Case IPR2013-00505
`Patent 6,974,569
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`
`CONOPCO, INC. d/b/a UNILEVER
`Petitioner
`
`v.
`
`THE PROCTER & GAMBLE COMPANY
`Patent Owner
`
`_________________________
`
`Case IPR2013-00505
`Patent 6,974,569
`_________________________
`
`
`
`DECLARATION OF DR. PHILIP A. GEIS
`
`
`Patent 6,974,569
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`
`CONOPCO, INC. d/b/a UNILEVER
`Petitioner
`
`v.
`
`THE PROCTER & GAMBLE COMPANY
`Patent Owner
`
`_________________________
`
`Case IPR2013-00505
`Patent 6,974,569
`_________________________
`
`
`
`DECLARATION OF DR. PHILIP A. GEIS
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`I.
`
`INTRODUCTION
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`Case IPR2013-00505
`Patent 6,974,569
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`1. My name is Dr. Philip A. Geis. I am an instructor at the University of
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`Florida in the Department of Microbiology and Cell Science. I teach MCS 4934. I
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`also perform consulting work for Geis Microbiological Quality. My address is
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`1630 Golden Ridge Drive, The Villages, Florida 32162. I base the following on
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`my personal knowledge and my review of United States Patent Number 6,974,569
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`(“the ’569 patent”), the Woods Reference (Exh. 1023), the Shin Reference (Exh.
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`1020), the Kanebo Reference (Exh. 1006), the Declaration of Arun Nandagiri (Exh.
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`1003) and the Institution Decision (Paper 9).
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`2.
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`I have been retained by The Procter & Gamble Company ( “P&G”),
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`owner of the ’569 patent. I have been asked to analyze the
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`bioavailability/coverage index described in the ’569 patent and compare it to
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`references purportedly disclosing similar indices.
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`3.
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`I understand that the Petitioner, Conopco, Inc. dba Unilever
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`(“Unilever”) filed a petition for inter partes review (“IPR”) of certain claims of
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`the ’569 patent. I further understand the Patent Trial and Appeal Board (“the
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`Board”) instituted proceedings with respect to claims 1-12, 15, 17-19, 23, 26, 28-
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`30, and 32. P&G asked me to compare the references relied on by Unilever’s
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`2
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`
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`expert Mr. Arun Nandagiri, to determine if they disclose the
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`bioavailability/coverage index described in the ’569 patent.
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`Case IPR2013-00505
`Patent 6,974,569
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`4.
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`This declaration provides my opinions to date concerning the
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`bioavailability/coverage index and the references relied on by Mr. Nandagiri and
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`cited by the Board. I reserve the right to supplement this declaration, as, and if,
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`permitted by the Board under the relevant rules, to address any new issues raised
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`by Unilever or Mr. Nandagiri, or resulting from further rulings of the Board or
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`otherwise from further proceedings.
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`II.
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`PROFESSIONAL BACKGROUND AND EXPERIENCE
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`5.
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`From 1971-1974, I was a Medical Laboratory Specialist with the U.S.
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`Army, with a primary focus on clinical microbiology. I studied in the U.S. Army’s
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`Medical Field Service School at Fort Sam Houston Brook Army Medical Center,
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`qualifying as a Medical Laboratory Specialist. During my service, I received a
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`National Defense Ribbon and Army Medal of Commendation for service to the
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`45th Field Hospital.
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`6.
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`After leaving the Armed Services, I obtained undergraduate
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`(Microbiology) and PhD (Microbiology and Mycology) degrees from The
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`University of Texas. During graduate school, I interned at the Texas Department
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`of State Health Services laboratories and worked at The University of Texas in the
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`Department of Microbiology, as a research assistant and a teaching assistant.
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`3
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`I began working for P&G in 1981. After joining P&G, I completed
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`Case IPR2013-00505
`Patent 6,974,569
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`7.
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`specialized training in disinfectant development and microbiological and
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`regulatory aspects of cosmetics, drugs and medical devices.
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`8.
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`These experiences include academic and applied training in mycology,
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`microbiology, chemistry, biochemistry, parasitology, serology, antimicrobials,
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`clinical operations, etc.
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`9.
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`I worked for P&G for 30 years and retired in 2011. During my tenure
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`at P&G, I served as section head globally for several P&G business units, with the
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`longest tenure in Beauty Care.
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`10. The Beauty Care business unit at P&G included shampoo products. I
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`have 20 years of experience in testing the microbiological properties of personal
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`care products, including shampoos.
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`11.
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`I am a member in good standing of a number of professional and
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`industrial organizations, including the American Society for Microbiology (ASM),
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`The Society for Industrial Microbiology and Biotechnology, The Ohio Academy of
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`Science (OAS) and the Personal Care Products Council (PCPC). Over my career, I
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`have been elected to various leadership positions in ASM, OAS and PCPC. I was
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`elected an OAS Fellow by the OAS’s Board of Directors and Officers.
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`12.
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`I have authored alone, or with others, numerous papers, articles,
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`chapters, and edited one book related to the microbiology of personal care products.
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`4
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`13. A true and correct copy of my curriculum vitae is included as Exhibit
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`Case IPR2013-00505
`Patent 6,974,569
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`2014.
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`14.
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`I am a named inventor on at least 16 United States patents.
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`15. Accordingly, I am an expert in the field of microbiology of consumer
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`products with special focus on personal care and beauty products.
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`16.
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`I am being compensated at a rate of $300 per hour and my
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`compensation is not based in any way on the outcome of this matter.
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`III. ANALYSIS
`A. The Bioavailability/Coverage Index Disclosed And Claimed
`In The ’569 Patent
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`17. The ’569 patent’s bioavailability/coverage index test is a deposition
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`assay that measures the inhibition of a single standard fungus by application of a
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`synthetic antifungal component incorporated into shampoo compositions. The
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`antifungal component is the independent variable (the variable being tested). Exh.
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`1001, ’569 patent at 33:33-46. The standard fungus to be used in the
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`bioavailability/coverage index test method is Malassezia furfur, which is consistent
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`with the etiology of dandruff. Id.
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`18. The ’569 patent states that the index is “indicative of anti-dandruff
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`efficacy provided by the shampoo. Generally, the higher the index value of the
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`composition, the better its anti-dandruff efficacy, due to increased bioavailability
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`5
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`Case IPR2013-00505
`Patent 6,974,569
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`of the anti-dandruff agent, increased coverage of the anti-dandruff agent, or both.”
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`Id. at 33:28-32.
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`19. Through measurements taken after performing the
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`bioavailability/coverage index test method described in the ’569 patent, one can
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`determine how particulates of zinc pyridinethione (“ZPT”) deposited on pigskin
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`squares by treatment with a shampoo composition affect the growth of a standard
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`fungus known to cause the formation of dandruff. Id. at 34:41-36:10.
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`20. The ’569 patent describes a test wherein full-strength shampoo
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`formulations, including both product and control formulations, are applied to
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`pigskin squares of a specific size. The pigskins are lathered, rinsed, and dried.
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`The pigskins are then pressed against agar plates that were previously treated with
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`Malassezia furfur via liquid medium. The pigskins are subsequently removed
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`from the agar plates, and the plates are incubated for 72 hours at 30 ºC. After that
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`time, the ’569 patent describes using imaging software to estimate the size of the
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`areas of colonization of the fungus on the product and control agar plates.
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`The ’569 patent further describes determining an index value from those area
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`estimates by comparing the growth coverage on the control plate to that on the
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`product plate. Id. at 36:1-10.
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`21. The bioavailability/coverage index described in the ’569 patent
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`enables one to determine an index value, which is a ratio of the colonized area of
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`6
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`the control plate versus the colonized area of the product plate. Id. at 36:1-6. The
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`Case IPR2013-00505
`Patent 6,974,569
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`ratio compares two-dimensional values, i.e., areas.
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`IV. THE TESTS DISCLOSED IN WOODS AND SHIN
`A. Woods (Exh. 1023)
`22. A POSA at the time of the invention of the ’569 patent would have
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`understood that Woods neither reports nor describes bioavailability of an anti-
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`dandruff agent. The article describes laboratory methods (diffusion and dilution
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`tests) to estimate the sensitivity of diverse bacteria to standard antibiotics. The
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`disclosed methods do not use fungi or skin. Exh. 1023, Woods at 1329-39. In
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`Woods, the independent variable is the bacterium, which is tested against standard,
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`specific antibiotics. Id. at 1328, 1332-33. The Woods reference does not disclose
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`anything related to dandruff or specific anti-dandruff agents such as ZPT.
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`23. By contrast, the ’569 patent describes inhibition of a single standard
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`fungus by a synthetic antifungal component with the antifungal component being
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`the independent variable. Exh. 1001, ’569 patent at 33:33-46.
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`Shin (Exh. 1020)
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`B.
`24. A POSA would have recognized that Shin describes the use of skin
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`discs for diffusion testing of anti-dandruff actives. Exh. 1020, Shin at 7:19-37. In
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`Shin’s diffusion assay, diluted shampoo formulations containing anti-dandruff
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`actives are applied to skin discs. Id. The treated skin discs are applied to an agar
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`7
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`plate that was previously cultured with a fungus. Id. The discs are left on the agar
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`Case IPR2013-00505
`Patent 6,974,569
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`plate, which is then incubated.
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`25. Shin’s diffusion assay uses chelating agents such as sodium lauroyl
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`ethylenediamine triacetate and disodium EDTA (“EDTA-Na2”) to solubilize ZPT
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`powder or ZPT in suspension. Id. at 4:39-43. These chelating agents bind to the
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`zinc of ZPT. With zinc removed, the remaining pyridinethione becomes soluble
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`and combines in solution to form the highly soluble sodium salt sodium
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`pyridinethione or “sodium PT.”
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`26.
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` In the deposition assay test described in the ’569 patent, the ZPT is in
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`particulate form (not solubilized) and is mechanically deposited onto the skin, then
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`transferred to the agar surface which is directly exposed to that skin. To
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`accomplish the deposition, the skin is brought into contact with the surface of the
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`agar plate and then removed. Bioavailability is determined by measurement of the
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`fungal growth area on the agar plate that was in intimate contact with skin.
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`27.
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`In contrast, Shin’s test is a diffusion assay. The ZPT is solubilized
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`and forms sodium PT. The skin disc is left on the surface of the agar plate during
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`incubation and the sodium PT diffuses outward from the treated surface. After
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`three days, one measures the linear distance the sodium PT has diffused away from
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`the skin. Shin discloses a test in which one determines how effective sodium PT is
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`in killing and destroying fungal growth for some distance removed from the skin
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`8
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`disc. The test measures, in millimeters, the linear distance that the solubilized anti-
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`Case IPR2013-00505
`Patent 6,974,569
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`dandruff active, sodium PT, diffuses outward from the edge of the skin disc. Exh.
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`1020, Shin at TABLE 2. Shin only reports absolute linear diffusion values for
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`different shampoos, but nowhere describes the estimation or derivation of a
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`coverage index ratio or value, as claimed in the ’569 patent.
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`28.
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`In the bioavailability/coverage index described in the ’569 patent, the
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`anti-dandruff active is not solubilized, and it does not diffuse across the treated
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`surface as in Shin. Rather, the anti-dandruff active remains in particulate form
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`suspended in the shampoo, and deposits onto particular locations of the pigskin.
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`This mimics the way in which the anti-dandruff agent deposits on the scalp during
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`shampooing. The bioavailability/coverage index measures the area of fungal
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`growth on the agar plate that had come in contact with the treated pigskin.
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`29. The ’569 patent’s deposition assay is described as a coverage index,
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`because it indicates to a POSA how well the ZPT particulate suspended in the
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`shampoo sample will cover the scalp by deposition. It is a measure of how well a
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`shampoo product distributes the anti-dandruff active particulate, contained therein,
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`over a surface.
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`30. Shin’s test does not allow a POSA to make this determination. In
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`Shin, the ZPT does not exist as particulates, but is dissolved uniformly throughout
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`the solution. Unlike ZPT particulates, solubilized sodium PT is able to diffuse
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`9
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`outward from the edge of the pigskin disc. The test described in Shin is used to
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`Case IPR2013-00505
`Patent 6,974,569
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`determine the effectiveness of an active, of different concentrations of an active, or
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`of combinations of actives to kill and destroy fungi remote from the area treated.
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`This is a purpose different from the bioavailability/coverage index of the ’569
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`patent, which is used to determine the ability to prevent fungal growth in the area
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`treated with a shampoo sample. In the ’569 patent’s bioavailability/coverage index,
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`one is concerned about what happens on the agar plate in the area where the
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`pigskin disc contacted the plate. In contract, the Shin test is only concerned about
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`what happens beyond the edge of the pigskin disc.
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`31.
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`In paragraph 81 of his declaration, Mr. Nandagiri compared the value
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`measured for Shin’s Example 6 with the value measured for Shin’s Comparative
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`Example 2 and concluded that this is comparable to calculating the
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`bioavailability/coverage index of the ’569 patent. Exh. 1003, Nandagiri Decl. at ¶
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`81. I disagree. The value obtained when taking the ratio of the distances in
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`Example 6 and Comparative Example 2 is materially different from the value
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`obtained when determining the bioavailability/coverage index of the ’569 patent.
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`The ’569 patent bioavailability/coverage index is established on the basis of areas
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`of ZPT coverage and deposition whereas Shin is based on linear measure of
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`diffusion of solubilized ZPT. Moreover, the claimed bioavailability/coverage
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`index is a measurement of the fungal growth (comparing a control to a shampoo
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`
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`10
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`
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`sample) versus Shin which is a measurement of how far a solubilized antifungal
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`Case IPR2013-00505
`Patent 6,974,569
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`agent has travelled away from the edge of a skin disc.
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`32. Shin’s disclosure regarding anti-dandruff efficacy is not comparable
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`to the disclosure of the ’569 patent. Shin describes anti-dandruff testing that takes
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`the form of collecting and measuring the weight of flakes that formed in the days
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`after a subject washed its hair. Exh. 1020, Shin at 7:50-8:30. By contrast, the ’569
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`patent describes a deposition assay for determining anti-dandruff efficacy of ZPT
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`suspended in a shampoo. Exh. 1001, ’569 patent at 34:41 – 36:10.
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`33. The major differences between the test described in the ’569 patent
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`and Shin are set forth in the following table:
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`Feature
`Form of ZPT
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`’569 patent
`Particles suspended in
`undiluted shampoo
`
`Type of application
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`Deposition; treated skin disc
`brought into contact with agar
`plate then removed
`Coverage measured Yes
`Form of measurement Two-dimensional; coverage
`area calculated; measuring kill
`where the skin disc contacted
`the agar plate
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`Yes
`Ratio disclosed
`Mimics shampoo use Yes; full strength shampoo;
`ZPT not dissolved
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`11
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`Shin
`Particles in diluted shampoo
`are then dissolved by a
`chelating agent
`Diffusion; treated skin disc left
`on plate during incubation
`period
`No
`Linear/one dimensional;
`distance outward from edge of
`skin disc measured; no
`measurement of ability to
`prevent fungal growth under
`the skin disc
`No
`No; diluted shampoo; ZPT
`dissolved to form sodium PT
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`
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`V. CONCLUSION
`34. Unilever cites references that do not teach or suggest the pigskin disc
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`Case IPR2013-00505
`Patent 6,974,569
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`deposition assay described in the ’569 patent for determining the
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`bioavailability/coverage index. Woods describes laboratory methods to estimate
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`the sensitivity of diverse bacteria to standard antibiotics by methods that employed
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`neither fungi nor skin discs. Shin teaches a diffusion assay in which the ZPT is
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`solubilized to form sodium pyridinethione and in which a result is obtained in
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`terms of distance rather than area.
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`12
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`Case IPR2013-00505
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`Patent 6,974,569
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`35.
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`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
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`believed to be true, and further that these statements were made with the
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`knowledge that willful false statements and the like so made are punishable by fine
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`or imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
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`
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` Executed on: 21 afilga'\LV anQQ£»—A
`
`PHILIP A.
`
`El
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`l3
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`
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