EXPERT INVALIDITY REPORT OF DR. JUSTIN C. WILLIAMS
`
`REGARDING U.S. PATENT NO. 9,059,532
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 1
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`

`
`I.
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`INTRODUCTION
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`1.
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`I have been retained by counsel for Natus Medical Inc. (“Natus” or “Petitioner”), and
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`asked to review and provide my opinion on the patentability of claims 1-9 and 13 of U.S. Patent No.
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`9,059,532 (Ex. 1001, “the ʼ532 Patent”) assigned to Nox Medical (“Nox” or “Patent Owner”).
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`2.
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`I am being compensated for my time at my normal consulting rate of $375 per hour.1
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`My compensation is not contingent on the outcome of this proceeding or the content of my opinions.
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`3.
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`I understand that this Report and my opinions will be submitted in connection with a
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`request for inter partes review of the ’532 Patent. Reference to exhibits in this Report is made to exhibits
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`filed with Patent Trial and Appeals Board, including this Report (Ex. 1002), along with the request for
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`inter partes review of the ’532 Patent.
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`II.
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`EXPERT QUALIFICATIONS AND CREDENTIALS
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`4.
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`My curriculum vitae (CV), detailing my educational background and professional
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`experience, is attached as Attachment B. My CV includes a list of all publications I have authored,
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`including all publications from the previous ten years.
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`5.
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`I am currently the chairman of the department of Biomedical Engineering at the
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`University of Wisconsin, a top 20 ranked program amongst United States Universities, and also hold
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`the Vilas Distinguished Achievement Endowed Professorship at the University of Wisconsin.
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`6.
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`I received Ph.D. and M.S. degrees in bioengineering from Arizona State University in
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`2001, and B.S. degrees in mechanical engineering and engineering physics from South Dakota State
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`University in 1995 and 1996, respectively. I am a member of the Biomedical Engineering Society, the
`
`
`1 In the event I am called to testify in connection with this matter, I will be compensated at my
`normal rate for presenting testimony at trial or deposition, which is $550 per hour.
`
`
`
`1
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`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 2
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`

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`Society for Neuroscience and am a fellow of the American Institute for Medial and Biological
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`Engineering.
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`7.
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`My general expertise is in the fields of biomedical engineering, mechanical engineering,
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`engineering physics, and materials. I have worked in the medical device field, including in the research,
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`teaching, design, development, modeling and characterization of medical devices and instrumentation
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`for over 20 years. Throughout this time, I have worked extensively in the area of biomedical electrodes
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`and sensors for measuring physiological function, the technology subject matter of the ’532 Patent
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`that is most relevant to my investigation. I have published more than 100 peer-reviewed manuscripts,
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`with more than half of them devoted to biomedical electrodes and/or instrumentation, and many in
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`top tier journals such as Science Translational Medicine, Nature Communications and Nature
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`Protocols, a complete listing of which is included in my CV (Attachment B). These have collectively
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`been cited more than 4000 times. I have designed and developed biomedical electrodes, connectors
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`and instrumentation for sensing activity from the brain, the peripheral nervous system and the retina.
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`These have been developed for use in a wide range of applications ranging from neural rehabilitation
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`to epilepsy monitoring and sleep research. Almost all of my research and development efforts involve
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`the use of electrodes, instrumentation and connection schemes to arrive at a medical device that is
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`suitable for use in a variety of medical applications. My research and development efforts have
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`garnered numerous awards, including Time Magazine’s top 50 inventions of the year in 2009.
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`8.
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`I also teach classes in areas that are germane to the ’532 Patent. These include:
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`Biomedical Instrumentation, which covers the basics of electronically sensing, amplifying, filtering and
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`analyzing biological signals; Introduction to Neural Engineering, which covers topics related to
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`electrodes for sensing neurological signals; Biological Micro Electro Mechanical Systems, which
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`covers approaches for microfabricating biosensors and mechanical components of biomedical
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`
`
`2
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 3
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`

`
`devices; and Biomedical Design, which exposes students to the design process for developing
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`biomedical devices.
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`9.
`
`I have been a consultant to numerous biomedical device companies regarding device
`
`design and intellectual property considerations, a complete listing of which is included in my CV
`
`(Attachment B). I have been previously retained as a technical expert. A listing of my previous
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`engagements as an expert is included in my CV (Attachment B). I am also a named inventor on several
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`U.S. and international patents related to medical devices and their applications, a complete listing of
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`which is included in my CV (Attachment B).
`
`III. BASIS FOR OPINIONS AND MATERIALS REVIEWED
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`10.
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`The opinions set forth in this expert report and declaration are based on my personal
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`knowledge gained from my education, personal experience, and on the review of the documents and
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`information described in this declaration.
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`11.
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`To prepare this report, in addition to any materials cited in or attached to this Report,
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`I reviewed the ’532 Patent and its file history, Natus’s invalidity contentions and Exhibits A to those
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`contentions, the prior art cited in the invalidity contentions, and the prior art and other references
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`mentioned in this report. I also discussed the legal standards (summarized herein) for construing claim
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`terms, for anticipation and obviousness, and for unenforceability with counsel for Natus. A list of
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`materials reviewed in preparation of this report is attached as Attachment C.
`
`IV.
`
`SUMMARY OF MY OPINIONS
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`12.
`
`It is my opinion that claims 1-9 and 13 of the ’532 Patent are unpatentable. My opinion
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`is based on the level of skill of a person having ordinary skill in the technology area of the ’532 Patent
`
`at the time the application from which it issued was filed, as well as my review of the ’532 Patent, its
`
`file history, and the prior art discussed herein and in Attachment A, incorporated herein by reference.
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`
`
`3
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 4
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`

`
`If the patent owner is allowed to submit additional evidence pertaining to the validity of the ’532
`
`Patent, I intend to review that as well and update my analysis and conclusions as appropriate and
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`allowed under the rules of this proceeding.
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`V.
`
`LEGAL STANDARDS APPLIED
`
`13.
`
`In considering the subject matter of the ’532 Patent and in preparing my opinions as
`
`set forth in this expert report and declaration, I have relied upon certain basic legal principles that
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`counsel for Natus has explained to me. Counsel for Natus provided me with relevant excerpts of the
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`current version of the Federal Circuit Bar Association Model Patent Jury Instructions, a copy of which
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`is attached as Attachment D. The following summarizes my understanding of the relevant principles
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`of claim construction, prior art, anticipation and obviousness. I provide my opinions in this report
`
`based on my understanding of these principles.
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`14.
`
`Counsel for Natus has informed me that because the application which issued as the
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`’532 Patent claims priority to an application filed prior to March 16, 2013, the ’532 Patent is a pre-
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`AIA (first to invent) patent and is subject to requirements of pre-AIA 35 U.S.C. §§ 102 and 103 with
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`respect to prior art and validity. (See MPEP 2159.01, Applications Filed Before March 16, 2013 [R-
`
`11.2013]).
`
`A. Claim Construction
`
`15.
`
`The property right protected by a patent is defined by the claims of the patent, which
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`appear as numbered paragraphs at the end of the text of the patent. Each claim stands on its own
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`when determining infringement or validity. The claims are the “metes and bounds” that define the
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`scope of the property right granted by the patent. Thus, the first step in analyzing either the
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`infringement or validity of a patent claim begins with an analysis of the claims and determination of
`
`
`
`4
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 5
`
`

`
`the precise nature and scope of the invention defined by each claim. This process is referred to as
`
`“claim construction.”
`
`16.
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`The first step in construing a claim is an analysis of how the claim language would be
`
`understood by a person having ordinary skill in the art (“PHOSITA,” also referred to as a person of
`
`ordinary skill in the art) at the time the invention was made. To understand the perspective of a person
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`of ordinary skill in the art, one must determine the field of art to which the patent pertains, and then
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`the background of one of ordinary skill in that art. The terms or phrases used in the claims are also
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`referred to as “claim limitations,” because, as discussed below, they limit what is covered by a claim.
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`Typically, claims that use different claim language are construed to be of different scope.
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`17.
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`After reviewing the precise language used in the claim, the patent specification and
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`prosecution history are reviewed to ensure that that they do not alter the way one skilled in the art
`
`would understand a claim limitation. At times, the specification might provide further clarification as
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`to the meaning of a claim limitation, including exemplary embodiments of one or more claimed
`
`inventions. However, claims are not limited to the disclosed embodiments, and claim limitations
`
`should not be narrowly construed solely because the disclosed embodiment contains a particular
`
`feature.
`
`18.
`
`Statements made by a patent applicant during prosecution of the patent application
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`can provide further clarification as to the meaning of a claim limitation. For example, the applicant
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`may make specific statements about the claimed invention or scope of the claims to argue that the
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`claims are distinguishable from and therefore allowable in view of prior art raised by an examiner. In
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`addition, the applicant may make other statements about the claimed invention or scope of the claims
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`vis-à-vis the prior art to correct or otherwise inform the examiner of the applicant’s understanding of
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`the scope of the claimed invention, claims, and claim terms. In addition to the claim language, the
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`patent specification and prosecution history (the “intrinsic sources”) are the preferred evidence for
`
`
`
`5
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 6
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`

`
`claim construction. Other outside evidence, such as prior art, dictionaries, encyclopedias, and treatises
`
`(“extrinsic sources”) may be used to demonstrate how one skilled in the art would have understood
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`specific terms or phrases recited in a claim at the time the invention was made, as well as to inform
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`the Court as to the state of the art at that time.
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`19.
`
`For purposes of an inter partes review proceeding (“IPR”) before the Patent Trial and
`
`Appeals Board (“PTAB”), I understand that each challenged claim must be given its “broadest
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`reasonable construction” or “broadest reasonable interpretation” (“BRI”) in light of the specification.
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`I am informed that the BRI standard dictates that claim terms be given their ordinary and customary
`
`meaning, as would be understood by a PHOSITA in the context of the entire disclosure. I further
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`understand that if a PHOSITA would understand the ordinary and customary meaning of a claim
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`term to reasonably encompass different or alternate meanings, then the BRI for the claim or claim
`
`term includes all such construction or interpretations of the claim or claim term. I also understand
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`that a patentee can be his own lexicographer; however, I further understand that any special definition
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`for a claim term must be set forth in the specification with reasonable clarity, deliberateness, and
`
`precision.
`
`20.
`
`I understand that the terms of the claims of the ’532 Patent have not been construed
`
`by the PTAB or by a Court. I reserve the right to supplement my expert report and declaration based
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`on alternative constructions proposed by the Patent Owner and the constructions adopted by PTAB
`
`and/or Court to the extent that these constructions differ from the ordinary and customary meaning
`
`of those terms as proposed by Natus.
`
`21.
`
`For purposes of this expert report and declaration, and my opinions expressed herein,
`
`I have interpreted the claim terms according their ordinary and customary meaning, consistent with
`
`how those terms would be understood by a PHOSITA under the broadest reasonable construction in
`
`view of the specification.
`
`
`
`6
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 7
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`

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`B. Prior Art
`
`22.
`
`“Prior art” refers to knowledge or information in the public domain before the earliest
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`priority date of a patent (generally based on its application date or the earliest filing date of an
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`application to which the patent claims priority). Prior art can establish that a claimed invention is not
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`new or is obvious. Prior art may include items that were publicly known or that have been used or
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`offered for sale or publications or patents that disclose the claimed invention or elements of the
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`claimed invention.
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`23.
`
`To be statutory prior art under the pre-AIA 35 U.S.C. § 102(a), an item must have
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`been known or used by others in the United States, or patented or described in a printed publication
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`in this or a foreign country, before the invention thereof by the patent applicant. Prior art defined by
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`the pre-AIA 35 U.S.C. § 102(b) includes references that were patented or described in a printed
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`publication in this or a foreign country or in public use or on sale in the United States more than one
`
`year prior to the earliest date to which the patent claims priority. Finally, the pre-AIA 35 U.S.C. §
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`102(e) defines inventions described in a U.S. patent application “by another” before the claimed
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`invention by the applicant as prior art. Counsel for Natus has informed me that a U.S. patent
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`application “by another” means any U.S. patent application that names different inventors than the
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`challenged patent. Counsel for Natus has further informed me that the existence of one or more
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`inventors in common between the prior filed U.S. patent application and the challenged patent is
`
`immaterial, i.e., under pre-AIA 35 U.S.C. § 102(e), any difference in inventorship between the prior
`
`filed U.S. patent application and challenged patent means that the prior filed U.S. patent application
`
`is “by another.”
`
`24.
`
`Counsel for Natus has further explained to me that in addition to statutory prior art, a
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`statement made by an applicant or patentee identifying the work of another as “prior art” is an
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`admission which can be relied upon for both anticipation and obviousness determinations, regardless
`
`
`
`7
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 8
`
`

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`of whether the admitted prior art would otherwise qualify as prior art under the statutory categories
`
`of prior art.
`
`C. Anticipation
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`25.
`
`In order for an applicant to be entitled to a patent, the claimed invention must actually
`
`be “novel” or “new” and not already known. A patent claim is invalid as anticipated under 35 U.S.C.
`
`§ 102 (pre-AIA) if a single prior art reference (e.g., a patent or publication) discloses every limitation
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`recited in the claim. If the prior art reference teaches all the limitations as recited in the claim, that
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`claim is not new but is “anticipated” by the prior art reference, and consequently is invalid. For
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`example, if a claim specifies the limitations of A, B and C, and a prior art reference teaches at least
`
`elements A, B and C, the claim is anticipated and invalid.
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`26.
`
`For a prior art reference to “teach” the limitations of a claim, a person of ordinary skill
`
`in the art must recognize the limitations as disclosed, expressly or inherently, in that single reference.
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`To the extent the claim specifies a relationship between the limitations, the disclosed limitations must
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`be in the same relationship as recited in the claim.
`
`D. Obviousness
`
`27.
`
`If a single prior art reference does not disclose all limitations of a claim, the claim may
`
`nonetheless be invalid as obvious under 35 U.S.C. § 103 (pre-AIA). For a claim to be obvious, all
`
`limitations of the claimed invention must be present in a combination of prior art references, or in
`
`one or more prior art references combined with the knowledge generally possessed by one of ordinary
`
`skill in the art. Thus, if a claim specifies the limitations A, B and C, and one reference shows only A
`
`and B, limitation C must be disclosed in a separate reference or, alternatively, must be part of the
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`general knowledge of a person of ordinary skill in the art.
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`28.
`
`That each and every element of a claimed invention exists in the prior art does not
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`necessarily prove obviousness, because most inventions are combinations of known elements. A
`
`
`
`8
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 9
`
`

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`claimed invention is therefore obvious if, at the time the claimed invention was made, there was a
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`basis or reason for a person of ordinary skill in the art to have been motivated to combine the known
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`elements in the way that the claimed invention does. Such rational bases that support a finding of
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`obviousness include, but are not limited to: (1) whether the claimed invention is merely the predictable
`
`result of using prior art elements according to their known function(s); (2) whether the claimed
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`invention is an obvious solution to a known problem; (3) whether the prior art teaches or suggests the
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`desirability of combining the claimed elements; (4) whether it would have been obvious to try the
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`claimed combination of elements, such as when there is a design need or market desire to solve the
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`problem using a finite number of identified predictable solutions; and (5) whether the claimed
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`combination resulted from design incentives or changes in the market and relevant technology. It is
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`improper to use hindsight in assessing obviousness by, for example, using the claim as a template for
`
`piecing together components (or steps) found in separate prior art references. Furthermore, a person
`
`skilled in the art must have a reasonable expectation of success that the references combined to
`
`establish obviousness would result in the claimed invention.
`
`29.
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`The following factual inquiries are also employed in an obviousness determination: (1)
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`the level of ordinary skill in the art; (2) the scope and content of the prior art; (3) the differences
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`between the prior art and the claims at issue; and (4) other objective evidence of non-obviousness,
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`commonly referred to as “secondary considerations.” These secondary considerations include
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`commercial success of the claimed invention(s); long felt but unresolved needs satisfied by the claimed
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`invention(s); copying of the claimed invention by others; the failure of others to make the claimed
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`invention(s); licensing of the patent by others; and unexpected results achieved by the claimed
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`invention(s).
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`VI.
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`PERSON HAVING ORDINARY SKILL IN THE ART (“PHOSITA”)
`
`
`
`9
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 10
`
`

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`30.
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`I understand that the hypothetical person having ordinary skill in the art is presumed
`
`to have knowledge of all references that are sufficiently related to one another and to the pertinent
`
`art, and to have knowledge of all arts reasonably pertinent to the particular problem that the claimed
`
`invention addresses. I also understand that a person of having ordinary skill in the art is a person of
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`ordinary creativity, not an automaton. A person having ordinary skill in the art is therefore capable of
`
`drawing inferences and taking creative steps. I understand that the hypothetical person of ordinary
`
`skill is a person having ordinary skill in the art at the time of the alleged invention.
`
`31.
`
`Based on my review of the ’532 Patent, the prosecution history of the ’532 Patent, and
`
`my personal and professional experience and training, it is my opinion that the field of the art of the
`
`’532 Patent is medical devices (including device design, fabrication, manufacturing, and materials of
`
`the same) and that one of ordinary skill in the art pertaining to the ’532 Patent, at the time of its
`
`alleged invention, would hold a Bachelor’s degree in mechanical engineering, bio-medical
`
`engineering, or an equivalent field from an accredited university, and have approximately one
`
`year of relevant experience in industry or academia. Alternately, a person of ordinary skill in
`
`the art the time of the alleged invention of the ’532 Patent could hold an associate’s degree in
`
`mechanical design or an equivalent field from an accredited university, and have approximately
`
`three years of relevant experience in the design of medical devices. Further alternatively, a person of
`
`ordinary skill in the art the time of the alleged invention of the ’532 Patent could hold a Master’s
`
`or Doctorate’s degree
`
`in mechanical engineering, bio-medical engineering, or an equivalent
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`field from an accredited university. Such level of ordinary level of skill in the art is consistent with
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`the level of skill in the field of those developing electro-mechanical medical devices such as that
`
`disclosed and claimed by the ’532 Patent at the time of the alleged invention of the ’532 Patent.
`
`32.
`
`As evidenced by my training and experience, documented herein, and in my curriculum
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`vitae attached as Attachment B, I have been a person having at least ordinary skill at the time of and
`
`10
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 11
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`

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`prior to the earliest filing date to which the ’532 Patent claims priority. Based on my professional
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`career both in industry and in academia, I have both worked with and taught persons having ordinary
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`skill in the field of medical devices. As such, I am personally familiar with the knowledge and
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`understanding of persons of ordinary skill in this field. All opinions expressed in this report are to a
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`reasonable degree of scientific certainty and are expressed from the vantage point of one of ordinary
`
`skill in the art, at the time of the alleged invention of the ’532 Patent.
`
`VII. TECHNOLOGY BACKGROUND
`
`A. Electrode Belts
`
`33.
`
`Electrode belts have been long known in the medical device field to position and fix
`
`sensory devices to the body of a patient. (See, e.g., U.S. Patent No. 4,026,278, titled “Electrode
`
`positioning and retaining belt,” issued May 31, 1977). Traditionally, the term “electrode” refers to a
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`conductive or sensing device applied directly to the skin of a patient. In some instances, an “electrode”
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`is a sensor used to ascertain electrical phenomena arising from physiological functions, for example,
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`electrocardiographic (ECG) data associated with heart function. Alternately, an “electrode” is used to
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`deliver electrical current to the skin of a patient, for example to stimulate nerves for therapeutic
`
`purposes by Transcutaneous Electrical Nerve Stimulation (TENS).
`
`34.
`
`Whether used to detect or deliver electrical current to the skin of a patient, it is
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`common for multiple electrodes to be placed on the body of a patient. When applied individually,
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`electrodes are attached to the skin of a patient by a variety of means including, by suction, adhesives,
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`adhesive patches, etc. The electrode must also be connected to the device that is measuring or
`
`delivering electrical current. Accordingly, each electrode has an associated electrode wire.
`
`35.
`
`Electrode belts provide an alternative to the individual placement of electrodes, and
`
`allow multiple electrodes to be positioned on (and removed from) a patient’s body simultaneously.
`
`Thus, electrode belts are often used to simplify and standardize the application of electrodes on a
`
`11
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 12
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`

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`body. In addition, electrode belts often are configured to route and organize the wires that run between
`
`each electrode and the associated medical device. Accordingly, electrode belts can minimize the effort
`
`associated with running discrete wires from each electrode to its associated device and help to organize
`
`and avoid a tangle of wires that can result when multiple electrode connections are made. As explained
`
`in the following section, respiratory inductance plethysmography belts (understood by PHOSITAs to
`
`be type of electrode belt) provide a mechanism for encircling a portion of a patient’s torso without
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`exposed or tangled wires.
`
`B. Respiratory Inductance Plethysmography (RIP) Belts2
`
`36.
`
`Respiratory Inductance Plethysmography (RIP) is a non-invasive method of
`
`monitoring respiration by monitoring the inductive changes in a wire loop that encircles the chest
`
`(and/or abdomen) of a patient. (See, e.g., U.S. Patent No. 4,308,872, titled “Method and Apparatus for
`
`Monitoring Respiration,” issued January 5, 1982). U.S. Patent No. 4,308,872 discloses a pair of RIP
`
`belts that encircle a person’s torso and abdomen to monitor the respiration of the person. (Id. fig. 2;
`
`see also id. col. 4 ll. 47-61 (describing the preferred construction of an RIP belt from “tubular stretch
`
`bandage” with a conductive wire attached in a zig-zag pattern thereto)).
`
`
`2 RIP belts are technically a transducer or inductance belt, as RIP belts do not typically include or
`connect to an electrode attached to the skin of a patient. It is, however, common in the medical device
`field for RIP belts to be referred to as a type of electrode belt. In fact, the ’532 Patent expressly groups
`RIP belts as a type of known electrode belts. (’532 Patent, col. 1 ll. 12-14). Accordingly, PHOSITAs
`would consider RIP belts to be part of the field of medical devices that encompasses electrode belts.
`
`
`
`12
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 13
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`

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`(U.S. Patent No. 4,308,872 fig. 2).
`
`
`
`37.
`
`RIP technology is based on the inductive properties of a conductive wire loop, which
`
`varies proportionally based on the cross-sectional area encircled by the loop. The inductance of a wire
`
`loop can be calculated according to the following formula, where L is inductance, μ0 is the magnetic
`
`constant of the wire, N is the number of loops, A is the cross-sectional area, and l is the length of the
`
`wire.
`
`38.
`
`Thus, when a wire loop is incorporated in an RIP belt worn around the torso of a
`
`
`
`person, the inductance of the wire changes along with the normal torso expansion and contraction
`
`associated with a person’s breathing. The monitoring device connected to the RIP belt can detect and
`
`
`
`13
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 14
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`

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`record the changes in inductance and such collected data can be used to determine various information
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`regarding a person’s respiration, including respiratory rate and volume.
`
`C. Relevant Materials Properties
`
`39.
`
`Two interrelated mechanical properties of real (i.e., not theoretical) materials are of
`
`particular relevance to the claims of the ’532 Patent: the elastic (or Young’s) modulus and the flexural
`
`modulus. The claims at issue are all directed to a “molded plastic frame including a receiving hole
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`having radial flexibility.” (See ’532 Patent, Claim 1). A “hole” has “flexibility” only to the extent the
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`material that bounds or defines the hole exhibits flexibility. As discussed in greater detail herein, all
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`elastic materials (metals, polymers (or plastics) and elastomers) exhibit “flexibility” or the ability to
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`deform under stress (force/area) and return to their original shape. Thus, it is an immutable fact that
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`a hole bounded by an elastic material is flexible, or has “radial flexibility.”3 Further, PHOSITAs
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`developing electrode connectors fully appreciated the importance of these material properties before
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`the earliest priority date of the ’532 Patent in selecting an appropriate material to create the desired fit
`
`between an electrode and the connector to which the electrode is connected. (See, e.g., Ex. 1010 (U.S.
`
`Patent No. 5,326,272, issued July 5, 1994) col. 3 ll. 30-35 (“The composition of the connector body
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`10 is chosen so as to provide sufficient resilience or compressibility in the sides 18a-18b of channel
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`18 and stop 30 to cause, e.g., an electrode post, to ‘snap’ into place adjacent stop 30, thereby providing
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`a secure restriction fit.”); see also, e.g., Ex. 1018 (U.S. Patent 8,251,736, filed September 23, 2008) col. 5
`
`l. 49-col. 6 l. 32 (describing an electrode connector retention plate as “sufficiently resilient” to deform
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`
`3 As discussed in greater detail herein, elastic materials have different moduli of elasticity which is the
`measure of a material’s stiffness (or lack of flexibility). Accordingly, the moduli of elasticity of the
`material that bounds or defines a hole will dictate the relative flexibility of the material under loads
`applied radially (i.e., normal or perpendicular) to the surface of the material that bounds the hole.
`Depending on the geometry of the structure that defines the hole and the applied loads, the flexural
`modulus of the material, separately discussed herein, may also be relevant.
`
`
`
`
`14
`
`Natus Medical Inc., Natus Neurology Inc.,
`Embla Systems LLC and Embla Systems Ltd.
`Ex. 1002, p. 15
`
`

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`and rebound so that an opening (hole) in the retention plate fits over and holds the electrode
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`connector to the “stud of a conventional snap-fit electrical contact.”)).
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`1. Elastic Behavior and Elastic Modulus (Young’s Modulus or Tensile
`Modulus)
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`40.
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`A basic principle of solid materials is that solids can be deformed when subjected to
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`an external load. It is further well-known and understood that most solids (and the vast majority of
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`engineering materials) exhibit elastic behavior, meaning that up to a certain applied load (known as the
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`elastic limit) the solid will return to its original dimensions when the load is removed. For many
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`materials, as long as the load does not exceed the elastic limit, the deformation is proportional to the
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`applied load. This relationship is known as Hooke’s law4 and is more frequently stated as “stress is
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`proportional to strain.” The proportional relationship between the applied stress (force per unit area)
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`and the resultant strain is known as the Young’s modulus (also referred to tensile or elastic modulus) of
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`the material. The resultant strain (change in dimension divided by the original dimension) for a given
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`applied stress for a material can be calculated according to the following formula, where e is the
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`resultant strain, σ is the applied stress and E is the Young’s modulus of the material.
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`
`
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`4 Hooke’s law requires that the load-deformation relationship be linear, which is generally true for
`most engineering metals up to their respective elastic limits. Other materials, like rubber, for example,
`exhibit elastic behavior, but have a non-linear load-deformation relationship, meaning that the strain
`rate of the material varies with the amount of applied stress. Although polymers do not exhibit a
`perfectly linear relationship, the load-deformation relationship for polymers can generally be
`approximated by a linear relationship. Thus, as shown in Table 1, there are commonly accepted elastic
`modulus values for many engineering polymers. These values allow the relative stiffness of different
`polymers to be compared with one another and with other materials. In addition, the elastic modulus
`values for poly