Infopia Co., Ltd.v.Polymer Technology Systems, Inc.

Patent Trial and Appeal Board

Oct 21, 2015

10329044 (P.T.A.B. Oct. 21, 2015)

Trials@uspto.gov Paper No. 14
571.272.7822 Entered: October 21, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

INFOPIA CO., LTD.,
Petitioner,

v.

POLYMER TECHNOLOGY SYSTEMS, INC.,
Patent Owner.
____________

Case IPR2015-01109
Patent 7,087,397 B2
____________

Before SUSAN L. C. MITCHELL, ZHENYU YANG, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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INTRODUCTION I.
Infopia Co., Ltd. (“Petitioner”) filed a Petition requesting an inter
partes review of claims 1–18 of U.S. Patent No. 7,087,397 B2 (Ex. 1001,
“the ’397 patent”). Paper 1 (“Pet.”). Polymer Technology Systems, Inc.
(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 10
(“Prelim. Resp.”).
We have jurisdiction under 35 U.S.C. § 314, which provides that an
inter partes review may not be instituted “unless . . . there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
the Petition and Preliminary Response, we determine that Petitioner has not
shown a reasonable likelihood that it would prevail with respect to any of the
challenged claims of the ’397 patent. Accordingly, we deny institution of
inter partes review in this proceeding.
A. Related Proceeding
The parties identify a related district court litigation pending in the
Central District of California, in which Petitioner is a party, involving the
’397 patent: Polymer Technology Systems, Inc. v. Jant Pharmacal Corp.,
Case No. 2:15-CV-02585-JAK-E (C.D. Cal.). Pet. 2; Paper 6, 1.
Additionally, Petitioner has also filed a separate petition for inter
partes review in Case IPR2015-01192, challenging claims 19 and 20 of the
’397 patent. We issue our decision denying institution in that proceeding
concurrently with our decision here.
B. The ’397 Patent (Ex. 1001)
The ’397 patent relates to a blood separation mechanism for a blood
test strip to determine component analyte amounts, more particularly, to
determine the level of HDL cholesterol in whole blood. Ex. 1001, 4:41–43.
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As noted in the Background section of the ’397 patent, “[t]he level of
cholesterol in blood is a significant indicator of risk of coronary heart
disease.” Id. at 1:21–22. However,
[t]he level of total cholesterol in blood, which is a measure of
the sum total of HDL, LDL, VLDL and chylomicrons, is not
generally regarded as an adequate indicator of the risk of
coronary heart disease because the overall level of total
cholesterol does not reveal the relative proportions of HDL,
LDL and VLDL. To better assess the risk of heart disease, it is
desirable to determine the amount of HDL cholesterol in
addition to total cholesterol.
Id. at 1:30–37.
The ’397 patent explains that, when measuring HDL cholesterol, “two
significant treatment steps to a whole blood sample are usually necessary.”
Id. at 1:38–40. First, erythrocytes (i.e. red blood cells) must be separated
from the whole blood sample to produce plasma. Id. at 1:40–43. “Second,
non-HDLs (i.e., LDL, VLDL and chylomicrons) must be removed from the
plasma to be tested because reagents used to determine the level of HDL will
also react with LDL and VLDL.” Id. at 1:43–46. The invention described in
the ’397 patent achieves this using a “multilayer vertical flow test strip” with
a first glass fiber matrix layer that separates the blood cells and a second
layer that “precipitates and retains non-HDL cholesterol.” Id. at 4:41–52.
In contrast to the prior art teaching “that two layers and two associated
process steps are necessary to precipitate and separate non-HDLs from
plasma,” the inventors of the ’397 patent found that “a single, substantially
uniform layer” can be used for the separation of non-HDLs from HDLs. Id.
at 10:49–65; see also id. at 5:56–61. Figure 1 of the ’397 patent is
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reproduced below:

Fig. 1 is an exploded perspective view of a test strip in accordance
with the invention described in the ’397 patent, showing 1) disbursement or
spreader layer 36 that provides a more uniform distribution of blood to the
subjacent layer, 2) red blood separation layer 38, which is generally a glass
fiber matrix, 3) non-HDL separation layer 40, and 4) reaction layer 42 that
generates a visible color change when cholesterol is present. Id. at 6:9–12,
8:41–66.
C. Illustrative Claim
Petitioner challenges claims 1–18 of the ’397 patent in this
proceeding. Independent claim 1 is illustrative and is reproduced below:
1. A method of determining concentration of HDL cholesterol
in a whole blood sample containing non-HDL cholesterol, said
method comprising:
a) providing a test strip holder and a test strip; said test strip
holder including an application window and a rest reading
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window, said windows comprising vertically aligned
openings in said holder; said test strip comprising a layered
stack comprising a red blood cell separation layer, a non-
HDL separation chemistry layer, and an HDL reaction layer;
said non-HDL cholesterol separation chemistry layer
containing non-HDL cholesterol separation chemicals for
separating the non-HDL blood components from the HDL
blood components so that the non-HDL components do not
participate in the reaction in said HDL reaction layer; said
HDL reaction layer containing chemicals for reacting with
said HDL, said layers arranged in a vertical stack with said
HDL reaction layer at the bottom of said stack; said test strip
located in said test strip holder between said windows, with
said reaction layer adjacent said test reading window;
b) applying blood to the top of said stack through said
application window and permitting fluid from said blood to
flow vertically downward in said stack to said HDL reaction
layer without substantial lateral migration of fluid below said
red blood cell separation layer;
c) separating said red blood cells from a fluid portion of said
blood;
d) separating said non-HDL cholesterol from said HDL
cholesterol with said non-HDL cholesterol separation
chemicals;
e) reacting said HDL with said chemicals in said HDL
reaction layer; and
f) reading a property of said reaction layer through said
reading window to determine said concentration of HDL
cholesterol.
Id. at 24:9–44.

D. The Asserted Grounds of Unpatentability
Petitioner challenges the patentability of claims 1–18 of the
’397 patent for obviousness based on the following combination of
references (Pet. 31–60):

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References Basis Claims challenged
Connolly,1 Patel,2 and Kozak3

§ 103 1, 3, 4, 5, and 10–18
Connolly, Patel, Kozak,
Kitajima,4 and Kawaguri5
§ 103 2, 6
Connolly, Patel, Kozak and
Jeng6
§ 103 7
Connolly, Patel, Kozak, Jeng
and Grage7
§ 103 8
Connolly, Patel, Kozak, Jeng,
Grage and Neyer8
§ 103 9
Carroll,9 Patel, and Kozak § 103 1, 3, 4, and 10–18
Carroll, Patel, Kozak, Kitajima,
and Kawaguri
§ 103 2, 5, and 6

DISCUSSION II.
A. Claim Construction
In an inter partes review, the Board interprets claim terms in an
unexpired patent according to the broadest reasonable interpretation in light
of the specification of the patent in which they appear. See 37 C.F.R.
§ 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed.
Cir. 2015). The Board, however, may not “construe claims during IPR so
broadly that its constructions are unreasonable under general claim

1 U.S. Patent No. 5,597,532, issued Jan. 28, 1997 (Ex. 1015, “Connolly”).
2 U.S. Patent No. 5,215,886, issued June 1, 1993 (Ex. 1014, “Patel”).
3 U.S. Patent No. 5,460,974, issued Oct. 24, 1995 (Ex. 1007, “Kozak”).
4 U.S. Patent No. 5,876,605, issued Mar. 2, 1999 (Ex. 1016, “Kitajima”).
5 U.S. Patent No. 5,171,689, issued Dec. 15, 1992 (Ex. 1017, “Kawaguri”).
6 U.S. Patent No. 5,064,541, issued Nov. 12, 1991 (Ex. 1018, “Jeng”)
7 U.S. Patent No. 5,968,765, issued Oct. 19, 1999 (Ex. 1019, “Grage”).
8 U.S. Patent No. 5,762,871, issued June 9, 1998 (Ex. 1020, “Neyer”)
9 U.S. Patent No. 6,040,195, issued Mar. 21, 2000 (Ex. 1008, “Carroll”).
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construction principles. . . . [T]he protocol of giving claims their broadest
reasonable interpretation . . . does not include giving claims a legally
incorrect interpretation.” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d
1292, 1298 (Fed. Cir. 2015) (citation omitted). Rather, “claims should
always be read in light of the specification and teachings in the underlying
patent.” Id. (citations omitted). The broadest reasonable interpretation must
“take[] into account any definitions presented in the specification.” In re
Bass, 314 F.3d 575, 577 (Fed. Cir. 2002)(citation omitted).
1. “non-HDL” (claim 1)
The claims require a “non-HDL separation chemistry layer” that
“contain[s] non-HDL cholesterol separation chemicals for separating the
non-HDL blood components from the HDL blood components so that the
non-HDL components do not participate in said HDL reaction layer.” Ex.
1001, 24:17–23. The Specification defines “[n]on-HDL” as “LDL, VLDL
and chylomicrons, i.e., lipoproteins other than HDL that will react with a
conventional cholesterol reaction membrane.” Id. at 7:38–40. The
Specification further states in the Background Section that “non-HDLs (i.e.,
LDL, VLDL and chylomicrons) must be removed from the plasma to be
tested because reagents used to determine the level of HDL will also react
with LDL and VLDL.” Id. at 1:43–46. In view of these statements in the
Specification, Patent Owner asserts that the patentee acted as its own
lexicographer in defining the term. Prelim Resp. 13–14.
Consistent with the express definition provided in the Specification,
we construe “non-HDL” as “LDL, VLDL and chylomicrons.”
2. Other Claim Terms
We determine that, for purposes of this Decision, none of the other
terms in the challenged claims requires express construction.
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B. Analysis
Petitioner asserts that independent claim 1 is rendered obvious by the
combination of Connolly or Carroll with Patel and Kozak. Pet. 31, 49. In
order to satisfy the claim requirement of a non-HDL separation chemistry
layer, Petitioner relies upon the teachings of Patel and Kozak. Id. at 33, 50.
Despite the express definition of “non-HDL” provided in the Specification,
as discussed above, Petitioner does not address chylomicrons at all in the
Petition. Rather, Petitioner only points to the teachings of Patel and Kozak
of removing VLDL and LDL fractions using a filter. Id. (citing Ex. 1014,
3:3–9, 6:48–55; Ex. 1007, 24:11–21, Fig. 4). Petitioner does not identify
any other prior art teaching regarding the separation of chylomicrons, nor
has Petitioner alleged that chylomicrons would inherently be removed by
using any of the prior art devices. Moreover, Petitioner has not alleged that
the separation of chylomicrons, in addition to LDL and VLDL, would
otherwise have been obvious.10 Because we construe the claims to require
the separation of all three types of lipoproteins defined as “non-HDL” (i.e.,
LDL, VLDL, and chylomicrons) by the non-HDL separation chemistry
layer, we conclude that Petitioner has not demonstrated a reasonable
likelihood of prevailing on any of the grounds presented.
CONCLUSION III.
We conclude that Petitioner has not demonstrated a reasonable
likelihood of prevailing on its assertion that any of claims 1–18 of the
’397 patent are unpatentable for obviousness.

10 The ’397 patent Specification describes that “reagents used to determine
the level of HDL will also react with LDL and VLDL.” Ex. 1001, 1:43–46.
Petitioner, however, does not argue that the reagents would not react with
chylomicrons or that the removal of chylomicrons is unnecessary to satisfy
the claim requirements.
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ORDER IV.
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is DENIED, and no trial is instituted.

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PETITIONER:

Aron Carnahan
Samuel Digirolamo
HUSCH BLACKWELL, LLP
Aron.carnahan@.huschblackwell.com
Samuel.Digirolamo@.huschblackwell.com

PATENT OWNER:
J. Andrew Lowes
Robert Ziemian
Kenneth G. Parker
Martin M. Ellison
HAYNES AND BOONE, LLP
andrew.lowes.ipr@haynesboone.com
robert.ziemian.ipr@haynesboone.com
ken.parker.ipr@haynesboone.com