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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/08/2025 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2020-0124448, filed on September 25, 2020.
Status of Claims
This Office Action is responsive to the claims filed on 08/08/2025. Claims 1, 10-13, and 16 have been amended. Claims 8, 9, 14, and 15 have been canceled. Claim 6 was previously canceled. Claims 1-5 7, 10-13, and 16-18 are presently pending in this application.
Claim Objections
Claims 1, 5, and 13 are objected to because of the following informalities:
Claim 1, line 25: “applies each of the unit scan data a learning model” should be amended to read “applies each of the unit scan data to a learning model”.
Claim 1, line 34: the abbreviated term “ROI” should be defined in the first instance of use in the claims.
Claim 5, line 2: the abbreviated term “LED” should be defined in the first instance of use in the claims.
Claim 13, line 1: “A operating method” should be amended to read “An operating method”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a central control device” in claim 1, line 6; “channel signal processing unit” in claim 1, line 12; “light irradiation module” in claim 1, line 13; “light collection module” in claim 1, line 13; “a first control unit” in claim 2, line 2; “a first communication unit” in claim 2, line 3.
The corresponding structure for the “central control device” defined within the specification is a central processing unit (CPU) (Paragraph [0090], Line 5) and any functional equivalents. The corresponding structure for the “channel signal processing unit” defined within the specification is a processor (Paragraph [0074], Line 3) and any functional equivalents. The corresponding structure for the “light irradiation module” defined within the specification is a laser diode (LD) (Paragraph [0053], Line 2) and any functional equivalents. The corresponding structure for the “light collection module” defined within the specification is a photodiode (Paragraph [0056], Line 2) and any functional equivalents. The corresponding structure for the “first control unit” defined within the specification is a processor (Paragraph [0074], Line 3) and any functional equivalents. The corresponding structure for the “first communication unit” defined within the specification is a communication module configured to transmit and receive wireless communication such as Wi-Fi or Bluetooth (Paragraph [0072], Line 1-4) and any functional equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 10, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (US 20130109963) in view of Cheng (US 8918153), Jones (US 20180168490), Mori (US 20170128037), and Lee (KR 20170062662 A; Translation of KR 20170062662 A relied on herein).
Regarding claim 1, Zhu teaches a breast cancer diagnosis system (Paragraph [0048]-[0049]; medical imaging apparatus and methods for medical imaging wherein diffusive optical tomography (DOT); advantageous in that it can be used for probing inclusions (e.g., cancers, tumors, lesions, and the like); Paragraph [0052]; such as a tumor within a female breast) using near-infrared measurement technology (Paragraph [0050]; Diffuse optical tomography (DOT) in the near infrared region (NIR)), comprising:
a probe (Paragraph [0056]; probe 4, Figs. 1 and 2) that sequentially outputs light of a plurality of wavelengths of a near-infrared area (Paragraph [0056]; emitter 10, Figs. 1 and 2; Paragraph [0075]; three pigtailed laser diodes 34 that emit light having wavelengths of 690 nm, 780 nm and 830 nm… the outputs of the laser diodes were sequentially delivered to 9 locations on the probe) to a target object (Paragraph [0056]; probe 4 that can be disposed on bodily tissue 6 to image an inclusion 8 therein), receives reflected light reflected from the target object (Paragraph [0056]-[0057]; first detector 12; first detectors 12 are capable of detecting radiation emitted by the emitters 10 and fluorescence within the target area; paragraph [0072]; light introduced into the tissue travels a crescent-like path, and thus may not impinge on inclusions that are closer to the skin, Fig. 4(b), the light reflected in the skin is detected by detectors 12), and sequentially processes the reflected light (Paragraph [0058]; radiation received by a detector can be processed and reconstructed into an image; Paragraph [0092]; This model is used to fit the measured amplitude and phase profiles after filtering out distant source-detector measurements and to estimate the first and the second-layer optical properties, which can be incorporated into the imaging reconstruction);
a central control device (Paragraph [0056]; central processing unit 18, Figs. 1 and 3) that controls an operation of the probe (Paragraph [0056]; The CPU 18 is capable of controlling the operation of the imaging system 200; imaging system 200 comprises a probe 4), receives optical data of the reflected light sensed by the probe (Paragraph [0056]; detector circuit 16 are operably connected to a central processing unit 18; Paragraph [0058]; radiation received by a detector can be processed and reconstructed into an image and displayed on display 20 by CPU 18), calculates a concentration of chromophore of the target object for each chromophore based on the optical data (Paragraph [0110]; major chromophores are deoxygenated (deoxyHb) and oxygenated (oxyHb) hemoglobin… direct estimate of the total hemoglobin concentration; Paragraph [0111]; In principle, any two wavelengths in the NIR window can be used to compute the total hemoglobin concentration from equation; Paragraph [0114]; three typical wavelengths of 690 nm, 780 nm, and 830 nm are implemented in our system for estimation of total hemoglobin concentration and blood oxygen saturation), and generates an image of the chromophores indicating a distribution of the concentration value of each chromophore (Paragraph [0141]; The total hemoglobin maps and the blood oxygen saturation maps at 50 MHz and 140 MHz are computed and the images are shown in FIG. 17(e1, e2) and (f1, f2), respectively); and
a display (Paragraph [0056]; display 20, Fig. 1) that outputs the image generated by the central control device (Paragraph [0056]; operably connected to a central processing unit 18… on which an image of the inclusion 8 can be generated; claim 16, provide diffusive optical tomography and fluorescent diffusive optical tomography),
wherein in the probe, N(N is a plural natural number) channel signal processing units (Paragraphs [0074] and [0078]; source circuit 14 with 4x1 and 1x9 optical switch and a detector circuit subsystem 54; comprises a plurality of parallel channels… , the detection subsystem comprises 10 parallel channels; Figs. 5 and 6) including one or more light irradiation modules (Paragraph [0058]; number of first emitters 10, Fig. 2) and one or more light collection modules are disposed (Paragraph [0058]; number of first detectors 12, Fig. 2), and each of the N channel signal processing units sequentially operates (Paragraph [0075]; laser diodes were sequentially delivered to 9 locations on the probe through 3x1 and 1x9 optical switches 36 and 38 respectively; the light is sequentially delivered; Paragraphs [0074]-[0078]; acquire data from 10 parallel detection channels… directly mixing the outputs of the corresponding transmit and receive oscillators at each modulation frequency; The reception is done sequentially for each light output) so that each of the N channel signal processing units generates the optical data of the reflected light (Paragraph [0078]; 20 kHz difference signals were further amplified by 50 dB and bandpass filtered before sampled by A/D converters, Fig. 6 shows the signal from the light guide is processed through the pre-amp, mixer, and op-amp/bandpass filter, and sent to the computer);
wherein the central control device sequentially receives the unit scan data transmitted from the probe (Paragraphs [0074]-[0078]; acquire data from 10 parallel detection channels… directly mixing the outputs of the corresponding transmit and receive oscillators at each modulation frequency; The reception is done sequentially for each light output), applies each of the unit scan data an algorithm to calculate the concentration of the chromophore (Paragraph [0112]; estimation of total hemoglobin concentration favors the wavelength pair of 780 nm and 830 nm; blood oxygenation saturation estimation is best for the wavelength pair of 660 nm and 830 nm), and displays each concentration of the chromophore on a two-dimensional coordinates to generate a unit frame image (Paragraph [0141]; total hemoglobin maps and the blood oxygen saturation maps are shown in Figs. 17E and 17F);
and wherein a measurement value for each wavelength of light (Paragraphs [0110]-[0114]; any two wavelengths in the NIR window can be used to compute the total hemoglobin concentration from equation (7)) and the concentration of each of a plurality of chromophore materials are matched respectively (Paragraphs [0110]-[0114]; three typical wavelengths of 690 nm, 780 nm, and 830 nm are implemented in our system for estimation of total hemoglobin concentration and blood oxygen saturation);
wherein the central control device outputs an examination interface for guiding a scanning procedure through the probe (Paragraph [0079]; Captured ultrasound images are directly sent to the display 20 for review and also for guiding near-infra-red imaging formation) and an area requiring imaging as a contrast area for the imaging area requiring the diagnosis (Paragraphs [0101]-[0107]; the entire tissue volume is segmented, including a background region, B; total absorption distributions are calculated based on the background absorption coefficient; In each reconstruction step, only one layer with finer mesh or ROI # is reconstructed and the other target layers are treated as background).
Zhu does not explicitly teach each channel signal processing unit generates unit scan data including a total of N pieces of the optical data,
the N channel signal processing units are disposed in a horizontal direction along one axis of the probe, and
the light irradiation modules and the light collection modules of two of the N channel signal processing units adjacent to each other are disposed adjacent to each other, the light irradiation modules are disposed in a row parallel to the one axis, and the light collection modules are disposed in a row parallel to the one axis by being spaced apart from the light irradiation modules by predetermined distances;
applying each of the unit scan data to a learning model to calculate the concentration of the chromophore, and
wherein the learning model is machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively; and
the examination interface includes a scanning guide interface indicating a state of securing the unit scan data of the probe and an imaging guide interface displaying a left breast area and a right breast area, respectively,
and a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging as a contrast area are displayed on the imaging guide interface, and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface or the second ROI interface, and
the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Cheng, however, teaches a diagnosis system using near-infrared measurement technology (Col. 1, ln. 15-22; techniques for monitoring vital functions of the human body, including cardiac functions such as cardiac output and central venous blood oxygenation; Col. 6, ln. 29-49; comprising a light source 20 that emits light in the 400 nm to 1000 nm wavelength range, e.g. visible and infra-red light) comprising:
a probe (Col. 14, ln. 27-51; device 300, patch probe 328, Fig. 13), wherein in the probe, N (N is a plural natural number) channel signal processing units including one or more light irradiation modules and one or more light collection modules are disposed (Col. 14, ln. 27-51; Each light source 320… is associated with a corresponding photodetector 330; Fig. 13; Col. 14, ln. 52-64; each photodetector is monitored … transmitted to a signal processing device; The signal processing device for each of the light source 320 associated with a corresponding photodetector 330 is considered to read on the claimed limitation of N channel signal processing units including one or more light irradiation modules and one or more light collection modules), and each of the N channel signal processing units sequentially operates so that each of the N channel signal processing units generates the optical data of the reflected light (Col. 14, ln. 27-64; a corresponding photodetector 330 suitable to detect reflected or transmitted light from its corresponding light source 320; output signal (e.g. current/voltage) of each photodetector is monitored (or transmitted to a signal processing device for translation to an alternate form of output such as a visual waveform output which is monitored) to determine whether there is an output or not), thereby generates unit scan data including a total of N pieces of the optical data (Col. 14, ln. 52-64; each photodetector is monitored… position (d) along the vein to yield an output, e.g. a waveform, is then determined based on the output from each photodetector in the sequence; The output of each photodetector is considered to read on the claimed limitation of generates unit scan data including a total of N pieces of the optical data as understood in its broadest reasonable interpretation),
the N channel signal processing units are disposed in a horizontal direction along one axis of the probe (Fig. 13 shows each pair of light source and detector are disposed in the d direction which is considered to read on the claimed limitation of disposed in a horizontal direction along one axis of the probe as understood in its broadest reasonable interpretation), and
the light irradiation modules and the light collection modules of two of the N channel signal processing units adjacent to each other are disposed adjacent to each other, the light irradiation modules are disposed in a row parallel to the one axis, and the light collection modules are disposed in a row parallel to the one axis by being spaced apart from the light irradiation modules by predetermined distances (Fig. 13 shows the light sources and photodetectors are disposed adjacent to each other, the light sources are disposed in a row parallel to the d axis, the photo detectors are disposed in a row parallel to the d axis spaced apart from the light sources by a predetermined distance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Zhu such that the each channel signal processing unit generates unit scan data includes a total of N pieces of the optical data, the N channel signal processing units are disposed in a horizontal direction along one axis of the probe, and the light irradiation modules and the light collection modules of two of the N channel signal processing units adjacent to each other are disposed adjacent to each other, the light irradiation modules are disposed in a row parallel to the one axis, and the light collection modules are disposed in a row parallel to the one axis by being spaced apart from the light irradiation modules by predetermined distances as taught by Cheng. Such an arrangement would allow processing the individual contributions from sensor, thereby allowing comparison of signals between each position to determine a position where the signal is maximized (Cheng; Col. 14, ln. 52-64 and Col. 16, ln. 38-52) and thus improve mapping of concentrations of vascularization of the tumor.
The system of Zhu in view of Cheng does not explicitly teach applying each of the unit scan data to a learning model to calculate the concentration of the chromophore, and
wherein the learning model is machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively; and
the examination interface includes a scanning guide interface indicating a state of securing the unit scan data of the probe and an imaging guide interface displaying a left breast area and a right breast area, respectively,
and a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging as a contrast area are displayed on the imaging guide interface, and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface or the second ROI interface, and
the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Jones, however, teaches a cancer diagnosis method (Paragraph [0005]; real time assessment of information relating to a subject; Paragraph [0020]; information relating to the subject comprises… cancer) based on near-infrared measurement technology (Paragraph [0042]; spectral data comprises… NIR spectral data) comprising:
receiving optical data of reflected light from a target object sensed by a probe (Paragraph [1031]-[1032]; spectrometer 20 includes a light source generating light in the near-infrared spectrum, and an accompanying photodetector sensitive to the near-infrared spectrum; generate spectral data for a sample within the GI tract of a subject);
calculating a concentration of chromophore of the target object for each chromophore based on the optical data (Paragraph [1293]-[1294]; PLS-based model for predicting concentration of Hemoglobin in water; Paragraph [1348]; predict the oxygenation level of a blood sample);
wherein in the central control device applies each of the unit scan data to a learning model to calculate the concentration of the chromophore, wherein the learning model is machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively (Paragraph [1293]; acquired transmission spectra corresponding to Hemoglobin solutions shown in FIGS. 44A-44D were used as training inputs for machine learning modeling, e.g., machine learning modeling that uses a PLS algorithm; used to predict the concentration of Hemoglobin of a solution to which one of the acquired spectra corresponds; unknown Hemoglobin concentration determined by (i) identifying one of a number of spectra corresponding to solutions having known concentrations of Hemoglobin that best matches the acquired spectrum, and (ii) assigning to the unknown concentration a value of the Hemoglobin concentration for the solution to which the identified spectrum corresponds; Paragraph [1348]; machine learning modeling for predicting blood oxygenation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Zhu to have included a learning model machine-learned based on training data to calculate the concentration of the chromophore, wherein the learning model is machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively, as taught by Jones because it would have been a well understood method of determining chromophore concentration from spectral data that would have had the benefit of further being able to determine the compounds in the a sample and more accurately predict concentrations of multiple analytes in samples comprising multiple compounds (Jones, Paragraphs [1080] and [1142]).
The system of Zhu in view of Cheng and Jones does not explicitly teach the examination interface includes a scanning guide interface indicating a state of securing the unit scan data of the probe and an imaging guide interface displaying a left breast area and a right breast area, respectively,
and a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging as a contrast area are displayed on the imaging guide interface, and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface or the second ROI interface, and
the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Mori, however, teaches a breast cancer diagnosis system (Paragraph [0032]; medical information-processing system for breast cancer examinations) comprising a central control device (Paragraph [0035]; image processing device 30 processes the mammographic image) configured to outputs an examination interface for guiding a scanning procedure through the probe (Paragraphs [0056]-[0058]; FIG. 5 depicts one example of the schematic diagram that is used by the position specifying function 35e; generates a schematic diagram to be archived in which a mark indicating a region of interest is positioned) and the examination interface includes an imaging guide interface displaying a left breast area and a right breast area, respectively, (Paragraph [0056]-[0057]; schematic diagram of a breast region; Fig. 5 shows the right and left breast areas) and a first ROI interface displaying an imaging area requiring diagnosis (Paragraph [0144]; displays scanning order indicating a region before scanning; Fig. 22 and 23 show a plurality of regions to be scanned) and a second ROI interface displaying an area requiring imaging displayed on the imaging guide interface (Paragraph [0144]; displays scanning order indicating a region before scanning; Fig. 22 and 23 show a plurality of regions to be scanned); and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface (Paragraph [0145] Subsequently, the setting-condition determining function 172 shows the region A that is scanned first in shades indicating that it is being scanned at step S401, and shows the rest of the regions, the region B, the regions C and C′, and the regions D and E in dots indicating that it is before scanning; Fig. 22 and 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the examination interface of Zhu in view of Cheng and Jones to have included an imaging guide interface displaying a left breast area and a right breast area, respectively, and displaying a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging, including the areas for contrast area wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface, as taught by Mori because use of the indication regions can allow the user to more clearly see which areas need examination and thus reduce the burden on the use. As a result, according to the first embodiment, time required for ultrasonic scanning can be shortened, to improve the workflow (Mori, Paragraph [0117]).
The system of Zhu in view of Cheng, Jones, and Mori does not explicitly teach the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Lee, however, teaches a breast cancer diagnosis system (Pg. 2, Para. 2; The present invention relates to a method for detecting breast cancer using a breast cancer examiner having a built-in calculation unit including a sensor position correction module) wherein the scanning guide interface displays a state indicating whether each unit scan data is collected (Pg. 19, Para. 3; The peripheral sensor unit 130 is displayed with different colors from CH2 to CH5 so that the values of the bio-signals measured at the corresponding sites are displayed; The value of the measurement displayed is considered to be a state indicating scan unit data is collected as understood in its broadest reasonable interpretation) for each preset plurality of positions (Pg. 6, Para. 2; sensor unit 100 is a sensor attached to one side of the subject's breast and attached to a site where the presence or absence of tumor of the subject is to be checked) in the area corresponding to the first ROI interface (Pg. 19, Para. 3; at the corresponding sites).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the scanning guide interface of Zhu in view of Cheng, Jones, and Mori to have displayed a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface as taught by Lee because it would have allowed measuring a bio-signal of a tumor more specifically based on determining a relative position of a plurality of sensor units (Lee, Pg. 12, Para. 5).
Regarding claim 10, together Zhu, Cheng, Jones, Mori, and Lee teach all of the limitations of claim 1 as noted above.
Zhu further teaches a plurality of the first ROI interfaces (Paragraph [0102]; the entire tissue volume is segmented based on co-registered ultrasound images into an inclusion region, L (region of interest, ROI); Paragraph [0102]; we divide the region of interest (ROI) into N zones in N layers denoted as ROI#1, ROI#2, . . . ROI#N respectively) the imaging area requiring diagnosis (Paragraph [0101]; co-registered ultrasound images into an inclusion region, L), and a plurality of the second ROI interfaces of the contrast area (Paragraph [0101]; and a background region, B; Paragraph [0107]; other target layers are treated as background).
Zhu does not explicitly teach the diagnosis interface displays a plurality of ROI interfaces and displaying an imaging area requiring diagnosis according to a user's selection;
wherein the number of the first ROI interfaces and the second ROI interfaces is the same, and the number of the first and second ROI interfaces is determined based on user selection.
Mori, however, further teaches the diagnosis interface displays a plurality of first ROI and plurality of second ROI interfaces (Paragraph [0144]; displays scanning order indicating a region before scanning, a region being scanned, and a region after scanning in respective different forms on the display 103; Figs. 22 and 23 show a plurality of regions) and displaying an imaging area requiring diagnosis according to a user's selection (Paragraph [0160]; the acquiring function 171 can acquire region-of-interest information based on information that is added by a technician that refers to an X-ray image; a technician refers to an X-ray image, and generates a schematic diagram to be archived, adding a mark at a position of a region of interest on a schematic diagram for breast diagnosis schematically expressing a breast); and
wherein the number of the first ROI interfaces and the second ROI interfaces is the same, and the number of the first and second ROI interfaces is determined based on user selection (Paragraphs [0144]-[0145]; function 172 displays scanning order indicating a region before scanning, a region being scanned, and a region after scanning in respective different forms on the display 103; entire region in the body mark with dots indicating it is before scanning… Subsequently, the setting-condition determining function 172 shows the region A that is scanned first in shades; Paragraph [0160]; a technician refers to an X-ray image, and generates a schematic diagram to be archived, adding a mark at a position of a region of interest on a schematic diagram for breast diagnosis schematically expressing a breast.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the diagnosis interface of Zhu in view of Cheng, Jones, Mori, and Lee to have included displaying a plurality of ROI interfaces and displaying an imaging area requiring diagnosis according to a user's selection as further taught by Mori because it would have allowed the user to more clearly see which areas need examination and thus reduce the burden on the user, and further allowed the user to choose which areas to examined and thus improve the workflow in efficiency in an examination using both mammographic images and ultrasonic images (Mori, Paragraph [0166]).
Regarding claim 13, Zhu teaches an operating method of a breast cancer diagnosis system (Paragraph [0048]-[0049]; medical imaging apparatus and methods for medical imaging wherein diffusive optical tomography (DOT); advantageous in that it can be used for probing inclusions (e.g., cancers, tumors, lesions, and the like); Paragraph [0052]; such as a tumor within a female breast) based on near-infrared measurement technology (Paragraph [0050]; Diffuse optical tomography (DOT) in the near infrared region (NIR)), the operating method comprising:
receiving unit scan data including optical data of reflected light from a target object (Paragraph [0056]-[0057]; first detector 12; first detectors 12 are capable of detecting radiation emitted by the emitters 10 and fluorescence within the target area; paragraph [0072]; light introduced into the tissue travels a crescent-like path, and thus may not impinge on inclusions that are closer to the skin, Fig. 4(b), the light reflected in the skin is detected by detectors 12) sensed by a probe (Paragraph [0056]; probe 4 that can be disposed on bodily tissue 6 to image an inclusion 8 therein);
calculating a concentration of chromophore of the target object for each chromophore based on the unit scan data (Paragraph [0111]; In principle, any two wavelengths in the NIR window can be used to compute the total hemoglobin concentration from equation; Paragraph [0114]; three typical wavelengths of 690 nm, 780 nm, and 830 nm are implemented in our system for estimation of total hemoglobin concentration and blood oxygen saturation; The hemoglobin and blood oxygen are considered to be chromophores as understood in its broadest reasonable interpretation);
generating an image of the chromophore indicating a distribution of the calculated concentration values of the chromophores (Paragraph [0141]; The total hemoglobin maps and the blood oxygen saturation maps at 50 MHz and 140 MHz are computed and the images are shown in FIG. 17(e1, e2) and (f1, f2), respectively) on a two-dimensional coordinates to generate a unit frame image (Paragraph [0141]; total hemoglobin maps and the blood oxygen saturation maps are shown in Figs. 17E and 17F); and
outputting the image of the generated chromophore through a display (Paragraph [0056]; display 20, Fig. 1; operably connected to a central processing unit 18… on which an image of the inclusion 8 can be generated; claim 16, provide diffusive optical tomography and fluorescent diffusive optical tomography),
outputting an examination interface for guiding a scanning procedure through the probe (Paragraph [0079]; Captured ultrasound images are directly sent to the display 20 for review and also for guiding near-infra-red imaging formation),
wherein in the probe, N(N is a plural natural number) channel signal processing units (Paragraphs [0074] and [0078]; source circuit 14 with 4x1 and 1x9 optical switch and a detector circuit subsystem 54; comprises a plurality of parallel channels… , the detection subsystem comprises 10 parallel channels; Figs. 5 and 6) including one or more light irradiation modules (Paragraph [0058]; number of first emitters 10, Fig. 2) and one or more light collection modules are disposed (Paragraph [0058]; number of first detectors 12, Fig. 2), and each of the N channel signal processing units sequentially operates (Paragraph [0075]; laser diodes were sequentially delivered to 9 locations on the probe through 3x1 and 1x9 optical switches 36 and 38 respectively; the light is sequentially delivered; Paragraphs [0074]-[0078]; acquire data from 10 parallel detection channels… directly mixing the outputs of the corresponding transmit and receive oscillators at each modulation frequency; The reception is done sequentially for each light output) so that each of the N channel signal processing units generates the optical data of the reflected light (Paragraph [0078]; 20 kHz difference signals were further amplified by 50 dB and bandpass filtered before sampled by A/D converters, Fig. 6 shows the signal from the light guide is processed through the pre-amp, mixer, and op-amp/bandpass filter, and sent to the computer), and
wherein in the step of calculating the concentration of the chromophore, the concentration of the chromophore of the target object is calculated (Paragraph [0112]; estimation of total hemoglobin concentration favors the wavelength pair of 780 nm and 830 nm; blood oxygenation saturation estimation is best for the wavelength pair of 660 nm and 830 nm) by inputting the unit scan data transmitted from the probe (Paragraphs [0074]-[0078]; acquire data from 10 parallel detection channels… directly mixing the outputs of the corresponding transmit and receive oscillators at each modulation frequency; The reception is done sequentially for each light output);
and wherein a measurement value for each wavelength of light (Paragraphs [0110]-[0114]; any two wavelengths in the NIR window can be used to compute the total hemoglobin concentration from equation (7)) and the concentration of each of a plurality of chromophore materials are matched respectively (Paragraphs [0110]-[0114]; three typical wavelengths of 690 nm, 780 nm, and 830 nm are implemented in our system for estimation of total hemoglobin concentration and blood oxygen saturation); and an area requiring imaging as a contrast area for the imaging area requiring the diagnosis (Paragraphs [0101]-[0107]; the entire tissue volume is segmented, including a background region, B; total absorption distributions are calculated based on the background absorption coefficient; In each reconstruction step, only one layer with finer mesh or ROI # is reconstructed and the other target layers are treated as background).
Zhu does not explicitly teach the receiving unit scan data including a total of N pieces of optical data,
each channel signal processing unit generates the unit scan data including a total of N pieces of the optical data,
the N channel signal processing units are disposed in a horizontal direction along one axis of the probe, and
the light irradiation modules and the light collection modules of two of the channel signal processing units adjacent to each other are disposed adjacent to each other, the light irradiation modules are disposed in a row parallel to the one axis, and the light collection modules are disposed in a row parallel to the one axis by being spaced apart from the light irradiation modules by predetermined distances; and
applying each of the unit scan data to a learning model machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively;
wherein the learning model is machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively; and
the examination interface includes a scanning guide interface indicating a state of securing the unit scan data of the probe and an imaging guide interface displaying a left breast area and a right breast area, respectively,
and a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging as a contrast area are displayed on the imaging guide interface, and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface or the second ROI interface, and
the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Cheng, however, teaches an operating method of a diagnosis system (Col. 1, ln. 15-22; techniques for monitoring vital functions of the human body, including cardiac functions such as cardiac output and central venous blood oxygenation) comprising:
the receiving unit scan data including a total of N pieces of optical data (Col. 14, ln. 52-64; each photodetector is monitored… position (d) along the vein to yield an output),
channel signal processing units including one or more light irradiation modules and one or more light collection modules are disposed (Col. 14, ln. 27-51; Each light source 320… is associated with a corresponding photodetector 330; Fig. 13; Col. 14, ln. 52-64; each photodetector is monitored … transmitted to a signal processing device; The signal processing device for each of the light source 320 associated with a corresponding photodetector 330 is considered to read on the claimed limitation of N channel signal processing units including one or more light irradiation modules and one or more light collection modules), and each of the N channel signal processing units sequentially operates so that each of the N channel signal processing units generates the optical data of the reflected light (Col. 14, ln. 27-64; a corresponding photodetector 330 suitable to detect reflected or transmitted light from its corresponding light source 320; output signal (e.g. current/voltage) of each photodetector is monitored (or transmitted to a signal processing device for translation to an alternate form of output such as a visual waveform output which is monitored) to determine whether there is an output or not), thereby generates unit scan data including a total of N pieces of the optical data (Col. 14, ln. 52-64; each photodetector is monitored… position (d) along the vein to yield an output, e.g. a waveform, is then determined based on the output from each photodetector in the sequence; The output of each photodetector is considered to read on the claimed limitation of generates unit scan data including a total of N pieces of the optical data as understood in its broadest reasonable interpretation),
the N channel signal processing units are disposed in a horizontal direction along one axis of the probe (Fig. 13 shows each pair of light source and detector are disposed in the d direction which is considered to read on the claimed limitation of disposed in a horizontal direction along one axis of the probe as understood in its broadest reasonable interpretation), and
the light irradiation modules and the light collection modules of two of the channel signal processing units adjacent to each other are disposed adjacent to each other, the light irradiation modules are disposed in a row parallel to the one axis, and the light collection modules are disposed in a row parallel to the one axis by being spaced apart from the light irradiation modules by predetermined distances (Fig. 13 shows the light sources and photodetectors are disposed adjacent to each other, the light sources are disposed in a row parallel to the d axis, the photo detectors are disposed in a row parallel to the d axis spaced apart from the light sources by a predetermined distance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Zhu such that the each channel signal processing unit generates unit scan data includes a total of N pieces of the optical data and further receiving the N pieces of optical data; modifying the probe such that the N channel signal processing units are disposed in a horizontal direction along one axis of the probe, and the light irradiation modules and the light collection modules of two of the N channel signal processing units adjacent to each other are disposed adjacent to each other, the light irradiation modules are disposed in a row parallel to the one axis, and the light collection modules are disposed in a row parallel to the one axis by being spaced apart from the light irradiation modules by predetermined distances as taught by Cheng. Such an arrangement would allow processing the individual contributions from sensor, thereby allowing comparison of signals between each position to determine a position where the signal is maximized (Cheng; Col. 14, ln. 52-64 and Col. 16, ln. 38-52) and thus improve mapping of concentrations of vascularization of the tumor.
The method of Zhu in view of Cheng does not explicitly teach applying each of the unit scan data to a learning model machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively;
the examination interface includes a scanning guide interface indicating a state of securing the unit scan data of the probe and an imaging guide interface displaying a left breast area and a right breast area, respectively,
and a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging as a contrast area are displayed on the imaging guide interface, and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface or the second ROI interface, and
the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Jones, however, teaches a cancer diagnosis method (Paragraph [0005]; real time assessment of information relating to a subject; Paragraph [0020]; information relating to the subject comprises… cancer) based on near-infrared measurement technology (Paragraph [0042]; spectral data comprises… NIR spectral data) comprising:
receiving optical data of reflected light from a target object sensed by a probe (Paragraph [1031]-[1032]; spectrometer 20 includes a light source generating light in the near-infrared spectrum, and an accompanying photodetector sensitive to the near-infrared spectrum; generate spectral data for a sample within the GI tract of a subject);
calculating a concentration of chromophore of the target object for each chromophore based on the optical data (Paragraph [1293]-[1294]; PLS-based model for predicting concentration of Hemoglobin in water; Paragraph [1348]; predict the oxygenation level of a blood sample);
wherein in the step of calculating the concentration of the chromophore, the concentration of the chromophore of the target object is calculated by inputting a measurement value for each wavelength of the reflected light sensed through the probe to a learning model machine-learned based on training data in which a measurement value for each wavelength of light and the concentration of each of a plurality of chromophore materials are matched respectively (Paragraph [1293]; acquired transmission spectra corresponding to Hemoglobin solutions shown in FIGS. 44A-44D were used as training inputs for machine learning modeling, e.g., machine learning modeling that uses a PLS algorithm; used to predict the concentration of Hemoglobin of a solution to which one of the acquired spectra corresponds; unknown Hemoglobin concentration determined by (i) identifying one of a number of spectra corresponding to solutions having known concentrations of Hemoglobin that best matches the acquired spectrum, and (ii) assigning to the unknown concentration a value of the Hemoglobin concentration for the solution to which the identified spectrum corresponds; Paragraph [1348]; machine learning modeling for predicting blood oxygenation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Zhu in view of Cheng to have included a learning model machine-learned based on training data to calculate the concentration of the chromophore as taught by Jones because it would have been a well understood method of determining chromophore concentration from spectral data that would have had the benefit of further being able to determine the compounds in the a sample and more accurately predict concentrations of multiple analytes in samples comprising multiple compounds (Jones, Paragraphs [1080] and [1142]).
The method of Zhu in view of Cheng does not explicitly teach the examination interface includes a scanning guide interface indicating a state of securing the unit scan data of the probe and an imaging guide interface displaying a left breast area and a right breast area, respectively,
and a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging as a contrast area are displayed on the imaging guide interface, and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface or the second ROI interface, and
the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Mori, however, teaches a breast cancer diagnosis system (Paragraph [0032]; medical information-processing system for breast cancer examinations) comprising a central control device (Paragraph [0035]; image processing device 30 processes the mammographic image) configured to outputs an examination interface for guiding a scanning procedure through the probe (Paragraphs [0056]-[0058]; FIG. 5 depicts one example of the schematic diagram that is used by the position specifying function 35e; generates a schematic diagram to be archived in which a mark indicating a region of interest is positioned) and the examination interface includes an imaging guide interface displaying a left breast area and a right breast area, respectively, (Paragraph [0056]-[0057]; schematic diagram of a breast region; Fig. 5 shows the right and left breast areas) and a first ROI interface displaying an imaging area requiring diagnosis (Paragraph [0144]; displays scanning order indicating a region before scanning; Fig. 22 and 23 show a plurality of regions to be scanned) and a second ROI interface displaying an area requiring imaging displayed on the imaging guide interface (Paragraph [0144]; displays scanning order indicating a region before scanning; Fig. 22 and 23 show a plurality of regions to be scanned); and
wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface (Paragraph [0145] Subsequently, the setting-condition determining function 172 shows the region A that is scanned first in shades indicating that it is being scanned at step S401, and shows the rest of the regions, the region B, the regions C and C′, and the regions D and E in dots indicating that it is before scanning; Fig. 22 and 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the examination interface of Zhu in view of Cheng and Jones to have included an imaging guide interface displaying a left breast area and a right breast area, respectively, and displaying a first ROI interface displaying an imaging area requiring diagnosis and a second ROI interface displaying an area requiring imaging, including the areas for contrast area wherein the unit scan data is collected by the probe in the area corresponding to the first ROI interface, as taught by Mori because use of the indication regions can allow the user to more clearly see which areas need examination and thus reduce the burden on the use. As a result, according to the first embodiment, time required for ultrasonic scanning can be shortened, to improve the workflow (Mori, Paragraph [0117]).
The method of Zhu in view of Cheng, Jones, and Mori does not explicitly teach the scanning guide interface displays a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface.
Lee, however, teaches a breast cancer diagnosis system (Pg. 2, Para. 2; The present invention relates to a method for detecting breast cancer using a breast cancer examiner having a built-in calculation unit including a sensor position correction module) wherein the scanning guide interface displays a state indicating whether each unit scan data is collected (Pg. 19, Para. 3; The peripheral sensor unit 130 is displayed with different colors from CH2 to CH5 so that the values of the bio-signals measured at the corresponding sites are displayed; The value of the measurement displayed is considered to be a state indicating scan unit data is collected as understood in its broadest reasonable interpretation) for each preset plurality of positions (Pg. 6, Para. 2; sensor unit 100 is a sensor attached to one side of the subject's breast and attached to a site where the presence or absence of tumor of the subject is to be checked) in the area corresponding to the first ROI interface (Pg. 19, Para. 3; at the corresponding sites).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the scanning guide interface of Zhu in view of Cheng, Jones, and Mori to have displayed a state indicating whether each unit scan data is collected for each preset plurality of positions in the area corresponding to the first ROI interface or the second ROI interface as taught by Lee because it would have allowed measuring a bio-signal of a tumor more specifically based on determining a relative position of a plurality of sensor units (Lee, Pg. 12, Para. 5).
Regarding claim 16, together Zhu, Cheng, Jones, Mori, and Lee teach all of the limitations of claim 13 as noted above.
Zhu further teaches 16 a plurality of ROI interfaces (Paragraph [0102]; the entire tissue volume is segmented based on co-registered ultrasound images into an inclusion region, L (region of interest, ROI); Paragraph [0102]; we divide the region of interest (ROI) into N zones in N layers denoted as ROI#1, ROI#2, . . . ROI#N respectively) an imaging area requiring diagnosis (Paragraph [0101]; co-registered ultrasound images into an inclusion region, L), and a plurality of ROI interfaces of a contrast area corresponding thereto (Paragraph [0101]; and a background region, B; Paragraph [0107]; other target layers are treated as background).
Zhu does not explicitly teach the diagnosis interface displays a plurality of ROI interfaces and displaying an imaging area requiring diagnosis according to a user's selection
wherein the number of the first ROI interfaces and the second ROI interfaces is the same, and the number of the first and second ROI interfaces is determined based on user selection.
Mori, however, further teaches the diagnosis interface displays a plurality of ROI interfaces (Paragraph [0144]; displays scanning order indicating a region before scanning, a region being scanned, and a region after scanning in respective different forms on the display 103; Figs. 22 and 23 show a plurality of regions) and displaying an imaging area requiring diagnosis according to a user's selection (Paragraph [0160]; the acquiring function 171 can acquire region-of-interest information based on information that is added by a technician that refers to an X-ray image; a technician refers to an X-ray image, and generates a schematic diagram to be archived, adding a mark at a position of a region of interest on a schematic diagram for breast diagnosis schematically expressing a breast);
wherein the number of the first ROI interfaces and the second ROI interfaces is the same, and the number of the first and second ROI interfaces is determined based on user selection (Paragraphs [0144]-[0145]; function 172 displays scanning order indicating a region before scanning, a region being scanned, and a region after scanning in respective different forms on the display 103; entire region in the body mark with dots indicating it is before scanning… Subsequently, the setting-condition determining function 172 shows the region A that is scanned first in shades; Paragraph [0160]; a technician refers to an X-ray image, and generates a schematic diagram to be archived, adding a mark at a position of a region of interest on a schematic diagram for breast diagnosis schematically expressing a breast.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the diagnosis interface of Zhu in view of Cheng, Jones, Mori, and Lee to have included displaying a plurality of ROI interfaces and displaying an imaging area requiring diagnosis according to a user's selection as further taught by Mori because it would have allowed the user to more clearly see which areas need examination and thus reduce the burden on the user, and further allowed the user to choose which areas to examined and thus improve the workflow in efficiency in an examination using both mammographic images and ultrasonic images (Mori, Paragraph [0166]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Cheng, Jones, Mori, and Lee as applied to claim 1 above, and further in view of Han (EP 3460453 A2).
Regarding claim 2, together Zhu, Cheng, Jones, Mori, and Lee teach all of the limitations of claim 1 as noted above.
Zhu further teaches the probe includes a body (Figs. 3 and 7A, probe 4 has a body) that includes the channel signal processing units (Paragraph [0009]; probe comprising… a source circuit connected in operational communication to the emitter; a detector circuit connected in operational communication to the detector); and
a contact surface that is disposed on a lower surface of the body (Paragraph [0057]; a faceplate 30, Figs. 2 and 3), the light irradiation module and the light collection module of the channel signal processing unit are disposed in a state of being exposed to the outside through an opening formed on the contact surface (Paragraphs [0057] and [0059]; plurality of first emitters 10 and first detectors 12 disposed on a faceplate 30, Fig. 2; disposed on the surface of the faceplate 30 so that they are in close proximity to the tissue 6 being imaged).
Zhu does not explicitly teach a first control unit controlling an operation of the channel signal processing unit, and a first communication unit transmitting output data of the first control unit to an outside of the probe.
Han, however, teaches a probe (Paragraph [0111]; Probe 1403, Fig. 14) that sequentially outputs light of a plurality of wavelengths of a near-infrared area to a target object (Paragraph [0132]; the processing circuit 2030 may sequentially drive the multiple light emission units 2010 and drive at least one detection unit adjacent to each driven light emission unit and thus can analyze biological constituent components corresponding to different locations in the subject 20), receives reflected light reflected from the target object (Paragraph [0110]; transmit light reflected from the subject to the light detector 12, Fig. 14), and sequentially processes the reflected light (Paragraph [0156]-[0157]; bio-signal analyzing apparatus 10 may sequentially obtain four or more output lights reflected… coefficient and an absorption coefficient at each discrete wavelength),
wherein in the probe, one or more channel signal processing units (Paragraph [0110]; housing 1404 including the processing circuit 13) including one or more light irradiation modules (Paragraph [0110]; light source, LD 11, Fig. 14) and one or more light collection modules are disposed (Paragraph [0110]; light detector 12, Fig. 14), and each of the channel signal processing units sequentially operates so that each of the channel signal processing units generates the optical data of the reflected light (Paragraph [0141]; by sequentially driving the light emission units and the detection units in the respective pairs D1-S 1, D2-S2, D3-S3, and D4-S4);
and further comprises a first control unit (Paragraph [0110]; processing circuit 13, Fig. 14) controlling an operation of the channel signal processing unit (Paragraph [0132]; the processing circuit 2030 controls the multiple light emission units 2010 and the multiple detection units 2020), and a first communication unit transmitting output data of the first control unit to an outside of the probe (Paragraph [0143]; a communication circuit (not illustrated) configured to transmit the result values of analysis of biological constituent components to another device); and the one or more channel signal processing units are disposed in a horizontal direction along one axis of the probe (Fig 17 shows the components of the probe are disposed in a horizontal direction along one axis of the probe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of in view of Zhu, Cheng, Jones, Mori, and Lee to have further included first control unit controlling an operation of the channel signal processing unit, and a first communication unit transmitting output data of the first control unit to an outside of the probe as taught by Han. This would have been a well understood arrangement of the components for controlling the light transmission on the probe that further would have simplified the use of the device as all the necessary components for controlling the device could be directly controlled from the probe itself, and further allowed transferring data to other parts of the diagnosis system for data analysis.
Regarding claim 3, together Zhu, Cheng, Jones, Mori, Lee, and Han teach all of the limitations of claim 2 as noted above.
Zhu further teaches each of the channel signal processing units includes one or more light irradiation modules disposed adjacent to each other (Paragraph [0072]; first emitters 10 and the first detectors 12 are disposed so as to be parallel to one another);
the light collection module disposed by being spaced apart from the light irradiation module by predetermined distance (Paragraph [0071]; First emitter 10 is a predetermined distance 84 and 86 from detectors 78 and 80, respectively).
Zhu does not explicitly teach a driving chip that sequentially outputs a driving signal for driving the light irradiation module according to a control signal of the first control unit and transmits the optical data of the reflected light detected by the light collection module to the first control unit, and
the driving chip of each of the channel signal processing units sequentially outputs 4 to 12 driving signals so that light of 4 to 12 different wavelengths is sequentially output from the light irradiation module.
Han, however, further teaches a driving chip (Paragraph [0059]; processing circuit 13) that sequentially outputs a driving signal for driving the light irradiation module (Paragraph [0059]; The processing circuit 13 may execute the program to control driving of the four or more LDs 11; Paragraph [0038]; sequentially driving four or more LDs configured to emit light) according to a control signal of the first control unit (Paragraph [0059]; processing circuit 13 may execute the program) and transmits the optical data of the reflected light detected by the light collection module to the first control unit (Paragraph [0058]; processing circuit 13 is configured to control overall operations of the bio-signal analyzing apparatus 10. For example, the processing circuit 13 may execute a bio-signal analyzing program), and
the driving chip of each of the channel signal processing units sequentially outputs 4 to 12 driving signals so that light of 4 to 12 different wavelengths is sequentially output from the light irradiation module (Paragraph [0038]; sequentially driving four or more LDs; Paragraph [0063]; processing circuit 13 may sequentially drive the selected two or more LDs… then drive LDs that emit light at a gradually longer wavelength).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the probe of Zhu in view of Cheng, Jones, Mori, Lee, and Han to have further included a driving chip that sequentially outputs a driving signal for driving the light irradiation module according to a control signal of the first control unit and transmits the optical data of the reflected light detected by the light collection module to the first control unit, and the driving chip of each of the channel signal processing units sequentially outputs 4 to 12 driving signals so that light of 4 to 12 different wavelengths is sequentially output from the light irradiation module as taught by Zhu. This would have allowed simplified use of the probe by having all necessary programs and circuitry for performing the data collection and analysis.
Regarding claim 4, together Zhu, Cheng, Jones, Mori, Lee, and Han teach all of the limitations of claim 2 as noted above.
Zhu further teaches the first control unit includes a first decoder that sequentially transmits a control signal for operating a driving chip of each of the channel signal processing units (Paragraph [0069]; near-infrared radiation at 780 nm and 830 nm that is modulated at predetermined frequencies (e.g., 350 MHz, 140 MHz and 50 MHz) by an oscillator (OSC2) 90); and
a second decoder that sequentially receives and outputting the optical data of the reflected light output from each of the driving chips (Paragraph [0077]; an output carrier signal having a predetermined frequency (e.g., 350.02 MHz, 140.02 MHz and 50.02 MHz) by a local oscillator (OSC1) 60 that is connected in electrical communication with the voltage via mixer 62. The heterodyned signals output by mixer 62 are filtered by a narrowband filters (F1) 64 and further amplified (e.g., by 30 dB) by amplifier (AMP) 66).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Cheng, Jones, Mori, Lee, and Han as applied to claim 2 above, and further in view of Murai (US 20150126865).
Regarding claim 5, together Zhu and Han teach all of the limitations of claim 2 as noted above.
Together Zhu and Han do not teach the probe further includes a blinking LED or liquid crystal display in a housing outside the body, and
upon receiving all of the optical data of the reflected light corresponding to a unit scan through each of the channel signal processing units, the first control unit displays that the unit scan is completed through the blinking LED or the liquid crystal display.
Murai, however, teaches a probe (Paragraph [0127]; Ultrasonic probe 50C, Fig. 11A) including a blinking LED or liquid crystal display in a housing outside the body (Paragraph [0057]; notification section 58 formed by an array of a plurality of LEDs, Fig. 11A), and
upon receiving all of the optical data of the reflected light corresponding to a unit scan through each of the channel signal processing units (Paragraph [0070]; notification pattern indicating "under tissue detection determination" of the notification section 58), the first control unit displays that the unit scan is completed through the blinking LED or the liquid crystal display (Paragraph [0058]; notification according to a notification pattern including blinking pattern, color, light and dark, and the like; Paragraph [0070]-[0075]; The end condition can be set as "when predetermined measurement time has passed"; When it is detected that the end condition is satisfied… measuring device performs control to turn off the notification section 58; The control to turn off the notification section when the measurement is completed is considered to read on the claim limitation of displaying that the unit scan is completed as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the probe of Zhu in view of Cheng, Jones, Mori, Lee, and Han to have further included a blinking LED or liquid crystal display in a housing outside the body, and upon receiving all of the optical data of the reflected light corresponding to a unit scan through each of the channel signal processing units, the first control unit displays that the unit scan is completed through the blinking LED or the liquid crystal display as it would have informed the user when the probe is properly in place and the measurement is proceeding, and further when the measurement is complete, allowing the user to know when to change positions for scanning or to conclude the diagnostic scan (Murai, paragraphs [0069]-[0075]), thereby reducing the overall imaging and diagnosis time.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Cheng, Jones, Mori, and Lee as applied to claim 1 above, and further in view of Stillwell (US 12004843).
Regarding claim 7, together Zhu, Cheng, Jones, Mori, and Lee teach all of the limitations of claim 1 as noted above.
Zhu further teaches the unit scan data includes the optical data of the reflected light reflected based on light of 4 or more and 12 or less different wavelengths output from the light irradiation module of each of the channel signal processing units (Paragraph [0069]; emitting near-infrared radiation at 660 nm or 690 nm and near-infrared radiation at 780 nm and 830 nm; Paragraph [0112]; two wavelengths in the NIR window can be used to compute the oxygenation saturation using… 660/830 nm, 690/830 nm, 730/830 nm and 780/830 nm percent ratios).
Together Zhu, Cheng, and Jones do not teach data of each coordinate and an empty space between the coordinates displays an estimated value through an interpolation algorithm.
Stillwell, however, teaches a breast cancer diagnosis system using near-infrared measurement technology (Col. 3, ln. 38-63; Frequency domain diffuse optical spectroscopy for characterizing biological tissue… using light ranging from about 650 nanometers to 1,350 nanometers… including monitoring chemotherapy treatments of breast cancer),
wherein data of each coordinate and an empty space between the coordinates displays an estimated value through an interpolation algorithm (Col. 7, ln. 21-53; electronic processing circuit 135 uses the concentration values to build bi-cubic interpolated images, Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Zhu in view of Cheng, Jones, Mori, and Lee to have included displaying an estimated value through an interpolation algorithm for data of each coordinate and an empty space between the coordinates as taught by Stillwell because it would have been a well understood method for visualizing concentration data and further improved the output image to more clearly identify tumorous tissue (Stillwell, Col. 7, ln. 21-53).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Cheng, Jones, Mori, and Lee as applied to claims 1 and 10 above, respectively, and further in view of McKinney (US 20220254023).
Regarding claim 11, together Zhu, Cheng, Jones, and Mori teach all of the limitations of claim 1 as noted above.
Zhu further teaches the central control device outputs a diagnosis interface that outputs the chromophore image indicating a distribution state of the chromophores (Paragraph [0141]; total hemoglobin maps and the blood oxygen saturation maps at 50 MHz and 140 MHz are computed and the images are shown in FIG. 17(e1, e2) and (f1, f2), respectively).
Together Zhu and Mori do not explicitly teach the diagnosis interface disposes and displays the chromophore image of a diagnosis area generated based on data collected using the first ROI interface and the chromophore image of the contrast area generated based on data collected using the second ROI interface, side by side.
McKinney, however, teaches a breast cancer diagnosis system (Paragraph [0002]; a method and system for interpretation of multiple medical images; Paragraph [0005]; method of processing a set of medical images… In a mammography) comprising a diagnosis interface that disposes and displays the chromophore image of a diagnosis area generated based on data collected using the first ROI interface and the chromophore image of a contrast area generated based on data collected using the second ROI interface, side by side (Paragraph [0006]-[0011]; identifying one or more regions of interest (e.g., potentially cancerous lesions); identifying a (respective) reference region in the associated counterpart image; cropping out the regions of interest and the reference regions identified in step b) from their respective images; generating a visualization of the set of medical images and the associated counterpart images; Fig. 6; The cropped images are side by side as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Zhu in view of Cheng, Jones, Mori, and Lee to have further included disposing and displaying the chromophore image of a diagnosis area generated based on data collected using the first ROI interface and the chromophore image of a contrast area generated based on data collected using the second ROI interface, side by side as taught by McKinney because it would alleviate some of the labor intensity of the double reading process as it would allow the user to more easily determine suspicious or non-suspicious regions in from the images (McKinney, Paragraph [0091]).
Regarding claim 12, together Zhu, Cheng, Jones, Mori, and Lee teach all of the limitations of claim 10 as noted above.
Zhu further teaches displaying the chromophore image of a contrast for each type of the chromophore (Figs. 17E and 17F show chromophore images of total hemoglobin and oxygen saturation).
Zhu does not teach the diagnosis interface disposes and displays the chromophore image of the diagnosis area and the chromophore image of the contrast area side by side for each type of the chromophore.
McKinney, however, teaches a breast cancer diagnosis system (Paragraph [0002]; a method and system for interpretation of multiple medical images; Paragraph [0005]; method of processing a set of medical images… In a mammography) comprising a diagnosis interface that disposes and displays the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side (Paragraph [0006]-[0011]; identifying one or more regions of interest (e.g., potentially cancerous lesions); identifying a (respective) reference region in the associated counterpart image; cropping out the regions of interest and the reference regions identified in step b) from their respective images; generating a visualization of the set of medical images and the associated counterpart images; Fig. 6; The cropped images are side by side as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the diagnosis interface of Zhu in view of Cheng, Jones, Mori, and Lee to have further included disposing and displaying the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side as taught by McKinney because it would alleviate some of the labor intensity of the double reading process as it would allow the user to more easily determine suspicious or non-suspicious regions in from the images (McKinney, Paragraph [0091]). It further would have been obvious to have performed the step of disposing and displaying the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side for each type of the chromophore as it would have been a mere duplication of steps that would have allowed the user to see the contrast maps for each chromophore and thus make a more informed decision about whether spots are suspicious or non-suspicious, thereby improving the diagnosis method.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Cheng, Jones, Mori, and Lee as applied to claim 13 above, and further in view of McKinney (US 20220254023).
Regarding claim 17, together Zhu, Cheng, Jones, Mori, and Lee teach all of the limitations of claim 13 as noted above.
Zhu further teaches the step of outputting the chromophore image includes a step of outputting a diagnosis interface that outputs the chromophore image indicating a distribution state of the chromophores (Paragraph [0141]; total hemoglobin maps and the blood oxygen saturation maps at 50 MHz and 140 MHz are computed and the images are shown in FIG. 17(e1, e2) and (f1, f2), respectively).
Together Zhu and Jones do not teach the diagnosis interface disposes and displays the chromophore image of a diagnosis area generated based on data collected using a first ROI interface and the chromophore image of a contrast area generated based on data collected using a second ROI interface, side by side.
McKinney, however, teaches a breast cancer diagnosis method (Paragraph [0002]; a method and system for interpretation of multiple medical images; Paragraph [0005]; method of processing a set of medical images… In a mammography) comprising a diagnosis interface that disposes and displays the chromophore image of a diagnosis area generated based on data collected using the first ROI interface and the chromophore image of a contrast area generated based on data collected using the second ROI interface, side by side (Paragraph [0006]-[0011]; identifying one or more regions of interest (e.g., potentially cancerous lesions); identifying a (respective) reference region in the associated counterpart image; cropping out the regions of interest and the reference regions identified in step b) from their respective images; generating a visualization of the set of medical images and the associated counterpart images; Fig. 6; The cropped images are side by side as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Zhu in view of Cheng, Jones, Mori, and Lee to have further included disposing and displaying the chromophore image of a diagnosis area generated based on data collected using the first ROI interface and the chromophore image of a contrast area generated based on data collected using the second ROI interface, side by side as taught by McKinney because it would alleviate some of the labor intensity of the double reading process as it would allow the user to more easily determine suspicious or non-suspicious regions in from the images (McKinney, Paragraph [0091]).
Regarding claim 18, together Zhu, Cheng, Jones, Mori, Lee, and McKinney teach all of the limitations of claim 17 as noted above.
Zhu further teaches Zhu further teaches displaying the chromophore image of a contrast for each type of the chromophore (Figs. 17E and 17F show chromophore images of total hemoglobin and oxygen saturation).
Zhu does not teach the diagnosis interface disposes and displays the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side for each type of the chromophore.
McKinney, however, further teaches a breast cancer diagnosis method (Paragraph [0002]; a method and system for interpretation of multiple medical images; Paragraph [0005]; method of processing a set of medical images… In a mammography) comprising a diagnosis interface that disposes and displays the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side (Paragraph [0006]-[0011]; identifying one or more regions of interest (e.g., potentially cancerous lesions); identifying a (respective) reference region in the associated counterpart image; cropping out the regions of interest and the reference regions identified in step b) from their respective images; generating a visualization of the set of medical images and the associated counterpart images; Fig. 6; The cropped images are side by side as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the diagnosis interface of Zhu in view of Cheng, Jones, Mori, Lee, and McKinney to have further included disposing and displaying the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side as taught by McKinney because it would alleviate some of the labor intensity of the double reading process as it would allow the user to more easily determine suspicious or non-suspicious regions in from the images (McKinney, Paragraph [0091]). It further would have been obvious to have performed the step of disposing and displaying the chromophore image of the diagnosis area and the chromophore image of a contrast area side by side for each type of the chromophore as it would have been a mere duplication of steps that would have allowed the user to see the contrast maps for each chromophore and thus make a more informed decision about whether spots are suspicious or non-suspicious, thereby improving the diagnosis method.
Response to Arguments
Claim Objections
Applicant's arguments filed 08/08/2025 regarding the objections to claims 1 and 13 have been fully considered but they are not persuasive. Applicant argues the claims have been amended to overcome previous objections to the claims. Claims filed, 08/08/2025, however, do not appear to be amended with respect to the objections. No further arguments have been made regarding the objections to claims 1 and 13. For these reasons, objections to claims 1 and 13 are maintained. Examiner has further underlined suggestions to the minor informalities in the objections noted above.
Further objections to the claims are now presented above.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to claims 7, 11, and 12 and withdraws all rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 and 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
12/28/25