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 .
Response to Arguments
Applicant's arguments filed 9/10/2026 have been fully considered are addressed below:
The information disclosure statement submitted 6/12/2026 was considered by the examiner.
Applicant’s amendments overcome the drawing objection. The objection to the drawings has been withdrawn.
Applicant’s amendments overcome the claim objections. The objections to the claims have been withdrawn.
Applicant’s amendments overcome the 112b rejections. The 112b rejections of the claims have been withdrawn.
Applicant's arguments regarding the 112f interpretation of “imaging device”, see page 10, have been fully considered but they are not persuasive. The examiner makes note that the claim interpretation under USC §112f is not a rejection. The term “imaging device” uses the generic placeholder “device” that is coupled with functional language, “imaging”, without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. The examiner’s interpretation of “imaging device” under USC §112f is consistent with the applicant’s arguments and specification and has been maintained.
Applicant's arguments regarding the 102 and 103 rejections, see page 11, have been fully considered but they are not persuasive. Applicant argues that Yafin, at most, teaches preparing or modifying a sample, placing different sample portions in different sample chambers, and focusing a microscope at different depth levels depending upon the depth of focus of the system and that Yafin does not disclose using the dilution ratio or a sample chamber depth dimension as a basis for selecting how many fields of view are to be imaged (see remarks page 12).
However, the examiner respectfully disagrees. Yafin teaches sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, in order to facilitate different measurands being measured using microscope images of respective sample chambers [0105]; [0107]). Although Yafin does teach that the height interval between successive additional depth levels at which the cell solution is imaged is dependent upon the depth of focus of the microscope optical system ([0115]), the depth of focus of the microscope optical system is directly related to the sample chamber depth dimension because the microscope may be focused at additional depth levels that are separated from each other by a given height difference over the height of the portion of the sample that is within the sample chamber ([0115]). Further, the number of fields of view can be interpreted to correspond to at least one image at the monolayer depth and at least one image at an additional depth, where the monolayer depth is located at the bottom of the sample chamber and is thus selected based on a sample chamber depth dimension ([0114]; [0111] monolayer of cells on the base surface of the sample chamber). Additionally, monolayer images will have a higher density of cells compared to images at other depths ([0115]), so the images will have different ratios of volume of the diluent to volume of the biological sample. Thus, Yafin teaches using the dilution ratio or a sample chamber depth dimension as a basis for selecting how many fields of view are to be imaged. As such, the rejection has been maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, and 15 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US20230003622A1 by Yafin et al. (hereinafter “Yafin”, cited in the IDS).
Regarding claim 1, Yafin teaches an apparatus for analyzing a biological sample (optical measurement unit 31; [0100]), the apparatus comprising:
at least one processor (Fig. 1; computer processor 28; [0096]); and
at least one memory storing instructions which, when executed by the at least one processor, cause the apparatus at least to perform (memory 30; [0096]):
focusing an imaging device (optical measurement device 24; [0110]) into a sample chamber (sample carrier 22 having sample chamber 52 and 54; [0098]); , the sample chamber having a bottom wall that is at least translucent and through which the imaging device is configured to image an inside of the sample chamber ([0096]; [0099] glass layer);
determining that the sample chamber contains at least a diluent and a biological sample comprising red blood cells and white blood cells ([0100] "The first portion of the blood sample is typically diluted with respect to the second portion of the blood sample"; [0130] blood sample contains white blood cells and red blood cells; [0008] computer processor can determine dilution) ; and
selecting, based at least on one of: (i) a ratio of volume of the diluent to volume of the biological sample, or (ii) at least one sample chamber depth dimension, a number of fields of view, each field of view of the number of fields of view containing at least a portion of the sample chamber ([0105] " sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, in order to facilitate different measurands being measured using microscope images of respective sample chambers"; [0107]; the depth of focus of the microscope optical system is directly related to the sample chamber depth dimension because the microscope may be focused at additional depth levels that are separated from each other by a given height difference over the height of the portion of the sample that is within the sample chamber [0115]; the number of fields of view can at least be interpreted to correspond to at least one image at the monolayer depth and at least one image at an additional depth, where the monolayer depth is located at the bottom of the sample chamber and is thus selected based on a sample chamber depth dimension [0114]; [0111] monolayer of cells on the base surface of the sample chamber; monolayer images will have a higher density of cells compared to images at other depths [0115], thus the images will have different ratios of volume of the diluent to volume of the biological sample)
controlling the imaging device to capture a plurality of images, the plurality of images comprising images of the selected number of fields of view ([0105]; [0107]; [0114] image the monolayer of cells [0115] acquiring microscopic images at additional depth levels).
Regarding claim 8, Yafin teaches a method for analyzing a biological sample (optical measurement unit 31; [0100]), the method comprising:
focusing an imaging device (optical measurement device 24; [0110]) into a sample chamber (sample carrier 22 having sample chamber 52 and 54; [0098]); the sample chamber having a bottom wall that is at least translucent and through which the imaging device is configured to image an inside of the sample chamber ([0096]; [0099] glass layer);
determining that the sample chamber contains at least a diluent and a biological sample comprising red blood cells and white blood cells ([0100] "The first portion of the blood sample is typically diluted with respect to the second portion of the blood sample"; [0130] blood sample contains white blood cells and red blood cells; [0008] computer processor can determine dilution) ; and
selecting, based at least on one of: (i) a ratio of volume of the diluent to volume of the biological sample, or (ii) at least one sample chamber depth dimension, a number of fields of view, each field of view of the number of fields of view containing at least a portion of the sample chamber ([0105] " sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, in order to facilitate different measurands being measured using microscope images of respective sample chambers"; [0107]; the depth of focus of the microscope optical system is directly related to the sample chamber depth dimension because the microscope may be focused at additional depth levels that are separated from each other by a given height difference over the height of the portion of the sample that is within the sample chamber [0115]; the number of fields of view can at least be interpreted to correspond to at least one image at the monolayer depth and at least one image at an additional depth, where the monolayer depth is located at the bottom of the sample chamber and is thus selected based on a sample chamber depth dimension [0114]; [0111] monolayer of cells on the base surface of the sample chamber; monolayer images will have a higher density of cells compared to images at other depths [0115], thus the images will have different ratios of volume of the diluent to volume of the biological sample)
controlling the imaging device to capture a plurality of images, the plurality of images comprising images of the selected number of fields of view ([0105]; [0107]; [0114] image the monolayer of cells [0115] acquiring microscopic images at additional depth levels).
Regarding claim 15, Yafin teaches a processor-readable medium storing instructions which, when executed by at least one processor of an apparatus, causes the apparatus at least to perform (optical measurement unit 31; [0100]; Fig. 1; computer processor 28; [0096], memory 30; [0096]):
focusing an imaging device (optical measurement device 24; [0110]) into a sample chamber (sample carrier 22 having sample chamber 52 and 54; [0098]); , the sample chamber having a bottom wall that is at least translucent and through which the imaging device is configured to image an inside of the sample chamber ([0096]; [0099] glass layer);
determining that the sample chamber contains at least a diluent and a biological sample comprising red blood cells and white blood cells ([0100] "The first portion of the blood sample is typically diluted with respect to the second portion of the blood sample"; [0130] blood sample contains white blood cells and red blood cells; [0008] computer processor can determine dilution) ; and
selecting, based at least on one of: (i) a ratio of volume of the diluent to volume of the biological sample, or (ii) at least one sample chamber depth dimension, a number of fields of view, each field of view of the number of fields of view containing at least a portion of the sample chamber ([0105] " sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, in order to facilitate different measurands being measured using microscope images of respective sample chambers"; [0107]; the depth of focus of the microscope optical system is directly related to the sample chamber depth dimension because the microscope may be focused at additional depth levels that are separated from each other by a given height difference over the height of the portion of the sample that is within the sample chamber [0115]; the number of fields of view can at least be interpreted to correspond to at least one image at the monolayer depth and at least one image at an additional depth, where the monolayer depth is located at the bottom of the sample chamber and is thus selected based on a sample chamber depth dimension [0114]; [0111] monolayer of cells on the base surface of the sample chamber; monolayer images will have a higher density of cells compared to images at other depths [0115], thus the images will have different ratios of volume of the diluent to volume of the biological sample)
controlling the imaging device to capture a plurality of images, the plurality of images comprising images of the selected number of fields of view ([0105]; [0107]; [0114] image the monolayer of cells [0115] acquiring microscopic images at additional depth levels).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-7, 9-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yafin.
Regarding claim 2, Yafin teaches the apparatus of claim 1, and Yafin further teaches wherein the selecting is based on the at least one sample chamber depth dimension (see claim 1), wherein the sample chamber comprises regions having different depth dimensions of the at least one sample chamber depth dimension ([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other), wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region ([0107] a first optical measurement upon (e.g., by acquiring microscopic images of) a portion of the sample that is disposed within a first sample chamber belonging to set 52); wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region (a second optical measurement upon (e.g., by acquiring microscopic images of) a portion of the sample that is disposed within a second sample chamber of set 52 of the sample carrier). Further, Yafin teaches a sample chamber of the sample carrier having a greater height may be used to perform a white blood cell count to reduce statistical errors which may result from a low count in a shallower region and red blood cells may be measured with a sample carrier having a relatively low height ([0105]).
Yafin does not explicitly teach wherein the sample chamber comprises a first region having a first depth dimension of the at least one sample chamber depth dimension and a second region having a second depth dimension of the at least one sample chamber depth dimension greater than the first depth dimension wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region having the first depth dimension, and wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region having the second depth dimension.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches a second set of sample chambers 54 for optical density measurements (Fig. 3B; on the same carrier as sample chambers 52) which define at least a first region 56 (which is typically deeper) and a second region 58 (which is typically shallower), the height of the sample chambers varying between the first and second regions in a predefined manner ([0109]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use two regions with different heights in the sample chamber. Therefore, it would have been obvious to modify Yafin to include wherein the sample chamber comprises a first region having a first depth dimension of the at least one sample chamber depth dimension and a second region having a second depth dimension of the at least one sample chamber depth dimension greater than the first depth dimension wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region having the first depth dimension, and wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region having the second depth dimension as suggested by the second embodiment in order to reduce statistical error.
Regarding claim 3, Yafin as modified above teaches the apparatus of claim 2, and Yafin further teaches wherein the second number of fields of view is less than the first number of fields of view ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample, thus the second number of fields of view at a greater depth is less than the first number of fields of view).
Regarding claim 4, Yafin as modified above teaches the apparatus of claim 2, and Yafin further teaches wherein the sample chamber comprises regions with different height dimensions ([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other) and that less images of fields of view are need at greater depths ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample). Further, Yafin shows in Fig. 3B that there are three sample chambers belonging to set 52.
Yafin does not explicitly teach wherein the sample chamber comprises a third region having a third depth dimension of the at least one sample chamber depth dimension greater than the second depth dimension, wherein the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture images of a third number of fields of view containing at least a portion of the third region having the third depth dimension, wherein the third number of fields of view is less than the second number of fields of view and is less than the first number of fields of view.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches a second set of sample chambers 54 for optical density measurements (Fig. 3B; on the same carrier as sample chambers 52) where the height of the sample chamber varies from the first region 56 to the second region 58, and the height then varies again from the second region to a third region 59, such that, along the sample chamber, first region 56 defines a maximum height region, second region 58 defines a medium height region, and third region 59 defines a minimum height region ([0109]).
Thus, it would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a sample chamber with three different height regions and that less fields of view are required for larger depths. Therefore, it would have been obvious to modify Yafin to include wherein the sample chamber comprises a third region having a third depth dimension of the at least one sample chamber depth dimension greater than the second depth dimension, wherein the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture images of a third number of fields of view containing at least a portion of the third region having the third depth dimension, wherein the third number of fields of view is less than the second number of fields of view and is less than the first number of fields of view as suggested by the second embodiment in order to perform a more robust measurement.
Regarding claim 5, Yafin as modified above teaches the apparatus of claim 4, and Yafin further teaches performing image acquisitions in order ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample). Yafin further teaches the settling dynamics of the platelets are determined by imaging the same imaging field a plurality of times, with a [t]ime interval between each of the image acquisitions, and/or by determining until what height within the sample chamber platelets are present at a given time ([0007]; [0120]).
Yafin does not explicitly teach controlling the imaging device to capture the images of the second number of fields of view after capturing the images of the first number of fields of view and to capture the images of the third number of fields of view after capturing the images of the second number of fields of view.
However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). One would perform the image acquisitions in the most efficient and accurate order.
It would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to perform the measurements at deeper depths after the shallower depths in order to allow the sample to settle. Therefore, it would have been obvious to modify Yafin to include wherein in the controlling the imaging device, the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture the images of the second number of fields of view after capturing the images of the first number of fields of view and to capture the images of the third number of fields of view after capturing the images of the second number of fields of view in order to account for settling time, thus reducing measurement error.
Regarding claim 6, Yafin teaches the apparatus of claim 1, and Yafin further teaches wherein the number of fields of view corresponds to a ratio of volume of the diluent to volume of the biological sample (([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, at different heights, there is a different ratio of volume of the diluent to volume of the biological sample due to settling dynamics of the sample; [0121]). Further, Yafin teaches for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample, thus the number of fields of view is greater is at the monolayer depth ([0115]).
Yafin does not explicitly teach in this embodiment wherein a great number of fields of view corresponds to a great ratio of volume of the diluent to volume of the biological sample.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches, for some applications, that a count of the platelets that have settled within the monolayer is compared to a count of the platelets that have not settled within the monolayer ([0121]). The platelets that have not settled would be images in the first, shallower region and would have a higher ratio of volume of diluent to the volume of the sample than the monolayer in the second, deeper region. This ratio distribution is the result of the sample settling to the bottom.
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention that the shallower regions would have a great ratio of volume of the diluent to volume of the biological sample than the deeper regions. Therefore, it would have been obvious to modify Yafin to include wherein a great number of fields of view corresponds to a great ratio of volume of the diluent to volume of the biological sample as suggested by the second embodiment in order to account for the settling of the sample, thus increasing measurement accuracy.
Regarding claim 7, Yafin teaches the apparatus of claim 1, and Yafin further teaches wherein the images of the a number of fields of view comprise images of at least one field of view containing at least a portion of a bottom of the sample chamber ([0112] at least one microscopic image of at least a portion of the monolayer of cells formed at the bottom of the sample chamber, an optimum depth level at which to focus the microscope in order to image the monolayer is determined),
Regarding claim 9, Yafin teaches the method of claim 8, and Yafin further teaches wherein the selecting is based on the at least one sample chamber depth dimension (see claim 8), wherein the sample chamber comprises regions having different depth dimensions of the at least one sample chamber depth dimension ([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other), wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region ([0107] a first optical measurement upon (e.g., by acquiring microscopic images of) a portion of the sample that is disposed within a first sample chamber belonging to set 52); wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region (a second optical measurement upon (e.g., by acquiring microscopic images of) a portion of the sample that is disposed within a second sample chamber of set 52 of the sample carrier). Further, Yafin teaches a sample chamber of the sample carrier having a greater height may be used to perform a white blood cell count to reduce statistical errors which may result from a low count in a shallower region and red blood cells may be measured with a sample carrier having a relatively low height ([0105]).
Yafin does not explicitly teach wherein the sample chamber comprises a first region having a first depth dimension of the at least one sample chamber depth dimension and a second region having a second depth dimension of the at least one sample chamber depth dimension greater than the first depth dimension wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region having the first depth dimension, and wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region having the second depth dimension.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches a second set of sample chambers 54 for optical density measurements (Fig. 3B; on the same carrier as sample chambers 52) which define at least a first region 56 (which is typically deeper) and a second region 58 (which is typically shallower), the height of the sample chambers varying between the first and second regions in a predefined manner ([0109]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use two regions with different heights in the sample chamber. Therefore, it would have been obvious to modify Yafin to include wherein the sample chamber comprises a first region having a first depth dimension of the at least one sample chamber depth dimension and a second region having a second depth dimension of the at least one sample chamber depth dimension greater than the first depth dimension wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region having the first depth dimension, and wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region having the second depth dimension as suggested by the second embodiment in order to reduce statistical error.
Regarding claim 10, Yafin as modified above teaches the method of claim 9, and Yafin further teaches wherein the second number of fields of view is less than the first number of fields of view ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample, thus the second number of fields of view at a greater depth is less than the first number of fields of view).
Regarding claim 11, Yafin as modified above teaches the method of claim 9, and Yafin further teaches wherein the sample chamber comprises regions with different height dimensions ([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other) and that less images of fields of view are need at greater depths ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample). Further, Yafin shows in Fig. 3B that there are three sample chambers belonging to set 52.
Yafin does not explicitly teach wherein the sample chamber comprises a third region having a third depth dimension of the at least one sample chamber depth dimension greater than the second depth dimension, wherein the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture images of a third number of fields of view containing at least a portion of the third region having the third depth dimension, wherein the third number of fields of view is less than the second number of fields of view and is less than the first number of fields of view.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches a second set of sample chambers 54 for optical density measurements (Fig. 3B; on the same carrier as sample chambers 52) where the height of the sample chamber varies from the first region 56 to the second region 58, and the height then varies again from the second region to a third region 59, such that, along the sample chamber, first region 56 defines a maximum height region, second region 58 defines a medium height region, and third region 59 defines a minimum height region ([0109]).
Thus, it would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a sample chamber with three different height regions and that less fields of view are required for larger depths. Therefore, it would have been obvious to modify Yafin to include wherein the sample chamber comprises a third region having a third depth dimension of the at least one sample chamber depth dimension greater than the second depth dimension, wherein method further comprising: controlling the imaging device to capture images of a third number of fields of view containing at least a portion of the third region having the third depth dimension, wherein the third number of fields of view is less than the second number of fields of view and is less than the first number of fields of view as suggested by the second embodiment in order to perform a more robust measurement.
Regarding claim 12, Yafin as modified above teaches the method of claim 11, and Yafin further teaches performing image acquisitions in order ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample).Yafin further teaches the settling dynamics of the platelets are determined by imaging the same imaging field a plurality of times, with a [t]ime interval between each of the image acquisitions, and/or by determining until what height within the sample chamber platelets are present at a given time ([0007]; [0120]).
Yafin does not explicitly teach controlling the imaging device to capture the images of the second number of fields of view after capturing the images of the first number of fields of view and to capture the images of the third number of fields of view after capturing the images of the second number of fields of view.
However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2114.04 IV. One would perform the image acquisitions in the most efficient and accurate order.
It would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to perform the measurements at deeper depths after the shallower depths in order to allow the sample to settle. Therefore, it would have been obvious to modify Yafin to include wherein in the controlling the imaging device, the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture the images of the second number of fields of view after capturing the images of the first number of fields of view and to capture the images of the third number of fields of view after capturing the images of the second number of fields of view in order to account for settling time, thus reducing measurement error.
Regarding claim 13, Yafin teaches the method of claim 8, and Yafin further teaches wherein the number of fields of view corresponds to a ratio of volume of the diluent to volume of the biological sample (([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, at different heights, there is a different ratio of volume of the diluent to volume of the biological sample due to settling dynamics of the sample; [0121]). Further, Yafin teaches for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample, thus the number of fields of view is greater is at the monolayer depth ([0115]).
Yafin does not explicitly teach in this embodiment wherein a great number of fields of view corresponds to a great ratio of volume of the diluent to volume of the biological sample.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches, for some applications, that a count of the platelets that have settled within the monolayer is compared to a count of the platelets that have not settled within the monolayer ([0121]). The platelets that have not settled would be images in the first, shallower region and would have a higher ratio of volume of diluent to the volume of the sample than the monolayer in the second, deeper region. This ratio distribution is the result of the sample settling to the bottom.
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention that the shallower regions would have a great ratio of volume of the diluent to volume of the biological sample than the deeper regions. Therefore, it would have been obvious to modify Yafin to include wherein a great number of fields of view corresponds to a great ratio of volume of the diluent to volume of the biological sample as suggested by the second embodiment in order to account for the settling of the sample, thus increasing measurement accuracy.
Regarding claim 14, Yafin teaches the method of claim 8, and Yafin further teaches wherein the images of the first number of fields of view comprise images of at least one field of view containing at least a portion of a bottom of the sample chamber ([0112] at least one microscopic image of at least a portion of the monolayer of cells formed at the bottom of the sample chamber, an optimum depth level at which to focus the microscope in order to image the monolayer is determined).
Regarding claim 16, Yafin teaches the processor-readable medium of claim 15, and Yafin further teaches wherein the selecting is based on the at least one sample chamber depth dimension (see claim 1), wherein the sample chamber comprises regions having different depth dimensions of the at least one sample chamber depth dimension ([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other), wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region ([0107] a first optical measurement upon (e.g., by acquiring microscopic images of) a portion of the sample that is disposed within a first sample chamber belonging to set 52); wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region (a second optical measurement upon (e.g., by acquiring microscopic images of) a portion of the sample that is disposed within a second sample chamber of set 52 of the sample carrier). Further, Yafin teaches a sample chamber of the sample carrier having a greater height may be used to perform a white blood cell count to reduce statistical errors which may result from a low count in a shallower region and red blood cells may be measured with a sample carrier having a relatively low height ([0105]).
Yafin does not explicitly teach wherein the sample chamber comprises a first region having a first depth dimension of the at least one sample chamber depth dimension and a second region having a second depth dimension of the at least one sample chamber depth dimension greater than the first depth dimension wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region having the first depth dimension, and wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region having the second depth dimension.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches a second set of sample chambers 54 for optical density measurements (Fig. 3B; on the same carrier as sample chambers 52) which define at least a first region 56 (which is typically deeper) and a second region 58 (which is typically shallower), the height of the sample chambers varying between the first and second regions in a predefined manner ([0109]).
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use two regions with different heights in the sample chamber. Therefore, it would have been obvious to modify Yafin to include wherein the sample chamber comprises a first region having a first depth dimension of the at least one sample chamber depth dimension and a second region having a second depth dimension of the at least one sample chamber depth dimension greater than the first depth dimension wherein the images of the number of fields of view include images of a first number of fields of view captured in the first region having the first depth dimension, and wherein the images of the number of fields of view include images of a second number of fields of view captured in the second region having the second depth dimension as suggested by the second embodiment in order to reduce statistical error.
Regarding claim 17, Yafin as modified above teaches the processor-readable medium of claim 16, and Yafin further teaches wherein the second number of fields of view is less than the first number of fields of view ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample, thus the second number of fields of view at a greater depth is less than the first number of fields of view).
Regarding claim 18, Yafin as modified above teaches the processor-readable medium of claim 16, and Yafin further teaches wherein the sample chamber comprises regions with different height dimensions of the at least one sample chamber depth dimension ([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other) and that less images of fields of view are need at greater depths ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample). Further, Yafin shows in Fig. 3B that there are three sample chambers belonging to set 52.
Yafin does not explicitly teach wherein the sample chamber comprises a third region having a third depth dimension of the at least one sample chamber depth dimension greater than the second depth dimension, wherein the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture images of a third number of fields of view containing at least a portion of the third region having the third depth dimension, wherein the third number of fields of view is less than the second number of fields of view and is less than the first number of fields of view.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches a second set of sample chambers 54 for optical density measurements (Fig. 3B; on the same carrier as sample chambers 52) where the height of the sample chamber varies from the first region 56 to the second region 58, and the height then varies again from the second region to a third region 59, such that, along the sample chamber, first region 56 defines a maximum height region, second region 58 defines a medium height region, and third region 59 defines a minimum height region ([0109]).
Thus, it would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention to use a sample chamber with three different height regions and that less fields of view are required for larger depths. Therefore, it would have been obvious to modify Yafin to include wherein the sample chamber comprises a third region having a third depth dimension of the at least one sample chamber depth dimension greater than the second depth dimension, wherein method further comprising: controlling the imaging device to capture images of a third number of fields of view containing at least a portion of the third region having the third depth dimension, wherein the third number of fields of view is less than the second number of fields of view and is less than the first number of fields of view as suggested by the second embodiment in order to perform a more robust measurement.
Regarding claim 19, Yafin as modified above teaches the processor-readable medium of claim 18, Yafin further teaches performing image acquisitions in order ([0115] for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample).Yafin further teaches the settling dynamics of the platelets are determined by imaging the same imaging field a plurality of times, with a [t]ime interval between each of the image acquisitions, and/or by determining until what height within the sample chamber platelets are present at a given time ([0007]; [0120]).
Yafin does not explicitly teach controlling the imaging device to capture the images of the second number of fields of view after capturing the images of the first number of fields of view and to capture the images of the third number of fields of view after capturing the images of the second number of fields of view
However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2114.04 IV. One would perform the image acquisitions in the most efficient and accurate order.
It would have been well known and obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to perform the measurements at deeper depths after the shallower depths in order to allow the sample to settle. Therefore, it would have been obvious to modify Yafin to include wherein in the controlling the imaging device, the instructions, when executed by the at least one processor, further cause the apparatus at least to perform: controlling the imaging device to capture the images of the second number of fields of view after capturing the images of the first number of fields of view and to capture the images of the third number of fields of view after capturing the images of the second number of fields of view in order to account for settling time, thus reducing measurement error.
Regarding claim 20, Yafin teaches the processor-readable medium of claim 15, and Yafin further teaches wherein the number of fields of view corresponds to a ratio of volume of the diluent to volume of the biological sample (([0105] sample chambers belonging to set 52 (which is used for microscopy measurements) have different heights from each other, at different heights, there is a different ratio of volume of the diluent to volume of the biological sample due to settling dynamics of the sample; [0121]). Further, Yafin teaches for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, in order to reduce the amount of time that it takes to image the portion of the sample, thus the number of fields of view is greater is at the monolayer depth ([0115]).
Yafin does not explicitly teach in this embodiment wherein a great number of fields of view corresponds to a great ratio of volume of the diluent to volume of the biological sample.
However, Yafin does address this limitation in a second embodiment.
Yafin teaches, for some applications, that a count of the platelets that have settled within the monolayer is compared to a count of the platelets that have not settled within the monolayer ([0121]). The platelets that have not settled would be images in the first, shallower region and would have a higher ratio of volume of diluent to the volume of the sample than the monolayer in the second, deeper region. This ratio distribution is the result of the sample settling to the bottom.
It would have been well known to someone of ordinary skill in the art before the effective filing date of the claimed invention that the shallower regions would have a great ratio of volume of the diluent to volume of the biological sample than the deeper regions. Therefore, it would have been obvious to modify Yafin to include wherein a great number of fields of view corresponds to a great ratio of volume of the diluent to volume of the biological sample as suggested by the second embodiment in order to account for the settling of the sample, thus increasing measurement accuracy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20240035952A1 by Hansen teaches a method of analysing a blood sample which includes a step to obtain image data of a prepared blood sample, the image data comprising data of a stack of images, where each image of the stack of images is associated with an image plane, wherein each image plane is associated with a different height along a z-axis of the prepared blood sample (claim 1).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E KIDWELL whose telephone number is (703)756-1719. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m. ET.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached at 571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/KAITLYN E KIDWELL/Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
