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 .
Information Disclosure Statement
The information disclosure statement’s (IDS) were submitted on 03/14/2025, 04/09/2025, 09/08/2025 & 11/11/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,204,172. Although the claims at issue are not identical, they are not patentably distinct from each other because this instant application claims different statutory classes as compared to method claims 1-13 in Patent No. ‘172. Furthermore, system claims 14-20 in Patent No. ‘172 are narrower in claim scope than this co-pending application.
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.
Claims 1-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US 20150309299) in view of Lahrmann et al. (herein after will be referred to as Lahrmann) (Sementic Focusing Allows Fully Automated Single-Layer Slide Scanning of Cervical Ctyology Slides).
Regarding claim 1, Watanabe discloses
a system for acquiring images of a plurality of cells distributed within a specimen affixed to a surface of a slide, the specimen having an uneven height relative to the slide surface, the system comprising: [See Watanabe [Figs. 1-2]. Also, see 0015, uneven thickness of a biological sample.]
a camera having an objective lens with an optical axis, wherein the camera is positioned such that the optical axis forms a non-orthogonal angle with the surface of the slide; and an image processor operatively coupled with the camera, [See Watanabe [Figs. 1-2]]
wherein the image processor is configured to: (a) receive a first plurality of images of a first linear portion of the specimen acquired by the camera; [See Watanabe [0065] Images region while moving the stage in the X direction. Also, see 0066, the region comprises a plurality of shots. Also, see Fig. 16, control unit (20).]
(c) calculate a z focus height curve of the best focus height of the specimen along the first linear portion; and [See Watanabe [Fig. 3B]]
(d) cause the camera to acquire a second plurality of images of the first linear portion or of a second linear portion of the specimen different from the first linear portion, [See Watanabe [Fig. 5A] Scanning multiple linear portions of a sample.]
wherein a height of the objective lens relative to the slide surface is varied during acquisition of the second plurality of images based on the evaluated focus [See Watanabe [0068 and Fig. 5A] Z axis height is varied. Also, See Fig. 8, Step (S105).]
Watanabe does not explicitly disclose
(b) evaluate a focus of each of the cells within the first linear portion of the specimen captured in the first plurality of images, including determining whether a total number of out-of-focus cells exceeds a threshold number and determining a best focus height of the specimen along the first linear portion;
However, Lahrmann does disclose
(b) evaluate a focus of each of the cells within the first linear portion of the specimen captured in the first plurality of images, including determining whether a total number of out-of-focus cells exceeds a threshold number and determining a best focus height of the specimen along the first linear portion; [See Lahrmann [Pg. 5 to Pg. 6] Slide Sharpness analysis. Also, see Fig. 4, The slide is divided into sub-regions and each cell is classified into the in-focus or out-of-focus category. The percentage of in-focus cells (0-100%) is used to calculate a score for each region (or in other words, the percentage of out-of-focus cells are used to calculate a score for each region). The regional division allows a time-saving re-scan of parts of the slide. Also, see Pg. 6 3rd para. line 14, The resulting score is compared with a user defined threshold. If the final score is lower than the threshold, the slide has to be rescanned. These scores basically represent the proportion of in-focus to out-of-focus cells that exist in the slides. Based on the outcome of this analysis, a decision is made whether to re-scan the whole slide or re-scan specific portions.]
[See Lahrmann [Abstract] Focus points are only set on cells.]
It would have been obvious to the person of ordinary skill in the art at the time of the effective filing date to modify the system by Watanabe to add the teachings of Lahrmann, in order to acquire high-quality imaging of LBC slides [See Lahrmann [Abstract, Last sentence]].
Regarding claim 2, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe discloses
wherein a height of the objective lens relative to the slide surface is constant during acquisition of the first plurality of images. [See Watanabe [0075 and 0094] Fixing the position of the imaging unit and moving the stage in the XY plane.]
Regarding claim 3, Watanabe (modified by Lahrmann) disclose the system of claim 2. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells captured in the first plurality of images at least in part by determining respective heights of the out-of-focus cells relative to the slide surface.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells captured in the first plurality of images at least in part by determining respective heights of the out-of-focus cells relative to the slide surface. [See Lahrmann [Fig. 2A] Shows the z axis is relative to the coverslip. Also, see Pg. 8 2nd para. lines 3-4, the focus points correspond to heights. Also, see Pg. 2, 3rd para lines 2-3, Z-heights at the focus points.]
Applying the same motivation as applied in claim 1.
Regarding claim 4, Watanabe (modified by Lahrmann) disclose the system of claim 3. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is outside of an in-focus range of the objective lens during acquisition in the first plurality of images.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is outside of an in-focus range of the objective lens during acquisition in the first plurality of images. [See Lahrmann [Fig. 1] Z-axis focus map which shows the in-focus and out-of focus layers.]
Applying the same motivation as applied in claim 1.
Regarding claim 5, Watanabe (modified by Lahrmann) disclose the system of claim 3. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is higher than a maximum height or lower than a minimum height, respectively, of an in-focus range of the objective lens during acquisition in the first plurality of images.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is higher than a maximum height or lower than a minimum height, respectively, of an in-focus range of the objective lens during acquisition in the first plurality of images. [See Lahrmann [Fig. 1] Z-axis focus map which shows the in-focus and out-of focus layers.]
Applying the same motivation as applied in claim 1.
Regarding claim 6, Watanabe (modified by Lahrmann) disclose the system of claim 2. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells captured in the first plurality of images at least in part by determining respective heights of the out-of-focus cells relative to the slide surface.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells captured in the first plurality of images at least in part by determining respective heights of the out-of-focus cells relative to the slide surface. [See Lahrmann [Fig. 2A] Shows the z axis is relative to the coverslip. Also, see Pg. 8 2nd para. lines 3-4, the focus points correspond to heights. Also, see Pg. 2, 3rd para lines 2-3, Z-heights at the focus points.]
Applying the same motivation as applied in claim 1.
Regarding claim 7, Watanabe (modified by Lahrmann) disclose the system of claim 6. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is outside of an in-focus range of the objective lens during acquisition in the first plurality of images.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is outside of an in-focus range of the objective lens during acquisition in the first plurality of images. [See Lahrmann [Fig. 1] Z-axis focus map which shows the in-focus and out-of focus layers.]
Applying the same motivation as applied in claim 1.
Regarding claim 8, Watanabe (modified by Lahrmann) disclose the system of claim 6. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is higher than a maximum height or lower than a minimum height, respectively, of an in-focus range of the objective lens during acquisition in the first plurality of images.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining whether respective out-of-focus cells are located at a height relative to the slide surface that is higher than a maximum height or lower than a minimum height, respectively, of an in-focus range of the objective lens during acquisition in the first plurality of images. [See Lahrmann [Fig. 1] Z-axis focus map which shows the in-focus and out-of focus layers.]
Applying the same motivation as applied in claim 1.
Regarding claim 9, Watanabe (modified by Lahrmann) disclose the system of claim 3. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining respective locations of out-of-focus cells within the first linear portion.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining respective locations of out-of-focus cells within the first linear portion. [See Lahrmann [Pg. 6 last 3 lines] This analysis also returns location-specific information of the cells. This is important especially for slides which contain a small number of cells as this information is used to improve the setting of focus points on these slides. Also, see Pg. 8 2nd para., The cells that are located in close proximity will have a similar location in the z-axis.]
Applying the same motivation as applied in claim 1.
Regarding claim 10, Watanabe (modified by Lahrmann) disclose the system of claim 2. Furthermore, Watanabe does not explicitly disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining respective locations of out-of-focus cells within the first linear portion.
However, Lahrmann does disclose
wherein the image processor evaluates the focus of each of the cells in the first plurality of images at least in part by determining respective locations of out-of-focus cells within the first linear portion. [See Lahrmann [Pg. 6 last 3 lines] This analysis also returns location-specific information of the cells. This is important especially for slides which contain a small number of cells as this information is used to improve the setting of focus points on these slides. Also, see Pg. 8 2nd para., The cells that are located in close proximity will have a similar location in the z-axis.]
Applying the same motivation as applied in claim 1.
Regarding claim 11, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe discloses
wherein one or both of the camera and the slide are configured to move laterally relative to the other one during acquisition of the images. [See Watanabe [0075 and 0094] XY drive unit to move the stage in the XY plane.]
Regarding claim 12, Watanabe (modified by Lahrmann) disclose the system of claim 2. Furthermore, Watanabe discloses
wherein one or both of the camera and the slide are configured to move laterally relative to the other one during acquisition of the images. [See Watanabe [0047] XY drive unit to move the stage in the XY plane.]
Regarding claim 13, Watanabe (modified by Lahrmann) disclose the system of claim 12. Furthermore, Watanabe discloses
wherein the height of the objective lens relative to the slide surface is varied by increasing and/or decreasing a height of the slide surface relative to the camera as a function of a linear position of the camera with respect to a lengthwise location of a respective linear portion. [See Watanabe [0075 and 0094] Fixing the position of the imaging unit and moving the stage in the Z direction.]
Regarding claim 14, Watanabe (modified by Lahrmann) disclose the system of claim 12. Furthermore, Watanabe discloses
wherein the height of the objective lens relative to the slide surface is varied by increasing and/or decreasing a height of the camera relative to the slide surface as a function of a linear position of the camera with respect to a lengthwise location of respective first or second linear portion. [See Watanabe [0075 and 0094] Alternatively, fix the sample and move the imaging unit.]
Regarding claim 15, see examiners rejection for claim 1 which is analogous and applicable for the rejection of claim 15. Claim 15 is a duplication of parts from claim 1 (i.e. repeating the same steps from claim1 but continuing these steps to second/third linear portions). The board has determined that duplication of steps is obvious unless any differences are claimed.
Regarding claim 16, see examiners rejection for claim 1 which is analogous and applicable for the rejection of claim 16. Claim 16 is a duplication of parts from claim 1 (i.e. repeating the same steps from claim1 but continuing these steps to second/third linear portions). The board has determined that duplication of steps is obvious unless any differences are claimed.
Regarding claim 17, see examiners rejection for claim 1 which is analogous and applicable for the rejection of claim 17. Claim 17 is a duplication of parts from claim 1 (i.e. repeating the same steps from claim1 but continuing these steps to second/third linear portions). The board has determined that duplication of steps is obvious unless any differences are claimed. Furthermore, Watanabe does not explicitly disclose
if the total number of out-of-focus cells in the first plurality of images does not exceed the threshold number, then cause the camera to acquire the second plurality of images of a second linear portion of the specimen directly adjacent to the first linear portion,
However, Lahrmann does disclose
if the total number of out-of-focus cells in the first plurality of images does not exceed the threshold number, then cause the camera to acquire the second plurality of images of a second linear portion of the specimen directly adjacent to the first linear portion, [See Lahrmann [Pg. 5 to Pg. 6] Slide Sharpness analysis. Also, see Fig. 4, The slide is divided into sub-regions and each cell is classified into the in-focus or out-of-focus category. The percentage of in-focus cells (0-100%) is used to calculate a score for each region (or in other words, the percentage of out-of-focus cells are used to calculate a score for each region). The regional division allows a time-saving re-scan of parts of the slide. Also, see Pg. 6 3rd para. line 14, The resulting score is compared with a user defined threshold. If the final score is lower than the threshold, the slide has to be rescanned. These scores basically represent the proportion of in-focus to out-of-focus cells that exist in the slides. Based on the outcome of this analysis, a decision is made whether to re-scan the whole slide or re-scan specific portions.]
Applying the same motivation as applied in claim 1.
Regarding claim 18, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe discloses
wherein the system is further configured to repeat steps (a)-(d) until images of an entirety of the specimen have been acquired. [See Watanabe [0012] Imaging the whole observation target.]
Regarding claim 19, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe does not explicitly disclose
wherein the specimen is a cytological specimen.
However, Lahrmann does disclose
wherein the specimen is a cytological specimen. [See Lahrmann [Title/Abstract] Imaging of cervical cytology slides.]
Applying the same motivation as applied in claim 1.
Regarding claim 20, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe does not explicitly disclose
wherein the cells distributed within the specimen comprise cervical cells.
However, Lahrmann does disclose
wherein the cells distributed within the specimen comprise cervical cells. [See Lahrmann [Title/Abstract] Imaging of cervical cytology slides.]
Applying the same motivation as applied in claim 1.
Regarding claim 22, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe discloses
wherein a coverslip covers the specimen. [See Watanabe [0013] Coverslip.]
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US 20150309299) in view of Lahrmann (Sementic Focusing Allows Fuly Automated Single-Layer Slide Scanning of Cervical Ctyology Slides) and in further view of Kumar (US Patent No. 10,304,188).
Regarding claim 21, Watanabe (modified by Lahrmann) disclose the system of claim 1. Furthermore, Watanabe does not explicitly disclose
wherein the cells distributed within the specimen comprise bladder cells.
However, Kumar does disclose
wherein the cells distributed within the specimen comprise bladder cells. [See Kumar [Col. 15 lines 12-14] Analysis of images containing bladder cells from urine cytology tests.]
It would have been obvious to the person of ordinary skill in the art at the time of the effective filing date to modify the system by Watanabe (modified by Lahrmann) to add the teachings of Kumar, in order to perform a simple substitution of an imaging subject.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US 20150309299) in view of Lahrmann (Sementic Focusing Allows Fuly Automated Single-Layer Slide Scanning of Cervical Ctyology Slides) and in further view of Angros (US 20070092408).
Regarding claim 22, Watanabe (modified by Lahrmann) disclose the system of claim 22. Furthermore, Watanabe does not explicitly disclose
wherein the coverslip is a film coverslip.
However, Angros does disclose
wherein the coverslip is a film coverslip. [See Angros [0038] Cytology specimens that need a film layer on the coverslip.]
It would have been obvious to the person of ordinary skill in the art at the time of the effective filing date to modify the system by Watanabe (modified by Lahrmann) to add the teachings of Angros, in order to perform a simple substitution of the coverslip. Furthermore, Angros discloses that cytology specimens require/need a film layer on the coverslip (para. 0038 Angros).
Conclusion
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/JAMES T BOYLAN/Examiner, Art Unit 2486
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