UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`CONOPCO, INC. dba UNILEVER
`Petitioner
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`v.
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`THE PROCTER & GAMBLE COMPANY
`Patent Owner
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`U.S. Patent No. 6,451,300
`_____________________
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`Inter Partes Review Case No. Unassigned
`_____________________
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`DECLARATION OF ARUN NANDAGIRI
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`TABLE OF CONTENTS
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`Introduction .................................................................................................. 1
`I.
`My Background and Qualifications ............................................................. 2
`II.
`List of Documents I Considered in Formulating My Opinion .................... 5
`III.
`Person of Ordinary Skill in the Art .............................................................. 7
`IV.
`The '300 Patent Specification ....................................................................... 8
`V.
`The Claims of the '300 Patent ...................................................................... 9
`VI.
`State of the Art as of May 3, 1999 ............................................................. 11
`VII.
`VIII. Summary Chart of Analysis Over the Art.................................................. 17
`IX.
`Basis of my Analysis with Respect to Anticipation .................................. 17
`X.
`Basis of my Analysis with Respect to Obviousness .................................. 18
`XI.
`Objective Indicia of Nonobviousness ........................................................ 70
`XII.
`Conclusion .................................................................................................. 70
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`I, Arun Nandagiri, hereby declare as follows.
`I.
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`Introduction
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`1.
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`I am over the age of eighteen (18) and otherwise competent to make
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`this declaration.
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`2.
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`I have been retained as an expert witness on behalf of CONOPCO, INC.
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`(UNILEVER) for the above-captioned inter partes review (IPR).
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`3.
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`I am being compensated for my time in connection with this IPR at
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`my standard legal consulting rate, which is $290 per hour.
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`4.
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`I understand that the petition for inter partes review involves U.S.
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`Patent No. 6,451,300 ("the '300 patent"), UNL 1001, which resulted from U.S.
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`Application No. 09/558,447 ("the '447 application"), filed on April 25, 2000, and
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`alleging a priority date of May 3, 1999. The '300 patent names David Scott
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`Dunlop, Susan Marie Guskey, Vincente Eduardo Leyba, and Douglas Allan Royce
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`as the inventors. The '300 patent issued on September 17, 2002, from the '447
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`application.
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`5.
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`I further understand that, according to the USPTO records, the '300
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`patent is currently assigned to The Procter & Gamble Company ("the patentee" or
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`"P&G").
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`6.
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`I submitted a Declaration dated August 14, 2013 in IPR2013-00509,
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`which also involved review of the '300 patent. IPR as to some of the claims of the
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`'300 patent was instituted by the U.S. Patent and Trademark Office on February 12,
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`2014.
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`7.
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`In preparing this Declaration, I have reviewed the '300 patent and
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`considered each of the documents cited herein, in light of general knowledge in the
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`art.
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`8.
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`In formulating my opinions, I have relied upon my experience,
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`education and knowledge in the relevant art.
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`9.
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`In formulating my opinions, I have also considered the viewpoint of a
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`person of ordinary skill in the art ("POSA") (i.e., a person of ordinary skill in the
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`field of shampoos and conditioners, defined further below in Section IV) prior to
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`May 3, 1999.
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`II. My Background and Qualifications
`I am an expert in the field of shampoos and conditioners, including
`10.
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`anti-dandruff conditioning shampoos.
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`11.
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`I have more than 30 years of experience in formulating shampoos and
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`conditioners and have been personally involved in the formulation of hundreds of
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`hair care products.
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`12.
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`I received my Masters of Science degree in Pharmacy from Andhra
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`University, India, and my master's thesis was titled "Manufacture of Antibiotics."
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`Declaration of Arun Nandagiri (UNL 1003)
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`13. Additionally, I received my Masters of Science degree in Pharmacy
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`Administration from Brooklyn College of Pharmacy in 1972. From 1970-1972, I
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`was an aerosol chemist at Block Drug company, where I worked with aerosol
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`shampoos and hairsprays.
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`14. From 1972 to 1975, I was a Senior Scientist for the Hair Care and
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`Antiperspirants division of Beecham, Inc. From 1975 to 1982, I was Group Leader
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`of the Hair Care and Antiperspirants division of Shulton, Inc. At both of these
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`positions, I was involved in formulating shampoos and conditioners, and was
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`involved in selecting formulation components and testing of conditioning
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`properties. As Group Leader at Shulton, I also had a group of formulation
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`chemists reporting to me.
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`15. From 1982 to 1989, I was Director of Research and Development for
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`Playtex-Jhirmack, Inc. As Director, I created, planned, delegated and coordinated
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`all research and development activities for the U.S. and Canadian markets. I was
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`actively involved in formulating all types of hair care products, including
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`shampoos and conditioners. In my role in creating shampoo and conditioner
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`formulations, I was involved in determining which components to use in the
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`formulations and at what concentrations. At Playtex-Jhirmack, I worked with anti-
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`dandruff shampoos, including shampoos containing zinc pyrithione and coal tar.
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`16.
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`In 1989, I joined Helene Curtis Industries, Inc., which was acquired
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`by Unilever in 1996. I was Director of the Hair Care Research and Development
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`division of Helene Curtis, and then Unilever, from 1989 to 2000. In this position, I
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`managed and directed all development products in hair shampoos, conditioners and
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`other hair products. I coordinated research activities associated with hair care
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`products and managed a staff of up to 40 scientists, stylists and administrators. I
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`also interacted with research and development personnel to create shampoo and
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`conditioning formulations. I also was involved with research and formulation of
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`anti-dandruff shampoos.
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`17. From 2000 to 2003, I was Director of Hair Care Projects of Unilever
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`de Argentina. In this position, I was on a global team managing Unilever's hair
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`care products around the world. I successfully expanded Unilever's hair care
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`market share in Latin America and established an independently functioning
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`research team.
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`18.
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`In 2003, I founded Bria Research Labs, a personal care consulting and
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`contract business. Bria Research Labs provides hair care product development and
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`testing services to the personal care industry. I am actively in charge of all of the
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`activities of Bria Research Labs, which include: developing customized shampoo
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`and conditioner formulations; substantiating product claims via hair swatch testing;
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`salon testing of products; providing small scale manufacturing on site; and
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`supporting large scale manufacturing. As founder of Bria, I have been involved in
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`multiple projects formulating shampoos and conditioners from scratch in order to
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`meet client needs. I personally formulated hundreds of shampoo and conditioner
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`formulations and also developed several test methods to evaluate the performance
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`of these products in the laboratory and salon.
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`19. Accordingly, I am an expert in the field of shampoos and conditioners
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`and I was an expert in this field prior to May 3, 1999.
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`20. My full background is detailed in my curriculum vitae. (UNL 1004.)
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`III. List of Documents I Considered in Formulating My Opinion
`In formulating my opinion, I have considered the following
`21.
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`documents:
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`Description
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`Unilever
`Exhibit #
`1001
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`1002
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`1005
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`Dunlop et al., U.S. Patent No. 6,451,300, "Anti-Dandruff and
`Conditioning Shampoos Containing Certain Cationic Polymers," (filed
`April 25, 2000; issued September 17, 2002)
`Amendment dated November 13, 2001 from the file history of U.S.
`Patent No. 6,451,300
`Kanebo, Ltd., Japanese Application No. 9-188614, "Composition
`having Pearl Lustre," (filed January 9, 1996; laid open July 22, 1997)
`(Japanese)
`Kanebo, Ltd., Japanese Application No. 9-188614, "Composition
`having Pearl Lustre," (filed January 9, 1996; laid open July 22, 1997)
`(English translation)
`1007 Marsh et al., U.S. Patent No. 7,481,846, "Method of Rapid Hair
`Dyeing," (filed September 22, 2005; issued January 27, 2009)
`Bowser et al., U.S. Patent No. 5,723,112, "Pyrithione Containing Hair
`Treatment Composition," (filed July 9, 1996; issued March 3, 1998)
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`1006
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`1009
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`Unilever
`Exhibit #
`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1018
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`1025
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`1028
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`1029
`1030
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`1031
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`1032
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`Description
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`Evans et al., WO 97/14405, "Conditioning Shampoos Containing
`Polyalkylene Glycol," (filed October 15, 1996; published April 24,
`1997)
`Birkofer, U.S. Patent No. 3,962,418, "Mild Thickened Shampoo
`Compositions with Conditioning Properties," (filed April 8, 1975;
`issued June 8, 1976)
`Bartolo et al., U.S. Patent No. 5,202,048, "Personal Cleansing Product
`with Odor Compatible Bulky Amine Cationic Polymer with Reduced
`Odor Characteristics," (filed December 30, 1991; issued April 13,
`1993)
`Coffindaffer et al., U.S. Patent No. 5,624,666, "Anti-Dandruff
`Shampoos with Particulate Active Agent and Cationic Polymer," (filed
`January 20, 1995; issued April 29, 1997)
`Cardin et al., U.S. Patent No. 5,104,645, "Antidandruff Shampoo
`Compositions," (filed February 2, 1990; issued April 14, 1992)
`Schwen et al., WO 95/03319, "Cyproterone Acetate Thioacetate,"
`(filed July 13, 1994; published on February 2, 1995)
`Reid et al., U.S. Patent No. 5,085,857, "Conditioning Shampoo
`Comprising a Surfactant, a Non-Volatile Silicone Oil and Guar
`Hydroxypropyltromium Chloride as a Cationic Conditioning
`Polymer," (filed December 3, 1990; issued February 4, 1992)
`Specification sheet for Polydimethylsiloxane, Food & Agriculture
`Organization of the United Nations, Joint FAO/WHO Expert
`Committee on Food Additives, 69th Meeting, Monograph 5, June
`2008
`Sime, U.S. Patent No. 5,037,818, "Washing Composition for the
`Hair," (filed July 26, 1998; issued August 6, 1991)
`Data sheet for Zinc Pyrithione, Arch Chemicals, Inc., 3 pages
`Gibson, U.S. Patent No. 5,015,470, "Cosmetic Composition," (filed
`December 17, 1987; issued May 14, 1991)
`Kalla et al., WO 97/26854, "Shampoo Compositions with Improved
`Deposition of Antimicrobial Agents," (filed January 6, 1997;
`published on July 31, 1997)
`Hoshowski, M.A., "Conditioning of Hair," Chapter 4 in Hair and Hair
`Care, Johnson, D.H., ed., pp. 65-104, Marcel Drekker, Inc. (1997)
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`Unilever
`Exhibit #
`1034
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`1038
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`1040
`1042
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`1044
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`1045
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`1046
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`1047
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
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`Description
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`Bar-Shalom, et al., U.S. Patent No. 5,618,798, "Use of Sucralfate to
`Treat Baldness," (filed May 23, 1994; issued April 8, 1997)
`Patent Owner's Preliminary Response Pursuant to 37 C.F.R. § 42.107
`in Case IPR2013-00510, Patent 6,649,155, Conopco, Inc. dba Unilever
`v. The Procter & Gamble Company, Paper No. 7, filed November 18,
`2013
`Product data sheet for COSMEDIA™ Guar C261
`Cseh, U.S. Patent No. 4,676,978, "Shampoo," (filed January 27, 1986;
`issued June 30, 1987)
`Cothran et al., WO 96/32919, "Shampoos with Insoluble Silicone
`Conditioning Agent and Cationic Polymer," (filed March 27, 1996;
`published on October 24, 1996)
`Uchiyama et al., WO 97/14406, "Conditioning Shampoo
`Compositions Having Improved Stability," (filed October 16, 1996;
`published April 24, 1997)
`File history of U.S. Patent No. 6,451,300 (exclusive of foreign patent
`documents listed in Information Disclosure Statements)
`Hsiung, et al., U.S. Patent No. 4,391,286, "Hair Conditioning and
`Compositions Therefor," (filed February 19, 1981; issued July 5,
`1983)
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`IV. Person of Ordinary Skill in the Art
`I understand that a person of ordinary skill in the art ("POSA") is a
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`hypothetical person who is presumed to be aware of all pertinent art, thinks along
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`conventional wisdom in the art, and is a person of ordinary creativity. A POSA of
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`anti-dandruff conditioning shampoos would have had knowledge of the scientific
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`literature concerning use of surfactants as conditioners, as of May 3, 1999. A
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`POSA as of 1999 would typically have (i) a Ph.D. or M.S. degree in pharmacy,
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`physical chemistry (colloidal chemistry), chemistry or biochemistry (or a related
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`field) with at least a 2-3 years of experience in the development of shampoo and
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`conditioner formulations, or (ii) a B.S. in pharmacy, chemistry or biochemistry (or
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`a related field) with significant practical experience (4 or more years) in the
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`development of shampoo and conditioner formulations. A POSA may work as part
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`of a multi-disciplinary team and draw upon not only his or her own skills, but also
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`take advantage of certain specialized skills of others in the team, to solve a given
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`problem. For example, a formulator, a colloidal chemist, and a surfactant
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`specialist may be a part of the team.
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`V.
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`The '300 Patent Specification
`23. This declaration is being submitted together with a petition for inter
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`partes review of the '300 patent.
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`24.
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`I have considered the disclosure and file history of the '300 patent in
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`light of general knowledge in the art as of the earliest alleged priority date of the
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`'300 patent, May 3, 1999.
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`25. The
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`'300 patent is directed to anti-dandruff and conditioning
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`shampoos. UNL 1001, Abstract. The '300 patent alleges that the shampoo
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`compositions "provide a superior combination of anti-dandruff efficacy and
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`conditioning . . . ." (UNL 1001, Abstract.) The '300 patent states that:
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`Disclosed are shampoo compositions that provide a
`superior combination of anti-dandruff efficacy and
`conditioning, and a method of cleansing and conditioning
`the hair comprising applying to the hair and scalp an
`amount of said compositions. The anti-dandruff and
`conditioning shampoos comprise: (A) from about 5% to
`about 50%, by weight, of an anionic surfactant; (B) from
`about 0.01% to about 10%, by weight, of a non-volatile
`conditioning agent; (C) from about 0.1% to about 4%, by
`weight, of an anti-dandruff particulate; (D) from about
`0.02% to about 5%, by weight, of at least one cationic
`polymer; (E) from 0.005% to about 1.5%, by weight of
`the composition, of a polyalkylene glycol corresponding
`to the formula: H(OCH2-CHR)n-OH, (i) wherein R is
`selected from the group consisting of hydrogen, methyl
`and mixtures thereof, (ii) wherein n is an integer having
`an average value from about 1,500 to about 120,000; and
`(F) water.
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`(UNL 1001, Abstract.)
`VI. The Claims of the '300 Patent
`26. Claim 1 of the '300 patent is directed to:
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`A shampoo composition comprising: a) from about
`5% to about 50%, by weight of the composition, of an
`anionic surfactant; b) from about 0.01% to about 10%, by
`weight of the composition, of a non-volatile conditioning
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`Declaration of Arun Nandagiri (UNL 1003)
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`agent; c) from about 0.1% to about 4%, by weight of the
`composition, of an anti-dandruff particulate; d) from
`about 0.02% to about 5%, by weight of the composition,
`of at least one cationic polymer; e) from 0.005% to about
`1.5%, by weight of the composition, of a polyalkylene
`glycol corresponding to the formula:
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`(i) wherein R is selected from the group consisting of
`hydrogen, methyl and mixtures thereof, ii) wherein n is
`an integer having an average value from about 1,500 to
`about 120,000; and f) water.
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`(UNL 1001, 33:47-67.)
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`27. Claims 12 and 29 recites that the "anti-dandruff particulate is a zinc
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`salt of 1-hydroxy-2-pyridinethione." It is clear from the specification of the '300
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`patent and the use of this term in the art that a zinc salt of 1-hydroxyl-2-
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`pyridinethione is equivalent to "zinc pyrithione." For example, the '300 patent
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`states that the preferred anti-dandruff agent is the zinc salt of 1-hydroxy-2-
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`pyridinethione, which is "(known as 'zinc pyridinethione' or 'ZPT')." (UNL 1001,
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`16:55-59.) The Example formulations use the term zinc pyrithione and state in a
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`footnote "ZPT having an average particle size of 2.5 μm, available from
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`Arch/Olin." (UNL 1001, 32:30-51, fn. 4.) When referring to the anti-dandruff
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`agent later in the '300 patent, the term "zinc pyrithione" is used. The '300 patent
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`states: "[i]t is also contemplated that when the anti-dandruff particulate employed
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`is zinc pyrithione, and/or if other optional hair growth regulating agents are
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`employed, the shampoo compositions of the present invention, may, provide for
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`the regulation of growth of the hair." (UNL 1001, 31:41-45.) Thus, the '300 patent
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`uses the terms "zinc salt of 1-hydroxy-2-pyridinethione," "ZPT," and "zinc
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`pyrithione" as all referring to the same chemical compound. With respect to the
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`molecular weight of shampoo components such as, cationic guar derivatives and
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`cationic cellulose, in the '300 patent, a POSA reading the patent would understand
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`that the specification of the '300 patent does not provide a specific method for
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`measuring molecular weight.
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`28. Any term I have not expressly defined above, I have given its plain
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`and ordinary meaning under a broadest reasonable claim construction.
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`VII. State of the Art as of May 3, 1999
`29. Anti-dandruff shampoos having good conditioning properties were
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`known before 1999. Anti-dandruff agents, such as ZPT, had already been
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`formulated into conditioning shampoos, as evidenced by the disclosures of, for
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`example, Kanebo, Bowser and Evans. UNL 1006, 1009, and 1010, respectively.
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`30. As shown by the references discussed herein, the process of
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`formulating a conditioning anti-dandruff shampoo was well understood by 1999.
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`Conditioning hair involves depositing a cationic polymer along the length of the
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`Declaration of Arun Nandagiri (UNL 1003)
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`anionically charged hair shaft in an amount sufficient to make the hair feel
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`conditioned without causing the hair to feel unclean. Effective conditioning while
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`maintaining a good clean feeling is often accomplished by using cationic
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`conditioning polymers with molecular weights ("MWs") less than 700,000 g/mol.1
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`31. Treating the hair and scalp for dandruff involves depositing an
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`antimicrobial agent, such as ZPT or ketoconazole, along the length of the hair shaft
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`and on the scalp. The anti-dandruff agents approved for use in the U.S. in 1999,
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`including ZPT, are insoluble and generally suspended in formulations to allow for
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`their deposition on the hair and scalp. (See, e.g., UNL 1009, 1:15-2:25.)
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`32.
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`It was known as of 1999 that water soluble cationic deposition aids
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`could be used to enhance the deposition of insoluble anti-dandruff agents on the
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`hair and scalp. (See, e.g., UNL 1009, 4:62-67.)
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`33.
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`The process of formulating an antidandruff ("AD") conditioning
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`shampoo was also well understood before 1999. For example, Kanebo discloses that
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`an object of the invention is to provide excellent usability and conditioning effect to
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`the hair, including an AD shampoo containing an anionic surfactant, a silicone
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`conditioning agent, an AD agent, and a cationic polymer. (UNL 1006, 3:¶[0004],
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`10-11:¶[0037].) Evans discloses conditioning shampoos containing an anionic
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`1 All molecular weights referred to are in g/mol unless otherwise noted.
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`surfactant, a silicone conditioning agent, polyalkylene glycols, cationic polymers,
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`Declaration of Arun Nandagiri (UNL 1003)
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`and an AD agent. (UNL 1010, 3, 11, 19, 24, 27 and 32.) A POSA would have
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`understood that each of Kanebo and Evans discloses a combination of ingredients
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`that forms conditioning, AD shampoos.
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`34.
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`The molecular weight ranges claimed for cationic polymers were well
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`known as by 1999. For example, Kalla, a P&G application which published in
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`1997, is drawn to AD shampoos, states that the molecular weight of cationic guar
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`gum derivatives "ranges generally from about 2,000 to about 3,000,000." (UNL
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`1031, 14:15-17.) Sime (UNL 1028), is also drawn to AD shampoos and discloses
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`that the "cationic polymers employed in this invention have a molecular weight
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`within the range from about 2,000 to about 3,000,000." (UNL 1028, 2:39-42.)
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`Cothran (UNL 1044), a P&G application which published in 1996, discloses
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`cationic guar gum derivatives and cationic cellulose derivatives having molecular
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`weights "from 400,000 to 2,000,000" (UNL 1044, 34:14-19.) Uchiyama (UNL
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`1045) a P&G application which published in 1997, discloses cationic guar gum
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`derivatives and states that the "cationic polymers hereof will generally have a
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`weight average molecular weight which is at least about 5,000, … Preferably, the
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`molecular weight is from about 100,000 to about 2 million." (UNL 1045, 18.) Thus,
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`it is clear from the teachings in the art that the claimed molecular weight ranges for
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`cationic polymers were well-known in the art prior to 1999.
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`35.
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`Sime also states that "cationic derivatives are obtained by reaction
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`between the hydroxyl groups of the polygalactomannan and reactive quaternary
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`ammonium compounds. The degree of substitution of the cationic groups is
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`sufficient to provide a cationic charge density of 0.0001 to 0.0017 [0.1 to 1.7
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`meq/g]." (UNL 1028, 2:66-68.) Thus, a POSA would have known to use the
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`claimed cationic guar gum derivatives in formulating AD shampoos.
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`36.
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`It was also well known by 1999 to use polyalkylene glycols to
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`enhance the spreadability of shampoos on the hair. For example, Evans teaches:
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`"[i]t has also been found that these selected polyalkylene glycols, when added to a
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`silicone-containing shampoo composition, enhance spreadability of the shampoo
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`compositions in hair. Enhanced spreading of the shampoo composition during
`
`application provides consumers with a perception of enhanced conditioning
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`performance." (UNL 1010, 20:28-32.)
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`37. The shampoo formulation field was well developed prior to May 3,
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`1999. The state of the art was well established with respect to the components of
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`the claimed shampoo compositions.
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`38. Exemplary relevant art that published before May 3, 1999 include the
`
`references described below.
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`14
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`39. Kanebo. Kanebo is Japanese Patent Application No. 08/019,389.
`
`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
`
`Kanebo was filed January 9, 1996 and published July 22, 1997.2 Kanebo is entitled
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`"Composition Having Pearl Lustre." Kanebo discloses anti-dandruff conditioning
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`shampoos containing 10.0% of the anionic surfactant ammonium lauryl sulphate,
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`5.0% of the conditioning agent dimethyl polysiloxane, 0.5% of the anti-dandruff
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`agent zinc pyrithione, 1.0% of the cationic polymer Catinal HC-200, 0.1% of the
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`polyethylene glycol Polyox WSR-301 and water. 3 (UNL 1006, ¶ [0037], pp. 10-
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`11.)
`
`40. Cothran. Cothran is International Application Publication Number
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`WO96/32919 to Cothran et al. Cothran was filed March 27, 1996 and published
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`October 24, 1996. Cothran is entitled "Shampoos With Insoluble Silicone
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`Conditioning Agent and Cationic Polymer." Cothran discloses anti-dandruff
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`shampoos comprising antionic surfactant, silicone conditioning agent and a
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`cationic polymer for stabilizing the silicone conditioning agent. (UNL 1044,
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`Abstract.)
`
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`2 A certified English translation of Kanebo is provided as UNL 1006. All
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`citations will be made to the English translation.
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`3 Unless otherwise noted, percentage values referred are percent by weight.
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`15
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`41.
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` Evans. Evans is International Patent Application Publication WO
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`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
`
`97/14405. Evans was filed October 15, 1996 and claims priority to U.S. Patent
`
`Application No. 08/543,665, which was filed October 16, 1995. Evans is entitled
`
`"Conditioning Shampoos Containing Polyalkylene Glycol." Evans discloses a hair
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`conditioning shampoo containing 5 to 30% of an anionic surfactant, 0.05 to 10% of
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`an insoluble silicone conditioning agent and a polyalkylene glycol with an average
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`n value of from 1,500 to 25,000. (UNL 1010, 3:6, 11:3, 32:claim 1.) Evans also
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`discloses optional anti-dandruff agents such as pyridinethione salts at
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`concentrations of 0.1% to 0.4% and cationic polymers as conditioning agents.
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`(UNL 1010, 24 and 27.)
`
`42. Cardin. Cardin is U.S. Patent No. 5,104,645. Cardin was filed
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`February 2, 1990 and issued April 14, 1992. Cardin is entitled "Antidandruff
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`Shampoo Compositions." Cardin discloses anti-dandruff shampoos containing
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`pyridinethione salts, including zinc pyridinethione. (UNL 1014, 6:4-26.) Cardin
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`discloses that "[t]he pyridinethione salts useful herein take the form of water-
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`insoluble flat platelet particles which have a mean sphericity of less than about
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`0.65, preferably from about 0.20 to about 0.54, and a median particle size of from
`
`about 2 µ to about 15 µ, preferably from about 5 µ to about 9 µ, the particle size
`
`being expressed as the median equivalent diameter of a sphere of equal volume."
`
`(UNL 1014, 6:26-36.)
`
`
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`16
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`

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`43. Coffindaffer. Coffindaffer is U.S. Patent No. 5,624,666. Coffindaffer
`
`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
`
`was filed January 20, 1995 and issued April 29, 1997. Coffindaffer is entitled
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`"Anti-Dandruff Shampoos with Particulate Active Agent and Cationic Polymer."
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`Coffindaffer discloses an "anti-dandruff shampoo composition …, wherein said
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`cationic polymer has a weight average molecular weight of from about 200,000 to
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`about 5,000,000 and a charge density of from about 0.6 meq/g to about 4 meq/g."
`
`(UNL 1013, 20:45-48.)
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`44. Cseh. Cseh is U.S. Patent 4,676,978. Cseh was filed January 27, 1986
`
`and issued June 30, 1987. Cseh discloses shampoos containing the cationic guar
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`derivative Cosmedia® Guar C 261. UNL 1042 2:15-17.
`
`VIII. Summary Chart of Analysis Over the Art
`'300 Patent Claims
`Grounds 35 U.S.C.
`Index of Reference(s)
`6-10
`1
`§103
`Kanebo and Cothran
`6
`2
`§103
`Kanebo, Cseh, and C261SPEC
`6, 8, 9
`3
`§103
`Kanebo, Reid, and Bartolo
`4
`§103
`Kanebo, Cseh, Sime, and C261SPEC 6
`5
`§103
`Kanebo, Cardin, and Kalla
`14, 15, 22
`6
`§103
`Kanebo and Bar-Shalom
`21, 23
`7
`§103
`Evans and Cothran
`6-10
`8
`§103
`Evans, Cseh, and C261SPEC
`6, 8, 9
`
`IX. Basis of my Analysis with Respect to Anticipation
`It is my understanding that a reference anticipates a claim if it
`45.
`
`discloses each and every element recited in the claim, arranged as in the claim, so
`
`as to enable one of skill in the art to make and use the claimed invention without
`
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`17
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`
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`the need for undue experimentation in light of the general knowledge available in
`
`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
`
`the art. The factors that I have considered in determining whether a reference sets
`
`forth the elements of a claim in a sufficient manner such that a POSA could have
`
`readily made and used the claimed invention include: the breadth of the claim, the
`
`nature of the invention, the state of the prior art, the level of one of ordinary skill,
`
`the level of predictability in the art, the amount of direction provided by the
`
`reference, the existence of working examples, and the quantity of experimentation
`
`needed to make or use the invention claimed.
`
`X.
`
`Basis of my Analysis with Respect to Obviousness
`
`46.
`
`I understand that an obviousness analysis involves comparing a claim
`
`to the prior art to determine whether the claimed invention would have been
`
`obvious to a person of ordinary skill in the art in view of the prior art, and in light
`
`of the general knowledge in the art. I also understand when a person of ordinary
`
`skill in the art would have reached the claimed invention through routine
`
`experimentation, the invention may be deemed obvious. I understand that a finding
`
`of obviousness for a specific range or ratio in a patent can be overcome if the
`
`claimed range or ratio is proven to be critical to the performance or use of the
`
`claimed invention.
`
`47.
`
`I also understand that obviousness can be established by combining or
`
`modifying the teachings of the prior art to achieve the claimed invention. It is also
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`
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`18
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`my understanding that where this is a reason to modify or combine the prior art to
`
`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
`
`arriving at the claimed invention, there must also be a reasonable expectation of
`
`success in so doing. I understand that the reason to combine prior art references
`
`can come from a variety of sources, not just the prior art itself or the specific
`
`problem the patentee was trying to solve. And I understand that the references
`
`themselves need not provide a specific hint or suggestion of the alteration needed
`
`to arrive at the claimed invention; the analysis may include recourse to logic,
`
`judgment, and common sense available to a person of ordinary skill that does not
`
`necessarily require explication in any reference.
`
`48.
`
`I understand that when considering the obviousness of an invention,
`
`one should also consider whether there are any secondary considerations that
`
`support the nonobviousness of the invention. I understand that secondary
`
`considerations of nonobviousness include failure of others, copying, unexpectedly
`
`superior results, perception in the industry, commercial success, and long-felt but
`
`unmet need.
`
`A. Ground 1: Claims 6-10 Would Have Been Obvious to a POSA Over
`Kanebo in View of Cothran
`
`49.
`
`Japanese Appl. No. 08/019,389 to Kanebo, Ltd., titled "Composition
`
`Having Pearl Lustre," was laid-open on July 22, 1997 as JP Laid-Open No. 9-
`
`188,614A ("Kanebo".) (UNL 1005.) Because the JP laid-open application is in
`
`
`
`
`19
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`

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`
`
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`Japanese, the certified English language translation will be referred to herein.
`
`Inter Partes Review of USPN 6,451,300
`Declaration of Arun Nandagiri (UNL 1003)
`
`(UNL 1006.) Intl. Appl. Publ. WO96/32919 to Cothran et al. (UNL 1044)
`
`published October 24, 1996.
`
`50. Kanebo discloses AD conditioning shampoos containing cationic
`
`polymers, e.g., guar gum derivatives and cationic cellulose derivatives, and having
`
`improved pearl lustre and spreadability. (UNL 1006, [0014], [0037].) Cothran
`
`discloses AD conditioning shampoos containing cationic polymers that enhance
`
`the stability of the shampoo. (UNL 1044, 3:10-21, 17:10-24, 25:8-20.)
`
`51. As shown by the following claim charts and discussion herein, claims
`
`6-10 would have been obvious over the teachings of Kanebo and Cothran. As
`
`discussed below, independent claim 1 and intervening claim 2 are anticipated by
`
`Kanebo.
`
`52. For the reasons discussed below, claims 6-10 would have been
`
`obvious over Kanebo and Cothran. Before turning to the challenged dependent
`
`claims, petitioner first provides a discussion of base claim 1, from which the
`
`challenged claims directly or indirectly depend.
`
`The '300 Patent
`1. A shampoo composition
`comprising:
`a) from about 5% to about 50%, by
`
`Disclosure in Kanebo
`Kanebo: "Example 10 (Anti-da