Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The status of claims 1-15 is:
Claims 1-15 were pending as of the Non-Final Rejection mailed 04/25/2025.
Claims 1-6, 8-9, and 12-15 are amended as of the amendments and remarks received 07/25/2025.
Claims 7 and 10-11 are cancelled as of the amendments and remarks received 07/25/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/01/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“imaging device” in claim 1.
Because this claim limitation(s) is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 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 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 being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
35 U.S.C. 101 requires that a claimed invention must fall within one of the four eligible categories of invention (i.e. process, machine, manufacture, or composition of matter) and must not be directed to subject matter encompassing a judicially recognized exception as interpreted by the courts. MPEP 2106. Three categories of subject matter are found to be judicially recognized exceptions to 35 U.S.C. § 101 (i.e. patent ineligible) (1) laws of nature, (2) physical phenomena, and (3) abstract ideas. MPEP 2106(II). To be patent-eligible, a claim directed to a judicial exception must as whole be integrated into a practical application or directed to significantly more than the exception itself (MPEP 2106). Hence, the claim must describe a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception.
Claims 1-6, 8-9, and 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. In the analysis below, the device of independent claim 1 is considered representative of independent claims 14-15. Each of the independent claims 1 and 14-15 are directed to one of the four statutory categories of eligible subject matter; thus, the claims pass Step 1 of the Subject Matter Eligibility Test (See flowchart in MPEP 2106).
Step 2A, Prong 1 Analysis
Independent claims 1 and 14-15 are directed to imaging a vessel in which a cell is seeded to acquire a vessel image; generating an image file including the vessel image and accessory information indicating an imaging date and time; transmitting the image file from the imaging device to the information processing device; receiving the image file by the processor and performing display control on the display based on the accessory information; acquiring two or more vessel images by receiving two or more image files obtained by imaging the same vessel at different dates and times; and causing the display to display the acquired two or more vessel images such that different imaging dates and times are distinguishable; performing positional deviation correction between two vessel images selected from among the acquired two or more vessel images on the basis of a scratch on the vessel in the vessel images; creating a difference image by calculating a difference between the two positionally corrected vessel images; and causing the display to display the created difference image. An individual can image a vessel in which a cell is seeded to acquire a vessel image, acquire two or more vessel images obtained by imaging the same vessel at different dates and times, and display the acquired two or more vessel images on a display such that different imaging dates and times are distinguishable. The steps of generating an image file including the vessel image and accessory information indicating an imaging date and time; transmitting the image file from the imaging device to the information processing device; receiving the image file by the processor and performing display control on the display based on the accessory information are insignificant extra-solution data acquisition. The steps of performing positional deviation correction between two vessel images selected from among the acquired two or more vessel images on the basis of a scratch on the vessel in the vessel images and creating a difference image by calculating a difference between the two positionally corrected vessel images are mathematical concepts which is also a category of abstract idea. Accordingly, the analysis under prong one of Step 2A of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106).
Additional elements
Independent claim 1 claims a determination support system comprising an imaging device, a display, and an information processing device including a processor. Independent claim 14 has the same additional elements as claim 1. Independent claim 15 claims a non-transitory computer-readable storage medium storing a program.
Step 2A, Prong 2 Analysis
The above-identified elements do not integrate the judicial into a practical application nor do they suggest an improvement.
The additional elements of an a determination support system comprising an imaging device, a display, and an information processing device including a processor, and a non-transitory computer-readable storage medium storing a program amounts to merely using generic computer hardware or components as a tool to perform the claimed mental process. Using a general purpose computer to apply a judicial exception does not qualify as a particular machine and therefore, does not integrate a judicial exception into a practical application (See MPEP 2106.05(b)). Furthermore, implementing an abstract idea on a computer does not integrate a judicial exception into a practical application (See MPEP 2106.05(f)).
Moreover, the additional elements of the claims do not recite an improvement in the functioning of a computer or another technology or technical field, the claimed steps do not effect a transformation, and the claims do not apply the judicial exception in any meaningful way beyond generically linking the use of the judicial exception to a particular technological environment (See MPEP 2106.04(d)). Therefore, the analysis under prong two of step 2A of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106).
Step 2B
Finally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Regarding independent claims 1 and 14-15, as noted above, the additional elements are generic computer features which perform generic computer functions that are well-understood, routine, and conventional and do not amount to more than implementing the abstract idea with a computerized system. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves and other technology. Their collective functions merely provide conventional computer implementation, and mere implementation on a generic computer does not add significantly more to the claims. Accordingly, the analysis under step 2B of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106).
Simply automating a mental process that can be performed manually by a person by using a computer or neural network is, by itself, not patent eligible. The fact that the computer or neural network can perform the process faster or more accurately is not enough for the process to be considered integrated into a practical application or for it to be considered to amount to significantly more than the process itself.
For all the foregoing reasons, independent claims 1 and 14-15 do not recite eligible subject matter under 35 USC 101.
Claim 2 recites wherein the processor acquires the two or more vessel images respectively from the image files corresponding to: a first vessel image captured before the seeding of the cell, a second vessel image captured on a day of the seeding of the cell, a third vessel image captured a day after the seeding of the cell, and a fourth vessel image captured in a culture process two or more days after the seeding of the cell. The features of claim 2 are directed to the mental process since acquiring multiple images does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 2 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 3 recites wherein the processor cause the display to display each of the two or more vessel images while changing a color of a frame such that different imaging dates and times are distinguishable. The feature of claim 3 is directed to the mental process since changing the color of a frame does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 3 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 4 recites wherein the processor causes the display to display the number of days elapsed since the seeding of the cell in association with each of the two or more vessel images such that different imaging dates and times are distinguishable. The feature of claim 4 is directed to the mental process since displaying the number of days elapsed since the seeding of the cell does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 4 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 5 recites wherein the processor causes the display to display two or more vessel images at positions corresponding to the number of days elapsed since the seeding of the cell such that different imaging dates and times are distinguishable. The feature of claim 5 is directed to the mental process since displaying images at positions corresponding to the number of days elapsed since the seeding of the cell does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 5 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 6 recites wherein the processor causes the display to synchronously display two or more vessel images. The feature of claim 6 is directed to the mental process since synchronously displaying two or more vessel images does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 6 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 8 recites wherein the processor creates the difference image from two images respectively obtained from the image files corresponding to: a first vessel image captured before the seeding of the cell, a second vessel image captured on a day of the seeding of the cell, a third vessel image captured a day after the seeding of the cell, and a fourth vessel image captured in a culture process two or more days after the seeding of the cell. The feature of claim 8 is directed to the mental process since having the difference image made from specific images does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 8 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 9 recites wherein the processor calculates a difference between the first vessel image and the second vessel image, the third vessel image, or the fourth vessel image to create the difference image. The feature of claim 9 is directed to the mental process since having the difference image made from specific images does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 9 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 12 recites wherein the processor receives input information input from an input operation device and selects two or more vessel images to be displayed on the display on the basis of the input information. The feature of claim 12 is directed to the mental process since selecting two or more images based on input information does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 12 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 13 recites wherein the processor acquires the vessel image captured at a different date and time for the same vessel as one of the vessel images being displayed on the display on the basis of the input information and causes the display to display the acquired vessel image on the display together with the vessel image being displayed on the display. The feature of claim 13 is directed to the mental process since it does not preclude the images from being analyzed as recited in claim 1. Accordingly, claim 13 does not integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
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.
Claim(s) 1, 5-6, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fujiwara (WO2019180811A1 using the translation provided herein, hereinafter “Fujiwara”) in view of Koehn et al. (U.S. Patent No 2018/0106713 provided in the IDS received 02/06/2024, hereinafter “Koehn”) and Weiss et al. (DE 69233061 T3 using the translation provided herein, hereinafter “Weiss”).
Regarding claim 1, Fujiwara discloses a determination support system comprising:
an imaging device configured to acquire a vessel image by imaging a vessel in which a cell is seeded (Fujiwara Page 3: “Upon receiving this measurement instruction, the imaging control unit 21 controls each part of the microscopic observation unit 10 to perform imaging (step S1)”), to generate an image file including the vessel image and accessory information indicating an imaging date and time (Fujiwara Page 3: “When collecting hologram data for the culture plate 13, the operator first sets the culture plate 13 on which the cells 14 to be observed are cultured at a predetermined position of the microscopic observation unit 10, and identifies the culture plate 13. The execution of measurement is instructed after inputting information such as a number and measurement date and time from the input unit 30. Upon receiving this measurement instruction, the imaging control unit 21 controls each part of the microscopic observation unit 10 to perform imaging (step S1)”), and to transmit the image file (Fujiwara Page 2: “The control / processing unit 20 controls the operation of the microscopic observation unit 10 and processes data acquired by the microscopic observation unit 10”);
a display (Fujiwara Page 2: “The cell observation apparatus of the present embodiment includes a microscope observation unit 10, a control / processing unit 20, and an input unit 30 and a display unit 40 that are user interfaces”); and
an information processing device including a processor (Fujiwara Fig. 1: processing unit (20)), the information processing device being configured to receive the image file and perform display control on the display based on the accessory information (Fujiwara Page 4: “The display processing unit 29 creates a cell determination result display screen 50 showing the cell state determination result based on the data stored in the determination result data storage unit 27, the reconstructed image data storage unit 25, and the hologram data storage unit 22. And it displays on the screen of the display part 40 (step S5)”),
wherein the processor:
receives two or more of the image files so as to acquire two or more vessel images obtained by imaging the same vessel at different dates and times (Fujiwara Page 4: “The cell determination result display screen 50 includes a detailed image display area 51 occupying a large area in the screen 50, a past image display area 54, a list display area 57, and an entire image display area 55”),
causes the display to display the acquired two or more vessel images such that different imaging dates and times are distinguishable (Fujiwara Page 6: “Accordingly, the reduced images acquired in the past for the culture plates having the same identification number are displayed together with the measurement date and time in the past image display area 54”), and
display the image processed by the information processing unit (Fujiwara Page 4: “The display processing unit 29 creates a cell determination result display screen 50 showing the cell state determination result based on the data stored in the determination result data storage unit 27, the reconstructed image data storage unit 25, and the hologram data storage unit 22. And it displays on the screen of the display part 40 (step S5)”).
Fujiwara does not explicitly disclose the system, wherein the processor:
performs positional deviation correction between two vessel images selected from among the acquired two or more vessel images on the basis of an identifying feature on the vessel in the vessel images, and
creates a difference image by calculating a difference between the two positionally corrected vessel images.
However, Koehn the system, wherein the processor:
performs positional deviation correction between two vessel images selected from among the acquired two or more vessel images on the basis of an identifying feature on the vessel in the vessel images (Koehn [0148]: “In the event that a first and a second image are recorded such that the coordinates or any other unique identifier assigned to cells and colonies cannot be directly compared between the first and second image, the two systems of coordinates or of other unique identifier used in the two images can be harmonized such that the comparison can be drawn. For example, if the point of origin of a (two-dimensional) coordinate system used in the first image lies a certain distance in a certain direction away from the point of origin of a (two-dimensional) coordinate system used in the second image, the coordinates assigned to cells in the first image can be adjusted by this distance in the appropriate direction in order to correspond to coordinates assigned to colonies in the second image, or vice versa”), and
creates a difference image by calculating a difference between the two positionally corrected vessel images (Koehn [0148]: “In the event that a first and a second image are recorded such that the coordinates or any other unique identifier assigned to cells and colonies cannot be directly compared between the first and second image, the two systems of coordinates or of other unique identifier used in the two images can be harmonized such that the comparison can be drawn. For example, if the point of origin of a (two-dimensional) coordinate system used in the first image lies a certain distance in a certain direction away from the point of origin of a (two-dimensional) coordinate system used in the second image, the coordinates assigned to cells in the first image can be adjusted by this distance in the appropriate direction in order to correspond to coordinates assigned to colonies in the second image, or vice versa”)
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the positional deviation correction of Koehn with the system of Fujiwara because it would improve the device because correcting the alignment and positioning of the two images will make the difference image more accurate. This motivation for the combination of Fujiwara and Koehn is supported by KSR exemplary rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. MPEP 2141 (III).
Further, Weiss teaches that a scratch on a vessel is a unique identifier of the vessel (Weiss Page 5: “the field can be identified by scratches in the plastic (arrowhead)”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Weiss with the combination of Fujiwara and Koehn because it would improve the device because correcting the alignment and positioning of the two images will make the difference image more accurate. This motivation for the combination of Fujiwara, Koehn, and Weiss is supported by KSR exemplary rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. MPEP 2141 (III).
Regarding claim 14, it is rejected under the same analysis as claim 1 above.
Regarding claim 15, it is rejected under the same analysis as claim 1 above along with Fujiwara’s disclosure of a non-transitory computer readable medium (Fujiwara Page 2: “Normally, the entity of the control / processing unit 20 is a personal computer installed with predetermined software (computer
program), a higher-performance workstation, or a high-performance computer connected to such a computer via a communication line. Including computer systems. That is, the function of each block included in the control / processing unit 20 is stored in the computer or the computer system, which is implemented by executing software installed in a computer system including a single computer or a plurality of computers”).
Regarding claim 5, Fujiwara discloses the system, wherein the processor causes the display to display two or more vessel images at positions corresponding to the number of days elapsed since the seeding of the cell such that different imaging dates and times are distinguishable (Fujiwara Fig. 4: Past image display area (54) has the images in the order they are taken which is also the position corresponding to the number of day elapsed since the seeding of the cell).
Regarding claim 6, Fujiwara discloses the system, wherein the processor causes the display to synchronously display two or more vessel images (Fujiwara Fig. 4: Past image display area (54) synchronously displays two or more vessel images).
Regarding claim 12, Fujiwara discloses the system, wherein the processor receives input information input from an input operation device and selects two or more vessel images to be displayed on the display on the basis of the input information (Fujiwara Page 6: “Accordingly, the reduced images acquired in the past for the culture plates having the same identification number are displayed together with the measurement date and time in the past image display area 54”; Fujiwara Page 3: “The execution of measurement is instructed after inputting information such as a number and measurement date and time from the input unit 30”, the inputting information of the date and time causes the selection of the images into the past image display area (54)).
Regarding claim 13, Fujiwara discloses the system, wherein the processor acquires the vessel image captured at a different date and time for the same vessel as one of the vessel images being displayed on the display on the basis of the input information (Fujiwara Page 3: “The execution of measurement is instructed after inputting information such as a number and measurement date and time from the input unit 30”) and causes the display to display the acquired vessel image on the display together with the vessel image being displayed on the display (Fujiwara Page 6: “Accordingly, the reduced images acquired in the past for the culture plates having the same identification number are displayed together with the measurement date and time in the past image display area 54”).
Claim(s) 2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over the Fujiwara, Koehn, and Weiss combination in view of Taro et al. (WO2019172395 provided in the IDS received 02/06/2024 but using the translation provided herein, hereinafter “Taro”).
Regarding claim 2, the Fujiwara, Koehn, and Weiss combination does not explicitly disclose the system, wherein the processor acquires the two or more vessel images respectively from the image files corresponding to:
a first vessel image captured before the seeding of the cell, a second vessel image captured on a day of the seeding of the cell, a third vessel image captured a day after the seeding of the cell, and a fourth vessel image captured in a culture process two or more days after the seeding of the cell.
However, Taro teaches the system, wherein the processor acquires the two or more vessel images respectively from the image files corresponding to:
a first vessel image captured before the seeding of the cell (Taro Page 3: “3A to 3C, “with cells” indicates an image of a culture container acquired during culture, “without cells” indicates an image of a culture container acquired before seeding cells, and “difference” indicates an image with “cells””), a second vessel image captured on a day of the seeding of the cell, a third vessel image captured a day after the seeding of the cell, and a fourth vessel image captured in a culture process two or more days after the seeding of the cell (Taro Page 3: “3A to 3C, “with cells” indicates an image of a culture container acquired during culture, “without cells” indicates an image of a culture container acquired before seeding cells, and “difference” indicates an image with “cells””).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the pre-seeding image and post-seeding images as taught by Taro with the system of the Fujiwara, Koehn, and Weiss combination because it would improve the device by allowing a user to see the progression of the cell culture over a period of time. This motivation for the combination of Fujiwara, Koehn, Weiss, and Taro is supported by KSR exemplary rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. MPEP 2141 (III).
Regarding claim 8, the Fujiwara, Koehn, and Weiss combination does not explicitly disclose the system, wherein the processor creates the difference image from two images respectively obtained from the image files corresponding to:
a first vessel image captured before the seeding of the cell, a second vessel image captured on a day of the seeding of the cell, a third vessel image captured a day after the seeding of the cell, and a fourth vessel image captured in a culture process two or more days after the seeding of the cell.
However, Taro discloses the system, wherein the processor creates the difference image from two images respectively obtained from the image files corresponding to:
a first vessel image captured before the seeding of the cell, a second vessel image captured on a day of the seeding of the cell, a third vessel image captured a day after the seeding of the cell, and a fourth vessel image captured in a culture process two or more days after the seeding of the cell (Taro Page 3: “3A to 3C, “with cells” indicates an image of a culture container acquired during culture, “without cells” indicates an image of a culture container acquired before seeding cells, and “difference” indicates an image with “cells”. And the difference image between the “cell-free” image””, as mapped this is the difference image between the first vessel image and the fourth vessel image).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the difference image as taught by Taro with the system of the Fujiwara, Koehn, and Weiss combination because it would improve the device by creating a visualization of the progression of cells over time which would allow a user to easily notice the changes in cells. This motivation for the combination of Fujiwara, Koehn, and Weiss, and Taro is supported by KSR exemplary rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. MPEP 2141 (III).
Regarding claim 9, the Fujiwara, Koehn, and Weiss combination does not explicitly disclose the system, wherein the processor calculates a difference between the first vessel image and the second vessel image, the third vessel image, or the fourth vessel image to create the difference image.
However, Taro teaches the system, wherein the processor calculates a difference between the first vessel image and the second vessel image, the third vessel image, or the fourth vessel image to create the difference image (Taro Page 3: “3A to 3C, “with cells” indicates an image of a culture container acquired during culture, “without cells” indicates an image of a culture container acquired before seeding cells, and “difference” indicates an image with “cells”. And the difference image between the “cell-free” image””, as mapped this is the difference image between the first vessel image and the fourth vessel image).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine Fujiwara and Taro for the same reason as used for claim 8 above.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over the Fujiwara, Koehn, and Weiss combination in view of Ohishi (U.S. Patent Publication No 2018/0279983, hereinafter “Ohishi”).
Regarding claim 3, the Fujiwara, Koehn, and Weiss combination does not explicitly disclose the system, wherein the processor causes the display to display each of the two or more vessel images while changing a color of a frame such that different imaging dates and times are distinguishable.
However, Ohishi teaches the system, wherein the processor causes the display to display each of the two or more vessel images while changing a color of a frame such that different imaging dates and times are distinguishable (Ohishi [0068]: “For example, the color code of the first frame defines that “red” is set at “0” of the flow time t, “red” gradually changes to “green” during “0” to “L/3”, and “green” is set at “L/3”. Furthermore, the color code of the first frame defines that “green” gradually changes to “blue” during “L/3” to “2L/3” and “blue” is set at “2L/3””).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the different frame colors as taught by Ohishi with the system of the Fujiwara, Koehn, and Weiss combination because it would improve the device by making it easier for a user to identify which image belongs to which time and date. This motivation for the combination of Fujiwara, Koehn, and Weiss, and Ohishi is supported by KSR exemplary rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. MPEP 2141 (III).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Fujiwara, Koehn, and Weiss combination and Yeh et al. (YEH et al., “A Microfluidic Single-Cell Cloning (SCC) Device for the Generation of Monoclonal Cells,” Cells, Vol. 9, No. 1482, June 18, 2020, pages 1-14 as provided in the IDS received 03/22/2023, hereinafter “Yeh”).
Regarding claim 4, the Fujiwara, Koehn, and Weiss combination does not explicitly disclose the system, wherein the processor causes the display to display the number of days elapsed since the seeding of the cell in association with each of the two or more vessel images such that different imaging dates and times are distinguishable.
However, Yeh teaches the system, wherein the processor causes the display to display the number of days elapsed since the seeding of the cell in association with each of the two or more vessel images such that different imaging dates and times are distinguishable (Yeh Fig. 3a: displays the days elapsed for each image).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the display of the number of days elapsed since the seeding of the cell as taught by Yeh with the system of the Fujiwara, Koehn, and Weiss combination because it would improve the device by providing more data to each image, thereby allowing a user to more easily identify which image corresponds to the number of days that have passed since seeding of the cell. This motivation for the combination of Fujiwara, Koehn, and Weiss, and Yeh is supported by KSR exemplary rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. MPEP 2141 (III).
Response to Arguments
Applicant's arguments filed 07/25/2025 have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. § 101
Examiner respectfully disagrees with Applicant’s arguments that the independent claims are eligible made on pages 7-8 of Applicant’s arguments and remarks. Regarding the amendments made to the independent claims, the amendments do not overcome the 101 rejections. The hardware elements added to the claims are general computer hardware that perform generic computer functions that are well-understood, routine, and conventional and do not amount to more than implementing the abstract idea with a computerized system. The limitations regarding the vessel scratch alignment and generating a corrected difference image are mathematical concepts which is also an abstract idea. As such, the independent claims do not amount to significantly more than a judicial exception and are not eligible under 101.
Rejections under 35 U.S.C. § 102 and 35 U.S.C. § 103
Applicant’s arguments on pages 8-10 of Applicant’s arguments and remarks with respect to the prior art rejections have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new reference is used to teach using a physical scratch on the vessel as a reference for alignment.
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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/AIDAN KEUP/Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666