Filed on behalf of ANCESTRY.COM DNA, LLC
`
`By: Daniel Becker, Reg. No. 38,376
`
`Jennifer R. Bush, Reg. No. 50,784
`
`Fenwick & West LLP
`
`801 California Street
`
`Mountain View, CA 94041
`
`Tel: (650) 988-8500
`
`Fax: (650) 938-5200
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`FOR INTER PARTES REVIEW OF
`U.S. PATENT 8,221,381
`_____________
`
`DECLARATION OF TERRY N. LAYTON, Ph. D.
`
`ANCESTRY EX. 1003
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`-1-
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`DNA Genotek, Inc. Exhibit 2008 Page 1
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`
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`By: Daniel Becker, Reg. No. 38,376
`
`Jennifer R. Bush, Reg. No. 50,784
`
`Fenwick & West LLP
`
`801 California Street
`
`Mountain View, CA 94041
`
`Tel: (650) 988-8500
`
`Fax: (650) 938-5200
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`FOR INTER PARTES REVIEW OF
`U.S. PATENT 8,221,381
`_____________
`
`DECLARATION OF TERRY N. LAYTON, Ph. D.
`
`ANCESTRY EX. 1003
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`DNA Genotek, Inc. Exhibit 2008 Page 1
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`I, Terry N. Layton, declare as follows:
`
`I.
`
`INTRODUCTION
`A. Terms And Scope Of Engagement
`1.
`Counsel for Ancestry.com DNA, LLC (“AncestryDNA” or
`
`“Petitioner”) has requested that I provide declaratory evidence in the above
`
`captioned Inter Partes Review proceeding (“IPR Engagement”). I understand that
`
`this Inter Partes Review proceeding involves U.S. Patent No. 8,221,381 (“the ’381
`
`patent”) (Ex. 1001).
`
`2.
`
`I have also been engaged by the same counsel as an expert witness in
`
`a related Inter Partes Review proceeding for the ’381 patent, IPR2016-00060
`
`(“first IPR”), and provided a declaration in that proceeding. I have also been
`
`engaged on behalf of defendants Spectrum DNA, Spectrum Solutions L.L.C., and
`
`Spectrum Packaging L.L.C. (collectively, “Spectrum”) in the litigation styled DNA
`
`Genotek, Inc. v. Spectrum DNA; Spectrum Solutions L.L.C., and Spectrum
`
`Packaging, LLC, Case No. 15-cv-00661-SLR (the “Spectrum litigation”) in which
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`the ‘381 patent has been asserted to be infringed. I have provided a declaration in
`
`support of Spectrum’s opposition to DNA Genotek’s Motion for Preliminary
`
`Injunction in the Spectrum litigation (my “litigation declaration”). I enclose a copy
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`of that declaration, with its attached exhibits, as Exhibit 1017.
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`-2-
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`DNA Genotek, Inc. Exhibit 2008 Page 2
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`3.
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`For this IPR Engagement, I have been asked to provide analysis and
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`expert opinions on whether any of claims 3, 6, 9, 10, 13, 14, 18, 19, 39, 40, 43, and
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`45-47 of the ’381 patent, under the claim construction standards that apply during
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`Inter Partes Review, are invalid under 35 U.S.C. § 103 as obvious over specific
`
`prior art references.
`
`4.
`
`For my work as an expert in this IPR Engagement, I am being
`
`compensated at the rate of $250 per hour, except that for my work providing
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`deposition or PTAB trial testimony I am compensated at a rate of $350 per hour.
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`My compensation is not contingent on the opinions I reach or on the outcome of
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`any legal action, mediation, arbitration, or the terms of any settlement in this case.
`
`5.
`
`I have been informed by counsel and understand that in contrast to the
`
`Spectrum litigation, the grounds of unpatentability discussed herein must be based
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`solely on prior patents and other printed publications. I understand that
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`AncestryDNA and Spectrum reserve all rights to assert other grounds for
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`invalidity, not addressed herein, at a later time or in other forums. Thus, absence
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`of discussion of such matters here should not be taken as indicating that there are
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`no such additional grounds for invalidity of the ’381 patent.
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`DNA Genotek, Inc. Exhibit 2008 Page 3
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`6.
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`I reserve the right to supplement my opinions to address any
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`information obtained, or positions taken, based on any new information that comes
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`to light throughout this proceeding.
`
`B. Qualifications
`
`7.
`
`I studied Electrical Engineering at the University of Illinois at Urbana-
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`Champaign and received a Bachelor of Science degree in Zoology/Physiology
`
`from the University of Wyoming in 1966. I earned a M.S. in Bioengineering from
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`the University of Illinois at Chicago in 1972, and a Ph.D. in Biomedical
`
`Engineering from the University of Virginia in 1975.
`
`8.
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`I have worked in the medical device field for more than 35 years, and
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`have been actively involved with the engineering, research, product design,
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`development, and manufacturing of medical devices, including FDA regulated
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`medical devices and medical fluid collection devices. A copy of my curriculum
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`vitae is attached as Exhibit 1004.
`
`9.
`
`From 1975 to 1988, I was employed by The Kendall Company,
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`starting out as a research scientist, and ultimately being promoted to Manager of
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`Medical & Sports Medicine Divisions. During that time, I designed, tested,
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`developed, and/or managed a variety of products in the dental, medical, and sports
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`fields. Several of these projects involved urine collection devices, lumbar puncture
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`-4-
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`DNA Genotek, Inc. Exhibit 2008 Page 4
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`spinal fluid collection vials, and thoracentesis collection bags and specimen
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`collection tubes and caps.
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`10. From 1988 to 1990, I was employed by Baxter Healthcare
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`Corporation (“Baxter”), where I was a manager of the Advanced Device
`
`Technology group. During that time, I was involved in the design and
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`management of products and components for IV systems and components, and
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`blood collection products.
`
`11. From 1991 to 1994, I was employed by Packer Engineering as its
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`Director of Biomedical Engineering. During that time, I consulted on and made
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`numerous technology assessments of a variety of health related products in the
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`biomedical field and conducted failure mode investigations of medical devices.
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`12. From 1994 to 1999, I was employed by Integra and the NeuroCare
`
`Group as its Vice-President, Group Technical Officer. During this time, I was
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`involved in developing and releasing to the market new products relating to
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`neurosurgical implants and monitoring devices, assessing new technologies,
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`licensing patents, and purchasing patents and companies. I was also involved in
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`developing and releasing to the market medical devices such as cerebral spinal
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`fluid (CSF) collection bags and valves.
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`DNA Genotek, Inc. Exhibit 2008 Page 5
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`13.
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`I am an inventor on eighteen issued patents, and have authored
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`numerous publications and presentations related to medical devices. A list of my
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`publications and patents is included in Exhibit 1004.
`
`C. Basis For Opinions
`
`1. Materials considered
`
`14.
`
`I have reviewed and considered the ’381 patent (Ex. 1001) and the
`
`prosecution file history for the ’381 patent (Ex. 1002).
`
`15. For purposes of my assessment, I have been informed by counsel and
`
`understand that the effective date of the ’381 patent claims is no earlier than
`
`December 9, 2005 and that I should consider that date in assessing the state of the
`
`art. I have reviewed and considered the following references, each of which I have
`
`been informed by counsel and understand qualifies as prior art to the ’381 patent:
`
` •
`
`•
`
`•
`
`•
`
`PCT Patent Publication WO 2003/104251 to DNA Genotek,
`Inc. (ex-US designations) and Birnboim (US designation)
`(“Birnboim”) (Ex. 1008);
`U.S. Pat. No. 7,645,424 to O’Donovan (“O’Donovan,” or “the
`’424 patent”) (Ex. 1007);
`U.S. Pre-grant Publication No. 2003/0089627 A1 (“Chelles”)
`(Ex. 1020); and
`PCT Patent Publication WO 2005/023667 (“Clarkson”)
`(Ex. 1021).
`
`
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`DNA Genotek, Inc. Exhibit 2008 Page 6
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`I understand that the above references form the basis for the grounds of rejections
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`that are proposed in the Petition for Inter Partes Review of the ’381 patent.
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`16.
`
`In addition, I have reviewed several other references that I have been
`
`informed by counsel and understand are also prior art to the ’381 patent, but that
`
`are not being asserted as grounds for unpatentability in the accompanying Petition
`
`for Inter Partes Review. They are, however, helpful in understanding the state of
`
`the art:
`
`•
`
`•
`
`•
`•
`
`U.S. Patent 6,228,323 to Asgharian, et al. (“Asgharian”) (Ex.
`1014);
`WO98/03265 (“KCCL”) (in certified English translation, Ex.
`1011);
`U.S. Pat. No. 6,152,296 (“Shih”) (Ex. 1009); and
`German patent publication DE 199 50 884 A1 (in certified
`English translation, Ex. 1013).
`
`17. For purposes of preparing my expert declaration in the Spectrum
`
`litigation, I also reviewed Plaintiff DNA Genotek Inc.’s Opening Brief in Support
`
`of Motion for Preliminary Injunction (Ex. 1005) and the plaintiff’s Declaration of
`
`Juan C. Lasheras, Ph.D (Ex. 1006). I also reviewed the Defendants’ Brief in
`
`Opposition to DNA Genotek’s Motion (Ex. 1016) and my declaration in support
`
`thereof (Ex. 1017).
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`DNA Genotek, Inc. Exhibit 2008 Page 7
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`18. Additionally, I am aware of information generally available to, and
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`relied upon by, persons of ordinary skill in the art at the relevant time, including
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`technical dictionaries and technical reference materials (including textbooks,
`
`manuals, and technical papers and articles); some of my statements below are
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`expressly based on such awareness.
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`2.
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`Level of Ordinary Skill in the Art
`
`19.
`
`I have been informed by counsel and understand that a claim is
`
`obvious, and therefore unpatentable, if the differences between the subject matter
`
`claimed and the prior art are such that the claimed subject matter as a whole would
`
`have been obvious at the time the invention was made to a person having ordinary
`
`skill in the art to which the claims pertain.
`
`20. With respect to the ’381 patent, I believe such a person of ordinary
`
`skill in the art would have at least a bachelor of science degree in an engineering
`
`field, such as mechanical engineering, and several years of experience designing
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`collection devices for the medical field.
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`21.
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`I consider myself to have at least such “ordinary skill in the art” with
`
`respect to the subject matter of the ’381 patent at the relevant time.
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`DNA Genotek, Inc. Exhibit 2008 Page 8
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`II. THE ’381 PATENT
`
`A. Technical Background
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`22. As stated in the Background section of the ’381 patent specification,
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`“[i]t is often desirable to store a substance, such as a liquid, solid, gas, mixtures
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`thereof, or the like, in a container prior to mixing the contents of the container with
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`another material.” Ex. 1001, 1:19-21. The ‘381 patent is drawn to such a
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`“container system for releasably storing a substance.” Ex. 1001, Title.
`
`23.
`
`“According to one embodiment ..., the container system ... is suitable
`
`for releasably storing a composition intended to stabilize, preserve, or facilitate the
`
`recovery of nucleic acid from a biological sample,” Ex. 1001, 10:18-22, such as
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`saliva, Ex. 1001, 10:55. “The combination of the composition to stabilize,
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`preserve, or facilitate the recovery of nucleic acid and saliva may then be used in
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`standard nucleic acid testing reactions....” Ex. 1001, 11:43-46. This embodiment,
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`a saliva/sputum test kit for the collection of a saliva sample for medical testing, is
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`known colloquially in the art as a “spit kit.”
`
`24. The ’381 container system is an explicit improvement over Patent
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`Owner’s prior spit kit, described in WO 2003/104251, “Compositions and methods
`
`for obtaining nucleic acids from sputum” (“Birnboim”; Ex. 1008). As described in
`
`the background section of the '381 patent, the Birnboim container system "has a
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`DNA Genotek, Inc. Exhibit 2008 Page 9
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`first region for collecting a biological sample, a second region containing a
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`composition for preserving a nucleic acid, and a barrier between the first region
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`and the second region, which … maintains the sample and composition separate."
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`Ex. 1001, 1:54-59. The device further includes "means for disturbing the integrity
`
`of the barrier such that the composition is capable of contacting the biological
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`sample." Ex. 1008, 9:22-24. "[T]he means for closing the container may be
`
`coupled to the disestablishment of the barrier…." Ex. 1008, 24:8-9.
`
`25.
`
`In an embodiment of the Birnboim spit kit discussed at greater length
`
`later in this Declaration, "the barrier may be a septum … that would separate the
`
`composition from the fluid until the septum ... is pierced" (Ex.1008, 23:29-31) or
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`"punctured" (Ex. 1008, 9:11). In the preferred embodiment of Birnboim, however,
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`the barrier is not a septum. As described in the ’381 patent’s background section,
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`the “exemplified barrier of WO 2003/104251 is a pivoting partition.” Ex. 1001,
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`1:59-60 (emphasis added). As explained in the ’381 patent background section,
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`“[a] drawback of this container is that it includes multiple parts..., which increases
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`the cost of manufacture of the container. Additionally, because the disk is held in
`
`place by friction fit, there must be a high degree of precision for the manufacture
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`of the components of the container.” Ex. 1001, 1:66-2:4. Accordingly, prior to the
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`effective date of the ’381 patent, “[t]here remain[ed] a need for an improved
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`container system for releasably and reliably storing a substance.” Ex. 1001, 2:5-6.
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`DNA Genotek, Inc. Exhibit 2008 Page 10
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`26.
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`I agree with the '381 patent's characterization of the drawbacks of the
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`Birnboim preferred embodiment: it is a complicated solution to a simple
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`problem—it includes multiple parts, which increases the cost of manufacture of the
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`container, and because the disk is held in place by friction fit, there must be a high
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`degree of precision in both the design and manufacturing of the components of the
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`container. A person of ordinary skill in the art prior to December 9, 2005 would
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`also have appreciated these drawbacks.
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`27. The Birnboim reference itself proposes a solution to the drawbacks of
`
`its preferred spit kit embodiment, one in which “the barrier may be a septum …
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`that would separate the composition from the fluid until the septum ... is pierced”
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`(Ex.1008, 23:29-31) or “punctured” (Ex. 1008, 9:11). However, that improvement
`
`is not described in detail. For example, Birnboim does not disclose how, in such
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`embodiment, the “means for closing the container may be coupled to the
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`disestablishment of the barrier.” Ex. 1008, 24:8-9.
`
`28. Accordingly, prior to the effective date of the ’381 patent, “[t]here
`
`remain[ed] a need for an improved container system for releasably and reliably
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`storing a substance.” Ex. 1001, 2:5-6.
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`29. The market need for storing a substance prior to mixing with another
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`substance exists across a wide variety of disciplines beyond spit kits. Given the
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`DNA Genotek, Inc. Exhibit 2008 Page 11
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`ubiquity of the need, a “variety of containers” had been developed prior to the ’381
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`patent’s earliest claimed filing date “for holding substances separately in such a
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`manner that a user may open a closure to combine the substances.” Ex. 1001, 1:44-
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`46. Routinely, this need was met by releasably storing the substance within the
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`container’s lid, with the contents released from the lid by attachment of the lid to
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`the body of the container—optionally with a further advancement of the lid, or of
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`lid components, toward the container body.
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`30. U.S. Pre-Grant publication no. 2003/0089627 A1 (“Chelles”) (Ex.
`
`1020), which I will describe in greater detail later in this Declaration, describes
`
`such a container system to meet the market need, as shown in FIG. 2, reproduced
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`below.
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`DNA Genotek, Inc. Exhibit 2008 Page 12
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`31.
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`In another example, “two-compartment bottle assemblies” had been
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`developed for contact lens cleaning solutions. See U.S. Patent 6,228,323 to
`
`Asgharian, et al., issued May 8, 2001 (“Ex. 1014”), 3:42-44. The “two-
`
`compartment device … keep[s] separate an enzyme composition and a diluting
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`composition prior to their initial use” (Ex. 1014, 3:42-44), which “allows for
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`ambient temperature shipping, and long shelf-life without significant loss of
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`enzyme activity.” Ex. 1014, 4:8-10. “When the user is ready to use the system,
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`the two components are combined and mixed aseptically, forming the multi-
`
`purpose composition.” Ex. 1014, 4:10-13.
`
`32.
`
`In the embodiment illustrated in FIGS. 5 and 6, reproduced below,
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`“[m]embrane disk 18 cover[s] bottom end 17” of a cap assembly containing the
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`proteolytic enzyme. See Ex. 1014, 5:5-9. “With cap … rotation, plunger 6 is …
`
`pushed downward…. When plunger 6 reaches membrane 18…, [a] sharp point 41
`
`punctures … [and then] slic[es] off membrane 18…. At this point, the [ ]trypsin
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`cleaning composition contained in housing 5 is exposed to interior 11 of bottle 2
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`and falls into aqueous diluting composition 9 of bottle 2.” Ex. 1014, 5:54-65.
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`DNA Genotek, Inc. Exhibit 2008 Page 13
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`33.
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`In another example, a “[c]ombination package” had been developed
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`“for packaging a first and a second flowable material,” in which the first and
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`second flowable materials “are kept separate … and … [then] mixed together for
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`… use” in home or salon as a “permanent hair waving cosmetic.” See DE 199 50
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`884 A1, published April 26, 2001 (“Ex. 1013”), 1:44-47; 4:51-54. The
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`combination package includes “an essentially rotationally symmetrical screw cap 8
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`[sic; 6] … contain[ing] the first material 2 and … closed liquid-tight by means of a
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`separation film 11” (Ex. 1013, 1:54-63), and a second package part 7, depicted as a
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`bottle. “In order to bring the two package parts 6, 7 together to produce a mixture
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`… of the two materials…, the first package part 6 is screwed onto the second
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`package part 7, so that in the course of the screwing on … separation film 11 is
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`
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`-14-
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`DNA Genotek, Inc. Exhibit 2008 Page 14
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`pierced by the piercing element 22, which is shown in Fig. 4.” Ex. 1013, 2:61-70.
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`With continued tightening, “the plug base 14 drops downward and the separation
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`film 11 is opened entirely… so that the material 2 from the container 10 flows into
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`the material 3 and by manual shaking of the combination package 1 a ready to use
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`mixture 4 is produced….” Ex. 1013, 3:6-11.
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`34. As I will discuss in detail later in this declaration, the ’424 patent to
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`O’Donovan, which is drawn to a “reagent cuvette,” also provided a container
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`system in which a substance is releasably stored within the container’s cap.
`
`35. A patent to Shih, “Additive Holder for a PET Bottle,” similarly
`
`releasably stores as substance in the lid, as shown in FIG. 5, which is reproduced
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`immediately below.
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`-15-
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`DNA Genotek, Inc. Exhibit 2008 Page 15
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`36. Another such container is described in the KCCL international
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`publication, “Cap-shape reagent container for analysis reagents,” FIG. 1 of which
`
`is shown below:
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`
`
`FIG. 1
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`-16-
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`DNA Genotek, Inc. Exhibit 2008 Page 16
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`37. The ’381 patent, drawn to a “[c]ontainer system for releasably storing
`
`a substance” (Ex. 1001, Title), employs this standard approach to “holding
`
`substances separately in such a manner that a user may open a closure to combine
`
`the substances.” Ex. 1001, 1:44-46. Claim 1 recites (formatting added):
`
`1. A container system for releasably storing a substance, comprising:
`a) a vial comprising
` a first open end for receiving a sample,
` a second end comprising a sample storage chamber and
` a piercing member
`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
`b) a lid configured to removable engage said vial, said lid comprising
` a reservoir for holding the substance, and
` a pierceable membrane sealing the substance within said
`reservoir,
`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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`-17-
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`DNA Genotek, Inc. Exhibit 2008 Page 17
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`38. One embodiment of the ’381 container system is shown in ’381
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`FIG. 23 (top perspective view of vial; the lid is not shown), FIG. 24 (side view of
`
`vial and cap prior to assembly, identifying pierceable membrane 160 and piercing
`
`member 6), and FIG. 22 (top perspective view of vial and cap after assembly):
`
`
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`
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`
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`A second embodiment is shown in ’381 FIG. 10 (top perspective view of vial and
`
`lid prior to assembly), FIG. 9 (side cross-sectional view of vial and lid after
`
`assembly), and FIG. 4 (top perspective view of vial and lid after assembly):
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`-18-
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`DNA Genotek, Inc. Exhibit 2008 Page 18
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`In a third embodiment, the piercing member is integrated into a separate funnel.
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`That embodiment corresponds to independent claim 21, which is not challenged in
`
`the accompanying Petition.
`
`B.
`
`The ’381 Patent Claims
`
`1.
`
`Legal Standard for Claim Construction
`
`39.
`
`I have been informed by counsel and understand that the words used
`
`in the ’381 patent claims should ordinarily be accorded their plain meaning as
`
`would be understood by a person of skill in the art to which the patent pertains,
`
`unless the specification makes clear that the patentee has acted as its own
`
`lexicographer, or the specification otherwise makes clear that a different meaning
`
`is intended.
`
`40.
`
`I have also been informed by counsel and understand that in an Inter
`
`Partes Review proceeding, claims are to be given their broadest reasonable
`
`
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`-19-
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`DNA Genotek, Inc. Exhibit 2008 Page 19
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`interpretation (“BRI”) in light of the patent’s specification. I have been informed
`
`by counsel and understand that the broadest reasonable interpretation may be
`
`different from construction of the same claim element by federal courts.
`
`41.
`
`I understand from counsel that only those terms which are in
`
`controversy need be construed, and only to the extent necessary to resolve the
`
`controversy, and that in the Decision instituting the first IPR, the panel found “that
`
`no term requires interpretation at this time.”
`
`2.
`
`Construction of the ’381 Patent Claims
`
`42. For ease of reference, I will use the designations set forth in the
`
`following chart when referring to portions of claim 1 of the ’381 patent. See also
`
`Ex. 1019. I refer to these “portions” interchangeably as “elements” and
`
`“limitations.”
`
`
`
`-20-
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`DNA Genotek, Inc. Exhibit 2008 Page 20
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`Designation
`
`[1.P]
`
`[1.1]
`[1.2]
`[1.3]
`[1.4]
`[1.5]
`
`[1.6]
`
`[1.7]
`[1.8]
`
`[1.9]
`
`[1.10]
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`
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`‘381 claim element or limitation
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`1. A container system for releasably storing a substance,
`comprising:
`a) a vial comprising
` a first open end for receiving a sample,
` a second end comprising a sample storage chamber and
` a piercing member,
`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
`b) a lid configured to removably engage said vial, said lid
`comprising
` a reservoir for holding the substance, and
` a pierceable membrane sealing the substance within said
`reservoir,
`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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`43. The broadest reasonable interpretation of the claim preamble
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`(limitation [1.P]), “[a] container system for releasably storing a substance,” is that
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`it does not limit the scope of the claim, doing no more than (i) providing a
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`collective term, “system,” to refer to the vial and lid elements recited both
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`separately and in combination in the body of the claim; and (ii) reciting the
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`-21-
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`DNA Genotek, Inc. Exhibit 2008 Page 21
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`
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`inherent function of the structural elements when used as set forth in the “wherein”
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`clauses in the claim. I have been informed by counsel and understand that whether
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`a claim preamble limits the scope of a claim is made on a case-by-case basis. If, in
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`present case, the PTAB decides that the preamble is limiting, the broadest
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`reasonable interpretation is the broadest plain meaning, which is a container
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`system suitable for releasably storing a substance, in which the word “container”
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`imposes no dimensional constraints and the word “substance” broadly covers “a
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`liquid, solid, gas, mixtures thereof, or the like.” Ex. 1001, 1:19-20.
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`44. Limitation [1.1] recites “a vial.” The specification of the ’381 patent
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`does not define the term “vial.” The plain meaning is “[a] small container, usually
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`with a closure, used especially for liquids.” Ex. 1015, p. 8 (original page 1915).
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`Although “small” connotes, in relative terms, that there must be some maximal
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`size, and although certain specified embodiments have chambers that
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`accommodate about 1 to about 4 ml of sample, and about 1 to about 16 ml of
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`sample, respectively (Ex. 1001, 6:10-13), the ’381 patent specification nonetheless
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`imposes no meaningful absolute constraints on size. Nor does the specification
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`constrain the shape. To the contrary, the vial explicitly “can be a variety of shapes,
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`as determined by the needs or preferences of the user and/or application of use.”
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`Ex. 1001, 5:51-53. In some embodiments, “the width of the first open end of vial 1
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`is approximately equivalent to the width of the second end.” Ex. 1001, 5:62-63. In
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`
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`-22-
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`DNA Genotek, Inc. Exhibit 2008 Page 22
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`
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`other embodiments, “the first open end of vial 1 is generally wider than the second
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`end [of] vial 1.” Ex. 1001, 5:64-65. In fact, the “second end” of the vial can be
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`open or closed. See Ex. 1001, 5:59-61. Thus, I conclude that the broadest
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`reasonable interpretation of “vial” is a small closed or closable vessel, with no
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`definitive size or shape requirements beyond being “small.”
`
`45. Limitation [1.2] recites that the vial comprises a “first open end for
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`receiving a sample.” Because the ‘381 specification teaches that the samples that
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`may be received by the vial range widely in size, shape, and volume — with even
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`the preferred embodiment, a “biological sample” (Ex. 1001, 2:52, emphasis
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`added), including such diverse “[n]on-limiting examples … [as] skin, hair, fecal
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`matter, bodily fluids, tissue, cells and the like” (Ex. 1001, 10:25-27) — the first
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`open end has no clear dimensional structural limitation; it has only a single
`
`functional requirement, i.e., it must be open when the “vial” is to receive sample.
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`Thus the broadest reasonable interpretation of this claim limitation is its plain
`
`meaning: an end that is sufficiently open as to receive a sample.
`
`46. Limitation [1.3] recites that the vial comprises “a second end
`
`comprising a sample storage chamber.” The “second end” of the vial, because it
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`must “compris[e] a … chamber,” cannot be limited to a specific point or a single
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`specified wall of the vial. Moreover, nothing in the specification of the ’381 patent
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`
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`-23-
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`DNA Genotek, Inc. Exhibit 2008 Page 23
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`requires that the “sample storage chamber” be structurally delimited within the
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`vial, or constitute less than the entire interior of the vial. Because the specification
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`of the ’381 patent imposes no restrictions on the type or volume of the “sample” to
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`be “receiv[ed]” by the vial (see above), the sample imposes no structural or
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`dimensional constraints on either the vial as a whole or, as here relevant, on the
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`“sample storage chamber” of the vial. Thus the broadest reasonable interpretation
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`of the phrase “second end comprising a sample storage chamber” is that the vial
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`has an interior portion that can store a received sample.
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`47. Limitation [1.4] recites that the “vial comprises … a piercing
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`member.” I have been informed by counsel and I understand that the claim term
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`“comprising” means “including” or “containing,” so that the named elements are
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`essential, but that other elements may also be present. Thus, I understand the
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`phrase as meaning that the vial can include or contain additional piercing
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`members; i.e., that it includes or contains at least one piercing member, or
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`equivalently, contains one or more piercing members.
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`48. The ʼ381 patent discloses two basic configurations of container
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`systems. “In accordance with one aspect of the present invention, there is provided
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`a container system for releasably storing a substance, comprising: a) a vial
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`comprising a first open end for receiving a sample, a second end comprising a
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`
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`-24-
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`DNA Genotek, Inc. Exhibit 2008 Page 24
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`
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`sample storage chamber and a piercing member; and b) a lid….” Ex. 1001,
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`2:17-21. This is the configuration of claim 1 of the ’381 patent. “In accordance
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`with another aspect of the present invention, there is provided a container system
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`for releasably storing a substance, comprising: a) a vial comprising a chamber for
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`retaining a sample[,] b) a lid comprising a reservoir for holding the substance, and
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`a pierceable membrane sealing the substance within said reservoir; and c) a funnel
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`comprising … a piercing member….” Ex. 1001, 2:32-38 (emphasis added). This
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`latter configuration is the configuration of claim 21, which I understand is not
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`being challenged in the accompanying Petition.
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`49.
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`In describing the embodiments in which the “vial comprises … a
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`piercing member,” the ʼ381 patent teaches that the piercing member extends from a
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`surface of the vial. For example, the ’381 patent states:
`
`Vial 1 comprises at least one piercing member 6. In the specific
`embodiment depicted in FIGS. 1-11 piercing member 6 extends
`from a base surface of chamber 2. In one example, piercing
`member 6 extends approximately perpendicular from the base. In
`another example, piercing member 6 is angled inwardly or outwardly
`toward the open end of vial 1. Alternatively, piercing member 6
`extends from an interior surface of said vial. In one example, piercing
`member 6 extends from an interior surface of said vial and is angled
`inwardly or outwardly toward the open end of vial 1.
`
`
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`
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`-25-
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`DNA Genotek, Inc. Exhibit 2008 Page 25
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`Ex. 1001, 6:14-23 (emphasis added). I interpret “extends from a … surface of
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`chamber 2” in these embodiments to mean that piercing member 6 is integral to the
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`chamber, and thus the vial. That interpretation is supported by the figures of the
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`ʼ381 patent, which depict the piercing members 6 as being an integral part of the
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`vial. See, e.g., FIGS. 9, 10 and 23 of the ’381 patent, in which the piercing
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`member is designated 6, which are reproduced below:
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`50. Thus, in my litigation declaration I concluded that “a vial
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`comprising . . . a piercing member” is a vial that includes a piercing member as a
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`component. That is, the piercing member is an integral part of the vial. Ex. 1017,
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`¶¶ 21-23.
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`51. However, I have been informed by counsel and understand that for
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`Inter Partes Review, the broadest reasonable interpretation should be broad enough
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`to include claim construction positions previously advanced by the Patent Owner
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`
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`-26-
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`DNA Genotek, Inc. Exhibit 2008 Page 26
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`in litigation, which constructions the Patent Owner cannot maintain are
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`“unreasonably broad.” Accordingly, I understand that the broadest reasonable
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`interpretation of “vial comprising … a piercing member” should include the
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`construction advanced by the Patent Owner and its expert in the Spectrum
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`litigation, in which “a vial comprising … a piercing member” includes a piercing
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`member first “located in the … lid,” which piercing member then “becomes
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`wedged in the top of the collection tube, completing the claimed ‘vial.’” Ex. 1016,
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`¶ 21 (citing Ex. 1005, p. 7).
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`52. With this understanding, I conclude for purposes of this declaration
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`that the broadest reasonable interpretation of “a vial comprising … a piercing
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`member” is a vial that includes at least one piercing member as an integrated, but
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`not necessarily integral, component. By “integrated” I mean that the piercing
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`mem
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