Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`Paper No. 7
`Entered: October 16, 2014
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`U.S. ENDOSCOPY GROUP, INC.,
`Petitioner,
`
`v.
`
`CDX DIAGNOSTICS, INC. and
`SHARED MEDICAL RESOURCES, LLC,
`Patent Owner.
`____________
`
`Case IPR2014-00642
`Patent 6,258,044 B1
`____________
`
`Before PHILLIP J. KAUFFMAN, SCOTT E. KAMHOLZ, and
`BARRY L. GROSSMAN, Administrative Patent Judges.
`
`KAMHOLZ, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`Paper No. 7
`Entered: October 16, 2014
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`U.S. ENDOSCOPY GROUP, INC.,
`Petitioner,
`
`v.
`
`CDX DIAGNOSTICS, INC. and
`SHARED MEDICAL RESOURCES, LLC,
`Patent Owner.
`____________
`
`Case IPR2014-00642
`Patent 6,258,044 B1
`____________
`
`Before PHILLIP J. KAUFFMAN, SCOTT E. KAMHOLZ, and
`BARRY L. GROSSMAN, Administrative Patent Judges.
`
`KAMHOLZ, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`IPR2014-00642
`Patent 6,258,044 B1
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`U.S. Endoscopy Group, Inc. (“Petitioner”) filed a Corrected Petition
`
`(Paper 4, “Pet.”), requesting institution of an inter partes review of claims 1-
`
`39 of U.S. Patent No. 6,258,044 B1 (“the ’044 patent”). Patent Owners CDx
`
`Diagnostics, Inc. and Shared Medical Resources, LLC (collectively “Patent
`
`Owner”) filed a Preliminary Response (Paper 6, “Prelim. Resp.”). We have
`
`jurisdiction under 35 U.S.C. § 314.
`
`We institute inter partes review because we determine that the
`
`information presented in the Petition and in the Preliminary Response shows
`
`that there is a reasonable likelihood that Petitioner would prevail with
`
`respect to at least one of the claims challenged in the Petition. See 35
`
`U.S.C. § 314(a). In particular, we institute inter partes review with respect
`
`to claims 1-17, 19, 20, 23-28, 32, and 35-39, but not as to claims 18, 21, 22,
`
`29-31, 33, and 34.
`
`B. The ’044 Patent
`
`The ’044 patent relates to an 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 may extend from wires that
`
`emanate from the distal end of the handle. The wires may form a toroid or
`
`2
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`IPR2014-00642
`Patent 6,258,044 B1
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`spiral shape that is oriented substantially perpendicular to the axis of the
`
`handle. Id. at 7:23-28; Fig. 4.
`
`Independent claims 1, 12, and 26 are illustrative of the claimed
`
`subject matter and are reproduced below.
`
`1. Apparatus to obtain cells in epithelial
`tissue of the body comprising:
`
`sampling
`transepithelial non-lacerational
`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.
`
`non-lacerational
`transepithelial
`12. A
`sampling 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:
`
`passing a transipithelial1 non-lacerational
`sampling means through the epithelial tissue to
`collect cells from at least two layers of said
`epithelial tissue.
`
`
`1 For purposes of this decision, we interpret the term “transipithelial” as
`“transepithelial.” The error appears to have been introduced by the Office.
`Compare Ex. 1002, 76 with id. at 42.
`
`3
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`IPR2014-00642
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`
`C. Prior Art Relied Upon in the Petition
`
`Petitioner relies upon the following references, as well as the
`
`declaration of Michael Kahaleh, M.D. (Ex. 1011):
`
`Parasher
`
`U.S. Pat. No. 5,535,756
`
`July 16, 1996 Ex. 1003
`
`Markus
`
`U.S. Pat. No. 5,407,807
`
`Apr. 18, 1995 Ex. 1005
`
`SpiraBrush Specimen of Use filed in U.S.
`Trademark Appl. Ser. No.
`74/370,500
`U.S. Pat. No. 4,759,376
`
`Stormby
`
`Boon
`
`Nomiya
`
`Boon et al., “Exploiting the
`‘Toothpick Effect’ of the
`CytoBrush by Plastic Embedding
`of Cervical Samples.” Acta
`Cytologica, 35(1): 57-63
`U.S. Pat. No. 2,675,572
`
`Mar. 22, 1993 Ex. 1006
`
`July 26, 1988 Ex. 1007
`
`Jan.-Feb. 1991 Ex. 1008
`
`Apr. 20, 1954 Ex. 1009
`
`D. The Asserted Grounds of Unpatentability
`
`Petitioner asserts that the challenged claims are unpatentable based on
`
`the following grounds:
`
`Reference(s)
`
`Parasher
`
`Basis
`
`§ 102
`
`Parasher and Markus
`
`§ 103
`
`Claims
`Challenged
`1-8, 11-17, 23-28,
`and 31-39
`9, 10, 19, and 20
`
`Parasher and SpiraBrush
`
`§ 103
`
`18, 21, and 22
`
`Parasher and Nomiya
`
`§ 103
`
`18, 21, and 22
`
`Stormby, Boon, and Parasher § 103
`
`Stormby, Boon, Parasher,
`and Markus
`
`§ 103
`
`1-8, 11-18, and
`21-39
`9, 10, 19, and 20
`
`4
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`IPR2014-00642
`Patent 6,258,044 B1
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`
`Reference(s)
`
`Stormby, Boon, Parasher,
`and SpiraBrush
`SpiraBrush and Parasher
`
`SpiraBrush, Parasher, and
`Markus
`
`
`II. DISCUSSION
`
`A. Claim Construction
`
`Basis
`
`§ 103
`
`§ 103
`
`§ 103
`
`Claims
`Challenged
`18, 21, and 22
`
`1-8, 11-18, and
`21-39
`9, 10, 19, and 20
`
`Petitioner proposes a construction of the terms “transepithelial”
`
`(occurring in all claims), “non-lacerational” (occurring in all claims),
`
`“abrasive surface” (in claims 4 and 24), and “tip stiffness” (in claims 9 and
`
`19). Pet. 7. Patent Owner does not comment on these proposed
`
`constructions in the Preliminary Response.
`
`We have considered Petitioner’s proposed constructions, but
`
`determine that no express constructions of these or other terms are necessary
`
`for purposes of this decision.
`
`B. Anticipation by Parasher
`
`Petitioner argues that claims 1-8, 11-17, 23-28, and 31-39 are
`
`anticipated by Parasher. Pet. 7-21.
`
`1. Claims 1-11, 14-17, and 37-39
`
`With regard to claim 1, Petitioner asserts that Parasher’s device 1
`
`includes brush 9 having semi-rigid bristles 11 that permit collection, without
`
`laceration, of a tissue sample sufficient to qualify as a biopsy. Pet. 8-10
`
`(citing, inter alia, Ex. 1003, 2:12-40, 4:46-59, 5:46-57, Figs. 4a-4c).
`
`Petitioner asserts, citing Dr. Kahaleh’s declaration for support, that a person
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`5
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`of ordinary skill in the art would have understood a biopsy sample to include
`
`fragments of tissue all the way down to the submucosa, as well as fragments
`
`of the basement membrane. Pet. 9-10 (citing Ex. 1011 ¶ 10).
`
`Patent Owner argues that Parasher does not disclose a brush that
`
`penetrates more than one epithelial layer, nor does it disclose a brush that
`
`reaches the submucosa or other connective tissue. Prelim. Resp. 4-6.
`
`We agree with Patent Owner that Parasher does not disclose expressly
`
`that its brush obtains tissue that includes deep epithelial layers, submucosa,
`
`or connective tissue. But Patent Owner does not address the testimony of
`
`Dr. Kahaleh, a physician and professor of clinical medicine whose relevant
`
`training and experience persuade us, on this record, that he is qualified to
`
`testify as to the understanding of a person of ordinary skill in the art at the
`
`time of the invention. See Ex. 1011 ¶ 2 (citing Dr. Kahaleh’s curriculum
`
`vitae); id. at ¶¶ 4-5.
`
`We accept, for purposes of this decision, Dr. Kahaleh’s testimony that
`
`one of ordinary skill in the art would have understood the term “biopsy” as
`
`referring to a tissue sample that contains fragments of epithelial tissue,
`
`basement membrane, and submucosa. See id. ¶ 10. On this record, we
`
`conclude that this evidence, in combination with Petitioner’s evidence that
`
`Parasher discloses the structural features recited in claim 1, is sufficient to
`
`demonstrate a reasonable likelihood that Petitioner would prevail in
`
`establishing that claim 1 is anticipated by Parasher. We also have
`
`considered the arguments and evidence of record concerning dependent
`
`claims 2-8, 11, and 14-17, see Pet. 12-15, and are persuaded of a reasonable
`
`likelihood that Petitioner would prevail in establishing that they are
`
`anticipated by Parasher as well. We determine that Petitioner has
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`6
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`IPR2014-00642
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`demonstrated a reasonable likelihood that it would prevail in establishing
`
`that Parasher anticipates claims 37-39 for the same reasons discussed as to
`
`claim 1. See Pet. 19-21.
`
`2. Claims 12, 13, and 23-25
`
`Claim 12 is directed to a “transepithelial non-lacerational sampling
`
`apparatus.” The recited purpose of the apparatus is “to harvest cells in an
`
`oral cavity from the epithelial tissue.” The epithelial tissue is recited as
`
`having “superficial, intermediate and basal layers, and a basement
`
`membrane,” the last of which is recited as being “located between the basal
`
`layer and the submucosa.” The only structure recited for the apparatus is
`
`“means to traverse said superficial, intermediate and basal layers and to
`
`collect cells from said three layers.”
`
`Although the structural limitation is presented, arguably, in means-
`
`plus-function format, we determine on the present record that it does not
`
`invoke 35 U.S.C. § 112, sixth paragraph.2 That statutory provision is limited
`
`to an element “in a claim for a combination.” 35 U.S.C. § 112, ¶ 6 (2010).
`
`Claim 12 recites only one structural limitation—the “means to traverse”
`
`limitation. It is thus a “single means” claim, which has been held not to
`
`invoke 35 U.S.C. §112, sixth paragraph. In re Hyatt, 708 F.2d 712, 715
`
`(Fed. Cir. 1983) (“[No] provision [of 35 U.S.C. § 112] saves a claim drafted
`
`
`
`2 Section 4(c) of the Leahy-Smith America Invents Act (“AIA”) re-
`designated 35 U.S.C. § 112, sixth paragraph as 35 U.S.C. § 112(f). Pub. L.
`No. 112-29, 125 Stat. 284, 296 (2011). Because the ’044 patent has a filing
`date before September 16, 2012 (effective date of § 4(c) of the AIA), we will
`refer to the pre-AIA version of § 112.
`
`7
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`IPR2014-00642
`Patent 6,258,044 B1
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`in means-plus-function format which is not drawn to a combination, i.e., a
`
`single means claim.”).
`
`We agree with the Petitioner on the present record that, whatever else
`
`claim 12 covers, it encompasses a non-lacerational brush with stiff bristles
`
`as described in the ’044 patent. We are persuaded of a reasonable likelihood
`
`that Petitioner would prevail in establishing that Parasher anticipates
`
`claim 12, for the same reasons as given above for claim 1. We also have
`
`considered the arguments and evidence of record concerning dependent
`
`claims 13 and 23-25, see Pet. 16-17, and are persuaded of a reasonable
`
`likelihood that Petitioner would prevail in establishing that they are
`
`anticipated by Parasher as well.
`
`3. Claims 26-28 and 31-36
`
`Petitioner’s argument concerning independent method claim 26 is
`
`substantially similar to its argument for claim 1. Pet. 17 (referring to
`
`Pet. 8-12). Petitioner does not address whether the recited “transepithelial3
`
`non-lacerational sampling means” invokes § 112, sixth paragraph. We
`
`determine on the present record that this limitation does not invoke § 112,
`
`sixth paragraph, because the limitation is not presented “in a claim for a
`
`combination.” See 35 U.S.C. § 112 ¶ 6. The “sampling means” is the only
`
`structural limitation recited in method claim 26, and it forms part of the only
`
`method step recited. There is no “combination” in claim 26, of either
`
`structure or method steps. On this basis, we determine for purposes of this
`
`decision that claim 26 does not invoke § 112, sixth paragraph.
`
`
`
`3 See n.1, supra.
`
`8
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`We determine that, whatever other structures it encompasses, the
`
`“transepithelial non-lacerational sampling means” covers a stiff-bristled non-
`
`lacerational brush capable of penetrating epithelium, as disclosed in the ’044
`
`patent. We agree with Petitioner, on the present record, that Parasher
`
`discloses a brush having this structure and capability, and that Parasher’s
`
`disclosure that the brush can obtain a sample that qualifies as a biopsy would
`
`be understood by one of ordinary skill in the art as disclosing that the brush
`
`collects cells from layers of the epithelium down to the submucosa. See
`
`Ex. 1011 ¶ 10. We also have considered the arguments and evidence of
`
`record concerning dependent claims 27, 28, 32, 35, and 36, see Pet. 18-19,
`
`and are persuaded of a reasonable likelihood Petitioner would prevail in
`
`establishing that that they are anticipated by Parasher as well.
`
`We are not persuaded of a reasonable likelihood that Petitioner would
`
`prevail in establishing that Parasher anticipates claims 31, 33, and 34.
`
`Claims 31 and 34 require that the epithelial tissue sampled include oral
`
`epithelial tissue, and claim 33 requires that the epithelial tissue have a
`
`keratinized layer from beneath which the sample is obtained. For claims 31
`
`and 34, Petitioner cites Parasher at column 1, lines 54-67; column 2, lines
`
`1-40; and column 3, lines 60-67, as disclosing the collecting of cells from
`
`oral epithelial tissue. Pet. 18-19 (chart). Upon review of this evidence, we
`
`discern no disclosure of sampling oral epithelium. The cited passages are
`
`concerned entirely with sampling the ducts of the biliary tree and other
`
`“duct-like” organs, such as the esophagus and stomach. See, e.g., Ex. 1003,
`
`2:35-40. There is no mention of oral epithelium tissue.
`
`For claim 33, Petitioner cites the same passages from Parasher as
`
`disclosing sampling from a keratinized epithelium. See Pet. 19. Petitioner
`
`9
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`IPR2014-00642
`Patent 6,258,044 B1
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`fails to explain, however, which of the anatomic structures disclosed, if any,
`
`have a keratinized epithelium. Petitioner relies on Dr. Kahaleh’s testimony
`
`to the effect that Parasher is capable of sampling oral epithelia and
`
`keratinized epithelia, Pet. 10 (citing Ex. 1011 ¶ 17), but evidence of
`
`capability is not sufficient to show that Parasher discloses the particular
`
`method recited in claim 33.
`
`For these reasons, we determine that Petitioner has demonstrated a
`
`reasonable likelihood that it would prevail in establishing that Parasher
`
`anticipates claims 1-8, 11-17, 23-28, 32, and 35-39, but not claims 31, 33,
`
`and 34.
`
`C. Obviousness over Parasher and Markus
`
`Petitioner challenges claims 9, 10, 19, and 20 for obviousness under
`
`35 U.S.C. § 103(a) over Parasher and Markus. Pet. 21-24. Claims 9 and 19,
`
`depending ultimately from claim 1 and claim 12, respectively, require that
`
`the “tip stiffness” of each bristle be “between 0.04 and 0.2 lbs/inch.”
`
`Claims 10 and 20, depending from claims 9 and 19, respectively, require that
`
`the bristles protrude “between 0.05-0.2 inches.”
`
`Petitioner acknowledges that Parasher does not disclose stiffness or
`
`length properties for its bristles, but argues that Markus discloses a
`
`similarly-structured and operated brush having bristle stiffness and length
`
`within the recited ranges. Pet. 22. Petitioner argues that the similarities
`
`between the Parasher and Markus brushes would have made the substitution
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`10
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`IPR2014-00642
`Patent 6,258,044 B1
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`of Markus’s bristles in the Parasher brush a simple substitution to obtain a
`
`predictable result. Id.4
`
`Patent Owner argues that Markus is not analogous to the claimed
`
`subject matter, because it concerns a brush that is used to sweep the bore of
`
`a catheter to retrieve fibrin for infectious contamination testing, not a “cell
`
`harvesting device.” Prelim. Resp. 6. This argument is unpersuasive,
`
`because Markus itself characterizes “cytology brushes which are used to
`
`collect cells” as within the prior art to its catheter brush. See Ex. 1005,
`
`2:8-9. Thus, the evidence presently of record does not support Patent
`
`Owner’s contention that catheter brushes are non-analogous to cell
`
`harvesting devices.
`
`Upon consideration of the parties’ arguments and evidence, we are
`
`persuaded of a reasonable likelihood that Petitioner would prevail in
`
`establishing that claims 9, 10, 19, and 20 are unpatentable over Parasher and
`
`Markus.
`
`D. Obviousness over Parasher and Nomiya
`
`Petitioner challenges claims 18, 21, and 22 for obviousness under
`
`35 U.S.C. § 103(a) over Parasher and Nomiya. Pet. 58-59. Claim 18, which
`
`depends from claim 12, requires that the bristles be held by wires, extending
`
`
`
`4 Petitioner argues, alternatively, that the claimed property ranges are merely
`optimal or workable ranges that would have been the obvious result of
`routine experimentation. Pet. 21-22. Petitioner cites In re Aller, 220 F.2d
`454, 456 (CCPA 1955) in support of its argument. This argument is not
`persuasive, because Petitioner has not explained how the properties in
`question are recognized as result-effective variables. See In re Antonie, 559
`F.2d 618, 620 (CCPA 1977) (recognizing limitation of the Aller rule to cases
`involving “result-effective variables”).
`
`11
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`from a distal end of the handle, to form brushing surfaces that abrade
`
`epithelial tissue. Claims 21 and 22, each depending from claim 18, require
`
`that the wires form a toroid or spiral shape, respectively, which is oriented
`
`substantially perpendicular to the axis of the handle.
`
`Petitioner argues that it would have been “routine and obvious” to
`
`“modify the brush of Parasher in the view of the brush structure of Nomiya.”
`
`Pet. 58. Petitioner argues further that the two brushes are capable of
`
`traversing passages and are similar in size and shape and that the
`
`modification is a simple substitution of “one brush for another.”
`
`Id. at 58-59.
`
`We determine that Petitioner has not demonstrated a reasonable
`
`likelihood that it would prevail in establishing that claims 18, 21, and 22 are
`
`unpatentable for obviousness over Parasher and Nomiya, because Petitioner
`
`has not explained adequately the nature of the modifications that would have
`
`been obvious to one of ordinary skill. Petitioner has asserted simply that it
`
`would have been obvious to modify the Parasher brush in view of the
`
`Nomiya brush structure, but Petitioner has not identified what structures
`
`would have been modified, or how they would have been modified, to reach
`
`the claimed subject matter. Petitioner’s generic assertion that the
`
`modification amounts to a simple substitution of “one brush for another” to
`
`obtain predictable results does not provide the specificity required to show
`
`unpatentability based on the proposed combination of references. Nor is
`
`Petitioner’s assertion supported by credible evidence establishing that the
`
`substitution is simple or would provide predictable results. See Unigene
`
`Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011)
`
`(“Obviousness requires more than a mere showing that the prior art includes
`
`12
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`separate references covering each separate limitation in a claim under
`
`examination. Rather, obviousness requires the additional showing that a
`
`person of ordinary skill at the time of the invention would have selected and
`
`combined those prior art elements in the normal course of research and
`
`development to yield the claimed invention.”) (citations omitted). In sum,
`
`Petitioner does not present a coherent obviousness argument.
`
`For this reason, we decline to institute review of claims 18, 21, and 22
`
`for obviousness over Parasher and Nomiya.
`
`E. Obviousness over Parasher and SpiraBrush
`
`Petitioner challenges claims 18, 21, and 22 for obviousness under
`
`35 U.S.C. § 103(a) over Parasher and SpiraBrush. Pet. 24-27.
`
`Petitioner argues that it would have been obvious “to modify the
`
`brush of Parasher in view of the brush structure of SpiraBrush” and that the
`
`modification is a simple substitution of “one bristle orientation for another,”
`
`without explaining what modifications would have been obvious to make,
`
`how they would have been made, or why the modification is no more than a
`
`“simple substitution.” See Pet. 26-27. As discussed above, this argument is
`
`too vague as to the nature of the combination to demonstrate a reasonable
`
`likelihood that Petitioner would prevail in establishing that the challenged
`
`claims are unpatentable over the asserted art. For this reason, we decline to
`
`institute review of claims 18, 21, and 22 for obviousness over Parasher and
`
`SpiraBrush.
`
`F. Obviousness over Stormby, Boon, and Parasher
`
`Petitioner challenges claims 1-8, 11-18, and 21-39 for obviousness
`
`under 35 U.S.C. § 103(a) over Stormby, Boon, and Parasher. Pet. 28-42.
`
`13
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`Petitioner challenges claims 9, 10, 19, and 20 for obviousness over Stormby,
`
`Boon, Parasher, and Markus. Id. at 43-44. Petitioner challenges claims 18,
`
`21, and 22 for obviousness over Stormby, Boon, Parasher, and SpiraBrush.
`
`Id. at 44-46.
`
`Petitioner argues that it would have been obvious to “modify . . .
`
`Stormby in view of Parasher” and that the modification is a simple
`
`substitution of “one set of brush components for another.” Pet. 30.
`
`Petitioner also argues that “[t]he Cytobrush® of Stormby modified in view
`
`of Parasher would yield transepithelial, non-lacerational brush with bristles
`
`having sufficient stiffness to collect cells from at least two layers of
`
`epithelial tissue.” Id. at 31. As discussed above, these arguments are too
`
`vague as to the nature of the modification, and unsupported by credible
`
`evidence showing that the modification is no more than a “simple
`
`substitution,” to demonstrate a reasonable likelihood that Petitioner would
`
`prevail in establishing that the challenged claims are unpatentable over the
`
`asserted art. For this reason, we decline to institute review of claims 1-39
`
`for obviousness over the various combinations of Stormby, Boon, Parasher,
`
`Markus, and SpiraBrush.
`
`G. Obviousness over SpiraBrush and Parasher
`
`Petitioner challenges claims 1-8, 11-18, and 21-39 for obviousness
`
`under 35 U.S.C. § 103(a) over SpiraBrush and Parasher. Pet. 46-57.
`
`Petitioner challenges claims 9, 10, 19, and 20 for obviousness over
`
`SpiraBrush, Parasher, and Markus. Id. at 57-58.
`
`Petitioner argues that it would have been obvious to “modify . . .
`
`SpiraBrush in view of Parasher” and that the modification is a simple
`
`substitution of “one set of brush components for another.” Pet. 47.
`
`14
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`
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`IPR2014-00642
`Patent 6,258,044 B1
`
`Petitioner also argues that “the brush of SpiraBrush modified in view of
`
`Parasher is a transepithelial, non-lacerational brush with bristles having
`
`sufficient stiffness to collect cells from at least two layers of epithelial
`
`tissue.” Pet. 48. As discussed above, these arguments are too vague, and
`
`unsupported by credible evidence, to demonstrate a reasonable likelihood
`
`that Petitioner would prevail in establishing that the challenged claims are
`
`unpatentable over the asserted art. For this reason, we decline to institute
`
`review of claims 1-39 for obviousness over the various combinations of
`
`SpiraBrush, Parasher, and Markus.
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine that Petitioner has
`
`demonstrated that there is a reasonable likelihood of its proving
`
`unpatentability of claims 1-17, 19, 20, 23-28, 32, and 35-39 of the ’044
`
`patent.
`
`The Board has not made a final determination on the patentability of
`
`the challenged claims.
`
`IV. ORDER
`
`Accordingly, it is
`
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`
`review is hereby instituted as to claims 1-17, 19, 20, 23-28, 32, and 35-39 of
`
`U.S. Patent No. 6,258,044 on the following grounds of unpatentability:
`
`A. Claims 1-8, 11-17, 23-28, 32, and 35-39 for anticipation under
`
`35 U.S.C. § 102 by Parasher; and
`
`B. Claims 9, 10, 19, and 20 for obviousness under
`
`35 U.S.C. § 103(a) over Parasher and Markus;
`
`15
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`
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`IPR2014-00642
`Patent 6,258,044 B1
`
`
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial, the trial
`
`commencing on the entry date of this decision; and
`
`FURTHER ORDERED that the trial is limited to the grounds
`
`identified above, and no other grounds are authorized.
`
`
`
`
`
`
`
`16
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`
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`IPR2014-00642
`Patent 6,258,044 B1
`
`
`
`
`For Petitioner:
`
`Todd. R. Tucker
`Mark W. McDougall
`CALFEE, HALTER & GRISWOLD LLP
`
`For Patent Owner:
`
`Peter L. Berger
`Tuvia Rotberg
`LEVISOHN BERGER LLP
`
`17
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`
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