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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the term “fertilized egg tray display” was amended in claim 11 (06/08/2026), but the specification fails to describe the structure of a fertilized egg tray display. Thus, it is unknown whether the fertilized egg tray display is structurally the same or different from the display module (element 52) described in the specification. Furthermore, for examination purposes, if a display element is employed to display information (such as images) for specifying the dish on display – this will be seen as meeting the limitation.
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, 4, 5, 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Noritaka Fukunaga (JP 2019170404 A and corresponding machine translation from prior office action) in view of Oonishi et al (US 20100195877 A1) (referenced in 892).
Regarding claim 1, Noritaka Fukunaga teaches an embryo culture device (See annotated FIG. 1 below, device 10) that keeps in a culture environment a treatment egg (“embryo culture device that stores a plurality of trays containing fertilized treated eggs and maintains them in a culture environment” - para. [0009] of MT) having been subjected to insemination (in-vitro fertilization) treatment (“This embryo culture device 10 is used to culture eggs that have been subjected to in vitro fertilization treatment” – para. [0022] of MT), the embryo culture device comprising:
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a culture unit provided with a culture chamber (R11 to R22 – culture chambers (para. [0028])) that accommodates a plurality of trays (“a culture unit that holds the multiple trays in the culture environment” – para. [0009] of MT – (Note: the terms “tray” and “dish” are interchangeable terms as established in para. [0002])) each including a plurality of recess parts (See Annotated FIG.6 below, well 95) that can each accommodate a treatment egg (FIG. 6, treated egg 25) (“the tray may include a plurality of recesses for holding treated eggs “ – para. [0010] of MT), and keeps the plurality of trays in the culture environment (“stores a plurality of trays containing fertilized treated eggs and maintains them in a culture environment.” – para. [0009] of MT). Noritaka Fukunaga further teaches a heater (panel heaters (H11 to H22 – para. [0028]) provided and gas supply ports (supply port and exhaust port, elements 43 and 44, respectively) that supply the gas mixture to the chambers (para. [0027]).
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a plurality of cameras (FIG. 6 - camera module 51, provided with CA1 to CA4) (“multiple imaging units may be provided for one tray in order to image all of the recesses” – para. [0009] of MT) that are each provided in association with each one of the trays held in the culture unit (“According to this embryo culture device, an imaging unit is provided for each of the multiple trays held in the culture environment” – para. [0009] of MT), and continuously or intermittently image at least two or more of the plurality of recess parts among locations of the trays at once (See annotated FIG 5. – regions U1-U4) (“imaging unit may capture images of at least some of the recesses at one time” - para. [0010] of MT).
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A memory that divides and stores an image captured by each of the imaging units per area including the plurality of recess parts. (“One captured image shows four wells 95, i.e., four treated egg 25, and the image may be saved as is on the memory card 59, or may be divided into four and saved for each treated egg 25” - para. [0046]). Specifically, a memory card 65 records the images captured by the camera module (para. [0034]). Thus, the memory stores image data per area including the plurality of recess parts, and a program for processing the image data (para. [0049] of MT).
a determination unit that determines using the corrected image whether or not the treatment egg is fertilized. (“an embryo culture device may be provided with a fertilization determination unit that determines whether at least one of the treated eggs in the tray has been fertilized based on the image captured by the imaging unit” – para. [0017] of MT). Specifically, machine learning is performed from the input images read from the memory card into this machine-learned judgement machine (para. [0049]). Since memory interface (element 64) exchanges data with a memory card (element 65), as is part of the control unit (element 60) and CPU (element 61), the determination unit uses the saved images in memory card with machine learning to determine if fertilization is possible (para. [0049]).
Noritaka Fukunaga fails to teach the following limitation:
A correction unit that corrects a difference in image caused by a position of the recess part on the dish.
Regarding limitation I, Noritaka Fukunaga teaches the divided and stored image per recess part from the memory, but fails to teach a correction unit used in correcting a difference in image caused by a position of the recess part on the dish. Oonishi et al. teaches an embryo quality evaluation assistance system (abstract) including a controller (element 21) – that comprises a CPU (para. [0061]) – that corrects the size, position of the images as pre-processing for comparison between two embryo images (para. [0107]) Specifically, with respect to time-series images, in order to execute accurate comparison processing, corrections in variations in the size and positional movement of the embryo are necessary (para. [0108 – 0110]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Oonishi et al. teaching of a correction operation performed by a CPU in Fukunaga’s embryo culture device because the correction allows accurate comparison processing to be performed between the embryos. This method of improving Fukunaga’s embryo culture device was within the ability of one of ordinary skill in the art based on the teachings of Oonishi et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Fukunaga and Oonishi et al. to obtain the invention specified in claim 1.
Regarding Claim 4, modified Noritaka Fukunaga teaches the embryo culture device according to claim 1. Modified Noritaka Fukunaga also teaches wherein the cameras image all of the plurality of recess parts provided to the trays at once. “The embryo culture device of the first embodiment described above is provided with a time lapse unit 50 for each of the 12 culture chambers R11 to R22, and can intermittently capture images of the treated eggs 25 contained in the tray 91.” Modified Noritaka Fukunaga also teaches “The image capturing process (step S310) is performed by simultaneously or sequentially driving the four camera units CA1 to CA4 present in the camera module 51 of one time lapse unit 50” (para. [0044] of MT).
Regarding claim 5, Noritaka Fukunaga teaches an embryo culture device (See annotated FIG. 1 below, device 10) that keeps in a culture environment a treatment egg (“embryo culture device that stores a plurality of trays containing fertilized treated eggs and maintains them in a culture environment” - para. [0009] of MT) having been subjected to insemination (in-vitro fertilization) treatment (“This embryo culture device 10 is used to culture eggs that have been subjected to in vitro fertilization treatment” – para. [0022] of MT), the embryo culture device comprising:
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a culture unit provided with a culture chamber (R11 to R22 – culture chambers (para. [0028])) that accommodates a plurality of trays (“a culture unit that holds the multiple trays in the culture environment” – para. [0009] of MT – (Note: the terms “tray” and “dish” are interchangeable terms as established in para. [0002])) each including a plurality of recess parts (See Annotated FIG.6 below, well 95) that can each accommodate a treatment egg (FIG. 6, treated egg 25) (“the tray may include a plurality of recesses for holding treated eggs “ – para. [0010] of MT), and keeps the plurality of trays in the culture environment (“stores a plurality of trays containing fertilized treated eggs and maintains them in a culture environment.” – para. [0009] of MT). Noritaka Fukunaga further teaches a heater (panel heaters (H11 to H22 – para. [0028]) provided and gas supply ports (supply port and exhaust port, elements 43 and 44, respectively) that supply the gas mixture to the chambers (para. [0027]).
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a plurality of cameras (FIG. 6 - camera module 51, provided with CA1 to CA4) (“multiple imaging units may be provided for one tray in order to image all of the recesses” – para. [0009] of MT) that are each provided in association with each one of the trays held in the culture unit (“According to this embryo culture device, an imaging unit is provided for each of the multiple trays held in the culture environment” – para. [0009] of MT), and continuously or intermittently image at least two or more of the plurality of recess parts among locations of the trays at once (See annotated FIG 5. – regions U1-U4) (“imaging unit may capture images of at least some of the recesses at one time” - para. [0010] of MT).
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A memory that divides and stores an image captured by each of the imaging units per area including the plurality of recess parts. (“One captured image shows four wells 95, i.e., four treated egg 25, and the image may be saved as is on the memory card 59, or may be divided into four and saved for each treated egg 25” - para. [0046]). Specifically, a memory card 65 records the images captured by the camera module (para. [0034]). Thus, the memory stores image data per area including the plurality of recess parts, and a program for processing the image data (para. [0049] of MT).
a determination unit that determines using the corrected image whether or not the treatment egg is fertilized. (“an embryo culture device may be provided with a fertilization determination unit that determines whether at least one of the treated eggs in the tray has been fertilized based on the image captured by the imaging unit” – para. [0017] of MT). Specifically, machine learning is performed from the input images read from the memory card into this machine-learned judgement machine (para. [0049]). Since memory interface (element 64) exchanges data with a memory card (element 65), as is part of the control unit (element 60) and CPU (element 61), the determination unit uses the saved images in memory card with machine learning to determine if fertilization is possible (para. [0049]).
a display that presents, by the CPU executing the program stored in the memory and determining that a predetermined abnormality occurs during the imaging, the contents of the abnormality caused. Display module (element 52) would be structurally capable of presenting the contents of the abnormality caused (para. [0040]).
Noritaka Fukunaga fails to teach the following limitation:
A correction unit that corrects a difference in image caused by a position of the recess part on the dish.
Regarding limitation I, Noritaka Fukunaga teaches the divided and stored image per recess part from the memory, but fails to teach a correction unit used in correcting a difference in image caused by a position of the recess part on the dish. Oonishi et al. teaches an embryo quality evaluation assistance system (abstract) including a controller (element 21) – that comprises a CPU (para. [0061]) – that corrects the size, position of the images as pre-processing for comparison between two embryo images (para. [0107]) Specifically, with respect to time-series images, in order to execute accurate comparison processing, corrections in variations in the size and positional movement of the embryo are necessary (para. [0108 – 0110]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Oonishi et al. teaching of a correction operation performed by a CPU in Fukunaga’s embryo culture device because the correction allows accurate comparison processing to be performed between the embryos. This method of improving Fukunaga’s embryo culture device was within the ability of one of ordinary skill in the art based on the teachings of Oonishi et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Fukunaga and Oonishi et al. to obtain the invention specified in claim 5.
Regarding claim 7, modified Noritaka Fukunaga teaches the embryo culture device of according to claim 1. Modified Noritaka Fukunaga also teaches a culture unit that includes a plurality of culture chambers partitioned per tray (dish). (“In such an embryo culture device, the culture section may be configured to include a plurality of culture chambers partitioned by the trays. (para. [0011] of MT - Noritaka Fukunaga).
Regarding claim 8, modified Noritaka Fukunaga teaches the embryo culture device of according to claim 7. Noritaka Fukunaga also teaches that the imaging units (cameras) are each provided on at least one surface of an upper surface, a side surface, and a bottom surface of each of the culture chambers facing the locations of the trays (dish) (“the imaging unit may be provided on at least one of the top, side, and bottom surfaces of the culture chamber, facing the location of the tray.” (para. [0012] of MT - Noritaka Fukunaga).
Regarding Claim 9, modified Noritaka Fukunaga teaches the embryo culture device of according to claim 8. Noritaka Fukunaga also teaches wherein:
The imaging units (cameras) each include an imaging focal depth change unit that captures a plurality of images of different focus positions during imaging (“the imaging unit may include a focal depth changing unit that captures multiple images with different focus positions during the imaging” (para. [0013] of MT - Noritaka Fukunaga);
The memory stores the plurality of images of the different focus positions as a set of images (“and the memory unit may store the multiple images with different focus positions as a single image” (para. [0013] of MT - Noritaka Fukunaga)
Regarding claim 10, modified Noritaka Fukunaga teaches the embryo culture device of according to claim 1. Noritaka Fukunaga also teaches that the device further comprises a light guide that guides light from a light source, and irradiates with the light at least a location of the treatment egg on the dish. “The above-described embryo culture device may further include a light guide that guides light from a light source to illuminate at least the area where the treated eggs are present in each of the plurality of trays. This allows the target to be illuminated and makes it easier to photograph the treated egg” (para. [0016] of MT - Noritaka Fukunaga).
Regarding claim 11, modified Noritaka Fukunaga teaches the embryo culture device of according to claim 1. Noritaka Fukunaga also teaches that “display unit may include an individual display unit provided for each of the plurality of trays, corresponding to the imaging unit” (para. [0014]). Furthermore, Fukunaga teaches that display unit displays the stored images for each tray (para.[0009]), and thus, is structurally capable of displaying information for specifying the dish on the display.
Regarding claim 12, Noritaka Fukunaga teaches an imaging device that is attached to a culture unit of an embryo culture device that accommodates a plurality of trays (“As a second aspect of the present invention, there is provided an imaging device that is attached to a culture section of an embryo culture device that stores a plurality of trays” - para. [0019]) each including a plurality of recess parts (“tray may include a plurality of recesses for holding treated eggs” - para. [0010]) that can each accommodate a treatment egg having been subjected to insemination treatment, and keeps the plurality of trays in the culture environment (“stores a plurality of trays containing fertilized treated eggs and maintains them in a culture environment.” – para. [0019], the image device comprising:
a plurality of cameras (FIG. 6 - camera module 51, provided with CA1 to CA4) (“multiple imaging units may be provided for one tray in order to image all of the recesses” – para. [0009] of MT) that are each provided in association with each one of the trays held in the culture unit (“According to this embryo culture device, an imaging unit is provided for each of the multiple trays held in the culture environment” – para. [0009] of MT), and continuously or intermittently image at least two or more of the plurality of recess parts among locations of the trays at once (See annotated FIG 5. – regions U1-U4) (“imaging unit may capture images of at least some of the recesses at one time” - para. [0010] of MT);
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a memory that divides and stores an image captured by each of the imaging units per area including the plurality of recess parts. (“One captured image shows four wells 95, i.e., four treated egg 25, and the image may be saved as is on the memory card 59, or may be divided into four and saved for each treated egg 25” - para. [0046]). Specifically, a memory card 65 records the images captured by the camera module (para. [0034]). Thus, the memory stores image data per area including the plurality of recess parts, and a program for processing the image data (para. [0049] of MT);
a display that presents, by the CPU executing the program stored in the memory and determining that a predetermined abnormality occurs during the imaging, the contents of the abnormality caused. Display module (element 52) would be structurally capable of presenting the contents of the abnormality caused (para. [0040]).
Noritaka Fukunaga fails to teach the following limitation:
A correction unit that corrects a difference in image caused by a position of the recess part on the dish.
Regarding limitation I, Noritaka Fukunaga teaches the divided and stored image per recess part from the memory, but fails to teach a correction unit used in correcting a difference in image caused by a position of the recess part on the dish. Oonishi et al. teaches an embryo quality evaluation assistance system (abstract) including a controller (element 21) – that comprises a CPU (para. [0061]) – that corrects the size, position of the images as pre-processing for comparison between two embryo images (para. [0107]) Specifically, with respect to time-series images, in order to execute accurate comparison processing, corrections in variations in the size and positional movement of the embryo are necessary (para. [0108 – 0110]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Oonishi et al. teaching of a correction operation performed by a CPU in Fukunaga’s embryo culture device because the correction allows accurate comparison processing to be performed between the embryos. This method of improving Fukunaga’s embryo culture device was within the ability of one of ordinary skill in the art based on the teachings of Oonishi et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Fukunaga and Oonishi et al. to obtain the invention specified in claim 12.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Noritaka Fukunaga (already referenced above), Oonishi et al. (already referenced) as applied to claim 1, and in further view of Tenney et al. (CN 112204380 A and corresponding MT from prior office action).
Regarding Claim 2, modified Fukunaga teaches the embryo culture device according to claim 1. Modified Fukunaga fails to teach explicitly that the correction is a correction of matching positions. Tenney et al. teaches a transformation step as part of the method (Figure 12) of detecting and characterizing micro-objects (including embryos) (Page 3). Tenney et al. specifically teaches an alignment engine that performs a transformation step, allowing a second image to be optically aligned with a first image (Page 50 of MT).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Tenney et al.’s teaching of an alignment engine that performs a transformation step in modified Fukunaga correction unit because the alignment engine would perform optical alignment on the image. Furthermore, the use of a transformation step in an alignment engine performs the same function as a correction of matching positions. This method (transformation step) of improving modified Noritaka Fukunaga’s device was within the ability of one of ordinary skill in the art based on the teachings of Tenney et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tenney et al. and modified Noritaka Fukunaga to obtain the invention specified in claim 2.
Regarding Claim 3, modified Fukunaga teaches the embryo culture device according to claim 1. Modified Fukunaga fails to teach that the correction is a correction of matching an imaging condition. Tenney et al. teaches a pre-processing step that includes calculating a distortion correction for each received image (Page 50 of MT). Tenney et al. also teaches that this pre-processing step is specifically to reduce abnormalities in image data (Page 3 of MT).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Tenney et al.’s teaching of a distortion correction in modified Noritaka Fukunaga’s correction unit because distortion corrections reduce abnormalities in the image data and is applied to each image. This method of improving modified Noritaka Fukunaga’s device was within the ability of one of ordinary skill in the art based on the teachings of Tenney et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tenney et al. and modified Noritaka Fukunaga to obtain the invention specified in claim 3.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Noritaka Fukunaga (already referenced above), Oonishi et al. (already referenced) (already referenced) as applied to claim 5 above, and in further view of Ramsing et al. (US 20080247628 A1) (referenced in 892).
Regarding Claim 6, modified Fukunaga teaches the embryo culture device according to claim 5. Modified Fukunaga fails to teach the abnormality of the correction cannot be normally performed per imaging position. Ramsing et al. teaches a system for estimating a quality measure of embryos and for selecting embryos for in vitro fertilization (abstract). Specifically, Ramsing et al. teaches that artefacts are dirt/spots positioned on the camera lens, spots due to camera artefacts, which need to be removed to improve image quality prior to translocation (para. [0135]).
It would have been obvious to one of ordinary skill in the art at the time of filing to use Ramsing et al.’s teaching of artefacts (which would cause correction to not be normally performed) in Noritaka Fukunaga’s embryo culture device because artefacts limit image quality and need to be removed prior to translocation. This method of improving modified Noritaka Fukunaga’s device was within the ability of one of ordinary skill in the art based on the teachings of Ramsing et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ramsing et al. and modified Noritaka Fukunaga to obtain the invention specified in claim 6.
Response to Arguments
Applicant’s arguments, see Page 1 of Remarks, filed 06/08/2026, with respect to the drawings have been fully considered and are persuasive. The objections of the drawings have been withdrawn.
The claim amendments have overcome the previously presented rejections under 35 U.S.C. § 112(a) and 112(b), and the respective rejections have been withdrawn.
Applicant’s arguments, see (p. 2-3, Rejections under 35 U.S.C. § 103), filed 06/08/2026 with respect to claims 1-12 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection has been made in view of Fukunaga and Oonishi et al. (See 35 USC § 103 Rejection – Claim 1 Rejection).
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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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
Prosecution Insights