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 .
Priority
Acknowledgement is made of Applicant’s claim of priority from Foreign Application No. JP2022-130658, filed August 18, 2022.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 22, 2026 has been entered.
Status of Claims
Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see p. 8-13, filed April 22, 2026, with respect to the 35 USC 103 rejections have been fully considered but are moot because of the new grounds of rejection, presented in the sections below. Applicant argues that the previously proposed references do not teach the newly added limitations, however, as described below, the Huergo reference teaches a growth image of a cell colony in an orthogonal coordinate system with the area of the colony on one axis and the distance from the colony center on the other for a plurality of time points. Under the broadest reasonable interpretation of “growth directions” and “growth degree” of the colony, Examiner asserts that Huergo’s teaching of the distance from the colony center is sufficient in teaching a growth direction and the area of the colony is sufficient as the “growth degree”. Therefore, the 35 USC 103 rejections are upheld.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-7, 12-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Larimer et al. (US 11,525,153 B2) in view of Felden et al. (US 2017/0044588 A1) further in view of Huergo et al. (“Dynamics and morphology characteristics of cell colonies with radially spreading growth fronts”).
Regarding claim 1, Larimer teaches an image processing apparatus comprising processing circuitry (Larimer, Col. 2, lines 56-65, one or more processors of an electronic device), the processing circuitry being configured to:
determine, based on time-sequential (Larimer, Col. 12, line 41-Col. 13, line 16, further analysis and calculation of parameters may be conducted using the set of microbial colony regions. The full analytical process can be repeated on multiple data sets or images in a series. If the images are collected over time then the time series also enables calculation of growth rates, doubling times, rates of decline, rates of inhibition, time-kill curves, and other time-dependent parameters).
Although Larimer teaches images in a series collected over time (Larimer, Col. 12, line 41-Col. 13, line 16), Larimer does not explicitly teach the photography images are “two-dimensional”. However, in an analogous field of endeavor, Felden teaches two-dimensional images taken by a camera of areas of interest in gray-scale or color to distinguish areas of interest where micro-colonies are growing (Felden, Para. [0083]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the apparatus of Larimer with the teachings of Felden by including that the images of the colony are two-dimensional. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for monitoring micro-colony growth, as recognized by Felden.
Although Larimer in view of Felden teaches determining the growth of a colony in the z-direction (Larimer, Col. 12, line 41-Col. 13), they do not explicitly teach to determine “a growth degree of the colony with respect to each of a plurality of growth directions of the colony in the photography images” and to “generate, based on the photography image, a growth image representing the growth degrees in the plurality of growth directions of the colony in an orthogonal coordinate system in which the growth directions are indicated on one axis and the growth degrees are indicated on an other axis”. However, in an analogous field of endeavor, Huergo teaches determining the average cell area (i.e., growth degree of the colony) versus the radial distance from the center of a type I colony (i.e., plurality of growth directions of the colony). Fig. 7 shows a growth image in an orthogonal coordinate system with the distance from colony center (i.e., growth direction) on one axis and the cell area (i.e., growth degree) on the other axis (Huergo, pg. 4; Fig. 7).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the apparatus of Larimer in view of Felden with the teachings of Huergo by including determining a growth degree (i.e., cell colony area) for a plurality of growth directions (i.e., distance from colony center) and generating a growth image by graphing the growth degree on one axis and growth direction on another axis in an orthogonal coordinate system. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for studying growth pattern characteristics of cell colonies over time, as recognized by Huergo. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 6, Larimer in view of Felden further in view of Huergo teaches the image processing apparatus of claim 1, wherein the processing circuitry is further configured to:
determine, based on the photography images, growth directions of a cell group proliferating from a predetermined cultured cell included in the colony, and a growth degrees of the cell group in the growth directions (Huergo, pg. 4, average cell area (i.e., growth degree of the colony) versus the radial distance from the center of a type I colony (i.e., plurality of growth directions of the colony)); and
generate, based on the photography images, the growth image further representing the growth directions and the growth degrees of the cell group (Huergo, pg. 4; Fig. 7, growth image in an orthogonal coordinate system with the distance from colony center (i.e., growth direction) on one axis and the cell area (i.e., growth degree) on the other axis).
The proposed combination as well as the motivation for combining the Larimer, Felden and Huergo references presented in the rejection of Claim 1, apply to Claim 6 and are incorporated herein by reference. Thus, the system recited in Claim 6 is met by Larimer in view of Felden further in view of Huergo.
Regarding claim 7, Larimer in view of Felden further in view of Huergo teaches the image processing apparatus of claim 6, and further teaches wherein the processing circuitry is further configured to determine the growth directions and the growth degrees of the cell group by executing tracking analysis of the predetermined cultured cell (Larimer, Col. 14, lines 1-31; Fig. 6A-6B, FIG. 6 shows the calculated/projected measured area and volume of a single BT colony as measured from the images shown in FIG. 5 (i.e., tracking analysis of the BT colony which is the predetermined cultured cell)).
Claim 12 recites a system with elements corresponding to the elements of the apparatus recited in Claims 1. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding apparatus claim. Additionally, the rationale and motivation to combine the Larimer, Felden and Huergo references, presented in rejection of Claim 1, apply to this claim. Finally, the Larimer, Felden and Huergo references discloses a camera configured to photograph a colony including a plurality of cultured cells in a time-sequential manner (Larimer, Col. 8, lines 23-32, the computing environment can further be used to acquire a series of 2D images (e.g., with some containing interference batters from a camera)) and an image memory configured to store the photography images (Larimer, Col. 8, lines 34-50, a system memory).
Claims 13 and 18-19 recite methods with steps corresponding to the elements of the apparatuses recited in Claims 1 and 6-7, respectively. Therefore, the recited steps of these claims are mapped to the proposed combination in the same manner as the corresponding elements in their corresponding apparatus claims. Additionally, the rationale and motivation to combine the Larimer, Felden and Huergo references, presented in rejection of Claim 1, apply to this claim.
Claims 2, 4-5, 8-10, 14, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Larimer et al. (US 11,525,153 B2) in view of Felden et al. (US 2017/0044588 A1) further in view of Huergo et al. (“Dynamics and morphology characteristics of cell colonies with radially spreading growth fronts”), as applied to claims 1, 6-7, 12-13 and 18-19 above, and further in view of Huang et al. (US 2014/0023260 A1).
Regarding claim 2, Larimer in view of Felden further in view of Huergo teaches the image processing apparatus of claim 1, as described above.
Although Larimer in view of Felden further in view of Huergo teaches height in the z-direction as growth direction and growth degree of a colony (Col. 12, line 41-Col. 13, line 16), they do not explicitly teach “wherein the processing circuitry is further configured to determine the growth directions and the growth degrees of the colony, in a polar coordinate system defined by an angle around a reference point of the photography image, and a distance from the reference point at the angle”. However, in an analogous field of endeavor, Huang teaches a polar coordinate plane may be divided into 12 30-degree bins. Each boundary point of the cell may be represented in the polar coordinate system by a two-tuple (theta, rho) where theta denotes the angular coordinate of the boundary point (i.e., angle around a reference point) and rho is the distance between the pole and the boundary point (i.e., distance from the reference point at the angle) (Huang, Para. [0039]; Fig. 3B).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Larimer in view of Felden further in view of Huergo with the teachings of Huang by including the growth direction of the colony is an angular coordinate, theta, of the boundary point and the growth degree of the colony is the distance, rho, between the pole and the boundary point. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for determining shape and scale of biological units, such as cells, as recognized by Huang. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 4, Larimer in view of Felden further in view of Huergo and Huang teaches the image processing apparatus of claim 2, and further teaches “wherein the processing circuitry is further configured to generate the growth image that represents the growth directions and growth degrees of the colony in an orthogonal coordinate system in which the angle is indicated on the one axis and the distance from the reference point at the angle is indicated on the other axis (Huergo, pg. 4; Fig. 7, growth image in an orthogonal coordinate system with the distance from colony center (i.e., growth direction) on one axis and the cell area (i.e., growth degree) on the other axis).
The proposed combination as well as the motivation for combining the Larimer, Felden, Huergo and Huang references presented in the rejection of Claim 2, apply to Claim 8 and are incorporated herein by reference. Thus, the apparatus recited in Claim 4 is met by Larimer in view Felden further in view of Huergo and Huang.
Regarding claim 5, Larimer in view of Felden further in view of Huergo and Huang teaches the image processing apparatus of claim 4, and further teaches wherein the processing circuitry is further configured to generate the growth image that represents the growth directions and the growth degrees of the colony at each of time points in the orthogonal coordinate system by a line corresponding to each time point (Larimer, Col. 17, lines 22-51; Figs. 11A-11C, initial image, Fig. 11A, single cell at 2 hours. Hours 6 (Fig. 11B) and 6.5 (Fig. 11C), growth of single cell into colony (i.e., graphs 11A-11C show growth direction and degree of colony at each time point)).
Regarding claim 8, Larimer in view of Felden further in view of Huergo teaches the image processing apparatus of claim 6, as described above.
Although Larimer in view of Felden further in view of Huergo teaches height in the z-direction as growth direction and growth degree of a colony (Larimer, Col. 12, line 41-Col. 13, line 16), they do not explicitly teach “wherein the processing circuitry is further configured to determine the growth directions and the growth degrees of the cell group in a polar coordinate system defined by an angle around a reference point of the photography image, and a distance from the reference point at the angle”. However, in an analogous field of endeavor, Huang teaches a polar coordinate plane may be divided into 12 30-degree bins. Each boundary point of the cell may be represented in the polar coordinate system by a two-tuple (theta, rho) where theta denotes the angular coordinate of the boundary point (i.e., angle around a reference point) and rho is the distance between the pole and the boundary point (i.e., distance from the reference point at the angle) (Huang, Para. [0039]; Fig. 3B).
The proposed combination as well as the motivation for combining the Larimer, Felden, Huergo and Huang references presented in the rejection of Claim 2, apply to Claim 8 and are incorporated herein by reference. Thus, the apparatus recited in Claim 8 is met by Larimer in view Felden further in view of Huergo and Huang.
Regarding claim 9, Larimer in view of Felden further in view of Huergo and Huang teaches the image processing apparatus of claim 8, and further teaches wherein the processing circuitry is further configured to generate the growth image that represents the growth directions and the growth degrees of the cell group in an orthogonal coordinate system in which the angle is indicated on one axis and a distance from the reference point at the angle is indicated on the other axis (Huergo, pg. 4; Fig. 7, growth image in an orthogonal coordinate system with the distance from colony center (i.e., growth direction) on one axis and the cell area (i.e., growth degree) on the other axis).
The proposed combination as well as the motivation for combining the Larimer, Felden, Huergo and Huang references presented in the rejection of Claim 2, apply to Claim 8 and are incorporated herein by reference. Thus, the apparatus recited in Claim 4 is met by Larimer in view Felden further in view of Huergo and Huang.
Regarding claim 10, Larimer in view of Felden further in view of Huergo and Huang teaches the image processing apparatus of claim 9, and further teaches wherein the processing circuitry is further configured to generate the growth image that represents the growth directions and the growth degrees of the cell group at each of time points in the orthogonal coordinate system by an arrow corresponding to each time point (Larimer, Col. 6, lines 36-67, observation and study of individual microcolonies and/or CFUs composing those microcolonies, which can enable highly accurate measurement of microbial CFU morphology, colony morphology, colony growth dynamics, and growth rate. In certain embodiments the sample parameters and values based on the sample parameters can be determined within a non-zero length of time that is less than or equal to 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, or 18 hours after plating (i.e., introducing) a biological sample potentially having a microbial CFU on the solid growth medium. Col. 6, lines 1-22, a microcolony can refer to a microbial CFU (e.g., a cell) (i.e., the colony forming unit (CFU) is the predetermined cultured cell from which the cell group grows).
Claims 14, 16-17 and 20 recite methods with steps corresponding to the elements of the apparatuses recited in Claims 2, 4-5 and 8, respectively. Therefore, the recited steps of these claims are mapped to the proposed combination in the same manner as the corresponding elements in their corresponding apparatus claims. Additionally, the rationale and motivation to combine the Larimer, Felden, Huergo and Huang references, presented in rejection of Claim 2, apply to this claim.
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Larimer et al. (US 11,525,153 B2) in view of Felden et al. (US 2017/0044588 A1) further in view of Huergo et al. (“Dynamics and morphology characteristics of cell colonies with radially spreading growth fronts”) and Huang et al. (US 2014/0023260 A1), as described in claims 2, 8, 14 and 20 above, and further in view of Marcelpoil et al. (US 2022/0325225 A1, filed December 20, 2021).
Regarding claim 3, Larimer in view of Felden further in view of Huergo and Huang teaches the image processing apparatus of claim 2, as described above.
Although Larimer in view of Felden further in view of Huergo and Huang teaches each boundary point of the cell may be represented in the polar coordinate system by a two-tuple (theta, rho) where theta denotes the angular coordinate of the boundary point (i.e., angle around a reference point) and rho is the distance between the pole and the boundary point (i.e., distance from the reference point at the angle) (Huang, Para. [0039]; Fig. 3B), they do not explicitly teach “wherein in the polar coordinate system, the processing circuitry is further configured to determine each of the growth directions of the colony, based on a corresponding angle at which each of the cultured cells constituting the colony is located, and specifies the growth degrees of the colony, based on a corresponding distance from the reference point to each of the cultured cells”. However, in an analogous field of endeavor, Marcelpoil marking colonies (i.e., cultured cells constituting the colony) to be picked on a real time image of a culture dish, at which time the x-y coordinates of the target colony is measured and the radius and angle are calculated (Marcelpoil, Para. [0037]). Marcelpoil further teaches the apparatus determines the radius of the culture plate and an angle in radians. That angle is between two lines, the first being an imaginary line between two fiducials (e.g. a label and the center of the dish) and the second being a line from one of the fiducials (e.g. the center of the dish) and the colony location (i.e., the coordinates of the colony relative to the position of the fiducials) (Marcelpoil, Para. [0005]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Larimer in view of Felden further in view of Huergo and Huang with the teachings of Marcelpoil by including specifying the growth direction based on an angle at which each of the cultured cells constituting the colony is located (i.e., angle between a reference line and the colony location) and the growth degree based on a distance from the reference point to each cultured cell (i.e., radius). One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for locating a colony on a culture dish, as recognized by Marcelpoil. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claim 15 recites a method with steps corresponding to the elements of the apparatus recited in Claim 3. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Larimer, Felden, Huergo, Huang and Marcelpoil references, presented in rejection of Claim 3, apply to this claim.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Larimer et al. (US 11,525,153 B2) in view of Felden et al. (US 2017/0044588 A1) further in view of Huergo et al. (“Dynamics and morphology characteristics of cell colonies with radially spreading growth fronts”), as applied to claims 1, 6-7, 12-13 and 18-19 above, and further in view of Hirai et al. (US 2003/0134269 A1).
Regarding claim 11, Larimer in view of Felden further in view of Huergo teaches the image processing apparatus of claim 6, as described above.
Although Larimer in view of Felden further in view of Huergo teaches extracting line profiles over the colony to delineate individual bacteria (Larimer, Col. 17, lines 22-51), they do not explicitly teach “wherein the processing circuitry extracts an image area including the cell group from the photography image, and generates the growth image in which the image area or a pattern obtained by processing the image area is composited”. However, in an analogous field of endeavor, Hirai teaches the computer receives the original image from the imaging device, analyzes the original image, and extracts the image of each cell (i.e., the cell group). The computer calculates an index related to the proliferation ability of each cell from the extracted image of the cell. The computer evaluates the proliferation ability of the cell population based on the index. The computer displays the evaluation result on the display (Hirai, Para. [0052]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Larimer in view of Felden further in view of Huergo with the teachings of Hirai by including extracting the image of the cell (i.e., cell group) from the original image and generates the growth image based on the extracted area. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for estimating and evaluating the proliferation of the observed cells, as recognized by Hirai. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Conclusion
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/Emma Rose Goebel/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662