United States Endoscopy Group, Inc.v.CDx Diagnostics, Inc.

Patent Trial and Appeal Board

Sep 14, 2015

10321010 (P.T.A.B. Sep. 14, 2015)

Trials@uspto.gov Paper 27
Tel: 571-272-7822 Entered: September 14, 2015
UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

U.S. ENDOSCOPY GROUP, INC.,
Petitioner,

v.

CDX DIAGNOSTICS, INC.,
Patent Owner.
____________

Case IPR2014-00639
Patent 6,676,609 B1
____________

Before PHILLIP J. KAUFFMAN, SCOTT A. DANIELS, and
BARRY L. GROSSMAN, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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I. BACKGROUND
A. Procedural History
Petitioner, U.S. Endoscopy Group, Inc., filed a Petition (Paper 1, “Pet.”)
seeking inter partes review of claims 1–4 of U.S. Patent No. 6,676,609 B1 (Ex.
1001, “the ’609 patent”).1 Patent Owner, CDx Diagnostics, Inc., filed a
preliminary response. Paper 7 (“Prelim. Resp.”).
In the Decision to Institute (Paper 8, “Inst. Dec.”), we instituted trial on
claims 1–4 based on the following grounds:
1) claims 1–4 based under 35 U.S.C. § 102(b) by Parasher2; and
2) claims 3 and 4 under 35 U.S.C. § 103(a) over Parasher and Eisen3.
Subsequently, Patent Owner filed a Patent Owner’s Response4 (Paper 17,
“PO Resp.”), and Petitioner filed a Reply (Paper 18, “Pet. Reply”).
Patent Owner did not file a motion to amend. Neither party filed a motion to
exclude evidence.
At the request of both parties, oral hearing was held on Thursday May 21,
2015. Papers 20, 22, 23. A transcript of the oral hearing is included in the record.
Paper 26 (“Tr.”).5

1 Subsequently, Petitioner filed an Exhibit List that was absent from the original
Petition. See Paper 5.
2 U.S. 5,535,756, issued July 16, 1996 (Ex. 1003).
3 U.S. 6,297,044 B1, filed April 23, 1999, issued October 2, 2001 (Ex. 1005).
4 Patent Owner filed a response and subsequently filed a corrected response.
Papers 15, 17, respectively.
5 A single transcript was created for the oral hearing for IPR2014-00639,
IPR2014-00641, and IPR2015-00642. See infra, Section I.B. (“Related
Proceedings”).
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For the reasons that follow, we determine that Petitioner has shown by a
preponderance of the evidence that claims 1–4 of the ’609 patent are unpatentable.
B. Related Proceedings
Patent Owner asserted the ’609 patent in CDx Diagnostics, Inc. v. U.S.
Endoscopy Grp., Inc., Case No. 1:13-cv-5669-NSR (S.D.N.Y.). Pet. 3; Paper 6, 1.
Related U.S. Patent No. 7,004,913 B1 (“the ’913 patent”) is involved in an
inter partes review designated IPR2014-00641. The ’913 patent is a continuation
of application No. 10/321,010, now the ’609 patent.

II. THE ’609 PATENT
The ’609 patent was filed on December 17, 2002, and is a continuation in
part of application No. 09/849,085 filed on May 4, 2001 (now U.S. 6,494,845 B2).
Ex. 1001, 1. It is undisputed that claims 1 and 2 are entitled to a May 4, 2001,
priority date, and claims 3 and 4 are entitled to a December 17, 2002, priority date.
See Pet. 5, 25.6 Petitioner contends that Eisen is prior art as to claims 3 and 4, but
not as to claims 1 and 2. Id.
To understand this case, it is helpful to understand that the term “biopsy”
can be used to refer to either (1) the procedure for removing tissue for examination,
or (2) the specimen obtained by that procedure. See Ex. 2003, 4; Ex. 2004, 5.7

6 Patent owner does not contest these priority dates, and consistent with this
interpretation, Patent Owner states that the “earliest priority date of the ’609 patent
is May 2001.” See PO Resp. 19.
7 The pages of Exhibits 2003 and 2004 are not numbered. See 37 C.F.R.
§ 42.63(d)(2)(i). For Exhibit 2003 we refer to page 200 of the portion of the
dictionary provided, and for Exhibit 2004 we refer to page 100 of the portion of the
dictionary provided.
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The ’609 patent is titled, “Retractable Brush for Use with Endoscope for
Brush Biopsy,” and is directed to a method and apparatus for obtaining trans-
epithelial specimens of body surfaces using a non-lacerating technique with
retractable tools, such as a brush used with endoscopes. Ex. 1001, 1:10–15.
Epithelial tissue can be comprised of a superficial, intermediate, and basal layer,
these three layers resting on the basement membrane which rests in turn on the
submucosa. The figure on slide 4 of Patent Owner’s Demonstrative illustrates this
tissue structure:

This figure depicts the layers of epithelial tissue adjacent to the basement
membrane and submucosa. See Ex. 2006, 48 (Patent Owner’s Demonstratives);
Ex. 1014, 2 (Petitioner’s Demonstratives).9

8 Citing Ex. 1001 at 4:34–37, 11:56–65 of related case IPR2014-00642.
9 Pursuant to our Order (Paper 23), these demonstratives have not been entered,
but this Decision directs the parties to do so. This information appears uncontested
in that the parties each depict the layers in the same manner. We discern no
evidence in the case that contradicts this depiction.
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Figure 3 of the ’609 patent depicting the retractable brush is reproduced
below:

Figure 3 of the ’609 patent is a preferred embodiment shown in partial
perspective and sectional view. Ex. 1001, 7:44–46.
The ’609 patent describes the claimed apparatus through a contrast to
cytology. Cytology uses a soft brush to gently remove (sweep) previously freed
cells (exfoliated or sloughed off) from the surface of the epithelium in non-
invasive manner that avoids or minimizes abrasion of the epithelium and is
intended to be painless. Id. at 3:24–31, 46–67; 4:67–5:3. A brush biopsy uses a
stiffer brush and rubs harder than cytology so that the surface of the epithelium is
penetrated. Id. at 5:64–67; 6:44–46. In other words, a brush biopsy penetrates the
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surface of the epithelium by dislodging cells (as opposed to sweeping up
previously freed cells) and picks up those cells.

III. THE CHALLENGED CLAIMS
In an inter partes review, claim terms in an unexpired patent are interpreted
according to their broadest reasonable construction in light of the specification of
the patent in which they appear. 37 C.F.R. § 42.100(b); Office Patent Trial
Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012); see also In re
Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275–79 (Fed. Cir. 2015) (“Congress
implicitly approved the broadest reasonable interpretation standard in enacting the
AIA,”10 and “the standard was properly adopted by PTO regulation.”). We
expressly interpret below only those claim terms that require analysis to resolve
arguments related to the patentability of the contested claims. See Vivid Techs.,
Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those
terms which are in controversy need to be construed and only to the extent
necessary to resolve the controversy). All claim terms not explicitly construed
below are given the plain and ordinary meaning that the term would have had to a
person of ordinary skill in the art, without further elaboration. See 37 C.F.R.
§ 42.100(b).
The ’609 patent includes claims 1–4. Independent claim 1, the sole
independent claim, follows:
1. An apparatus to be used in conjunction with an endoscope to
examine tissue cells located within epithelium tissue having a surface,
said apparatus comprising a channel extending the length of the
endoscope; said apparatus comprising a rod passing through said

10 The Leahy-Smith America Invents Act, Pub. L. No. 11229, 125 Stat. 284
(2011) (“AIA”).
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channel having a distal and a proximal end; a retractable non-
lacerational brush attached to the distal end of the rod, said brush
being movable to bear against the tissue being examined and being
controlled by said rod to remove tissue from a tissue area being
examined, said brushing apparatus comprising bristles which exert
sufficient pressure to conduct a biopsy to dislodge cells and pick up a
specimen of the tissue area located below the surface of said
epithelium tissue.
A. Institution Decision
We construed the following terms in the Institution Decision.
1. “said apparatus comprising a channel extending the length of the
endoscope”
Petitioner contended that claim 1 is potentially ambiguous because it may be
interpreted in two ways: one, that the endoscope comprises a channel, or two, that
the apparatus comprises a channel. Pet. 10–11, 18–19. We interpreted that claim 1
unambiguously requires the apparatus to include a channel. Inst. Dec. 7.
2. “said brushing apparatus”
In the Institution Decision we noted that Claim 1 recites “said brushing
apparatus comprising bristles which exert sufficient pressure to conduct a biopsy to
dislodge cells and pick up a specimen of the tissue area located below the surface
of said epithelium tissue,” and the phrase “said brushing apparatus” technically
lacks an antecedent basis. See Inst. Dec. 8; Pet. 13, 21. We determined that this
oversight does not render claim 1 indefinite.
3. “bristles which exert sufficient pressure to conduct a biopsy to
dislodge cells and pick up a specimen of the tissue area located below
the surface of said epithelium tissue”
Petitioner contended that the broadest reasonable interpretation of this
limitation is: “bristles having penetrating edges of a sufficient stiffness to obtain a
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biopsy sample including cells located below the surface layer of the epithelium
where the epithelium is glandular epithelial tissue having a surface layer and a
basement membrane.” Pet. 13.
We corrected two aspects of this interpretation. Inst. Dec. 9–10. First, we
clarified that claim 1 recites “‘epithelium tissue having a surface,’ not glandular
epithelial tissue.” Id. at 9. Second, we interpreted that claim 1 “is not limited to a
brush that includes bristles having penetrating edges of sufficient stiffness.”
Rather, “this limitation requires that the brushing apparatus include bristles capable
of exerting sufficient pressure to obtain a biopsy that dislodges cells and picks up a
specimen of tissue located below the surface layer of the epithelium.” Id. at 10.
B. Current Interpretation
Petitioner asks, “[t]o the extent the Board did not adopt Petitioner’s
proposed claim constructions, Petitioner respectfully requests reconsideration.”
Pet. Reply 10. This request is not in the form of a timely request for
reconsideration under 37 C.F.R. § 42.71(d). More importantly, this request,
without a cogent explanation of how our claim construction is in error, is
unpersuasive.
We adopt our interpretations from the Institution Decision with one
exception. We preliminarily interpreted that the brushing apparatus of claim 1
requires bristles capable of exerting sufficient pressure to obtain a biopsy that
dislodges cells and picks up a specimen of tissue located “below the surface layer
of the epithelium.” Inst. Dec. 10 (emphasis added). However, as explained below,
claim 1 requires the specimen to include cells taken from tissue located below the
surface (verses the surface layer) of the epithelium.
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C. Claim 1 - “bristles which exert sufficient pressure to conduct a biopsy to
dislodge cells and pick up a specimen of the tissue area located below the
surface of said epithelium tissue”
In the Patent Owner’s Response, Patent Owner argues that Parasher’s
reference is silent regarding obtaining tissue from the area “located below the
surface of the epithelium.” PO Resp. 4 (emphasis added). Then later in the
Response, Patent Owner argues that Petitioner has not shown that Parasher’s
device collects cells from at least two layers of the epithelium. PO Resp. 13.
Although not explicit, this argument implies that Patent Owner interprets claim 1
to require that the uppermost layer of the epithelium is penetrated so that cells from
the second layer are obtained.11
Patent Owner’s interpretation is inconsistent with the plain language of
claim 1 in that claim 1 recites “below the surface of said epithelium tissue,” not
“below the surface layer of said epithelium tissue” (emphasis added).12 Likewise,
“the surface” has antecedent basis in the preamble which recites “epithelium tissue
having a surface,” not “epithelium tissue having a surface layer.”
The ’609 patent does not contain a lexicographical definition of the claim
term “surface,” and an ordinary meaning of this term is “the exterior boundary of a
solid object.”13 Ex. 3001, 6.14 Consistent with the ordinary meaning of “surface,”

11 At oral argument, Patent Owner was presented with, and responded to, our
interpretation that “surface” as claimed means the boundary of the epithelium. Tr.
56–63. Those arguments are addressed below.
12 Claim 1 does not describe the specimen collected as a “biopsy.” Rather, only
the procedure performed is described as a “biopsy.”
13 We depart from the ordinary meaning of a term only for a lexicographical
definition or clear disavowal of claim scope, neither of which is present here. See
e.g., Hill-Rom Srvs., Inc., v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014).
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the ’609 patent describes that exfoliated cells may be present “on the superficial
epithelial surface.” See, e.g., Ex. 1001, 3:58–61. This disclosure also illustrates
how Patent Owner’s interpretation is inconsistent with the Specification.
Specifically, if “surface” as claimed, means the uppermost layer of the epithelium,
then it would be redundant to refer to the “superficial epithelial surface.”
Patent Owner contends that the purpose of the ’609 patent is to detect pre-
cancerous cells before cancer spreads which requires the specimen to include cells
from beneath the uppermost layer of the epithelium. Tr. 60. The ’609 patent
describes that it is “important” to determining whether a patient has a precancerous
or cancerous condition to reach through the superficial layer to the basement
membrane. Ex. 1001, 7:9–14. The ’609 patent does not describe that the basement
membrane must be reached in every case. Id. Likewise, the ’609 patent does not
state that abnormal cells never penetrate the uppermost layer of the epithelium;
rather, it states that in many oral cavity lesions abnormal cells never reach the
surface. Id. at 5:4–8. Further, although the ’609 patent refers to specimens
obtained by the claimed device as “transepithelia” specimens (see, e.g., id. at 1:10–
11), the claimed device samples cells from “all levels,” including the basal,
intermediate, and superficial layers (id. at 5:64–67, 6:49–52). That is, the claimed
device may penetrate one, two, or all three layers of the epithelium. Consistent
with this interpretation, the ’609 patent describes that the claimed device removes
tissue by being rotated and moved against the tissue. Id. at 6:35–37; see also Ex.
2005, 28 (describing repeating brushing to obtain a deeper sample). Thus, greater
rotation and movement produces a deeper sample and vice versa. The variability

14 “Surface,” TABER’S CYCLOPEDIC MEDICAL DICTIONARY, (12th ed. 1973), Ex.
3001, 6.
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of the extent of the specimen is also reflected in claims 1 and 4 (below the surface
verus to the submucosa, respectively).
Consequently, claim 1 does not require penetrating the superficial layer so
that the specimen includes cells from the intermediate layer of the epithelium.
Instead, claim 1 requires the specimen to include cells taken from tissue located
below the exterior boundary (surface) of the epithelium.
D. Claims 2–4
Claim 2 depends from claim 1 and adds that the “brush bristles are at least
1000 microns in length.” Claim 3 depends from claim 1 and adds that the
“epithelium tissue comprises metaplastic glandular epithelium tissue.” Claim 4
depends from claim 3 and adds, “wherein said specimen of the tissue area
comprises a disaggregated specimen of the whole tissue, said whole tissue being
defined of at least glandular cells, plus basement membrane fragments, plus
elements of the submucosa in the area being examined.”

IV. EVIDENTIARY ISSUES15
A. Parasher Article (Ex. 1004)
As evidence that the device disclosed in Parasher16 (“the Parasher brush”) is
inherently capable of collecting a tissue sample as claimed, Petitioner contends that
the Parasher Article17 describes using the Parasher brush to obtain a biopsy sample
of tissue located below the surface of the epithelium. Pet. 22. It is critical to this

15 This analysis is applicable to both grounds of unpatentability.
16 Ex. 1003.
17 Parasher, et al., ENDOSCOPIC RETROGRADE WIRE-GUIDED CYTOLOGY OF
MALIGNANT BILIARY STRUCTURES USING A NOVEL SCRAPING BRUSH,
Gastrointestinal Endoscopy, Vol. 48, No. 3, 1998, (Ex. 1004).
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assertion that the brush used in the experiments described in the Parasher Article is
the Parasher brush.
Although the Parasher device and the Parasher Article are each attributed to
Vinod K. Parasher, that does not demonstrate convincingly the brush used in the
experiments described in the Parasher Article is the Parasher brush. See Ex. 1003,
1; Ex. 1004, 1. Petitioner asserts that the Parasher Article “describes patient trials
of the device disclosed in the patent [the Parasher brush].” Pet. 22. This attorney
argument is not supported by citation to evidence. See In re Pearson, 494 F.2d
1399, 1405 (CCPA 1974) (attorney’s arguments do not take the place of evidence).
Petitioner does not identify, nor do we discern, an explicit disclosure that the brush
used for the experiments described in the Parasher Article was the Parasher brush.
See Pet. 22; Ex. 1004, 1–3.
Petitioner asserts that the Parasher Article utilized a brush having semi-rigid
and rough bristles made from a Velcro® pad. Id. (citing Ex. 1004, 290–91).
Although the Parasher Article discloses this information (Ex. 1004, 290),18
Petitioner does not explain how this information demonstrates that the brush used
in the experiments described in the Parasher Article is the Parasher brush. For
example, Petitioner does not explain the relevance of this information by pointing
out that the Parasher brush includes a Velcro® pad, nor does Petitioner cite to such
disclosure in Parasher. We recognize that a preferred embodiment of the Parasher
brush includes bristles comprised of a Velcro® pad. See, e.g. Ex. 1003, Abstract,
1:15. We also recognize that there are other similarities between the Parasher
brush and the brush described in the Parasher Article. For example, both brushes

18 Exhibit 1004 does not contain a page 291. It appears that the Exhibit is not
missing a page because page 290 of the Parasher Article is numbered as page 3 of
the Exhibit.
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are described as having mushroom-shaped bristles. See Ex. 1003, 2:51–57; Ex.
1004, 1. However, it is Petitioner’s burden to set forth the relevance of evidence to
the challenge raised, including identifying specific portions of the evidence that
support the challenge, and the Board may give no weight where a petitioner has
failed to do so. 37 C.F.R. § 42.104(b)(5). Petitioner does not explain based on
persuasive evidence, nor identify specific portions of the evidence to demonstrate
persuasively that the brush described in the Parasher Article is the Parasher brush.
Patent Owner pointed out that Petitioner did not establish adequately that the
Parasher Article describes use of the Parasher brush. PO Resp. 10–11. Petitioner
responds with the contention that Patent Owner’s inherency arguments are not
relevant, and that the Board did not reply upon inherency in the Institution
Decision. See Pet. Reply. 12. These contentions are inapposite to Patent Owner’s
argument. Petitioner had, and failed to use, a second opportunity to establish
adequately that the experiments of the Parasher Article utilized the Parasher brush.
Accordingly, we give no weight to the Parasher Article in our analysis.
B. Dr. Michel Kahaleh
Dr. Michel Kahaleh, Petitioner’s witness, provided a Declaration (Ex. 1010)
and was deposed by Patent Owner (Ex. 2005). Dr. Kahaleh is a medical doctor
and professor. Ex. 1010 ¶ 5.
1. Capabilities of Parasher’s Brush
In support of the contention that Parasher’s brush is capable of collecting a
specimen that includes cells from tissue located below the surface of the
epithelium, Petitioner stated, “[o]ne of ordinary skill in the art would understand
that a biopsy sample necessarily includes fragments of the epithelial tissue, as well
as portions of the basement membrane and submucosa below the epithelium.” Pet.
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17, 22 (citing Exhibit 1010 ¶ 10). That is, Petitioner asserts that if a specimen is a
“biopsy,” it necessarily includes cells from epithelial tissue, the basement
membrane, and submucosa.
We are not persuaded by this evidence for several reasons. First, at
deposition, Dr. Kahaleh consistently referred to a sample taken using a brush as a
“brushing,” and a sample taken using a biopsy forceps as a “biopsy.” See, e.g., Ex.
2005, 15–17.19 This suggests that the definition of a biopsy specimen in paragraph
10 of Dr. Kahaleh’s Declaration was not referring to a specimen collected with a
brush. Indeed, Dr. Kahaleh confirmed during his deposition that paragraph 10 of
his Declaration was referring to a biopsy specimen obtained via a forceps biopsy
procedure. PO Resp. 5–6; Ex. 2005, 16; see also Ex. 1010 ¶ 6 (Parasher not listed
as a document reviewed in preparation for the Declaration). For these reasons,
paragraph 10 of Dr. Kahaleh’s Declaration adds nothing to Petitioner’s contention
that Parasher’s brush is capable of collecting a specimen that includes cells from
tissue located below the surface of the epithelium.
Petitioner asserts that paragraph 16 of Dr. Kahaleh’s Declaration supports
the contention that a brush biopsy specimen includes “tissue located below the top
surface of the epithelium including basement membrane and submucosa” as
required by claim 1. Pet. Reply 4–5 (quoting Ex. 1010 ¶ 16). As explained above,
Dr. Kahaleh did not review Parasher before making this statement. See PO Resp.
9–10; Ex. 2005, 6:18–7:6.20 Therefore, at most, Dr. Kahaleh’s statement conveys
that some unspecified brush is capable of obtaining such a specimen. The question

19 When asked “so that when you use the brush you’re really not doing a biopsy, is
that your opinion?,” Dr. Kahaleh responded, “right.” Ex. 2005, 17:8–10.
20 Further supporting this conclusion, Petitioner objected to Patent Owner’s
question as beyond the scope of direct, suggesting that Dr. Kahaleh’s Declaration
did not address the Parasher reference. See Ex. 2005, 6:25–7:3.
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before us is not whether some brush has the claimed capability; the question is
whether Parasher’s brush has such capability. The proffered evidence sheds little
or no light on the capabilities of Parasher’s brush.
Petitioner contends that Dr. Kahaleh testified that “brushing” (use of a brush
to obtain a specimen for examination) can obtain a specimen as claimed. Pet.
Reply. 5 (citing Ex. 2005, 17–18, 27–28). In the cited portions, Dr. Kahaleh
testified with regard to the capabilities of the U.S. Endoscopy brush (“biliary
brush”) and not with regard to Parasher’s brush. Therefore, this evidence sheds
little or no light on the capabilities of Parasher’s brush.
For these reasons, we determine that paragraphs 10 and 16 of Dr. Kahaleh’s
Declaration (Ex. 1010) and the portions of Dr. Kahaleh’s testimony relied upon as
detailed above, to be unpersuasive regarding the capability of Parasher’s brush to
gather a specimen as claimed.
Because we do not rely on Dr. Kahaleh’s definition of biopsy, we need not
address Patent Owner’s arguments why Dr. Kahaleh’s definition of biopsy is
incorrect and why relying upon such evidence would be improper gap filling. See
PO Resp. 5–10, 14–16.
2. Dr. Kahaleh’s Qualifications
Petitioner relies upon Dr. Kahaleh for other evidentiary issues, including for
example, to provide evidence that Parasher’s brush can examine glandular
epithelium and as to the depth of the submucosa. See Pet. 23, 25 (citing Ex. 1010
¶¶ 11, 12). Before considering this evidence below, we address Patent Owner’s
arguments regarding Dr. Kahaleh’s qualifications.
Patent Owner makes two arguments why we should give the testimony of
Dr. Kahaleh little or no weight. PO Resp. 16–20. First, Patent Owner contends
that Dr. Kahaleh is not an expert qualified to testify as to what constitutes a biopsy,
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analyzing biopsy specimens, diagnosing disease based on review of biopsy
specimens, and or to make determinations as to the sufficiency and/or adequacy of
biopsy specimens. Id. at 16–17 (citing Ex. 2005, 30). According to Patent Owner,
the relevant expert would be a pathologist or someone with similar knowledge of
biopsies. PO Resp. 16–18.
As an initial matter, we note that Patent Owner is not seeking to exclude
Dr. Kahaleh’s testimony, and therefore the proper inquiry is not whether
Dr. Kalaleh is qualified under the Federal Rules of Evidence (“Fed. R. Evid.”).
See 37 C.F.R. §§ 42.62, 42.64; Fed. R. Evid. 702, 703. In other words, contrary to
what Patent Owner’s argument suggests, it is not necessary that Dr. Kahaleh
qualify as an expert under for the Federal Rules of Evidence for us to consider
evidence from him. We consider Dr. Kahaleh’s qualifications to determine what
weight should be accorded to the evidence he provided.
We disagree with Patent Owner’s assertion that the relevant expert is limited
to a pathologist.21 The field of the ’609 patent relates to obtaining transepithelial
specimens with an endoscope, not the study of the specimens so obtained. See Ex.
1001, 1:10–12. Indeed, all of the claims of the ’609 patent deal with obtaining a
specimen with an endoscope, and none of the claims deal with examination of that
specimen. Therefore, expertise in the obtaining of specimens with an endoscope
has relevance to the claimed subject matter.
Dr. Kahaleh has expertise in obtaining specimens with an endoscope.
Dr. Michel Kahaleh has a medical science degree (cum Laude) as well as a doctor
of medicine. Ex. 1010 ¶ 8. He completed an internship in surgery, two

21 “Pathologist: [a] specialist in diagnosing the morbid changes in tissues removed
at operations and postmortem examinations,” TABER’S CYCLOPEDIC MEDICAL
DICTIONARY, (12th ed. 1973), Ex. 3001, 3.
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fellowships in gastroenterology,22 and an internship and residency in internal
medicine. Id. at 8–9. He is skilled in the art and use of endoscopic tools, including
brushes for use in gastroenterology. Id. ¶ 4. For example, he has served as a Chief
of Endoscopy and a Chief of Advanced Endoscopy, is board certified in internal
medicine and gastroenterology, and has performed between 3,000 and 5,000 brush
biopsies. Id. at 9; Ex. 2005, 27:7–11. From this and other information provided
regarding Dr. Kahaleh, we determine that Dr. Kahaleh has experience relevant to
the field of the invention, and Patent Owner’s argument that we should give such
testimony little or no weight is not persuasive.
Second, Patent Owner contends that we should give Dr. Kahaleh’s testimony
little or no weight because, “Dr. Kahaleh did not ‘have the skill and experience of
an ordinary worker in the field,’ and he did not ‘have knowledge of all pertinent
prior art’ . . . in May of 2001.” PO Resp. 18–20 (citing Custom Accessories, Inc. v.
Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962–63 (Fed. Cir. 1986), and Schott
Gemtron Corp. v. SSW Holding Co., Inc., Case IPR2013-00358, slip op. at 18
(PTAB Aug 20, 2014) (Paper 106)).
The cited portion of Custom Accessories explains that when analyzing the
level of skill in the art in a Graham analysis, the critical question is whether the
claimed invention would have been obvious at the time to a person of ordinary
skill in the art, who is a hypothetical person presumed to be aware of all the
pertinent prior art. Custom Accessories, 807 F.2d at 962 (referring to Graham v.
John Deere Co., 383 U.S. 1 (1966)). Custom Accessories does not address

22 “Gastroenterology: [t]he branch of medical science concerned with study of
physiology and pathology of the stomach, intestines, and related structures such as
the esophagus, liver, gallbladder, and pancreas.” Id. at 4.
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whether an expert must have been qualified as of the critical date of the patent
being discussed. Id.
Schott, a non-precedential Board decision, does not stand for the proposition
that an expert witness must have been a person of ordinary skill in the art at the
time of the claimed invention of the patent challenged. The Board did not cite to
any legal authority with regard to being a person of ordinary skill as of the critical
date. Rather, in context, the Board determined that Petitioner’s witness was not a
person of ordinary skill in the art at any time, to include at the time of the invention
of the challenged patent. Schott at 17–18. A witness must provide testimony
about the level of skill in the art as of the critical date; however, the witness need
not have acquired that knowledge as of the critical date. We note that in Schott,
where the witness was not a person of ordinary skill in the art, the Board reduced
the weight given that testimony and did not elect to give the testimony no weight.
Accordingly, Patent Owner’s second argument that we should give
Dr. Kahaleh’s testimony little or no weight is not persuasive.

V. ANTICIPATION BY PARASHER
“Because the hallmark of anticipation is prior invention, the prior art
reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose
all elements of the claim within the four corners of the document, but must also
disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign,
Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck &
Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Accordingly, an anticipatory reference
must show all of the limitations of the claims “arranged or combined in the same
way as recited in the claims.” Id. at 1370; see Finisar Corp. v The DirecTV Grp.,
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Inc., 523 F.3d 1323, 1334–37 (Fed. Cir. 2008); Ecolochem, Inc. v. S. Cal. Edison
Co., 227 F.3d 1361, 1366–68 (Fed. Cir. 2000).
To prevail in its challenges to the patentability of claims, Petitioner must
establish facts supporting its challenges by a preponderance of the evidence.
35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
The burden of showing something by a preponderance of the
evidence ... simply requires the trier of fact to believe that the
existence of a fact is more probable than its nonexistence before [he]
may find in favor of the party who has the burden to persuade the
[judge] of the fact's existence.
Metro. Stevedore Co. v. Rambo, 521 U.S. 121, 137 n.9 (1997) (alteration in
original) (quoting Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers
Pension Tr. for S. Cal., 508 U.S. 602, 622 (1993)).
Petitioner contends that claims 1–4 are unpatentable as anticipated by
Parasher. Pet. 14–25. We have considered the arguments and evidence presented
by both parties, and we determine Petitioner has shown by a preponderance of the
evidence that claims 1–4 are unpatentable as anticipated by Parasher.
A. Uncontested Aspects
Parasher discloses an apparatus (device 1) to be used in conjunction with an
endoscope to examine tissue cells located within epithelium tissue. Pet. 14–17, 19;
Ex. 1003, 1:10–11, 54–67; 2:20–40; 3:6–32; 5:58–6:20; see also Ex. 1001, 1:16–
19 (noting that the upper esophagus is lined with epithelium).
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Figure 3 of Parasher follows:

Figure 3 is a partial elevation view of a third embodiment of Parasher’s
device. Ex. 1003, 4:12–13.
Parasher’s device includes a channel extending the length of the endoscope
(formed by sheath of sleeve 17), a rod (catheter 3) passing through that channel,
and a retractable non-lacerational23 brush (brush 9) attached to the distal end of that
rod.24 Pet. 17–20; Ex. 1003, 3:7–32; 4:46–48; 5:33–45, 5:58–6:20; Figs. 1–3.
Parasher’s brush is movable to bear against the tissue being examined and is
controlled by the rod to remove tissue from a tissue area being examined.
Specifically, Parasher’s brush is pushed and pulled back and forth over the inner
wall of the duct to collect scrapings of tissue and brushings of cells. Pet. 21; Ex.
1003, 3:21–28; 6:6–10. This process is also described as a “scrape biopsy.” Pet.
15; Ex. 1003, 1:10–11; see also Ex. 1003, 1:14–17 (describing abrading against the
duct walls); cf. Ex. 1001, 6:35–37, 44–47 (describing the brush as moved or rubbed
against the tissue to collect a specimen).

23 Parasher’s brush reduces the risk of perforating the duct, suggesting the brush is
non-lacerational. See Pet. 16, Ex. 1003, 2:16–19; see also Pet. 16–17; Ex. 1003,
3:60–67 (Parasher’s brushing procedure is safer than surgical extraction); Ex.
1012, 101 (Patent Owner’s witness, Dr. Fromowitz, acknowledging that Parasher’s
brush is non-lacerational).
24 Parenthetical nomenclature is to Parasher’s nomenclature.
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Parasher’s brush 9 is comprised of bristles 11 that are stiff or semi-rigid.
Pet. 21; Ex. 1003, 4:46–58. The tips of bristles 11 have features that facilitate
collection of cell and tissue, such as hook ends, ball-tips, mushroom tips, loops, or
the like. Pet. 21–22; Ex. 1003, 4:46–58; Figs 4a–4c; cf. Ex. 1001, 7:15–20 (like
the brush of the claim 1, the stiffness and shape of the bristle tips of Parasher
contribute to the effectiveness of retrieving a specimen).
These contentions are not contested by Patent Owner. See 37 C.F.R.
§ 42.23(a) (any material fact not specifically denied may be considered admitted).
B. Contested Aspect25
Patent Owner contends that not all of the claimed elements are found within
the four corners of Parasher, as is required for anticipation, because Parasher is
silent regarding obtaining a specimen that includes tissue from below the surface
of the epithelium. PO Resp. 3–4, 11–12. This contention is premised on the claim
construction that claim 1 requires penetrating at least two layers of epithelium. Id.
at 13. Patent Owner puts forth several reasons why Dr. Kahaleh’s definition of
biopsy proffered by Petitioner does not cure this deficiency. Id. at 5–10.
Patent Owner’s arguments are unpersuasive for two reasons. First, Patent
Owner’s argument is not based upon proper claim construction. Second, Patent
Owner mischaracterizes what is required for anticipation and does not address
persuasively the merits of Petitioner’s contentions regarding Parasher.

25 Our analysis does not address new arguments by Patent Owner because those
arguments were not in the record prior to oral hearing. See Office Patent Trial
Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012); Paper 25
(Petitioner’s Objections to Patent Owner’s Demonstratives). Later in this opinion
we address one such new argument in greater detail.
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1. Claim Construction
Patent Owner contends that claim 1 requires penetrating as least two layers
of the epithelium. To the contrary, as explained above, claim 1 requires the
specimen to include cells from below the exterior boundary of the epithelium.
Consequently, all that is required is that the exterior boundary (surface) of the
epithelium is penetrated so that cells are dislodged and picked up. Therefore,
patent Owner’s arguments are not commensurate in scope with claim 1.
With the properly construed claim in mind we turn to the reference. See
Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928, 933 (Fed. Cir. 2003) (citations
omitted) (“Both anticipation under § 102 and obviousness under § 103 are two-step
inquiries. The first step in both analyses is a proper construction of the claims. . . .
The second step in the analyses requires a comparison of the properly construed
claim to the prior art.”).
2. Parasher
Patent Owner contends that Parasher is silent regarding the ability of the
brush to pick up tissue from the area below the surface of the epithelium. PO
Resp. 4, 12, 14. We disagree both with the implication that Parasher must disclose
such capability in the words of the ’609 patent and with Patent Owner’s
characterization of the reference.
Parasher need not explicitly state that the device picks up tissue from below
the surface of the epithelium. See generally In re Bond, 910 F.2d 831, 832 (Fed.
Cir. 1990) (“These elements must be arranged as in the claim under review, but
this is not an ‘ipsissimis verbis test’”) (citation omitted); In re Gleave, 560 F.3d
1331, 1334 (Fed. Cir. 2009) (Although a reference must disclose each and every
limitation in a claim to anticipate the claim, the reference need not satisfy an
ipsissimis verbis test.).
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The proper inquiry is what a person of ordinary skill in the art would
understand as the capability of Parasher’s brush. Further, contrary to Patent
Owner’s characterization, Parasher is not silent regarding the capabilities of the
brush. Instead, as detailed below, Petitioner identifies and explains numerous
disclosures regarding the extent of the specimen that is collected by Parasher’s
brush.
As detailed above, Parasher’s device includes a brush having stiff or semi-
rigid bristles with tips that facilitate the collection of cell and tissue. Further,
Parasher’s device obtains a specimen by bearing against the tissue being examined.
Regarding the composition or extent of the specimen collected, Parasher’s
brush is capable both of collecting cells (cytology) and of collecting a larger
(greater) sample of tissue (biopsy). Pet. 15, 20; Pet. Reply 9; Ex. 1003, 1:8–11,
2:20–40, 3:26–28; see also Ex. 1003, Title (“Catheter with Simultaneous Brush
Cytology and Scrape Biopsy Capability); 3:60–67 (describing the sample collected
as “more substantial” than that collected with conventional cytology).26 Parasher
describes that the device enables collection of a “gross tissue sample or biopsy.”
Pet. 16, Pet. Reply 9; Ex. 1003, 1:56–58; 2:20–25. Parasher also describes the
brush as capable of collecting “scrapings of tissue.” Pet. 21; Pet. Reply 10; Ex.
1003, 3:24–28.
A person of ordinary skill in the art would have considered these disclosures
in the context that “tissue” is an aggregation of similarly specialized cells and that

26 Petitioner identifies numerous other examples of Parasher referring to the
sample collected as a tissue sample. See, e.g., Pet. 14, 16, 21–22; Ex. 1003, 2:12–
20.
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“gross” means large enough to be visible to the naked eye. See Ex. 2003, 4; Ex.
2004, 6; Ex. 3001,27 5.
In sum, Parasher’s brush, like the claimed device, includes bristles that are
stiff and have a shape that contributes to collecting a specimen. Parasher’s brush,
like the claimed device, obtains a specimen by bearing against the tissue being
examined. The specimen obtained by Parasher’s brush is an aggregation of cells
large enough to be visible to the naked eye. Considering the evidence to this point,
Petitioner has shown by a preponderance of the evidence that Parasher’s brush
obtains such a specimen by dislodging cells from below the exterior boundary of
the epithelium.
C. Dr. Fromowitz
Dr. Frank Fromowitz, Patent Owner’s expert witness, provided a
Declaration (Ex. 2001) and was deposed by Petitioner (Ex. 1012). Dr. Fromowitz
is a licensed physician with 35 years of experience as a pathologist. Ex. 2001 ¶¶ 3,
4, 7. Each party relies upon the testimony of Dr. Fromowitz, and it is uncontested
that Dr. Fromowitz is qualified to provide expert testimony. See e.g., PO Resp. 21;
Pet. Reply 1–2, 7–8.
1. Patent Owner
Patent Owner relies upon the testimony and Declaration of Dr. Fromowitz to
attempt to counter Dr. Kahaleh’s evidence regarding the composition of a biopsy
specimen. PO Resp. 12. Because we are not considering Dr. Kahaleh’s evidence
regarding the composition of a biopsy specimen, Patent Owner’s arguments are not
relevant.

27 “Gross,” TABER’S CYCLOPEDIC MEDICAL DICTIONARY, 12th ed. (1973), Ex.
3001, 5
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Patent Owner does not rely upon evidence from Dr. Fromowitz to attempt to
counter Petitioner’s analysis of Parasher. PO Resp. passim.
2. Petitioner’s Use of Dr. Fromowitz’s Testimony
Petitioner contends that Dr. Fromowitz testified that the “brush of Parasher
collects a specimen of tissue located below the surface of the epithelium as
required by the claims of the ‘609 Patent.” Pet. Reply 7–8 (citing Ex. 1012, 94–
101).28 Our interpretation of this portion of Dr. Fromowitz’s testimony follows.
As background, Parasher discloses that “[t]o diagnose a malignancy
associated with a stricture, for example, it may be appropriate to examine the
mucous lining of the duct, the tissue of the duct wall and even adjacent tissues.”
Ex. 1003, 1:61–64 (emphasis added). Petitioner asked Dr. Fromowitz if “adjacent
tissue” in this context included submucosa. Ex. 1012, 94:8–95:12. Dr. Fromowitz
stated that it could refer to a different organ, such as the liver or duodenum, but
subsequently added that it “would have to include the submucosa.” Id.
Petitioner subsequently directed Dr. Fromowitz’s attention to the disclosure
that Parasher’s device can obtain a larger tissue than may be obtained with
cytology so that the sample obtained is a gross tissue sample or biopsy. Id. at
95:13–22 (referring to Ex. 1003, 2:20–25). Dr. Fromowitz interpreted this
disclosure to state that a brush can be used to get more tissue than may be obtained
by cytology, and that the sample obtained would be a biopsy. Id. at 94:8–96:12.
Dr. Fromowitz disagrees with the reference in that obtaining more cells does not
mean the constituents of a biopsy have been obtained. Id. at 96:5–12. This
observation must be interpreted in the light that Dr. Fromowitz considers a biopsy

28 Petitioner’s argument is previewed at pages 1–2 of the Reply and provided in
detail at pages 7–8. Our analysis focuses on pages 7–8.
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specimen to be “a segment of intact tissue,” as may be obtained by cutting, pulling,
excising or the like (methods other than brushing). Id. at 21:18–19. Therefore,
Dr. Fromowitz is stating that he thinks a brush cannot obtain a segment of intact
tissue. None of the challenged claims require the specimen to be a segment of
intact tissue. Nor do the claims recite that the specimen obtained is a “biopsy;”
rather, the claims specify the composition of the specimen obtained. See, e.g., Ex.
1001, claim 1 (requiring the specimen to include cells from tissue located below
the surface of the epithelium). Consequently, this particular portion of
Dr. Fromowitz’s testimony sheds little or no light on whether Parasher’s brush can
obtain a specimen as claimed.
Petitioner contends that Dr. Fromowitz stated that the sample collected by
Parasher is similar to a specimen as claimed. Pet. Reply 7 (citing Ex. 1012, 96:13–
18). Dr. Fromowitz did not explicitly state that the sample collected by Parasher is
similar to a specimen as claimed. Ex. 1012, 96:13–18. Rather, in context,
Dr. Fromowitz testified that a “gross tissue sample,” as used in Parasher, means a
sample of tissue that you can actually see. Ex. 1012, 95:16–96:18 (referring to Ex.
1003, 2:20–25).
Subsequently, Petitioner pointed out that Parasher’s device is capable of
obtaining “scrapings of tissue,” and asked, if Parasher’s device were to be used to
obtain a specimen from tissue such as shown in Figure 5 of the ’609 patent, would
the specimen obtained include cells from the submucosa. Ex. 1012, 97:15–98:24
(referring to Ex. 1003, 3:26–28). Dr. Fromowitz initially did not understand the
question, and asked Petitioner to start again. Id. at 98:25–99:4. Petitioner then
asked if scraping as disclosed by Parasher would obtain a specimen that included
cells from the submucosa. Id. at 99:5–10. Dr. Fromowitz replied, “not
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necessarily,” and then added that Parasher’s device could obtain such a specimen,
but not reliably so. Id. at 99:11–16.
Petitioner referred again to the disclosure that Parasher’s device can obtain a
specimen that qualifies as a gross tissue sample or biopsy, and asked whether a
person of ordinary skill in the art would understand this disclosure to mean that the
specimen obtained includes portions of the submucosa. Id. at 99:20–100:4
(referring to Ex. 1003, 2:24–25). Dr. Fromowitz stated that in some instances it
could. Id.
In light of this, we determine Dr. Fromowitz testified that Parasher’s device
can obtain a gross tissue sample, meaning a sample that is visible to the naked eye,
and this sample would include more cells than would be obtained by cytology. See
Ex. 1012, 95:16–96:18 (referring to Ex. 1003, 2:20–25), 94:8–96:12 (referring to
Ex. 1003, 2:20–25). The size of the specimen collected (more cells than cytology
and visible to the naked eye) supports Petitioner’s contention that Parasher’s
device dislodges cells from below the exterior boundary of the epithelium. This
information is consistent with our analysis of Parasher above.
Further, Dr. Fromowitz testified three times that Parasher’s could obtain a
specimen that included portions of the submucosa. Id. at 94:8–95:12 (referring to
Ex. 1013, 1:61–64 and stating that a specimen “would have to also include the
submucosa”), 99:12–16 (referring to Ex. 1003, 3:26–28 and stating that Parasher’s
device could obtain a specimen that included submucosa, but not reliably so),
99:20–100:4 (referring to Ex. 1003, 2:24–25 and stating that in some instances
Parasher’s device could obtain such a specimen). This evidence is consistent with
our analysis of Parasher above. This evidence suggests that Parasher’s brush not
only is capable of dislodging cells from below the surface of the epithelium, but
can also penetrate to the submucosa.
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D. Conclusions by Claim
1. Claim 1
Petitioner identifies and explains how Parasher discloses each element of
claim 1, with the only contested aspect being whether Parasher’s brush is capable
of dislodging and collecting cells from the tissue below the surface of the
epithelium. Patent Owner challenges Dr. Kahaleh’s evidence regarding the
composition of a biopsy; however, this challenge is not persuasive because our
analysis of Petitioner’s case does not rely on this evidence. With regard to
Petitioner’s analysis of Parasher, Patent Owner simply contends that Parasher is
silent regarding the capabilities of the brush. To the contrary, Parasher is not
silent, and Petitioner’s analysis of Parasher demonstrates that it is more likely than
not that Parasher’s brush obtains such a specimen by dislodging cells from below
the exterior boundary of the epithelium. Dr. Fromowitz’s testimony is consistent
with, and further supports Petitioner’s case.
We conclude that Petitioner has shown by a preponderance of the evidence
that claim 1 is anticipated by Parasher.
2. Claim 2
Claim 2 depends from claim 1 and adds that the “brush bristles are at least
1000 microns in length.” Parasher discloses that bristles 11 of brush 9 may extend
1 to 3 millimeters. Pet. 23; Ex. 1003, 4:59–64. Patent Owner repeats the
arguments for claim 1, and these arguments are not persuasive for the reasons
given above. PO Resp. 13. Further, these arguments do not address persuasively
the additional limitation of claim 2. See 37 C.F.R. § 42.23(a).
We conclude that Petitioner has shown by a preponderance of the evidence
that claim 2 is anticipated by Parasher.
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3. Claim 3
Claim 3 depends from claim 1 and adds that the “epithelium tissue
comprises metaplastic glandular epithelium tissue.” Petitioner explains that
Parasher’s device is capable of obtaining samples from metaplastic glandular
epithelium tissue.29 Pet. 23–24; Ex. 1010 ¶ 12. Patent Owner repeats the
arguments for claim 1. These arguments are unpersuasive for the reasons given
above. Further, these arguments do not address persuasively the additional
limitation of claim 3. See 37 C.F.R. § 42.23(a).
We conclude that Petitioner has shown by a preponderance of the evidence
that claim 3 is unpatentable as anticipated by Parasher.
4. Claim 4
Claim 4 depends from claim 3 and adds, “wherein said specimen of the
tissue area comprises a disaggregated specimen of the whole tissue, said whole
tissue being defined of at least glandular cells, plus basement membrane fragments,
plus elements of the submucosa in the area being examined.” Petitioner contends
that Parasher’s brush is capable of obtaining a specimen as required by claim 4.
Pet. 24–25.
The ’609 patent describes that by rubbing harder than normal cytological
sampling with a stiff device which penetrates epithelium, the basement membrane
can be reached. Ex. 1001, 6:42–50. As explained above Parasher’s device
includes stiff or semi-rigid bristles and operates in a similar manner.

29 Metaplastic glandular epithelium tissue can be present in the esophagus and
Parasher’s device may be used in the esophagus. Ex. 1001, 9:30–33; Ex. 1003,
1:27–30.
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Parasher’s brush 9 has bristles that are 1 to 3 millimeters in length, which
Petitioner contends is long enough to reach the submucosa and is not contested by
Patent Owner. See Pet. 25; Ex. 1010 ¶ 11; Ex. 1003, 4:59–64.
Beyond this similarity in structure and method of obtaining a sample,
Petitioner contends that Parasher’s brush obtains a specimen from adjacent tissue,
which includes the submucosa. Pet. 25 (citing Ex. 1003, 1:54–67). As explained
above, Dr. Fromowitz testified that Parasher’s brush could obtain a specimen that
included portions of the submucosa. See Pet. Reply 7–8. In fact, as detailed
above, Dr. Fromowitz was asked in three different ways if Parasher’s brush was
capable of obtaining a specimen from the submucosa, and each time testified that it
could.
We conclude that Petitioner has shown by a preponderance of the evidence
that claim 4 is unpatentable as anticipated by Parasher.

VI. OBVIOUSNESS OVER PARASHER AND EISEN
Petitioner contends that claims 3 and 4 are unpatentable over Parasher (Ex.
1003) and Eisen (Ex. 1005). Pet. 25–29; Pet. Reply 12. Specifically, Petitioner
contends that Eisen discloses a brush that obtains samples that are the functional
equivalent of tissue samples taken by laceration, and it would have been obvious to
substitute Eisen’s brush for Parasher’s brush to reach the subject matter of claims 3
and 4. Pet. 25–29. Regarding claim 3, Petitioner contends that Eisen’s brush 126
is capable of obtaining a biopsy sample of metaplastic glandular epithelium tissue.
Pet. 27–28; Pet. Reply. 12. Regarding claim 4, Eisen’s brush is capable of
penetrating all layers of the epithelia so that the brush is capable of obtaining
disaggregated specimen of glandular cells, basement membrane fragments, and
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elements of the submucosa. Pet. 28; Ex. 1005, 12:30–45, 13:48–14:7. As
explained below, these findings are adequately supported.
Eisen discloses brush 126 for performing a brush biopsy of epithelial tissue
to obtain a cellular sample for diagnosis of cancer. Pet. 25; Ex. 1005, 2:20–32,
5:59–67. Bristles 140 of brush 126 have an upper limit on stiffness to avoid
bleeding, trauma, discomfort, and scarring (non-lacerational). Pet. 26–27; Ex.
1005, 12:30–45, 13:2–6. Bristles 140 are stiff or semi-rigid, and are capable of
exerting sufficient pressure to conduct a brush biopsy that dislodges cells from all
epidermal layers. Pet. 26–27; Ex. 1005, 12:30–45, 13:2–6. The sample obtained is
the functional equivalent of samples taken by lacerating biopsy procedures. Pet.
26; Ex. 1005, 3:56–4:12. The brush may be used in various areas of the body, to
include the esophagus. Pet. 26; Ex. 1005, 4:25–30.
Petitioner’s reasoning that modifying Parasher’s device to utilize Eisen’s
brush is a simple substitution with predictable results is supported by the factual
underpinning that Eisen’s and Parasher’s brushes have the same purpose and
perform the same function. See Pet. 22 (citing Ex. 1003, 1:54–67; 2:17–19, 35–
40), 25–27 (citing at least Ex. 1005, 2:20–32; 5:59–67; 4:24–30).
In the Preliminary Response, Patent Owner argued that Petitioner relies upon
improper hindsight analysis, the combination would not have been obvious to try,
and the combination would have been counter-intuitive. Prelim. Resp. 6–7. In the
Institution Decision we stated that these arguments were unpersuasive without
supporting evidence. Inst. Dec. 13–14. Patent Owner does not repeat these
arguments in the Response, or provide supporting evidence. Consequently our
analysis has not changed.
In the Response, Patent Owner repeats the argument that Parasher’s brush is
not capable of dislodging cells and picking up a specimen as claimed. PO Resp.
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14–15. Such argument is not responsive because Petitioner’s arguments
supporting this ground of unpatentability rely upon Eisen’s brush, not Parasher’s.
See Pet. 25–29.
At the oral hearing, Patent Owner argued that Eisen’s brush cannot be
substituted into Parasher’s endoscope. See Ex. 2006, 49–51, Tr. 72–75. Petitioner
correctly objects that this is a new argument. Paper 25, 330; Office Patent Trial
Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012).31 Therefore, we do
not consider this argument.
In light of this, Patent Owner has not challenged effectively any material fact
in Petitioner’s ground of unpatentability. See 37 C.F.R. § 42. 23(a).
Petitioner has demonstrated by a preponderance of the evidence that claims
3 and 4 are unpatentable over Parasher and Eisen.

VII. CONCLUSION
Petitioner has met its burden of proof by a preponderance of the evidence
that (1) claims 1–4 are anticipated by Parasher and (2) claims 3 and 4 would have
been obvious over Parasher and Eisen.

30 The pages of this exhibit are not numbered.
31 See also Paper 23, 3 (directing the parties to St. Jude Med., Cardiology Div.,
Inc. v. Bd. of Regents of the Univ. of Mich., IPR2013-00041 (PTAB January 27,
2014) (Paper 65), for guidance regarding the appropriate content of demonstrative
exhibits).
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VIII. ORDER
Accordingly, it is
ORDERED that claims 1–4 of U.S. Patent 6,676,609 B1 are determined by a
preponderance of the evidence to be unpatentable;
ORDERED that no later than five business days from the entry of this
decision, that Petitioner’s Demonstratives be filed as Exhibit 1014 and Patent
Owner’s Demonstratives be filed as Exhibit 2006; and
FURTHER ORDERED that because this is a final written decision of the
Board under 35 U.S.C. § 318(a), parties to the proceeding seeking judicial review
of the decision must comply with the notice and service requirements of 37 C.F.R.
§ 90.2.

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PETITIONER:
Todd Tucker
ttucker@calfee.com

Mark McDougall
ipdocket@calfee.com
PATENT OWNER:
Peter Berger
pberger@llbl.com

Tuvia Rotberg
trotberg@llbl.com

David Soofian
David.soofian@kayescholer.com

David Barr
David.barr@kayescholer.com