Filed on behalf of ANCESTRY.COM DNA, LLC
`By: Daniel Becker, Reg. No. 38,376
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`Jennifer R. Bush, Reg. No. 50,784
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`Fenwick & West LLP
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`801 California Street
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`Mountain View, CA 94041
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`Tel: (650) 988-8500
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`Fax: (650) 938-5200
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`ANCESTRY.COM DNA, LLC,
`Petitioner
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`FOR INTER PARTES REVIEW OF
`U.S. PATENT 8,221,381
`_____________
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`DECLARATION OF TERRY N. LAYTON, Ph. D.
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`ANCESTRY EX. 1003
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`1
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`By: Daniel Becker, Reg. No. 38,376
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`Jennifer R. Bush, Reg. No. 50,784
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`Fenwick & West LLP
`
`801 California Street
`
`Mountain View, CA 94041
`
`Tel: (650) 988-8500
`
`Fax: (650) 938-5200
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`ANCESTRY.COM DNA, LLC,
`Petitioner
`
`FOR INTER PARTES REVIEW OF
`U.S. PATENT 8,221,381
`_____________
`
`DECLARATION OF TERRY N. LAYTON, Ph. D.
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`ANCESTRY EX. 1003
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`1
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`I, Terry N. Layton, declare as follows:
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`I.
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`INTRODUCTION
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`A.
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`TERMS AND SCOPE OF ENGAGEMENT
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`1. Counsel for Ancestry.com DNA, LLC (“AncestryDNA” or “Petitioner”)
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`has requested that I provide declaratory evidence in the above captioned Inter
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`Partes Review proceeding (“IPR Engagement”). I understand that this Inter Partes
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`Review proceeding involves U.S. Patent No. 8,221,381 (“the ’381 patent”) (Ex.
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`1001).
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`2. I have also been engaged by the same counsel as an expert witness on
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`behalf of defendants Spectrum DNA, Spectrum Solutions L.L.C., and Spectrum
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`Packaging L.L.C. (collectively, “Spectrum”) in the litigation styled DNA Genotek,
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`Inc. v. Spectrum DNA; Spectrum Solutions L.L.C., and Spectrum Packaging, LLC,
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`Case No. 15-cv-00661-SLR (the “Spectrum litigation”) in which the ‘381 patent
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`has been asserted to be infringed. I have provided a declaration in support of
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`Spectrum’s opposition to DNA Genotek’s Motion for Preliminary Injunction in the
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`Spectrum litigation (my “litigation declaration”). I attach a copy of that
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`declaration, with its attached exhibits, as Exhibit 1017.
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`3. For the IPR Engagement, I have been asked to provide analysis and expert
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`opinions on whether any of claims 1-20, 39-41, 43-47, and 49 of the ’381 patent,
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`under the claim construction standards that apply during Inter Partes Review, are
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`invalid under 35 U.S.C. § 102 as anticipated by, or under 35 U.S.C. § 103 as
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`having been obvious over, specific references in the prior art.
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`4. For my work as an expert in the IPR Engagement, I am being
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`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.
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`5. I have been informed by counsel and understand that in contrast to the
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`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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`6. 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
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`throughout this proceeding.
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`B. QUALIFICATIONS
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`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
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`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
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`Engineering from the University of Virginia in 1975.
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`8. 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.
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`9. From 1975 to 1988, I was employed by The Kendall Company, starting
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`out as a research scientist, and ultimately being promoted to Manager of Medical
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`& Sports Medicine Divisions. During that time, I designed, tested, developed,
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`and/or managed a variety of products in the dental, medical, and sports fields.
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`Several of these projects involved urine collection devices, lumbar puncture spinal
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`fluid collection vials, and thoracentesis collection bags and specimen collection
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`tubes and caps.
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`10. From 1988 to 1990, I was employed by Baxter Healthcare Corporation
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`(“Baxter”), where I was a manager of the Advanced Device Technology group.
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`During that time, I was involved in the design and management of products and
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`components for IV systems and components, and blood collection products.
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`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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`From 1994 to 1999, I was employed by Integra and the NeuroCare Group as its
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`Vice-President, Group Technical Officer. During this time, I was involved in
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`developing and releasing to the market new products relating to neurosurgical
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`implants and monitoring devices, assessing new technologies, licensing patents,
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`and purchasing patents and companies. I was also involved in developing and
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`releasing to the market medical devices such as cerebral spinal fluid (CSF)
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`collection bags and valves.
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`12. I am an inventor on eighteen issued patents, and have authored numerous
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`publications and presentations related to medical devices. A list of my
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`publications and patents is included in Exhibit 1004.
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`C. BASIS FOR OPINIONS
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`1. Materials considered
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`13. I have reviewed and considered the ’381 patent (Ex. 1001) and the
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`prosecution file history for the ’381 patent (Ex. 1002). For purposes of my
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`assessment, I have been informed by counsel and understand that the effective date
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`of the ‘381 patent claims is no earlier than December 9, 2005 and that I should
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`consider that date in assessing the state of the art.
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`14. I have also reviewed and considered the following references, each of
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`which I have been informed by counsel and understand qualifies as prior art to the
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`’381 patent:
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`U.S. Pat. No. 7,645,424 to O’Donovan (“O’Donovan,” or
`“the ’424 patent”) (Ex. 1007);
`WO98/03265 (“KCCL”) (in certified English translation,
`Ex. 1011);
`U.S. Pat. No. 6,152,296 (“Shih”) (Ex. 1009); and
`PCT Patent Publication WO 2003/104251 to DNA
`Genotek, Inc. (ex-US designations) and Birnboim (US
`designation) (“Birnboim”) (Ex. 1008).
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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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`15. In addition, I have reviewed several other references that I have been
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`informed by counsel and understand are also prior art to the ’381 patent, but that
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`are not being asserted as grounds for unpatentability in the accompanying Petition
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`for Inter Partes Review. They are, however, helpful in understanding the state of
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`the art:
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`U.S. Patent 6,228,323 to Asgharian, et al. (“Asgharian”) (Ex.
`1014); and
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`German patent publication DE 199 50 884 A1 (in certified
`English translation, Ex. 1013).
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`16. For purposes of preparing my expert declaration in the Spectrum
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`litigation, I also reviewed Plaintiff DNA Genotek Inc.’s Opening Brief in Support
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`of Motion for Preliminary Injunction (Ex. 1005) and the plaintiff’s Declaration of
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`Juan C. Lasheras, Ph.D (Ex. 1006). I also reviewed the Defendants’ Brief in
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`Opposition to DNA Genotek’s Motion (Ex. 1016) and my declaration in support
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`thereof (Ex. 1017).
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`17. 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,
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`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
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`18. I have been informed by counsel and understand that a claim is obvious,
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`and therefore unpatentable, if the differences between the subject matter claimed
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`and the prior art are such that the claimed subject matter as a whole would have
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`been obvious at the time the invention was made to a person having ordinary skill
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`in the art to which the claims pertain.
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`19. With respect to the ’381 patent, I believe such a person of ordinary skill
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`in the art would have at least a bachelor of science degree in an engineering field,
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`such as mechanical engineering, and several years of experience designing
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`collection devices for the medical field.
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`20. I consider myself to have at least such “ordinary skill in the art” with
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`respect to the subject matter of the ’381 patent at the relevant time.
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`II. THE ’381 PATENT
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`A.
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`Technical background
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`21. As stated in the Background section of the ’381 patent specification, “[i]t
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`is often desirable to store a substance, such as a liquid, solid, gas, mixtures thereof,
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`or the like, in a container prior to mixing the contents of the container with another
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`material.” Ex. 1001, 1:19-21.
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`22. This market need exists across a wide variety of disciplines. Given the
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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 is met by releasably storing the substance within the
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`container’s lid.
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`23. For example, “two-compartment bottle assemblies” had been developed
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`for contact lens cleaning solutions. See U.S. Patent 6,228,323 to Asgharian, et al.,
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`issued May 8, 2001 (“Ex. 1014”), 3:42-44. The “two-compartment device …
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`keep[s] separate an enzyme composition and diluting composition prior to their
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`initial use” (Ex. 1014, 3:42-44), which “allows for ambient temperature shipping,
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`and long shelf-life without significant loss of enzyme activity.” Ex. 1014, 4:8-10.
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`“When the user is ready to use the system, the two components are combined and
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`mixed aseptically, forming the multi-purpose composition.” Ex. 1014, 4:10-13.
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`24. 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 …
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`pushed downward…. When plunger 6 reaches membrane 18…, [a] sharp point 41
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`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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`25. In another example, a “[c]ombination package” had been developed “for
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`packaging a first and a second flowable material,” in which the first and second
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`flowable materials “are kept separate … and … [then] mixed together for … use”
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`in home or salon as a “permanent hair waving cosmetic.” See DE 199 50 884 A1,
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`published April 26, 2001 (“Ex. 1013”), 1:44-47; 4:51-54. The combination
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`package includes “an essentially rotationally symmetrical screw cap 8 [sic; 6] …
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`contain[ing] the first material 2 and … closed liquid-tight by means of a separation
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`film 11” (Ex. 1013, 1:54-63), and a second package part 7, depicted as a bottle.
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`“In order to bring the two package parts 6, 7 together to produce a mixture … of
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`the two materials…, the first package part 6 is screwed onto the second package
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`part 7, so that in the course of the screwing on … separation film 11 is pierced by
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`the piercing element 22, which is shown in Fig. 4.” Ex. 1013, 2:61-70. With
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`continued tightening, “the plug base 14 drops downward and the separation film 11
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`is opened entirely… so that the material 2 from the container 10 flows into the
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`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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`26. 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, as did
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`the patent to Shih, drawn to an “Additive Holder for a Pet Bottle,” FIG. 5 of which
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`is reproduced immediately below,
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`as did the KCCL international publication, “Cap-shape reagent container for
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`analysis reagents,” FIG. 1 of which is shown below:
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`FIG. 1
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`27. The ’381 patent, drawn to a “[c]ontainer system for releasably storing a
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`substance” (Ex. 1001, Title), employs this standard approach to “holding
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`substances separately in such a manner that a user may open a closure to combine
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`the substances.” Ex. 1001, 1:44-46. Claim 1 recites:
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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 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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`Ex. 1001, claim 1 (formatting added).
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`28. One embodiment of the ’381 container system is shown in ’381 FIG. 23
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`(top perspective view of vial; the lid is not shown), FIG. 24 (side view of vial and
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`cap prior to assembly, identifying pierceable membrane 160 and piercing
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`member 6), and FIG. 22 (top perspective view of vial and cap after assembly):
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`A second embodiment is shown in ’381 FIG. 10 (top perspective view of vial and
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`lid prior to assembly), FIG. 9 (side cross-sectional view of vial and lid after
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`assembly), and FIG. 4 (top perspective view of vial and lid after assembly):
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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
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`the accompanying Petition.
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`B.
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`The ’381 Patent Claims
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`1. Legal Standard for Claim Construction
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`29. I have been informed by counsel and understand that the words used in
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`the ’381 patent claims should ordinarily be accorded their plain meaning as would
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`be understood by a person of skill in the art to which the patent pertains, unless the
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`specification makes clear that the patentee has acted as its own lexicographer, or
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`the specification otherwise makes clear that a different meaning is intended.
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`30. I have also been informed by counsel and understand that in an Inter
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`Partes Review proceeding, claims are to be given their broadest reasonable
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`interpretation (“BRI”) in light of the patent’s specification. I have been informed
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`by counsel and understand that the broadest reasonable interpretation should be
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`broad enough to include claim construction positions previously advanced by the
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`Patent Owner in the Spectrum litigation. I also have been informed by counsel and
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`understand that the broadest reasonable interpretation may be different from
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`construction of the same claim element by federal courts.
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`2.
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`Construction of the ’381 Patent Claims
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`31. For ease of reference, I will use the designations set forth in the
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`following chart when referring to portions of claim 1 of the ’381 patent. See also
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`Ex. 1019. I refer to these “portions” interchangeably as “elements” and
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`“limitations.”
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`Designation
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`[1.P]
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`[1.1]
`[1.2]
`[1.3]
`[1.4]
`[1.5]
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`[1.6]
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`[1.7]
`[1.8]
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`[1.9]
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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
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`Designation
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`[1.10]
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`‘381 claim element or limitation
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`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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`32. The broadest reasonable interpretation of the claim preamble (limitation
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`[1.P]), “[a] container system for releasably storing a substance,” is that it does not
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`limit the scope of the claim, doing no more than (i) providing a collective term,
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`“system,” to refer to the vial and lid elements recited both separately and in
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`combination in the body of the claim; and (ii) reciting the inherent function of the
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`structural elements when used as set forth in the “wherein” clauses in the claim. I
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`have been informed by counsel and understand that whether a claim preamble
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`limits the scope of a claim is made on a case-by-case basis. If, in present case, the
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`PTAB decides that the preamble is limiting, the broadest reasonable interpretation
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`is the broadest plain meaning, which is a container system suitable for releasably
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`storing a substance, in which the word “container” imposes no dimensional
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`constraints and the word “substance” broadly covers “a liquid, solid, gas, mixtures
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`thereof, or the like.” Ex. 1001, 1:19-20.
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`33. 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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`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.
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`34. 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
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`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
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`meaning: an end that is sufficiently open as to receive a sample.
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`35. Limitation [1.3] recites that the vial comprises “a second end comprising
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`a sample storage chamber.” The “second end” of the vial, because it must
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`“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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`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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`36. Limitation [1.4] recites that the “vial comprises … a piercing member.”
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`I have been informed by counsel and I understand that the claim term “comprising”
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`means “including” or “containing,” so that the named elements are essential, but
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`other elements may also be present. Thus, I understand the phrase as meaning that
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`the vial can include or contain additional piercing members; i.e., that it includes or
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`contains at least one piercing member, or equivalently, contains one or more
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`piercing members.
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`37. The ʼ381 patent discloses two basic configurations of container systems.
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`“In accordance with one aspect of the present invention, there is provided a
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`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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`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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`38. 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:
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`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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`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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`39. Thus, in my litigation declaration I concluded that “a vial comprising . . .
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`a piercing member” is a vial that includes a piercing member as a component. That
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`is, the piercing member is an integral part of the vial. Ex. 1017, ¶¶ 21-23.
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`40. However, I have been informed by counsel and understand that for Inter
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`Partes Review, the broadest reasonable interpretation should be broad enough to
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`include claim construction positions previously advanced by the Patent Owner in
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`litigation. Accordingly, I understand that the broadest reasonable interpretation of
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`“vial comprising … a piercing member” should include the construction advanced
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`by the Patent Owner and its expert in the Spectrum litigation, in which “a vial
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`comprising … a piercing member” includes a piercing member first “located in the
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`… lid,” which piercing member then “becomes wedged in the top of the collection
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`tube, completing the claimed ‘vial.’” Ex. 1016, ¶ 21 (citing Ex. 1005, p. 7).
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`41. With this understanding, I conclude for purposes of this declaration that
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`the broadest reasonable interpretation of “a vial comprising … a piercing member”
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`is a vial that includes at least one piercing member as an integrated, but not
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`necessarily integral, component. By “integrated” I mean that the piercing member
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`is attached to and fixed (i.e., stationary) in the vial when the vial is in use. And
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`regardless whether the piercing member is integral to or simply integrated into the
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`vial, the vial must in use have “a first open end for receiving a sample” and “a
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`second end comprising a sample storage chamber.”
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`42. Limitation [1.5] recites “wherein said piercing member comprises a side
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`wall, a first cutting edge extending from a first pointed corner to a second corner
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`that defines the intersection between said cutting edge and said side wall.” That is,
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`the first corner ― but not necessarily the second corner ― must be “pointed.”
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`43. FIG. 3 of the ʼ381 patent is reproduced below. In this figure, the “first
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`pointed corner” is labeled 30; the “first cutting edge” is labeled 32; and the “side
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`wall” is labeled 34. See, e.g., Ex. 1001, 6:33-38. I have annotated the figure to
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`identify with particularity the “second corner,” which is undesignated in the ’381
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`patent’s FIG. 3, and also, for contrast, “first pointed corner” 30.
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`The American Heritage Dictionary defines a “corner” as “[t]he position at which
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`two lines, surfaces, or edges meet and form an angle.” Ex. 1015, p. 3 (original p.
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`318).
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`44. As illustrated in FIG. 3, the first pointed corner comes to a beveled point,
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`while the second corner does not. The ʼ381 patent discusses the first pointed
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`corner (30) as follows:
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`Piercing member 6 can be approximately trapezoidal in shape and
`includes first cutting edge 33 [sic; 32] having pointed end 30 at one
`corner of the trapezoid and a second end at a second corner of the
`trapezoid where cutting edge 32 intersects side wall 34.
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`Ex. 1001, 6:33-37; 8:32-37. By describing the cutting edge as “having pointed
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`end 30 at one corner,” the ʼ381 patent explains that the first corner comes to a point
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`at the end.
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`45. The ʼ381 patent uses the word “pointed” consistent with its plain and
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`ordinary meaning. For example, The American Heritage Dictionary defines a
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`“point” as “a sharp or tapered end.” See Exhibit 1015, p. 6 (original p. 1355).
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`Thus, in my litigation declaration, I construed “a first pointed corner” to be an edge
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`with a sharp, tapering, or otherwise narrowly converging end. The pointed end
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`(30) in FIG. 3 of the ʼ381 patent is an example of such a “first pointed corner”:
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`46. However, the claim construction position advanced by the Patent Owner
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`in the Spectrum litigation is different. Since I have been informed by counsel and
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`understand that for Inter Partes Review the broadest reasonable interpretation
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`applies, and that the broadest reasonable interpretation should be broad enough to
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`include the Patent Owner’s litigation construction, I understand that the Patent
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`Owner cannot now argue in this Inter Partes Review for a construction that does
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`not include the claim construction positions previously advanced by the Patent
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`Owner in litigation. Thus, although I stated in my litigation declaration that the
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`product pictured below, which does not have an edge with a sharp, tapering or
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`otherwise narrowly converging end, does not have a piercing member with a “first
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`pointed corner” under the claim construction standard applicable in the litigation
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`context,
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`first squared-off corner;
`not pointed
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`second squared-off corner;
`not pointed
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`(Ex. 1017, ¶ 39), I understand that for purposes of Inter Partes Review the
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`broadest reasonable interpretation of “pointed corner” must also include a squared
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`off corner, as set forth in Patent Owner’s expert declaration:
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`See Ex 1006, ¶ 20.
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`47. As discussed above, I conclude that in claim 1, the first corner ― but not
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`the second corner ― must be “pointed.” Since I understand that squared off
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`corners must qualify as “pointed” for purposes of Inter Partes Review, the
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`broadest reasonable interpretation of “pointed corner” requires merely that first
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`pointed corner 30 be capable of performing the required function, which is
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`disrupting the pierceable membrane:
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`In operation, in moving to the piercing position, pointed end 30 is
`brought into contact with pierceable membrane 160 and subsequently
`pierces pierceable membrane 160. Continued twisting moves cutting
`edge 32 through the pierceable membrane 160, thereby disrupting
`pierceable membrane 160 and producing an opening in pierceable
`membrane 160 to permit the substance to enter interior chamber 422.
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`Ex. 1001, 9:59-65. I thus conclude that the piercing member’s “first pointed
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`corner” is a corner of the piercing member capable of disrupting the pierceable
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`membrane.
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`48. Thus, in view of the above constructions, the broadest reasonable
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`interpretation of element “a)” of claim 1, which element encompasses limitations
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`[1.1]-[1.5], is a small closed or closable vessel sufficiently open at one end so as to
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`be able to receive a sample, with an interior portion that can store the sample, and
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`at least one piercing member as an integrated component, i.e., with the at least one
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`piercing member attached to and fixed (i.e., stationary) in the vial when the vial is
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`in use, the piercing member having a first cutting edge extending from a first
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`corner to a second corner that defines the intersection between said cutting edge
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`29584/95068/DOCS
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