Ex Parte Herzog et al

Patent Trial and Appeal Board

Jun 11, 2018

13204415 (P.T.A.B. Jun. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/204,415
50811 7590
O""Shea Getz P.C.
FILING DATE FIRST NAMED INVENTOR
08/05/2011 David Herzog
06/13/2018
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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Alexandria, Virginia 22313-1450
www .uspto.gov
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NOTIFICATION DATE DELIVERY MODE
06/13/2018 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID HERZOG, ZHIZHOU WANG,
STEPHEN C. WARDLAW, and MIN XIE
Appeal2017-005242
Application 13/204,415
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for identifying at least one type of white blood cell. The Examiner rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part.
Statement of the Case
Background
"Medical diagnostics often include analyses of a whole blood sample
from a patient" (Spec. ,r 3). "One of the more popular diagnostics is a
complete blood count (referred to as a 'CBC'), which is a suite of tests that
1 Appellants identify the Real Party in Interest as Abbott Point Of Care, Inc.
(see Appeal Br. 3).
Appeal2017-005242
Application 13/204,415
may include ... the identification and enumeration of the types of white
blood cells (WBCs) present in the blood sample" (Spec. ,r 3). See also id.
( explaining that analysis of the white blood cell population of whole blood,
"a leukocyte differential count ('LDC'[), is] sometimes referred to as a
'white blood cell differential"').
According to the Specification:
What is needed is an apparatus and method for performing
automated analyses on a whole blood sample, including an
LDC, which can overcome the limitations of the prior art,
including the time required to perform the analysis, the operator
skill level required to perform the analysis, and one that can
provide greater versatility than known prior art methods and
apparatus.
(Spec. ,r 6).
The Claims
Claims 1-13, 15-25, and 39 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A method for identifying at least one type of white blood
cell (WBC) within an undiluted whole blood sample,
comprising the steps of:
adding at least one colorant to the undiluted whole blood
sample, which colorant is operable to differentially identify at
least one WBC type from another WBC type;
disposing the blood sample into a chamber defined by at
least one transparent panel;
creating at least one fluorescence image of an area of the
undiluted sample quiescently residing within the chamber,
using an epi-fluorescent light source;
creating at least one transmittance image of the area of
the undiluted sample quiescently residing within the chamber,
2
Appeal2017-005242
Application 13/204,415
using a transmittance light source, which transmittance image is
independent of the fluorescence image;
identifying at least one WBC in the sample area using a
programmable analyzer;
identifying a type of the identified WBC based on a
plurality of predetermined features, wherein each of said
predetermined features is defined by one or more quantitative
values, and using the analyzer to quantitatively analyze the at
least one fluorescence image and the at least one transmittance
image to determine quantitative values associated with at least
one of the features.
The Issues
A. The Examiner rejected claims 1-3, 6, 8, 9, 12, 21-25, and 39 under 35
U.S.C. § I03(a) as obvious over Resnick, 2 Wardlaw, 3 Spring,4 Paddock, 5
Zhang, 6 and Kunikiyo 7 (Final Act. 4--7).
B. The Examiner rejected claims 1-7, 9-11, 13, and 15-20 under 35
U.S.C. § I03(a) as obvious over Resnick, Wardlaw, Spring, Paddock,
Zhang, Kunikiyo, Khashman, 8 Chen,9 and Mircic1 ° (Final Act. 8-13 ).
2 Resnick et al., US 4,125,828, issued Nov. 14, 1978.
3 Wardlaw et al., WO 99/45384 Al, published Sept. 10, 1999.
4 K. Spring, Fluorescence Microscopy in Encyclopedia of Optical
Engineering 548-55 (2003).
5 Paddock et al., Imaging Modes, https://web.archive.org/web/2009011914
2 5 5 3/http://www.microscopyu.com/ articles/ confocal/ confocalintro
imaging.html (2009).
6 Zhang et al., Transmittance measurements for filters of optical density
between one and ten, 36 Applied Optics 8889-95 (1997).
7 Kunikiyo, US 2012/0217605 Al, published Aug. 30, 2012.
8 A. Khashman, IBCIS: Intelligent blood cell identification system, 18
Progress Natural Science 1309-14 (2008).
9 Chen et al., Cell classification by moments and continuous
wavelet transform methods, 2 Int. J. Nanomedicine 181-9 (2007).
3
Appeal2017-005242
Application 13/204,415
A. 35 US.C. § 103(a) over Resnick, Wardlaw, Spring, Paddock, Zhang,
and Kunikiyo
The issue with respect to obviousness is: Does the evidence of record
support the Examiner's conclusion that the combination of prior art renders
the claims obvious?
Findings of Fact
1. Resnick teaches:
A complete blood count (CBC) consists of a red cell (RBC)
count, a white cell (WBC) and a differential white cell count.
The RBC and WBC counts indicate the total number of red and
white cells, respectively, per unit volume of blood. The
differential white cell count indicates the relative number of the
different types of white cells which make up the white cell
count.
(Resnick 1 :50-56).
2. Resnick teaches "white blood cells (WBC) ... are subdivided
into mononuclear cells, lymphocytes and polymorphonuclear (PMN)
leukocytes. The PMN are further divided into neutrophils, eosinophils and
basophils" (Resnick 5:8-12).
3. Resnick teaches: "Specimen preparation begins with the
collection of a small amount of whole venous blood ... a measured portion
of the sample should be mixed with a measured quantity of an
anticoagulant" (Resnick 6:28-38).
10 Mircic et al., Application of Neural Network for Automatic
Classification of Leukocytes, 8th Seminar on Neural Network Applications
in Electrical Engineering, NEUREL-2006 (2006).
4
Appeal2017-005242
Application 13/204,415
4. Resnick teaches "to automate the identification and counting of
the various type cells in a biological sample, a method ... has been
developed: First, a standard volume of the biological sample is exposed to a
standard volume of a mixture of a number ( one or more) of stains" (Resnick
4:12-18).
5. Resnick teaches "material containing the stained cells is
precipitated under the force of gravity, analysis of a specimen, or by
centrifugal force, onto a surface (i.e., slide)" (Resnick 4:27-29).
6. Resnick teaches
the field of view of the microscope on the surface
containing the cells is illuminated through the microscope
objective which also acts as a condenser lens .... the
fluorescent light, whose wavelength and amplitude depends
upon the stain and cell materials from which it originated, is
subjected to a selected one of a number of filters before being
imaged by the microscope. Each of these filters is designed to
pass only the wavelengths which are characteristic of one of the
aforementioned stain/cellular material combinations. Thus,
each filter serves to identify a particular cell type or cell
material type.
(Resnick 4:33-51 ).
7. Resnick teaches to "determine the type of individual cells on
the basis of the fluorescent response, size, number of lobes, shape and
texture" (Resnick4:67 to 5:1).
8. Figure 17 of Resnick, showing optical separation of different
white blood cell types, is reproduced below:
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Appeal2017-005242
Application 13/204,415
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