IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 15-cv-00661-SLR
`
`JURY TRIAL DEMANDED
`
`)))))))))
`
`DNA GENOTEK INC.,
`
`Plaintiff,
`
`
`
`v.
`
`SPECTRUM DNA, SPECTRUM
`SOLUTIONS L.L.C., and SPECTRUM
`PACKAGING L.L.C.,
`
`
`
`Defendants.
`
`DECLARATION OF TERRY LAYTON, PH.D. IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO DNA GENOTEK’S MOTION FOR PRELIMINARY INJUNCTION
`
`ANCESTRY EX. 1017
`
`1
`
`

`
`I, Terry Layton, Ph.D., declare as follows:
`
`1.
`
`I have been retained as an expert witness on behalf of Defendants Spectrum DNA,
`
`Spectrum Solutions L.L.C., and Spectrum Packaging L.L.C. (collectively, “Spectrum”) in this
`
`case. I submit this declaration in support of Spectrum’s Opposition to DNA Genotek Inc.’s
`
`(“Genotek’s”) Motion for a Preliminary Injunction.
`
`2.
`
`For my work as an expert in this case, I am being compensated at the rate of $250
`
`per hour, except that for my work providing deposition or trial testimony, I am compensated at a
`
`rate of $350 per hour. My compensation is not contingent on the opinions I reach or on the
`
`outcome of any legal action, mediation, arbitration, or the terms of any settlement in this case.
`
`3.
`
`I have been asked to give my opinions regarding whether the Spectrum DNA
`
`collection device infringes claim 1 of U.S. Patent 8,221,381 (“the ʼ381 patent”), either literally or
`
`under the doctrine of equivalents. I have also been asked to give my opinions regarding the
`
`validity of claim 1 of the ʼ381 patent in view of U.S. Patent No. 7,645,424 and WO 98/03265.
`
`This declaration contains my opinions resulting from that analysis.
`
`4.
`
`In providing my opinions expressed below, I relied upon my education, my
`
`experience, and the documents referenced herein.
`
`5.
`
`The analysis and opinions described in this report are based on the record that is
`
`currently available in this lawsuit. I am able to render an opinion at this time based on that
`
`information. However, my analysis is ongoing. I may revise or expand upon my opinions as
`
`additional information becomes available, including, but not limited to, views and opinions
`
`expressed by other expert witnesses, and additional documentary and testimonial evidence
`
`produced during ongoing discovery or at trial.
`
`1
`
`2
`
`

`
`
`
`I.
`
`EDUCATION AND PROFESSIONAL BACKGROUND
`6.
`I studied Electrical Engineering at the University of Illinois at Urbana-Champaign
`
`and received a Bachelor of Science degree in Zoology/Physiology from the University of
`
`Wyoming in 1966. I earned a M.S. in Bioengineering from the University of Illinois at Chicago
`
`in 1972, and a Ph.D. in Biomedical Engineering from the University of Virginia in 1975.
`
`7.
`
`I have worked in the medical device field for more than 35 years, and have been
`
`actively involved with the engineering, research, product design, development, and
`
`manufacturing of medical devices, including FDA regulated medical devices and medical fluid
`
`collection devices. A copy of my curriculum vitae is attached as Exhibit A.
`
`8.
`
`From 1975 to 1988, I was employed by The Kendall Company, starting out as a
`
`research scientist, and ultimately being promoted to Manager of Medical & Sports Medicine
`
`Divisions. During that time, I designed, tested, developed, and/or managed a variety of products
`
`in the dental, medical, and sports fields. Several of these projects involved urine collection
`
`devices, lumbar puncture spinal fluid collection vials, and thoracentesis collection bags and
`
`specimen collection tubes and caps.
`
`9.
`
`From 1988 to 1990, I was employed by Baxter Healthcare Corporation
`
`(“Baxter”), where I was a manager of the Advanced Device Technology group. During that
`
`time, I was involved in the design and management of products and components for IV systems
`
`and components, and blood collection products.
`
`10.
`
`From 1991 to 1994, I was employed by Packer Engineering as its Director of
`
`Biomedical Engineering. During that time, I consulted on and made numerous technology
`
`assessments of a variety of health related products in the biomedical field and conducted failure
`
`mode investigations of medical devices.
`
`2
`
`
`
`3
`
`

`
`
`
`11.
`
`From 1994 to 1999, I was employed by Integra and the NeuroCare Group as its
`
`Vice-President, Group Technical Officer. During this time, I was involved in developing and
`
`releasing to the market new products relating to neurosurgical implants and monitoring devices,
`
`assessing new technologies, licensing patents, and purchasing patents and companies. I was also
`
`involved in developing and releasing to the market medical devices such as cerebral spinal fluid
`
`(CSF) collection bags and valves.
`
`12.
`
`I am an inventor on eighteen issued patents, and have authored numerous
`
`publications and presentations related to medical devices. A list of my publications and patents
`
`is included in Exhibit A.
`
`II.
`
`INFRINGEMENT ANALYSIS
`13.
`Genotek’s expert, Dr. Lasheras, has asserted that Spectrum’s DNA Saliva
`
`Collection Kit with Solution for DNA Preservation (the “Spectrum Product”) infringes claim 1
`
`of the ’381 patent, either literally or under the doctrine of equivalents.
`
`14.
`
`I have reviewed the ʼ381 patent (attached as Exhibit B), the file history of the
`
`ʼ381 patent, and the Spectrum Product. I have also reviewed pictures and materials relating to
`
`the Spectrum Product, including those on Spectrum’s website, www.spectrum-dna.com, and the
`
`exhibits attached to Dr. Lasheras’ declaration. I have also reviewed WO 2015/017701 (attached
`
`as Exhibit J).
`
`15.
`
`As shown on the information sheet for the Spectrum Product (attached as
`
`Exhibit C), the Spectrum DNA sample collection device includes three main components:
`
`
`
`3
`
`
`
`4
`
`

`
`
`
`
`
`
`
` 3
`
`
`
`2
`
`
`
`
`
`1
`
`
`
`16.
`
`In the figure above, the collection tube of the Spectrum Product is labelled (1), the
`
`funnel is labelled (2), and the cap is labelled (3). As explained in more detail below, the cap (3)
`
`contains a piercing insert, a separate container with a stabilization liquid, and a membrane
`
`covering the opening of the separate container so the liquid does not spill out until the membrane
`
`is pierced by the piercing insert.
`
`17.
`
`The instructions for the Spectrum Product (attached as Exhibit D) describe four
`
`steps. First, with the funnel (2) attached to the collection tube (1), the user fills the collection
`
`tube (1) with saliva to the black wavy line, as shown in the figure below:
`
`
`
`
`
`
`
`
`
`
`
`Second, the funnel (2) is removed (see figure below) and the cap (3) is placed on the
`
`collection tube (1):
`
`
`
`
`
`
`
`
`
`
`
`4
`
`
`
`5
`
`

`
`
`
`Third, the user places the cap on the collection tube and tightens the cap (3), which
`
`moves the piercing insert in the cap (3) upward and into the membrane, thereby piercing the
`
`membrane and releasing the stabilization fluid into the collection tube (1), as shown in the figure
`
`below:
`
`
`
`
`
`
`
`
`
`
`
`Finally, the user shakes the sealed collection tube for at least five seconds:
`
`
`
`
`
`
`
`
`
`
`
`18.
`
`Claim 1 of the ʼ381 patent recites:
`
`A container system for releasably storing a substance, comprising:
`
`(a) a vial comprising a first open end for receiving a sample, a second end
`comprising a sample storage chamber and a piercing member, wherein said
`piercing member comprises a side wall, a first cutting edge extending from a first
`pointed corner to a second corner that defines the intersection between said
`cutting edge and said side wall; and
`
`(b) a lid configured to removably engage said vial, said lid comprising a reservoir
`for holding the substance, and a pierceable membrane sealing the substance
`within said reservoir,
`
`wherein, when said system is closed by removable engagement of said vial with
`said lid, said vial and said lid are movable to a piercing position in which the
`
`5
`
`
`
`6
`
`

`
`piercing member disrupts the pierceable membrane to allow fluid communication
`between said reservoir and said chamber, wherein the chamber is sealed against
`leakage to the outside of the container system in the piercing position.
`
`19.
`
`I have been informed by counsel for Spectrum, and I understand, that a product
`
`literally infringes a patent claim if every element recited in the claim is literally found in the
`
`accused product.
`
`20.
`
`I understand that, although a claim element may not literally be present in an
`
`accused product, that product may nonetheless infringe under the doctrine of equivalents if the
`
`accused product contains an element that is equivalent to the claim element that is not literally
`
`met. I understand that courts look to whether the differences between a limitation of the claimed
`
`invention and an element of the accused product are insubstantial. I further understand that a
`
`function-way-result test may be used to determine insubstantiality, and that the function-way-
`
`result test asks whether an element of an accused product performs substantially the same
`
`function in substantially the same way to obtain substantially the same result as an element of the
`
`patented invention. I understand that the doctrine of equivalents analysis is performed on an
`
`element by element basis, and not on the invention as a whole.
`
`A.
`
`21.
`
`The Spectrum Product Does Not Include a “Vial Comprising . . . a Piercing
`Member.”
`The container system of claim 1 of the ʼ381 patent includes “a vial comprising a
`
`first open end for receiving a sample, a second end comprising a sample storage chamber and a
`
`piercing member.” I have been informed by counsel for Spectrum, and I understand, that the
`
`claim term “comprising” means “including” or “containing.” I also understand that the claim
`
`term “comprising” means that the named elements are essential, but other elements may also be
`
`present.
`
`6
`
`7
`
`

`
`
`
`22.
`
`The ʼ381 patent discloses container systems with a vial, a lid, and an optional
`
`funnel. See, e.g., ʼ381 patent, 4:6-9. In describing vials with a piercing member, the ʼ381 patent
`
`teaches that the piercing member extends from a surface of the vial and is therefore an integral
`
`part of the vial. For example, the patent states:
`
`Vial 1 comprises at least one piercing member 6. In the specific embodiment depicted in
`FIGS. 1-11 piercing member 6 extends from a base surface of chamber 2. In one
`example, piercing member 6 extends approximately perpendicular from the base. In
`another example, piercing member 6 is angled inwardly or outwardly toward the open
`end of vial 1. Alternatively, piercing member 6 extends from an interior surface of said
`vial. In one example, piercing member 6 extends from an interior surface of said vial and
`is angled inwardly or outwardly toward the open end of vial 1.
`
`
`Id., 6:14-23 (emphasis added). Likewise, the figures of the ʼ381 patent only show piercing
`
`members that are an integral part of the vial. See, e.g., id., Figures 10 and 23.
`
`
`
`
`
`
`
`Thus, I conclude that “a vial comprising . . . a piercing member” is a vial that includes a piercing
`
`member as a component. That is, the piercing member is an integral part of the vial.
`
`23.
`
`It is my opinion that the Spectrum Product does not have “a vial comprising . . . a
`
`piercing member,” and therefore does not literally infringe claim 1 of the ʼ381 patent. The
`
`collection tube of the Spectrum Product, which Dr. Lasheras identifies as the recited vial, is
`
`pictured below:
`
`7
`
`
`
`8
`
`

`
`
`
`
`
`
`
`As clearly shown in the picture, this collection tube does not include a piercing member as
`
`required by claim 1 of the ʼ381 patent.
`
`24.
`
`Dr. Lasheras identifies the component pictured below as the piercing member of
`
`the Spectrum Product:
`
`
`
`
`
`
`
`
`
`See, e.g., Lasheras Decl., ¶ 20 and Ex. F (p. 5).
`
`25.
`
`However, in the Spectrum Product, this piercing insert is in the cap as shown
`
`below, not in the vial:
`
`cap
`
`piercing insert
`
`
`
`
`
`
`
`
`
`8
`
`
`
`9
`
`

`
`
`
`26.
`
`Dr. Lasheras admits that “[t]he piercing member is located in the bottom of the lid
`
`apart from the collection tube when the Spectrum Product is shipped in its packaging.” Lasheras
`
`Decl., ¶ 21. Dr. Lasheras also admits that, to get a picture of the Spectrum Product piercing
`
`insert, the product had to first be disassembled to remove the piercing insert from the lid. For
`
`example, Dr. Lasheras states that the picture “of the Spectrum Product’s piercing member was
`
`taken after it was pulled out of the lid of the Spectrum Product.” Id., ¶ 20.
`
`27.
`
`Dr. Lasheras does not provide a construction of the claim term “a vial
`
`comprising . . . a piercing member.” But he concludes that the Spectrum Product meets this
`
`claim limitation because, “[w]hen in use, the piercing member becomes wedged in the top of the
`
`collection tube, completing the claimed ‘vial.’” Id., ¶ 21.
`
`28.
`
`I do not agree with Dr. Lasheras for several reasons. First, Dr. Lasheras has not
`
`shown that the piercing insert, which is in the cap of the Spectrum Product, becomes wedged in
`
`the top of the collection tube when the product is in use. Instead, Genotek disassembled the
`
`Spectrum Product by taking the piercing insert out of the cap, and then placed the piercing insert
`
`on top of the collection tube opening for the picture shown in paragraph 21 of Dr. Lasheras’
`
`declaration. See id., ¶ 20. Dr. Lasheras does not provide any evidence that the piercing insert is,
`
`in fact, “wedged” in the vial opening when in use. More importantly, the piercing insert of the
`
`Spectrum Product is a component of the cap, NOT the vial. Even if the piercing member comes
`
`into contact with, or is “wedged” in, the opening of the vial when the cap is screwed on, the
`
`piercing member remains a component of the cap, not the vial. Indeed, when the cap is screwed
`
`on and then removed again, the piercing insert comes off with the cap. It does not stay
`
`associated with the vial. This is because there are flanges on the outside wall of the piercing
`
`9
`
`
`
`10
`
`

`
`insert. The flanges are configured to rest in the grooves on the inside of the cap, holding the
`
`piercing insert in the cap and at a distance from the seal until the cap is screwed on the tube.
`
`29.
`
`In addition, while the ʼ381 patent teaches that the vial or optional funnel may
`
`include a piercing member, the patent does not teach any lid with a piercing member. The ʼ381
`
`patent also does not teach any lid with a piercing member that becomes “wedged” in the vial
`
`when in use. Therefore, there is no support in the ʼ381 patent for concluding that “a vial
`
`comprising . . . a piercing member” reads on a lid with a piercing insert, even if that piercing
`
`insert allegedly becomes “wedged” in the vial when in use.
`
`30.
`
`Finally, if one assesses the Spectrum Product with the cap on (when the piercing
`
`member is allegedly wedged in the vial), as Dr. Lasheras does, the vial no longer has a “first
`
`open end for receiving a sample” as required by claim 1 because the cap is covering the opening
`
`of the vial, as shown in the figure below:
`
`In that case, the Spectrum Product still does not have all of the elements of claim 1 of the ʼ381
`
`patent (because the vial does not include a “first open end for receiving a sample”), and therefore
`
`still does not literally infringe.
`
`31.
`
`For all of the reasons explained above, I conclude that the Spectrum Product does
`
`not include “a vial comprising . . . a piercing member” and therefore does not literally infringe
`
`claim 1 of the ʼ381 patent. Below, I address whether the Spectrum Product includes an
`
`equivalent of this element under the doctrine of equivalents.
`
`10
`
`11
`
`

`
`32.
`
`As explained above, the Spectrum Product includes a piercing insert in the cap
`
`and a separate collection tube. In contrast, claim 1 is directed to a lid (with no piercing member)
`
`and a “vial comprising . . . a piercing member.” The “vial comprising . . . a piercing member” of
`
`claim 1 and the cap of the Spectrum Product are very different components. For example, the
`
`vial of claim 1 is used to collect a sample, while the cap of the Spectrum Product is used to cover
`
`the opening of the collection tube. Also, during use of the device of claim 1, sample is delivered
`
`to the “vial comprising . . . a piercing member,” and the sample flows past the piercing member.
`
`However, in the Spectrum Product, the sample does not come into contact with the piercing
`
`insert because it is located in the cap. In addition, the ʼ381 patent describes a vial with stationary
`
`piercing members that are formed as part of the vial. The Spectrum Product, however, has a
`
`piercing insert that is a separate component that is nested within the cap. The piercing insert is
`
`not stationary, but instead can spin within the cap and move vertically within that cap when the
`
`flanges on the piercing insert are within the grooves of the cap.
`
`33.
`
`The piercing insert in the cap of the Spectrum Product also functions in a different
`
`way than the “vial comprising . . . a piercing member.” As explained above, the piercing insert
`
`of the Spectrum Product can move vertically within the cap. When the cap is placed on the
`
`collection tube and screwed on, the piercing member is pushed upward into the membrane of the
`
`reagent chamber, which pierces the membrane and releases the stabilization solution into the
`
`collection tube.
`
`34.
`
`The “vial comprising . . . a piercing member” of claim 1 works in a different way.
`
`The ʼ381 patent explains that the piercing members, which are an integral part of the vial, are
`
`twisted to pierce the membrane of the reservoir. For example, the ʼ381 patent states:
`
`11
`
`12
`
`

`
`
`
`Continued twisting moves lid 100 and vial 1 from the open
`position, or the first position, to the piercing position, in which
`movement of lid 100 and vial 1 together results in disruption of
`pierceable membrane 160 by piercing member 6 . . . .
`Continued twisting moves cutting edge 32 through pierceable
`membrane 160, disrupting pierceable membrane 160 . . . .
`
`ʼ381 patent, 7:12-24.
`
`35.
`
`The piercing insert of the Spectrum Product does not twist to pierce the
`
`membrane. Instead, as explained above, the piercing insert is pushed vertically into the piercing
`
`membrane. Thus, the “vial comprising . . . a piercing membrane” of claim 1 functions in a
`
`different way than the lid with the piercing insert present in the Spectrum Product.
`
`36.
`
`I conclude that the piercing insert in the cap of the Spectrum Product is not an
`
`equivalent of the “vial comprising . . . a piercing member” of claim 1 at least because these two
`
`elements do not function in substantially the same way. It is therefore my opinion that the
`
`Spectrum Product does not infringe claim 1 under the doctrine of equivalents.
`
`B.
`
`37.
`
`The Spectrum Product Does Not Include a “Piercing Member
`Compris[ing] . . . a First Pointed Corner.”
`Claim 1 of the ʼ381 patent also recites “wherein said piercing member comprises
`
`a side wall, a first cutting edge extending from a first pointed corner to a second corner that
`
`defines the intersection between said cutting edge and said side wall.” That is, in claim 1, the
`
`first corner ― but not the second corner ― must be “pointed.” Figure 3 of the ʼ381 patent is
`
`reproduced below. In this figure, the side wall is labelled 34 and the first cutting edge is labelled
`
`32. See, e.g., ʼ381 patent, 6:33-38. The first pointed corner (labelled 30) and the second corner
`
`are also shown below:
`
`12
`
`
`
`13
`
`

`
`
`
`first pointed corner
`
`second corner
`
`
`
`
`
`
`
`
`
`As illustrated in Figure 3, the first pointed corner comes to a beveled point, while the second
`
`corner does not. The ʼ381 patent discusses the first pointed corner (30) as follows:
`
`Piercing member 6 can be approximately trapezoidal in shape and includes
`first cutting edge 33 [sic; 32] having pointed end 30 at one corner of the
`trapezoid and a second end at a second corner of the trapezoid where
`cutting edge 32 intersects side wall 34.
`
`Id., 6:33-37 and 8:32-37. By describing the first corner as “having pointed end 30 at one
`
`corner,” the ʼ381 patent makes clear that the first corner comes to a point at the end. The ʼ381
`
`patent also explains that the first pointed corner 30 is used to disrupt the pierceable membrane:
`
`In operation, in moving to the piercing position, pointed end 30 is brought
`into contact with pierceable membrane 160 and subsequently pierces
`pierceable membrane 160. Continued twisting moves cutting edge 32
`through the pierceable membrane 160, thereby disrupting pierceable
`membrane 160 and producing an opening in pierceable membrane 160 to
`permit the substance to enter interior chamber 422.
`
`Id., 9:59-65.
`
`38.
`
`The ʼ381 patent uses the word “pointed” consistent with its plain and ordinary
`
`meaning. For example, Webster’s Dictionary defines a “point” as “a sharp, tapering, or
`
`otherwise narrowly converging end.” See Exhibit E. Thus, I understand “a first pointed corner”
`
`13
`
`
`
`14
`
`

`
`
`
`to be an edge with a sharp, tapering or otherwise narrowly converging end. The pointed end (30)
`
`in Figure 3 of the ʼ381 patent is an example of such a “first pointed corner”:
`
`first pointed corner
`
`
`
`
`
`
`
`
`
`39.
`
`The piercing insert of the Spectrum Product, which is pictured below, does not
`
`have a piercing member with a “first pointed corner.”
`
`squared‐off corners; 
`not pointed
`
`
`
`
`
`
`
`
`
`
`
`For example, these corners do not taper, do not have narrowly converging ends, and do not come
`
`to a sharp point. Instead, both corners of the piercing members of the Spectrum Product are
`
`squared-off. Therefore, the Spectrum Product does not literally infringe claim 1 of the ʼ381
`
`patent for the additional reason that the Spectrum Product does not include a “piercing member
`
`compris[ing] . . . a first pointed corner.”
`
`14
`
`
`
`15
`
`

`
`
`
`40.
`
`I have been informed by counsel for Spectrum, and I understand that, an estoppel
`
`arising from a claim amendment that narrows a claim limitation creates a rebuttable presumption
`
`that the doctrine of equivalents is unavailable for that limitation. I understand that Genotek
`
`amended claim 1 during prosecution to add “wherein said piercing member comprises a side
`
`wall, a first cutting edge extending from a first pointed corner to a second corner that defines the
`
`intersection between said cutting edge and said side wall.” I further understand that this
`
`amendment was made to overcome a rejection of claim 1 based on prior art. Thus, it is my
`
`understanding that the doctrine of equivalents is not available for the claim element “wherein
`
`said piercing member comprises a side wall, a first cutting edge extending from a first pointed
`
`corner to a second corner that defines the intersection between said cutting edge and said side
`
`wall.”
`
`41.
`
`In summary, I conclude that the Spectrum Product does not infringe claim 1 of the
`
`ʼ381 patent, either literally or under the doctrine of equivalents, at least because the Spectrum
`
`Product does not include a “vial comprising . . . a piercing member” or a “piercing member
`
`compris[ing] . . . a first pointed corner.”
`
`III. ANALYSIS OF THE VALIDITY OF CLAIM 1 OF THE ʼ381 PATENT
`42.
`The ʼ381 patent claims priority to a provisional patent application filed on
`
`December 9, 2005.
`
`43.
`
`It is my understanding that a claim may be found to be “anticipated,” and
`
`therefore invalid, when a single prior art reference discloses each and every limitation of the
`
`claim.
`
`44.
`
`I have been informed by counsel for Spectrum, and I understand that, a claim is
`
`obvious, and therefore invalid, when the differences between the claimed invention and the prior
`
`15
`
`
`
`16
`
`

`
`
`
`art would have been obvious to a person having ordinary skill in the art to which the patent
`
`pertains at the time the invention was made. I understand that factors relevant to the obviousness
`
`analysis include: (a) the scope and content of the prior art; (b) the differences between the prior
`
`art and the claim at issue; (c) the level of ordinary skill in the pertinent art; and (d) secondary
`
`considerations of non-obviousness.
`
`45. While I am still considering the credentials of a person of ordinary skill in the art
`
`in the field of the ʼ381 patent, I believe such a person of ordinary skill in the art would have at
`
`least a bachelor of science degree in an engineering field, such as mechanical engineering, and
`
`several years of experience designing collection devices for the medical field.
`
`46.
`
`It is my opinion that claim 1 of the ʼ381 patent is invalid because it is either
`
`anticipated by the prior art or rendered obvious by the prior art. Below I provide the analysis
`
`through which I have reached that conclusion.
`
`A.
`47.
`
`U.S. Patent No. 7,645,424
`U.S. Patent 7,645,424 (“the ʼ424 patent”) issued from a patent application that
`
`was filed on May 16, 2006, which was a continuation application of PCT/IE2004/000162 (filed
`
`on Nov. 18, 2004), which in turn claims priority to a provisional patent application filed on
`
`November 19, 2003. I understand that the ʼ424 patent is prior art to the ʼ381 patent. A copy of
`
`the ʼ424 patent is attached as Exhibit F.
`
`48.
`
`The ʼ424 patent is titled “Reagent Cuvette.” As illustrated in Figure 1 of the ʼ424
`
`patent, which is reproduced below, the ʼ424 patent discloses a container system (reagent cuvette
`
`1) with a first chamber (labelled 2) and a second chamber (labelled 3).
`
`16
`
`
`
`17
`
`

`
`49.
`
`The first chamber 2 has a first open end for receiving a sample and a second
`
`closed end that forms a sample chamber. The open end is depicted with a foil (labelled 7), which
`
`is installed during manufacture, covering the open end. The foil is removed by the end user at
`
`the time of use. See, e.g., ʼ424 patent, 3:11-14 (“In use, at the point-of-care the foil membrane 7
`
`is peeled away by the therapist . . . [a] sample, such as blood, is added to the chamber 2[.]”)
`
`50.
`
`As illustrated in Figure 3 of the ʼ424 patent, reproduced below, the first chamber
`
`2 has a socket (labelled 6) that receives the second chamber 3 by way of a friction fit. See, e.g.,
`
`17
`
`18
`
`

`
`
`
`id., 3:29-30 (“the chamber 3 being a friction fit within the socket 6”). Socket 6 includes a set of
`
`spikes (labelled 20) arranged at the base of the socket.1
`
`  
`
`
`
`51.
`
`The second chamber 3, located in the lid, holds a starter reagent, which is sealed
`
`within the second chamber by a foil membrane. See, e.g., id., 3:4-5 (“a starter reagent is injected
`
`into the chamber 3, and this is also sealed with a foil membrane”).
`
`
`1 See, e.g., ʼ424 patent, 2:60-67 (“Referring particularly to FIGS. 3 and 4 there are four
`piercing members, in this embodiment spikes 20 equally spaced-apart around the base of the
`socket 6, on the shoulder connecting it to the inspection part 5.”)
`
`18
`
`
`
`19
`
`

`
`
`
`52.
`
` When the second chamber 3 is pushed down into socket 6 of the first chamber 2,
`
`spikes 20 of the first chamber 2 are pushed through the foil membrane covering the reservoir of
`
`second chamber 3, and the reagent flows downward into the first chamber 2.2
`
`53.
`
`Once the second chamber 3 is “gently” pushed down into socket 6, a friction fit is
`
`created between the second chamber and the socket of the first chamber 2, which prevents liquid
`
`from leaking out. See, e.g., id., 3:28-30 (“The combination of the chambers 2 and 3 are
`
`effectively a single chamber, with the chamber 3 being a friction fit within the socket 6.”).
`
`54.
`
`In the claim chart attached as Exhibit G, I compare the elements of claim 1 of the
`
`’381 patent to the disclosure of the ʼ424 patent. My analysis is summarized below.
`
`55.
`
`Claim 1 of the ʼ381 patent is directed to “[a] container system for releasably
`
`storing a substance.” The ʼ424 patent teaches a second chamber 3 that can be pressed onto a first
`
`chamber 2. As explained above, when the second chamber 3 is pushed down into socket 6 of
`
`first chamber 2, the spikes 20 of first chamber 2 are pushed through the foil membrane that seals
`
`the reagent in the second chamber 3. Therefore, the ʼ424 patent teaches “[a] container system for
`
`releasably storing a substance.” See Exhibit G, element 1A.
`
`56.
`
`The container system of claim 1 includes “a vial comprising a first open end for
`
`receiving a sample” and “a second end comprising a sample storage chamber.” As shown below,
`
`the first chamber 2 of the ʼ424 patent includes a first open end for receiving a sample, which is
`
`temporarily covered with a foil membrane (labelled 7) and that is peeled away by the therapist at
`
`
`2 See, e.g., ʼ424 patent, 2:19-22 (“the second chamber is pushed into a socket of the first
`chamber, said piercing member is within the socket, and the reagent of the second chamber flows
`downwardly into the first chamber when the membrane is pierced”).
`
`19
`
`
`
`20
`
`

`
`
`
`the time of use to form an open end for receiving a sample. The lower portion of the first
`
`chamber (labelled 5), forms the sample storage chamber.
`
`                            
`
`
`
`57.
`
`Thus, the first chamber 2 of the ʼ424 patent is a “vial comprising a first open end
`
`for receiving a sample” and “a second end comprising a sample storage chamber,” as recited in
`
`claim 1. See Exhibit G, element 1B.
`
`58.
`
`The vial recited in claim 1 also “compris[es] . . . a piercing member.” As
`
`explained above, the proper construction of this term is a vial with a piercing member as a
`
`component of the vial (i.e., integrated into the vial). As shown below, the ’424 teaches a first
`
`20
`
`
`
`21
`
`

`
`
`
`chamber 2 with integrated spikes 20. Thus, the ʼ424 patent discloses a vial “comprising . . . a
`
`piercing member.” See Exhibit G, element 1B.
`
`                                             
`
`
`
`59.
`
`The piercing member of claim 1 “comprises a side wall, a first cutting edge
`
`extending from a first pointed corner to a second corner that defines the intersection between
`
`said cutting edge and said side wall.” As shown in Figure 3 above, the ʼ424 patent teaches a set
`
`of spikes (labelled 20; also called piercing members) integrated into the first chamber 2. See
`
`Exhibit G, element 1C. The picture of one of the spikes 20 from Figure 3 is reproduced below.
`
`21
`
`
`
`22
`
`

`
`60.
`
`Using Dr. Lasheras’ view of the “first pointed corner,” the side wall, first cutting
`
`edge, first pointed corner, and the second corner of the spike 20 of the ʼ424 patent are labelled
`
`above. If “first pointed corner” is construed to mean an edge with a sharp, tapering or otherwise
`
`narrowly converging end, then the ʼ424 patent still discloses a “first pointed corner.” For
`
`example, Figure 4 of the ʼ424 patent illustrates piercing members with a first pointed corner:
`
`22
`
`23
`
`

`
`
`
`first pointed corner
`
`
`
`
`
`
`
`The ʼ424 patent also discloses that “there may be different configuration[s] of [the] piercing
`
`member. . . . [For example,] [i]n another embodiment, the piercing member takes the form of a
`
`blade to cut along a longer length of the membrane.” ʼ424 patent, 3:48-53. I conclude that the
`
`ʼ424 patent discloses a piercing member with “a side wall, a first cutting edge extending from a
`
`first pointed corner to a second corner that defines the intersection between said cutting edge and
`
`said side wall.” See Exhibit G, element 1C.
`
`61.
`
`Next, claim 1 of the ʼ381 patent recites “a lid configured to removably engage
`
`said vial.” With respect to the term “removably engage,” the ʼ381 patent teaches that the lid can
`
`be releasably attached to the vial using a “threaded screw, snap-fit, and the like.” ʼ381 patent,
`
`9:10-12 (“The open end of vial 500 is also configured for securing attachment with a standard
`
`23
`
`
`
`24
`
`

`
`
`
`cap 520, as shown in FIG. 21. Cap 520 can be secured by a threaded screw, snap-fit, and the
`
`like.”). The ʼ381 patent also teaches that the particular means used to removably engage the lid
`
`to the vial is not important, as long as the lid and vial are moveable to a piercing position:
`
`In the specific embodiment depicted in the Figures, lid 100 comprises internal helical
`threads 108 on the inner surface of outer wall 110, which are adapted to engage external
`helical threads 18 on the outer surface of wall 12 on vial 1. As would be appreciated by a
`skilled worker, alternative means for releasable attachment of lid 100 to vial 1 can be
`used in the contain