Case IPR2013-00448
`Patent 5,891,453
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_________________________
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`CLIO USA, INC.
`Petitioner
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`v.
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`THE PROCTER & GAMBLE COMPANY
`Patent Owner
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`_________________________
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`Case IPR2013-00448
`Patent 5,891,453
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`_________________________
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`DECLARATION OF DR. HARALD O. HEYMANN
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`Patent 5,891,453
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________________
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_________________________
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`CLIO USA, INC.
`Petitioner
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`v.
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`THE PROCTER & GAMBLE COMPANY
`Patent Owner
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`_________________________
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`Case IPR2013-00448
`Patent 5,891,453
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`_________________________
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`DECLARATION OF DR. HARALD O. HEYMANN
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`Case IPR2013-00448
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`I.
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`INTRODUCTION
`1. My name is Dr. Harald O. Heymann. I am a professor at the
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`University of North Carolina at Chapel Hill (UNC) School of Dentistry. My office
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`mailing address is UNC Chapel Hill School of Dentistry, 442 Brauer Hall, Chapel
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`Hill, NC 27599-7450. I base the following on my personal knowledge and
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`experience, as well as my review of the relevant documents as listed below.
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`2.
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`I have been retained by the Patent Owner, The Procter & Gamble
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`Company, which I will refer to in this report as “P&G.” I have been asked to
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`analyze the validity of certain claims of United States Patent No. 5,891,453, which
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`I will call “the ’453 Patent.”
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`3.
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`I understand that the Petitioner, Clio USA, Inc. (“Clio”), filed a
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`petition for inter partes review of certain claims of the ’453 patent. I further
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`understand that the Patent Trial and Appeal Board (“Board”) instituted proceedings
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`only with respect to claims 1, 19 and 21 of the ’453 patent. I have been asked to
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`compare the challenged claims of the ’453 patent to the references identified by
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`Clio to determine if, in my expert opinion, claims 1, 19 or 21 of the ’453 patent are
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`unpatentable in view of the art relied on by the Board.
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`4.
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`This declaration provides my opinions to date concerning the validity
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`of claims 1, 19 and 21 of the ’453 patent with respect to the references relied on by
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`the Board. I reserve the right to supplement this declaration, if allowed by the
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`Board under the relevant rules, to address any new issues raised by Clio or its
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`expert, or resulting from further rulings of the Board or otherwise from further
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`proceedings.
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`II.
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`PROFESSIONAL BACKGROUND AND EXPERIENCE
`5.
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`Since 1978, I have been a licensed dentist in the State of North
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`Carolina and have participated in a full-service dental practice at UNC. I am
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`currently a Professor of Operative Dentistry at the UNC School of Dentistry. I was
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`Chair of the Department of Operative Dentistry from January 1988 to June 2000
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`and Graduate Program Director from July 2000 to June 2010.
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`6.
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`I am a member of the American Dental Association, the North
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`Carolina Dental Society, and the International Association of Dental Research
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`(Dental Materials Group). I am a fellow of: the Academy of Dental Materials, the
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`International College of Dentists, the American Academy of Esthetic Dentistry,
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`and the American College of Dentists. I am past president of the American
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`Academy of Esthetic Dentistry. I am a consultant to the American Dental
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`Association. I am the Editor-in-Chief of the Journal of Esthetic and Restorative
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`Dentistry. A complete listing of my society memberships is set forth in my
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`Curriculum Vitae, which is attached as Exhibit 2019.
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`7.
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`I received a Bachelor of Arts degree in Biology in 1974 from
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`Appalachian State University. In 1978, I received a Doctor of Dental Surgery
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`degree from the UNC School of Dentistry. In 1980, I received a Masters of
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`Education degree from the UNC School of Education.
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`8.
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`I have authored over 185 publications and have given over 1,300
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`lectures worldwide on esthetic dentistry, the majority of which included a
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`discussion of tooth bleaching. A list of my publications and lectures is set forth in
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`my Curriculum Vitae and Addendum attached as Exhibit 2019.
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`9.
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`I have extensive experience with the development, formulation and
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`application of tooth bleaching compositions. In 1989, I co-authored the landmark
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`paper that is widely considered to be the first publication regarding at-home,
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`nightguard vital bleaching. Haywood VB, Heymann HO: Nightguard vital
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`bleaching. Quintessence Int. 20:173-176, 1989. Since that time I have been
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`involved in numerous clinical trials and research studies involving vital bleaching.
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`III. ORDINARY SKILL IN THE ART
`10.
`I understand that patents are viewed from the perspective of a person
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`of ordinary skill in the art at the time the patent application was filed. I understand
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`that the ’453 patent claims priority to June 6, 1997.
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`11. A person of ordinary skill in the art in early 1997 would have had
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`knowledge in oral care products (including tooth whitening) and associated clinical
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`methods, and/or knowledge of the chemical formulations, properties and/or
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`mechanisms involved in oral care treatments, including tooth bleaching or delivery
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`systems for drugs and other therapeutic substances.
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`12. The usual person with such knowledge would have had at least a
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`Bachelor’s degree (or a commensurate amount of experience), although it was not
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`unusual for a person with such knowledge also to have had an advanced degree.
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`Also, this person may have had some clinical experience administering tooth
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`bleaching products, such as through trays or mouthguards. Alternatively, this
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`person may have had some experience in assessing the chemical formulations,
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`properties and/or mechanisms of such products or delivery systems for drugs and
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`other therapeutic substances. The amount of experience could vary widely, but I
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`believe it would have been between about 1 to 5 years of relevant experience.
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`13.
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`I have read Clio’s position regarding the level of ordinary skill in the
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`art. Petition at 17-18. In my opinion, the level of expertise required under Clio’s
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`recitation of the standard is unrealistic for the time the ’453 patent was filed. Clio
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`has described the level of skill in the art that an expert would have possessed, not
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`an ordinary person.
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`IV.
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`INVALIDITYAND CLAIM CONSTRUCTION
`A. Claim Construction
`14.
`I have been advised that during an inter partes review proceeding, the
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`Patent Office must give claim terms their broadest reasonable interpretation
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`consistent with the specification.
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`B. Anticipation
`15. My understanding of the law is that a patent may be invalid if a prior
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`art reference discloses all of the elements of the claims of that patent. I understand
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`that this is referred to as anticipation. It is my understanding that for a prior art
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`reference to anticipate a particular claim of a patent, the reference must disclose
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`each claim limitation in a single document.
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`C. Obviousness
`16.
`It is my understanding that where a single reference does not disclose
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`all of the limitations of a claim, the claim may still be invalid if all of the
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`limitations are disclosed in multiple references, and it would have been obvious to
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`combine those references. I understand that an obviousness inquiry centers on
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`whether the claimed invention as a whole would have been obvious to one skilled
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`in the art at the time of the invention.
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`17.
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`I further understand that to establish that a claim is obvious based on a
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`combination of elements in the prior art, the law requires a motivation to select the
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`references and to combine them in the particular claimed manner to reach the
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`claimed invention. I understand that the law requires that there must be some
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`articulated reasoning with some rational underpinning to support the legal
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`conclusion of obviousness.
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`18.
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`It is also my understanding that objective evidence of secondary
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`considerations, such as commercial success, industry praise of the invention, long-
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`felt but unsolved needs, and the failure of others, must be considered before
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`determining whether the claimed invention would have been obvious to one of
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`skill in the art at the time of invention.
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`D. Burden of Proof
`19.
`It is my understanding that Clio bears the burden of proving that
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`claims 1, 19 and 21 of the ’453 patent are invalid by a preponderance of the
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`evidence.
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`20.
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`I have applied the standards described above to the best of my ability
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`in my analysis of the validity of claims 1, 19 and 21 of the ’453 patent as described
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`herein.
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`V.
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`SUMMARY OF OPINIONS
`21. Based on my review of the claims, specification and file history of the
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`’453 Patent, as well as the references brought to my attention, I conclude that
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`claims 1, 19 and 21 of the ’453 patent are not obvious in view of any of the
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`references described below.
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`In providing my opinions herein, I have applied my education and
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`22.
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`experience of nearly 36 years in dentistry, including tooth whitening research and
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`clinical treatments. I have considered the issues discussed herein from the
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`perspective of a person having ordinary skill in the art as defined above.
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`VI. THE REFERENCES
`23.
`I understand that the Board instituted proceedings with respect to the
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`following references that Clio relied on its Petition.
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`A. United States Patent No. 2,835,628 to Saffir (“Saffir”)
`24. Saffir (Exhibit 1002) issued on May 20, 1958. The Saffir patent is
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`directed to a means for focal treatment of localized defects in a tooth or a portion
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`of a tooth (as opposed to a plurality of teeth), using a material that physically
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`resembled what was known as “Scotch tape” at the time. Saffir is focused on the
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`controlled delivery of various medicaments or therapeutic agents to a specific area
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`of a tooth, and sealing that area off so that saliva, air, food or other substances
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`common in the oral cavity do not interfere with the medicament. This localized
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`and sealed treatment in Saffir is also for the purpose of preventing toxic and/or
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`potentially harmful substances from spreading and creating irritations elsewhere in
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`the mouth. Further, Saffir is directed to the localized application of a medicament
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`and does not discuss or suggest the generalized treatment of multiple teeth at the
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`same time.
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`It is my understanding that Saffir was before the Patent Examiner
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`25.
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`during prosecution of the ’453 patent.
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`B. United States Patent No. 5,326,685 to Gaglio et al. (“Gaglio”)
`26. Gaglio (Exhibit 1003) issued on July 5, 1994. The Gaglio patent is
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`directed to an applicator for applying a viscous fluid to a surface. Gaglio describes
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`an applicator that includes a backing material made of a closed-cell material and a
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`dispensing material made of an open-celled material The preferred embodiment of
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`Gaglio includes a hollow pocket between the two materials that can be filled with
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`medicaments for skin, oxidizing agents for whitening teeth, makeup remover,
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`moisturizers, etc. These pockets are attached to the site of interest by using a
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`separate piece of adhesive material. The applicator pad described in Gaglio is not
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`particularly thin (approximately 2.4 mm-12.7 mm in thickness), and does not
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`appear to conform to the gaps and interstitial spaces between the teeth and/or
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`between the teeth and the gums.
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`27.
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`It is my understanding that Gaglio was before the Patent Examiner
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`during prosecution of the ’453 patent.
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`C. United States Patent No. 5,462,067 to Shapiro (“Shapiro”)
`28. Shapiro (Exhibit 1006) issued on October 31, 1995. The Shapiro
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`patent is directed to a disposable shield device for keeping food and food particles
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`away from the teeth and gums during eating. The Shapiro device adheres to the
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`gums rather than the teeth, and the figures suggest that the shield is not intended to
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`conform to the shape of the teeth but rather simply has a curved trough-like shape.
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`Shapiro has nothing to do with the treatment or whitening of teeth, nor with the
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`delivery of any substance to the teeth. Rather, Shapiro is intended only to be a
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`barrier or shield to food particles.
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`VII. COMPARISON BETWEEN THE REFERENCES AND CLAIMS 1, 19
`AND 21 OF THE ’453 PATENT
`29. Based on my review of the ’453 Patent, including the file histories
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`leading to that patent, and the references identified in Clio’s Petition, it is my
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`opinion that none of claims 1, 19 or 21 is rendered obvious by any of the Saffir,
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`Gaglio or Shapiro patents, either taken alone or in the combinations identified by
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`Clio.
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`A.
`Saffir/Gaglio
`30. Clio alleges that it would have been obvious to combine Saffir and
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`Gaglio, and that this combination renders obvious claims 1, 19 and 21 of the ’453
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`Patent.
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`31. Clio does not explain why a person of ordinary skill in the art would
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`have been motivated to combine Saffir with Gaglio, and Clio provides no citations
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`or explanation regarding any motivation to combine. In my opinion, a person of
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`ordinary skill in the art would not have been motivated to combine Saffir and
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`Gaglio because there is nothing in the disclosure of Saffir, which is directed to the
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`focal treatment of localized defects in a tooth or a portion of a tooth, that would
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`have motivated a person of ordinary skill in the art to modify the Saffir device for
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`the purpose of whitening a plurality of teeth.
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`32. Even if Saffir and Gaglio were combined, the resulting combination
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`would not render obvious claims 1 or 19 of the ’453 Patent.
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`Claims 1 and 19
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`i.
`It is my understanding that Clio alleges that Saffir discloses all of the
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`33.
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`limitations of claims 1 and 19 of the ’453 patent except for a delivery system that
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`is applicable to a “plurality of adjacent teeth.” Clio concedes that Saffir does not
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`disclose this limitation. In my opinion, Saffir does not disclose any of the other
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`limitations of claims 1 and 19.
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`34.
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`Independent claims 1 and 19 of the ’453 Patent require a strip of
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`flexible material that is “readily conformable to tooth surfaces and to interstitial
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`tooth spaces[.]” In my opinion, Saffir does not disclose a strip that is conformable
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`to the interstitial tooth spaces, as required by claim 1 of the ’453 Patent. Saffir
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`makes no mention of a strip that conforms to the gaps between the teeth. This is
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`not surprising, because Saffir is directed to the treatment of a single tooth or of a
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`specific area of a single tooth.
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`35.
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`Independent claims 1 and 19 of the ’453 Patent also require that the
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`strip of material is readily conformable to tooth surfaces and to interstitial tooth
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`spaces “without permanent deformation when said delivery system is placed
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`thereagainst[.]” I understand that the Board has construed “without permanent
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`deformation” to mean “without permanently conforming to the shape of the teeth.”
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`36.
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`I understand that the only support that Clio provides for its position
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`that Saffir discloses this limitation is that “[T]he cellulosic film physically
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`resembles “Scotch tape” (Exhibit 1002, Saffir at 2:6-7), which is known not to be
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`permanently deformed when used.”
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`37. Clio provides no explanation for this statement. Clio does not explain
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`what are the relevant physical properties of “Scotch tape.” Nor does Clio explain
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`what the properties of a Scotch tape of 1958 might have been or how those
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`properties might differ from a Scotch tape product in 1997. In my opinion, these
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`unsupported conclusory statements are insufficient to establish that Saffir discloses
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`this limitation. I further understand that the Board has rejected a similar inherency
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`argument.
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`38.
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`I also note that none of the figures of Saffir disclose a strip that is
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`readily conformable to the shape of a tooth and its adjoining soft tissue. In fact, all
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`of the figures of Saffir show only the crown and root of a tooth, and do not show
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`any soft tissue.
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`39.
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`Independent claims 1 and 19 of the ’453 Patent also require a delivery
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`system that is applicable to a plurality of adjacent teeth. Clio relies on Gaglio as
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`disclosing this limitation. But Clio does not explain how or why a person of
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`ordinary skill in the art would have been motivated to combine Gaglio with Saffir.
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`In my opinion, a person of ordinary skill in the art would not have been so
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`motivated. Saffir was specifically designed for spot treatments of specific portions
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`of a tooth, or for a single tooth. And while Saffir does mention in one place that it
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`could be used for spot-treating a stain on a portion of a single tooth, a person of
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`ordinary skill in the art would recognize and understand that Saffir was not
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`designed for the type of broader-scale tooth whitening disclosed and claimed in the
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`’453 patent.
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`40.
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`In contrast, it is my opinion that Saffir actually discloses several
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`reasons why one of ordinary skill in the art would not extend it to a plurality of
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`adjacent teeth. Saffir teaches away from a patch being placed across multiple teeth
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`because a stated object of Saffir is “limiting medication to only a given spot or area
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`so that the danger of a strong drug’s spreading where it is not needed and can cause
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`irritation, is eliminated.” Exhibit 1002, Saffir at 1:71-2:2. Saffir further states:
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`“This device contemplates sealing the medicament against the tooth by means of a
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`thin sheath of cellulosic film or the like, one surface of which has been coated with
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`a medicated adhesive.” Id. at 2:3-6. A person of ordinary skill in the art reading
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`Saffir would recognize that applying the single-tooth product of Saffir to a
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`plurality of adjacent teeth would severely compromise Saffir’s stated goal of
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`sealing a medicament against a tooth. A person of ordinary skill in the art would
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`not be motivated to modify the Saffir single-tooth system as Clio contends.
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`41.
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`I understand that Clio may also allege that Gaglio discloses a film that
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`is readily conformable to the tooth surfaces and interstitial spaces. I further
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`understand that Clio may rely on Figures 6-8 of Gaglio. Even if these Figures are
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`sufficient to show a device that has sufficient flexibility to form a curved shape on
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`a plurality of adjacent teeth, they do not disclose a film that is readily conformable
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`to tooth surfaces and to interstitial tooth spaces. And aside from a single
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`conclusory statement, Clio does not provide any explanation as to how or where
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`Gaglio discloses these limitations. Indeed, in my opinion, Gaglio does not disclose
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`these limitations.
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`42. Figures 6-8 of Gaglio all show a device that does not conform to the
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`interstitial tooth spaces. The device of Figure 6 forms a hemispherical shape,
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`contacting only the outermost surfaces of the teeth. And Figures 7-8 show that the
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`device does not conform to the gaps between the teeth and the gums. This can be
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`contrasted with Figures 5-8 of the ’453 Patent, which show a strip that conforms to
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`the interstitial tooth spaces as well as the space between the tooth and the gums.
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`43. The combination of Saffir and Gaglio does not render claims 1 or 19
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`of the ’453 patent obvious.
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`B.
`Saffir/Gaglio/Shapiro
`44. Clio alleges that it would have been obvious to combine Saffir, Gaglio
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`and Shapiro, and that the resulting combination renders claim 21 of the ’453 patent
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`obvious.
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`45. Clio does not explain why a person of ordinary skill in the art would
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`have been motivated to combine Saffir or Gaglio with Shapiro, and Clio provides
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`no citations or explanation regarding any motivation to combine.
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`46. Further, it is my opinion that these references are so fundamentally
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`different, a person of ordinary skill in the art would not have been motivated to
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`combine them. Saffir discloses a means for focal treatment of localized defects in
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`a tooth or a portion of a tooth. Gaglio discloses an applicator for applying a
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`viscous fluid to a surface. To the contrary, Shapiro has nothing to do with dental
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`treatment at all.
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`47. Shapiro’s fundamental goal is “to keep food away from the gums and
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`teeth during eating[.]” See Exhibit 1006, Shapiro at Abstract. In other words, the
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`purpose of Shapiro is to prevent contact of particulates with the teeth. See id. at
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`1:30-33 (“It is accordingly an object of the present invention to provide a
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`disposable shield device to be worn upon the teeth and gums during chewing of
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`food to prevent food particles from lodging between the teeth.”).
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`In contrast, the fundamental operation of the Saffir and Gaglio devices
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`48.
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`is to facilitate contact of materials with teeth. See Exhibit 1002, Saffir at 1:15-17
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`(“This invention relates to a means for the application of various substances or
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`medicaments in therapeutics, and more especially in the treatment of teeth”);
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`Exhibit 1003, Gaglio at Abstract (“It is still another object of this invention to
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`provide an apparatus for applying a whitening agent to a patient’s teeth in a safe
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`and sanitary manner”).
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`49. Shapiro has nothing to do with the treatment or whitening of teeth, nor
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`as a delivery system of any substance to the teeth. Rather, Shapiro is intended only
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`to be a barrier or shield to food particles. Owing to the fundamentally different
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`operation and purpose of Shapiro compared to Saffir and Gaglio, a person of
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`ordinary skill in the art would not consider combining Shapiro with Saffir or
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`Gaglio. Accordingly, it is my opinion that the combination of Saffir, Gaglio and
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`Shapiro cannot render any of the claims of the ’453 Patent obvious.
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`50. Based on my thirty-five years as a practicing dentist involved with
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`tooth bleaching, it is my opinion that, because Shapiro’s device is directed to a
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`fundamentally opposite purpose, no person with ordinary skill in the art would ever
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`have looked to Shapiro in an attempt to modify or improve upon Saffir or Gaglio in
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`any way. Nor would a person of ordinary skill in the art have looked to devices
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`such as braces, retainers, dental picks, toothbrushes, or dental floss.
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`It is also my opinion that a person of ordinary skill in the art at the
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`51.
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`time of the invention concerned with application of substances to the teeth, who
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`had no knowledge of the invention claimed in the ’453 patent, would never have
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`turned to Shapiro—a device designed for the exact opposite function—for
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`guidance.
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`52.
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`In my opinion, there is nothing in the Shapiro patent that would
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`motivate a person of ordinary skill in the art to ever consider using the Shapiro
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`shield as a delivery system for any substance. It is a barrier, and is intended to
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`keep things off of the teeth.
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`53.
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`In light of these deficiencies, and the fact that a person of ordinary
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`skill in the art would not have been motivated to combine the fundamentally
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`different Saffir/Gaglio and Shapiro devices, the combination of Saffir, Gaglio and
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`Shapiro does not render obvious claim 21 of the ’453 Patent.
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`54. Even if Saffir, Gaglio and Shapiro were combined, the resulting
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`combination would not render obvious claim 21 of the ’453 Patent.
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`55. The only thing that Clio cites to in Shapiro for this combination is the
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`disclosure of a “release liner.” Petition at 27-29. Shapiro does not disclose a
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`release liner.
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`56. Clio cites to Shapiro’s disclosure of a “peel-off” paper in support of
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`its argument that Shapiro discloses a release liner. But the “peel off” paper that
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`Shapiro describes is depicted as item “23” in Figure 1 of Shapiro. This is not a
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`release liner that protects the entirety of the shield device. Rather, this is a small,
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`thin piece of paper that provides a covering restricted only to the small strip of
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`adhesive on the device. Exhibit 1006, Shapiro at 2:53-62; see also Figure 1. Prior
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`to use of the Shapiro device, this piece of paper is removed to expose only the
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`small adhesive portion of the device. Id. at 3:1-3. Shapiro does not disclose a
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`release liner as that term is used in claim 21.
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`VIII. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS
`57.
`It is my opinion that Saffir, Gaglio and Shapiro do not render obvious
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`any of the challenged claims of the ’453 patent. It is my additional opinion that
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`secondary considerations, such as the commercial success and industry praise of
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`the P&G Crest Whitestrips® products and the long-felt need that Crest Whitestrips®
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`met, further establish that claims 1, 19 and 21 of the ’453 patent would not have
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`been obvious to a person of ordinary skill in the art at the time of the invention. It
`
`is my understanding that if such evidence exists, it must be considered as part of
`
`the determination of obviousness.
`
`58.
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`I understand that evidence of secondary considerations is only
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`significant if there is a nexus between the claimed invention and the secondary
`
`considerations. I also understand that a nexus is presumed where the marketed
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`product embodies the claimed features, and is coextensive with them.
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`59. As I have explained herein, the references on which Clio relies vary
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`widely in both subject matter and time. In my opinion as described in this
`
`declaration, a person of ordinary skill in the art would not have been motivated to
`
`combine Saffir, Gaglio and Shapiro. Clio has improperly used the benefit of
`
`hindsight to cherry-pick various disclosures from very different references. It is
`
`my understanding that evidence of secondary considerations is especially
`
`important in guarding against this type of hindsight analysis.
`
`A. Commercial Success
`60.
`I understand that commercial success of a product that embodies the
`
`invention may be considered as evidence that the claimed invention would not
`
`have been obvious to a person of ordinary skill in the art at the time of the
`
`invention. It is my understanding that P&G’s Crest Whitestrips® products embody
`
`claims 1, 19 and 21 of the ’453 patent. I have reviewed sales figures provided by
`
`P&G (Exhibits 2016, 2017), and I understand that P&G’s Crest Whitestrips®
`
`products have achieved approximately $3 billion in net sales since their launch in
`
`2000. In my opinion, this level of sales is remarkably significant and constitutes a
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`commercially successful product line.
`
`61.
`
`I have conducted my own assessment of the P&G Crest Whitestrips®
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`products with respect to the “almost/substantially unnoticeable when worn”
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`18
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`Case IPR2013-00448
`Patent 5,891,453
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`limitation. See Section IX below. It is my opinion that the P&G Crest
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`Whitestrips® products embody this limitation.
`
`62.
`
`I have also reviewed the declaration of Dr. Jerry Atwood, dated
`
`March 14, 2014 (Exhibit 2020). I understand that he concludes that the P&G Crest
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`Whitestrips® products embody claims 1, 19 and 21 of the ’453 patent. Based on
`
`my training and my nearly 36 years of experience as a practicing dentist, it is my
`
`opinion that the commercial success of the P&G Crest Whitestrips® products is due
`
`to the claimed features of the ’453 patent, such as being substantially unnoticeable
`
`when worn, being thin and flexible and readily conformable to the curvature of the
`
`teeth and the spaces between the teeth, and providing a substance that both delivers
`
`an active to the teeth and provides the adhesive attachment to the teeth.
`
`B.
`63.
`
`Industry Praise
`
`I understand that industry praise for a product also may be considered
`
`as evidence that the claimed invention would not have been obvious to a person of
`
`ordinary skill in the art at the time of the invention. Based on my nearly 36 years
`
`of experience as a practicing dentist, as well as my extensive history and
`
`experience with tooth bleaching, I understand that the P&G Crest Whitestrips®
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`products have received numerous awards as well as substantial industry accolades.
`
`64.
`
`I have also reviewed documents (See Exhibits 2011-2014), which
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`further confirm my understanding regarding the industry praise of P&G’s Crest
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`19
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`Patent 5,891,453
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`Whitestrips® products. For example, P&G Crest Whitestrips® was named one of
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`the top ten products of the decade (2000-2010). Exhibit 2014. I also understand
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`that Paul Sagel, who was the lead inventor of the ’453 patent, was awarded the SCI
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`Gordon E. Moore Medal for his work relating to P&G’s Crest Whitestrips®
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`products. Exhibit 2015.
`
`65. Based on my training and my nearly 36 years of experience as a
`
`practicing dentist, it is my opinion that the industry praise received by the P&G
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`Crest Whitestrips® products is due to the claimed features of the ’453 patent, such
`
`as being substantially unnoticeable when worn, being thin and flexible and readily
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`conformable to the curvature of the teeth and the spaces between the teeth, and
`
`providing a substance that both delivers an active to the teeth and provides the
`
`adhesive attachment to the teeth.
`
`C. Long-Felt But Unmet Need
`66.
`I also understand that where there was a long-felt but unmet need for a
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`product, and the claimed invention fills that need, this fact also can be considered
`
`as evidence that the claimed invention would not have been obvious to a person of
`
`ordinary skill in the art at the time of the invention. As a practicing dentist and one
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`of the early pioneers of at-home tooth bleaching, I am very familiar with the needs
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`and/or desires of consumers in the tooth whitening field at the time of P&G’s
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`invention.
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`67. At the time of P&G’s invention, the predominant at-home tooth
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`bleaching option was a pre-formed dental tray that the patient filled with a tooth
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`bleaching material and wore at home. This method of tooth bleaching had a
`
`number of undesirable characteristics. For example, it was comparatively
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`expensive and time consuming, it required elastomeric impressions for tray
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`fabrication, multiple trips to the dentist, and it could be uncomfortable. Tray
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`bleaching also required the use of a substantial amount of tooth bleaching material,
`
`the volume of which was difficult to control, often resulting in unwanted side
`
`effects (such as tooth sensitivity, tissue irritation, and occasional sore throat). This
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`method was the most prevalent tooth whitening option for more than a decade
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`before P&G launched its Crest Whitestrips® product.
`
`68.
`
`In my opinion, in the late 1990s there was a long-felt but unsolved
`
`need for an inexpensive, at-home tooth whitening system, that would be non-
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`bulky, easily conformable to the wearer’s teeth, and that could potentially be worn
`
`during normal daily activity without being readily apparent to others. In my
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`opinion, P&G’s Crest Whitestrips® products, which embody claims 1, 19 and 21 of
`
`the ’453 patent, met this long-felt but unmet need. Due to the features claimed in
`
`the Patents-in-Suit, P&G’s Crest Whitestrips®
`
`represented a significant
`
`improvement over traditional tooth whitening approaches, because they virtually
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`eliminated many of the aforementioned problems of tray bleaching. In fact, owing
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`Patent 5,891,453
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`to the claimed attributes, I have recommended P&G’s Crest Whitestrips® products
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`to many patients over the last 13 years.
`
`IX. ALMOST UNNOTICEABLE WHEN WORN
`69.
`I understand that in the parallel litigation, the “almost unnoticeable
`
`when worn limitation was construed to mean “not readily apparent to others when
`
`worn.” Based on my training and experience as a practicing dentist, I concur that
`
`this is how a person of ordinary skill in the art would construe this limitation. I
`
`have applied this construction in my analysis below.
`
`70.
`
`I have inspected certain P&G Crest Whitestrips® products. The
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`products I inspected were labeled PGTTCL00121475 (“Advanced Seal”) (See
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`Exhibit 2027) and PGTTCL00121480 (“Vivid”) (See Exhibit 2029). It is my
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`understanding that these products are representative of the two generations of P&G
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`Crest Whitestrips®. I understand that the “Vivid” product is representative of the
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`“hydrogel” line of P&G Crest Whitestrips® products and has the same appearan
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