DETAIL OFFICE ACTIONS
The United States Patent & Trademark Office appreciates the response filed for the current application that is submitted on 10/03/2025. The United States Patent & Trademark Office reviewed the following documents submitted and has made the following comments below.
Amendment
Applicant submitted amendments on 10/03/2025. The Examiner acknowledges the amendment and has reviewed the claims accordingly.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Receipt is acknowledged that application claims priority to foreign application with application number JP2022-029284 dated 02/28/2022. Copies of certified papers required by 37 CFR 1.55 have been received. Priority is acknowledged under 35 USC 119(e) and 37 CFR 1.78.
Information Disclosure Statement
The IDS(s) dated 05/09/2025 and 02/23/2023 that have been previously considered remain placed in the application file.
Overview
Claims 1-10 are pending in this application and have been considered below.
Claims 5-6 and 9-10 are canceled.
Claims 1, 4, and 7-8 are rejected.
Applicant Arguments:
In regards to the argument on Argument 1, Applicant/s state/s “They recite more than an abstract idea or mental process. They are tied to specific imaging hardware for data acquisition and to computer implemented processing that uses a particular inter modality dependency to achieve improved segmentation and shape identification in three dimensional analysis. The ordered combination reflects a practical application and, even under a significantly more analysis, an inventive concept.” (See Remarks Pg 7 ¶03). Therefore the U.S.C 101 rejection on the pending amended claims should be withdrawn.
In regards to the argument on Argument 2, Applicant/s state/s “The limitation of claim 3 along with the subject matter of claim 2 is incorporated into independent claim 1.” (See Remarks Pg 8 ¶02) and “claims 9 and 10 are amended herein rendering the rejection moot.” (See Remarks Pg 8 ¶04). And therefore the 35 U.S.C 112(b) rejection is moot.
In regards to the argument on Argument 3, Applicant/s state/s “claims 9 and 10 are cancelled herein rendering the rejection moot.” (See Remarks Pg 8 ¶06). And therefore the 35 U.S.C 112(f) interpretation is moot.
In regards to the argument on Argument 4, Applicant/s state/s “ neither Hamamah nor Shinoda discloses or suggests the features of "d) analyzing, using the computer, the three-dimensional image to determine, based on an indicator in the two-dimensional analysis result, areas in the three-dimensional image corresponding to respective cells of the embryo such that a number of the areas corresponds to the number of cells in the two-dimensional analysis result and to output, based on the determined areas, a three dimensional analysis result including identification of shapes of the cells in the embryo," wherein "c) analyzing, using the computer, the two-dimensional image to output a two-dimensional analysis result including a number of the cells in the embryo," as recited in amended independent claim 1….the applied combination of the cited references, alone or in combination, fails to disclose or suggest each and every feature of amended independent claim 1” (See Remarks Pg 11 ¶01-¶02). Therefore the 35 U.S.C 102 and 35 U.S.C 103 rejection on the pending amended claims should be withdrawn.
Examiner’s Responses:
In response to Argument 1, Applicant’s arguments, see Remarks, filed 10/03/25, with respect to the U.S.C 101 rejection, have been fully considered and are persuasive, therefore the rejection is removed.
In response to Argument 2, Applicant’s arguments, see Remarks, filed 10/03/25, with respect to the U.S.C 112b rejection, have been fully considered and are persuasive, therefore the rejection is removed.
In response to Argument 3, Applicant’s arguments, see Remarks, filed 10/03/25, with respect to the U.S.C 112f claim interpretation, have been fully considered and are persuasive.
In response to Argument 4, Applicant’s arguments, see Remarks, filed 10/03/25, with respect to the rejection(s) of claim 1 and 7-8 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for claims 1 and 7-8 under 35 U.S.C. 103 in view of Hamamah (US Patent Pub US 2017/0140535 Al hereafter referred to as Hamamah) in view of Lou et al (Lou, Xinghua, et al. "A rapid and efficient 2D/3D nuclear segmentation method for analysis of early mouse embryo and stem cell image data." Stem cell reports 2.3 (2014): 382-397. hereafter referred to as Lou). Additionally, upon further consideration, a new ground(s) of rejection is made for claim 4 under 35 U.S.C. 103 Hamamah (US Patent Pub US 2017/0140535 Al hereafter referred to as Hamamah) in view of Lou et al (Lou, Xinghua, et al. "A rapid and efficient 2D/3D nuclear segmentation method for analysis of early mouse embryo and stem cell image data." Stem cell reports 2.3 (2014): 382-397. hereafter referred to as Lou) in further view of Shinoda (US Patent Publication 2021/0287366 A1, hereafter referred to as Shinoda).
The Examiner finds that Hamamah teaches on the amendment claim language “in which a plurality of cells in the embryo” and “dimensional analysis result including a number of the cells in the embryo” and “analyzing, using the computer, the two-dimensional image” in Claim 1.
Specifically, Hamamah teaches a method for determining the quality of an embryo in ¶01 and ¶11-¶13. Hamamah also teaches accounting for the number of cells in the embryo in ¶0053 and ¶0040, and ¶0098. Hamamah also teaches the use of tomography inquiring 3D images in ¶0067, ¶0072, ¶0087, and Fig 6B. Hamamah teaches analyzing the two dimensional image using a computer in ¶0095, and in Figure 5A. Hamamah also teaches outputting a two dimensional analysis result including the number of cells in ¶0053 and ¶0040, and ¶0098. Applicant argues that Hamamah does not teach an analysis based on the 3D dimensional image corresponding to the indicator in the two dimensional image. However, the Examiner interprets that Hamamah teaches the main concept of analyzing the two dimensional image and accounting for the number of cells in the embryo, the additional details of the functions of the main concepts as stated above by the applicant in the amendments is taught by Lou in the details of the rejection below. The Examiner will maintain prior art Hamamah and details of the rejection are below.
The Examiner finds that Shinoda teaches on the amendment claim language “according to Veeck’s classification” in claim 4.
Specifically, Shinoda teaches the use of Veeck’s classification for categorizing in ¶0067 and ¶0092. The Examiner will maintain prior art of Shinoda for the rejection of Claim 4 and details of the rejection are below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1, and 7-8 are rejected under 35 U.S.C. 103 as unpatentable over Hamamah (US Patent Pub US 2017/0140535 Al hereafter referred to as Hamamah) in view of Lou et al (Lou, Xinghua, et al. "A rapid and efficient 2D/3D nuclear segmentation method for analysis of early mouse embryo and stem cell image data." Stem cell reports 2.3 (2014): 382-397. hereafter referred to as Lou).
Regarding Claim 1, Hamamah teaches an analysis method for analyzing: an embryo (¶0001, Hamamah "methods and devices for determining the quality of an embryo.") in which a plurality of cells in the embryo (Hamamah ¶0053 discloses determining the position of a plurality of different types of cells in the embryo) ;
b) acquiring, by a three- dimensional photographing unit configured to photograph a tomographic image (Hamamah ¶0067, ¶0072, ¶0087, Fig 6B discloses using OCT to obtain images);
c) analyzing, using the computer, the two-dimensional image (¶0095, Hamamah "A computer receives the images from the two cameras and pilots automatically the displacements of the motorized xyz stage (5) to make stacks of pictures of the different planes of the embryo alternatively illuminated by the SPIM.") to output a two- dimensional analysis result including a number of the cells in the embryo (Hamamah ¶0053 discloses determining the position of a plurality of different types of cells in the embryo);
in the two-dimensional analysis result (Hamamah ¶0053 discloses determining the position of a plurality of different types of cells in the embryo),
in the two-dimensional analysis result (Hamamah ¶0053 discloses determining the position of a plurality of different types of cells in the embryo).
Hamamah does not explicitly teach are three-dimensionally distributed, the analysis method comprising the following steps performed by a computer:
a) acquiring, by a two- dimensional photographing unit using an optical microscope, a two-dimensional image of the embryo;
d) analyzing, using the computer, the three-dimensional image to determine, based on an indicator,
areas in the three-dimensional image corresponding to respective cells of the embryo such that a number of the areas corresponds to the number of cells and to output, based on the determined areas a three-dimensional analysis result including identification of shapes of the cells in the embryo.
Lou is in the same field of embryo image analysis. Further, Lou teaches are three-dimensionally distributed (Lou Fig 2 A discloses 3D florescent images with the cells clearly distributed), the analysis method (Lou Summary discloses the purpose of the image analysis method) comprising the following steps performed by a computer (Lou Pg 4 Col 1 ¶02 discloses the software being executed on a computer):
a) acquiring, by a two- dimensional photographing unit using an optical microscope (Lou Fig 1 A discloses acquiring 2D images using an optical microscope), a two-dimensional image of the embryo (Lou Fig 1 B discloses a 2D image of the embryo);
d) analyzing, using the computer (Lou Pg 4 Col 1 ¶02 discloses the software being executed on a computer), the three-dimensional image to determine (Lou Fig 1 B and C discloses a 3D image of the embryo), based on an indicator (Lou Fig 1 D discloses the number of cells and location of cells being an indicator for the D projection of the image)
areas in the three-dimensional image corresponding to respective cells of the embryo (Lou Fig 1 D (see below) discloses the area of the 3D image in where the cells are present an how the analysis can differentiate between the types and number of cells) such that a number of the areas corresponds to the number of cells (Lou Fig 2 D discloses the number of areas being numbered and identified as nuclei) and to output, based on the determined areas (Lou Fig 1 D discloses determining the areas the cells are present in the 2D image) a three-dimensional analysis result including identification of shapes of the cells in the embryo (Lou Fig 1 D discloses the output being the number and types of the cells I the embryo).
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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 invention of Hamamah by including the analysis method being performed on a computer to identify and count the cells in the 3D images based on the number of cells in the 2D image as taught by Lou, to make the invention of an analysis method than can use the 2D image to indicate the amount of cells to be classified and counted in the 3D image; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to increase the accuracy and ease of use of analysis methods being implemented for single cell level image analysis (Sun, Summary)
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 7, Hamamah in view of Lou teaches the analysis method according to claim 1, wherein
the step a) includes photographing in a bright-field view (¶0007, Hamamah, "Light sheet microscopy including Selective Plane Illumination Microscopy (SPIM) is also a new technique in which the illuminated plane in a sample is the only being imaged,") while changing a focus position, to acquire a plurality of the two-dimensional images (¶0079, Hamamah "Modifying the focus, it is possible to obtain a stack of images"), and
the step c) includes analyzing the plurality of two-dimensional images, to acquire the two-dimensional analysis result (¶0095, Hamamah "A computer receives the images from the two cameras and pilots automatically the displacements of the motorized xyz stage (5) to make stacks of pictures of the different planes of the embryo alternatively illuminated by the SPIM."). See rational for Claim 1 (its parent claim).
Regarding Claim 8, Hamamah in view of Lou teaches the analysis method according to claim 1, wherein, in the step b), the three-dimensional image is acquired using optical coherence tomography (¶0008 Hamamah "Moreover, OCT and light sheet microscopy (including SPIM) represent the best attractive innovations to develop non-invasive image acquisitions of human oocyte and embryo for 3D reconstructions and printing."). See rational for Claim 1 (its parent claim).
Claim 4 is rejected under 35 U.S.C. 103 as unpatentable over Hamamah in view of Lou in further view of Shinoda (US Patent Publication 2021/0287366 A1, hereafter referred to as Shinoda).
Regarding Claim 4, Hamamah in view of Lou teaches the analysis method according to claim 1, further comprising the step of e) outputting a classification result (¶0096 Hamamah, "In vitro fertilization, embryo quality classification and IVF outcomes.") representing a state of the embryo based on the three-dimensional analysis result (Hamamah ¶0077 discloses using a 3D volume rendering to better see the nuclei in the images for analysis), after the step d).
Hamamah in view of Lou does not teach Veeck’s classification representing a state of the embryo.
Shinoda is in the same field of biomedical image analysis. Further, Shinoda teaches according to Veeck’s classification representing a state of the embryo (¶0067, Shinoda "In the machine learning algorithm, examples of input data which is information regarding the fertilized eggs input to the classifier by a supervisor ( embryologist) in a supervised learning method can include….Veeck classification,"), after the step d).
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 invention of Hamamah in view of Lou by including an Veeck’s classification to represent the state of the embryo that is taught by Shinoda, to make the invention of an analysis method than can identify embryo cell classification according to Veeck’s classification; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to deal with cells having ability to divide more appropriately while further reducing cost required for analyzing captured images of the cells having ability to divide (¶0013, Shinoda).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
27. 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).
28. 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.
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL LYNN ROBERTS whose telephone number is (571)272-6413. The examiner can normally be reached Monday- Friday 7:30am- 5:00pm. 32. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 33. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Oneal Mistry can be reached on 313-446-4912. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 34. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RACHEL L ROBERTS/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674