throbber

`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`CONOPCO, INC. dba UNILEVER
`Petitioner
`
`v.
`
`THE PROCTER & GAMBLE COMPANY
`Patent Owner
`
`U.S. Patent No. 6,974,569
`_____________________
`
`Inter Partes Review Case No. Unassigned
`_____________________
`
`DECLARATION OF ARUN NANDAGIRI
`
`
`
`

`

`
`
`
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`
`
`TABLE OF CONTENTS
`
`I. 
`II. 
`III. 
`IV. 
`V. 
`VI. 
`VII. 
`VIII. 
`IX. 
`X. 
`
`XI. 
`
`XII. 
`
`XIII. 
`
`XIV. 
`
`XV. 
`
`XVI. 
`
`Introduction ............................................................................................... 3 
`My Background and Qualifications .......................................................... 4 
`List of Documents I Considered in Formulating My Opinion .................. 7 
`Person of Ordinary Skill in the Art ......................................................... 10 
`The '569 Patent Specification .................................................................. 11 
`The Claims of the '569 patent .................................................................. 12 
`State of the Art as of May 3, 1999 .......................................................... 16 
`Summary Chart of Analysis Over the Art ............................................... 24 
`The Basis of my Analysis with Respect to Obviousness ........................ 24 
`Ground 1: Claims 16 and 20 – 22 would have been obvious over
`Kanebo and Kalla .................................................................................... 25 
`Ground 2: Claim 27 would have been obvious over Kanebo, Kalla
`and Evans ................................................................................................. 40 
`Ground 3: Claims 20 - 22 Would Have Been Obvious to a POSA
`Over Kanebo, Sime and Hoshowski Hair Care ....................................... 43 
`Ground 4: Claims 14 and 16 would have been Obvious over
`Kanebo, Sime and Cardin. ....................................................................... 48 
`Ground 5: Claims 20 and 21 Would Have Been Obvious Over
`Kanebo, Cseh and Cosemedia ................................................................. 51 
`Ground 6: Claims 24 and 25 Would Have Been Obvious Over
`Kanebo and Cothran ................................................................................ 53 
`Ground 7: Claim 13 Would Have Been Obvious Over Kanebo,
`Ramachandran and Hoeschele ................................................................. 57 
`XVII.  Ground 8: Claims 31 and 33 Would Have Been Obvious Over
`Kanebo, Ramachandran and Bar-Shalom ............................................... 59 
`XVIII.  Ground 9: Claims 20 - 22 would have been obvious over Reid,
`Sime and Cardin ...................................................................................... 62 
`Objective Indicia of Nonobviousness ...................................................... 71 
`Conclusion ............................................................................................... 74 
`
`XIX. 
`XX. 
`
`
`
`2
`
`

`

`
`
`
`I, Arun Nandagiri, hereby declare as follows.
`I.
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`Introduction
`1.
`
`I am over the age of eighteen (18) and otherwise competent to make
`
`this declaration.
`
`2.
`
`I have been retained as an expert witness on behalf of CONOPCO, INC.
`
`(UNILEVER) for the above-captioned inter partes review (IPR). I am being
`
`compensated for my time in connection with this IPR at my standard legal
`
`consulting rate, which is $290 per hour. I understand that the petition for inter
`
`partes review involves U.S. Patent No. 6,974,569 ("the '569 patent"), UNL 1001,
`
`which resulted from U.S. Application No. 09/558,465 ("the '465 application"),
`
`filed on April 25, 2000, and alleging a priority date of May 3, 1999. The '569
`
`patent names David Scott Dunlop, Roberta Atwood Boyd, Susan Marie Guskey,
`
`James Robert Schwartz, and Anthony Raymond Marchetta as inventors. The '569
`
`patent issued on December 13, 2005, from the '465 application. I further
`
`understand that, according to the USPTO records, the '569 patent is currently
`
`assigned to the Procter & Gamble Company ("P&G").
`
`3.
`
`I submitted a Declaration dated August 14, 2013 in IPR2013-00505,
`
`which also involved review of the '569 patent. IPR as to some of the claims of the
`
`'569 patent was instituted by the U.S. Patent and Trademark Office on February 12,
`
`2014.
`
`
`
`3
`
`

`

`
`
`
`
`4.
`
`In preparing this Declaration, I have reviewed the '569 patent and
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`considered each of the documents cited herein, in light of general knowledge in the
`
`art. In formulating my opinions, I have relied upon my experience, education and
`
`knowledge in the relevant art. In formulating my opinions, I have also considered
`
`the viewpoint of a person of ordinary skill in the art ("POSA") (i.e., a person of
`
`ordinary skill in the field of shampoos and conditioners, defined further below in
`
`Section IV) prior to May 3, 1999.
`
`II.
`
`My Background and Qualifications
`5.
`
`I am an expert in the field of shampoos and conditioners, including
`
`anti-dandruff conditioning shampoos. I have more than 30 years' experience in
`
`formulating shampoos and conditioners and have been personally involved in the
`
`formulation of hundreds of hair care products. I received my Masters of Science
`
`degree in Pharmacy from Andhra University, India where master's thesis was
`
`entitled "Manufacture of Antibiotics." Additionally, I received my Masters of
`
`Science degree in Pharmacy Administration from Brooklyn College of Pharmacy
`
`in 1972. From 1970-1972, I was an aerosol chemist at Block Drug company, where
`
`I worked with aerosol shampoos and hairsprays.
`
`6.
`
`From 1972 to 1975, I was a Senior Scientist for the Hair Care and
`
`Antiperspirants division of Beecham, Inc. From 1975 to 1982, I was Group Leader
`
`of the Hair Care and Antiperspirants division of Shulton, Inc. At both of these
`
`
`
`4
`
`

`

`
`
`
`positions, I was involved in formulating shampoos and conditioners, and was
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`involved in selecting formulation components and testing of conditioning
`
`properties. As a Group Leader at Shulton, I also had a group of formulation
`
`chemists reporting to me.
`
`7.
`
`From 1982 to 1989, I was Director of Research and Development for
`
`Playtex-Jhirmack, Inc. As Director, I created, planned, delegated and coordinated
`
`all research and development activities for the U.S. and Canadian markets. I was
`
`actively involved in formulating all types of hair care products, including
`
`shampoos and conditioners. In my role in creating shampoo and conditioner
`
`formulations, I was involved in determining which components to use in the
`
`formulations and at what concentrations. At Playtex-Jhirmack, I worked with anti-
`
`dandruff shampoos, including shampoos containing zinc pyrithione ("ZPT") and
`
`coal tar.
`
`8.
`
`In 1989, I joined Helene Curtis Industries, Inc., which was acquired
`
`by Unilever in 1996. I was Director of the Hair Care Research and Development
`
`division of Helene Curtis, and then Unilever, from 1989 to 2000. In this position, I
`
`managed and directed all development products in hair shampoos, conditioners and
`
`other hair products. I coordinated research activities associated with hair care
`
`products and managed a staff of up to 40 scientists, stylists and administrators. I
`
`also interacted with research and development personnel to create shampoo and
`
`
`
`5
`
`

`

`
`
`
`conditioning formulations. I also was involved with research and formulation of
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`anti-dandruff shampoos.
`
`9.
`
`From 2000 to 2003, I was Director of Hair Care Projects of Unilever
`
`de Argentina. In this position, I was on a global team managing Unilever's hair
`
`care products around the world. I successfully expanded Unilever's hair care
`
`market share in Latin America and established an independently functioning
`
`research team.
`
`10.
`
`In 2003, I founded Bria Research Labs, a personal care consulting and
`
`contract business. Bria Research Labs provides hair care product development and
`
`testing services to the personal care industry. I am actively in charge of all of the
`
`activities of Bria Research Labs, which include: developing customize shampoo
`
`and conditioner formulations; substantiating product claims via hair swatch testing;
`
`salon testing of products; providing small scale manufacturing on site; and
`
`supporting large scale manufacturing. As founder of Bria, I have been involved in
`
`multiple projects formulating shampoos and conditioners from scratch in order to
`
`meet client needs. I personally formulated hundreds of shampoo and conditioner
`
`formulations and also developed several test methods to evaluate the performance
`
`of these products in the laboratory and salon.
`
`
`
`6
`
`

`

`
`
`
`
`11. Accordingly, I am an expert in the field of shampoos and conditioners
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`and I was an expert in this field prior to May 3, 1999. My full background is
`
`detailed in my curriculum vitae. UNL 1004.
`
`III.
`
`List of Documents I Considered in Formulating My Opinion
`12.
`
`In formulating my opinion, I have considered
`
`the following
`
`documents:
`
`Unilever
`Exhibit #
`
`Description
`
`1001
`
`1002
`1005
`
`1006
`
`Dunlop et al., U.S. Patent No. 6,974,569, "Shampoos Providing a
`Superior Combination Anti-Dandruff Efficacy and Condition,"
`(filed April 25, 2000; issued December 13, 2005)
`File history of U.S. Patent No. 6,974,569
`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)
`Evans et al., WO 97/14405, "Conditioning Shampoos Containing
`Polyalkylene Glycol," (filed October 15, 1996; published April 24,
`1997)
`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)
`
`1009
`
`1010
`
`1012
`
`
`
`7
`
`

`

`
`
`
`
`Unilever
`Exhibit #
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`Description
`
`1013
`
`1014
`
`1015
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`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)
`Drakoff, U.S. Patent No. 3,964,500, "Lustering Shampoo
`Containing a Polysiloxane and a Hair-Bodying Agent," (filed June
`18, 1975; issued June 22, 1976)
`Shin et al., U.S. Patent No. 5,886,031, "Hair-Care Cosmetic
`Compositions Having Dandruff Formation-Suppressing Effect,"
`(filed May 22, 1997; issued March 23, 1999)
`Hoshowski et al., U.S. Patent No. 5,137,715, "Hair Shampoo-
`Conditioner Composition," (filed December 7, 1990; issued
`August 11, 1992)
`Liu et al., U.S. Patent No. 5,456,851, "Ketoconazole Shampoo
`Containing Butylated Hydroxytouluene or Butylated
`Hyrdoxyanisole," (filed April 7, 1994; issued October 10, 1995)
`1023 Woods, G.L. and Washington, J.A., "Antibacterial Susceptibility
`Tests: Dilution and Disk Diffusion Methods," Manual of Clinical
`Microbiology Sixth Edition: 1327-1341 (1995)
`Garcia, M.L. and Diaz, J., "Combability Measurements on Human
`Hair," J. Soc. Cosmet. Chem. 27: 379-398 (1976)
`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
`Embrechts et al., European Patent Application No. 0 872 230,
`"Compositions containing an antifungal and cationic agent," (filed
`April 14, 1997; published October 21, 1998)
`
`1024
`
`1025
`
`1026
`
`
`
`8
`
`

`

`
`
`
`
`Unilever
`Exhibit #
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`Description
`
`1027
`
`1028
`
`1029
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1040
`1042
`
`Somasundaran et al., WO 96/03972, "Deposition of Materials to
`Surfaces Using Zwitterionic Carrier Particles," (filed July 8, 1995;
`pulished February 15, 1996)
`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)
`Ramachandran, et al., U.S. Patent No. 5,900,393, "Scalp Care
`Products Containing Anti Itching/Anti Irritant Agents," (filed June
`24, 1996; issued May 4, 1999)
`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)
`European Patent Application 00928693.1-2108 / 1181008, Letter
`from the proprietor of the patent on November 8, 2012, The
`Procter & Gamble Company response to European Oppositions
`Hoeschele, J.D., et al., "In Vitro Analysis of the Interaction
`between Sucralfate and Ketoconazole," Antimicrobial Agents and
`Chemotherapy 38(2):319-325 (1994)
`Staudigel et al., U.S. Publication No. 2013/0089587, "Personal
`Care Compositions and Methods of Making Same," (filed October
`5, 2012; issued April 11, 2013)
`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)
`
`
`
`9
`
`

`

`
`
`
`
`Unilever
`Exhibit #
`1044
`
`1045
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`Description
`
`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)
`
`
`IV.
`
`Person of Ordinary Skill in the Art
`13.
`
`I understand that a person of ordinary skill in the art is a hypothetical
`
`person who is presumed to be aware of all pertinent art, thinks along conventional
`
`wisdom in the art, and is a person of ordinary creativity. A person of ordinary skill
`
`in the art ("POSA") of anti-dandruff conditioning shampoos would have had
`
`knowledge of the scientific literature concerning use of surfactants as conditioners,
`
`as of 1999. A POSA as of 1999 would typically have (i) a Ph.D. or M.S. degree in
`
`pharmacy, physical chemistry (colloidal chemistry), chemistry or biochemistry (or
`
`a related field) with at least a 2-3 years of experience in the development of
`
`shampoo and conditioner formulations, or (ii) a B.S. in pharmacy, chemistry or
`
`biochemistry (or a related field) with significant practical experience (4 or more
`
`years) in the development of shampoo and conditioner formulations. A POSA may
`
`work as part of a multi-disciplinary team and draw upon not only his or her own
`
`skills, but also take advantage of certain specialized skills of others in the team, to
`
`
`
`10
`
`

`

`
`
`
`solve a given problem. For example, a formulator, a colloidal chemist and a
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`surfactant specialist be part of the team.
`
`V.
`
`The '569 Patent Specification
`14. This declaration is being submitted together with a petition for inter
`
`partes review of claims 13, 14, 16, 20 – 22, 24, 25, 27, 31 and 33 of the '569
`
`patent.
`
`15.
`
`I have considered the disclosure and file history of the '569 patent in
`
`light of general knowledge in the art as of the earliest alleged priority date of the
`
`'569 patent, May 3, 1999.
`
`16. The
`
`'569 patent is directed to anti-dandruff and conditioning
`
`shampoos. UNL 1001, Abstract. The '569 patent alleges that the shampoo
`
`compositions "provide a superior combination of anti-dandruff efficacy and
`
`conditioning…." UNL 1001, Abstract. The '569 patent states that:
`
`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
`
`
`
`11
`
`

`

`
`
`
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`weight, of an anti-dandruff agent; (D) from about 0.02%
`to about 5%, by weight, of at least one cationic polymer;
`and
`(E) water. The compositions
`(A) have a
`bioavailability/coverage index value, as defined herein,
`of at least about 1.25; (B) have a first conditioning index
`value, as defined herein, of less than or equal to about
`1.0; (C) have a second conditioning index value, as
`defined herein, of at least about 1.5; and (D) have a
`minimal inhibitory concentration index value, as defined
`herein, of at least about 0.125.
`
` UNL 1001, Abstract.
`
`VI.
`
`The Claims of the '569 patent
`17. Claim 1 of the '569 patent is directed to:
`
`1. A shampoo composition comprising:
`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 a
`cationic polymer;
`e) water;
`f) from about 0.1% to about 10%, by weight of the
`composition, of a suspending agent; wherein said
`composition:
`i. has a bioavailability/coverage index value, of at least
`about 1.25;
`
`
`
`12
`
`

`

`
`
`
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`ii. has a first conditioning index value, of less than or
`equal to about 1.0;
`iii. has a second conditioning index value, of at least
`about 1.5; and
`iv. has a minimal inhibitory concentration index value, of
`at least about 0.125.
`
`
`18. The claim term "bioavailability/coverage index value" encompasses
`
`results obtained in skin disk diffusion assays that were well known in 1999. See
`
`UNL 1023, 1337-1340. The '569 patent discloses a testing method where skin
`
`disks treated with shampoo compositions are contacted with agar plates and the
`
`average area colonized on the plate is assessed. UNL 1001, 34:42-36:10 The
`
`bioavailability/coverage test disclosed in the '569 patent is comparable to skin disk
`
`diffusion tests known in the art, such as those disclosed in Woods and Shin. UNL
`
`1023, 1337-1340; UNL 1020, 7:19-37. For example, Woods discloses "Disk
`
`Diffusion Testing" measuring the zone of inhibition around a disk treated with an
`
`antimicrobial agent. UNL 1023, 1337, col. 1. And Shin discloses a method where
`
`skin discs treated with shampoo are then contacted with agar plates, followed by
`
`measurement of the inhibition zone after inhibition of the plate. UNL 1020, 7:19-
`
`37.
`
`19. The claim term "first conditioning index value" encompasses results
`
`obtained in combing force assays that were well known in 1999. See UNL 1024;
`
`UNL 1021, 25:36-61. The '569 patent discloses a testing method where the force
`
`
`
`13
`
`

`

`
`
`
`neded to pull a comb through a swatch of hair is measured by a force transducer.
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`UNL 1001, 37:31-38:58. The first conditioning index test disclosed in the '569
`
`patent is comparable to combing force tests known in the art, such as those
`
`disclosed in Garcia and Hoshowski. UNL 1024; UNL 1021, 25:36-61. Garcia
`
`discussed an "instrumental method for MEASURING the effect of cosmetic
`
`products or any other treatment of the COMBABILITY of HUMAN HAIR." UNL
`
`1024, Abstract. And Hoshowski discusses a "combing study measures the energy
`
`required to comb through a hair tress to compare the energy required to comb
`
`through an untreated tress to the energy required to comb through a tress treated
`
`with a composition of the present invention." UNL 1021, 25:43-48.
`
`20. The claim term "second conditioning index value" encompasses
`
`results obtained in clean hair feel assays that were well known in 1999. See UNL
`
`1021, 22:12-44. Hoshowski discloses tests in which trained panelists evaluate the
`
`hair for different properties, including "wet feel." UNL 1021, 22:28-43. The '569
`
`patent discloses a testing method where a panel of testers evaluates the clean hair
`
`feel of swatches of hair by touch. UNL 1001, 40:28-42:11. The second
`
`conditioning index test disclosed in the '569 patent is comparable to clean hair feel
`
`tests known in the art, such as that disclosed in Hoshowski. UNL 1021, 22:12-44.
`
`21. The claim term "minimal inhibitory concentration index value"
`
`encompasses results obtained in minimal inhibitory concentration ("MIC") assays
`
`
`
`14
`
`

`

`
`
`
`that were well known in 1999. See UNL 1020, 6:59-7:17. The '569 patent discloses
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`a standard MIC assay for determining the minimal concentration at which an agent
`
`prevents antimicrobial growth. UNL 1001, 42:50-43:11. The MIC test disclosed in
`
`the '569 patent is comparable to MIC tests known in the art, such as those disclosed
`
`in Shin. UNL 1020, 6:59-7:17.
`
`22. Claim 12 recites that the "anti-dandruff particulate is a zinc salt of 1-
`
`hydroxy-2-pyridinethione." It is clear from the specification of the '569 patent and
`
`the use of this term in the art that a zinc salt of 1-hydroxyl-2-pyridinethione is
`
`equivalent to "zinc pyrithione". For example, the '569 patent states that the
`
`preferred anti-dandruff agent is the zinc salt of 1-hydroxy-2-pyridinethione, which
`
`is "(known as 'zinc pyridinethione' or 'ZPT')." UNL 1001, 16:55-59. The Example
`
`formulations use the term zinc pyrithione and state in a footnote "ZPT having an
`
`average particle size of 2.5 μm, available from Arch/Olin." UNL 1001, 32:30-51,
`
`fn. 4. When referring to the anti-dandruff agent later in the '569 patent, the term
`
`"zinc pyrithione" is used. The '569 patent states: "[i]t is also contemplated that
`
`when the anti-dandruff particulate employed is zinc pyrithione, and/or if other
`
`optional hair growth regulating agents are employed, the shampoo compositions of
`
`the present invention, may, provide for the regulation of growth of the hair." UNL
`
`1001, 31:41-45. Thus, the '569 patent uses the terms "zinc salt of 1-hydroxy-2-
`
`
`
`15
`
`

`

`
`
`
`pyridinethione," "ZPT," and "zinc pyrithione" as all referring to the same chemical
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`compound.
`
`23. Some of the challenged claims recite molecular weights of cationic
`
`polymers. A POSA would also understand that the specification of the '569 patent
`
`does not provide a specific method for measuring molecular weights of polymers.
`
`24. Any term I have not expressly defined above, I have given its plain
`
`and ordinary meaning under a broadest reasonable claim construction.
`
`VII.
`
`State of the Art as of May 3, 1999
`25. Anti-dandruff shampoos having good conditioning properties were
`
`known before 1999. Anti-dandruff agents, such as ZPT, had already been
`
`formulated into conditioning shampoos, as evidenced by the disclosures of, for
`
`example, Kanebo (UNL 1006), Sime (UNL 1028), Reid (UNL 1018) and Evans
`
`(UNL 1010).
`
`26. As shown by the references discussed herein, the process of
`
`formulating a conditioning anti-dandruff shampoo was well understood by 1999.
`
`Conditioning hair involves depositing a cationic polymer along the length of the
`
`anionically charged hair shaft in an amount sufficient to make the hair feel
`
`conditioned without causing the hair to feel unclean. UNL 1032 68-69. Effective
`
`conditioning while maintaining a good clean feeling is often accomplished by
`
`
`
`16
`
`

`

`
`
`
`using cationic conditioning polymers with molecular weights ("MWs") less than
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`700,000 g/mol1.
`
`27. Treating the hair and scalp for dandruff involves depositing an
`
`antimicrobial agent, such as ZPT and ketoconazole, along the length of the hair
`
`shaft and on the scalp. The anti-dandruff agents approved for use in the U.S. in
`
`1999, including ZPT, are insoluble and generally suspended in formulations to
`
`allow for their deposition on the hair and scalp. See, e.g., UNL1009, 1:15-2:25. It
`
`was known as of 1999 that water soluble cationic deposition aids could be used to
`
`enhance the deposition of insoluble anti-dandruff agents on the hair and scalp. See,
`
`e.g., UNL 1009, 4:62-67.
`
`28.
`
`It was also well known in 1999 to use coacervate conditioning
`
`systems to deliver both conditioners and anti-dandruff agents to the hair and scalp.
`
`As discussed in U.S Patent 3,964,500, coacervate silicone polymer systems have
`
`been used in shampoos since at least 1976. See UNL 1019, 3:11-18. Kanebo
`
`discloses coacervate systems containing anionic surfactant, silicone conditioning
`
`agent, anti-dandruff agent and cationic polymer. UNL1006, [0037], pp. 10-11. A
`
`POSA would have understood that Kanebo discloses a combination of ingredients
`
`that would form coacervates upon dilution in water, leading to enhanced deposition
`
`of both conditioning and anti-dandruff agents.
`
`1 All molecular weights referred to are in g/mol unless otherwise noted.
`
`
`
`17
`
`

`

`
`
`
`
`29.
`
`It was further well known by 1999 to use polyalkylene glycols to
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`enhance the spreadability of shampoos on the hair. For example, Evans teaches:
`
`"[i]t has also been found that these selected polyalkylene glycols, when added to a
`
`silicone-containing shampoo composition, enhance spreadability of the shampoo
`
`compositions in hair. Enhanced spreading of the shampoo composition during
`
`application provides consumers with a perception of enhanced conditioning
`
`performance." UNL 1010, 20.
`
`30. Exemplary relevant art that published before May 3, 1999 includes the
`
`references described below.
`
`31. Kanebo. Kanebo is Japanese Patent Application No. 08/019,389.
`
`Kanebo was filed January 9, 1996 and published July 22, 1997.2 Kanebo is entitled
`
`"Composition Having Pearl Lustre." Kanebo discloses anti-dandruff conditioning
`
`shampoos containing 10.0% of the anionic surfactant ammonium lauryl sulphate,
`
`5.0% of the conditioning agent dimethyl polysiloxane, 0.5% of the anti-dandruff
`
`agent zinc pyrithione, 1.0% of the cationic polymer Catinal HC-200, 0.1% of the
`
`polyethylene glycol Polyox WSR-301 and water3. UNL1006, [0037], pp. 10-11.
`
`
`2 A certified English translation of Kanebo is provided as UNL 1006. All
`citations will be made to the English translation.
`3 Unless otherwise noted, percentage values referred to are percent by
`weight.
`
`
`
`18
`
`

`

`
`
`
`
`32. Reid. Reid is U.S. Patent 5,085,857. Reid was filed December 3, 1990
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`and issued February 4, 1992. Reid is entitled "Conditioning shampoo comprising a
`
`surfactant, a non-volatile silicone oil and guar hydroxypropyltrimonium chloride as
`
`a cationic conditioning polymer." Reid discloses shampoo compositions containing
`
`anionic surfactant, cationic conditioning polymer, non-volatile silicon conditioning
`
`agent, water and an antidandruff agent. UNL 1018, 5:15-16, 8:11-21.
`
`33. 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
`
`derivative Cosmedia® Guar C 261. UNL 1042 2:15-17.
`
`34. Cosmedia. Cosmedia is Product Data Sheet COSMEDIA® GUAR
`
`C261 and was published in 1997. Cosmedia discloses that the cationic guar
`
`derivative Guar C261 has a "Molecular weight approx. 220,000 g/mol." UNL
`
`1040.
`
`35. Sime. Sime is U.S. Patent 5, 037,818. Sime was filed July 26, 1988
`
`and issued August 6, 1991. Sime is entitled "Washing Composition for the Hair."
`
`Sime discloses washing compositions, including shampoos, containing cationic
`
`guar derivatives having a molecular weight from about 2,000 to about 3,000,000
`
`and charge densities from 0.1 to 1.0 meq/g. UNL 1028, 2:27-42; 8:Experiment 2.
`
`Sime discloses compositions containing cationic guar derivatives, such as
`
`JAGUAR C13 and JAGUAR C17. UNL 1028, 43-59.
`
`
`
`19
`
`

`

`
`
`
`
`36. Hoshowski Hair Care. Hoshowski Hair Care is Chapter 4 of Hair
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`and Hair Care, Dale Johnson, ed., is titled "Conditioning of Hair," and was written
`
`by Myra A. Hoshowski. Hoshowski Hair Care is copyrighted 1997. Hoshowski
`
`Hair Care is part of a general manual of shampoo formulation. Hoshowski Hair
`
`Care discusses the general properties of hair conditioners. Hoshowski Hair Care
`
`teaches that "[g]uar hydroxyl propyltrimonium chloride is an excellent thickener
`
`which disperses easily in water, in pH-stable over a wide range, and is compatible
`
`with surfactants and salts. Guar gums are available in a variety of viscosities and
`
`degrees of quaternization, offering the cosmetic chemist formulation flexibility."
`
`UNL 1032, 76.
`
`37. Kalla. Kalla
`
`is International Application Publication Number
`
`WO97/26854 to Kalla et al. Kalla was filed January 6, 1997 and published July 31,
`
`1997. Kalla is entitled "Shampoo Compositions with Improved Deposition of
`
`Antimicrobial Agents." Kalla discloses "antidandruff shampoo compositions with
`
`improved deposition of antimicrobial agents, which compositions comprise (a) …
`
`anionic surfactant, … (b) … an antimicrobial agent; (c) … a suspending agent; (d)
`
`… a cationic guar polymer having a charge density of from about 0.01 meq/g to
`
`about 3 meq/gm; and (e) … water…." UNL 1031, Abstract.
`
`38. Cothran. Cothran is International Application Publication Number
`
`WO96/32919 to Cothran et al. Cothran was filed March 27, 1996 and published
`
`
`
`20
`
`

`

`
`
`
`October 24, 1996. Cothran is entitled "Shampoos With Insoluble Silicone
`
`Inter Partes Review of USPN 6,974,569
`Declaration of Arun Nandagiri (UNL 1043)
`
`Conditioning Agent and Cationic Polymer." Cothran discloses anti-dandruff
`
`shampoos comprising antionic surfactant, silicone conditioning agent and a
`
`cationic polymer for stabilizing the silicone conditioning agent. UNL 1044,
`
`Abstract.
`
`39. Ramachandran. Ramachandran is U.S. Patent No. 5,900,393 to
`
`Ramachandran et al. Ramachandran was filed June 24, 1996 and issued May 4,
`
`1999. Ramachandran is entitled "Scalp Care Products Containing Anti Itching /
`
`Anti Irritant Agents." Ramachandran discloses anti-dandruff shampoos containing
`
`ketoconazole, selenium sulfide, zinc pyrithione, coal tar, sulfur and mixtures
`
`thereof. UNL 1033, 4: 59-64.
`
`40. Bar-Shalom. Bar-Sh

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket