UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CLIO USA, INC.
`Petitioner
`v.
`THE PROCTER AND GAMBLE COMPANY
`Patent Owner
`
`Case IPR: Unassigned
`
`PETITION FOR INTER PARTIES REVIEW OF U.S. PATENT NO. 5,891,453
`
`DECLARATION OF ABDUL GAFFAR, Ph.D.
`
`CLIO USA
`EXHIBIT 1011
`PAGE 000001
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CLIO USA, INC.
`Petitioner
`v.
`THE PROCTER AND GAMBLE COMPANY
`Patent Owner
`
`Case IPR: Unassigned
`
`PETITION FOR INTER PARTIES REVIEW OF U.S. PATENT NO. 5,891,453
`
`DECLARATION OF ABDUL GAFFAR, Ph.D.
`
`CLIO USA
`EXHIBIT 1011
`PAGE 000001
`
`
`
`Inter Partes Review of US 5,891,453
`Declaration ofAbdul Gaffar, Ph.D. (Exhibit 1011)
`
`I, Abdul Gaffar, declare and state as follows:
`
`1.
`
`I am over the age of eighteen (18) and otherwise competent to make this
`
`declaration. I have a Ph.D. degree in immunochemistry/microbiology and
`
`have worked for over 30 years in the oral care industry, and extensively in the
`
`teeth whitening field. Please see my Curriculum Vitae attached hereto as
`
`Exhibit 1013.
`
`2.
`
`I understand that the petition for inter partes review involves U.S. Patent No.
`
`5,891,453 ("the '453 patent"), Exhibit 1001. The ‘453 patent issued on April
`
`6, 1999.
`
`3.
`
`I have reviewed the ‘453 patent and considered each of the
`
`following documents.
`
`Exhibit 1002
`Exhibit 1003
`Exhibit 1004
`Exhibit 1005
`Exhibit 1006
`Exhibit 1007
`Exhibit 1008
`Exhibit 1009
`Exhibit 1010
`
`U.S. 2,835,628 (Saffir)
`U.S. 5,326,685 (Gaglio)
`U.S. 4,713,243 (Schiraldi)
`U.S. 5,725,843 (Fischer)
`U.S. 5,642,067 (Shapiro)
`U.S. 3,899,452 (Koch)
`J. SCI. INSTRUM., 1965, vol.42, 591 (Morton)
`U.S. 2,444,830 (Kellgren)
`ASTM D2923-95
`
`2
`
`PAGE 000002
`
`
`
`Inter Partes Review of US 5,891,453
`Declaration ofAbdul Gaffar, Ph.D. (Exhibit 1011)
`
`In formulating my opinions, I have relied upon my experience in the relevant
`
`art. In formulating my opinions, I have also considered the viewpoint of a
`
`person of ordinary skill in the art ("POSA"). See below. I have been asked to
`
`provide my opinions as of the timeframe of June 6, 1997.
`
`4.
`
`In my opinion, a person of ordinary skill in the art (POSA) relevant to the
`
`‘453 patent’s technology as of June 6, 1997, and the state of the relevant art
`
`(delivery systems for an oral care substance using a strip of material having
`
`low flexural stiffness) as of the same date are as follows:
`
`5.
`
`A POSA, by early 1997, would have had knowledge of the patent literature
`
`and printed publications describing the professional, non-professional and
`
`hybrid devices and systems used in oral care, including the whitening of teeth
`
`and the bleaching formulations used therewith, plus a knowledge of related
`
`arts dealing with the delivery of medicaments to the teeth and/or gums of the
`
`oral cavity. A POSA would also (1) be a practicing dentist with at least one
`
`year’s experience or (2) have at least an undergraduate college degree in a
`
`scientific or engineering area and at least one year’s experience in research
`
`and/or development of the design and/or development of devices or systems
`
`3
`
`PAGE 000003
`
`
`
`Inter Partes Review of US 5,891,453
`Declaration ofAbdul Gaffar, Ph.D. (Exhibit 1011)
`
`for delivering a medicament to the teeth and/or gums of the oral cavity, or of
`
`medicament formulations usable with such devices or systems.
`
`6. By early 1997, the POSA knew of the existence of various tray or trough
`
`devices for use in the dental office or at home for delivery of bleaching agents
`
`to the surface of a plurality of teeth. In addition, by that time, the POSA
`
`would have known of the existence of small conformable film strips for the
`
`delivery of a bleaching agent to a single tooth, of the existence of longer
`
`multi-layer films for the delivery of medicaments to the teeth and/or gums, of
`
`the existence of prior art multi-layer curved applicator delivery systems for
`
`delivering a bleaching agent to a plurality of teeth, and would have known of
`
`the existence of the use of thin films for covering the teeth and gums for non-
`
`medicated purposes. The POSA also would have known that a transparent
`
`thin cellulose or polyethylene film was used in the art for delivery of
`
`medicaments to the teeth and/or gums, or for application to the teeth and/or
`
`gums for non-medicated purposes, and of the physical properties of the films
`
`as required for those purposes.
`
`4
`
`PAGE 000004
`
`
`
`Inter Partes Review of US 5,891,453
`Declaration ofAbdul Gaffar, Ph.D. (Exhibit 1011)
`
`7.
`
`I possess a level of skill in the relevant art that is beyond that of the person of
`
`ordinary skill in the art. In formulating my opinions herein, however, I have
`
`considered the viewpoint of the POSA.
`
`8.
`
`I have been asked to provide my opinion on the flexural stiffness of a
`
`regenerated cellulose film (commonly called Cellophane) usable in
`
`manufacturing the Saffir device as the film that is coated with a
`
`medicated adhesive.
`
`9.
`
`Regarding the Saffir film or tape, Cellophane film (regenerated cellulose) as
`
`used as the base film of the common “Scotch tape” product was available
`
`from Minnesota, Mining and Manufacturing Company (now 3M). (See the
`
`following 3M website showing the 3M tape innovation timeline:
`
`http://solutions.3m.com/wps/portal/3M/en_JM/GlobalScotchBrand/Scotch/Re
`
`sources/Two/).
`
`10.
`
`The Cellophane film used was very thin, less than 2 mils in thickness; see
`
`U.S. 2,444,830 to Kellgren et al. (Ex. 1009) I note that Saffir describes that it
`
`uses a cellulosic film such as a regenerated cellulose film, the film resembling
`
`“Scotch tape.”
`
`5
`
`PAGE 000005
`
`
`
`Inter Partes Review of US 5,891,453
`Declaration ofAbdul Gaffar, Ph.D. (Exhibit 1011)
`
`11.
`
`The Saffir regenerated cellulose film has a flexural stiffness of less than about
`
`5 grams/centimeter as measured on a Handle-O-Meter per ASTM Test
`
`Method D2923-95. I base this conclusion on my knowledge of the physical
`
`characteristics of thin regenerated cellulose film plus information available to
`
`me from U.S. 3,899,452 to Koch (Ex. 1007) and “The measurement of
`
`flexural rigidity of thin polymeric films,” J. SCI. INSTRUM., 1965, vol.42
`
`(Morton) (Ex. 1008).
`
`12. Koch in Table 4 (col. 4) states that the “Total Hand” for a regenerated
`
`cellulose film measured on the Handle-O-Meter is 8.7 (g/cm). Since this is
`
`the “total” of four film stiffness measurements (3:44-47), the “average”
`
`measurement was below about 5 (g/cm).
`
`13. Morton in its Fig. 7 (p. 594), provides Handle-O-Meter flexural stiffness
`
`measurements using the Handle-O-Meter device for a regenerated cellulose
`
`film of 60 g/m2. The measured values range from 5.5 to below 7 (g/cm),
`
`depending on specimen length. In my opinion, the measured stiffness 5.5
`
`g/cm is substantially the same as a measured stiffness of less than about 5
`
`g/cm.
`
`6
`
`PAGE 000006
`
`
`
`Jul 11 13 02:54p
`
`Pharmhealth Technologies
`
`6098950051
`
`p.2
`
`Inter Partes Review of US 5,891,453
`Declaration ofAbdul Gafi‘ar: PhD. (Exhibit 10} 1)
`
`14. The flexural stiffness values measured by Koch and Morton would correlate
`
`well with those obtained in accordance with ASTM D2923-95.
`
`15.
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be
`
`true, and further that these statements were made with the knowledge that
`
`willful false statements and the like so made are punishable by fine or
`
`imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`Code.
`
`Respectfully submitted,
`
` 4532,94“ 44%...
`
`Abdul Gaffar
`
`Kg; ’7Lmandate)
`
`Till 320]“ Ififilfilfii
`
`PAGE 000007
`
`PAGE 000007
`
`
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