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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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`BECTON, DICKINSON AND COMPANY
`Petitioner,
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`v.
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`B. BRAUN MELSUNGEN AG
`Patent Owner.
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`______________
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`
`
`Case IPR2017-01589
`Patent 8,597,249
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`______________
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`Declaration of Richard Meyst in Support of Patent Owner’s
`Preliminary Response to Petition for Inter Partes Review
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`1
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`B. Braun 2001
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`TABLE OF CONTENTS
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`BACKGROUND AND QUALIFICATIONS ................................................. 1 
`I. 
`II.  MATERIAL CONSIDERED .......................................................................... 5 
`III.  OVERVIEW AND LEGAL STANDARD ..................................................... 6 
`IV.  DESCRIPTION OF THE RELEVANT FIELD AND THE
`RELEVANT TIME FRAME ........................................................................... 9 
`LEVEL OF ORDINARY SKILL IN THE ART ........................................... 10 
`V. 
`VI.  CLAIM CONSTRUCTION .......................................................................... 11 
`“Needle Protective Device” Should be Construed as “Tip
`A. 
`Protector” ............................................................................................. 11 
`“Needle Protective Device” is Not a Means-Plus-Function
`Term .................................................................................................... 15 
`The ’249 Patent Teaches a POSITA That “Needle
`1. 
`Protective Device” is A Structure ............................................. 16 
`The ’249 Patent Prosecution History Teaches a POSITA
`That “Needle Protective Device” is A Structure ...................... 19 
`“Needle Protective Device”/“Tip Protector” is a Class of
`Structures Well-Known to a POSITA ...................................... 20 
`Surrounding Claim Language Teaches “Needle
`Protective Device” is Structural and Not Limited to
`Spring Clips ............................................................................... 22 
`VII.  OPINIONS ABOUT THE ’249 PATENT .................................................... 23 
`The ’249 Patent is Not Obvious in Light of Woehr and
`A. 
`Callaway (Grounds 1 and 3) ................................................................ 24 
`The ’249 Patent is Not Obvious in Light of Woehr and Villa
`(Grounds 2 and 4) ................................................................................ 32 
`C.  A POSITA Would Not Modify the Valve of Woehr to Add a
`Skirt Section in View of Basta or Rogers (Grounds 1-4) ................... 40 
`VIII.  CONCLUSION .............................................................................................. 42 
`
`B. 
`
`B. 
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`2. 
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`3. 
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`4. 
`
`
`
`i
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`2
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`

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`I, Richard Meyst, declare as follows:
`
`I.
`
`BACKGROUND AND QUALIFICATIONS
`1.
`
`I have been retained by Greenberg Traurig, on behalf of Patent Owner
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`B. Braun Melsungen AG (“B. Braun”), as an expert in the above-captioned
`
`proceeding. I have been asked to render an opinion regarding the validity of
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`claims 1 and 4 of U.S. Patent No. 8,597,249 (the “’249 patent”), a copy of which
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`was previously submitted as Exhibit 1001. I am being compensated for the time I
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`spend on this proceeding at a rate of $425 per hour. I am also being reimbursed for
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`reasonable and customary expenses associated with my work and testimony in this
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`matter. My compensation is not contingent on the outcome of this matter or the
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`specifics of my testimony.
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`2.
`
`I submit this declaration based on my personal knowledge and in
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`support of B. Braun’s preliminary response (“Preliminary Response”) to Becton,
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`Dickinson and Company’s (“BD” or “Petitioner”) inter partes review petition
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`(“Petition”) regarding the ’249 patent.
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`3. My name is Richard Meyst. I am currently the President and Chief
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`Executive Officer of Fallbrook Engineering, Inc. I am an engineer and consultant
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`in the field of medical devices and related technologies, including intravenous
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`(“IV”) catheters. A copy of my curriculum vitae (“CV”), which includes, among
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`3
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`

`

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`other things, my academic credentials and my employment history, is attached as
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`Exhibit 2020.
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`4.
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`I received a M.S. (1972) and B.S. (1971) in mechanical engineering
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`from the University of Wisconsin, Madison. My undergraduate academic work
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`focused on design, manufacturing methods, fluid mechanics, and heat transfer. My
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`graduate academic focus was on computer-based automatic controls of systems
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`and my Master’s thesis was on concept development, design, fabrication, and
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`testing of a prototype bench-top
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`implantable mechanical human heart.
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`Additionally, I have participated in industry seminars and training programs
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`covering design of experiments, statistical analysis, biocompatibility testing,
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`sterilization method selection and validation, design of plastic parts, design for
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`manufacturability, package design and testing, cellular therapy, and many others.
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`5.
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`As an engineer, designer, consultant, program manager and
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`entrepreneur at Fallbrook Engineering, Inc., I have been involved in the advanced
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`design and development of a wide range of medical technology products for the
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`healthcare industry for more than 40 years. Prior to 1989 when I became a partner
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`in Fallbrook Engineering, I held various leadership positions at technology and
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`product development companies; first at the USCI division of CR Bard, then
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`Fenwal Laboratories (a division of Baxter Travenol Laboratories), Oak
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`Communications, Imed Corp. (a division of Warner Lambert) and finally Diatek
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`Corp. For the last 25+ years, I have been an owner of Fallbrook Engineering.
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`Since 2003, I have been the President and Chief Executive Officer. For a detailed
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`list of my prior employment history, see my CV.
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`6.
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`Over the years, I have had a consistent focus on medical devices and
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`related technologies which utilize my particular expertise in inventing, product
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`design and manufacturing methods design, fluid mechanics, drug delivery, cellular
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`therapy, high volume sterile disposables and FDA regulatory matters.
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`7. My medical product experience includes, but is not limited to, product
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`and packaging design, the development of implantable vascular prostheses, DNA
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`amplifiers, vital signs monitoring devices, IV drug infusion pumps and
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`administration sets, over the needle IV catheters, self-injection training devices,
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`cardiac catheters, various balloon catheters, introducer sheaths, diagnostic
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`catheters, special purpose syringes, safety syringes, diagnostic and therapeutic
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`medical lasers and optical catheters, surgical instruments, microprocessor based
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`diagnostic and
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`therapeutic
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`instruments, blood cell collection, separation,
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`processing, and administration devices, filtration devices for blood and intravenous
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`solutions, stem-cell harvesting and cell expansion systems. In the early 1990’s my
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`firm performed design and development contract engineering for several clients
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`that had safety syringe concepts and designs. We designed, built and tested
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`numerous prototypes, none of which were ever commercialized.
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`I have been a Principal Investigator on a National Institute of Health
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`8.
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`Small Business Innovation Research (“SBIR”) grant from the National Heart, Lung
`
`and Blood Institute developing a device for the improved collection of umbilical
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`cord blood stem cells. This product was designed to safely collect cord blood
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`without exposed sharps and in a shielded state to prevent blood spatter. I served on
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`the Board of Directors for the Society of Plastics Engineers/Medical Plastics
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`Division and am a long time member. I am a member of the American Association
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`of Blood Banks, the Association for the Advancement of Medical Instrumentation,
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`and the American Filtration Society. I have also been a long time member of the
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`Medical Device Steering Committee of BIOCOM, the largest, most experienced
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`leader and advocate for California’s life science sector representing over 750
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`biotechnology, pharmaceutical, digital health and medical device/diagnostic
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`companies. I have been a judge in the San Diego CONNECT capital competition
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`for startup companies. On several occasions I have been a juror in the
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`UBM/Cannon Medical Design Excellence Awards competition (“MDEA”). This
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`annual competition is the premier design awards program for the medtech industry.
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`9.
`
`I also have experience as an innovator and inventor, where my
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`inventions have been awarded sixteen United States patents (all of which are for
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`medical devices), and have been awarded multiple international patents and have
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`several applications pending.
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`I also have been an invited speaker, presenting technical and business
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`10.
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`talks at numerous scientific and medical industry meetings and have authored
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`articles published in trade magazines.
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`11. My CV lists the prior matters that I have been involved in as an
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`expert. I have served as an independent technical expert consultant or expert
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`witness in numerous intellectual property and patent litigations, product failure
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`analyses, analyses of the use and misuse of various medical devices, medical
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`product development contract disputes, and medical product liability matters. I
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`have been deposed, have testified in State and Federal court, including at a
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`Markman hearing, and have provided testimony in an American Arbitration
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`Association (“AAA”) hearing.
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`II. MATERIAL CONSIDERED
`12. The analysis provided in this Declaration is based on my education as
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`well as my experience in the field. In addition to relying upon my knowledge
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`based on written materials and other information that was known prior to
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`November 3, 2006, which I have been told is the earliest possible priority date for
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`the ’249 patent, I have considered the exhibits to the Petition (Exs. 1001-1035) and
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`the exhibits to the Preliminary Response (Exs. 2002-2022). A list of materials that
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`I have considered for my analysis is attached as Exhibit 2021.
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`Page 5 of 42
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`III. OVERVIEW AND LEGAL STANDARD
`13.
`I have been asked to provide opinions regarding claim construction of
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`the term “needle protective device” and the validity of claims of the ’249 patent in
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`light of several prior art patents.
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`14.
`
` For the purposes of this Declaration, I understand that certain
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`principles of law are relevant to my analysis and opinions. For example, I
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`understand that, before a validity determination can be made, the claims must be
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`construed by the Board.
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`15.
`
`I understand that in an inter partes review, the Board construes claim
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`terms in an unexpired patent according to their broadest reasonable construction in
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`light of the specification of the patent in which they appear. I further understand
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`that a claim construction analysis begins with the ordinary meaning of the disputed
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`claim term, and there is a presumption that claim terms carry their accustomed
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`meaning among a person of ordinary skill in the art (“POSITA”). I have also been
`
`informed that the ordinary and customary meaning of a claim term may be
`
`determined by reviewing a variety of sources, including the claims themselves, the
`
`specification (or “written description”) of a patent, its prosecution history, and
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`dictionaries and treatises.
`
`16.
`
`I understand
`
`that
`
`the
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`intrinsic evidence, namely
`
`the patent
`
`specification and the prosecution history, may clarify whether the patentee
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`intended a claim term to have a meaning different from its ordinary and customary
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`meaning, or clearly disavowed the ordinary meaning in favor of some special
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`meaning. The specification may include a special definition given to a claim term
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`by the patentee that differs from its ordinary meaning. In such cases, the
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`inventor’s lexicography governs.
`
`17.
`
`I understand that extrinsic evidence, which includes expert and
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`inventor testimony, dictionaries, and learned treatises, may also be considered
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`during the claim construction process. However, extrinsic evidence is given less
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`weight than the intrinsic record in determining the meaning of disputed claim
`
`terms. I understand that dictionary definitions may reflect or establish the plain
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`and ordinary meaning of claim terms; however, when construing claim terms,
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`reference should also be made to the intrinsic record to determine which dictionary
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`definition(s) are most appropriate in light of the use of the claim terms by the
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`inventor.
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`18.
`
`I understand that claims may be drafted in “means-plus-function”
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`form, in which case a person of ordinary skill in the art would look to structures
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`disclosed in the specification to perform the function recited in the claims. I
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`further understand that there is a presumption that, where a claim does not recite
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`the term “means,” the claim does not invoke means-plus-function claiming. In this
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`instance, the presumption can only be overcome if the claim fails to recite
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`sufficiently definite structure, or recites a function without reciting sufficient
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`structure for performing that function. I understand that it is sufficient if the claim
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`term is used in common parlance or by a POSITA to designate structure, even if
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`the term covers a broad class of structures.
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`19.
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`It is my understanding that a claimed invention is unpatentable under
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`35 U.S.C. § 103 if the differences between the invention and the prior art are such
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`that the subject matter as a whole would have been obvious at the time the alleged
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`invention was made to a POSITA. This is sometimes described as “obviousness.”
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`I understand that an obviousness analysis takes into account the level of ordinary
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`skill in the art, the scope and content of the prior art, and the differences between
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`the prior art and the claimed subject matter.
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`20.
`
`I understand that a petitioner in an inter partes review bears the
`
`burden for showing the obviousness of the claimed invention. My understanding is
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`that obviousness is not proven by mere conclusory statements or conclusory expert
`
`testimony. Instead, I understand there must be some articulated reasoning with
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`rational underpinning to satisfy the legal standard of obviousness. I also
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`understand that obviousness cannot be based on a hindsight combination of
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`components.
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`21.
`
`It is my understanding that the Supreme Court has recognized several
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`rationales for combining references or modifying a reference to show obviousness
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`Page 8 of 42
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`of the claimed subject matter. Some of these rationales include the following:
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`combining prior art elements according to known methods to yield predictable
`
`results; simple substitution of one known element for another to obtain predictable
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`results; a predictable use of prior art elements according to their established
`
`functions; applying a known technique to a known device to yield predictable
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`results; choosing from a finite number of identified, predictable solutions, with a
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`reasonable expectation of success; and some teaching, suggestion, or motivation in
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`the prior art that would have led a POSITA to modify the prior art or combine prior
`
`art teachings to arrive at the claimed invention. I also understand that a POSITA is
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`a person of ordinary ingenuity and creativity, not an automaton. I further
`
`understand that if a combination of references would render the prior art device
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`inoperable, or fundamentally change the manner of operation of the device, a
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`POSITA would likely not be motivated to make that combination.
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`IV. DESCRIPTION OF THE RELEVANT FIELD AND THE RELEVANT
`TIME FRAME
`22.
`
`I have carefully reviewed the specification, drawings, claims and
`
`prosecution histories of the ’249 patent and its related patents, including U.S.
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`Patent Nos. 8,308,691; 8,419,688; 8,460,247; 8,591,468; and 9,370,641.
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`23. For convenience, all of the information I have considered in arriving
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`at my opinions is listed in Exhibit 2021.
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`24. Based on my review of these materials, I believe that the relevant field
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`for purposes of the ’249 patent is intravenous catheter insertion devices. I have
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`been informed that the relevant timeframe is prior to November 3, 2006.
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`25. As described above and in my CV, I have extensive experience in the
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`relevant technical field, including experience relating to medical devices and
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`related technologies, including catheters. Based on my experience and expertise in
`
`this field, I have an understanding of the relevant field in the relevant time frame.
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`V. LEVEL OF ORDINARY SKILL IN THE ART
`26.
`I understand that, to determine the appropriate level of a POSITA, the
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`following four factors may be considered: (a) the types of problems encountered
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`by those working in the field and prior art solutions thereto; (b) the sophistication
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`of the technology in question, and the rapidity with which innovations occur in the
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`field; (c) the educational level of active workers in the field; and (d) the
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`educational level of the inventor.
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`27.
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`I am well acquainted with the level of ordinary skill required to
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`implement the subject matter of the ’249 patent as of its filing date.
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`28.
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`It is my opinion that a POSITA at the time of the invention of the ’249
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`patent would have at least an associate’s degree in engineering or Physics or the
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`equivalent, and at least five years of experience with IV catheters. Alternatively,
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`more education, such as a Bachelor of Science degree, could reduce the number of
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`years of experience to at least two years of experience.
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`VI. CLAIM CONSTRUCTION
`A.
`“Needle Protective Device” Should be Construed as “Tip
`Protector”
`I understand that Mr. Griffis and the Petitioner contend that “needle
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`29.
`
`protective device” is a means-plus-function term. I disagree.
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`30. A POSITA would understand from the ’249 patent specification and
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`prosecution history that “needle protective device,” means “tip protector.”
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`31. For example, the Summary states:
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`[T]he present invention include[s] . . . a tip protector positioned
`adjacent the valve opener for blocking the needle tip, wherein the tip
`protector comprises: (1) a tip protector housing having an interior
`surface; (2) a first arm extending from a distal wall of the tip protector
`housing biased towards the interior surface of the catheter hub; (3) a
`second arm extending from a proximal wall of the tip protector
`housing biased towards the interior surface of the catheter hub; and
`(4) a third arm extending from the proximal wall of the tip protector
`housing biased against a side of the needle.
`(Ex. 1001 at 2:15-34).
`32. The Summary further equates tip protector with needle protective
`
`device by stating, “a preferred embodiment of the present invention [has] a raised
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`bump or projection [] formed within the interior cavity of the catheter hub for
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`retaining a tip protector within the catheter hub during retraction of the needle hub
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`away from the catheter hub.” (Id. at 3:32-36.)
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`33. The Abstract also indicates the invention comprises a “tip protector []
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`incorporated to block the needle tip and prevent the same from accidental needle
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`stick.” (Ex. 1001 at Cover.)
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`34. The Brief Description of the Drawings, the Figures, and the Detailed
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`Description further make clear that the embodiments of the invention include a “tip
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`protector” (e.g., elements 50/94/202) which covers the tip of the needle to
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`completely protect and block it. (Ex. 1001 at 3:52-55; 4:1-41; FIGS. 3, 6-7, 8C,
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`9D, 13-14; 5:48-62, 6:46-7:4, 7:53-8:12, 9:61-10:6, 11:23-12:3, 12:7-25.)
`
`35.
`
`In fact, Petitioner’s expert explicitly points to FIG. 14 and element
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`202 as the “needle protective device,” thus admitting “tip protector” (202) and
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`“needle protective device” are synonymous (Ex. 1002 at ¶35):
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`Page 12 of 42
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`36. Mr. Griffis asserts that the claimed “needle protective device”/“tip
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`protector” has “at least one arm that covers the tip of the needle automatically as it
`
`is withdrawn.” (Ex. 1002 at ¶40.)
`
`37.
`
`In fact, Mr. Griffis also equates “needle protective device” and “tip
`
`protector” in arguing obviousness by asserting that the Woehr ’630 patent teaches
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`the same tip protector disclosed in Woehr. (Ex. 1002 at ¶40, 87-88, 93.)
`
`38.
`
`I therefore disagree with Mr. Griffis’ statement that there is nothing in
`
`the patent specification that “defines any structure for the term ‘needle protective
`
`device.’” (Id. at ¶56.)
`
`39.
`
`I also disagree with Mr. Griffis’ statement that nothing in the file
`
`history indicates structure for the term “needle protective device.” (Id.)
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`40. The United States Patent & Trademark Office (“PTO”) repeatedly
`
`interchanged “needle protective device” with “tip protector” during prosecution of
`
`the ’249 patent and related patents:
`
` “Woehr [’630] teaches a catheter assembly (figure 6a) comprising a self-
`activating device for covering a needle comprising a tip protector third
`housing (figure 6b, item 40a) and a tip protector comprising a spring
`clip (figure 6b, item 66) accommodated within the third housing for
`blocking the needle tip; and an arm (figure 6b, item 67) extending from
`the third housing to engage a catheter hub (figure 6a, item 32) and retain
`the third housing to the proximal end of the catheter hub in a ready to use
`position (figure 6a). It would have been obvious to one of ordinary skill
`in the art at the time of the invention to modify the structure taught by
`Nakajima, with the use of a self-activating needle protective device, as
`taught by Woehr ...” (Ex. 2003 at 76-77);
`
` “Woehr [’630] teaches a catheter assembly (figure 6a) comprising a
`needle protective device comprising a tip protector housing (figure 6b,
`item 40a) and a spring loaded arm (figure 6b, items 65/66/67),
`extending from the tip protector housing, in a ready to use position
`(figure 6a) and positioned proximally and at least in part around a needle
`to prevent unintended contact with the needle tip in a protective position
`(figure 6b); and a third hub (figure 6a, item 12), comprising an arm
`(figure 6b, item 92) extending distally into the first hub, and positioned
`substantially proximally of the first hub.” (Ex. 2004 at 149-150); and
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` “Woehr [’630] teaches a catheter assembly (figure 6b) comprising a tip
`protector (figure 6b, items 65/66) inside a hollow cylindrical tip protector
`housing (figure 6b, item 40a) that could be positioned proximally within
`a housing relative to a valve (figure 6b).” (Ex. 2005 at 102).
`
`41. Like the PTO, Mr. Griffis similarly interchanges “tip protector” with
`
`“needle protective device.” (See Ex. 1002 at ¶¶40, 62, 65, 87-88, 93.)
`
`42. Accordingly, under the broadest reasonable construction, in light of
`
`the specification and prosecution history, a POSITA would recognize that “needle
`
`protective device” should be construed as “tip protector”.
`
`B.
`“Needle Protective Device” is Not a Means-Plus-Function Term
`43. The term “needle protective device” does not include the word
`
`“means,” and I therefore understand that there is a presumption that it is not a
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`means-plus-function term.
`
`44. For the reasons discussed below, in light of the patent specification,
`
`prosecution history, knowledge in the art, and the surrounding claim language, I
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`disagree with Mr. Griffis’ conclusory assertion that “there is nothing in the patent
`
`claims, specification, or the file history that defines any structure for the term
`
`‘needle protective device.’” (Ex. 1002 at ¶56).
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`Page 15 of 42
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`1.
`
`
`The ’249 Patent Teaches a POSITA That “Needle
`Protective Device” is A Structure
`45. A POSITA reviewing the ’249 specification would understand that
`
`“needle protective device”/“tip protector” is a structure that covers and blocks the
`
`needle tip to protect against unintended needle-sticks.
`
`46. As discussed above (Paragraphs 31-38), the patent specification
`
`describes the “needle protective element”/“tip protector” as a structure that
`
`“comprises: (1) a tip protector housing having an interior surface; (2) a first arm
`
`extending from a distal wall of the tip protector housing biased towards the interior
`
`surface of the catheter hub; (3) a second arm extending from a proximal wall of the
`
`tip protector housing biased towards the interior surface of the catheter hub; and
`
`(4) a third arm extending from the proximal wall of the tip protector housing
`
`biased against a side of the needle.” (Ex. 1001 at 2:15-34; see also 3:32-36, 3:52-
`
`4:3, 5:48-62, 6:46-7:4, 7:53-8:12, 9:61-10:6, 11:23-12:3, 12:7-25, FIGS. 3, 6-7,
`
`8C, 9D, 13-14.)
`
`47. Petitioner’s own expert, Mr. Griffis, as discussed above, admits the
`
`specification teaches “a number of tip protectors” that have “at least one arm that
`
`covers the tip of the needle automatically as it is withdrawn.” (Ex. 1002 at ¶¶40-
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`41, 45-46, 51, 62; Petition at 5-6.)
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`48. But, a POSITA would recognize
`
`that
`
`the “needle protective
`
`device”/“tip protector” is not limited to a structure with at least one arm that covers
`
`the tip of the needle automatically as it is withdrawn.
`
`49. The ’249 specification specifically incorporates by reference the tip
`
`protectors disclosed in U.S. Patent Nos. 6,616,630 (Ex. 1011), 6,709,419,
`
`7,125,397 and U.S. Application Nos. 10/109,797 (now U.S. Patent No. 7,500,965),
`
`10/468,923 (now U.S. Patent No. 7,214,211), 10/677,810, 10/954,041 (now U.S.
`
`Patent No. 7,651,476), 11/496,769 (now U.S. Patent No. 8,382,718). (Ex. 1001 at
`
`5:51-55; 6:56-62; 6:65-7:4; 12:12-25.)
`
`50. The Woehr ’630 patent (Ex. 1011) describes a spring clip, but also
`
`describes the needle protective devices from the following patents: U.S. Re.
`
`34,416, U.S. Pat. Nos. 5,558,651, 5,135,504, 5,697,907, 4,978,344, 4,929,241 and
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`5,053,017. (Ex. 1011 at 1:60-67.) These patents include numerous structurally
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`different “tip protectors.”
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`51. For example, U.S. Patent No. 5,558,651 (Ex. 2006) discloses a tip
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`protector with no arms:
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`52. U.S. Patent No. 5,697,907 (Ex. 2007) also discloses a tip protector
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`
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`with no arms:
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`53. Moreover, as discussed in Paragraphs 57-63 below, a POSITA would
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`understand that “needle protective device”/“tip protector” is a well-known class of
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`structures that include structures other than just spring clips. For example, a
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`POSITA would be aware of the patents cited on the face of the ’249 patent that
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`disclose a variety of structures that function to prevent unintended needle-sticks,
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`including, but not limited to, U.S. Patent No. 6,001,080 (Ex. 2008) (comprising a
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`resilient member that advances a needle guard over a needle tip); U.S. Patent No.
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`5,851,196 (Ex.2009) (comprising a needle that retracts into the body of a needle
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`protector); U.S. Patent No. 6,379,333 (Ex. 2010) (comprising a tabbed disk that
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`locks a needle into a needle shield); U.S. Patent No. 5,718,688 (Ex. 2011)
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`(comprising a leaf spring that locks a needle tip protector to the end of a needle).
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`2.
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`The ’249 Patent Prosecution History Teaches a POSITA
`That “Needle Protective Device” is A Structure
`54. As discussed above (Paragraphs 40-42), the prosecution history of the
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`’249 patent and related patents also indicates the PTO considers “needle protective
`
`device”/“tip protector” to be a structural limitation:
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` “The claims in this application have been allowed because the prior art of
`record fails to disclose or render obvious the structure recited in
`independent claims 1, 22 and 27.” (Ex. 2003 at 154-155; see also Ex.
`2004 at 235-236; Ex. 2005 at 402-403);
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` “[T]he combination of Van Heugten and McGurk does indeed disclose
`and/or render obvious the structural limitations of the claims of the
`instant invention. Applicant is directed to Fig. 3 of McGurk disclosing a
`tip protector comprising a first arm (96) extending from a distal wall
`(e.g. 50, 98) of a tip protector housing and biased toward the interior
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`surface of the catheter hub; a second arm (100) extending from a
`proximal wall (e.g. 66) of the tip protector housing biased toward the
`interior surface of the catheter hub; and a third arm (e.g. 86 or 80)
`extending from the proximal wall of the tip protector housing biased
`against a side of the needle.” (Ex. 2012 at 123-124.)
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`55. The PTO did not find “tip protector” or “needle protective device”
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`were means-plus-function limitations in the ’249 patent or any related patents.
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`3.
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`“Needle Protective Device”/“Tip Protector” is a Class of
`Structures Well-Known to a POSITA
`56. The plain language of the term “needle protective device”/“tip
`
`protector” invokes a “class of structures” well-known to a POSITA. Specifically, a
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`POSITA would recognize that the claimed “needle protective device” refers to the
`
`class of structures included in safety IV catheters that prevent unintended needle-
`
`sticks by covering (i.e., protecting or guarding) the needle tip. For example,
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`Petitioner’s own patent, U.S. RE 38,996 (Ex. 2014) (cited on the face of the ’735
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`patent as U.S. Patent No. 5,601,536) states:
`
`U.S. Pat. No. 4,846,804 has a needle tip protector with a collapsible
`sleeve disposed about the shank of the needle and a protective cap
`located at the distal end thereof. The cap surrounds and encloses the
`tip of the needle. . . . U.S. Pat. No. 4,139,009 has a needle tip
`protector with a permanently attached cover surrounding the needle
`and a number of elastic arms which extend along the length of the
`needle. . . . U.S. Pat. No. 4,660,570 shows a needle tip protector with
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`a membrane extending over the sharp point of the needle whereby
`penetration causes the needle to extend through the membrane and the
`skin of the patient.
`(Id. at 1:66-2:17.)
`
`57. Literature and patents contemporaneous with the priority date of the
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`’249 patent make clear that “needle protective device”/“tip protector” is a well-
`
`known class of structures. Petitioner’s own expert admits, “Catheters including
`
`many different tip protector designs to prevent accidental needle sticks were well
`
`known as of 2006. Indeed, the ‘249 patent incorporates many known designs of
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`different tip protectors.” (Ex. 1002 at ¶46). Mr. Griffis continues, “The ’249
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`patent incorporates known designs of different hubs or housing structures to
`
`house tip protectors. (Ex. 1001, ’249 patent at 12:12-25). Several other
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`references disclosed using an additional housing to contain a tip protector.” (Id.
`
`at ¶48.)
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`58. Dictionaries from the relevant time frame also indicate that a POSITA
`
`knew “needle protective device”/“tip protector” is a structure in connection with
`
`IV catheters that protects the operator from unintended needle-sticks.
`
`59. For example, “needle” is defined as noun denoting structure: “the long
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`hollow pointed part of a hypodermic which goes under the skin when giving an
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`injection (putting a drug into the body through the skin).” (Ex. 2015);
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`“Protector” is also a noun denoting structure, for example: “a thing
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`60.
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`that protects,” or “a device that protects: guard.” (Ex. 2016; Ex. 2017.)
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`61. Therefore, a POSITA would readily understand “needle protective
`
`device”/“tip protector” is a class of structures in connection with IV catheters that
`
`protect the operator from unintended needle-sticks.
`
`4.
`
`Surrounding Claim Language Teaches “Needle Protective
`Device” is Structural and Not Limited to Spring Clips
`62. The language of the ’249 patent claims describing the “needle
`
`protective device” indicates to a POSITA that it is structural.
`
`63. For example, Claim 1 requires that the “needle protective device” be
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`“positioned proximally of the valve and at least in part around the needle to
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`prevent unintended contact with the needle tip in a protective position.”
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`Dependent claim 5 requires that the “needle protective device is positioned
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`adjacent to the leg element.” Independent claim 10 indicates that the tip protector
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`comprises “a tip protector housing; and an arm extending from the tip protector
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`housing to . . . retain the tip protector in a ready to use position and wherein the tip
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`protector is spring loaded and in t