UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD. & ACRUX LIMITED
`Petitioners
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
`Patent Owner and Licensee
`_______________
`
`Patent No. 7,214,506
`Issue Date: May 8, 2007
`Title: Method for Treating Onychomycosis
`_______________
`
`DECLARATION OF KENNETH A. WALTERS, PH.D.
`
`
`
`
`
`
`
`
`
`
`
`ACRUX DDS PTY LTD. et al.
`EXHIBIT 1005
`IPR Petition for
`U.S. Patent No. 7,214,506
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`TABLE OF CONTENTS
`
`I. 
`Qualifications, Background, and Experience .................................................. 1 
`Scope of Assignment ....................................................................................... 6 
`II. 
`III.  Materials Considered ....................................................................................... 7 
`IV. 
`Summary of Opinions .................................................................................... 13 
`V. 
`Legal Principles Used in Analysis ................................................................. 14 
`A. 
`Patent Claims in General ..................................................................... 14 
`B. 
`Person of Ordinary Skill in the Art ..................................................... 15 
`C. 
`Claim Construction ............................................................................. 16 
`D. 
`Prior Art ............................................................................................... 16 
`E. 
`Priority ................................................................................................. 17 
`F. 
`Patentability ......................................................................................... 17 
`VI.  A Person of Ordinary Skill in the Relevant Art ............................................. 21 
`A. 
`Relevant Field ...................................................................................... 21 
`B. 
`Person of Ordinary Skill in the Art ..................................................... 21 
`VII.  Background of the Relevant Technology ...................................................... 22 
`VIII.  The ’506 Patent .............................................................................................. 26 
`A. 
`The Claims of the ’506 Patent ............................................................. 30 
`B. 
`Problem Addressed by the ’506 Patent ............................................... 31 
`C. 
`Solution Set Forth in the ’506 Patent .................................................. 33 
`IX.  Priority Date of the ’506 Patent ..................................................................... 37 
`X.  Obviousness Analysis .................................................................................... 40 
`A. 
`Summary of Opinions ......................................................................... 40 
`B. 
`Ground 1: The Methods of Claims 1 and 2 of the ’506 Patent Would
`Have Been Obvious Over Japanese Pat. App. Pub. No. 10-226639 in
`View of Ogura ..................................................................................... 42 
`i. 
`Summary of JP ’639 .................................................................. 42 
`ii. 
`Summary of Ogura .................................................................... 45 
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`E. 
`
`F. 
`
`C. 
`
`The Combination of JP ’639 and Ogura ................................... 46 
`iii. 
`Ground 2: The Methods of Claims 1 and 2 of the ’506 Patent Would
`Have Been Obvious Over U.S. Pat. No. 5,391,367 in View of Ogura
` .............................................................................................................49
`i. 
`Summary of the ’367 Patent ..................................................... 49 
`ii. 
`Summary of Ogura .................................................................... 50 
`iii. 
`The Combination of the ’367 Patent and Ogura ....................... 51 
`D.  Ground 3: The Methods of Claims 1 and 2 of the ’506 Patent Would
`Have Been Obvious Over Hay 1985 in View of Ogura ...................... 53 
`i. 
`Summary of Hay 1985 .............................................................. 53 
`ii. 
`Summary of Ogura .................................................................... 54 
`iii. 
`The Combination of Hay 1985 and Ogura ................................ 54 
`Ground 4: The Methods of Claims 1 and 2 of the ’506 Patent Would
`Have Been Obvious Over JP ’639 in view of the Kaken Abstracts .... 57 
`i. 
`Summary of JP ’639 .................................................................. 57 
`ii. 
`Summary of the Kaken Abstracts ............................................. 57 
`iii. 
`The Combination of JP’639 and the Kaken Abstracts .............. 58 
`Ground 5: The Methods of Claims 1 and 2 of the ’506 Patent Would
`Have Been Obvious over the ’367 Patent in View of the Kaken
`Abstracts. ............................................................................................. 61 
`i. 
`Summary of the ’367 Patent ..................................................... 61 
`ii. 
`Summary of the Kaken Abstracts ............................................. 61 
`iii. 
`The Combination of the ’367 Patent and the Kaken
`Abstracts .................................................................................... 62 
`G.  Ground 6: The Methods of Claims 1 and 2 of the ’506 Patent Would
`Have Been Obvious over the Hay 1985 in view of the Kaken
`Abstracts. ............................................................................................. 64 
`i. 
`Summary of Hay 1985 .............................................................. 64 
`ii. 
`Summary of the Kaken Abstracts ............................................. 64 
`iii. 
`The Combination of Hay 1985 and the Kaken Abstracts ......... 64 
`Secondary Considerations ................................................................... 66 
`
`H. 
`
`iii
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`3 of 108
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`
`i. 
`
`ii. 
`
`The Alleged Unexpected Results Relied on by the
`Applicants During Prosecution Were Actually Known
`Beneficial Results of the Use of KP-103 .................................. 67 
`The Data Presented in the ’506 Specification is Flawed and
`Does Not Provide Evidence of an Unexpected Effect .............. 70 
`iii.  Contrary to the Applicants’ Argument During Prosecution,
`the Data Demonstrate That the Claimed Compounds Do
`Not Eradicate the Infection. ...................................................... 73 
`Claim Charts ........................................................................................ 76 
`I. 
`XI.  Conclusions .................................................................................................... 76 
`
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`1. My name is Kenneth A. Walters. I was the Director of Research and
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`Development and Business Development and am currently the Director of QA/QC
`
`at An-eX Analytical Services Limited in Cardiff, United Kingdom (“An-eX”). An-
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`eX is an independent contract research and development company that offers a
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`range of dermatological and transdermal services to the pharmaceutical, cosmetic,
`
`chemical and agrochemical industries. I understand that my declaration is being
`
`submitted in connection with a Petition for Inter Partes Review of U.S. Patent No.
`
`7,214,506 (the “’506 patent”) (Ex. 1001).
`
`I.
`
`Qualifications, Background, and Experience
`
`2.
`
`I received CBiol and MIBiol degrees in physiology/pharmacology
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`from Stockport Technical College (now Stockport College) in Stockport (United
`
`Kingdom) in 1973, a Ph.D. in Toxicology from University of Strathclyde in
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`Glasgow (United Kingdom) in 1978. I held a post-doctoral position at the
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`University of Michigan from 1978-1980 focusing on transungual delivery. I also
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`held a post-doctoral position at the University of Bath (United Kingdom) from
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`1980-1981 focusing on pharmaceutical formulations. I am currently an elected
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`Fellow of the Royal Society of Biology.
`
`3.
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`I have edited or co-edited 9 scientific and technical books and
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`authored or co-authored over 100 scientific and technical journal articles and book
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`chapters; I am listed as an inventor on 1 U.S. patent, and I have almost 40 years of
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`experience in topical pharmaceutical formulations.
`
`4. While working at ICI's Central Toxicology Laboratory from 1968 to
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`1978, I gained experience in basic scientific techniques. My specialist subjects
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`included renal physiology, gastrointestinal transport mechanisms and percutaneous
`
`absorption. From 1978 to 1980, I completed a postdoctoral fellowship in the
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`laboratories of Dr. Gordon Flynn at the University of Michigan's College of
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`Pharmacy. During this period, I gained knowledge of and experience in drug
`
`delivery into and through the nail plate and the skin. Following a further
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`postdoctoral period at the University of Bath's School of Pharmacy, I was
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`employed by Fisons Pharmaceuticals Ltd. (“Fisons”) to establish a section
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`concerned with skin drug delivery. I worked at Fisons for 5 years from 1981 to
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`1986 as head of a development team, during which time I was involved in the
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`research and development of systems designed to deliver drugs both into and
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`through the skin.
`
`5.
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`During the period at Fisons, I also maintained academic links by
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`acting as the industrial supervisor for several industry funded Council for
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`Advancement and Support of Education-award Ph.D. students at the University of
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`Nottingham and the University of Bath. The Ph.D. projects that I supervised
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`related to the study of dermal and transdermal drug delivery. I co-supervised four
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`Ph.D. students with Professor Jonathan Hadgraft, which involved meeting with the
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`student and Professor Hadgraft to discuss progress and direction of the PhD
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`project.
`
`6.
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`In 1986 I was recruited by the Eastman Kodak Company in Rochester,
`
`New York to work in its emerging Pharmaceutical Division as a transdermal
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`delivery scientist. I resigned from Eastman Kodak in 1987 shortly before its
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`pharmaceutical division, Eastman Pharmaceuticals, was acquired by Sterling
`
`Pharmaceuticals. From 1987 to 1988, I was a senior scientist at Controlled
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`Therapeutics Limited in East Kilbride, Scotland. My work involved leading a
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`team developing hydrogel-based transmucosal formulations for the controlled
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`release of pharmaceuticals, including a formulation related to a morphine
`
`suppository, a drug delivery system inserted into the rectum for the slow release of
`
`morphine after a surgical operation.
`
`7.
`
`In 1988, I formed, with two colleagues, the pharmaceutical contract
`
`organisation Pharmaserve Ltd. (“Pharmaserve”). My specialisation at Pharmaserve
`
`related to dermal and transdermal drug delivery and my work involved conducting
`
`skin permeation tests at rented facilities at An-eX. Between 1988 and 1992, I
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`contributed to the development of dermal and transdermal delivery systems. I
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`subsequently left Pharmaserve and joined An-eX as a Director in 1992. I currently
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`own a 30% share of An-eX. Dr. Keith Brain and Professor Hadgraft also own 30%
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`each, while Dr. Darren Green owns the remaining 10% of the shares of An-eX.
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`8.
`
`An-eX has secure laboratory facilities based at Capital Business Park,
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`Cardiff, UK. The laboratory at An-eX has state-of-the-art equipment for
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`conducting dermal, transungual and transdermal drug delivery techniques (such as
`
`drug release tests and in vitro skin permeation tests) and analytical techniques
`
`(such as microscopy, solubility testing and High Pressure Liquid Chromatography
`
`(“HPLC”)). An-eX has acquired equipment as it has become necessary for its
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`business, including development equipment, such as stability ovens, tube fillers
`
`and crimpers, viscometers and a skin peel adhesion tester. The research and
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`development activities of An-eX focuses primarily in the dermatological,
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`transungual and transdermal fields and includes prediction of permeation,
`
`formulation development, formulation evaluation, assessment of bioequivalence
`
`(including analysis of blood plasma/serum samples), skin penetration enhancement
`
`or retardation, demonstration of efficacy, claim substantiation and risk assessment.
`
`9.
`
`An-eX routinely performs (approximately 10-15 times a year) in vitro
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`human skin permeation studies according to current appropriate guidelines (such as
`
`the American Association of Pharmaceutical Scientists (“AAPS”) and US Food
`
`and Drug Administration (“FDA”) Guidelines (published in 1987 for studies
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`conducted before 2004 and the 2004 OECD Guidelines for studies since 2004).
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`Data generated in the An-eX laboratories has been included in a number of
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`successful submissions to a range of international bodies. In or about 2000 and
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`2005, An-eX took part in inter-laboratory method validation studies, in which
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`laboratories from a number of different countries, including the United States,
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`Australia, South Africa and Europe, worked together to establish and validate
`
`uniform experimental methods for in vitro skin permeation studies.
`
`10. From 2001 to 2004, I had a leave of absence from An-eX to work on
`
`drug delivery to the eye at a specialty pharmaceutical company called Control
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`Delivery Systems Inc (“CDS”) (now, pSivida Inc.) based in Boston, USA. As Vice
`
`President of Research and Development at CDS, I was responsible for all research
`
`and development activities, including obtaining ethical and regulatory approval for
`
`pre-clinical and clinical trials (Phase I, II and III) and for submitting
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`Investigational New Drug submissions (“INDs”) and New Drug Applications
`
`(“NDAs”) with the US Food and Drug Administration (“FDA”). During my time at
`
`CDS, the FDA granted regulatory approval for CDS’s intra-ocular implant
`
`containing fluocinolone acetonide.
`
`11.
`
`I returned to An-eX in 2004 and since then have worked on the
`
`development of several dermatological and transdermal systems.
`
`12. Since the mid-1980s I have regularly attended and presented my work
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`at international conferences in the United States, Europe and Australia relevant to
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`the field of formulation science and percutaneous absorption. Since 1993, I have
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`been a principal organizer of each biennial Perspectives in Percutaneous
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`Penetration Conference, which is the largest and most significant conference in
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`Europe on percutaneous absorption. As one of the principal organisers, I am
`
`responsible for developing the scientific program. This involves reviewing articles
`
`in the field and proposing to the scientific advisory board the most significant
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`research and a corresponding wish list of speakers. I have also organized sessions
`
`and participated in symposia, debates and round-table sessions at AAPS Meetings
`
`and at Gordon Research Conferences since the early 1990s. These are two of the
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`largest and most significant conferences in the United States on formulation
`
`science and percutaneous absorption.
`
`13. A more complete recitation of my professional experience including a
`
`list of my journal publications, patents, conference proceedings, book authorship,
`
`and committee memberships may be found in my Curriculum Vitae and
`
`Publication List, which are attached to my declaration as Appendix A.
`
`II.
`
`Scope of Assignment
`
`14.
`
`I have been retained in this matter by Rothwell, Figg, Ernst &
`
`Manbeck, P.C. (“Rothwell Figg”) as a scientific expert in the field of
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`pharmaceutical formulations and methods, including treatment of fungal infections
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`of the nail and skin using topical formulations. I am being compensated for my
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`work in this matter at my usual and customary rate of $400 per hour. I have no
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`personal or financial stake or interest in the outcome of the Petition for Inter Partes
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`Review or any related action. My compensation in no way depends upon my
`
`testimony or the outcome of the Petition for Inter Partes Review.
`
`15.
`
`I have been advised that Rothwell Figg represents Acrux DDS Pty
`
`Ltd. and Acrux Limited (collectively, “Acrux” or “Petitioners”) in this matter and
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`that Kaken Pharmaceutical Co., Ltd. (“Kaken” or “Patent Owner”) owns the ’506
`
`patent. I have also been advised that the ’506 patent is believed to be licensed to
`
`Valeant Pharmaceuticals International, Inc. and that its subsidiary, Valeant
`
`Pharmaceuticals North America LLC, is the New Drug Application (“NDA”)
`
`holder of the Jublia® NDA (collectively, “Valeant”). I have no personal or
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`financial stake or interest in Acrux, Kaken, Valeant, or the ’506 patent.
`
`III. Materials Considered
`
`16.
`
`In forming the opinions expressed below, I considered the ’506 patent
`
`(Ex. 1001) and its file history (Ex. 1006) (including the prior art cited therein as
`
`well as the alleged priority documents (Exs. 1002, 1007, 1008 and 1011)). I have
`
`also considered the following documents:
`
`(1) A Certified English translation of Japanese Patent Application No.
`
`11/214369 (filed July 28, 1999) (“JP priority document”) (Ex. 1002).
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`(2) A Certified English translation of Japanese Patent Application
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`Publication No. 10-226639 (filed December 1, 1997 and published
`
`August 25, 1998) (“JP ’639”) (Ex. 1011).
`
`(3)
`
`“Synthesis and Antifungal Activities of (2R,3R)-2-Aryl-1-azolyl-3-
`
`(substituted amino)-2-butanol Derivatives as Topical Antifungal Agents,”
`
`by Ogura, H. et al., Chem. Pharm. Bull., 47(10) 1417-1425 (October
`
`1999) (“Ogura”) (Ex. 1012).
`
`(4) U.S. Patent No. 5,391,367 to DeVincentis et al. (filed July 28, 1993)
`
`(issued February 21, 1995) (“’367 patent”) (Ex. 1013).
`
`(5)
`
`“Tioconazole nail solution—an open study of its efficacy in
`
`onychomycosis,” by Hay, R.J., et al., Clinical and Experimental
`
`Dermatology, 10:111-115 (1985) (“Hay 1985”) (Ex. 1014);
`
`(6) Abstracts F78, F79 and F80 from Abstracts of the Interscience
`
`Conference on Antimicrobial Agents and Chemotherapy (ICAAC), 36th
`
`ICAAC, held on September 15-18 (1996) (“Kaken Abstracts”) (Ex.
`
`1015).
`
`(7)
`
`“Management of Onychomycoses,” by Niewerth, M. and Korting, H.C.,
`
`Drugs, 58(2):283-296 (1999) (“Niewerth and Korting”) (Ex. 1026).
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`(8)
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`“Diffusion of water through dead plantar, palmar and torsal human skin
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`and through toe nails,” by Burch, G.E. and Winsor, T., Arch. Derm.
`
`Syphilol., 53: 39-41 (1946) (“Burch and Winsor”) (Ex. 1027).
`
`(9)
`
`“A comparative study of the physicochemical properties of human
`
`keratinized tissues,” by Baden H.P., et al., Biochim. Biophys. Acta.,
`
`322:269–278 (1973) (“Baden”) (Ex. 1028).
`
`(10) “The azole antifungal drugs,” by Hay, R.J., Journal of Antimicrobial
`
`Chemotherapy, 20: 1-5 (1987) (“Hay 1987”) (Ex. 1029).
`
`(11) “Amorolfine nail lacquer: a novel formulation,” by Marty, J.L., Journal
`
`of the European Academy of Dermatology and Venereology, 4 (Supp. 1)
`
`S17-S21 (1995) (“Marty”) (Ex. 1030).
`
`(12) “Epidemiology and ecology of onychomycosis,” by Summerbell, R.C.,
`
`Dermatology, 194 (Supp. 1): 32-36 (1997) (“Summerbell”) (Ex. 1031).
`
`(13) “Ecology and epidemiology of dermatophyte infections,” by Aly, R., J.
`
`Am. Acad. Dermatol., 31:S21–S25 (1994) (“Aly”) (Ex. 1032).
`
`(14) “Onychomycosis: therapeutic update,” by Scher, R.K., Journal of the
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`American Academy of Dermatology, 40 (Suppl):S21–6 (1999) (“Scher”)
`
`(Ex. 1033).
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`(15) “New therapies for onychomycosis,” by Odom, R. B., Journal of the
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`American Academy of Dermatology, 35:3(2): S26-S30 (1996) (“Odom”)
`
`(Ex. 1034).
`
`(16) “Miconazole alcoholic solution in the treatment of mycotic nail
`
`infections,” by Vanderdonckt, J., et al., Mykosen, 19(7):251-256 (1975)
`
`(“Vanderdonckt”) (Ex. 1035).
`
`(17) “Comparison of Two Topical Preparations for the Treatment of
`
`Onychomycosis: Melaleuca alternifolia (Tea Tree) Oil and
`
`Clotrimazole,” by Buck, D.S. et al., The Journal of Family Practice,
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`38(6): 601-605 (1994) (“Buck”) (Ex. 1036).
`
`(18) “Amorolfine- A Review of its Pharmacological Properties and
`
`Therapeutic Potential in the Treatment of Onychomycosis and Other
`
`Superficial Fungal Infections,” by Haria, M. and Bryson, H.M., Drugs,
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`49(1): 103-120 (1995) (“Haria”) (Ex. 1037).
`
`(19) “Ciclopirox nail lacquer 8%: in vivo penetration into and through nails
`
`and in vitro effect on pig skin.” Ceschin-Roques C.G., et al., Skin
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`Pharmacol., 4: 89-94 (1991) (“Ceschin-Roques”) (Ex. 1017).
`
`(20) “Absorption of amorolfine through human nail,” Franz, T.J., Dermatol.,
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`184(Suppl 1): 18-20 (1992) (“Franz”) (Ex. 1018).
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`(21) “Nail penetration of the antifungal oxiconazole after repeated topical
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`application in healthy volunteers, and the effect of acetylcysteine,” by
`
`van Hoogdalem, E.J. et al., Eur. J. Pharm. Sci., 5: 119-127 (1997) (“van
`
`Hoogdalem”) (Ex. 1019).
`
`(22) “Enhancing effect of N-acetyl-L-cysteine or 2-mercaptoethanol on the in
`
`vitro permeation of 5-fluorouracil or tolnaftate through the human nail
`
`plate,” by Kobayashi Y. et al., Chem. Pharm. Bull., 46: 1797-1802
`
`(1998) (“Kobayashi”) (Ex. 1024).
`
`(23) “In vitro permeability of the human nail and of a keratin membrane from
`
`bovine hooves: Influence of the partition coefficient octanol/water and
`
`the water solubility of drugs on their permeability and maximum flux,”
`
`by Mertin, D. and Lippold, B.C., Journal of Pharmacy and
`
`Pharmacology, 49(1): 30-34 (1997) (“Merton and Lippold I”) (Ex. 1021).
`
`(24) “In vitro permeability of the human nail and of a keratin membrane from
`
`bovine hooves: Penetration of chloramphenicol from lipophilic vehicles
`
`and a nail lacquer,” by Mertin, D. and Lippold, B.C., Journal of
`
`Pharmacy and Pharmacology, 49(3): 241-245 (1997) (“Mertin and
`
`Lippold II”) (Ex. 1022).
`
`(25) “In vitro permeability of the human nail and of a keratin membrane from
`
`bovine hooves: Prediction of the penetration rate of antimycotics through
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`the nail plate and their efficacy,” by Mertin, D. and Lippold, B.C.,
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`Journal of Pharmacy and Pharmacology, 49(9): 866-872 (1997)
`
`(“Mertin and Lippold III”) (Ex. 1023).
`
`(26) “The effect of keratolytic agents on the permeability of three imidazole
`
`antimycotic drugs through the human nail,” by Quintanar-Guerrero, D. et
`
`al., Drug. Dev. Ind. Pharm., 24: 685-690 (1998) (“Quintanar-Guerrero”)
`
`(Ex. 1020).
`
`(27) “Measurement of water vapor loss through human nail in vivo,” by
`
`Spruit, D., J. Invest. Dermatol., 56(5): 359-361 (1971) (“Spruit”) (Ex.
`
`1038).
`
`(28) “Bioavailability, skin and nail penetration of topically applied
`
`antimycotics,” Stuttgen, G. and Bauer, E., Mycoses 25: 74-80 (1982)
`
`(“Stuttgen and Bauer”) (Ex. 1016).
`
`(29) “Physicochemical characterization of the human nail: I. Pressure sealed
`
`apparatus for measuring nail plate permeabilities,” by Walters, K.A.,
`
`Flynn, G.L. and Marvel, J.R., J. Invest. Dermatol., 76: 76-79 (1981)
`
`(“Walters 1981”) (Ex. 1039).
`
`(30) “Physicochemical characterization of the human nail: Permeation pattern
`
`for water and the homologous alcohols and differences with respect to
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`the stratum corneum,” by Walters, K.A., Flynn, G.L. and Marvel, J.R., J.
`
`Pharm. Pharmacol. 35: 28-33 (1983) (“Walters 1983”) (Ex. 1040).
`
`(31) “Penetration of the human nail: the effects of vehicle pH on the
`
`permeation of miconazole,” by Walters, K.A., Flynn, G.L. and Marvel,
`
`J.R., J Pharm Pharmacol, 37: 498-499 (1985) (“Walters 1985 I”) (Ex.
`
`1041).
`
`(32) “Physicochemical characterization of the human nail: solvent effects on
`
`the permeation of homologous alcohols,” by Walters, K.A., Flynn, G.L.
`
`and Marvel, J.R., J. Pharm. Pharmacol., 37: 771-775 (1985) (“Walters
`
`1985 II”) (Ex. 1042).
`
`(33) Jublia® (efinaconazole) topical solution, 10% [package insert]. Valeant
`
`Pharmaceuticals North America LLC; 5/2016 (Ex. 1043).
`
`I have also relied upon my education, background, and experience.
`
`IV. Summary of Opinions
`
`17. Based on my investigation and analysis and for the reasons set forth
`
`below, it is my opinion that claims 1 and 2 of the ’506 patent would have been
`
`obvious to one of ordinary skill in the art at the time of the alleged invention in
`
`view of the following combinations of references:
`
`1) JP ’639 in view of Ogura;
`
`2) The ’367 patent in view of Ogura;
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`3) Hay 1985 in view of Ogura;
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`4) JP ’639 in view of the Kaken Abstracts;
`
`5) The ’367 patent in view of the Kaken Abstracts; and
`
`6) Hay 1985 in view of the Kaken Abstracts.
`
`V. Legal Principles Used in Analysis
`
`18.
`
`I am not a patent attorney nor have I independently researched the law
`
`on patentability. Rather, Acrux’s attorneys have explained the legal principles to
`
`me that I have relied on in forming my opinions set forth in this declaration.
`
`A.
`
`19.
`
`Patent Claims in General
`
`I have been informed that patent claims are the numbered sentences at
`
`the end of each patent. I have been informed that the claims are important because
`
`the words of the claims define what a patent covers. I have also been informed that
`
`the figures and text in the rest of the patent provide a description and/or examples
`
`and help explain the scope of the claims, but that the claims define the breadth of
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`the patent’s coverage.
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`20.
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`I have also been informed that an “independent claim” expressly sets
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`forth all of the elements that must be met in order for something to be covered by
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`that claim. I have also been informed that a “dependent claim” does not itself
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`recite all of the elements of the claim but refers to another claim for some of its
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`elements. In this way, the claim “depends” on another claim and incorporates all
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`of the elements of the claim(s) from which it depends. I also have been informed
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`that dependent claims add additional elements. I have been informed that, to
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`determine all the elements of a dependent claim, it is necessary to look at the
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`recitations of the dependent claim and any other claim(s) on which it depends.
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`B.
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`21.
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`Person of Ordinary Skill in the Art
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`I understand that the person of ordinary skill in the art is a
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`hypothetical person who is presumed to have known the relevant art at the time of
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`the invention. Factors that may be considered in determining the level of ordinary
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`skill in the art may include: (A) the type of problems encountered in the art; (B)
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`prior art solutions to those problems; (C) rapidity with which innovations are
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`made; (D) sophistication of the technology; and (E) educational level of active
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`workers in the field. In a given case, every factor may not be present, and one or
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`more factors may predominate.
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`22.
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`I understand that a person of ordinary skill in the art is also a person
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`of ordinary creativity, not an automaton. I further understand that the hypothetical
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`person having ordinary skill in the art to which the claimed subject matter pertains
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`would, of necessity, have the capability of understanding the scientific and
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`engineering principles applicable to the pertinent art.
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`C. Claim Construction
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`23.
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`I understand that, in an inter partes review, claim terms are given their
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`broadest reasonable interpretation consistent with the specification, and that, under
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`the broadest reasonable interpretation standard, the words of a claim are generally
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`given their ordinary and customary meaning as would be understood by a person of
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`ordinary skill in the art in question at the time of the invention in the context of the
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`entire disclosure.
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`24.
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`I also understand that, in determining the meaning of a disputed claim
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`limitation, the intrinsic evidence of record is considered by examining the claim
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`language itself, the written description, and the prosecution history. I further
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`understand that a patentee may act as its own lexicographer and depart from the
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`ordinary and customary meaning by defining a term with reasonable clarity,
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`deliberateness and precision, but that there is a presumption that a claim term
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`carries its ordinary and customary meaning.
`
`D.
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`25.
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`Prior Art
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`I have been informed that the law provides categories of information
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`(known as “prior art”) that may be used to anticipate or render obvious patent
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`claims. I have been informed that, to be prior art with respect to a particular
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`patent, a reference must have been made, known, used, published, or patented, or
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`be the subject of a patent application by another, before the priority date of the
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`patent.
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`26. Further, I have been informed that statements by a patent applicant or
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`patentee, including statements in the patent that something is in the “prior art,” can
`
`constitute prior art that can be used to anticipate or render obvious patent claims.
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`That is, prior art can be created by admissions of the patent applicant or patentee.
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`27.
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`I also understand that a person of ordinary skill in the art is presumed
`
`to have knowledge of all prior art.
`
`E.
`
`28.
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`Priority
`
`I have been informed that in some circumstances, a patentee may have
`
`claimed priority to an earlier application filing date, the date of which is referred to
`
`as a “priority date.” I have been informed that the patentee bears the burden of
`
`demonstrating entitlement to the priority date.
`
`29.
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`I have been informed and understand that a patent is entitled to
`
`the benefit of the filing date of an earlier filed application only if the disclosure of
`
`the earlier application provides sufficient support for the claims of the patent.
`
`F.
`
`30.
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`Patentability
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`I have been informed that a determination of whether the claims of a
`
`patent are rendered obvious by prior art is a two-step analysis: (1) determining the
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`meaning and scope of the claims, and (2) comparing the properly construed claims
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`to the prior art. I have endeavored to undertake this process herein.
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`31.
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`I have been informed and understand that, even if every element of a
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`claim is not found explicitly or implicitly in a single prior art reference, the claim
`
`may still be unpatentable if the differences between the claimed elements and the
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`prior art are such that the subject matter as a whole would have been obvious at the
`
`time the invention was made to a person of ordinary skill in the art.
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`32.
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`I have been informed and understand that a patent claim is obvious
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`when it is only a combination of old and known elements, with no change in their
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`respective functions, and that these familiar elements are combined according to
`
`known methods to obtain predictable results. I have been informed and understand
`
`that the following four factors are considered when determining whether a patent
`
`claim is obvious: (1) the scope and content of the prior art; (2) the differences
`
`between the prior art and the claim; (3) the level of ordinary skill in the art; and (4)
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`additional considerations of objective evidence, sometimes referred to as
`
`“secondary considerations,” tending to prove obviousness or non-obviousness.
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`Additional considerations may include: unexpected, surprising, or unusual results;
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`nonanalogous art; teachings away from the invention; substantially superior
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`results; synergistic results; long-felt, but unmet, need; commercial success;
`
`copying by others; and nearly-simultaneous invention by others. I have also been
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`informed and understand that there must be a connection between these additional
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`factors and the scope of the claim language.
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`33.
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`In determining obviousness based on a combination of prior art
`
`references, I also understand that there must have been a reason to combine the
`
`teachings, and thus reasons for combining the references must be considered, along
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`with any evidence that one or more of the references would have taught away from
`
`the claimed invention at the time of the invention.
`
`34.
`
`I have also been informed and understand that some examples of
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`rationales that may support a conclusion of obviousness include:
`
`(A) combining prior art elements according to known methods to
`
`yield predictable results;
`
`(B) simply substituting one known element for another to obtain
`
`predictable results;
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`(C) using known techniques to improve similar devices (methods, or
`
`products) in the same way;
`
`(D) applying a known technique to a known device (method, or
`
`product) ready for improvement to yield predictable results;
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`(E) choosing from a finite number of identified, predictable solutions,
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`with a reasonable expectation of success—in other words, whether
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`something is “obvious to try;”
`
`