Filed on behalf of Histologics, LLC
`
`By:
`
`Rudolph A. Telscher (rtelscher@hdp.com)
`Bryan K. Wheelock (bwheelock@hdp.com)
`Greg W. Meyer'(gmeyer@hdp.com)
`Harness, Dickey_& Pierce, PLC
`7700 Bonhomme Ave, Suite 400
`St. Louis, MO 63105
`Telephone: (314) 726-7500
`Facsimile: (314) 726-7501
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Trial Number: TBA
`
`Attorney Docket No; 15298-400036
`
`Petitioner: Histologics, LLC
`
`Panel: To Be Assigned
`
`In the Inter Panes Review of:
`
`US. Patent No. 6,258,044
`
`,
`
`Issued: November 19, 2002 '
`
`‘
`
`_
`
`‘
`
`‘_
`
`Inventor(s): Neal M. Lonky; Yorba
`Linda; Jeremy James Michael
`Papadopoulos
`
`Assignee: Shared Medical Resources,
`LLC, and CDX Diagnostics, Inc. .
`
`Title: Apparatus and Method for:
`Obtaining Transepithelial Specimen of a
`Body Surface Using a Non-bacerating
`Technique
`’A
`
`DECLARATION OF EDWARD W. FHE 5, Ph. D.
`
`1
`
`Histologics, LLC
`Exhibit 1025
`
`
`
`By:
`
`Rudolph A. Telscher (rtelscher@hdp.com)
`Bryan K. Wheelock (bwheelock@hdp.com)
`Greg W. Meyer'(gmeyer@hdp.com)
`Harness, Dickey_& Pierce, PLC
`7700 Bonhomme Ave, Suite 400
`St. Louis, MO 63105
`Telephone: (314) 726-7500
`Facsimile: (314) 726-7501
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Trial Number: TBA
`
`Attorney Docket No; 15298-400036
`
`Petitioner: Histologics, LLC
`
`Panel: To Be Assigned
`
`In the Inter Panes Review of:
`
`US. Patent No. 6,258,044
`
`,
`
`Issued: November 19, 2002 '
`
`‘
`
`_
`
`‘
`
`‘_
`
`Inventor(s): Neal M. Lonky; Yorba
`Linda; Jeremy James Michael
`Papadopoulos
`
`Assignee: Shared Medical Resources,
`LLC, and CDX Diagnostics, Inc. .
`
`Title: Apparatus and Method for:
`Obtaining Transepithelial Specimen of a
`Body Surface Using a Non-bacerating
`Technique
`’A
`
`DECLARATION OF EDWARD W. FHE 5, Ph. D.
`
`1
`
`Histologics, LLC
`Exhibit 1025
`
`
`
`1, Edward W. Funk, Ph.D., state under oath the following:
`
`I.
`
`BACKGROUND
`
`1.
`
`I am over 18 years of age and otherwise competent to make this
`
`declaration.
`
`2.
`
`I have been retained-as an expert witness to provide testimony on
`
`behalf of Histologics, LLC, as part of an Inter Parties review (“IPR”) directed to
`
`US. Patent No. 6,258,044 ((Exhibit 1001), “the ‘044 patent”). I am being
`
`compensated for my time in Connection with this IPR at a rate of $200 per hour.
`3.
`I have been asked to. provide my opinion relative to the patentability
`ofclaims 1-39 (“the challenged claims”) of the ‘044 patent. Independent claims 1,
`12, 2.6 and 37 ofthe ‘044 patent are directed to apparatuses and methods related to
`
`the collection of epithelial tissue of a body. I have reviewed the following
`
`documents:
`
`0 U.S. Patent No. 6,250,044, Exhibit 1001
`
`. us. Patent No. 5,713,369 to Tao et al., Exhibit 1004
`
`I Technical Information Brochure — DuPont Filaments, Exhibit 1027
`
`4.
`My opinions are baséd on the documents listed above, and on my
`general understanding ofchemical. engineering and work in the field of synthetic
`
`polymers, including, for example, nylon, before July 1998, which I understand is
`
`before the filing of the “044 patent.
`
`
`
`S.
`
`I have considered the ‘044 patent in light of expertise in my field in
`
`1998, and I have given claimterms their broadest reasonable meaning in the
`
`context of the ‘044 patent.
`
`[1. MY EXPERIENCE AND QUALIFICATIONS
`
`6.
`I am a Professor of Chemical Engineering at the University of Illinois,
`and previously served as Research & Development Director at both Exxon and
`
`Honeywell. A true and correct copy of my curriculum vitae is attached as Exhibit
`
`l026.
`
`7.
`
`I have a Ph.D., in Chemical Engineering which I received from the
`
`University of California, Berkeley in 1970.
`which I received from Yale in l9t37.
`8.
`I specialize in the field ofchemical engineering, and have particular
`
`l have a B.S. in Engineering Science
`
`knowledge and experience inthe’field of synthetic polymers, including nylons.
`
`9.
`
`Since 1992, I have been a technical consultant to medium-sized
`
`chemical companies and national'laboratories, and routinely provide consulting
`
`services in the field of polymer process and product design.
`
`10.
`
`I have authored numerous technical papers and presentations,
`
`including several papers on polymers. I am also a named inventor on six United
`
`States patents and managed R&D groups that obtained over 60 US patents.
`
`
`
`111. THE ‘044 PATENT '
`
`11.
`
`The “044 patent is directed to a transepithelial, non—lacerating
`
`sampling brushes, and techniques for using the same. Exhibit 1001 at claim 1.
`
`12.
`
`The detailed description of the ‘044 patent describes a non—lacerating
`
`brush, which has bristles sufficiently stiffto collect a nansepitheiial sample. The
`
`brush is illustrated in FIGS. 4-5, reproduced below:
`
`
`
`13.
`
`As shown, the brush'includes a handle 20 with a proximal end 22 and
`
`a distal end 24, and a brush head 26. The brush head 26 includes bristles 40.
`
`14.
`
`The ‘044 patent specifically describes the stiffness of the bristles 40 as
`
`having “a stifiiless of between 0.04-0.2 lbs/inch.” Exhibit 1001, 7:51-54. The
`
`‘044 patent states: “[a] although in the prior art, the sampling brushes provided
`have been sofi brushes with soft bristles, in the present invention, bristles 40 are
`
`specifically made stiff or semi-rigid, going against the teachings of the art.”
`
`Exhibit 1001, at 59-62.
`
`
`
`13.
`
`The ‘044 patent filrtlier states: “in the present invention, bristles 40 of
`
`brush head 26 are each stiff or set‘ni~rigid. The bristles are preferably made of
`
`Tyne):® brand nylon laid in a double layer and have a diameter of between 0.010
`
`cm and 0.022 cm. The Tynexgfi brand bristles have their own cantilever stiffiiess
`
`which may be at a modulus of 500,000 psi. Preferably, the bristles have a diameter
`ofapproximately 0.016 cm arid protrude 0.10 inches from the wire spine. Although
`triple and single row densities may be used, double row density bristles are
`preferred. A range ofprotrudinglengths of0.08 to 0.16 inches could be used."
`Exhibit 1001, at 3:20-30.
`,
`"
`
`IV. THE PRIOR ART
`
`A.
`
`Tno
`
`16.
`
`I have reviewed-US. Patent 5,713,369 to Liang—Che Tao et al., which
`
`is Exhibit 1004 (“Tao”) to the petition.
`
`I understand Tao is prior art to the ‘044
`
`patent.
`
`17.
`
`Tao discloses a brush' for obtaining samples of tissue from the uterine
`
`endometriurn. Exhibit 1004, fibétract. FIG. 1 is reproduced below.
`
`#9
`
`-. FIG. I ofTao
`
`
`
`18.
`
`Tao describes brush—10 having “good ability to exfoliate endometrial
`
`tissue without trauma to the uterine canal, and good ability to collect the exfoliated
`
`tissue on the brush member 18.” .Exhibit 1004, 6:2-7. Tao specifically discloses
`
`bristles spaced apart by 0.5 to 1.5 mm and having bristle stiffiiess equivalent to
`
`nylon-6,12 at a diameter of 0.076‘to 0.152 mm. Exhibit 1004, 2:4l~45 and 5:65-
`
`6:2.
`
`The bristles 20 in Tao are directed radially outwardly from the core 12
`19.
`to provide a diameter of 0.2 — 0.3‘inches, i.e., radius being between 0.1 and 0.15
`inches. Exhibit 1004, 2:43- 44.
`.
`
`20.
`
`The thickness ofthe’bristles is disclosed in Tao as up to 0.006 inches.
`
`Exhibit 1004, 2:41—45. The bristles in the “044 patent has that same thickness of
`
`0.006 inches. Exhibit 1001 at 7:57-58. Even if I assume the wires 22 of core 12
`
`(FIG. 1 and 7 of Exhibit 1004) account for a portion of the overall diameter, it is
`clear that the bristles 20, based on the illustrations in Tao, and the function ofthe
`
`brush described in Tao, necessarily protrude between OBS-0.2 inches. This length
`
`of the protruding bristles was a very conventional size range for bristles, at the time
`of filing of the ‘044 patent, given-the brush’s intended use.
`
`21.
`
`Tao states that a desirable stiffness for cell collection is the stiffitess of
`
`a nylon- 6,12 bristle that has a diameter of up to 0.006 inches:
`
`
`
`Each of the morality of Wattles 20 has a stillness (flexural
`strength) equivalent‘ito that possessed by nylon-6,12 at a
`districts: of about (11.076 to 0.152 mm (0.003 to 0.006 in.)=.
`
`preferably equivalent to that possessed at a dimeter of
`about 0.127 mm (0.005 in). This particular sliifness has
`been found critical to simultaneously giving the brush 111i
`good ability to exfoliate endometrial tissue without trauma
`to the nun-inc canal1 and good ability to collect the exfoliated
`tissue on the brush member 18. Avariety of synthetic. plastic
`and polymeric materials should be useful for the bristles 2Ill.
`but most conveniently the mistles 20 are composed of
`nylon»ti,12 and havo'the diameters indicated. It is important
`to remember that it is not the specific composition of the
`bristles 20 that is important to the success enjoyed by the
`present invention, but rather that the bristles 20 have a
`stifiuess (and therefore an exfoJiating and a collecting
`ability) equivalent to that recited~
`
`Exhibit 1004, 5:65-6:14.
`
`22.
`
`Nylon-6,12 (more commonly written “nylon 6/12”) is a low moisture
`
`absorbing nylon. The numerical nomenclature for nylon is derived from the
`
`number of carbon atoms in the diamine and dibasic acid monomers used to
`
`manufacture it. The ratio of carbOn atoms is what gives each nylon type its unique
`
`property characteristics; the greater the number of carbon atoms separating the
`
`amine groups, the lower the moisture absorbed. Hence, Nylon 6/12 has lower
`
`moisture absorption, than, for example, Nylon 6/6.
`
`
`
`The ‘044 patent refers to “Tynexi' brand nylon”. Tynex‘g is at DuPont
`23.
`registered trademark for its nylon‘lfilaments. Tynex® 6,12 is the same as nylon 6-
`
`12 in terms of the chemical structure of the filament.
`
`24.
`
`From the diameter of and length ofa known filament type, one can
`
`calculate its stiffness. Given the stated modulus E=500,000, the diameter of
`
`d=0.006 inches, and a length'of '6 of the length of the shortest bristles 5.08 mm!
`
`(2*25.4 trim/inch) or L=0.1 inch,lthe stiffness of the Tao bristles in WfD
`
`=0.1473Ecr‘/L3 = (0.1473)(500000)(0.006)"/(0.1)3 = 0.094 lbs/inch. The
`
`stiffness is calculated from the eqoation given in the Technical Information
`
`Brochure produced by DuPont Filaments. Exhibit 1027.
`
`25.
`
`The ‘044 Patent claims a range of stiffness between 0.04 and 0.2
`
`lstinch. See Claim 9. Per the aboye calculation, the stiffiiess disclosed in Tao is
`
`within this range.
`
`26.
`
`This is confirmed by, the fact that the materials of Tao [nylon 6,12),
`
`and the ‘044 Patent (Tynex 6,12)jare the same, the diameters of the bristles of Tao
`
`and the ‘044 Patent (0.006 incheslare the same, the lengths ofthe bristles ofTao
`and the ‘044 Patent (0.] inches and ODS—0.2 inches) overlap.
`
`In my opinion and based on the Specification ofthe materials
`27.
`referenced in the detailed description, Tao discloses bristles made ofNylon-6,12,
`
`which is the same as Tynexfi' 6,12 disclosed in the ‘044 patent. This results in
`
`
`
`bristles of Tao having a stiffness virithin the range claimed in the ‘044 patent, and
`
`in my opinion means Claim 9'of the ‘044 patent lacks novelty, and was obvious in
`
`View of Tao.
`
`it
`
`3i!
`
`'1‘
`
`I, Edward W. Funk, declare under penalty of perjury under the laws of the
`
`United States that the foregoing is true and correct.
`
`Executed this 23rd day of May, 2014, in Highland Park, Illinois.
`
`EDWARD W. FUNK, PhD.
`
`
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