UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`ANCESTRY.COM DNA, LLC.
`Petitioner
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`v.
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`DNA GENOTEK, INC.
`Patent Owner
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`
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`Patent No. 8,221,381 B2
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`_______________
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`Inter Partes Review No. IPR2016-00060
`____________________________________________________________
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`DECLARATION OF JOHN M. COLLINS, Ph.D.
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`I, John M. Collins, declare as follows:
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`1.
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`I make this declaration in support of DNA Genotek Inc.’s (“DNA Genotek’s”)
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`Patent Owner’s Response. The following declaration is based on my personal knowledge. If
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`called to testify, I could testify competently as to the matters set forth herein.
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`I.
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`2.
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`INTRODUCTION AND QUALIFICATIONS
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`I hold a B.S. in mechanical engineering with a minor in economics from
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`Rensselaer Polytechnic Institute. I also hold a Ph.D. and M.S. in Mechanical Engineering from
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`the Massachusetts Institute of Technology, with a concentration on fluid mechanics, and heat and
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`mass transfer, and I have over 30 years’ experience in the design and development of medical
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`products. Attached as Exhibit 1 is a copy of my curriculum vitae.
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`3.
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`Since 2008, I have held a leadership position at the Consortia for Improving
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`Medicine with Innovation and Technology (“CIMIT”). Founded by Massachusetts General
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`Hospital, Massachusetts Institute of Technology, Brigham and Women’s Hospital, and Draper
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`Labs in 1998, CIMIT is a non-profit consortium of Boston’s leading teaching hospitals and
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`universities along with a growing list of national and international affiliates. CIMIT is directed
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`to stimulating and accelerating translational medical research into patient care in the domain of
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`devices, procedures, and clinical systems engineering. I am CIMIT’s Chief Operating Officer.
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`4.
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`Since 2008, I have also held the position of Chief Technology and Innovation
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`Officer at Reed Collins, LLC, a company which provides consulting services for academic
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`institutions and businesses in the fields of technology, commercialization, and business
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`development.
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`5.
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`I am a named inventor on over 20 U.S. patents, including 11 patents related to
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`medical devices. I have designed many products, including minimally invasive surgical access
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`devices, trocars, and a saliva testing device for female fertility monitoring.
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`6.
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`I have provided expert opinions in 19 patent cases in my career, including one
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`case involving a fluid collection device for chest drainage. I have testified in deposition
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`approximately 25 times and at trial approximately 10 times.
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`7.
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`Counsel for DNA Genotek contacted me and inquired whether I would help the
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`Board to better understand the evidence in the inter partes review. Specifically, I was asked to
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`consider (1) whether claims 1, 2, 4, 5, 8, 11, 12, 15-17, 20, 41, 44, and 49 are anticipated under
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`35 U.S.C. § 102(e)(2) by U.S. Patent 7,645,424 (“O’Donovan”); and (2) whether claim 7 is
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`allegedly unpatentable under 35 U.S.C. § 103(a) over O’Donovan in view of WO 98/03265
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`(“KCCL”).
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`8.
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`For my work as an expert, I am being compensated at the rate of $400 per hour.
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`My compensation is not contingent on the opinions I reach or on the outcome of any legal action,
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`mediation, arbitration, or the terms of any settlement in this case.
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`9.
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`I reserve the right to supplement my opinions to address any information
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`obtained, or positions taken, based on any new information that comes to light throughout this
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`litigation.
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`II.
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`BASIS FOR OPINIONS
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`A. Materials Considered
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`10.
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`I have reviewed and considered the ’381 Patent (Ex. 1001) and its prosecution
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`history (Ex. 1002).
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`11.
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`I have also reviewed and considered the following references, which I have been
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`asked to assume for purposes of this declaration are prior art to the ’381 Patent:
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` Ex. 1007—O’Donovan;
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` Ex. 1010—KCCL; and
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` Ex. 1011—English translation of KCCL;
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`12.
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`In addition, I have reviewed the following documents:
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` Paper 5—Ancestry’s Resubmitted Petition;
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` Ex. 1003—Declaration of Terry N. Layton Ph.D. in support of Ancestry’s
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`Resubmitted Petition;
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` Paper 19—Institution of Inter Partes Review;
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` Ex. 2004—Transcript of Deposition of Terry Layton, Ph.D., May 25, 2016; and
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` Ex. 2008—Declaration of Terry Layton, Ph.D. in Support of Petition for Inter
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`Partes Review of U.S. Patent No. 8,221,381, filed June 3, 2016.
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` Ex. 2001—ASTM D 1894-01, “Standard Test Method for Static and Kinetic
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`Coefficients of Friction of Plastic Film and Sheeting”
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`13.
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`Additionally, I am aware of information generally available to, and relied upon
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`by, persons of ordinary skill in the art at the time of the invention in this case and the references
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`cited above, such as technical dictionaries and reference materials.
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`B.
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`Legal Principles Applied
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`14.
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`I have been informed by counsel and understand that the patent laws include a
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`novelty requirement. If a device has been previously disclosed to the public, then it is not novel.
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`If it is not novel, a claimed invention is said to be “anticipated” by the prior art. To demonstrate
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`anticipation, the party asserting invalidity must show that the claimed invention is “described in
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`a printed publication,” meaning that each claim limitation is disclosed explicitly or inherently in
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`a single prior art reference.
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`15.
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`I have also been informed by counsel and understand that a claim is obvious, and
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`therefore invalid, if the differences between the subject matter claimed and the prior art are such
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`that the claimed subject matter as a whole would have been obvious at the time the invention was
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`made to a person having ordinary skill in the art to which the claims pertain. I have also been
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`informed by counsel and understand that the analysis of the scope and content of prior art must
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`consider the prior art as a whole; it is not proper to “pick and choose” or isolate portions of
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`references from the whole, or to ignore portions of the reference that led away from obviousness.
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`16.
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`I have considered the definition of a person of ordinary skill in the art set by Dr.
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`Layton in his expert declaration. Dr. Layton stated that with respect to the ’381 Patent, a person
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`of ordinary skill in the art would have “at least a bachelor of science degree in an engineering
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`field, such as mechanical engineering, and several years of experience designing collection
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`devices for the medical field.” I do not think the level of skill in the art is quite that high. A
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`person of ordinary skill in the art would have a Bachelor of Science degree in some scientific
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`field, but not necessarily engineering, plus some experience with medical devices, but not
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`necessarily “several years” of experience.
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`17.
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`I consider myself to have at least such “ordinary skill in the art” with respect to
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`the subject matter of the ’381 Patent since at least 1983.
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`III. U.S. PATENT NO. 8,221,381
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`18.
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`The ’381 Patent describes several embodiments of container systems for
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`releasably storing a “substance” in a “lid” before a “sample” is collected in a separate “vial.”
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`The specification describes uses of the invention in which the “substance” is a Deoxyribonucleic
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`acid (“DNA”) preservative, the “sample” is human saliva, and the “vial” is a collection tube that
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`is either a customized collection chamber or a commercially available vial.
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`19.
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`Claim 1 of the ʼ381 Patent recites:
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`A container system for releasably storing a substance, comprising:
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`a) a vial comprising
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`a first open end for receiving a sample,
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`a second end comprising a sample storage chamber and
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`a piercing member,
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` wherein said piercing member comprises a side wall, a first
`cutting edge extending from a first pointed corner to a second
`corner that defines the intersection between said cutting edge and
`said side wall; and
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`b) a lid configured to removably engage said vial, said lid
`comprising
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`a reservoir for holding the substance, and
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`a pierceable membrane sealing the substance within said
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`reservoir,
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`wherein, when said system is closed by removable engagement of
`said vial with said lid, said vial and said lid are movable to a
`piercing position in which the piercing member disrupts the
`pierceable membrane to allow fluid communication between said
`reservoir and said chamber, wherein the chamber is sealed against
`leakage to the outside of the container system in the piercing
`position.
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`
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`IV. CLAIM CONSTRUCTION
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`20.
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`In his declaration, Dr. Layton construes “a lid configured to removably engage
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`said vial” to mean a lid that can be releasably attached to a vial (Ex. 1003, ¶ 49 (“I construe ‘a lid
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`configured to removably engage said vial’ to mean a lid that can be releasably attached to the
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`vial.”)) and/or a lid that can be attached in various ways and can later be removed (Id. at ¶ 50
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`(“Thus, the broadest reasonable interpretation of this term is a lid that can be attached in various
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`ways and can be later removed.”)). I disagree with both of Dr. Layton’s constructions.
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`21.
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`Dr. Layton’s constructions fail to give “configured to” meaning. One of skill in
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`the art would understand that the only reason “configured to” would been added to the claim is
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`that they have meaning when read in light of the ’381 Patent. I can think of no two-piece
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`assembly (e.g., a “vial” and a “lid”) that cannot be separated in some way after being attached.
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`For example, a vial and lid that are welded together can be separated through the use of a cutting
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`instrument (saw, laser, etc.).
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`22.
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`The ’381 Patent’s systems are configured to store samples in a vial and permit
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`later access to the sample for “subsequent processing.” (Ex. 1001, Col. 4:4-5.) If the lids were
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`not configured for later removal, but merely capable of later removal, then the operator may not
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`be able to access the stored sample in the intended environment and/or procedure. A mere
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`capability for release is insufficient to provide for subsequent processing. A lid “configured to
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`removably engage” means that the lid has features that enable it to be removed under the
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`intended conditions. In the case of the ‘381 patent, the screw thread connection is a clear
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`example of “[a] lid configured to removably engage [a] vial.”
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`V.
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`23.
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`U.S. PATENT NO. 7,654,424 B2
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`In his declaration, Dr. Layton concludes that “each element of claim 1 of the ’381
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`Patent is disclosed in” U.S. Patent No. 7,645,424 B2 (“O’Donovan”). I have compared
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`O’Donovan to claim 1 of the ’381 Patent, and I disagree with Dr. Layton’s conclusions.
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`24.
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`O’Donovan is titled “Reagent Cuvette.” (Ex. 1007.) As depicted in Figure 1, it
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`discloses a reagent cuvette (1) with a first chamber (2) and a second chamber (3). (Id., Fig. 1
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`annotations added.)
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`Chamber wall
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`Rim
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`Reagent cuvette
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`Second chamber
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`Peel-away foil membrane
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`Socket
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`First chamber
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`Transparent inspection part
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`25.
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`The first chamber (2) is pre-filled with a buffer reagent, and the second chamber
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`(3) is pre-filled with a starter reagent. (Ex. 1007, col. 3:1-10.) The device works by first peeling
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`away the foil membrane (7), adding a sample of interest to the buffer reagent in the first chamber
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`(2), and then placing the entire second chamber (3) (including chamber wall 10 and the rim 11)
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`within the socket (6) at the top portion of the first chamber (2). (Id. at 2:60- 3:24.) Socket (6)
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`has a series of spikes at the shoulder where the socket (6) connects with the lower inspection part
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`(5) of the first chamber (2). (Id. at 2:60-67.)
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`26. When second chamber (3) is placed within socket (6) and pressed downward, the
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`spikes in socket (6) pierce a foil membrane at the mouth of second chamber (3). (Ex. 1007, col.
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`3:17-20.) That causes three things to mix: the collected sample, the starter reagent (dropping
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`down from second chamber (3)), and the buffer reagent (already in first chamber (2)). The
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`device then looks like Figures 2-4.
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`27.
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`As can be seen in Figure 2 above, the second chamber (2) sits within socket (6)
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`after it is placed in the piercing position. Its side wall is no longer visible, meaning there is no
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`way to retract or remove it because the second chamber at that point is wedged within the socket.
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`The specification describes the friction fit between second chamber (3) and socket (6) at the
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`location of the spikes (20):
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`Referring particularly to FIGS. 3 and 4 there are four piercing
`members, in this embodiment spikes 20 equally spaced-apart
`around the base of the socket 6, on the shoulder connecting it to the
`inspection part 5. The spikes 20 are located so that there is just
`enough space for the rim 11 of the chamber 3 to fit between the
`spikes 20 and the wall of the socket 6 with a friction fit when the
`chamber 3 is pressed down into the socket 6 with its opening
`facing downwardly.
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`(Ex. 1007, col. 2:60-67.)
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`28.
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`Once the second chamber (3) is pushed to the bottom of socket (6) of the first
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`chamber (2), the two chambers become stuck together with a friction fit. The specification calls
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`the two chambers “effectively a single chamber.” (Ex. 1007, col. 3:28-29.) At that point, the
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`three fluids have mixed and fallen to the translucent inspection part (5). To inspect the mixture
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`of the sample and the reagents, an analyst inserts the entire reagent cuvette into an optical
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`inspection instrument to look through the walls of the transparent inspection part (5) and assess
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`the sample. There is no need to reopen the device to inspect the sample.
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`The resultant transfer of the starter reagent into the mixture of
`sample and buffer reagent in the chamber 2 provides a mixture
`which can be analyzed by an optical instrument at the point of
`care. The combination of the chambers 2 and 3 are effectively a
`single chamber, with the chamber 3 being a friction fit within the
`socket 6. The inspection part 5 is inserted into an optical inspection
`instrument for optical analysis of the sample/reagent mixture.
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`(Ex. 1007, col. 3:25-32.)
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`A.
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`29.
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`O’Donovan Does Not Anticipate Claim 1 of the ’381 Patent
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`I have considered Dr. Layton’s declaration and his analysis of O’Donovan. I
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`disagree with Dr. Layton’s conclusion that O’Donovan anticipates claim 1 of the ’381 Patent for
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`at least each of the reasons outlined in more detail below:
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`a. O’Donovan device lacks “[a] lid configured to removably engage [a] vial,”
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`b. O’Donovan does not disclose an “inherent feature” for lid removal, and
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`c. Dr. Layton fails to show that O’Donovan necessarily teaches a lid that can be later
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`removed.
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`a.
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`O’Donovan’s device lacks “[a] lid configured to removably
`engage [a] vial”
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`30.
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`As stated above, it is my understanding that for prior art to anticipate a patent
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`claim, the prior art reference must have, explicitly or inherently, elements corresponding to every
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`claim limitation. It is my opinion that O’Donovan’s device lacks “[a] lid configured to
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`removably engage [a] vial.”
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`31.
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`There is no explicit teaching in O’Donovan of a lid configured to be removed.
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`There is no need to configure O’Donovan’s lid for removal, and it teaches away from the lid
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`removably engaging a vial. O’Donovan teaches a “point of care” device that has all the reagents
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`required pre-loaded in the cap or vial. (Ex. 1007, Col. 3:35-40.) One of skill in the art would
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`understand that a “point of care” device is to be read at the place in which the sample is collected
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`and not need to be transported to a different place for later analysis and/or additional processing.
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`A point of care device is configured to be utilized at the point of care and so additional structure
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`for later analysis is unnecessary.
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`32.
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`O’Donovan provides a transparent chamber for examination of the sample in
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`combination with the desired reagents at the point of care. That is, O’Donovan contemplates no
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`direct access to the sample once the lid is attached to the vial. So there is no need for the lid to
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`removably engage a vial.
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`33.
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`In fact, O’Donovan teaches a lid configured to be non-removable. When a user
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`inserts O’Donovan’s lid into the vial, the top of the vial and lid are flush and the gap between the
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`lid and vial is very small (see relevant portion of Figure 4, reproduced below). This arrangement
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`of structural features prevents a user from removing the lid. O’Donovan does not disclose an
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`“inherent feature” for lid removal.
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`34.
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`There is no inherent feature in O’Donovan to allow removal of the lid from the
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`vial. There is no structure on the lid for a user to “apply [the force] in reverse” because the lid is
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`closed in the vial.
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`35.
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`A user cannot access the vial to push on the bottom of the lid. Nor could a user
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`pull on the lid’s flat top end because there is nowhere to grip the flat top end. Thus, O’Donovan
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`does not teach an inherent feature for removing the lid from the vial and thus does not teach a lid
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`“removably engaged” to a vial.
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`36.
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`I have reviewed Dr. Layton’s declaration (Ex. 2008) in support of Ancestry’s
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`second IPR Petition for the ’381 Patent. In his declaration, Dr. Layton states
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`I would add that there is nothing in the nature of a friction fit that itself
`requires that the two components, once engaged, create a flush end. For
`example, a stopper in a test tube is an example of a friction fit, and such
`stoppers are often inserted so that the top of the stopper extends beyond the
`opening of the test tube.
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`(Ex. 2008, ¶¶ 127.)
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`37.
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`I agree with Dr. Layton that there is nothing in a friction fit that “requires that the
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`two components, once engaged, create a flush end.” However, O’Donovan is configured to have
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`so that the two components create a flush end and is thus configured to be non-removable.
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`b.
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`Dr. Layton fails to show that O’Donovan necessarily teaches a
`lid that can be later removed”
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`38.
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`Dr. Layton opines that “a friction fit is known to be removable because the same
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`force used to form the friction fit can be applied in reverse to remove the friction fit between the
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`parts.” (Ex. 1003, ¶ 112.) Dr. Layton is incorrect that the same force applied in reverse releases
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`a friction fit. Considering O’Donovan in its entirety, O’Donovan’s apparatus requires a different
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`force to remove the lid, if it is removable at all.
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`39. When a user pushes on O’Donovan’s lid before the friction fit engages, there is
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`relative motion, so as the friction fit engages it does so in a condition referred to as sliding or
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`dynamic friction. The friction fit engages at the level of the spikes because “[t[he spikes are
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`located so that there is just enough space for the rim of 11 of the chamber 3 to fit between the
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`spikes 20 and the wall of the socket 6 with a friction fit.” (Ex. 1007, Col. 2:63-66.) Examine
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`Figure 4 (reproduced in part below)—the spikes (and, hence, the friction fit) only occupy a small
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`lower portion of the opening in the chamber 3.
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`40.
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`To remove the lid after insertion requires more force because the lid is initially at
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`rest and the static friction condition applies. It is well known that static friction is higher than
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`dynamic friction. Table 2 in the ASTM’s “Standard Test Method for Static and Kinetic
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`Coefficient’s of Friction of Plastic Film” shows that static friction can be at least 1/3rd higher
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`(0.330/0.246).
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`(Ex. 2011.)
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`41.
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`I have reviewed Dr. Layton’s declaration (Ex. 2008) in support of Ancestry’s
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`second IPR Petition for the ’381 Patent. In his declaration, Dr. Layton states
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`O’Donovan additionally teaches that further assurance against leakage may
`be desired, such as a “cover for covering the starter reagent chamber after it
`has been inserted into the socket ... [to] ensure that it is held in place in the
`socket.”
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`As described above, a POSITA would have credited the desire for additional
`assurance against leakage, whether contemplating use of a threaded
`engagement as in Birnboim or a friction fit engagement as in O’Donovan, to
`accommodate the possibility that a container portion might be defective,
`susceptible to leakage or need a tamper evidence indication. A POSITA
`would particularly have credited the desire for additional assurance when
`the fluids contained within the vial were biological samples, such as “saliva,
`serum, plasma, blood, urine, mucus, gastric juices, pancreatic juices, semen,
`products of lactation or menstruation, tears, or lymph,” as in Birnboim, or
`“blood,” as in O’Donovan, and thus were a potential source of infectious
`agents.
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`The motivation to include additional sealing means would have been
`particularly strong with friction fit embodiments, both for the reason
`articulated in O’Donovan (“[to] ensure that it is held in place in the socket,”
`and for the additional reason articulated in the ’381 patent in describing
`challenges presented by the friction fit used in its preferred pivoting
`partition embodiment (“there must be a high degree of precision for the
`manufacture of the components of the container.” The need for high-
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`precision manufacturing to prevent leakage would have provided additional
`motivation to include further sealing means for a friction fit embodiment.
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`(Ex. 2008, ¶¶ 161-63.)
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`42.
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`I agree with Dr. Layton that further assurance against leakage is particularly
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`important with friction fit embodiments, as in O’Donovan, and where fluids contained within the
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`vial are biological samples, as in O’Donovan.
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`VI.
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`43.
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`PCT INTERNATIONAL APPLICATION NO. WO98/03265
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`KCCL’s abstract describes the invention as a “reagent container for analysis
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`reagents, which makes a water quality analysis simple.” (Ex. 4 at Abstract.)
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`44.
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`KCCL depicts a container with several components as depicted in Figures 1 and
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`4. Specifically, the container system includes a “vessel main body” (15), a “pedestal” (17), a cap
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`body (3), and “cutters” (8) and (20), and other components depicted, but not labeled with
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`numbers, in Figures 1-4.
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`
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`Packing 11
`(not numbered)
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`Vessel main body
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`Cap body
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`Cutter
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`Pedestal
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`Packing 11
`(not numbered)
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`Vessel main body
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`Cap body
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`Cutter
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`Pedestal
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`FIG. 1
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`FIG. 4
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`14
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`sd-683112
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`DNA Genotek, Inc. Exhibit 2005 Page 15
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`IPR2016-00060
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`45.
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`The container in the KCCL is used as a testing device for water quality. A user
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`pours water into the main vessel body (15). The cap body (3) is pre-filled with reagent storage
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`vessels. The user then screws the cap body (3) onto the vessel main body 15, causing the cutter
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`8A (or 20) to be pushed into reagent storage vessels (5) and (4), which releases the reagents into
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`the vessel main body 15. (See Ex. 4 at Abstract.)
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`A.
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`O’Donovan in view of KCCL does not render Claim 7 obvious
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`46.
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`I have considered Dr. Layton’s declaration and his description of KCCL. I
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`disagree with Dr. Layton’s conclusion that O’Donovan in view of KCCL renders obvious claim
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`1 and 7 of the ’381 Patent for at least the reason that one of skill in the art would be motivated to
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`substitute O’Donovan’s vial with KCCL’s vial. Specifically, Dr. Layton’s proposed combination
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`provides no motivation to combine or mechanism to pierce and tear O’Donovan’s foil
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`membrane.
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`47.
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`O’Donovan Figure 4 (reproduced below) illustrates O’Donovan’s vial and lid.
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`Note the shoulder (highlighted in red) at the top of the vial positioned between the socket 6 and
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`the inspection part 5. The spikes are positioned on the top of the shoulder of the vial. KCCL
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`Figure 4 is also reproduced below. Note that KCCL’s spikes are in the lid and remain above the
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`packing (11) and pedestal (7) so are never in the vial.
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`15
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`sd-683112
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`DNA Genotek, Inc. Exhibit 2005 Page 16
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`IPR2016-00060
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`
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`48.
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`Substituting KCCL’s vial with O’Donovan’s vial would leave a system with no
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`structure to tear the foil membrane—O’Donovan’s spikes are in the vial and KCCL’s spikes are
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`in the lid, and neither one is in Petitioner’s proposed combination. KCCL’s vial cannot rupture
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`O’Donovan’s foil membrane because KCCL’s vial has no spikes at any point during its use.
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`49.
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`The proposed combination results in a non-functional device because
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`O’Donovan’s buffer reagent cannot be released. Thus, one of skill in the art would not be
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`motivated to substitute O’Donovan’s vial with KCCL’s vial as Petitioner proposes because the
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`combination results in a non-functional device.
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`16
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`sd-683112
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`DNA Genotek, Inc. Exhibit 2005 Page 17
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`IPR2016-00060
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`50.
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`This declaration is based on my present assessment of materials and information
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`currently available to me. My investigation and assessment may continue, which may include
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`reviewing documents and other information that may yet be made available to me. Accordingly,
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`I expressly reserve the right to continue my study in connection with this case and to expand or
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`modify my opinions and conclusions as my study continues.
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`51.
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`I hereby declare that all statements made herein of my own knowledge are true
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`and that all statements made on information and belief are believed to be true; and further that
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`these statements were made with knowledge that willful false statements and the like so made
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`are punishable by fine or imprisonment, or both, under 18 U.S.C. 1001 and that such willful false
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`statements may jeopardize the petition for inter partes review.
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`6/22/2016
`Date
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`17
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`sd-683112
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`DNA Genotek, Inc. Exhibit 2005 Page 18