Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 25
`Entered: October 15, 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 IPR2014-00642
`Patent 6,258,044 B1
`____________
`
`
`Before PHILLIP J. KAUFFMAN, SCOTT A. DANIELS, and
`BARRY L. GROSSMAN, Administrative Patent Judges.
`
`
`
`DANIELS, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`

`
`IPR2014-00642
`Patent 6,258,044 B1
`
`
`I. BACKGROUND
`
`A.
`
`
`
`Procedural History
`
` Petitioner, U.S. Endoscopy Group, Inc., filed a Petition (Paper 4, “Pet.”)
`
`seeking inter partes review of claims 1–39 of U.S. Patent No. 6, 258,044 B1 (Ex.
`
`1001, “the ’044 patent”).1 Patent Owner, CDx Diagnostics, Inc., filed a
`
`Preliminary Response. Paper 6 (“Prelim. Resp.”).
`
`In the Decision to Institute (Paper 7, “Inst. Dec.”), we instituted trial on
`
`claims 1–17, 19–20, 23–28, 32, and 35–39 based on the following grounds:
`
`1) claims 1–8, 11–17, 23–28, 32, and 35–39 based under 35 U.S.C. § 102(b)
`
`by Parasher2; and
`
`2) claims 9, 10, 19, and 20 under 35 U.S.C. § 103(a) over Parasher and
`
`Markus.3
`
`Subsequently, Patent Owner filed a Patent Owner Response4 (Paper 14, “PO
`
`Resp.”), and Petitioner filed a Reply (Paper 16, “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 18, 20, and 21. A transcript of the oral hearing is included in the
`
`record. Paper 24 (“Tr.”).5
`
`
`1 We refer to the Corrected Petition, filed April 28, 2014.
`2 U.S. 5,535,756, issued July 16, 1996 (Ex. 1003).
`3 U.S. 5,407,807, issued April 18, 1995 (Ex. 1005).
`4 We refer to Patent Owner’s Corrected Patent Owner’s Response, filed February
`9, 2015.
`5 A single Transcript was created for the oral hearing for IPR2014-00639,
`IPR2014-00641, and IPR2015-00642. See the Related Proceedings section below.
`
`2
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`

`
`IPR2014-00642
`Patent 6,258,044 B1
`
`
`For the reasons that follow, we determine that Petitioner has shown by a
`
`preponderance of the evidence that claims 1–17, 19, 20, 23–28, 32, and 35–39 of
`
`the ’044 patent are unpatentable.
`
`B.
`
`Related Proceedings
`
`Petitioner asserted the ’044 patent in CDx Diagnostics, Inc. v. U.S.
`
`Endoscopy Group, Inc., Case No. 1:13-cv-5669-NSR (S.D.N.Y.). Pet. 2.
`
`The parties are also involved in IPR2014-00639, a challenge to U.S.
`
`6,676,609 B1 (the “’609 patent”) and IPR2014-00641 challenging U.S. Patent No.
`
`7,004,913 B1 (the “’913 patent”). The ’609 patent, the ’913 patent, and the ’044
`
`patent all relate to similar subject matter of a brush for obtaining a patient biopsy.
`
`The ’044 patent is, however, not related to the ’609 patent or the ’913 patent.
`
`
`
`II. THE ’044 PATENT
`
`The ’044 patent relates to a method and apparatus for obtaining cells from
`
`multiple layers of epithelium by abrasion and without laceration. Ex. 1001, 4:55–
`
`5:8; 5:25–28. In a preferred embodiment, the apparatus includes a brush having
`
`bristles of sufficient stiffness to allow them to dislodge and sweep up cells from
`
`superficial, intermediate, and basal layers of epithelium, and to penetrate the
`
`basement membrane underlying the epithelium to reach the submucosa, without
`
`having to resort to the dangers of incisional-based biopsy. Id. at 4:63–5:8; 5:24–
`
`40; 9:19–20. The brush is mounted on the distal end of a handle. Id. at 7:8–9. The
`
`bristles extend from wires that emanate from the distal end of the handle. The
`
`wires may form a toroid or spiral shape that is oriented substantially perpendicular
`
`to the axis of the handle. Id. at 7:23–28; Fig. 4. Figure 4 of the ’044 patent is
`
`reproduced below:
`
`
`
`3
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`

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`IPR2014-00642
`Patent 6,258,044 B1
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`
`
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`Figure 4 of the ’044 patent illustrates a preferred embodiment shown in perspective
`
`view. Id. at 7:44–46.
`
`Also helpful to our Decision, below, is an illustration of the layers of
`
`epithelial tissue. 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
`
`follows:
`
`
`
`4
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`

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`IPR2014-00642
`Patent 6,258,044 B1
`
`This figure depicts the layers of epithelial tissue adjacent to the basement
`
`membrane and submucosa. See Ex. 3002, 46 (Patent Owner’s demonstratives);
`
`Ex. 3003, 2 (Petitioner’s demonstratives).7
`
`The ’044 patent describes its claimed apparatus through a contrast to
`
`cytology as well as lacerating biopsy. Cytology uses a soft brush to gently remove
`
`(sweep) previously freed cells (exfoliated or sloughed off) from the surface of the
`
`epithelium in a non-invasive manner that avoids or minimizes abrasion of the
`
`epithelium and is intended to be painless. Ex. 1001 at 2:26–4:24. On the other
`
`hand, a lacerating biopsy uses a cutting instrument such as a scalpel or a laser to
`
`remove tissue for evaluation. Id. at 1:65–2:3. The described brush uses a stiffer
`
`brush and rubs harder than cytology so that the surface of the epithelium is
`
`penetrated. Id. at 4:63–5:2. In other words, the stiff brush penetrates the surface of
`
`the epithelium by dislodging cells (as opposed to sweeping up previously freed
`
`cells) and picks up those cells without the invasive effects and discomfort of
`
`lacerating biopsy. Id.
`
`
`
`III. THE CHALLENGED CLAIMS
`
`Independent claims 1, 12, and 26 are illustrative of the claimed subject
`
`matter and are reproduced below.
`
`
`
`
`6 Citing Ex. 1001 at 4:34–37, 11:56–65.
`7 We exercise our discretion and enter the parties’ demonstratives, which we
`earlier ordered to be served and not filed. See Paper 21, 2–3. This information
`appears uncontested in that the parties each depict the layers in the same manner.
`Compare Ex. 3002, 4, with Ex. 3003, 2. We discern no evidence in the case that
`contradicts this depiction.
`
`5
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`

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`IPR2014-00642
`Patent 6,258,044 B1
`
`
`1. Apparatus to obtain cells in epithelial
`tissue of the body comprising:
`
`sampling
`non-lacerational
`transepithelial
`apparatus to collect cells from at least two layers of
`said
`epithelial
`tissue,
`said
`transepithelial non-
`lacerational sampling apparatus comprising a brush,
`said brush comprising bristles having
`sufficient
`stiffness to penetrate at least said two layers of said
`epithelial tissue.
`
`sampling
`non-lacerational
`transepithelial
`12. A
`apparatus to harvest cells in an oral cavity from the
`epithelial
`tissue, said epithelial
`tissue comprising
`superficial,
`intermediate and basal
`layers, and a
`basement membrane located between the basal layer
`and the submucosa, said non-lacerational sampling
`apparatus comprising means to traverse said superficial,
`intermediate and basal layers and to collect cells
`from said three layers.
`
`26. A method to collect cells in epithelial tissue of
`the body comprising:
`
`transipithelial8
`non-lacerational
`a
`passing
`sampling means through the epithelial tissue to collect
`cells from at least two layers of said
`epithelial tissue.
`
`
`
`We determined in our Decision to Institute that no claim terms needed
`
`construction and that neither the term “means to traverse” in claim 12, nor
`
`“sampling means” in claim 26, invoked 35 U.S.C. § 112, sixth paragraph. Inst.
`
`Dec. 5, 7–8. Neither party disputed this determination nor offered further
`
`constructions of any claim terms or words. See PO Resp. 1, Reply 1–2. We
`
`
`8 For purposes of this Decision, we understand the term “transipithelial” as
`“transepithelial.” The error appears to have been introduced by the Office.
`Compare Ex. 1001, 11:50, with id. at 13:28.
`
`6
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`IPR2014-00642
`Patent 6,258,044 B1
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`expressly interpret 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 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. 37 C.F.R. § 42.100(b).
`
`Because no part of our Decision relies on any specific construction of any claim
`
`term, no claim construction is necessary and the claims are accorded their broadest
`
`reasonable interpretation consistent with the specification of the ’044 patent,
`
`reading claim language in light of the specification as it would be interpreted by
`
`one of ordinary skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359,
`
`1364 (Fed. Cir. 2004).
`
`IV. EVIDENTIARY ISSUES9
`
`A.
`
`Parasher Article (Ex. 1004)
`
`As evidence that the device disclosed in Parasher (Ex. 1004, “the Parasher
`
`brush”) is inherently capable of collecting a tissue sample as claimed, Petitioner
`
`contends that the Parasher Article10 describes using the Parasher brush to obtain a
`
`biopsy sample of tissue located below the surface of the epithelium. Pet. 11. It is
`
`critical to Petitioner’s contention that the brush used in the experiments described
`
`in the Parasher Article is the Parasher brush.
`
`
`9 This analysis is applicable to both grounds of unpatentability.
`10 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).
`
`7
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`

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`IPR2014-00642
`Patent 6,258,044 B1
`
`
`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 is the Parasher brush. See Ex. 1003, 1; Ex. 1004, 1. The Petition
`
`asserts that the Parasher Article, “describes patient trials of the brush [the Parasher
`
`brush].” Pet. 11. 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) (citation omitted). The Petition 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. 11–12; Ex.
`
`1004.
`
`Petitioner asserts that the Parasher Article utilized a brush having semi-rigid
`
`and rough bristles made from a Velcro® pad. Id. (citing Ex. 1004, 290–291).11
`
`Although the Parasher Article arguably discloses this information (Ex. 1004, 290),
`
`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, the Petition does not explain the relevance of this information by pointing
`
`out that the Parasher brush includes a Velcro® pad, nor does the Petition 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 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
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`11 Exhibit 1004 does not contain a page 291.
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`8
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`IPR2014-00642
`Patent 6,258,044 B1
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`petitioner has failed to identify specific portions of the evidence that support the
`
`challenge. 37 C.F.R. § 42.104(b)(5). Petitioner does not explain sufficiently the
`
`relevance of the Parasher Article, nor identify specific portions of the evidence (the
`
`Parasher Article and Parasher) to demonstrate persuasively that the brush described
`
`in the Parasher Article is the Parasher brush.
`
`During the course of this proceeding, Patent Owner pointed out that
`
`Petitioner did not establish adequately that the Parasher Article describes use of the
`
`Parasher brush. PO Resp. 11–12. Petitioner responded 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. Petitioner’s
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`contentions are inapposite to Patent Owner’s argument. Petitioner’s Reply was a
`
`second opportunity to establish adequately that the experiments of the Parasher
`
`Article utilized the Parasher brush. Petitioner did not utilize that opportunity
`
`effectively.
`
`According, 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. 1011)
`
`and was deposed by Patent Owner (Ex. 2005). Dr. Kahaleh is a medical doctor
`
`and professor. Ex. 1011 ¶ 5.
`
`1.
`
`Composition of a Biopsy Specimen
`
`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.
`
`9
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`

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`IPR2014-00642
`Patent 6,258,044 B1
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`9–10 (citing Exhibit 1011 ¶ 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, 15–17.12 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. 6; Ex. 2005, 16; see also Ex. 1011 ¶ 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 5 (quoting Ex. 1011 ¶ 16). As explained above,
`
`Dr. Kahaleh did not review Parasher before making this statement. See PO Resp.
`
`10–11; Ex. 2005, 6:18–7:6.13 Therefore, at most, Dr. Kahaleh’s statement conveys
`
`that some unspecified brush is capable of obtaining such a specimen. The question
`
`
`12 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.
`13 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.
`
`10
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`

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`IPR2014-00642
`Patent 6,258,044 B1
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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 4 (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. 1011) and the portions of Dr. Kahelel’s testimony relied upon as
`
`detailed above, to be unpersuasive regarding the capability of Parasher’s brush to
`
`gather a specimen as claimed.14
`
`2.
`
`Dr. Kahaleh’s Qualifications
`
`Patent Owner makes two arguments why we should give the testimony of
`
`Dr. Kahaleh little or no weight. First, Patent Owner contends that Dr. Kahaleh is
`
`not an expert to testify as to what constitutes a biopsy, analyzing biopsy specimens,
`
`diagnosing disease based on review of biopsy specimens, and making
`
`determinations as to the sufficiency and/or adequacy of biopsy specimens. PO
`
`Resp. 22 (citing Ex. 2005, Tr. 30). According to Patent Owner, the relevant expert
`
`would be a pathologist or someone with similar knowledge of biopsies. PO Resp.
`
`22–23. For these reasons, Patent Owner contends that we should give
`
`Dr. Kahaleh’s testimony little or no weight. Id. at 25.
`
`
`14 Because we do not rely upon Dr. Kahaleh’s definition of biopsy, we need not
`address Patent Owner’s argument that to do so is improper gap filling. See PO
`Resp. 21.
`
`11
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`

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`IPR2014-00642
`Patent 6,258,044 B1
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`As an initial matter, we note that Patent Owner is not seeking to exclude
`
`Dr. Kahaleh’s testimony, and therefore we need not consider whether Dr. Kalaleh
`
`is qualified as an expert under the Federal Rules of Evidence (“Fed. R. Evid.”).
`
`See 37 C.F.R. §§ 42.62, 42.64; Fed. R. Evid. 702.
`
`We disagree with Patent Owner’s assertion that the relevant expert is limited
`
`to a pathologist.15 The field of the ’044 patent relates to obtaining transepithelial
`
`specimens, not the study of the specimens so obtained. See Ex. 1001, 1:10–12.
`
`Indeed, all of the claims of the ’044 patent deal with obtaining a specimen with a
`
`brush, and none of the claims deal with examination of that specimen. Therefore,
`
`expertise in the obtaining of specimens with a brush has relevance to the claimed
`
`subject matter.
`
`Dr. Kahaleh has a medical science degree (cum laude) as well as a doctor of
`
`medicine. Ex. 1011 ¶ 2 (referring to Exhibit A attached thereto). He completed an
`
`internship in surgery, two fellowships in gastroenterology,16 and an internship and
`
`residency in internal medicine. Id. 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 procedures for obtaining cells from multiple layers of
`
`epithelium. Ex. 2005, 27. From this and other information provided regarding Dr.
`
`
`15 “Pathologist: [a] specialist in diagnosing the morbid changes in tissues removed
`at operations and postmortem examinations,” TABER’S CYCLOPEDIC MEDICAL
`DICTIONARY (F.A. Davis Company, 12th ed. 1973), Ex. 3003, 3.
`16 “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.” TABER’S CYCLOPEDIC MEDICAL
`DICTIONARY (F.A. Davis Company, 12th Ed. 1973), Ex. 3003, 4.
`
`12
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`

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`Kahaleh, we determine that Dr. Kalahel 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. 24 (citing Custom Accessories, Inc. v.
`
`Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962–63 (Fed. Cir. 1986); Schott Gemtron
`
`Corp. v. SSW Holding Co., 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
`
`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 18–19. A witness must provide testimony
`
`about the level of skill in the art as of the critical date; however, the witness need
`
`13
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`

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`IPR2014-00642
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`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) (internal quotation marks omitted).
`
`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 DirecTV Grp., Inc., 523 F.3d 1323, 1334–37 (Fed. Cir.
`
`2008); Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361 (Fed. Cir. 2000).
`
`To prevail in its challenges to the patentability of claims, the 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) (quoting Concrete
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`Pipe & Prods. of Cal., Inc. v. Constr. Laborers Pension Tr. for S. Cal., 508 U.S.
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`602, 622 (1993)).
`
`14
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`IPR2014-00642
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`Petitioner contends that claims 1–8, 11–17, 23–28, 32, and 35–39 are
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`unpatentable as anticipated by Parasher. Pet. 7–21. We have considered the
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`arguments and evidence presented by both parties, and we determine that
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`Petitioner has shown by a preponderance of the evidence that claims 1–8, 11–17,
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`23–28, 32, and 35–39 are unpatentable as anticipated by Parasher.
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`A. Uncontested Aspects
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`Parasher discloses an apparatus, specifically a brush, to collect tissue cells
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`located within epithelium tissue. Pet. 8; Ex. 1003, 1:8–11; 2:20–40; 3:6–32; 5:58–
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`6:20; see also Ex. 1001, 1:16–19.
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`Figure 1 of Parasher follows:
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`Figure 1 is a partial elevation view of a first embodiment of Parasher’s
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`apparatus. Ex. 1003, 4:7–8.
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`Parasher’s device includes non-lacerational17 brush 9 having stiff or semi-
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`rigid bristles 11. Pet. 8–9; Ex. 1003, 3:7–32; 4:46–48; 5:33–45, 5:58–6:20; Figs.
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`1–3. Parasher’s brush is movable to bear against the tissue being examined and is
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`17 Parasher’s brush reduces the risk of perforating the duct, suggesting the brush is
`non-lacerational. See Pet. 9–10, Ex. 1003, 2:16–19; see also Ex. 1003, 3:60–67
`(Parasher’s brushing procedure is safer than surgical extraction); Ex. 1013, 84
`(Patent Owner’s witness, Dr. Fromowitz, acknowledging that Parasher’s brush is
`non-lacerational).
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`15
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`controlled to remove tissue from a tissue area being examined. Ex. 1003, 6:6–10.
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`Specifically, Parasher’s brush is pushed and pulled back and forth over the inner
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`wall of the duct to collect scrapings of tissue and brushings of cells. See Ex. 1003,
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`3:21–28; 6:6–10. Parasher describes this process as a “scrape biopsy.” Ex. 1003,
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`1:10–11; see also Ex. 1003, 1:14–17 (describing abrading against the duct walls);
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`Cf. Ex. 1001, 6:35–37, 44–47 (describing the brush as moved or rubbed against the
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`tissue to collect a specimen).
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`Parasher’s brush 9 is comprised of bristles 11 that are stiff or semi-rigid.
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`Pet. 21; Ex. 1003, 4:46–58. As shown in Parasher’s Figures 4a–c, below, the tips
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`of bristles 11 have features that facilitate collection of cell and tissue, such as hook
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`ends, ball-tips, mushroom tips, loops, or the like. Pet. 8–9; Ex. 1003, 4:46–58;
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`Figs 4a–4c; Cf. Ex. 1001, 7:15–20 (like the brush of the claim 1, the stiffness and
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`shape of the bristle tips of Parasher contribute to the effectiveness of retrieving a
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`specimen).
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`Figures 4a–c illustrate different embodiments of the bristles 11.
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`These contentions are not contested by Patent Owner. See 37 C.F.R.
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`§ 42.23(a) (any material fact not specifically denied may be considered admitted).
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`B.
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`Contested Aspect18
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`Patent Owner contends that all of the claimed elements are not found within
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`the four corners of Parasher, as is required for anticipation, because Parasher is
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`silent regarding obtaining a specimen that includes tissue from below the surface
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`of the epithelium. PO Resp. 3–4. Patent Owner sets forth several reasons why
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`Dr. Kahaleh’s definition of biopsy proffered by Petitioner does not cure this
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`deficiency. Id. at 5–10. Patent Owner’s arguments are, however, unpersuasive
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`because Patent Owner mischaracterizes what is required for anticipation and does
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`not address persuasively the merits of Petitioner’s contentions regarding Parasher.
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`1.
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`Parasher
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`Patent Owner contends that Parasher is silent regarding the ability of the
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`brush to penetrate and collect tissue from at least two layers of epithelial tissue.
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`PO Resp. 3–5. We disagree both with the implication that Parasher must disclose
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`such capability in the words of the ’044 patent and with Patent Owner’s
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`characterization of the reference.
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`Parasher need not explicitly state that the device picks up tissue from
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`multiple layers of the epithelium. See generally In re Bond, 910 F.2d 831, 832
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`(Fed. Cir. 1990) (“These elements must be arranged as in the claim under review,
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`but this is not an ipsissimis verbis test”) (citation omitted); In re Gleave, 530 F.3d
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`1331, 1334 (Fed. Cir. 2009) (although a reference must disclose each and every
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`limitation in a claim to anticipate the claim, the reference need not satisfy an
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`ipsissimis verbis test).
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`18 Our analysis does not address new arguments by Patent Owner meaning those
`arguments 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 23
`(Petitioner’s objections to Patent Owner’s demonstratives).
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`The proper inquiry is what a person of ordinary skill in the art would
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`understand as the capability of Parasher’s brush. Further, contrary to Patent
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`Owner’s characterization, Parasher is not silent regarding the capabilities of the
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`brush. Instead, as detailed below, Petitioner identifies and explains numerous
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`disclosures regarding the extent of the specimen that is collected by Parasher’s
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`brush.
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`As detailed above, Parasher’s device includes a brush having stiff or semi-
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`rigid bristles with tips that facilitate the collection of cell and tissue. Further,
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`Parasher’s device obtains a specimen by bearing against the tissue being examined.
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`Regarding the composition or extent of the specimen collected, Parasher’s brush is
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`capable both of collecting cells (cytology) and of collecting a larger (greater)
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`sample of tissue (biopsy). Pet. 11; Pet. Reply 9; Ex. 1003, 1:8–11, 2:20–40, 3:26–
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`28; see also Ex. 1003, Title (“Catheter with Simultaneous Brush Cytology and
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`Scrape Biopsy Capability); 3:60–67 (describing the sample collected as “more
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`substantial” than that collected with conventional cytology). Parasher describes
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`that the device enables collection of a “gross tissue sample” or biopsy. Pet. 11;
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`Pet. Reply 7; Ex. 1003, 1:56–58; 2:20–25. Petitioner points out that Parasher also
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`describes the brush as capable of collecting “a gross tissue sample that includes the
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`mucous lining of the duct, the tissue of the duct, and even adjacent connective
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`tissues (e.g., the submucosa).” Pet. 9 (citing Ex. 1003, 1:54–67); Pet. Reply 7–8.
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`A person of ordinary skill in the art would have considered these disclosures
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`in the context that “tissue” is an aggregation of similarly specialized cells and that
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`“gross” means large enough to be visible to the naked eye. See Ex. 2003, 4; 2004,
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`6; Ex. 3001,19 5.
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`19 “Gross,” TABER’S CYCLOPEDIC MEDICAL DICTIONARY, 12th Ed., copyright 1973,
`F.A. Davis Company, Ex. 3001, 5
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`In light of this, Parasher’s brush, like the claimed device, includes bristles
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`that are stiff and have a shape that contributes to penetrating the tissue sample and
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`collecting a specimen. Parasher’s brush, like the claimed device, obtains a
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`specimen by bearing against the tissue being examined. The specimen obtained by
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`Parasher’s brush is an aggregation of cells large enough to be visible to the naked
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`eye. In light of the foregoing, we find that Petitioner has shown, by a
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`preponderance of the evidence, that Parasher’s brush obtains such a specimen by
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`penetrating into the tissue being examined and, with sufficient force applied,
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`penetrating through the tissue to the submucosa.
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`C. Dr. Fromowitz
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`Dr. Frank Fromowitz, Patent Owner’s expert witness, provided a
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`Declaration (Ex. 2001) and was deposed by Petitioner (Ex. 1013). Dr. Fromowitz
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`is a licensed physician with 35 years of experience as a pathologist. Ex. 2001 ¶¶ 3,
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`4, 7. Each party relies upon the testimony of Dr. Fromowitz, and it is uncontested
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`that Dr. Fromowitz is qualified to provide expert testimony. See e.g., PO Resp. 26;
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`Pet. Reply 1–2, 6–7.
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`1.
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`Patent Owner
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`Patent Owner relies upon the testimony and Declaration of Dr. Fromowitz to
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`attempt to counter Dr. Kahaleh’s evidence regarding the composition of a biopsy
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`specimen. PO Resp. 12. Because we are not considering Dr. Kahaleh’s evidence
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`regarding the composition of a biopsy specimen, Patent Owner’s arguments are not
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`relevant.
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`Patent Owner does not rely upon evidence from Dr. Fromowitz to attempt to
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`counter Petitioner’s analysis of Parasher. PO