ABBOTT POINT OF CARE, INC.

Patent Trials and Appeals Board

Jul 16, 2020

2019003615 (P.T.A.B. Jul. 16, 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.
14/768,680 08/18/2015 Manav Mehta 7564-0100WOUS 6368
50811 7590 07/16/2020
O''''Shea Getz P.C.
10 Waterside Drive, Suite 205
Farmington, CT 06032
EXAMINER
TURK, NEIL N
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
07/16/2020 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):
shenry@osheagetz.com
uspto@osheagetz.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MANAV MEHTA and ROBERT HOLT
Appeal 2019-003615
Application 14/768,680
Technology Center 1700
Before CATHERINE Q. TIMM, JEFFREY R. SNAY, and
LILAN REN, Administrative Patent Judges.
TIMM, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 15, 16, 22, 24, and 26–35. See Final
Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

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 Abbot Point of
Care, Inc. Appeal Br. 3.
Appeal 2019-003615
Application 14/768,680
2
CLAIMED SUBJECT MATTER
The claims are directed to a method of analyzing a biologic fluid
sample (see, e.g., claims 15 and 29). The method involves disposing a
biologic fluid sample in an analysis chamber defined by two panels (shown
as panels 12 and 14 in Figure 1). See, e.g., claims 15 and 29; Spec. ¶ 23.
Within the chamber, the biological fluid sample is mixed with fluorescent
dye. See, e.g., claims 15 and 29; Spec. ¶ 41. Beads (shown as beads 16 in
Figure 1) are disposed between the two panels. See, e.g., claims 15 and 29;
Spec. ¶ 23. The beads “are configured to not reflect light incident to the
beads in an amount that appreciably interferes with a photometric analysis of
the fluid sample.” See, e.g., claims 15 and 29; Spec. ¶ 27. In this context,
“‘appreciably’ means that to the extent that there is reflection of incident
light off a bead 16, if any, the amount of that reflected light is such that the
bead 16 is readily distinguishable from constituents within the sample (e.g.,
platelets, etc).” Spec. ¶ 27.
Claim 29, reproduced below with emphasis on the limitation most at
issue, is illustrative of the claimed subject matter:
29. A method of analyzing a biological fluid sample,
comprising:
providing an analysis chamber defined by a transparent
first chamber panel having a first interior surface, and a
transparent second chamber panel having a second interior
surface;
disposing the biologic fluid sample in the analysis
chamber, and quiescently holding the fluid sample in the
analysis chamber;
disposing a plurality of beads, each having an exterior
surface, between the interior surface of the first chamber panel
and the interior surface of the second chamber panel, which
Appeal 2019-003615
Application 14/768,680
3
beads are configured to not reflect light incident to the beads in
an amount that appreciably interferes with a photometric
analysis of the fluid sample;
creating one or more images of the fluid sample by
transmitting light at one or more wavelengths of light through
the fluid sample while the fluid sample is quiescently residing
with the beads within the analysis chamber, and the beads are
disposed within the chamber such that the exterior surface of
each bead is in direct contact with the fluid sample during the
creation of the images, wherein the one or more images are
created using a captured portion of the light transmitted through
the sample ; and
analyzing the quiescently residing fluid sample using at
least a portion of the one or more images of the sample.
Appeal Br. 17 (Claims Appendix) (emphasis added).
Claim 15, the other independent claim, adds a further requirement on
the beads. Claim 15 requires each bead be “configured to inhibit the at least
one fluorescent dye from attaching to the exterior surface of that bead.”

REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Van Ness US 5,232,830 Aug. 3, 1993
Mariella US 6,154,276 Nov. 28, 2000
Harmon US 2008/0166328 A1 July 10, 2008
Wardlaw US 2011/0294198 A1 Dec. 1, 2011

REJECTIONS
The Examiner maintains the following rejections.
Appeal 2019-003615
Application 14/768,680
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Claims 15, 16, 22, 24, and 27–34 are rejected under pre-AIA
35 U.S.C. § 103(a) as being unpatentable over Wardlaw in view of Van Ness
and further evidenced by Harmon. Final Act. 4.
Claims 26 and 35 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Wardlaw in view of Van Ness and evidenced by
Harmon, and further in view of Mariella. Final Act. 7.

OPINION
As pointed out by Appellant, Appellant’s claimed method is directed
to performing an analysis on a fluid sample quiescently residing within an
analysis chamber. Appeal Br. 8. It was known in the art to include beads in
the chamber, but a problem occurs during imaging, light reflecting off the
beads interferes with the imaging of the sample. Spec. ¶¶ 6–9. Appellant
solves the reflectance problem by using non-reflecting beads. Id. All of the
claims require the limitation concerning the non-reflectivity of the beads.
Wardlaw teaches analyzing a quiescent biological fluid sample using
an analysis chamber having beads that separate two panels as required by the
claims. Wardlaw ¶ 36; Fig. 3. There is no dispute that Wardlaw fails to
specify using non-reflective beads. Final Act. 5.
The Examiner turns to Van Ness to support a finding of a reason to
use beads in Wardlaw’s analyzer “that will not provide optical responses in
response to the incident light radiation and provide to yield more accurate
photometric and fluorescence assays of the biologic sample wherein noise
from the beads is avoided in the imaging and analysis of the sample.” Final
Act. 6.
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Application 14/768,680
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We agree with Appellant that the Examiner has reversibly erred in the
finding of a reason to make the combination. The Examiner’s finding is not
grounded in the teachings of the prior art. Nor does the Examiner provide a
basis grounded on knowledge within the skill in the art.
A clue that the finding is unmoored from the teachings of the prior art
is the fact that Van Ness is directed to a method with different problems than
the method of Wardlaw.
Wardlaw is concerned with the flexibility of the beads and panels, not
their reflectivity. Wardlaw points out that it was conventional to use rigid
particles, such as glass beads, to separate the panels. Wardlaw ¶ 7. Wardlaw
replaces these beads with plastic beads that can be compressed. Wardlaw
¶ 36. Wardlaw’s beads are said to be formed from polymers such as
polystyrene, polycarbonate, and silicone. Wardlaw ¶ 36. Wardlaw
compresses the beads between planar members 12, 14 to form a chamber
that holds the biologic fluid sample. Id. Wardlaw’s chamber is used in a
process of counting particles such as blood cells in a liquid medium such as
whole blood. Wardlaw ¶ 5. The chamber is used in an image analyzer, such
as the optical analysis system of Figure 8. This system images the chamber
using a light source 48 and a CCD camera 50. Wardlaw ¶ 42. Figure 11
shows the analysis field 66 from the sample film 64 of Figure 10. Wardlaw
¶ 45. What are shown are red blood cells 56, white blood cells 58, platelets
60, all surrounded by the blood plasma 62. Id. According to Wardlaw, beads
16 “are also seen but are readily distinguished from all other elements
because of their size and refractive index.” Id. Wardlaw presumes that the
beads have a reflective index, which would have suggested to the ordinary
artisan that the beads are transparent enough to allow light to travel through
them.
Appeal 2019-003615
Application 14/768,680
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Van Ness is not directed to a process of counting particles in a liquid
medium such as blood. Instead, Van Ness is directed to a process of
detecting sequences of nucleic acids by quantifying the extent of ligand pair
binding on solid supports, where the solid supports may be beads. Van Ness
col. 1, ll. 13–27; col. 2, ll. 8–36. The beads themselves are the solid support.
Van Ness col. 2, ll. 23–26. The beads may intrinsically fluoresce and the
ligand pair detected by fluorescent quenching. Van Ness col. 2, ll. 20–35.
Or, if the product being detected is fluorescent, the beads may have their
intrinsic or natural fluorescence quenched or masked, by, for instance,
applying a dye and the fluorescence of the bound product detected. Van
Ness col. 2, ll. 53–61. For instance, white nylon beads may be dyed black or
another color that does not fluoresce at the same wavelength as the
fluorescent product being detected. Van Ness col. 7, ll. 45–52.
Wardlaw’s beads are separators. Van Ness’s beads are supports for
ligand pairs. Wardlaw seeks to image and count particles not attached to the
beads. Van Ness seeks to detect fluorescence of either the beads or the
ligand pair on the beads. The suggestion of using Van Ness’s quenched or
masked beads as Wardlaw’s separator beads does not flow from the
teachings of the prior art, but from hindsight.
Mariella does not cure the deficiency.
We do not sustain the Examiner’s rejections.
CONCLUSION
The Examiner’s decision to reject claims 15, 16, 22, 24, and 26–35 is
REVERSED.
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Application 14/768,680
7
DECISION SUMMARY
In summary:
Claim(s) 35 U.S.C. § Basis/Reference(s) Affirmed Reversed
15, 16, 22,
24, 27–34
103(a) Wardlaw, Van
Ness, Harmon
15, 16, 22,
24, 27–34
26, 35 103(a) Wardlaw, Van
Ness, Harmon
Mariella
26, 35
Overall
Outcome
15, 16, 22,
24, 26–35

REVERSED