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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`APOTEX CORP.,
`Petitioner
`
`v.
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`
`Case IPR2013-00428
`U.S. Patent No. 8,268,299 B2
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`
`
`
`DECLARATION OF GEORGE G. ZHANEL, Ph.D.
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`1
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`ALCON 2005
`Apotex Corp. v. Alcon Research, Ltd.
`Case IPR2013-00428
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`
`
`TABLE OF CONTENTS
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`
`
`I.
`
`Introduction ...................................................................................................... 3
`A.
`Background and Qualifications ............................................................. 3
`B. Assignment ............................................................................................ 7
`C.
`The Person of Ordinary Skill in the Art ................................................ 7
`II. Opinions ........................................................................................................... 8
`The POSA Would Not Want to Use a Concentration of Zinc
`A.
`that Is Lower than the Concentration Used in Xia Example 18 ........... 8
`1.
`The Xia disclosure. ..................................................................... 9
`2.
`The POSA would be concerned that decreasing the
`concentration of zinc below the concentration in Xia
`Example 18 would result in a composition that could fail
`preservative efficacy testing. .................................................... 12
`Even if the POSA Were to Reduce the Concentration of Zinc
`from Xia Example 18, the POSA Would Not Have a Reason to
`Combine Xia with Chowhan ............................................................... 16
`
`B.
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`
`2
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`
`I.
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`I, George G. Zhanel, hereby declare as follows:
`
`Introduction
`1.
`
`I am over the age of eighteen and am otherwise competent to
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`make this declaration.
`
`2.
`
`I understand that the Patent Trial and Appeal Board has granted
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`Apotex’s petition to institute this Inter Partes Review (“IPR”) regarding claims 1-
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`28 of United States Patent No. 8,268,299 (the “’299 patent”) on obviousness
`
`grounds.
`
`A. Background and Qualifications
`3.
`I am currently a Professor in the Department of Medical
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`Microbiology, Faculty of Medicine, University of Manitoba, Winnipeg, Canada.
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`4.
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`I received a Ph.D. in Medical Microbiology from the University
`
`of Manitoba in 1994 and a Doctor of Pharmacy from the University of Minnesota
`
`in 1986.
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`5.
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`For approximately the last 25 years, the focus of my work has
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`been antimicrobials and agents with antimicrobial activity.
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`6.
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`I am currently the Chair of the Canadian Antimicrobial
`
`Resistance Alliance (CARA) and on the Faculty of Medicine at the University of
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`Manitoba. I also am the Coordinator of the antimicrobial resistance program in the
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`3
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`
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`
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`Department of Clinical Microbiology and Section of Infection Control, Department
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`of Internal Medicine at the Health Sciences Centre, Winnipeg, Canada.
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`7.
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`The focus of my research is the study of antimicrobial agents in
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`the treatment and prevention of infectious diseases. I gave my first presentation on
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`antimicrobials in 1985 while working toward my Doctor of Pharmacy. In addition,
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`as early as 1985, I began advising clinicians regarding the use and optimization of
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`antimicrobials for the treatment and prevention of infectious diseases, and I began
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`teaching about antimicrobials in 1987. The subject of my doctoral thesis in
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`Medical Microbiology, submitted in 1994, was “Cellular and Molecular Evaluation
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`of Fluoroquinolone Resistance in Pseudomonas aeruginosa.”
`
`8.
`
`By virtue of my education and experience, I am familiar with
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`microorganisms that are likely to grow in liquid pharmaceutical compositions such
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`as ophthalmic solutions, the preservative efficacy standards that pharmaceutical
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`products must meet so as to minimize or inhibit growth of such microorganisms,
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`the testing and evaluation of antimicrobial agents, and the testing and evaluation of
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`the preservative efficacy of pharmaceutical formulations. As part of my education
`
`and experience, I have also prepared numerous pharmaceutical formulations,
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`including topical ophthalmic formulations.
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`9.
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`I currently teach medical students at the University of Manitoba
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`in the first, second, third and fourth years of the Medical curriculum. I also teach
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`4
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`internal medicine residents and medical microbiology/infectious diseases
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`postdoctoral fellows. In addition, I teach physician assistants, nurse practitioners,
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`and Masters and Doctoral students in both Medical Microbiology and Clinical
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`Pharmacology, as well as undergraduate students in Science, Pharmacy, Nursing
`
`and Medical Technology.
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`10. My work on antimicrobials has led me to serve as a consultant
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`(through advisory boards or otherwise) to many pharmaceutical/biotech
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`companies. These companies include the following companies and/or their
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`affiliates: Abbott, Achaogen, Affinium, Apotex, Arpida, Astellas, AstraZeneca,
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`Bayer, Cangene, Cerexa, Cubist, Forest Labs, GlaxoSmithKline, Janssen
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`Ortho/Ortho McNeil, Kane BioTech, Merck, Micrologix, Novexel, Optimer, Oryx,
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`Pfizer, Procter & Gamble, Sanofi-Aventis, Sepracor, Sunovion, TaiGen, The
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`Medicines Co., Theravance, Triton, and Trius. As part of my research and
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`consultancy role for these companies, I am routinely called on to provide advice
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`concerning the potential indications for antimicrobials based on a compound’s
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`properties, as well as to make comparative evaluations among antimicrobials.
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`Specific topics on which I am asked to advise include comparative mechanism of
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`action and resistance, in-vitro activity and factors that influence antimicrobial
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`activity, pharmacokinetics and pharmacodynamics, animal studies including
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`efficacy and toxicity, and clinical uses including indications, adverse effects in
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`5
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`humans, drug interactions, the risks versus benefits of antimicrobial treatment and
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`prevention, and pharmacoeconomics. The guidance I provide to companies on
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`scientific matters generally pertains to particular indications and uses for
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`antimicrobial compounds.
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`11.
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`I am frequently consulted by clinical specialists and generalists
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`on matters pertaining to the treatment and prevention of infections, especially
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`antimicrobial resistant infections, including in the ophthalmic context. These
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`consultations focus on the selection of specific antimicrobials, dosages, and dosage
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`regimens; risk-benefit analyses of particular antimicrobial treatments; and the
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`monitoring of patients to determine the efficacy and/or toxicity of selected
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`antimicrobial treatments. These consultations range from accompanying
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`physicians to bedside visits to, more commonly, telephone consultations (local or
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`with clinicians from all over North America), hallway discussions and discussions
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`at medical/scientific meetings.
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`12.
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`In formulating my opinions discussed herein, I have relied upon
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`my training, knowledge, and experience, as well as the various materials discussed
`
`herein. I have also considered the declaration of Dr. Michael Miller (APO 1002),
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`as well as the references cited in Dr. Miller’s declaration. A copy of my current
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`curriculum vitae is provided as Exhibit AL 2006.
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`6
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`13.
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`I am being compensated for my time at my usual rate of $500
`
`per hour. My compensation is in no way dependent on the outcome of this
`
`proceeding.
`
`B. Assignment
`14.
`I have been retained by Williams & Connolly LLP on behalf of
`
`Alcon Research, Ltd. (“Alcon”) to serve as an expert witness in these proceedings.
`
`15.
`
`I have been asked to opine on various issues that I understand
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`to relate to whether the compositions claimed in the ’299 patent would have been
`
`obvious to the person of ordinary skill in the art (“POSA”), described in Section
`
`I.C below, including issues related to the antimicrobial activity of (1) the zinc
`
`compositions that are the subject of World Intellectual Property Organization
`
`International Patent Application Number 2005/097067 A1 (“Xia”), APO 1003, (2)
`
`the water-soluble borate-polyol complexes that are the subject of United States
`
`Patent No. 6,143,799 (“Chowhan”), APO 1004, and (3) the compositions claimed
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`in the ’299 patent, APO 1001.
`
`C. The Person of Ordinary Skill in the Art
`16.
`I understand that the POSA is a hypothetical person who may
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`possess the combined skills of more than one actual person. With respect to the
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`’299 patent, one technical aspect involved in the inventions described in the patent
`
`is the use of antimicrobial agents as preservatives in multi-dose ophthalmic
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`7
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`compositions. Accordingly, in my opinion, the hypothetical POSA would have, in
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`addition to other education and experience relevant to the preparation of
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`ophthalmic formulations, (a) education in the area of microbiology, and/or (b)
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`training and/or experience in the area of antimicrobial activity of pharmaceutical
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`formulations and preservative efficacy testing.
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`17.
`
`I have considered the definition of the person of ordinary skill
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`in the art provided in the Declaration of Dr. Miller. APO 1002 ¶ 15. The opinions
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`I express herein would not change were that definition applied.
`
`18.
`
`I have undertaken to determine the knowledge a POSA would
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`have regarding the use of antimicrobial agents as preservatives in multi-dose
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`ophthalmic compositions as of September 21, 2006 (the “priority date”), which I
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`have been advised is the relevant date for making this determination. When I refer
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`to a POSA in this Declaration, I am referring to a person of ordinary skill in the art
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`as of that date.
`
`II. Opinions
`A. The POSA Would Not Want to Use a Concentration of Zinc that
`Is Lower than the Concentration Used in Xia Example 18
`21.
`
`I have been asked to respond to the opinion of Dr. Miller that
`
`Xia suggests the use of a concentration of a zinc compound (and in particular zinc
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`chloride) as low as 0.001 wt.% to 0.005 wt.% in an ophthalmic formulation. I
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`disagree with Dr. Miller on this point. As discussed below, the POSA would not
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`8
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`have wanted to use less zinc than the concentration disclosed in Example 18 of Xia
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`(0.48 mM as zinc chloride).
`
`1.
`The Xia disclosure.
`22. Xia discloses ophthalmic compositions that use zinc as a
`
`preservative. In particular, it states that the disclosed invention “relates to a
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`composition that includes a preservative-effective amount of a soluble zinc
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`compound and has less than a preservative effective amount of a primary
`
`preservative agent.” APO 1003, 3. Xia further provides that, in its preferred
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`embodiment, the composition does not contain any primary preservative agent in
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`addition to zinc. Id. Xia defines “primary preservative agents” to mean “non-zinc
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`containing compounds that derive their preservative activity through a chemical or
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`physiochemical interaction with the microbial organisms.” Id. at 4. The POSA
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`would recognize that there are many such compounds; Xia discloses various
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`classes of such agents, and in particular suggests the use of Polymer JR. Id. at 3.
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`Xia neither refers to nor suggests use of a borate-polyol complex as a preservative
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`system to be combined with zinc.
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`23.
`
`In terms of zinc content, Xia states that the invention
`
`encompasses compositions having “a minimum of about 0.001 wt.%, about 0.005
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`wt.%, about 0.01 wt.%, or about 0.05 wt.% of a zinc compound per total weight of
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`the composition and/or a maximum of about 1 wt.%, about 0.5 wt.%, about 0.1
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`9
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`wt.% or about 0.05 wt.% of the zinc compound per total weight of the
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`composition.” APO 1003, 5. However, the POSA would not understand Xia to
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`support the notion that a concentration of zinc as low as 0.001 wt.% or even 0.005
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`wt.% can pass preservative efficacy testing, without the presence of an additional
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`preservative agent.
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`24. Xia provides data regarding the antimicrobial activity of
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`Example compositions in which zinc is the only preservative ingredient. In
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`particular, each of Examples 16, 17, and 18 of Xia discloses a composition that (a)
`
`contains zinc as the only preservative agent, and (b) passes the preservative
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`efficacy test utilized in the reference.1 APO 1003, 20–23. The Examples employ,
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`respectively, 1.84 mM (0.025 wt.%), 0.92 mM (0.0125 wt.%), and 0.48 mM
`
`(0.0065 wt.%) of zinc (as zinc chloride), which are concentrations that exceed
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`0.001 wt.% and 0.005 wt.% (0.074 mM and 0.37 mM, respectively). APO 1002
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`(Miller Declaration) ¶ 51 (setting forth the value in mM for the 0.001 wt.% and
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`1 The Xia reference used the FDA/ISO 14730 preservative efficacy test, APO
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`1003, 14, which is one of the standard preservative efficacy tests discussed in the
`
`specification of the ’299 patent (see APO 1001, col. 7, ll. 46-50). That test differs
`
`in some respects from the USP 27 preservative efficacy test that is referred to in
`
`the claims of the ’299 patent, but the differences between the two tests would not
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`be regarded as significant by the POSA.
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`10
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`
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`0.005 wt.% values). The POSA would understand that, in Xia’s hands, the
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`concentration of zinc employed in any of Examples 16, 17, or 18 was sufficient to
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`pass preservative efficacy testing, APO 1003, 23 (Table 11), but—given these data
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`and other prior art (discussed further below)—would not understand Xia as
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`providing sufficient information or data to teach that lower concentrations of zinc
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`would do so.
`
`25. Moreover, Xia discusses two different ways of providing
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`preservative efficacy to a formulation: (1) using zinc ions, without any other
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`preservative agents, and (2) using zinc ions in combination with another
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`preservative agent, such as a cationic polymer like Polymer JR. APO 1003, 3.
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`Because Xia’s discussion of the minimum concentrations of zinc is part of a
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`general discussion of Xia’s invention and not about formulations using zinc alone
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`in particular, and given other prior art concerning the properties of zinc as a
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`preservative agent (discussed further below), the POSA would understand that the
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`lowest concentrations of zinc disclosed are intended for use in compositions that
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`have a preservative agent (such as a cationic polymer) in addition to zinc. These
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`other preservative agents provide broad spectrum antimicrobial activity and
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`therefore can potentially make up for or remedy deficiencies in antimicrobial
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`activity that the POSA would be concerned could result from use of lower
`
`concentrations of zinc. The POSA would therefore understand that the low ends of
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`11
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`
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`the zinc concentration ranges in Xia were intended for compositions with such an
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`additional preservative, not for compositions using zinc alone.
`
`2.
`
`The POSA would be concerned that decreasing the
`concentration of zinc below the concentration in Xia
`Example 18 would result in a composition that could fail
`preservative efficacy testing.
`26. While the POSA would understand, based on the data in Xia,
`
`that zinc is potentially effective as a sole preservative at a concentration as low as
`
`0.48 mM (i.e., the concentration in Xia Example 18), the POSA would have
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`concerns about attempting to use a lower concentration of zinc, whether the zinc is
`
`used by itself or in combination with another preservative agent. That is because
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`other data in the prior art suggested that, if the concentration of zinc used in
`
`Example 18 were reduced, the resulting composition could fail preservative
`
`efficacy testing and even stimulate bacterial growth.
`
`27.
`
`In a publication by Winslow (AL 2045), the authors reported on
`
`the effect of various metal cations, including zinc, on the survival of Escherichia
`
`coli, which is one of the types of bacteria used both in USP 27 and the preservative
`
`efficacy test disclosed in Xia. See APO 1001, col. 10, ll. 44-55; APO 1003, 14.
`
`Winslow reported that when a 0.0005 M (0.5 mM) solution of zinc (from zinc
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`chloride) was used, it only partially reduced survival of E. coli, i.e., the observed
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`bacterial counts were 57% of the control. AL 2045, 54, Table 2. A 0.001 M (1.0
`
`mM) zinc solution was required for a 100% lethal effect. Id. However, when the
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`12
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`
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`concentration of zinc was reduced to a 0.00025 M (0.25 mM) solution—one
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`dilution step below the 0.5 mM zinc preparation—bacterial growth increased to
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`135% of the control, i.e., the zinc actually stimulated bacterial growth. Id. The
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`POSA would understand from these data that zinc, unlike the vast majority of
`
`agents with antimicrobial activity, is a micronutrient that is essential for cellular
`
`growth and function of organisms. In other words, the POSA would recognize that
`
`use of too low a concentration of zinc could result in the undesirable outcome of
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`promoting growth of organisms rather than inhibiting their growth or killing them.
`
`Under such circumstances, the zinc would fail to serve its purpose as a preservative
`
`and indeed would be counterproductive.
`
`28. The POSA would reach the following conclusions about
`
`Winslow’s data: (a) a 1.0 mM concentration of zinc resulted in bacterial
`
`eradication of E. coli—which is the desired effect when creating a preservative
`
`system for ophthalmic use, and in particular is consistent with the goals of
`
`preservative efficacy testing, which generally seeks a reduction of 99.9% (three
`
`logs) in the bacteria (and ideally complete bacterial eradication); (b) one dilution
`
`step lower (0.5 mM) only partially reduced survival of E. coli (57% of the control
`
`survived), which is suboptimal as compared to complete bacterial eradication, and
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`less than the required effect in preservative efficacy testing; and (c) one dilution
`
`step lower of zinc actually stimulated E. coli growth. AL 2045, 54 (Table 2).
`
`
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`13
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`
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`29.
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`In addition, the POSA would understand that a prior art
`
`publication by McCarthy had reported that zinc ions have “little effect against the
`
`troublesome Pseudomonas aeruginosa,” AL 2046, 52, a statement which, based on
`
`the data in Table 1 of the reference, the POSA would understand applied to
`
`concentrations of up to 50 µg/mL of zinc ions (i.e., 0.76 mM),2 which is more zinc
`
`than the concentration in Xia Example 18, AL2046, 52.3 P. aeruginosa—another
`
`bacteria included in tests for preservative efficacy, see APO 1001, col. 10, ll. 44-
`
`55; APO 1003, 14—would be of particular concern to the POSA because, unlike
`
`many other organisms, (a) it is highly virulent and well known as a cause of
`
`difficult-to-treat, potentially sight-threatening ocular infections, see, e.g., APO
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`1001 col. 2, ll. 12-19; and (b) it can thrive in environments with limited nutrients,
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`including an ophthalmic composition, see, e.g., AL 2047, 504 (“The resistance of
`
`this bacterium [P. aeruginosa], especially in organic tissues, is very well
`
`2 This calculation was performed by converting the concentration of zinc ions from
`
`50 µg/mL to 0.05 g/L, multiplying that number by the molecular weight of zinc
`
`(65.38 g/mol) to obtain a molar concentration, and then multiplying the resulting
`
`number by 1000 to obtain the value in mM.
`
`3 A publication by Zeelie, which is cited in the ’299 patent, APO 1001, 2, provided
`
`that the minimum lethal concentration of zinc ions was 1917 x 10-3 g dm-3, which is
`
`even greater than 0.76 mM, AL 2047, 505.
`
`
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`14
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`
`
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`documented. It is a bacterium which can survive on simple inorganic chemicals,
`
`being able to convert them to more elaborate organic requirements.”).
`
`30. Xia provides neither data nor any discussion that addresses the
`
`issue of how low concentrations of zinc can promote microbial growth rather than
`
`decrease survival. But based on the data in Winslow, McCarthy, and Zeelie, the
`
`POSA would have had concerns about lowering the zinc concentration value from
`
`what was used in Xia Example 18. While the test conditions in the references are
`
`not identical (for example, the Xia test was conducted over a longer time period
`
`than the Winslow, McCarthy, or Zeelie tests), the POSA would regard them as
`
`being sufficiently similar such that Winslow, McCarthy, and Zeelie would cause
`
`the POSA to be concerned that lowering the zinc below the 0.48 mM value of Xia
`
`Example 18 could fail to provide sufficient preservative efficacy, and even risk
`
`converting the formulation from an antibacterial composition to a bacterial-
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`stimulating composition.
`
`31.
`
`Indeed, were the POSA to rely on Xia to prepare an ophthalmic
`
`formulation, the POSA would start with the concentration of zinc used in one of
`
`Examples 16, 17, or 18, as, unlike the lower ends of the zinc concentration ranges
`
`discussed in Xia (which is what Dr. Miller focuses on), the reference actually
`
`discloses preservative efficacy data in connection with those concentrations of
`
`zinc. And were the POSA to use a concentration of zinc that differed from the
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`
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`15
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`
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`concentration employed in Xia Example 18, the POSA would have reasons to
`
`increase the zinc concentration, not decrease it, as the POSA would recognize that
`
`(a) zinc is a relatively safe agent with dose-dependent antimicrobial activity that
`
`can be used safely in concentrations higher than the one set forth in Xia Example
`
`18, see AL 2048, 7089 (regulatory determination that zinc sulfate is “generally
`
`recognized as safe” at a concentration of 0.25%); and (b) a higher concentration of
`
`zinc would only serve to ensure that the resulting composition would pass
`
`preservative efficacy testing.
`
`B.
`
`Even if the POSA Were to Reduce the Concentration of Zinc from
`Xia Example 18, the POSA Would Not Have a Reason to Combine
`Xia with Chowhan
`32. Even if the POSA were to use one of the zinc concentrations in
`
`Xia that Dr. Miller focuses on—and thereby employ a lower concentration than
`
`what was used in Xia Example 18—the POSA still would not have a reason to
`
`make the invention claimed in the ’299 patent, as the POSA would not have a
`
`reason to combine such a lower concentration of zinc with a borate-polyol complex
`
`as disclosed in Chowhan.
`
`33. As an initial matter, the POSA would not understand from
`
`Chowhan that a borate-polyol complex has sufficient antimicrobial properties to be
`
`able to pass preservative efficacy on its own, without another preservative agent.
`
`The reference presents neither data nor statements to that effect. To the contrary,
`
`
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`16
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`
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`Chowhan suggests that borate-polyol complexes “are particularly useful as
`
`adjunctive disinfecting agents,” APO 1004, col. 2, ll. 26-35 (emphasis added), i.e.,
`
`while a borate-polyol complex may be able to be used in combination with another
`
`preservative agent, its role is not as a preservative agent in its own right.
`
`34. Moreover, there is no suggestion in Chowhan that borate-polyol
`
`complexes enhance antibacterial activity of ophthalmic compositions, let alone
`
`any suggestion that the borate-polyol complexes should be combined with zinc or
`
`are somehow interchangeable with Polymer JR (the preservative agent that Xia
`
`suggests can be used in combination with zinc and pass preservative efficacy). To
`
`the contrary, the POSA would recognize from Chowhan that the disclosed borate-
`
`polyol compositions may be useful for their antifungal properties. Chowhan
`
`specifically notes that the borate-polyol complexes are particularly effective
`
`against fungi, especially Aspergillus niger, but does not highlight any activity
`
`against bacteria. Indeed, the data in Chowhan are consistent with this teaching,
`
`and show that borate-polyol complexes have activity against fungi, but do not
`
`provide any indication that they are active against bacteria. There are three
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`Examples in Chowhan with any antimicrobial data: Examples 10, 11, and 12.
`
`Example 10 of Chowhan compares the effectiveness of two formulations, one (A)
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`that does not contain a borate-polyol combination, and one (B) that does.
`
`Chowhan then compares their antimicrobial effects versus microorganisms that are
`
`
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`17
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`
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`used in USP 27 and the preservative efficacy test in Xia. APO 1004, col. 8, l. 48 –
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`col. 9, l. 30. The data reflect that while the borate-polyol complex demonstrates an
`
`enhanced effect versus A. niger, as well as versus the fungus Candida albicans, it
`
`has no added antibacterial effect versus the three bacteria tested (P. aeruginosa, E.
`
`coli, and Staphylococcus aureus). Examples 11 and 12 provide data for A. niger
`
`alone, again demonstrating Chowhan’s emphasis on antifungal activity.
`
`35. As discussed above in Section II.A, the POSA would be
`
`concerned that reducing the concentration of zinc employed in Xia Example 18
`
`could have a detrimental impact on the antimicrobial properties of the composition
`
`at issue, in particular with respect to E. coli and P. aeruginosa. Chowhan would
`
`not provide the POSA any reason to think that adding in a borate-polyol
`
`combination would compensate for any anticipated loss in antibacterial activity as
`
`a result of decreasing the concentration of zinc used in Xia Example 18. Instead,
`
`the POSA would expect that, were one to use such a lower concentration of zinc,
`
`another well-known and established primary preservative agent, such as Polymer
`
`JR, Polyquad, or other agents identified in the literature, would be required.
`
`*
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`*
`
`*
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`*
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`*
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`36.
`
`I hereby declare that all statements made herein of my own
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`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
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`18
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`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`Code.
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`19
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