UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
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`KSP Co. LTD
`Petitioner
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`v.
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`GUALA PACK S.P.A,
`Patent Owner
`__________
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`IP Case No. IPR2016-01065
`Patent 8,528,757
`__________
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`
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`DECLARATION OF HOWARD R. LEARY
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`IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 8,528,757
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`TABLE OF CONTENTS
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`Page
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`I. 
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`II. 
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`INTRODUCTION ........................................................................................... 1 
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`EXPERT QUALIFICATIONS AND CREDENTIALS .................................. 1 
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`III.  BASIS FOR OPINIONS, AND MATERIALS REVIEWED ......................... 3 
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`IV.  SUMMARY OF MY OPINIONS ................................................................... 5 
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`V. 
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`LEGAL STANDARDS APPLIED .................................................................. 6 
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`A.  Anticipation ........................................................................................... 6 
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`B. 
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`C. 
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`Obviousness ........................................................................................... 9 
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`Claim Interpretation in Inter Partes Review ....................................... 16 
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`VI.  THE PERSON OF ORDINARY SKILL IN THE ART ............................... 16 
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`VII.  TECHNOLOGY BACKGROUND ............................................................... 17 
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`A.  Overview of Tamper Evident Containers ........................................... 17 
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`B. 
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`Overview of Non-Choke Caps ............................................................ 18 
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`VIII.  THE ’757 PATENT ....................................................................................... 20 
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`A. 
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`B. 
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`C. 
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`Features and Embodiments of the ’757 Patent .................................... 20 
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`Claims of the ’757 Patent .................................................................... 22 
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`Grounds of Unpatentability ................................................................. 29 
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`IX.  THE PRIOR ART .......................................................................................... 29 
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`A.  Overview of Julian .............................................................................. 29 
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`B. 
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`C. 
`
`D 
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`Overview of Marshall .......................................................................... 31 
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`Overview of Tacchella ........................................................................ 33 
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`Overview of Vaughan ......................................................................... 34 
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`E 
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`Overview of Kimura ............................................................................ 35 
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`D.  A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Combine Julian and Marshall ........................................ 36 
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`E. 
`
`F. 
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`A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Combine Julian, Marshall and Tacchella ...................... 38 
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`A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Combine Julian, Marshall and Kimura .......................... 39 
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`G.  A Person of Ordinary Skill in the Art Would Have Been
`Motivated to Combine Julian, Marshall and Kimura .......................... 41 
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`X.  OPINIONS IN SUPPORT OF GROUNDS OF UNPATENTABILITY
`OF CLAIMS 1-16 .......................................................................................... 42 
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`A. 
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`B. 
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`C. 
`
`D. 
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`E. 
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`Julian Renders Claims 1-3 and 10 Obvious ........................................ 42 
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`Julian in View of Marshall Renders Claims 1-3 and 10
`Obvious ............................................................................................... 50 
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`Julian in View of Marshall and Further in View of Tacchella
`and Vaughan Renders Claims 1-12 Obvious ...................................... 52 
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`Julian in View of Marshall and Further in View of Tacchella
`and Vaughan Renders Claims 1-12 Obvious ...................................... 56 
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`Julian in View of Marshall and Further in View of Kimura
`Renders Claims 13-16 Obvious .......................................................... 58 
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`XI.  CONCLUSION .............................................................................................. 74 
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`I, Howard R. Leary, declare:
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`I.
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`INTRODUCTION
`1.
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`My name is Howard R. Leary. I presently work as an
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`independent engineering consultant specializing in packaging technology. In
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`addition, I work as an independent expert witness.
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`2.
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`I have been retained by KSP Ltd. Co. ( “Petitioner”) to provide
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`my expert opinions regarding U.S. Patent No. 8,528,757 (“the ’757 Patent”). More
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`specifically, I have also been asked to compare Claims 1-16 (“the IPR Claims”) of
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`the ’757 Patent to prior art patents and publications, and to render an opinion on
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`the validity of those claims. I submit this Declaration in support of Petitioner’s
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`petition for Inter Partes Review of the ’757 Patent.
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`3.
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`I am being compensated for my work in this matter at a rate of
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`$250 per hour. I am also reimbursed for my reasonable expenses incurred in
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`connection with my work on this proceeding. My compensation in no way
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`depends upon the outcome of this proceeding.
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`II. EXPERT QUALIFICATIONS AND CREDENTIALS
`4.
`My qualifications for presenting the opinions in this declaration
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`are set forth in my curriculum vitae, a copy of which is attached as Appendix A to
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`this Declaration.
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`5.
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`I am a licensed Professional Engineer. I received a Bachelor of
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`Sciences in Mechanical Engineering and Master of Sciences in Mechanical
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`Engineering from the Newark College of Engineering (presently known as New
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`Jersey Institute of Technology.)
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`6.
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`As reflected in my curriculum vitae, I also have more than 30
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`years of experience as a member of technical staff, manager of technical staff,
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`consultant, author, and visiting lecturer, in the packaging industries.
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`7.
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`With respect to these industries, I have designed, and directed
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`the design of numerous packages of varying types as well as packaging machinery.
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`When the Tylenol poisonings of 1982 occurred, I was Manager of Packaging
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`Engineering at a Johnson and Johnson company and I became actively involved in
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`the design and production of tamper evident technologies. I have continued to
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`work on those technologies since that time. I have worked with the design of
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`numerous container caps and closures and developed the injection mold tooling to
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`produce them.
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`8.
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`As of October 27, 2006—the alleged priority date of the ’757
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`Patent—I had (i) a master’s degree in mechanical engineering; (ii) over thirty years
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`of experience in the design and development of packaging; (iii) had published 21
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`technical articles and a textbook chapter; (iv)made 16 technical presentations and
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`(v) ran several packaging training courses. Thus, as of the alleged priority date of
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`the ’757 Patent, I was at least a person of ordinary skill in the art of the ’757 Patent
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`(Section VI, infra), and I had direct personal knowledge of the technologies
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`described in the ’757 Patent.
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`9.
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`I have received the following awards and recognitions:
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` Past President and Chairman of the Institute of Packaging
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`Professionals
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` Ameristar and Worldstar awards for package design.
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`III. BASIS FOR OPINIONS, AND MATERIALS REVIEWED
`10.
`The opinions set forth in my declaration are based on my
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`personal knowledge gained from my education, personal experience, and on the
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`review of the documents and information described in this Declaration.
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`11.
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`In preparation of this Declaration, I have reviewed:
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` U.S. Patent No. 8,528,757, “Cap For Container Provided With
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`Guarantee Seal,” to Bisio et al., filed April 10, 2009, granted
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`September 10, 2013, (“the ’757 Patent”) (Ex. 1001);
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` U.S. Patent No. 5,056,675, “Tether Web Ratchet Drive Tamper
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`Indicating Band Closure,” to Julian, issued January 18, 1991
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`(“Julian”) (Ex. 1003);
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` U.S. Patent No. 5,853,095, “Tamper Evidence Splitting Closure,” to
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`Marshall, et al., issued December 29, 1998 (“Marshall”) (Ex. 1004);
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` U.S. Design Patent No. D547,657, “Closure for Containers,” to
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`Tacchella, filed December 24, 2002 (“Tacchella”) (Ex. 1005);
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` U.S. Patent Publication no. US2005/0011911 A1, “Closure” to
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`Vaughan, published January 20, 2005 (“Vaughan”) (Ex. 1006);
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` U.S. Patent No. 4,669,124, “Beverage Container With Tamperproof
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`Screwthread Cap,” to Kimura, issued May 26, 1987 (“Kimura”) (Ex.
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`1007);
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` U.S. Patent No. 4,545,496, “Plastic Closure with Mechanical Pilfer
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`Band,” to Wilde, et al., issued October 8, 1995 (“Wilde”) (Ex. 1008);
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` U.S. Patent No. 4,305,516, “Bottle Cap With Guarantee Strip,” to
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`Perne, et al., issued December 15, 1981 (“Perne”) (Ex. 1009);
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` U.S. Patent No. 4,813,562, “Reversed Band For Tamper Evidence
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`Cap,” to Begley, issued May 21, 1989 (“Begley”) (Ex. 1010);
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` U.S. Patent No. 6,202,871, “Vented Beverage Closure” to Kelly,
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`issued March 20, 2001 (“Kelly”) (Ex. 1011);
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` U.S. Patent Publication no. 2006/0043056A1, “Spout Assembly For
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`Liquid Container” to Lee, published March 2, 2006 (“Lee”) (Ex.
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`1012);
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` U.S. Patent No. 5,716,152, “Writing Tool” to Kudo, issued February
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`10, 1998 (“Kudo”) (Ex. 1013.)
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` FDA Compliance Policy Guides Section 450.500 Tamper Resistant
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`Packaging Requirements, Revised May 21, 1992 (Ex. 1014); and
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` The File History of the ’757 Patent (“the ’757 File History”) (Ex.
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`1015).
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`IV. SUMMARY OF MY OPINIONS
`12.
`My opinions expressed herein are in support of the Inter Partes
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`Review of the ’757 Patent Claims 1-16.
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`13.
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`It is my opinion that:
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`a. Claims 1-3, and 10 are invalid under 35 U.S.C. §103(a) as being
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`obvious over Julian;
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`b. Claims 1-3, and 10 are invalid under 35 U.S.C. §103(a) as being
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`obvious over Julian in view of Marshall;
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`c. Claims 4-9 are invalid under 35 U.S.C. §103(a) as being obvious
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`over Julian in view of Marshall and further in view of Tacchella;
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`d. Claims 11-12 are invalid under 35 U.S.C. §103(a) as being
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`obvious over Julian in view of Marshall and further in view of
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`Vaughan; and
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`e. Claim 13-16 are invalid under 35 U.S.C. §103(a) as being obvious
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`over Julian in view of Marshall and further in view of Kimura.
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`V. LEGAL STANDARDS APPLIED
`14.
`In preparing and expressing my opinions and considering the
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`subject matter of the ’757 Patent, I am relying on certain basic legal principles that
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`counsel have explained to me. These principles are discussed below.
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`A. Anticipation
`15.
`I have been informed by counsel that a patent claim is invalid as
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`anticipated if each element of that claim is present either explicitly or inherently in
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`a single prior art reference. I have also been informed that for a claim element to
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`be inherently present in a prior art reference, the claim element must be
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`“necessarily present” in the disclosed apparatus, system, product, or method, and
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`not probably or possibly present. In other words, the mere fact that the apparatus,
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`system, product, or method described in the prior art reference might possibly (or
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`sometimes) practice or contain a claimed limitation is insufficient to establish that
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`the reference inherently discloses the limitation.
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`16.
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`I understand it is acceptable to examine evidence outside the
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`prior art reference (extrinsic evidence) in determining whether a feature, while not
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`expressly discussed in the reference, is necessarily present in it. In determining
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`whether or not every one of the elements of the claimed invention is found in the
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`item of prior art, I understand one should take into account what a person of
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`ordinary skill in the art (POSITA) would have understood from his examination of
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`the particular item of prior art.
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`17.
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`I have been informed that there are several ways in which a
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`patent claim can be invalid under 35 U.S.C. § 102. First, I have been informed that
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`a patent claim is invalid under 35 U.S.C. § 102(a) if the invention defined by the
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`patent claim was known or used by others in the United States, or patented or
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`described in a printed publication authored by others, such as a journal, magazine
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`article, or newspaper, anywhere in the world before applicant’s invention date.
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`18.
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`Second, I have been informed that a patent claim is invalid
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`under 35 U.S.C. § 102(b) if an invention reflected in a patent claim was patented or
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`described in a printed publication anywhere in the world or was in public use or on
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`sale in the United States more than one year before the effective filing date of the
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`patent claim in the United States.
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`19.
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`Third, I have been informed that the patent claim at issue is
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`invalid under 35 U.S.C. § 102(e) if the invention defined by the claim was
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`disclosed in a patent by another inventor that was filed in the United States before
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`the applicant’s invention date.
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`20.
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`I have been informed that each of the above-described types of
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`35 U.S.C. § 102 prior art can individually be a basis for invalidating a patent, or
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`these references can be combined to show a patent is invalid under 35 U.S.C.
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`§ 103(a).
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`21.
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`I have been informed that unless the patent owner comes
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`forward with evidence proving that it is entitled to an earlier priority date for a
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`patent claim, the date of the invention for that patent claim for purposes of Sections
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`102(a) and (e) is the filing date of the patent. I have been informed that to establish
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`a priority date earlier than the filing date, the patentee must show (i) an earlier
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`reduction to practice of the invention, or (ii) an earlier date of conception followed
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`by a diligent attempt to reduce the invention to practice.
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`22.
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`I have been informed that for a document to constitute a
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`“printed publication” under 35 U.S.C. § 102 and thus potentially qualify as prior
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`art, that document must be reasonably accessible to that portion of the public most
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`likely to use it. The date that a printed publication becomes available to the public
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`is the date that it becomes prior art. I have been informed that any printed
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`publication that was published more than one year before the application for the
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`patent was filed will constitute prior art regardless of the alleged date of invention.
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`23.
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`I have also been informed that a prior art reference must only be
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`shown to perform or disclose the steps of a method claim to anticipate that claim.
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`24.
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`I understand that the test for anticipation is essentially identical
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`to the test for literal infringement, leading to the use of the phrase “that which
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`infringes if later anticipates if earlier.” In other words, if granting patent protection
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`on the disputed claim would allow the patentee to exclude the public from
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`practicing the prior art, then that claim is anticipated. I have been further informed
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`that it is improper to read limitations into the claims that are not there in order to
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`prevent an anticipation – if the claims are broad enough to read onto the prior art,
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`courts will find them anticipated.
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`B. Obviousness
`25.
`I further understand that a claim is invalid for obviousness if the
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`differences between the subject matter sought to be patented and the prior art are
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`such that the subject matter as a whole would have been obvious at the time the
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`invention was made (or, in some cases, at the statutory “critical date” of the patent
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`claim) to a POSITA to which the subject matter pertains.1 In deciding this
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`question, I understand it is relevant whether a person of ordinary skill in the art
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`would have been motivated to combine or modify the prior art to achieve the
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`claimed invention and whether there would have been a reasonable expectation of
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`success.
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`1 As used throughout this Declaration, any reference to what a POSITA would
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`have known, understood, or been motivated to do, and the like, refers to the alleged
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`priority date of the ’757 Patent.
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`26.
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`I understand that an obviousness evaluation can be based on
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`more than one item of prior art. I have also been informed that the analysis of
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`obviousness generally requires consideration of the following four factual inquiries
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`(although not necessarily in the listed order): (i) the scope and content of the prior
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`art, (ii) the differences between the prior art and the claim, (iii) the level of
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`ordinary skill in the pertinent art at the time of the invention, and (iv) the existence
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`of any objective factors (also referred to as secondary considerations) indicating
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`obviousness or non-obviousness that may be present in any particular case, such as
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`commercial success, long-felt but unresolved needs, failure of others, and so on.
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`27.
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`I understand that to be part of the “scope and content of the
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`prior art” for purposes of an obviousness determination, in addition to qualifying as
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`prior art under Section 102 discussed above, the referenced prior art must be
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`“analogous” prior art. I understand a reference constitutes analogous prior art if it
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`is within the same field as the inventor’s endeavor. I also understand that even
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`though a prior art reference may be in a different field from that of the inventor’s
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`endeavor, the reference may still be used as an obvious reference if it is
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`“reasonably pertinent” to the particular problem with which the inventor was
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`involved. I understand a reference is reasonably pertinent if it is one that, because
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`of the matter with which it deals, logically would have commended itself to an
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`inventor’s attention in considering the inventor’s problem.
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`28.
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`I have been informed that, in seeking to determine whether an
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`invention that is a combination of known elements would have been obvious to a
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`person of ordinary skill in the art at the time of the invention, one must consider
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`the references in their entirety to ascertain whether the disclosures in those
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`references render the combination obvious to such a person.
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`29.
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`I also understand that the historical framework applicable for
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`assessing obviousness was whether there was a teaching, suggestion, or motivation
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`either explicitly or implicitly in the prior art to combine the teachings of the
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`reference. I have been informed, however, that although the claimed subject
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`matter can still be found obvious when that test is satisfied, the obviousness
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`inquiry is actually broader and more flexible than that. One need not identify such
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`teachings, suggestion, or motivation explicitly in the prior art. Instead, one can
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`take into account the inferences, creative steps, common knowledge, and common
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`sense that a person of ordinary skill in the art would employ.
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`30.
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`I further understand that an obviousness analysis recognizes
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`that market demand, rather than scientific literature, often drives innovation, and
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`that a motivation to combine references also may be supplied by the direction of
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`the marketplace.
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`31.
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`I have been informed that, if a technique has been used to
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`improve one device, and a POSITA would recognize that it would improve similar
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`devices in the same way, using the technique is obvious unless its actual
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`application is beyond that person’s skill. Stated differently, I understand that the
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`proper question is whether one of ordinary skill, facing the wide range of needs
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`created by developments in the field of endeavor, would have seen a benefit to
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`combining the teachings of the prior art.
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`32.
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`I understand that a particular combination may be proven
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`obvious merely by showing that it was “obvious to try” the combination. For
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`example, when there is a design need or market pressure to solve a problem and
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`there are a finite number of identified, predictable solutions, a POSITA has good
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`reason to pursue the known options within his or her technical grasp because the
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`result is likely the product not of innovation but of ordinary skill and common
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`sense.
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`33.
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`I have been informed that the combination of familiar elements
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`according to known methods is likely to be obvious when it does no more than
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`yield predictable results. Thus, where all of the elements of a claim are used in
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`substantially the same manner, in devices in the same field of endeavor, the claim
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`is likely obvious. Additionally, I understand that a patent is likely to be invalid for
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`obviousness if a person of ordinary skill can implement a predictable variation or if
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`there existed at the time of the invention a known problem for which there was an
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`obvious solution encompassed by the patent’s claims. Therefore, when a work is
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`available in one field of endeavor, design incentives and other market forces can
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`prompt variations of it, either in the same field or a different one.
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`34.
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`I further understand that a claim can be obvious in light of a
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`single reference without the need to combine references if the elements of the
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`claim that are not found explicitly or inherently in the reference can be supplied by
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`the teachings of multiple embodiments disclosed in the reference, or by the
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`common sense of one of skill in the art. I further understand that combining
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`embodiments related to each other in a single prior art reference would not
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`ordinarily require a leap of inventiveness.
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`35.
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`I have also been informed that certain objective factors,
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`sometimes referred to as “secondary considerations,” must also be taken into
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`account in determining whether a claimed invention would have been obvious. I
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`understand that secondary considerations such as commercial success, a long felt
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`but unmet need in the prior art that was satisfied by the invention of the patent, and
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`failures of others may be evidence of nonobviousness. I also understand that there
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`must be a connection or “nexus” between any such secondary considerations and
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`the claimed invention if the evidence is to be given any weight in the obviousness
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`analysis.
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`36.
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`I further understand that contemporaneous and independent
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`invention by others is a secondary consideration supporting an obviousness
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`determination. I also understand that a strong case of obviousness can overcome
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`evidence of secondary considerations of non-obviousness.
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`37.
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`I have been informed that a person of ordinary skill in the art is
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`one who is presumed to have had full knowledge of the relevant prior art at the
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`time of the alleged priority date and is presumed to think along the lines of
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`conventional wisdom in the art. I understand that the person of ordinary skill is not
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`an automaton, and may be able to fit together the teachings of multiple prior art
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`references employing ordinary creativity and the common sense that familiar items
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`may have obvious uses beyond their primary purposes. In many cases, a person of
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`ordinary skill will be able to fit the teachings of multiple prior art references
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`together like the pieces of a puzzle.
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`38.
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`I understand that the hypothetical person of ordinary skill is a
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`person of ordinary skill at the time of the alleged invention. I have been informed
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`that several factors may help determine the level of skill in the art, such as types of
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`problems encountered in the art, prior art solutions to those problems, the
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`sophistication of the technology involved, and the education level of active
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`workers in the field. I understand the hypothetical POSITA to which the claimed
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`subject matter pertains would, of necessity, have the capability of understanding
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`the scientific and engineering principles applicable to the pertinent art. This
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`standard prevents one from using his or her own insight or hindsight in deciding
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`whether a claim is obvious.
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`39.
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`I am informed that when a work is available in one field of
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`endeavor, design incentives and other market forces can prompt variations of it,
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`either in the same field or a different one. Similarly, if the claimed invention is a
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`predictable variation from the prior art that a POSITA can implement, then I
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`understand the invention is unpatentable as obvious. For example, if a technique
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`has been used to improve one device, and a person of ordinary skill in the art
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`would recognize that it would improve similar devices in the same way, using the
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`technique is obvious unless its actual application is beyond his or her skill.
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`40.
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`I am informed that it is often necessary for one addressing the
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`obviousness of a claim to look at interrelated teachings of multiple patents,
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`references, and prior art products; the effects of demands known to the design
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`community or present in the marketplace; and the background knowledge
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`possessed by a POSITA, all in order to determine whether there was an apparent
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`reason to combine the known elements in the fashion claimed by the patent at
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`issue.
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`41.
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`In determining whether the subject matter of a patent claim is
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`obvious, I understand that neither the particular motivation nor the avowed purpose
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`of the patentee controls; if the claim extends to what is obvious, it is invalid. One
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`of the ways in which a patent’s subject matter can be shown to be obvious is by
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`noting that there existed a known problem for which there was an obvious solution
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`encompassed by the patent’s claims.
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`C. Claim Interpretation in Inter Partes Review
`42.
`I understand that the first step in determining the validity of a
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`claim is for the claim to be properly construed.
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`43.
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`For purposes of this IPR, I understand that each challenged
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`claim must be given “its broadest reasonable construction in light of the
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`specification.” I am informed that broadest reasonable construction standard
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`dictates that claim terms be given their ordinary and customary meaning, as would
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`be understood by one of ordinary skill in the art in the context of the entire
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`disclosure of the patent. I understand a patentee can be his or her own
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`lexicographer, but I also understand that any special definition for a claim term
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`must be set forth in the specification with “reasonable clarity, deliberateness, and
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`precision.”
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`44.
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`I provide my opinions in this Declaration based on the
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`guidelines set forth above.
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`VI. THE PERSON OF ORDINARY SKILL IN THE ART
`45.
`I have reviewed the ’757 Patent (Ex. 1001), several of the prior
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`art references cited in the ’757 Patent, and the prior art documents referenced
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`above. Based on this review and my knowledge of tamper-proof container
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`closures, it is my opinion that a person of ordinary skill in the art as of the alleged
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`priority date of the ’757 Patent, would have had either: (1) a bachelor’s degree in
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`packaging science, or the equivalent; or (2) a bachelor’s degree in mechanical
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`engineering engineering, or a related field, and at least two years’ experience in the
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`design and development of packaging containers, or the equivalent.
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`46.
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`In my opinion, such a person would have been capable of
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`reading and understanding the scientific and engineering principles applicable to
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`the field of ’757 Patent’s disclosure.
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`VII. TECHNOLOGY BACKGROUND
`A. Overview of Tamper Evident Containers
`47.
`Products have been packaged in tamper evident (TE) containers
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`for decades. One such example is the foil wrap on the neck of a wine bottle.
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`Interest in TE containers was greatly increased in 1982, when 7 people were killed
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`by poison that was put into Tylenol capsules by a tamperer who returned the
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`products to store shelves. The FDA made tamper evident packaging mandatory for
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`all drug products and other industries, notably foods, adopted the practice. (See
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`Ex. 1014.) Companies that make and sell package components rushed to come up
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`with tamper evident devices.
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`48.
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`Various names are used for this type of packaging: tamper
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`proof, tamper resistant, tamper indicating, tamper evident, guarantee seal and
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`freshness seal for example. Reasons for the distinctions are the questioning of
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`whether tampering can actually be prevented and the desire to not make the
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`customer suspect that something is wrong with the product. Tamper evident
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`packaging has many forms, such as plastic neck bands, foil seals on bottle and jar
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`necks, tape over carton flaps, plastic film overwraps and bottle caps or tub lids
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`with break-away features.
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`49.
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`By the time the Patent Owner filed Italian Patent No.
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`BS2006A0190—the foreign patent to which the ’757 Patent claims priority, the
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`technology for caps with TE features was quite mature. Many designs had been
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`developed and used for years and numerous patents had been granted. The idea of
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`thin sections in the plastic or aluminum cap that break while opening the cap, or
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`must be broken to allow opening the cap, appeared in virtually all commercial
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`designs.
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`B. Overview of Non-Choke Caps
`50.
`Caps designed to minimize the risk of choking were also well
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`known as of the alleged priority date of the ’757 Patent. For example, the risk of
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`an infant choking on a loose cap was addressed in U.S. Patent No. 5,716,152 to
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`Kudo, which was filed on February 11, 1997 and issued February 10, 1998. (See
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`Ex. 1013, “Kudo”.) Specifically, Kudo discloses a pen cap designed with “two
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`longitudinal grooves extending continuously in parallel from the cap head portion
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`toward the opening portion” and an “air flow gap” to mitigate the risk of chocking
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`“in the event an infant for example should swallow the cap.” (Id., 2:58-65.)
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`51.
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`The same safety issue was addressed in the context of container
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`caps by U.S. Patent Publication No. 2005/0011911 to Vaughan, which was filed
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`July 9, 2002 and published January 20, 2005. (See Ex. 1006, “Vaughan”).
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`Vaughan identifies that a container cap is “a fairly small item and can give rise to a
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`risk of choking if swallowed accidentally. This is a particular danger to children.”
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`(Id., at ¶ 7.) Vaughan addresses this risk of choking by providing a cap with an
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`“airway” formed by “one or more apertures in the cover that allow the flow of air
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`through the cover if it is swallowed and becomes lodged in the throat.” (Id., at ¶
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`8.)
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`52.
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`Kudo and Vaughan each disclose caps, as illustrated in the
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`figures below, which include internal channels or airways for the purpose of
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`mitigating the risk of choking should the cap be accidentally swallowed. Thus, by
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`the time the Patent Owner filed Italian Patent No. BS2006A0190—the foreign
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`patent to which the ‘757 Patent claims priority, the technology for caps with non-
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`choke features was quite mature.
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`VIII. THE ’757 PATENT
`A.
`Features and Embodiments of the ’757 Patent
`53.
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`The ’757 Patent is directed to a cap with a guarantee seal. The
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`guarantee seal acts as a tamper indicating band. The guarantee seal has guarantee
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`portions, which are further subdivided into an engagement portion 40 and a
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`connecting portion 30. (Ex. 1001 at Abstract.) The connecting portion of the
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`guarantee seal is connected to the cap through frangible webs 32. (Id.) These
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`frangible webs deform and break when the cap is rotated. The engagement portion
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`of the guarantee seal is connected to the cap through a non-frangible safety portion
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`36. (Id.) This engagement portion does not break when the cap is rotated and acts
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`to retain the guarantee seal after the seal has been broken by rotation. (Ex. 1001 at
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`Fig. 1.)
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