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.
Status of Claims
Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see p. 9, filed November 24, 2025, with respect to the objection to the title have been fully considered and are persuasive. The amendment to the Title has overcome the previous objection and it has therefore been withdrawn.
Applicant’s arguments, see p. 9, filed November 24, 2025, with respect to the 35 USC 112(f) interpretations have been fully considered and are persuasive. The amendment to the claims has overcome the previous interpretation and it has therefore been withdrawn.
Applicant’s arguments, see p. 10-12, filed November 24, 2025, with respect to the 35 USC 102 and 103 rejections have been fully considered but they are moot because of the new grounds of rejection, presented below. Applicant argues that Larimer does not teach each newly added limitation; however, Felden and Wei are relied upon to teach the new limitations. Therefore, the 35 USC 103 rejection of the claims is upheld, and consequently, THIS ACTION IS FINAL.
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 18-18 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 Wei et al. (US 2015/0169072 A1).
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 photography images relating to a colony including a plurality of cultured cells (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), a growth direction of the colony in the photography images (Larimer, Col. 11, line 51-Col. 12, line 4, intensity at each pixel in a Z-correlated image stack is analyzed to extrapolate the vertical position of each X-Y location, resulting in a topographical surface map. Unexpectedly, the height measurement (i.e., image intensity as a reflection of z-direction position or distance) assisted in detection of microcolonies (i.e., z-direction is growth direction of colony)), and a growth degree of the colony in the growth direction (Larimer, Col. 12, line 41-Col. 13, line 16, the measured parameters may include height, area, volume, morphology, roughness, or others (i.e., height in z-direction is growth degree)); and
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 “generate, based on the photography image, a growth image representing the growth direction and the growth degree of the colony in an orthogonal coordinate system in which the growth direction is indicated on one axis and the growth degree is indicated on an other axis”. However, in an analogous field of endeavor, Wei teaches a calculation module that calculates a distance (i.e., growth direction) and an angle (i.e., growth degree) relative to the origin of each of the sampling points and draw a waveform diagram as shown in Fig. 3B by using the distance as a vertical axis and using the angle as a horizontal axis (Wei, Para. [0045]; Figs. 3A and 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 Huang with the teachings of Wei by including generating the growth image representing the growth direction (i.e., angle) on one axis and growth degree (i.e., distance) on the other axis. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for creating a diagram of angle vs. distance representing a shape, as recognized by Wei. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 6, Larimer in view of Felden further in view of Wei teaches the image processing apparatus of claim 1, wherein the processing circuitry is further configured to:
determine, based on the photography images, a growth direction of a cell group proliferating from a predetermined cultured cell included in the colony, and a growth degree of the cell group in the growth direction (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); and
generate, based on the photography images, the growth image further representing the growth direction and the growth degree of the cell group (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. Bacterial growth by cellular division and growth rates are shown to be exponential, as expected. FIG. 6A shows that measuring growth by simple observation of lateral expansion (projected area) appears to be an accurate measure of growth rate in the early hours, when the colony grows laterally. However, the inventors determined, unexpectedly, that when a second layer of microbes emerges around 11 hrs, the projected area no longer follows an exponential growth curve. By comparison, FIG. 6B shows that the volume, calculated from WLI data, matches the exponential growth of bacteria throughout the experiment).
Regarding claim 7, Larimer in view of Felden further in view of Wei teaches the image processing apparatus of claim 6, and further teaches wherein the processing circuitry is further configured to determine the growth direction and the growth degree 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 Wei references, presented in rejection of Claim 1, apply to this claim. Finally, the Larimer, Felden and Wei references discloses a camera configured to photograph a colony including a plurality of cultured cells in a time-sequential manner (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 (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 Wei 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 Wei et al. (US 2015/0169072 A1), 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 Wei teaches the image processing apparatus of claim 1, as described above.
Although Larimer in view of Felden further in view of Wei 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 direction and the growth degree 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 Wei 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 Wei 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 direction and growth degree of the colony in an orthogonal coordinate system in which the angle is indicated on one axis and the distance from the reference point at the angle is indicated on an other axis (Wei, Para. [0045]; Figs. 3A and 3B, a calculation module that calculates a distance and an angle relative to the origin of each of the sampling points and draw a waveform diagram as shown in Fig. 3B by using the distance as a vertical axis and using the angle as a horizontal axis).
The proposed combination as well as the motivation for combining the Larimer, Felden, Wei 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 Wei and Huang.
Regarding claim 5, Larimer in view of Felden further in view of Wei 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 direction and the growth degree 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 Wei teaches the image processing apparatus of claim 6, as described above.
Although Larimer in view of Felden further in view of Wei 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 direction and the growth degree 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, Wei 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 Wei and Huang.
Regarding claim 9, Larimer in view of Felden further in view of Wei 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 direction and the growth degree 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 (Wei, Para. [0045]; Figs. 3A and 3B, a calculation module that calculates a distance and an angle relative to the origin of each of the sampling points and draw a waveform diagram as shown in Fig. 3B by using the distance as a vertical axis and using the angle as a horizontal axis).
The proposed combination as well as the motivation for combining the Larimer, Felden, Wei 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 Wei and Huang.
Regarding claim 10, Larimer in view of Felden further in view of Wei 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 direction and the growth degree 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, Wei 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 Wei et al. (US 2015/0169072 A1) 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 Wei and Huang teaches the image processing apparatus of claim 2, as described above.
Although Larimer in view of Felden further in view of Wei 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 the growth direction of the colony, based on an angle at which each of the cultured cells constituting the colony is located, and specifies the growth degree of the colony, based on a 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 Wei 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, Wei, 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 Wei et al. (US 2015/0169072 A1), 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 Wei teaches the image processing apparatus of claim 6, as described above.
Although Larimer in view of Felden further in view of Wei 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 Wei 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
THIS ACTION IS MADE FINAL. 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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/Emma Rose Goebel/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662