Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 1 of 21
`
`Nathan D. Thomas (USB #11965)
`nthomas@j oneswaldo.com
`JONES WALDO HOLBROOK & McDONOUGH PC
`170 South Main Street, Suite 1500
`Salt Lake City, Utah 84101
`Telephone: (801) 521-3200
`
`Jonathan Hangartner (Pro Hac Vice)
`X-Patents, APC
`5670 La Jolla Blvd.
`La Jolla, California 92037
`Telephone: (858) 454-4313
`jon@x -patents. com
`
`Attorneys for Defendant
`
`IN THE UNITED STATES COURT FOR THE DISTRICT OF UTAH
`
`CENTRAL DIVISION
`
`CATHETER CONNECTIONS, INC., a
`Delaware corporation,
`
`Plaintiff,
`
`vs.
`
`DECLARATION OF KARL R.
`LEINSING, MSME, PE IN SUPPORT
`OF DEFENDANT IVERA MEDICAL
`CORPORATION'S MEMORANDUM
`IN OPPOSITION TO CATHER
`CONNECTIONS' MOTION FOR
`PRELIMINARY INJUNCTION
`
`IVERA MEDICAL CORPORATION, a
`California corporation,
`
`Case No.: 2:14-CV-00070
`
`Defendant.
`
`The Honorable Tena Campbell
`
`1
`
`CCI 2007
`
`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 2 of 21
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`I, Karl R. Leinsing, hereby declare as follows:
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`1.
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`I have been engaged by I vera Medical Corporation to provide expert
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`testimony in connection with this case. I am being compensated at my usual and
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`customary rate of$350 per hour plus reimbursement of reasonable expenses. I have
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`received no additional compensation for my work on this Declaration and my
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`compensation for this Declaration is not contingent on its contents or the outcome of this
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`or any other matter. I do not have any financial or other interest in the outcome of these
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`proceedings or in any of the parties. Except as otherwise indicated, I have personal
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`knowledge of all matters set forth herein and, if called as a witness, I could and would
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`competently testify as to each of the matters stated herein.
`
`2.
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`I have a Bachelor of Science degree in Mechanical Engineering from the
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`University ofNew Hampshire, and a Master of Science degree in Mechanical Engineering
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`from North Carolina A&T State University. I have worked as an engineer for more than
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`23 years, and I have worked as an engineer designing medical devices since 1992. I have
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`won a variety of different awards for my medical product designs, and I have been granted
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`nineteen U.S. patents. I also have extensive experience relating to high volume
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`production of medical devices, including injection molding of all different types of
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`medical devices. A copy of my curriculum vitae is attached hereto as Exhibit A.
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`3.
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`I have extensive experience working on the design and development of
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`medical intravenous ("IV") line related products, including IV disposable sets and
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`components, syringe pumps, IV pump systems, valves, etc. Among many other medical
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`devices, I am the sole inventor ofthe SmartSite® Needle-Free Valve, an extremely
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`successful Luer activated needle-free valve. Luer activated valves ("LAYs") serve as
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`2
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 3 of 21
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`needle-free access ports to allow for the introduction of fluids into a patient's bloodstream
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`via an IV line.
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`4.
`
`I have reviewed Catheter Connections' motion for a preliminary
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`injunction alleging infringement by I vera's Curos Tips product of U.S. Patent No.
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`8,641,681 (the "'681 patent") and U.S. Patent No. 8,647,308 (the '"308 patent"). I have
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`been asked to evaluate issues relating to the alleged infringement and prior art relevant to
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`the validity of the asserted patents. I have also been asked to review the testimony of
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`William W. Durgin in his declaration dated February 3, 2014, filed in support of the
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`preliminary injunction motion.
`
`The Accused Tips Product
`
`5.
`
`The accused Tips® product is a disinfecting cap designed to disinfect a
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`male Luer cormector and protect it against recontamination between uses. Male Luer
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`connectors are used with IV sets to establish fluid tight connections with female Luer
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`connectors such as Luer activated valves. Male connectors have a post with an open end
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`that provides an entry point into a tubular structure that connects to an IV line. The inside
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`of this tubular structure through which fluids will flow is commonly referred to as the
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`"lumen." The post itself is tapered so that it has a conical shape, and typically has a
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`standard 6 percent taper to conform to a standard for fluid-tight Luer connections. A skirt
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`extends around the base of the post. This skirt has threads around its interior surface to
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`secure the Luer connection.
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`6.
`
`From an engineering perspective, the design of the Tips product is quite
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`elegant. With medical devices, simplicity is critical to control cost and improve
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`3
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 4 of 21
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`reliability. The fewer parts that can be used to achieve the product requirements the
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`better. The Tips product consists of just four ( 4) parts: (i) a hard plastic cap, (ii) a plunger
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`made of the same hard plastic as the cap, (iii) isopropyl alcohol, and (iii) a laminated foil
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`sealing strip. The following photograph provided in Dr. Durgin's report shows a
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`longitudinally sectioned Tips cap, with the plunger visible inside the cap. The sealing
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`strip and alcohol are no longer present.
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`7.
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`The plastic cap and plunger in the Tips product are both injection molded.
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`The cap itself is a basic male connector cap that is virtually identical in form and function
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`to dozens of prior ati caps that have been around for more than a decade. Commonly
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`referred to by clinicians as "dead-enders," these have typically been provided with the
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`male connectors themselves and sold separately. Examples from the product catalog of a
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`medical device supplier called Qosina from the year 2000 are shown here:
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`6S709
`
`4
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 5 of 21
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`8.
`
`Another example of such a prior art cap is shown below. This example,
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`shown in white and clear, was from a medical device suppler called the Kipp Group and is
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`from my own inventory of devices that I keep in my lab. This example dates to January
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`1995.
`
`For complete details contact ™
`
`9.
`
`Other examples of prior art caps for male connectors that I have in my
`
`own lab and that have been provided by I vera are shown in the attached Exhibit B.
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`10.
`
`There are many other examples of such prior art caps. The following
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`images were provided to me by I vera, and while I have not yet confirmed the prior art
`
`status of these caps I believe that many of these were available prior to 2005:
`
`5
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 6 of 21
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`11.
`
`These various prior art caps commonly are made of hard plastic and have
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`a generally cylindrical body with an opening at one end to receive the post of the male
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`connector. Most have a gripping feature on the cap body such as ribs or recesses. On the
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`examples shown above this gripping feature typically is on the portion of the cap body that
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`is distal to (or "away from") the opening and the part ofthe cap body that receives the
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`post, while on others it extends along the length of the cap body. In either case, the
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`gripping feature extends beyond the skirt of the male connector when the post received
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`into the cap to allow the user's fingers to grasp the gripping feature and use it to tighten or
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`loosen the cap. In some examples such as the Qosina caps shown above, the entire length
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`of the cap is hollow, while in others like the Kipp Med cap shown above only the portion
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`of the cap body with the opening that receives the post (to the right in the photo) is hollow.
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`These prior art caps typically have threads or other protrusions designed to engage the
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`threads in the skirt of male connector. The cap part used in the Tips product has these
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`same features common to the prior art cap examples.
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`12.
`
`The plunger part in the Tips cap is unique. The plunger is basically
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`capsule shaped, with a thin, relatively rigid, annular flange or "skirt" encircling it around
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`the midsection. This flange has a diameter at its outermost point that is slightly larger than
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`the inner dian1eter of the hollow cap body, and it fits into the hollow interior of the cap. I
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`am informed that during assembly, the plunger is placed into the cap after the hollow
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`interior of the cap is partially filled with isopropyl alcohol. The plunger sits on top of the
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`IP A and the plunger flange presses against the inner wall of the cap, containing the IP A
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`below the plunger.
`
`13.
`
`The foil strip part is then sealed over the opening of the caps to maintain
`
`6
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 7 of 21
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`the plunger and IP A in the cap prior to use.
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`14.
`
`To use it, the Tips product is removed from the foil strip by the clinician
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`and placed over the post of the male connector. The post contacts the top surface of the
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`plunger and pushes it deeper into the cap, forcing IP A around the plunger and past the
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`flange so that it contacts the outer surfaces ofthe post ofthe male connector. Excess IPA
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`flows on past the post and out of the cap via venting channels cut into the inner walls of
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`the cap body.
`
`15.
`
`These venting channels are relatively large to provide a direct, low-
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`pressure pathway for the IP A to flow beyond the post and out of the cap. This is an
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`important design feature of the Tips product. Unlike all of the examples of disinfecting
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`caps shown in the asserted patents, there is nothing in the Tips cap that applies any biasing
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`force to the plunger to press it against the tip of the post of the male connector. Thus,
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`there is only light contact between the tip of the male post and the top surface of the
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`plunger. That contact area, however, prevents fluid from flowing through the opening in
`
`the post and into the lumen of the male connector. Fluids will follow the path of lowest
`
`pressure. By providing a low-pressure pathway out of the cap for the IP A, the venting
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`channels in the Tips cap prevent the buildup of pressure in the cap that would tend to force
`
`IPA into the lumen.
`
`16.
`
`It is this kind of subtle design feature that I was referring to above when I
`
`described the Tips design as elegant. By carefully managing the flow of the IPA during
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`attachment of the cap to the male post, Ivera eliminated the need for any biasing device
`
`pushing the plunger against the male post - thus reducing the number of parts and
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`simplifying the manufacturing and assembly process, which significantly reduces
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`7
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 8 of 21
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`production cost.
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`17.
`
`The Tips product is designed as a single use product. The clinician or
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`nurse then discards the Tips cap and uses a new cap when it is desired to protect the male
`
`Luer again. This feature and practice assures a clean, sterile, and freshly IPA filled cap
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`for disinfecting the Male Luer.
`
`The Asserted Patents
`
`18.
`
`I have reviewed the '681 and '308 patents, which share the same drawings
`
`and written description. These patents disclose various embodiments of a disinfecting cap
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`for a male connector. All of the disclosed embodiments use some form of a biasing
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`member, and most of the disclosed embodiments use that biasing member to actively push
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`a sealing member against the tip of the post of the male connector to seal it off and prevent
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`the disinfecting agent from entering the lumen.
`
`Invalidity Analysis
`
`19.
`
`Based on my own knowledge of the prior art and on my review of several
`
`prior art publications and devices, it is my opinion that asserted claiml of the '308 patent
`
`is invalid. Claim 1 of the '308 patent describes exactly the prior art protective caps
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`discussed above, with the sole addition of"an antiseptic agent disposed in the chamber."
`
`20.
`
`As discussed above, prior art caps for male Luer connectors dating back
`
`to at least the year 2000 included each of the elements of claim 1 of the '308 patent except
`
`the disinfecting agent. The following claim chart sets this out more directly:
`
`8
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 9 of 21
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`Claims of the '308 Patent
`
`Prior Art Caps
`
`The prior art caps are sterile protective caps
`1. A male-disinfecting cap for
`for the exact same type of male Luer-lock
`disinfecting a male Luer-lock connector
`connectors of the type having a post with a
`of the type including a post having a
`lumen through which fluid flows and an
`lumen through which fluid flows and an
`internally helically threaded skirt around the
`internally helically threaded skirt
`surrounding the post, the cap comprising: post.
`
`The prior art caps have a body with an outer
`a cap body having an outer surface
`surface defining a gripping portion and a
`defining a gripping portion and only one
`receiving portion, and they define a
`receiving portion and defining a
`longitudinal axis. The receiving portion is a
`longitudinal axis, the receiving portion
`hollow chamber with a single opening at the
`defining one chamber having a single
`receiving end. The post ofthe male Luer-lock
`opening, said opening being in the
`connector is received through the opening.
`receiving portion, into which the post of
`The open end of the cap fits with the skirt of
`the male Luer-lock connector can be
`the male connector when the post is received.
`received, wherein an exterior surface of
`the receiving portion near the opening of The prior art caps all have some form of
`the chamber fits within the skirt of the
`protrusions on the exterior surface near the
`opening to engage the threads on the skirt of
`male Luer-lock connector when the post
`the male connector.
`is received into the single opening of the
`chamber, the exterior surface ofthe
`receiving portion having protrusions
`shaped to engage helical threads of the
`internally helically threaded skirt;
`
`the chamber defining an interior portion
`extending within the gripping portion of
`the cap body, wherein the gripping
`portion extends the cap body
`longitudinally beyond the skirt of the
`male Luer-lock connector when the post
`is received into the chamber; and
`
`the gripping portion comprising at least
`one recess having a length and depth,
`wherein the depth varied monotonically
`along the length of the recess; and
`
`The hollow inner portion of many of the prior
`art caps extends into the portion of the cap
`with the gripping feature, and the gripping
`feature portion extends past the skirt of the
`male connector so that the user can actually
`grip the cap and twist it on and off.
`
`The gripping portions of the prior caps
`include examples of both recesses and ribs in
`a wide range of different configurations.
`Among those with recesses, rather than ribs,
`the depth of the recesses varies monotonically
`in that it increases or is flat, or decreases or is
`flat along the length of the recess.
`
`9
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 10 of 21
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`an antiseptic agent disposed in the
`chamber.
`
`It would have been obvious to a person of
`skill in the art to put a disinfecting agent in the
`cap if the cap was intended to be a
`disinfecting cap.
`
`21.
`
`In particular, the file history of the '308 patent indicates that the element
`
`of claim 1 that was used to distinguish over the prior art of record - which did not include
`
`the prior art caps described above - was the monotonically varying
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`depth of the gripping feature. Prior art caps such as the Baxter
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`Mini Cap example shown here, clearly demonstrate the use of a
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`gripping feature having recesses in which the depth of the recess varies
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`monotonically as you move from the end nearest the opening to the
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`distal-most end of the cap. Here, the recess gets deeper relatively
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`quickly, then stays relatively consistent until the end. Thus, the depth increases then
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`remains constant, but never decreases.
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`22.
`
`Based on my review of some initial prior art research, I also believe that
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`the asserted claims of the '681 patent are invalid in view of the prior art. Asserted claims
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`1 and 18 of the '681 patent are identical except that claim 1 requires a "gripping element"
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`that is absent from claim 18. These two claims include many of the same elements as
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`claim 1 of the '308 patent, all of which are disclosed in various prior art caps as discussed
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`above.
`
`23.
`
`The file history ofthe '681 patent indicates that the element of claims 1
`
`and 18 that distinguished over the prior art of record - in particular the Peluso reference
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`attached as Exhibit C - and led to allowance was:
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`10
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 11 of 21
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`a member movably disposed within the chamber, the member shaped to enter the
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`lumen so as to engage against an interior edge of an opening of the 1 umen when
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`the post is received into the receiving portion to diminish the flow of the
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`antiseptic agent into the lumen while permitting flow of the antiseptic agent past
`
`the member of the post of the male luer-lock connector.
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`This sounds far more complicated than it is. An easy analogy is to the old story of the
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`Dutch boy who put his finger into a hole in the dike. The hole is the opening to the
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`lumen, and the boy's finger is the "movable member" shaped to enter the lumen. When
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`the boy moves his finger and places it in the hole, his finger conforms to the shape of the
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`hole and thus engaging the interior edge of the opening of the hole, diminishing the flow
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`(and saving the town).
`
`24.
`
`Application of this same concept to the lumen of a
`
`FIG.4
`
`male connector is common. The prior art is replete with examples
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`of use of a member that is j arnmed into the opening of the lumen,
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`engaging the interior edge of the opening to the lumen to diminish
`
`or completely stop flow. An example is U.S. Patent No. 5,184,742
`
`to DeCaprio, attached as Exhibit D. This engagement feature can
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`be seen readily in this image from DeCaprio at right.
`
`25.
`
`I have been provided with various
`
`prior art references by I vera that include prior art
`
`patents that were not considered by the patent
`
`FIG. 8
`(IYPE B)
`
`FIG.9
`
`11
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`72
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`

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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 12 of 21
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`office during prosecution ofthe '681 patent. Among these is U.S. Patent No. 4,597,758
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`to Aalto, which issued on July 1, 1986. A copy is attached as Exhibit E. The Aalto
`
`reference discloses a cap for attachment to a male connector that has a member ( 68)
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`movably disposed within the chamber, as shown in Figs. 8 and 9 here. The member
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`shaped to enter the lumen so as to engage against an interior edge of an opening of the
`
`lumen when the post is received into the receiving portion. This engagement is shown in
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`a slightly different embodiment in Fig. 5 below, as the top (55) of member (36) engages
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`the interior edge of the opening of the lumen (60):
`
`F/6.5
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`26.
`
`Thus, the feature that resulted in allowance of the claims of the '681
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`patent over the prior art is clearly disclosed in prior art that was not before the examiner
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`during prosecution of the '681 patent. It would have been obvious to a person of ordinary
`
`skill in the art at the time of the invention to combine this feature of the prior art with the
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`features already found present in the prior art during examination to arrive at the claimed
`
`invention.
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`Non-Infringement Analysis
`
`27.
`
`I have also evaluated the alleged infringement ofthe '681 and '308
`
`12
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 13 of 21
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`patents by the accused Tips product. It is my opinion that - if valid - none of the asserted
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`claims are infringed, as at least one element of each asserted claim is not present in the
`
`accused Tips product.
`
`28.
`
`As discussed above, claims 1 and 18 of the '681 patent both require "a
`
`member movably disposed within the chamber, the member shaped to enter the lumen so
`
`as to engage against an interior edge of an opening of the lumen when the post is received
`
`into the receiving portion to diminish the flow of the antiseptic agent into the lumen while
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`permitting flow of the antiseptic agent past the member of the post ofthe male Luer-lock
`
`connector." The accused Tips product does not satisfy this claim limitation.
`
`29.
`
`Catheter Connections alleges that the top surface of the plunger in the
`
`Tips product is "shaped to enter the lumen so as to engage against an interior edge of an
`
`opening ofthe lumen ... to diminish the flow of the antiseptic agent into the lumen."
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`While the top surface of the plunger contacts the tip of the post of the male connector, it is
`
`my opinion that it does not "engage against an interior edge of an opening of the 1 umen."
`
`30.
`
`A person of ordinary skill in the art at the time of the invention would
`
`understand the requirement that the movable member "engage against an interior edge of
`
`an opening of the lumen" to require something more than contact. The term "engage"
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`means more than to merely touch, it is commonly used to describe parts that interlock or
`
`mesh together. Gears engage when their teeth mesh together. Threads engage when one
`
`mating thread interlocks with its counterpart. Latches engage when their latching
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`components interlock. Even when used to describe human relationships, engagement is
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`more than just contact.
`
`31.
`
`The term engage is used consistent with this understanding in the '681
`
`13
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 14 of 21
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`patent. The term "engage" is use extensively in the '681 patent to describe the
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`engagement of protrusions on the outside of the cap with the threads on the skirt of the
`
`male connector. An example is at col. 7, 11. 3-15 and 23-46. The term "engage" is also
`
`used to describe the interaction between elements of a "connection interface 1 042" that
`
`provides coupling in a "secure, yet selectively removable fashion." Col. 8, 11. 45-47.
`
`Examples of such a "connection interface 1 042" include threads, "friction-fit, snap fit, or
`
`other suitable interfacing arrangements." Col. 8, 11. 35-54. These examples all engage by
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`an interlocking or intenneshing of components, not just contact.
`
`32.
`
`The term "engage" is not used specifically with respect to the interaction
`
`between any moveable member and the edge of the opening of the lumen. However, an
`
`example of the difference between contact and engagement at that interface can be seen in
`
`Figures 66A-D. Figure 66A shows the point in time when "the Luer 2020 has been
`
`advanced sufficiently far into the disinfection chamber 3058 to contact the sealing
`
`member 3090 and to form a seal therewith." Col. 52, 11. 17-37.
`
`3004 (
`
`"
`
`FIG. 66A
`
`The subsequent figures show the interaction among the various components as the cap is
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`14
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 15 of 21
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`screwed farther onto the male connector, with Figure 66D showing the cap fully on the
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`male cmmector. In that view, the sealing member 3090 is engaged with the interior edge
`
`of the opening of the lumen 2022 at the tip 2021 of the male Luer post, having deformed
`
`around that edge so that the sealing member and edge of the opening are interlocked.
`
`2{)1)0
`
`/
`)
`
`/
`\::011
`'")
`3070
`30i6"""----
`
`' 30S2
`
`FIG. 66D
`
`33.
`
`As explained above, the accused Tips product does not have any sort of
`
`spring or other biasing member behind the plunger to exert a force against the tip of the
`
`male post. When the tip of the male post makes contact with the top of the plunger, it
`
`presses it down and in normal use contact will be maintained until the cap is removed.
`
`However, there is no resilient force pushing the plunger back towards the tip of the post to
`
`create an engagement between the top surface of the plunger and any part of the tip of the
`
`male post. On that basis, it is my opinion that the Tips product does not have a "member
`
`movably disposed within the chamber, the member shaped to enter the lumen so as to
`
`engage against an interior edge of an opening of the lumen when the post is received into
`
`the receiving pmiion" as required by claims 1 and 18 of the '681 patent.
`
`34.
`
`These claims further require that such engagement "diminish the flow of
`
`15
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 16 of 21
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`the antiseptic agent into the lumen." It is my understanding that the Tips product is
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`designed to prevent the flow of alcohol into the lumen of the male connector, not to
`
`diminish such flow.
`
`3 5.
`
`I have reviewed Dr. Durgin's testimony based on the testing performed by
`
`Dr. Austin. In my opinion, Dr. Austin's testing procedure as presented in the materials I
`
`have been provided is fundamentally flawed, and does not provide any evidence of a
`
`diminished flow of alcohol relating to the interface between the top of the plunger and the
`
`opening ofthe lumen.
`
`36.
`
`First, Dr. Austin's testing protocol fails to account for the potential
`
`presence of alcohol on the top of the plunger prior to testing. While most of the alcohol in
`
`a Tips caps will be contained behind the plunger by the plunger and its flange prior to use,
`
`I have observed in some samples ofTips when I remove them from the foil laminate strip
`
`that alcohol has migrated onto the top surface of the plunger during storage and shipment.
`
`Because Dr. Austin's protocol neither checks for, nor cleans away any such alcohol prior
`
`to attachment to the male connector, this could be the source of the extremely small
`
`quantities of IP A that Dr. Austin has measured inside the lumen at the end of this test.
`
`3 7.
`
`Second, the test protocol requires the insertion and removal of water from
`
`the back side of the male connector three (3) times, all conducted with the device
`
`positioned so that the cap is below the male connector. As Dr. Durgin testified in his
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`deposition, this results in back-pressure (referred to as "head height pressure") against the
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`top surface of the plunger at the interface between the top surface of the plunger and the
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`opening to the lumen. Again, because there is no biasing member such as a spring behind
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`the plunger, this force would tend to push the plunger away from the tip of the male post.
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`16
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 17 of 21
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`If this pressure was sufficient to break contact between the top surface of the plunger and
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`the top of the post, it could result in a loss of contact between those two surfaces and allow
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`direct access for IPA into the opening of the lumen. There is no such back-pressure
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`against the top surface of the plunger during ordinary use.
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`38.
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`Thus, even assuming the accuracy of Dr. Austin's measurements finding
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`very small quantities ofiPA in the lumen after completion of his tests of the Tips product,
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`there is no way to determine whether that alcohol reflects a "diminished flow" past the
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`plunger into the lumen. The IP A in the line could be a false positive due to alcohol on top
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`of the plunger at the time ofthe test, or a test artifact resulting from the testing procedure.
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`3 9.
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`At this point, it is my opinion that there is no evidence indicating that IP A
`
`is flowing past the plunger into the opening of the lumen during ordinary use of the Tips
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`product. Moreover, my understanding of the Tips design is that it is intended to prevent
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`the flow of any IP A into the opening of the lumen. A person of ordinary skill in the art at
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`the time of the invention would understand the claim requirement to "diminish the flow of
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`the antiseptic agent into the lumen" to require some flow into the lumen, but at a rate that
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`is less than it would otherwise be flowing. A flow rate of zero is not a "diminished flow,"
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`it is zero flow. Thus, I have not seen any evidence that the tips device diminishes flow of
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`IP A into the lumen, and it is my opinion that the Tips product does not satisfy this claim
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`limitation.
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`40.
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`For these reasons, it is my opinion that the accused Tips device does not
`
`include all of the limitations of claims 1 and 18 of the '681 patent and thus does not
`
`infringe those claims.
`
`41.
`
`Turning to the '308 patent, claims 1 and 7 differ in the requirements they
`
`17
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 18 of 21
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`impose on the gripping feature. Looking first to claim 1, this claim requires that "the
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`gripping portion comprising at least one recess having a length and depth, wherein the
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`depth varied monotonically along the length of the recess." I understand that the word
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`"varied" is a typographical en-or, and that this word should be "varies." I have reviewed
`
`the Tips product and I do not believe that it satisfies this limitation because the gripping
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`feature does not include any recesses.
`
`42.
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`A person of ordinary skill in the art at the time of the invention would
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`recognize a well-understood distinction between a "recess" which is made by removing
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`material from the body of an object and a "rib" which is made by adding material to the
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`body of an object. While this may sound somewhat technical, it is an important
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`distinction that impacts how a device is designed and modeled using computer aided
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`design ("CAD") software.
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`43.
`
`Looking at the Tips product, when I examined it I immediately understood
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`its gripping feature to be formed as ribs extending out from the cap body rather than as
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`recesses carved out from the cap body. CAD images provided by I vera confirmed this
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`understanding. As seen here, the
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`cap body itself is formed oftwo
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`primitive shapes, a cylindrical
`
`portion that includes the opening
`
`to the cap, and a conical portion
`
`that extends from the distal end
`
`ofthe cylindrical portion. To create the gripping feature, a series of ribs were then added
`
`to the conical portion of the cap body.
`
`18
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 19 of 21
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`44.
`
`This can be seen in the following series of CAD images showing the
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`buildup ofthe ribs from left to right:
`
`45.
`
`Based on on the shape of the ribs, it would not have been possible to form
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`the gripping feature on the Tips product using recesses into a cylindrical cap body, as
`
`there is no primitive shape or easily defined geometric shape that could be used to create
`
`the recess. Thus, it is my opinion that the Tips product does not have a gripping feature
`
`with recesses as required by claim 1 of the '308 patent.
`
`46.
`
`Claim 7 of the '308 patent differs from claim 1 in that it requires a
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`gripping portion "comprising at least one recess having a bottom, the cap body having a
`
`cross sectional thiclmess at the bottom of the recess gradually increasing from a distal(cid:173)
`
`most end of the cap body and towards the receiving portion." As discussed above with
`
`respect to claim 1, the accused Tips product does not include any recesses and thus does
`
`not meet this limitation.
`
`47.
`
`In addition, I have reviewed Dr. Durgin's testimony regarding this claim
`
`limitation and agree with him that it requires the thiclmess of the cap body wall to
`
`gradually increase as you move fi:om the end of the cap farthest from the opening toward
`
`19
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`Case 2:14-cv-00070-TC Document 47 Filed 03/12/14 Page 20 of 21
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`the receiving portion. I have sectioned samples of the Tips product in several locations
`
`throughout the gripping feature, measured the wall thickness using a tool makers
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`microscope, and determined that the cap body wall does not gradually increase in
`
`thickness as required by this claim. Rather, the cap body wall thickness stays the same
`
`over this area once normal statistical and measurement variability are taken into account.
`
`My observations are confirmed by the CAD image provided by I vera and attached as
`
`Exhibit F, which indicates a cap body wall thickness between the ribs of the gripping
`
`portion that maintains a constant thickness of0.030" throughout.
`
`48.
`
`Based on these observations, it is my opinion that the accused Tips
`
`product does not infringe claims 1 or 7 ofthe '308 patent.
`
`49.
`
`Because this preliminary injunction motion is proceeding on a relatively
`
`fast schedule early in the case, I have conducted my analysis as set out in this declaration
`
`under significant time pressure. I anticipate continuing my evaluation of all the technical
`
`issues discussed herein, and reserve the right to modify or amend my opinions if
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`appropriate based on my further analysis of the relevant issues and devices, and based on
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`further information developed in this matter.
`
`I declare under penalty of perjury under the laws of the United States of America
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`that the fore