue …” in Claims 1 and 18, “the edge analysis is performed by differentiation filtering …” in Claim 2, “determining whether or not the biological tissue is a normal tissue” and “… a normal tissue is determined based on a magnitude relationship between the focusing measure and a predetermined threshold” in Claim 8, and “identifying whether or not the biological tissue contains cancer” in Claim 9, which are, under their broadest reasonable interpretation, limitations that cover performance of the limitations in the mind, and/or mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or mathematical calculations, then it falls within the “Mental Processes” or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – irradiating tissue with light in Claims 1, 3, 7 and 18, acquiring image of tissue after light irradiation in Claims 1 and 18, using laser light in Claim 4, and performing focusing adjustment in Claim 5 and Claim 6. The laser light, light irradiation, image acquisition and focusing adjustment are recited at a high-level of generality (i.e., using a generic laser-light source to image a tissue sample) such that they amount no more than mere instructions to apply the exception using a generic laser-light imaging apparatus. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of irradiating tissue sample with laser light, focusing adjustment, and acquiring an image amount to no more than mere instructions to apply the exception using a generic laser-light imaging apparatus. Mere instructions to apply an exception using a generic laser-light imaging apparatus cannot provide an inventive concept.
For the reasons set forth above, Claims 1-9 and 18 are not patent eligible.
With regard to Claims 10-11 and 13-17:
Step 1: the claims are drawn to an apparatus/device, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “a calculation analysis unit capable of determining a mid-infrared absorption or mid-infrared reflection …; determining a difference … calculating focusing measures … by an edge analysis …; and identifying the biological tissue …” in Claim 10, “subjecting the measurement image to differentiation filtering …” in Claim 11, and “determining whether or not the biological tissue is a normal tissue; and … a normal tissue is identified based on a magnitude relationship between the focusing measure and a predetermined threshold” in Claim 13, which are, under their broadest reasonable interpretation, limitations that cover performance of the limitations in the mind, and/or mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or mathematical calculations but for the recitation of generic computer components (i.e. “a computer including a calculation analysis unit”), then it falls within the “Mental Processes” or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – a light source and an imaging element in Claim 10, an image forming unit for mapping the focusing measures in Claim 14, laser light sources in Claims 15-16, and a storage unit for storing a program for calculating focusing measures in Claim 17. The laser light sources, the imaging element, the image forming unit, and the storage unit are recited at a high-level of generality (i.e., a generic laser-light imaging device with light irradiation and detection capability, and a generic computer with displaying and storage capability) such that they amount no more than mere instructions to apply the exception using a generic laser-light imaging device coupled with a generic computer. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of laser light sources, imaging element, image forming unit, and storage unit amount to no more than mere instructions to apply the exception using a generic laser-light imaging device coupled with a generic computer. Mere instructions to apply an exception using a generic laser-light imaging device and a generic computer cannot provide an inventive concept.
For the reasons set forth above, Claims 10-11 and 13-17 are not patent eligible.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the broadest reasonable interpretation of the “biological tissue identification program” of Claim 18 encompasses software per se. It is suggested that Claim 18 be amended to recite a non-transitory computer readable medium on which a program for identifying a biological tissue.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 13-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 10 and 18 recite “determining a mid-infrared absorption …” (Lines 10-12), “determining a difference …” (Lines 13-15) and “the focusing measures representing …” (Lines 17-21), which are not described explicitly in Specification.
Claims 2-9, 11 and 13-17 are also rejected under 35 U.S.C. 112(a) because they inherit the deficiencies of the claim(s) they respectively depend upon.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 13-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, Lines 3-4, recites “a mid-infrared measurement light having a specific wavelength λ1 in a range of 2 μm to 20 μm”. It is unclear whether the recited “measurement light” has wavelength in the specific range of 2 μm to 20 μm or has mid-infrared wavelength. Specifically, the term “mid-infrared” could be defined to have a wavelength range different from 2-20 μm. For present purposes of examination, the recited “mid-infrared measurement light” in Lines 3-4, Lines 6-7, Lines 7-8 of Claim 1 are interpreted to refer to “light having a specific wavelength in a range of 2 μm to 20 μm”.
Claim 3 (Line 3), Claim 4 (Line 2), Claim 6 (Lines 3-4), Claim 10 (Lines 3, 6, 7), and Claim 18 (Lines 3-4, 6-7, 7-8), recite “mid-infrared measurement light”, and are interpreted in the same way as discussed above for Claim 1.
Claim 1 (Lines 10, 11, 13-14, 19), Claim 10 (Lines 10, 11, 13-14, 19), and Claim 18 (Lines 10, 11, 13-14, 19), recite “mid-infrared absorption … mid-infrared reflection … at the specific wavelength λ1”. For the same reason discussed above, all recited “mid-infrared” are not considered for present purposes of examination.
Claim 1, Lines 16-21, recites “calculating focusing measures … by an edge analysis …, the focusing measures … varies according to the difference … between the portion … and the other portion …”. It is unclear whether the recited “focusing measures” are calculated by the “edge analysis”, OR based on the difference in absorption or reflection between two different portions of the biological tissue. Based on disclosure in Specification, “edge analysis” is a pixel-by-pixel analysis, so is totally un-related with operation between different portions of the tissue (new matter that is not disclosed in Specification). For present purposes of examination, the recited “the focusing measures representing …” on Lines 17-21 of Claim 1 is not consider in interpreting the claim.
Claim 10 (Lines 17-21) and Claim 18 (Lines 17-21) recites “the focusing measures representing …”, the same as Claim 1 (Lines 17-21), and therefore are interpreted in the same way as discussed above for present purposes of examination.
Claims 2, 5, 7-9, 11 and 13-17 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 8-11 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kroeger-Lui (US 10317655 B2; hereafter Kroeger), in view of Takeo et al (US 20040081343 A1; hereafter Takeo).
With regard to Claim 1, Kroeger discloses a method for identifying a biological tissue (Kroeger, Column 2, Para 3; “… cost-effective and rapid IR analysis devices and methods, in particular for examining biological samples”), the method comprising:
irradiating a predetermined region of the biological tissue with a mid-infrared measurement light having a specific wavelength λ1 in a range of 2 μm to 20 μm (Kroeger, Column 2, Para 5; “… comprising the steps of irradiating the sample with an infrared (IR) radiation …”; Column, Para 21; “…is sufficient for the analysis of the middle infrared spectrum of thin tissue sections.”) (Kroeger, Column 7, Para 5; “In a preferred embodiment, the IR radiation emitted by the QCL is in a range from 5 to 12.5 μm.”);
acquiring a measurement image (Kroeger, Column 4, Para 5; “… hyperspectral imagings of a sample with a spatial resolution of less than 20 μm are possible as a result of the high measurement accuracy.”; multiple disclosures in Kroeger indicate that images of individual wavelength are available as the outcome of image acquisition) by imaging the mid-infrared measurement light transmitted through the biological tissue or the mid-infrared measurement light reflected at the biological tissue (Kroeger, Column 2, Para 4; “… a sensor which detects an IR radiation which is transmitted and/or reflected by the sample …”);
determining a mid-infrared absorption or mid-infrared reflection of a portion of the biological tissue and a mid-infrared absorption or mid-infrared reflection of another portion of the biological tissue at the specific wavelength λ1 (Kroeger, Column 22, Para 1; “The absorption spectrums were calculated as negative natural logarithms of the transmission spectrums for each pixel individually.” The disclosure indicates that absorption for each single wavelength is determined, and for each pixel (which can be interpreted as “each portion”));
determining a difference in the mid-infrared absorption or the mid-infrared reflection at the specific wavelength λ1 between the portion of the biological tissue and the other portion of the biological tissue (Kroeger, Column 22, Para 4; “The recording of the infrared transmission at 1218 cm−1 (±1.2 cm−1) over the complete large intestine section clearly showed the central lumen surrounded by large intestine epithelium and muscle tissue (Lamina muscularis mucosae). By digital zoom, the substructure of the epithelium could also be identified.” In the disclosed image acquired at the selected wavelength, a contrast between different portions (“central lumen” vs “intestine epithelium” for example) is visually determined so as to identify the different structures);
identifying the biological tissue (Kroeger, Column 17, Para 3; “… in the case of a tissue sample the arrangement and the state of the cells and other tissue structures (for example, connective tissue) can be identified.”).
Kroeger does not clearly and explicitly disclose:
calculating focusing measures in a plurality of regions of the measurement image by an edge analysis of the measurement image, the focusing measures representing a degree of focusing of the measurement image that varies according to the difference in the mid-infrared absorption or the mid-infrared reflection between the portion of the biological tissue and the other portion of the biological tissue at the specific wavelength λ1; and
identifying the biological tissue based on the focusing measures.
Takeo in the same field of endeavor discloses:
calculating focusing measures in a plurality of regions of the measurement image (Takeo, Para 0076; “… for each pixel among all of the pixels constituting the given image, the pixel is taken as a pixel of interest, and the degree of convergence C of the gradient vectors with respect to the pixel of interest is calculated with Formula (2) shown below”) by an edge analysis of the measurement image (Takeo, Para 0073; “For each pixel j among all of the pixels constituting a given image, the orientation θ of the gradient vector of the image signal representing the image is calculated with Formula (1) shown below”; Para 0069 “The iris filter calculates the gradients of image signal values … as gradient vectors and feeds out the information representing the degree of convergence of the gradient vectors. With the iris filtering processing a tumor pattern is detected in accordance with the degree of convergence of the gradient vectors”; Para 0078; “the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns”. These disclosures of Takeo indicates that the method of Takeo can be interpreted as an edge analysis), the focusing measures representing a degree of focusing of the measurement image that varies according to the difference in the mid-infrared absorption or the mid-infrared reflection between the portion of the biological tissue and the other portion of the biological tissue at the specific wavelength λ1 (due to 35 USC 112(b) issue, this limitation is not considered in Examiner’s interpretation); and
identifying the biological tissue based on the focusing measures (Takeo, Para 0185; “… an image area, which is associated with a high degree of convergence of image density gradient vectors, is detected as a temporary candidate for an abnormal pattern (a tumor pattern)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger, as suggested by Takeo, in order to compute a measure based on edge analysis and use it for identifying biological tissue. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved capability of detecting tissue abnormality by identifying characteristic gradient or edge patterns of tumors (Takeo, Para 0068; “It has been known that … in the tumor pattern, the gradients of the image density values can be found in local areas, and the gradient lines (i.e., gradient vectors) converge in the directions heading toward the center point of the tumor pattern.”).
With regard to Claim 2, Kroeger and Takeo disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the edge analysis is performed by differentiation filtering of the measurement image.
Takeo further discloses wherein the edge analysis is performed by differentiation filtering of the measurement image (Takeo, Para 0073; “For each pixel j among all of the pixels constituting a given image, the orientation θ of the gradient vector of the image signal representing the image is calculated with Formula (1) shown below: θ = tan-1 [( f3 + f4 + f5 + f6 + f7) - ( f11 + f12 + f13 + f14 + f15 )/[( f1 + f2 + f3 + f15 + f16 ) - ( f7 + f8 + f9 + f10 + f11 )”. Here the equation of gradient vector involves applying discrete differentiation for each pixel of an image, i.e. a type of differentiation filtering). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to use differentiation filtering for edge analysis. One of ordinary skill in the art would have been motivated to make the modification for the benefit of efficiently extracting edge- or gradient-related information from images.
With regard to Claim 3, Kroeger and Takeo disclose all the limitations of Claim 1 as discussed above. Kroeger further discloses wherein the biological tissue is irradiated with laser light having a wavelength λ1 as the mid-infrared measurement light (Kroeger, Abstract; “having a beam path having at least one quantum cascade laser (QCL) (3) which emits an infrared (IR) radiation … detects an IR radiation which is transmitted and/or reflected by the sample (2) …”).
With regard to Claim 4, Kroeger and Takeo disclose all the limitations of Claim 3 as discussed above. Kroeger further discloses wherein the mid-infrared measurement light is quantum cascade laser light or laser light amplified by optical parametric oscillation (Kroeger, Abstract; “having a beam path having at least one quantum cascade laser (QCL) (3) which emits an infrared (IR) radiation …”).
With regard to Claim 5, Kroeger and Takeo disclose all the limitations of Claim 1 as discussed above. Kroeger further discloses wherein focusing adjustment is performed before the measurement image is acquired (Kroeger, Column 16, Para 5; “the method further comprises the step of focusing the sample in accordance with the wavelength of the IR radiation of the QCL.” Column 17, Para 2; “In this manner, it is ensured that the sample for each wavelength is sharply imaged on the detector.”).
With regard to Claim 8, Kroeger and Takeo disclose all the limitations of Claim 1 as discussed above. Kroeger further discloses wherein the identification of the biological tissue based on the focusing measures includes determining whether or not the biological tissue is a normal tissue (Kroeger, Column 1, Para 2; “… changes of the tissue which are triggered by different organic malfunctions can lead to similar or even identical symptoms.”; Column 17, Para 3; “… in the case of a tissue sample the arrangement and the state of the cells and other tissue structures (for example, connective tissue) can be identified.”. The disclosed identification of arrangement and state of cells and tissue structures would enable determination on whether the tissue is normal or not).
Kroeger and Takeo as discussed above do not clearly and explicitly disclose wherein whether or not the biological tissue is a normal tissue is determined based on a magnitude relationship between the focusing measures and a predetermined threshold.
Takeo further discloses wherein whether or not the biological tissue is a normal tissue is determined based on a magnitude relationship between the focusing measures and a predetermined threshold (Takeo, Para 0078; “… a tumor pattern can be detected by …, and rating whether the value of the degree of convergence C is or is not larger than a predetermined threshold value”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to identify normal tissue based on the magnitude of the focusing measure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of determining a tissue to be normal or without tumor in an objective and efficient manner (Takeo, Para 0078; “… the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns.”).
With regard to Claim 9, Kroeger and Takeo disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the identification of the biological tissue based on the focusing measures includes determining whether or not the biological tissue contains cancer.
Takeo further discloses wherein the identification of the biological tissue based on the focusing measures includes determining whether or not whether or not the biological tissue contains cancer (Takeo, Para 0078; “… a tumor pattern can be detected by …, and rating whether the value of the degree of convergence C is or is not larger than a predetermined threshold value”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to detect cancer based on the magnitude of the focusing measure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of detecting tumor regions in an objective and efficient manner (Takeo, Para 0078; “… the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns.”).
With regard to Claim 10, Kroeger discloses a biological tissue identification apparatus (Kroeger, Abstract; “… a microscope for the molecular spectroscopic analysis of a sample (2) …”) comprising:
a light source (Kroeger, Abstract; “… having at least one quantum cascade laser (QCL) (3) which emits an infrared (IR) radiation …”) capable of irradiating a predetermined region of a biological tissue with a mid-infrared measurement light having a specific wavelength λ1 in a range of 2 μm to 20 μm (Kroeger, Column 2, Para 5; “… comprising the steps of irradiating the sample with an infrared (IR) radiation …”; Column, Para 21; “…is sufficient for the analysis of the middle infrared spectrum of thin tissue sections.”) (Kroeger, Column 7, Para 5; “In a preferred embodiment, the IR radiation emitted by the QCL is in a range from 5 to 12.5 μm.”);
an imaging element (Kroeger, Abstract; “… and a sensor (4) which detects an IR radiation …”) for acquiring a measurement image (Kroeger, Column 4, Para 5; “… hyperspectral imagings of a sample with a spatial resolution of less than 20 μm are possible as a result of the high measurement accuracy.”; multiple disclosures in Kroeger indicate that images of individual wavelength are available as the outcome of image acquisition) by imaging the mid-infrared measurement light transmitted through the biological tissue or the mid-infrared measurement light reflected at the biological tissue (Kroeger, Column 2, Para 4; “… a sensor which detects an IR radiation which is transmitted and/or reflected by the sample …”); and
a computer including a calculation analysis unit (Kroeger, Column 2, Para 3; “… a need for cost-effective and rapid IR analysis devices”. This disclosure does not explicitly disclos such a unit or device, but in its motivation indicates that such device based on the disclosed method, including tissue identification, are needed) capable of:
determining a mid-infrared absorption or mid-infrared reflection of a portion of the biological tissue and a mid-infrared absorption or mid-infrared reflection of another portion of the biological tissue at the specific wavelength λ1 (Kroeger, Column 22, Para 1; “The absorption spectrums were calculated as negative natural logarithms of the transmission spectrums for each pixel individually.” The disclosure indicates that absorption for each single wavelength is determined, and for each pixel (which can be interpreted as “each portion”));
determining a difference in the mid-infrared absorption or the mid-infrared reflection at the specific wavelength λ1 between the portion of the biological tissue and the other portion of the biological tissue (Kroeger, Column 22, Para 4; “The recording of the infrared transmission at 1218 cm−1 (±1.2 cm−1) over the complete large intestine section clearly showed the central lumen surrounded by large intestine epithelium and muscle tissue (Lamina muscularis mucosae). By digital zoom, the substructure of the epithelium could also be identified.” In the disclosed image acquired at the selected wavelength, a contrast between different portions (“central lumen” vs “intestine epithelium” for example) is visually determined so as to identify the different structures);
identifying the biological tissue (Kroeger, Column 17, Para 3; “… in the case of a tissue sample the arrangement and the state of the cells and other tissue structures (for example, connective tissue) can be identified.”).
Kroeger does not explicitly and clearly disclose:
calculating focusing measures in a plurality of regions of the measurement image by an edge analysis of the measurement image, the focusing measures representing a degree of focusing of the measurement image that varies according to the difference in the mid-infrared absorption or the mid-infrared reflection between the portion of the biological tissue and the other portion of the biological tissue at the specific wavelength λ1; and
identifying the biological tissue based on the focusing measures.
Takeo in the same field of endeavor discloses calculating focusing measures in a plurality of regions of the measurement image (Takeo, Para 0076; “… for each pixel among all of the pixels constituting the given image, the pixel is taken as a pixel of interest, and the degree of convergence C of the gradient vectors with respect to the pixel of interest is calculated with Formula (2) shown below”) by an edge analysis of the measurement image (Takeo, Para 0073; “For each pixel j among all of the pixels constituting a given image, the orientation θ of the gradient vector of the image signal representing the image is calculated with Formula (1) shown below”; Para 0069 “The iris filter calculates the gradients of image signal values … as gradient vectors and feeds out the information representing the degree of convergence of the gradient vectors. With the iris filtering processing a tumor pattern is detected in accordance with the degree of convergence of the gradient vectors”; Para 0078; “the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns”. These disclosures of Takeo indicates that the method of Takeo can be interpreted as an edge analysis), the focusing measures representing a degree of focusing of the measurement image that varies according to the difference in the mid-infrared absorption or the mid-infrared reflection between the portion of the biological tissue and the other portion of the biological tissue at the specific wavelength λ1 (due to 35 USC 112(b) issue, this limitation is not considered in Examiner’s interpretation); and
identifying the biological tissue based on the focusing measures (Takeo, Para 0185; “… an image area, which is associated with a high degree of convergence of image density gradient vectors, is detected as a temporary candidate for an abnormal pattern (a tumor pattern)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger, as suggested by Takeo, in order to compute a measure based on edge analysis and use it for identifying biological tissue. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved capability of detecting tissue abnormality by identifying characteristic gradient or edge patterns of tumors (Takeo, Para 0068; “It has been known that … in the tumor pattern, the gradients of the image density values can be found in local areas, and the gradient lines (i.e., gradient vectors) converge in the directions heading toward the center point of the tumor pattern.”).
With regard to Claim 11, Kroeger and Takeo disclose all the limitations of Claim 10 as discussed above, but do not clearly and explicitly disclose wherein the calculation analysis unit calculates the focusing measures by subjecting the measurement image to differentiation filtering.
Takeo further discloses wherein the calculation analysis unit calculates the focusing measures by subjecting the measurement image to differentiation filtering (Takeo, Para 0073; “For each pixel j among all of the pixels constituting a given image, the orientation θ of the gradient vector of the image signal representing the image is calculated with Formula (1) shown below: θ = tan-1 [( f3 + f4 + f5 + f6 + f7) - ( f11 + f12 + f13 + f14 + f15 )/[( f1 + f2 + f3 + f15 + f16 ) - ( f7 + f8 + f9 + f10 + f11 )”. Here the equation of gradient vector involves applying discrete differentiation for each pixel of an image, i.e. a type of differentiation filtering). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to use differentiation filtering to compute focusing measure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of extracting the gradient-related information that would enable improved differentiation capability of the characteristic patterns of different tissue types (Takeo, Para 0068; “It has been known that … in the tumor pattern, the gradients of the image density values can be found in local areas, and the gradient lines (i.e., gradient vectors) converge in the directions heading toward the center point of the tumor pattern.”).
With regard to Claim 13, Kroeger and Takeo disclose all the limitations of Claim 10 as discussed above. Kroeger further discloses wherein in the calculation analysis unit, the identification of the biological tissue based on the focusing measures includes determining whether or not the biological tissue is a normal tissue (Kroeger, Column 1, Para 2; “… changes of the tissue which are triggered by different organic malfunctions can lead to similar or even identical symptoms.”; Column 17, Para 3; “… in the case of a tissue sample the arrangement and the state of the cells and other tissue structures (for example, connective tissue) can be identified.”. The disclosed identification of arrangement and state of cells and tissue structures would enable determination on whether the tissue is normal or not).
Kroeger and Takeo as discussed above do not clearly and explicitly disclose wherein whether or not the biological tissue is a normal tissue is determined based on a magnitude relationship between the focusing measures and a predetermined threshold.
Takeo further discloses wherein whether or not the biological tissue is a normal tissue is determined based on a magnitude relationship between the focusing measures and a predetermined threshold (Takeo, Para 0078; “… a tumor pattern can be detected by …, and rating whether the value of the degree of convergence C is or is not larger than a predetermined threshold value”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to identify normal tissue based on the magnitude of the focusing measure. One of ordinary skill in the art would have been motivated to make the modification for the benefit of determining a tissue to be normal or without tumor in an objective and efficient manner (Takeo, Para 0078; “… the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns.”).
With regard to Claim 14, Kroeger and Takeo disclose all the limitations of Claim 10 as discussed above, but do not clearly and explicitly disclose wherein the computer includes an image forming unit for mapping the focusing measures to form an analysis image.
Takeo further discloses wherein the computer includes an image forming unit for mapping the focusing measures to form an analysis image (Takeo, Para 0122; “… a peripheral edge image (the IFED image) is formed by the utilization of the iris filtering processing.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to form a map of the focusing measures. One of ordinary skill in the art would have been motivated to make the modification for the benefit of visualizing pattern or texture in an image so as to detect abnormal tissues quickly.
With regard to Claim 15, Kroeger and Takeo disclose all the limitations of Claim 10 as discussed above. Kroeger further discloses wherein the light source is a laser light source capable of scanning wavelengths (Kroeger, Column 21, Para 4; “there were used two quantum cascade lasers (Daylight Solutions Inc., USA) which could be tuned over 1027 to 1087 cm-1 and 1167 to 1319 cm-1 (corresponds to a wavelength range of 9.74 μm to 9.20 μm and 8.57 μm to 7.58 μm).” This disclosure discloses light sources that generate laser of tunable wavelength, so can be regarded as being capable of scanning wavelengths).
With regard to Claim 16, Kroeger and Takeo disclose all the limitations of Claim 10 as discussed above. Kroeger further discloses wherein the light source is a source of quantum cascade laser or a laser source including an optical parametric oscillator (Kroeger, Abstract; “having a beam path having at least one quantum cascade laser (QCL) (3) which emits an infrared (IR) radiation …”).
With regard to Claim 17, Kroeger and Takeo disclose all the limitations of Claim 10 as discussed above, including the calculation analysis unit to execute processing in which the measurement image acquired by the imaging element is subjected to edge analysis to calculate the focusing measures in the plurality of regions of the measurement image. Kroeger and Takeo as discussed above do not explicitly and clearly disclose wherein a program for causing to executing the processing is stored in a storage unit of the computer.
Takeo further discloses wherein a program for causing unit to execute the processing is stored in a storage unit of the computer (Takeo, Para 0184; “The abnormal pattern candidate detection processing system 100 comprises abnormal pattern candidate detecting means 10 …”; Para 0185; “The abnormal pattern candidate detecting means 10 stores an algorithm for abnormal pattern candidate detection processing utilizing an iris filter …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as further suggested by Takeo, in order to store the program for the proposed processing in the storage unit of the computer of the system. One of ordinary skill in the art would have been motivated to make the modification for the benefit of performing the processing locally in real time and therefore achieving diagnosis with high efficiency.
With regard to Claim 18, Kroeger discloses a biological tissue identification program (Kroeger, Column 2, Para 3; “… cost-effective and rapid IR analysis devices and methods, in particular for examining biological samples”. To one of ordinary skill in the art, the methods and their implementation in devices are inherently in the form of programs) comprising a processing procedure for causing a computer to execute the steps of:
irradiating a predetermined region of a biological tissue with a mid-infrared measurement light having a specific wavelength λ1 in a range of 2 μm to 20 μm (Kroeger, Column 2, Para 5; “… comprising the steps of irradiating the sample with an infrared (IR) radiation …”; Column, Para 21; “…is sufficient for the analysis of the middle infrared spectrum of thin tissue sections.”) (Kroeger, Column 7, Para 5; “In a preferred embodiment, the IR radiation emitted by the QCL is in a range from 5 to 12.5 μm.”);
acquiring a measurement image (Kroeger, Column 4, Para 5; “… hyperspectral imagings of a sample with a spatial resolution of less than 20 μm are possible as a result of the high measurement accuracy.”; multiple disclosures in Kroeger indicate that images of individual wavelength are available as the outcome of image acquisition) by imaging the mid-infrared measurement light transmitted through the biological tissue or the mid-infrared measurement light reflected at the biological tissue (Kroeger, Column 2, Para 4; “… a sensor which detects an IR radiation which is transmitted and/or reflected by the sample …”);
determining a mid-infrared absorption or mid-infrared reflection of a portion of the biological tissue and a mid-infrared absorption or mid-infrared reflection of another portion of the biological tissue at the specific wavelength λ1 (Kroeger, Column 22, Para 1; “The absorption spectrums were calculated as negative natural logarithms of the transmission spectrums for each pixel individually.” The disclosure indicates that absorption for each single wavelength is determined, and for each pixel (which can be interpreted as “each portion”));
determining a difference in the mid-infrared absorption or the mid-infrared reflection at the specific wavelength λ1 between the portion of the biological tissue and the other portion of the biological tissue (Kroeger, Column 22, Para 4; “The recording of the infrared transmission at 1218 cm−1 (±1.2 cm−1) over the complete large intestine section clearly showed the central lumen surrounded by large intestine epithelium and muscle tissue (Lamina muscularis mucosae). By digital zoom, the substructure of the epithelium could also be identified.” In the disclosed image acquired at the selected wavelength, a contrast between different portions (“central lumen” vs “intestine epithelium” for example) is visually determined so as to identify the different structures); and
identifying the biological tissue (Kroeger, Column 17, Para 3; “… in the case of a tissue sample the arrangement and the state of the cells and other tissue structures (for example, connective tissue) can be identified.”).
Kroeger does not clearly and explicitly disclose:
calculating focusing measures in a plurality of regions of the measurement image by an edge analysis of the measurement image, the focusing measures representing a degree of focusing of the measurement image that varies according to the difference in the mid-infrared absorption or the mid-infrared reflection between the portion of the biological tissue and the other portion of the biological tissue at the specific wavelength λ1; and
identifying the biological tissue based on the focusing measures.
Takeo in the same field of endeavor discloses:
calculating focusing measures in a plurality of regions of the measurement image (Takeo, Para 0076; “… for each pixel among all of the pixels constituting the given image, the pixel is taken as a pixel of interest, and the degree of convergence C of the gradient vectors with respect to the pixel of interest is calculated with Formula (2) shown below”) by an edge analysis of the measurement image (Takeo, Para 0073; “For each pixel j among all of the pixels constituting a given image, the orientation θ of the gradient vector of the image signal representing the image is calculated with Formula (1) shown below”; Para 0069 “The iris filter calculates the gradients of image signal values … as gradient vectors and feeds out the information representing the degree of convergence of the gradient vectors. With the iris filtering processing a tumor pattern is detected in accordance with the degree of convergence of the gradient vectors”; Para 0078; “the processing with the iris filter has the features over an ordinary difference filter in that the processing with the iris filter is not apt to be adversely affected by blood vessel patterns, mammary gland patterns, or the like, and can efficiently detect tumor patterns”. These disclosures of Takeo indicates that the method of Takeo can be interpreted as an edge analysis), the focusing measures representing a degree of focusing of the measurement image that varies according to the difference in the mid-infrared absorption or the mid-infrared reflection between the portion of the biological tissue and the other portion of the biological tissue at the specific wavelength λ1 (due to 35 USC 112(b) issue, this limitation is not considered in Examiner’s interpretation); and
identifying the biological tissue based on the focusing measures (Takeo, Para 0185; “… an image area, which is associated with a high degree of convergence of image density gradient vectors, is detected as a temporary candidate for an abnormal pattern (a tumor pattern)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger, as suggested by Takeo, in order to compute a measure based on edge analysis and use it for identifying biological tissue. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved capability of detecting tissue abnormality by identifying characteristic gradient or edge patterns of tumors (Takeo, Para 0068; “It has been known that … in the tumor pattern, the gradients of the image density values can be found in local areas, and the gradient lines (i.e., gradient vectors) converge in the directions heading toward the center point of the tumor pattern.”).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kroeger and Takeo, in view of Domenicali (US 20090096914 A1; hereafter Domenicali) and Grimbergen et al (US 20180259848 A1; hereafter Grimbergen).
With regard to Claim 6, Kroeger and Takeo disclose all the limitations of Claim 5 as discussed above. Kroeger further discloses wherein in the focusing adjustment,
the predetermined region of the biological tissue is irradiated with the mid-infrared measurement light (Kroeger, Column 16, Para 5; “An adaptation of the focus in accordance with the wavelength of the QCL is consequently advantageous. This can be carried out, for example, by the synchronised displacement of the sample or the detector.” In this disclosure, irradiation of the measurement light onto the sample is the first step, followed by the “adaption of the focus”.),
light having wavelength in a range of 2 μm to 20 μm is used (Kroeger, Column 16, Para 5; “An adaptation of the focus in accordance with the wavelength of the QCL is consequently advantageous.” This disclosure indicates that the focusing adjustment is based on the measurement QCL, the wavelength of which is in the range of 2-20 μm as disclosed in the reference.), and
a position of a sample containing the biological tissue and/or a position of another optical element is adjusted (Kroeger, Column 16, Para 5; “This can be carried out, for example, by the synchronised displacement of the sample or the detector. … In order to position the detector or the sample in accordance with the wavelength emitted by the QCL, the position thereof can be controlled by means of a computer unit.”) so that the degree of focusing of the focusing adjusting image increases (Kroeger, Column 16, Para 5; “In this manner, it is ensured that the sample for each wavelength is sharply imaged on the detector.”).
Kroeger and Takeo do not explicitly and clearly disclose wherein a focusing adjusting image is acquired by imaging light having wavelength λ0, and wherein the wavelength λ0 is different from the wavelength λ1.
Domenicali in the same field of endeavor discloses wherein a focusing adjusting image is acquired (Domenicali, Para 0051; “The position of the optical element can be adjusted to maintain a focus of the image in response to the wavelength band selection.” The reference discloses a dynamic focusing adjustment procedure, so that images are formed in the procedure of focusing). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger and Takeo, as suggested by Domenicali, in order to form an image with the focusing-adjustment light. One of ordinary skill in the art would have been motivated to make the modification for the benefit of visualizing the outcome of focusing adjustment in a real-time manner so as to determine whether more adjustment is needed.
Kroeger, Takeo and Domenicali do not explicitly and clearly disclose using a focusing-adjusting light with different wavelength as the measurement light.
Grimbergen in the same field of endeavor discloses using a focusing-adjusting light with different wavelength as the measurement light (Grimbergen, Para 0007; “Focus adjustment and evaluation of the spot size and location can then be done at a single wavelength. This single wavelength can be conveniently chosen in the visible part of the spectrum for set-up, and the same focus will apply to a broad range of wavelengths …” In this disclosure, the focusing-adjustment setting at one wavelength is used for imaging of other wavelengths in a range). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kroeger, Takeo and Domenicali, as suggested by Grimbergen, in order to use a light with wavelength different from the measurement light for focusing adjustment. One of ordinary skill in the art would have been motivated to make the modification for the benefit of saving acquisition time in situations when images of multiple wavelengths (or hyperspectral imaging as termed in Kroeger) are acquired.
With regard to Claim 7, Kroeger, Takeo, Domenicali and Grimbergen discloses all the limitations of Claim 6 as discussed above, including using laser light having different wavelength from the measurement light. Kroeger further discloses wherein in the focusing adjustment, the biological tissue is irradiated with laser light having a wavelength λ0 (Kroeger, Column 16, Para 5; “An adaptation of the focus in accordance with the wavelength of the QCL is consequently advantageous.” This disclosure inherently indicates that QCL laser light is irradiated onto the tissue or sample).
Conclusion
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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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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