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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`
`DNA GENOTEK INC., a Delaware
`Corporation,
`
`Plaintiff,
`
`v.
`SPECTRUM SOLUTIONS L.L.C.,
`a Utah Limited Liability Company; and
`SPECTRUM DNA, a Utah Limited
`Liability Company,
`Defendants.
`
`Case No. 3:16-cv-01544-JLS-NLS
`DECLARATION OF
`JOHN M. COLLINS, PH.D.
`IN SUPPORT OF
`PLAINTIFF’S REPLY IN SUPPORT
`OF MOTION FOR
`PRELIMINARY INJUNCTION
`Judge: Hon. Janis L. Sammartino
`Ctrm:
`4A
`Date:
`Sept. 29, 2016
`Time:
`1:30 p.m.
`
`(cid:36)(cid:49)(cid:38)(cid:40)(cid:54)(cid:55)(cid:53)(cid:60)(cid:3)(cid:40)(cid:59)(cid:17)(cid:3)(cid:20)(cid:19)(cid:21)(cid:25)
`
`CASE NO. 3:16-cv-01544-JLS-NLS.
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`I, John M. Collins, Ph.D., hereby declare as follows:
`
`I make this declaration in support of DNA Genotek Inc.’s (“DNA
`1.
`Genotek’s”) Reply in Support of its Motion for Preliminary Injunction. The
`following declaration is based on my personal knowledge. If called to testify, I
`could testify competently as to the matters set forth herein.
`I.
`INTRODUCTION AND QUALIFICATIONS
`2.
`I hold a B.S. in mechanical engineering with a minor in economics
`from Rensselaer Polytechnic Institute. I also hold a Ph.D. and M.S. in Mechanical
`Engineering from the Massachusetts Institute of Technology, with a concentration
`on fluid mechanics, and have over 30 years’ experience in the design and
`development of medical products.
`3.
`Since 2008, I have held a leadership position at the Consortia for
`Improving Medicine with Innovation and Technology (“CIMIT”). Founded by
`Massachusetts General Hospital, Massachusetts Institute of Technology, Brigham
`and Women’s Hospital, and Draper Labs in 1998, CIMIT is a non-profit consortium
`of Boston’s leading teaching hospitals and universities and a growing list of
`national and international affiliates. CIMIT is directed to stimulating and
`accelerating translational medical research into patient care in the domain of
`devices, procedures, and clinical systems engineering. I am CIMIT’s Chief
`Operating Officer.
`4.
`Since 2008, I have also held the position of chief technology and
`innovation officer at Reed Collins, LLC, a company which provides consulting
`services for academic institutions and businesses in the fields of technology,
`commercialization, and business development.
`5.
`I am a named inventor on over 20 U.S. patents, including 11 patents
`related to medical devices. I have designed many products, including minimally
`
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`invasive surgical access devices, trocars, and a saliva testing device for female
`fertility monitoring.
`6.
`I have been retained as an expert in more than 20 patent cases in my
`career, including one case involving a fluid collection device for chest drainage. I
`have testified in deposition approximately 25 times and at trial approximately 10
`times.
`In 2015, counsel for DNA Genotek contacted me and inquired whether
`7.
`I would help the court to better understand the evidence in the litigation entitled
`DNA Genotek Inc. v. Spectrum DNA and Spectrum Solutions L.L.C., and Spectrum
`Packaging, LLC, Case No. 15-cv-00661-SLR (D. Del.) (“the Delaware Action”).
`Specifically, I was asked to consider the validity of U.S. Patent No. 8,221,381 (“the
`’381 patent”) in the context of DNA Genotek’s Motion for a Preliminary Injunction
`against the Spectrum entities in the United States District Court for the District of
`Delaware. After considering the ’381 patent and some prior art references, I agreed
`to help. I since served as an expert in an Inter Partes Review proceedings before
`the United States Patent and Trademark Office, regarding the ’381 patent. I have
`now been asked to serve as an expert regarding U.S. Patent No. 9,207,164 (“the
`’164 patent) in the context of DNA Genotek’s motion for preliminary injunction in
`this case.
`I have been asked to provide analysis and expert opinions on whether
`8.
`any of claims 1, 7, 9, 16, 42, 54, and 55 of the ’164 patent is invalid as anticipated
`under 35 U.S.C. § 102 or invalid as obvious under 35 U.S.C. § 103 in light of
`specific prior art cited by the Spectrum Defendants and their expert, Dr. Terry
`Layton, in conjunction with Spectrum’s opposition to DNA Genotek’s motion for a
`preliminary injunction. I have also been asked to provide analysis and expert
`opinions on whether any of these claims are invalid for lack of written description.
`9.
`For my work as an expert, I am being compensated at the rate of $400
`per hour. My compensation is not contingent on the opinions I reach or on the
`CASE NO. 3:16-cv-01544-JLS-NLS.
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`
`outcome of any legal action, mediation, arbitration, or the terms of any settlement
`in this case.
`I reserve the right to supplement my opinions to address any
`10.
`information obtained, or positions taken, based on any new information that comes
`to light throughout this litigation.
`II.
`BASIS FOR OPINIONS
`A. Materials Considered
`I have reviewed and considered the ’164 patent, a true and correct
`11.
`copy of which is attached to this declaration as Exhibit 1, and its prosecution
`history. I have also reviewed and considered the ’381 patent, a true and correct
`copy of which is attached to this declaration as Exhibit 2.
`12.
`I have also reviewed and considered the following materials, which I
`have been asked to assume for purposes of this declaration are prior art to the ’164
`patent:
`
`(cid:120) U.S. Pat. No. 7,645,424 to O’Donovan (“O’Donovan,” “the ’424
`patent”, or “the O’Donovan ’424 patent”), a true and correct copy of
`which is attached to this declaration as Exhibit 3.
`(cid:120) WO 98/03265 (“the KCCL ’265 application”) (in the form of an
`English translation provided by Spectrum’s counsel), a true and correct
`copy of which is attached to this declaration as Exhibit 4; and
`(cid:120) WO 03/104251 A2 (“the Birnboim ’251 application”), a true and
`correct copy of which is attached to this declaration as Exhibit 5.
`In addition, I have reviewed the following documents:
`(cid:120) The October 2, 2015, declaration of Terry N. Layton, Ph.D. in Support
`of Defendants’ Opposition to DNA Genotek’s Motion for Preliminary
`Injunction, true and correct excerpts of which are attached to this
`declaration as Exhibit 6.
`
`13.
`
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`(cid:120) The November 19, 2015, declaration of Terry N. Layton, Ph.D. in
`Support of Defendants’ Surreply in Support of Defendants’ Brief in
`Opposition to DNA Genotek’s Motion for Preliminary Injunction, true
`and correct excerpts of which are attached to this declaration as
`Exhibit 7.
`(cid:120) The prosecution history of the ’381 patent, true and correct excerpts of
`which are attached to this declaration as Exhibits 8 through 12;
`(cid:120) The transcript of Dr. Layton’s August 26, 2016, deposition, true and
`correct excerpts of which are attached to this declaration as Exhibit 13;
`(cid:120) The transcript of Dr. Layton’s October 14, 2015, deposition, true and
`correct excerpts of which are attached to this declaration as Exhibit 14;
`(cid:120) Plaintiff’s deposition exhibit PX57, a true and correct copy of which is
`attached to this declaration as Exhibit 15;
`(cid:120) Plaintiff’s deposition exhibit PX153, a true and correct copy of which
`is attached to this declaration as Exhibit 16;
`(cid:120) Plaintiff’s deposition exhibit PX154, a true and correct copy of which
`is attached to this declaration as Exhibit 17;
`(cid:120) Plaintiff’s deposition exhibit PX155, a true and correct copy of which
`is attached to this declaration as Exhibit 18;
`(cid:120) A document titled Standard Test Method for Static and Kinetic
`coefficients of Friction of Plastic Film and Sheeting, a true and correct
`copy of which is attached to this declaration as Exhibit 19;
`(cid:120) The August 24, 2015, Declaration of Juan C. Lasheras, Ph.D. in
`support of DNA Genotek’s Motion for Preliminary Injunction, true
`and correct excerpts of which are attached to this declaration as
`Exhibit 20;
`
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`(cid:120) Excerpts of the July 26, 2016, deposition of Dr. Lasheras, attached to
`the Declaration of Brian M. Kramer in Support of Plaintiff’s Reply in
`Support of its Motion for Preliminary Injunction (“Kramer Decl.”);
`(cid:120) DNA Genotek Inc.’s Opening Brief in Support of its Motion for
`Preliminary Injunction, D.I. 12;
`(cid:120) The June 21, 2016, declaration of Juan C. Lasheras, Ph.D. in Support
`of DNA Genotek’s Motion for Preliminary Injunction, D.I. 12-2
`(“Lasheras Decl.”);
`(cid:120) The publicly-filed version of the declaration of Jonathan Sanders in
`Support of Defendants’ Brief in Opposition to DNA Genotek’s Motion
`for Preliminary Injunction and accompanying exhibits, D.I. 35-1; and
`(cid:120) The July 28, 2016, declaration of Terry Layton, Ph.D. in Support of
`Defendants’ Opposition to DNA Genotek’s Motion for Preliminary
`Injunction, and accompanying exhibits, D.I. 35-29 (“Layton Calif.
`Decl.”).
`I understand that in response to DNA Genotek’s motion, the
`14.
`O’Donovan ’424 patent, the KCCL ’265 application, and the Birnboim ’251
`application were cited as the basis for Spectrum’s argument that claims 1, 7, 9, 16,
`42, 54, and 55 of the ’164 patent are invalid. This declaration is limited to
`responding to invalidity arguments based on those three references and Spectrum’s
`separate written description argument. While I do not have Spectrum’s opposition
`brief to DNA Genotek’s motion for summary judgment because it was filed under
`seal, I understand from counsel for DNA Genotek that Dr. Layton’s public
`declaration contains Spectrum’s invalidity arguments.
`15. Additionally, I am aware of information generally available to, and
`relied upon by, persons of ordinary skill in the art at the time of the invention in this
`case and the references cited above, such as technical dictionaries and reference
`materials.
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`Legal Principles Applied
`B.
`I have been informed by counsel and understand that the patent laws
`16.
`include a novelty requirement. If a device has been previously disclosed to the
`public, then it is not novel. If it is not novel, a claimed invention is said to be
`“anticipated” by the prior art. To demonstrate anticipation, the party asserting
`invalidity must show that the claimed invention is “described in a printed
`publication,” meaning that each claim limitation is disclosed in a single prior art
`reference.
`I have also been informed by counsel and understand that a claim is
`17.
`obvious, and therefore invalid, if the differences between the subject matter claimed
`and the prior art are such that the claimed subject matter as a whole would have
`been obvious at the time the invention was made to a person having ordinary skill
`in the art to which the claims pertain. I have also been informed by counsel and
`understand that the analysis of the scope and content of prior art must consider the
`prior art as a whole; it is not proper to “pick and choose” or isolate portions of
`references from the whole, or to ignore portions of the reference that led away from
`obviousness.
`18.
`I have considered the definition of a person of ordinary skill in the art
`set for by Dr. Layton in his expert declaration. Dr. Layton stated that with respect
`to the ’164 patent, 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.”
`(See Layton Calif. Decl. ¶ 41.) I do not think the level of skill in the art is quite that
`high. A person of ordinary skill in the art would have a Bachelor of Science degree
`in some scientific field, but not necessarily engineering, plus some experience with
`medical devices, but not necessarily “several years” of experience.
`19.
`I consider myself to have at least such “ordinary skill in the art” with
`respect to the subject matter of the ’164 patent since at least 1983. None of my
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`opinions below would differ if I applied Dr. Layton’s proposed definition or my
`own proposed definition for one of ordinary skill in the art.
`III. U.S. PATENT NO. 9,207,164
`A.
`Background and Relevant Claims
`20.
`The ’164 patent, much like the related ’381 patent, describes several
`embodiments of container systems for releasably storing a “substance” in a “lid”
`before a “sample” is collected in a separate “vial.” Among other things, the
`specification describes uses of the invention in which the “substance” is a
`Deoxyribonucleic acid (“DNA”) preservative, the “sample” is human saliva, and
`the “vial” is a collection tube that is either a customized collection chamber or a
`commercially available vial.
`21. Claim 1 of the (cid:1932)164 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 at least two piercing members, wherein
`i) each of said at least two piercing members
`comprises a side wall, a first cutting edge extending
`from a first pointed end to a second end that defines
`the intersection between said cutting edge and said
`side wall, and/or
`ii) said at least two piercing members are arranged
`in a semi-circular fashion; 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
`piercing members disrupt 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.
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`I recited claim 1 the way it is organized in the ’164 patent. Dr. Layton
`22.
`organized the claims differently. I am reprinting Dr. Layton’s arrangement of claim
`1 for ease of reference:
`
`Designation
`
`’164 Claim 1 Limitations
`
`[1.P]
`
`[1.1]
`
`[1.2]
`
`[1.3]
`
`[1.4]
`
`[1.5a]
`
`[1.5b]
`
`[1.6]
`
`[1.7]
`
`1. 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
`
`at least two piercing members
`
`i) each of said at least two piercing members comprises a
`side wall, a first cutting edge extending from a first
`pointed end to a second end that defines the intersection
`between said cutting edge and said side wall, and/or
`ii) said at least two piercing members are arranged in a
`semi-circular fashion
`b) a lid configured to removably engage said vial, said lid comprising
`
`a reservoir for holding the substance
`
`[1.8]
`
`[1.9]
`
`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 piercing members disrupt 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.
`The other claims raised in DNA Genotek’s motion for preliminary
`23.
`injunction include claims 7, 9, 16, 42, 54, and 55. Those claims recite:
`
`[1.10]
`
`
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`7. The container system of claim 1, wherein the width of
`said first end is equivalent to the width of said second
`end.
`The container system of claim 1, wherein said
`9.
`chamber is configured to receive about 1 ml to about 16
`ml of said sample.
`16. The container system of claim 1, wherein said vial
`comprises three piercing members.
`42. A method of combining a substance with a
`biological sample, comprising:
`a) providing a container system of claim 1;
`b) providing the sample to the chamber in the vial;
`and
`c) closing said container system by removably
`attaching said lid to said vial; and
`d) piercing said membrane to release said substance
`into said chamber by moving said lid and said vial
`to said piercing position.
`54. The container system of claim 1, wherein said
`substance is a composition for the stabilization and
`recovery of a nucleic acid from a biological sample.
`55. The container system of claim 54, wherein said
`nucleic acid is DNA or RNA.
`The ’164 patent also has other claims, some of which are independent
`24.
`claims. In this declaration, I am responding to Dr. Layton’s opinion regarding
`claims 1, 7, 9, 16, 42, 54, and 55 of the ’164 patent.
`B.
`Prosecution History of “Piercing Members” Limitation
`25.
`The “two piercing members” recited in claim 1 of the ’164 patent are
`required either to be a particular shape or to be “arranged in a semi-circular
`fashion.” During prosecution of the application that led to the ’381 patent and the
`’164 patent, DNA Genotek drafted claims requiring merely a “piercing member,”
`without any structural limitation for the piercing member. (Collins Decl. Ex. 8,
`6/9/2008 ’381 patent prosecution history, original claim 1; Collins Decl. Ex. 9,
`6/9/2008 Preliminary Amendment, claim 1.)
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`The United States Patent and Trademark Office (“PTO”) rejected
`26.
`original claim 1 as anticipated by European Patent No. EP 273,015 A2 (“Loretti”).
`(Collins Decl. Ex. 10, 12/27/2011 Non-Final Rejection at 3.) The PTO said that
`Loretti disclosed the limitations of original claim 1, including the required piercing
`member, which, according to the PTO, corresponded to “trocar (13)” in the Loretti
`reference.
`The Loretti reference was discussed during Dr. Layton’s deposition in
`27.
`the Delaware Action and was marked as PX57, attached as Exhibit 15 hereto.
`Figures 2, 5, and 6 of the Loretti reference show trocar (13) that the PTO claimed
`satisfied the original “piercing member” limitation of original claim 1 of the ’381
`patent application
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`28. As Dr. Layton explained, trocars generally are cylindrical.
`
`
`
`Q. Well, just using your general understanding of what a
`trocar is, does a trocar have a side wall?
`MR. SACKSTEDER: Objection, lacks foundation.
`Vague and ambiguous. Seeks a legal conclusion.
`THE WITNESS: My definition of a trocar is a cylinder, it
`has no side walls. It’s round.
`BY MR. KRAMER:
`Q. So because a trocar is round, it can’t have a side wall
`and therefore it can’t be a piercing member?
`A. No, I didn’t say that. I said that – you asked me if a
`trocar had a side wall.
`Q. Yes.
`A. And I said my medical device definition, a trocar is a
`cylinder with a point. And a cylinder doesn’t have a side
`wall, it’s circumferential. So that was the question that
`you asked.
`Q. So if a piercing member were cylindrical, it wouldn’t
`fit the 381 Patent’s definition of piercing member,
`because it couldn’t have a side wall?
`
`
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`CASE NO. 3:16-cv-01544-JLS-NLS.
`COLLINS DECL. ISO REPLY RE PRELIM. INJ. MOTION
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`A. I don’t know. You’re asking a hypothetical and I
`haven’t investigated that aspect of it. I would have to look
`at it. Sitting here, I can’t answer that.
`Q. But I’m just asking about trocars that you do know
`about. Trocars have spikes on them, right?
`A. Yes.
`Q. And they’re cylindrical, right?
`A. Yes.
`Q. And they don’t have side walls, right?
`A. Because they are cylinder.
`Q. Spikes don’t have side walls, right?
`MR. SACKSTEDER: Objection, vague and ambiguous.
`THE WITNESS: A spike, in my definition, is a cylinder.
`BY MR. KRAMER:
`Q. And therefore does not have a side wall?
`MR. SACKSTEDER: Same objection.
`THE WITNESS: Not as per the definition that is in the
`381 Patent.
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`(Collins Decl. Ex. 14 at 111:23-113:13.) While Dr. Layton’s testimony in the
`Delaware Action referred to the ’381 patent, both the ’381 patent and the ’164
`patent have the same “side wall” limitation.
`29.
`To overcome the rejection by the PTO that a “trocar” satisfies the
`definition of a “piercing member,” DNA Genotek amended the claims to include
`the requirements that the piercing members comprise “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.” Specifically, on
`February 2, 2012, DNA Genotek added the “side wall” and other limitations,
`noting:
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`[T]o further distinguish Loretti, Applicant has amended
`independent claims 1 and 22 to recite a piercing member
`CASE NO. 3:16-cv-01544-JLS-NLS.
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`that “comprises a side wall, and 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.” Loretti teaches only trocar 13 as a
`piercing member. Trocar 13 of Loretti has a tubular body
`and lacks a "side wall" and "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." Thus, Loretti fails to teach these limitations of the
`container system of present independent claims 1 and 22
`and their dependent claims.
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`(Collins Decl. Ex. 12, 2/2/2012 Reply to Office Action at 12-13.) Thereafter, the
`PTO allowed what is now claim 1, noting specifically that the amendment
`overcame the Loretti reference.
`With respect to claims 1 and 22, the applicant amended
`the claim to recite a vial comprising a piercing member
`comprising 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,
`which is not disclosed or suggested by the closest prior art
`of record, the Loretti reference. Claims 2-13, 15-29, 31-
`38, 40-43 and 51-54 depend directly or ultimately from
`claim 1 or claim 22 and are thus also allowed.
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`(4/5/2012 Reasons for Allowance at 2.)
`IV. U.S. PATENT NO. 7,654,424 B2
`30.
`In his declaration, Dr. Layton opines that each of the claims raised in
`DNA Genotek’s motion for preliminary injunction is invalid as anticipated or
`obvious in light of the O’Donovan ’424 patent, either by itself or in combination
`with other references. I have compared the O’Donovan ’424 patent to the relevant
`claims of the ’381 patent, and I disagree with Dr. Layton’s conclusions.
`31.
`The O’Donovan ’424 patent is titled “Reagent Cuvette.” (Collins
`Decl. Ex. 3.) As depicted in Figure 1, it discloses a reagent cuvette (1) with a first
`chamber (2) and a second chamber (3). (Id., Fig. 1 annotations added.)
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`To consider the operation of the device described in the O’Donovan
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`’424 patent, it is helpful to view the description of the device in the text of the
`reference itself and to consider some demonstrative images that are based on
`Figures 1-4 in the O’Donovan ’424 patent. During his August 16, 2016 deposition,
`Dr. Layton agreed that a demonstrative exhibit marked as PX153 represented a fair
`graphical depiction of how the O’Donovan ’424 patent works. (Collins Decl. Ex.
`13 at 128:7-130:21, 141:5-142:6; Collins Decl. Ex. 16.)
`33.
`The first chamber (2) is pre-filled with a buffer reagent, and the second
`chamber (3) is pre-filled with a starter reagent. (Collins Decl. Ex. 3, ’424 patent,
`col. 3:1-10.)
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`(Collins Decl. Ex. 16 at 2.)
`34.
`The device works by first peeling away the foil membrane (7), adding
`a sample of interest to the buffer reagent in the first chamber (2), and then placing
`the entire second chamber (3) (including chamber wall 10 and the rim 11) within
`the socket (6) at the top potion of the first chamber (2). (Collins Decl. Ex. 3, ’424
`patent, at 2:60-3:24.) Socket (6) has a series of spikes at its base where the bottom
`shoulder of the socket (6) connects with the lower inspection part (5) of the first
`chamber (2). (Id. at 2:60-67.)
`35. When second chamber (3) is placed within socket (6) and pressed
`downward, the spikes in socket (6) pierce a foil membrane at the mouth of second
`chamber (3). (Id. at 3:17-20.) That causes three things to mix: the collected
`sample, the starter reagent (dropping down from second chamber (3)), and the
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`buffer reagent (already in first chamber (2)). The device then looks like Figures 2-4
`and like the colored version of those exhibits in PX153.
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`Case 3:16-cv-01544-JLS-NLS Document 51 Filed 08/19/16 Page 18 of 65
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`36. As can be seen in both the black & white and color versions of Figure
`2, the second chamber (2) sits within socket (6) after it is placed in the opening. Its
`side wall is no longer visible, meaning there is no way to retract or remove it
`because the second chamber at that point is wedged within the socket. The
`specification describes the friction fit between second chamber (3) and socket (6):
`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. The spikes
`20 are located so that there is just enough space for the
`rim 11 of the chamber 3 to fit between the spikes 20 and
`the wall of the socket 6 with a friction fit when the
`chamber 3 is pressed down into the socket 6 with its
`opening facing downwardly.
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`(Collins Decl. Ex. 3, ’424 patent at 2:60-67.)
`37. Once the second chamber (3) is pushed to the bottom of socket (6) of
`the first chamber (2), the two chambers become stuck together with a friction fit.
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`The specification calls the two chambers “effectively a single chamber.” (Id., col.
`3:28-29.) At that point, the three fluids have mixed and fallen to the translucent
`inspection part (5).
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`To inspect the mixture of the sample and the reagents, an analyst
`38.
`inserts the entire reagent cuvette into an optical inspection instrument to look
`through the walls of the transparent inspection part (5) and assess the sample.
`There is no need to reopen the device to inspect the sample.
`The resultant transfer of the starter reagent into the
`mixture of sample and buffer reagent in the chamber 2
`provides a mixture which can be analyzed by an optical
`instrument at the point of care. 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. The
`inspection part 5 is inserted into an optical inspection
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`instrument for optical analysis of the sample/reagent
`mixture.
`(Collins Decl. Ex. 3, ’424 patent at 3:25-32.)
`39.
`Every claim in the O’Donovan ’424 patent describes at least one of the
`components as “being for single and destructive use.” There are no claims without
`that requirement. While the specification notes that the O’Donovan ’424 patent
`should not be limited to the specific embodiments disclosed in the patent, the only
`embodiment described and claimed is a device that would be thrown away after a
`single use.
`40. A person of ordinary skill in the art for the ’164 patent would have
`some general understanding of “optical inspection instruments,” as such
`instruments are common in the sample testing industry. For example, I understand
`that Dr. Layton was shown the below image at his deposition. (Collins Decl. Ex.
`17.)
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`The device depicted above is a Palintest Photometer 8000. That particular
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`product is designed for water analysis. See
`http://www.palintest.com/en/products/photometer-8