Zahniser, David et al.

Patent Trials and Appeals Board

Aug 19, 2020

2019003127 (P.T.A.B. Aug. 19, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/526,223 06/18/2012 David Zahniser 28441-0006001 5342
108932 7590 08/19/2020
Fish & Richardson PC (ROCHE DIAGNOSTICS)
P.O. Box 1022
Minneapolis, MN 55440-1022
EXAMINER
BECKER, JOSEPH W
ART UNIT PAPER NUMBER
2483
NOTIFICATION DATE DELIVERY MODE
08/19/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
jackie.pike@roche.com
pair_roche@firsttofile.com
patdoctc@fr.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID ZAHNISER,
MICHAEL ZAHNISER, and ADAM YIE

Appeal 2019-003127
Application 13/526,223
Technology Center 2400
____________

Before RICHARD M. LEBOVITZ, JASON V. MORGAN, and
JOHN A. EVANS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected the claims under 35 U.S.C. § 103 as obvious.
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s
decision to reject the claims. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Roche
Diagnostics Hematology, Inc. Appeal Br. 1.
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STATEMENT OF THE CASE
The Examiner rejected the claims as follows:
1. Claims 1–8, 15–18, 21–27, 29, 30, 33, 35, 36, 39–43, 48–51, and
53–61 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of Yamada (US
2010/0169811 A1, published July 1, 2010) (“Yamada”), Ortyn et. al. (US
2010/0232675 A1, published Sept. 16, 2010) (“Ortyn”), and Winkelman et.
al. (US 2011/0070606 A1, published Mar. 24, 2011) (“Winkelman”). Ans. 4;
Office Act.2 5.
2. Claims 19 and 31 under pre-AIA 35 U.S.C. § 103(a) as obvious in
view of Yamada, Ortyn, Winkelman, and Bacus (EP 0 549 905 A1,
published July 7, 1993) (“Bacus”). Ans. 17; Office Act. 22.
3. Claims 34, 45, and 63–66 under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Yamada and Ortyn. Ans. 18; Office Act. 23.
4. Claim 62 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of
Yamada, Ortyn, Winkelman, and Herbert (US 2003/0161003 A1, published
Aug. 28, 2003) (“Herbert”). Ans. 21; Office Act. 26.
Independent claim 1 is representative and reproduced below
(annotated with bracketed numbers for reference to the specific limitations
in the claim):
1. A method of displaying images of cells in a sample, the
method comprising:
[1] obtaining a first set of images of a plurality of cells in
the sample;
[2] determining values of a property for each one of the
cells based on the first set of images; and
[3] displaying a second set of cell images in an ordered
array on a display device,

2 Office Action, mailed May 23, 2017.
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[4] wherein each member of the second set of cell images
corresponds to and shows only one of the plurality of cells;
[5] wherein each member of the second set of cell images
corresponds to a different one of the plurality of cells;
[6] wherein each member of the second set of cell images
is ordered in the array based on the value of the property
determined for the cell that corresponds to the member; and
[7] wherein each one of the plurality of cells is a red blood
cell or a platelet.

REJECTION BASED ON YAMADA, ORTYN
The Examiner found that Yamada describes a system for visually
inspecting blood cells comprising obtaining images of cells as in the first
step [1] of claim 1. Office Act. 5. The Examiner also found that Yamada
determines ordering images of cells “based on the value of the property
determined for the cell” as recited in limitation [6] claim. Id. The Examiner
determined, however, that Yamada does not describe displaying a second set
of images which show only one of the plurality of cells, where each image
corresponds to a different cell as required by limitations [4] and [5] of the
claim. Id. However, the Examiner found that Ortyn makes up for this
deficiency and describes displaying images of a second set of single blood
cells and selecting the images for the different properties they exhibit. Id. at
6. The Examiner determined it would have been obvious to one of ordinary
skill in the art to combine Yamada and Ortyn to acquire multispectral
images of single cells from a population of cells as described in Ortyn (citing
paragraph 13). Id.
The Examiner further cited Winkelman as providing a reason to
analyze red blood cells in the blood cell samples of Yamada and Ortyn,
meeting limitation [7] of the claim. Office Act. 6–7.
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Appellant argued 20 groups of claims separately. The arguments do
not identify the specific rejection associated with the claims. We address the
claims in accordance with the specific groups argued by Appellant.
To the extent that any claim is not specifically addressed, the claim
stands or falls in the group in which it was argued, or with the independent
claim from which it depends. 37 C.F.R. § 41.37(c)(1)(iv).

DISCUSSION
Group 1: 1–3, 6, 8, 18, 19, 21–24, 27, 29, 31, and 33
Appellant states that Yamada’s disclosure describes a doctor or
technician reclassifying white bloods among various white blood cell types.
Appeal Br. 14. Appellant contends that the technician or doctor must take
into account the nature of the cell and its “local environment,” particularly if
the cell metrics were obtained from overlapping cells or cells in contact with
one another. Id. Appellant states that Yamada’s images allow such an
assessment, “as they show each classified white blood cell in its local
environment within the sample, surrounded by additional cells.” Id. (citing
Fig. 13 of Yamada). For this reason, Appellant argues that applying Ortyn’s
single cell display to Yamada would “impair” Yamada’s method. Id. at 15.
Appellant’s argument does not persuade us that the Examiner erred.
Appellant has not pointed to persuasive disclosure in Yamada which
supports the contention that the local environment of neighboring cells is
used to reclassify the cells. An argument made by counsel in a brief does not
substitute for evidence lacking in the record. Estee Lauder, Inc. v. L’Oréal,
S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). Appellant identified paragraph 137
of Yamada as support for its contention. Reply Br. 3. However, Appellant
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did not point to the specific disclosure in this paragraph where the “local
environment” of cells was used to reclassify the white blood cells as asserted
by Appellant. As explained below, Yamada does not teach in paragraph 137
that the local environment of neighboring cells is used to reclassify the cells.
Yamada teaches that reclassification of the cells is facilitated by
ordering the images by the properties used to classify the cell. Yamada
¶¶ 134–37. Yamada explains that the blood cell images in the array of
images are arranged in “imaging sequence” in Fig. 19 and “in the sequence
in accordance with the characteristic parameter values” in Fig. 13. Yamada
¶ 137. The “imaging sequence” is the order in which the images were
obtained during the scanning of the slide. Yamada explains that by ordering
cells in the array by the parameter used to classify them, such as the nucleus
to cytoplasm ratio (“NC”), it is easier to find the erroneously classified cells
because cells having similar nuclear shapes are in the same “vicinity” than
when they are in imaging sequence,3 allowing the user to more easily
identify and compare the misclassified cells.4

3 “In the screen in which the blood cell images are aligned in imaging
sequence as shown in FIG. 19, the adjacent blood cell images may not have
a similar shape. For this reason, the surveyor such as a laboratory technician
or a doctor must carefully confirm all the blood cell images and it is
impossible to easily find erroneous classifications.” Yamada ¶ 137
4 “On the other hand, in the screen in which the blood cell images are
aligned in descending sequence with respect to the ‘NC ratio’ of the
characteristic parameter as shown in FIG. 13, the blood cell images with a
small NC ratio among the lymphocytes with a large NC ratio are generally
arranged in the latter part. In addition, as described above, since the
monocyte has a NC ratio smaller than that of the lymphocyte, the blood cell
images of the lymphocyte with a small NC ratio which are arranged close to
the monocyte group are approximate to the shape of the monocyte, so that
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The discussion of cells being in the “vicinity” of each other (¶ 137) is
reference to the array of the plurality of images, not to the individual cells in
the image. This is explained in more detail below with reference to Fig. 13
of Yamada, which is copied below:

Fig. 13, reproduced above, shows an array of a plurality of images,
where each image is represented by a square and shows a darkly stain cell
nucleus aligned in the middle of each image. Yamada teaches that a
computer obtains the images of the cells, classifies the cells, and arranges

the blood cell images of the monocyte have a high possibility of being
erroneously classified as lymphocytes.” Yamada ¶ 137.
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the images in sequence based on a characteristic of the cell.5 The images are
displayed in each square of Fig. 13, and the “vicinity” is the neighboring
image squares. While it is true that each individual image contains a number
of different cells, only one nucleus is stained and analyzed in each image.
Appellant did not direct us to disclosure in Yamada, or any other fact-based
evidence, where the additional cells displayed in single square image were
used by Yamada to classify the cells. Thus, applying Ortyn’s teaching about
displaying single cells would not impair Yamada.
We further note that the Examiner relied on Yamada for a display
device as illustrated in Fig. 13 reproduced above, and Ortyn for disclosing
additional ways to display and sort cells. Office Act. 5–6; Ans. 22. Thus,
Yamada’s teaching about the advantage of sorting cells by their properties to
facilitate accurate classification would be applicable to Ortyn’s system of
displaying single cells when flow cytometry is utilized to classify cells.
Ortyn does not have neighboring cells because it separates single cells by
flow cytometry and therefore is not impaired by Yamada’s teaching of
arranging cells by a property of interest.

5 “A fourth aspect of the present invention is a computer program product
comprising: a computer readable medium, and instructions, on the computer
readable medium, adapted to enable a general purpose computer to perform
operations comprising: (a) obtaining characteristic parameter values based
on a plurality of cell images obtained by imaging a sample including the
plurality of cells, wherein each of the characteristic parameter values
respectively indicates characteristic of each of the cells; (b) determining
types of the cells based on the characteristic parameter value obtained in the
step (a); and (c) controlling the display so as to display the cell images in a
sequence based on the types of the cells obtained in the step (b) and the
characteristic parameter values obtained in the step (a).” Yamada ¶ 11.
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Appellant also argues that the Examiner did not provide an adequate
reason to combine Yamada and Ortyn. We do not agree.
The Examiner states that it would have been obvious to combine the
teaching in the two publications because “having encoded thereon computer
readable instructions for visual inspection of cells by fluorescence channels
as taught by Ortyn to acquire dark/light field and fluorescence images . . .
would allow acquire multispectral images from a population of cells” as
described in Ortyn. Office Act. 6. Appellant argues that this rationale is not
relevant because Yamada does not used spectral images for classification
purposes, while Ortyn does. Appeal Br. 15. Appellant further states that it
“would been appreciated by a person of ordinary skill in the art, Yamada’s
classification methods apparently perform satisfactorily without such
[spectral] images.” Id. at 15–16.
This argument does not persuade us that the Examiner erred. As we
understand the Examiner’s rationale, when spectral images of cells are
obtained as described by Ortyn, it would have been obvious to one of
ordinary skill in the art to apply Yamada’s teaching about ordering cells
based on the properties observed in Ortyn’s spectral images. Applying
Yamada to Ortyn in this way would preserve Ortyn’s teaching about
displaying spectral images of “only one of the plurality of cells” as recited in
limitation [4] of claim 1.
Appellant also states that it “does not agree with the Office’s apparent
contention that in Ortyn, ‘each member of the second set of cell images
corresponds to a different one of the plurality of cells’” as in limitation [5] of
claim 1. Appeal Br. 16. Appellant argues that there are multiple images
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displayed in Ortyn of the same white blood cell, pointing to Fig. 5 of Ortyn
which shows four images of each cell. Appeal Br. 16–17.
This argument is not persuasive. As discussed by the Examiner, each
horizontal row in Fig. 5 of Ortyn is of a different cell. Ans. 23; Office Act. 6.
In view of Yamada’s teaching of ordering cells based on only a single
characteristic, such as the NC ratio, it would have been obvious to one of
ordinary skill in the art to arrange the single cells based only one spectral
property – not all four as shown in Fig. 5. Appellant is disparaging the
rejection by focusing on the disclosure in Ortyn individually, but the
rejection was based on the obviousness of modifying Ortyn’s teaching based
on Yamada. “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). Thus, while Ortyn teaches in one embodiment displaying
different spectral images of the same cell, Appellant has not identified any
reason why it would be necessary to use each of the different spectral
images, when it is desired to look at only one characteristic as taught by
Yamada. Consistently, Ortyn specifically teaches analyzing only one
characteristic of the population.6 Thus, while Appellant argues it is
“fundamental” to Ortyn’s method to use all four images, Appellant’s main
support for this statement is that one of Ortyn’s embodiments shows all four

6 “The photometric and/or morphometric image features calculated from the
collected images are analyzed to enable at least one characteristic of a cell or
population of cells to be measured.” Ortyn ¶ 14. “As noted above, in
addition to collecting image data from a population of biological cells, an
aspect of the concepts disclosed herein involves processing the image data
collected to measure at least one characteristic associated with a disease
condition in the imaged population.” Id. at ¶ 64.
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images. Appeal Br. 18. But Appellantfails to take into account the teaching
that only one characteristic of a cell may be relevant to a determination of
the cell type or condition (see fn. 6), and that Yamada uses only one
characteristic in its analysis.
Appellant also contends that it would not have been obvious to have
applied the teachings of Yamada and Ortyn to red bloods or platelets as
required by claim 1 because their teachings are designed to be used for white
blood cells. Appeal Br. 19.
This argument is also not persuasive. The Examiner does not suggest
applying the same teachings in Yamada and Ortyn relating to white blood
cell characteristics to red blood cells. For example, the Examiner specifically
pointed to Winkelman’s teaching about measuring hemoglobin content of
the red blood cells (Office Act. 8), a property that would not be measurable
in a white blood cell. Winkelman also teaches measuring red blood cell
morphology.7 We further note also Fig. 13 of Yamada reproduced above
contains the heading “red blood cell shape,” reasonably suggesting, along
with Winkelman, that one of ordinary skill in the art had reason to apply the
teachings about the characterizing the cytology of white blood cells as
described in Yamada and Ortyn to red blood cells.

7 “In an embodiment of the invention capable of preparing and analyzing
cells from blood samples, the computer 300 may be able to calculate the
number of a specific type of cell in a particular volume of blood, for
example for blood, red cell, white cell, and platelet counts and other
measured and derived components of the CBC such as: hemoglobin content,
red blood cell morphology.” Winkelman ¶ 36 (emphasis added). See also
Winkelman ¶ 50.

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Group 2: claims 4 and 25
Claim 4 and 25 are dependent claims that recite where the measured
property “comprises a cell hemoglobin content.” Appellant contends that
Winkelman does not teach how to make the calculation regarding
hemoglobin content. Appeal Br. 20. This argument is not persuasive.
An examiner is entitled to presume that the prior art is enabling,
shifting the burden to patent applicant to rebut the presumption. In re Antor
Media Corp., 689 F.3d 1282, 1287–88 (Fed. Cir. 2012). When the reference
relied on expressly anticipates or makes obvious all of the elements of the
claimed invention, the reference is presumed to be operable. Once such a
reference is found, the burden is on applicant to provide facts rebutting the
presumption of operability. In re Sasse, 629 F.2d 675 (CCPA 1980); see
also MPEP § 2121.I (9th Edition, Revision 10.2019, Last Revised June
2020).
Winkelman discloses that “wavelengths of approximately 405–430
nm are useful for imaging a hemoglobin-only image for assessing RBC
morphology and hemoglobin content.” Winkelman ¶ 50. Appellant did not
provide evidence that Winkelman’s disclosure is insufficient to enable one
of ordinary skill in the art at the time of the invention to determine the
hemoglobin content of the red blood cell. Appellant therefore did not meet
the burden of establishing that Winkelman is not enabling.

Group 3: claims 5 and 26
Claims 5 and 26 are dependent claims that recite where the measured
property “comprises a cell volume of each of the cells.” Appellant makes the
same argument as for Group 2 that Winkelman is not enabling for
determining cell volume. Appeal Br. 21. Winkelman discloses measuring
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mean corpuscular volume using cell cytometry (at ¶ 4) and Ortyn also
discloses that a morphological characteristic that can be measured is cell
volume (at ¶¶ 74, 80). Ortyn uses flow cell cytometry (at ¶ 53). Appellant
has not met the burden of establishing the determining cell volume by flow
cytometry is not enabled at the time of the invention, particularly when two
publications cited in the rejection state that it can be measured. See Sasse,
629 F.2d 675.

Group 4: claim 7
Claim 7 is a dependent claims that recite where the measured property
“comprises an optical density of each of the cells.” While Appellant
acknowledges that Winkelman describes measuring optical density,
Appellant contends that neither Winkelman, Yamada, nor Ortyn disclose or
suggest “actually ordering images based on optical density.” Appeal Br. 22.
This argument is not persuasive. The Examiner relied on Yamada for
teaching ordering cells based on their properties. Winkelman teaches one
such property. Office Act. 9. It would have been obvious to one of ordinary
skill in the art to order cells by any useful property for classification and
diagnostic purposes.

Group 5: claim 15
Claim 15 depends from claim 1 and further recites “comprising
detecting a disease condition in a patient based on the second set of cell
images.” Appellant argues that Winkelman’s disclosure about determining
viral and infected cells in a sample is “purely aspirational.” Appeal Br. 22–
23.
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While we agree with Appellant that there is limited disclosure in
Winkelman about detecting disease based on images of red blood cells,
Winkelman discloses measuring hemoglobin content of cells (at ¶ 50) and
one of ordinary skill in the art at the time of the invention, such as the doctor
or technician examining the data, would know that a cell has a normal range
of hemoglobin, and a content outside the normal range would be indicative
of a disease. See, e.g., Spec. 27–28 which indicates acceptable ranges for
hemoglobin. It is commonsense that Winkelman describes measuring the
hemoglobin content of red blood cells because it is indicative of the health of
a red blood cell. While Winkelman does not expressly state such a reason,
“[a] person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Thus,
Winkelman reasonably suggests that such measurements, when made to red
blood cells, would be useful to detect a disease condition in a patient.

Group 6: Claims 16, 17, and 30
Claims 16, 7, and 30 are dependent claims that recite analyzing the
images for inclusions, such as size, shape and number. The Examiner found,
citing paragraphs 14 and 59, that Winkelman describes measuring inclusions
in a cell. Office Act. 11.
Appellant contends that neither Winkelman, Yamada, or Ortyn
disclose or suggest “actually ordering cell images in an array based on a
property of inclusions, nor any specific examples of such inclusion
properties such as size, shape, or number.” Appeal Br. 23. This argument is
not persuasive because the Examiner relied on Yamada for teaching of
ordering cells by their characteristics, making it obvious to order cells by
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any desired characteristic. Appellant did not identify a defect in the
Examiner’s reasoning.

Group 7: claims 34, 41, 43, 45, 50, 62, and 64
Independent claim 34 recites that “each member of the second set of
cell images corresponds to one of the plurality of cells and is displayed as a
user-selectable control on the display device” and that when “when one of
the user-selectable controls is selected, the method further comprises
displaying a third image on the display device.” The third image is recited in
the claim to be a different field of view than the second image and “showing
the cell associated with the selected control and one or more neighboring
cells in the sample.”
The Examiner found that Ortyn’s disclosure of a dot plot in Figure 5
represents neighboring cells in the sample. Office Act. 24.
Appellant contends that the Examiner’s finding is erroneous. Appeal
Br. 26. Appellant argues:
[T]he collection of “dots” in in plot 59a is not a “third image” or
even an “image” at all. Instead, each of the dots in plot 59a
represents a point in a two dimensional feature space, where the
features correspond to the x- and y-axis values. Clustering of the
dots in the two dimensional feature space allows the different
groups of dots to be assigned to different types of white blood
cells. Thus, while each dot in plot 59a represents a particular
white blood cell with particular values of the features on the x-
and y-axes, the dots are not “images” of cells. There is no image
information associated with any of the dots, nor is there a “field
of view” associated with the dots. To the contrary, each dot is a
zero-dimensional marker in a scatter plot (i.e., plot 59a), with no
spatial extent.
Appeal Br. 26.
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We agree with Appellant. As discussed by Appellant, Fig. 5 of Ortyn
shows a dot plot representing clusters of cells, grouped by a property of the
cell indicative of their cell type. As explained in Ortyn, “dot plot 59b
(displayed at the center right of FIG. 5) substitutes a nuclear texture
parameter, ‘nuclear frequency’ for CD45 expression on the x-axis, revealing
a putative NK cell population (purple in a full color image).” Ortyn ¶ 116.
There is no showing of “one or more neighboring cells in the sample” as
required by the claim. The cluster do not represent neighboring cells, but
rather represent properties of cells with no spatial information as to the cell’s
location.
The rejection of claim 34 is reversed; dependent claims 41, 43, and 64
are reversed as well. Independent claim 45 has the same limitation as claim
34 with respect to the third image and is reversed as well; dependent claim
50 is also reversed.
Appellant grouped claim 62 into Group 7. However, claim 62 depends
from claim 1 and does not require a third image as in claim 34. The rejection
of this claim is, therefore, affirmed because Appellant did not explain why it
was separately patentable from claim 1.

Group 8: claim 35
Claim 35 depends from claim 34. The rejection of this claim is
therefore reversed for the same reason as claim 34.

Group 9: claim 36
Claim 36 depends from claim 34. The rejection of this claim is
therefore reversed for the same reason as claim 34.
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Group 10: claims 39 and 48
Claims 39 and 48 depend from claims 34 and 45, respectively. The
rejection of these claims is therefore reversed for the same reason as claims
34 and 45.

Group 11: claim 40 and 49
Claims 40 and 49 depend from claims 34 and 45, respectively. The
rejection of these claims is therefore reversed for the same reason as claims
34 and 45.

Group 12: claim 42
Claim 42 depends from claim 34. The rejection of this claim is
therefore reversed for the same reason as claim 34.

Group 13: claim 51
Claim 51 depends from claim 45. The rejection of this claim is
therefore reversed for the same reason as claim 45.

Group 14: claims 53, 54, 58, and 59
Claim 53, depends from claim 1, and further comprises “displaying a
graphical representation of a distribution of the values of the property on the
display device.”
The Examiner found that Ortyn discloses a histogram in Figure 8
which is a graphical representation. Office Act. 15. Appellant contends that
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“while Ortyn constructs the histograms shown in Figs. 8C–8M, nothing in
Ortyn suggests that such histograms are actually displayed.” Appeal Br. 33.
This argument is not persuasive. Ortyn reproduces histograms in Figs.
8D–8M. Ortyn ¶ 128. The computer has a display. Id. at ¶ 35. Ortyn
discloses that the computer “may be able to display numerical data, cell
population histograms, scatterplots, and direct assessments of cellular
morphology using images of blood cells displayed on the monitor.” Id. at
¶ 36. Thus, it evident that histograms are “actually displayed” on the
computer monitor of Ortyn.
The rejection of claim 53 is therefore affirmed. Appellant did not
provide separate arguments for claims 54, 58, and 59. These claims fall with
claim 53. 37 C.F.R. § 41.37(c)(1)(iv).

Group 15: claim 55
Claim 55 depends from claim 53 and further recites:
wherein each image in the second set of cell images is
displayed as a user-selectable control on the display device, and
wherein each user-selectable control is configured so that, when
selected, a marker is displayed on the graphical representation at
a position corresponding to a value of the property of the cell
associated with the selected control.
The Examiner found that Ortyn describes this additional limitation at
paragraph 116. Office Act. 16. Appellant contends that “this portion of
Ortyn merely states that when an image in Ortyn’s gallery is selected, the
corresponding dot in dot plot 59a is highlighted. But highlighting an existing
dot in plot 59a is not the same as displaying a marker that did not already
exist.” Appeal Br. 34.
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We are not persuaded by Appellant’s argument that the Examiner
erred. Appellants admits that when a cell is selected, a dot in the dot plot is
highlighted.8 The highlighting therefore serves as a marker for the position
of the cell in in dot plot 59a; the highlighting of the spot is not present until
the cell is selected and therefore “does “not already exist” until the selection
is made. Accordingly, the rejection of the claim is affirmed.

Group 16: claim 56
Claim 56 depends from claim 53 and further recites “comprising
displaying an expected distribution of the values of the property on the
graphical representation of the distribution.” The Examiner cited Fig. 9 of
Ortyn as meeting this additional limitation. Office Act. 17.
Appellant argues that Fig. 9 shows abundance data which is actual,
measured data and not an expected distribution. Appeal Br. 35.
Appellant’s argument is unpersuasive because Ortyn’s Figure 10B
illustrates the comparison of scatter plot data, such as that illustrated in
Ortyn’s Figure 9, with a “CD45 bivariate plot[] for normal peripheral blood
mononuclear cells.” Ortyn ¶ 134. That is, Ortyn’s Fig. 10B shows the
distribution of “normal PBMC”—an expected distribution of normal cells—
with an overlaid second distribution of mammary carcinoma cells. Id. ¶ 45.
The image showing the expected distribution of normal cells superimposed
on the distribution of carcinoma cells illustrates “how the distribution of
mammary carcinoma cells is distinguishable from the distribution of the
normal PBMC cells.” Id. The claim does not require how the “expected

8 “Cell imagery can be selected to highlight the corresponding dot in every
plot in which that cell appears.” Ortyn ¶ 116.
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distribution” is determined. Thus, Appellant’s argument that Ortyn shows
“actual, measured data” does not distinguish the claim for Ortyn’s
disclosure. In addition, while the expected distribution is graphical, it
represents values and therefore meets the limitation of “an expected
distribution of the values of the property.”
Nonetheless, we also consider the recited limitation of threshold
values to be non-functional descriptive matter under the printed matter
doctrine, which are therefore inadequate to distinguish the claimed subject
matter from the prior art. In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004); In re
Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983).

Group 17: claim 57
Claim 57 depends from claim 53, and further recites “comprising
displaying upper and lower threshold values of the property on the graphical
representation of the distribution, wherein the upper and lower threshold
values define a range of values of the property that are expected for a
patient.”
The Examiner found that Ortyn discloses Table 1 with threshold
values as recited in the claim. Office Act. 18. See also Office Act. 21
describing the display of expected values for claims which depend from
claim 57. Appellant argues that Table 1 does not contain threshold values
and they are not displayed on the graphical representation of the distribution.
We agree with Appellant that Table 1 of Ortyn, which is “an
exemplary listing of exemplary photometric and morphometric definitions
that can be identified for every image” (Ortyn ¶ 116), does not alone meet
the claim limitation. However, the table lists “threshold” under “user-defined
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masks,” indicating that thresholds may be determined and used.
Consistently, Ortyn specifically discloses drawing a “gate” in Fig. 8B
around an area of cells, “being sufficiently large to exclude debris, and the
aspect ratio being greater than −0.5, which eliminates doublets and clusters
of cells.” Id. at ¶ 126. The “gate” serves as a threshold to include cells while
excluding inclusions. See Office Act. 21 for discussion of the gate in Figs.
8B and 9.
Values are also displayed side by side the images in Yamada (see,
e.g., Fig. 13 showing “Hgb,” “MCV,” etc.). Thus, the display of any value
would have been obvious to one of ordinary skill in the art, including the
gate values described in Ortyn.
Nonetheless, we also consider the recited limitation of threshold
values to be non-functional descriptive matter under the printed matter
doctrine, which are therefore inadequate to distinguish the claimed subject
matter from the prior art. In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004); In re
Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983).

Group 18: claims 60 and 61
Claim 60, which depends from claim 57, further recites “for each cell
having a value of the property that falls outside the expected range of values,
displaying the corresponding member of the second set of cell images in a
highlighted display modality in the ordered array.”
The Examiner cited Fig. 9 of Ortyn as showing a gate (the “threshold”
of the claim) and for displaying cells in the array. Office Act. 21. Fig. 9 is
copied below:
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Fig. 9, reproduced above, shows CD45 marker expression on various
cell types and how the relative abundance of this marker allows the cells to
be separated into distinct cell type populations (“Neutro,” “Eos,” “Baso,”
etc.). A gate (the square box in the figure) is drawn around “Baso,” which
represents the basophils.
As explained in paragraph 126 of Ortyn (with respect to Fig. 8B
which shows the same type of data), the gate separates single cells from
debris, doublets, cell clusters, etc. Ortyn explains that the “veracity of the
gating was tested by examining random cells both within and outside of the
gate using the click-on-a-dot visualization functionality.” Ortyn ¶ 126. When
a dot in the dot plot is selected, an image that corresponds to the dot is
displayed, allowing the user to visualize the image and verify that the dot
represents a cell, debris, etc. Thus, the claim limitation reciting “for each cell
having a value of the property that falls outside the expected range of
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values” is met because the gate is a threshold that defines properties inside
and outside of the expected range of values, i.e., single cells, debris,
doublets, cell clusters. The further requirement of the claim of “displaying
the corresponding member of the second set of cell images in a highlighted
display modality in the ordered array” is also met because of the “click on-
dot functionality.”
Appellant contends that the clicking on the dots “has nothing
whatever to do with particular cells having a value of a property that falls
outside an expected range of values.” Appeal Br. 36. However, this does not
address Ortyn’s explicit disclosure of a gate drawn around the population of
cells which displays the expected threshold for single cells. Ortyn ¶ 126.
Appellant also raises the issue of a “third image,” but the claims do
not require it. Appeal Br. 37. Thus, Appellant is arguing a limitation that
does not appear in the claim.
Appellant also contends the plots shown in Figs. 8B and 9 “are not the
‘second set of images’ either, and the borders or ‘gates’ that establish the
population boundaries in these figures do not correspond to boundary
elements that highlight individual cells when those cells have a value of a
property that falls outside an expected range of values.” Appeal Br. 37.
This argument is not persuasive. The dots in the figures were not
identified by the Examiner as images; rather the Examiner specifically cited
paragraph 126 of Ortyn which describes selecting a dot inside or outside the
gate to display the corresponding image. Office Act. 20–21. Appellant is
incorrect about what the gates show. Ortyn, as discussed above, discloses
that the gates define the boundary or threshold values for single cells: dots
within the gate meet the threshold and are single cells; dots outside the gate
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do not meet threshold are not single cells. Ortyn ¶ 126.9 The claim does not
require that the cells outside the gate threshold are “individual cells” as
asserted. Thus, cells doublets and clusters outside the gate meet the claim
limitation of cells outside the threshold value.
The rejection of claim 60 is affirmed. Appellant argued claim 61 in
the same grouping and it therefore falls for the same reason.

Group 19: claim 65
Claim 65 depends from claim 34. The rejection of this claim is
therefore reversed for the same reason as claim 34.

Group 20: claim 66
Claim 66 depends from claim 34. The rejection of this claim is
therefore reversed for the same reason as claim 34.

9 “A gate (not separately shown) was drawn around the population
containing putative single cells based on the criteria of the area being
sufficiently large to exclude debris, and the aspect ratio being greater than -
0.5, which eliminates doublets and clusters of cells. The veracity of the
gating was tested by examining random cells both within and outside of the
gate using the click-on-a-dot visualization functionality.” Ortyn ¶ 126
(Discussing Fig. 8B; Fig. 9 shows the gate.)
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § References Affirmed Reversed
1–8, 15–18,
21–27, 29,
30, 33, 35,
36, 39–43,
48–51, 53–61
103 Yamada, Ortyn,
Winkelman
1–8, 15–18,
21–27, 29,
30, 33,
53–61
35, 36,
39–43,
48–51
19, 31 103 Yamada, Ortyn,
Winkelman,
Bacus
19, 31
34, 45, 63–66 103 Yamada, Ortyn 34, 45,
63–66
62 103 Yamada, Ortyn,
Winkelman,
Herbert
62
Overall
Outcome
1–8, 15–19,
21–27, 29,
30, 31, 33,
53–62
34–36,
39–43, 45,
48–51,
63–66

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART