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`
`AFFIDAVIT OF CHRISTOPHER BUTLER
`
`. I am the Office Manager at the [ntemet Arch ive, located in San Francisco,
`]
`California. I make this declaration of my own personal knowledge.
`2. The Internet Archive is a website that provides access to a digital library of
`Internet sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers. historians, scholars. and the general public. The lntemet
`Archive has partnered with and receives support from various institutions, including the
`Library of Congress.
`3. The [ntemel Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to surf more than 150 billion pages stored in the
`Internet Archive's web archive. Visitors to the Wayback Machine can search archives
`by URL (i .e., a website address). If archived records for a URL are available, the visitor
`will be presented with a list of‘ available dates. The visitor may select one of those
`dates, and then begin surfing on an archived version of the Web. The links on the
`archived files, when served by the Wayback Machine. point to other archived files
`(whether HTML pages or images}. If a visitor clicks on a link on an archived page, the
`Wayback Machine will serve the archived file with the closest available date to the page
`upon which the link appeared and was clicked.
`4. The archived data made viewable and browscable by the Wayback Machine is
`compiled using software programs known as crawlers, which surfthe Web and
`automatically store copies of web files. preserving these files as they exist at the point of
`time of capture.
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http:2'/web.archive.org/webf[Year in yyyy][Month in ntrn][Day in dd][Tirne code in
`hh:rnm:ss]/[Archived URL]. Thus, the Internet Archive URL
`httpzf/web.archiveorg/web} l 9970] 260453232’ht1p:b‘ww'w.archive.orgf would be the
`URL for the record of the Internet Archive home page HTML file
`(http://1.vw\v.archive.orgf) archived on January 26, 1997 at 4:58 am. and 28 seconds
`(l997!0lI26 at 04:58:28). A web browser may be set such that a printout fi‘om it will
`display the URL of it web page in the printout"s footer. The date assigned by the Internet
`Archive applies to the HTML file but not to image files linked therein. Thus images that
`appear on a page may not have been archived on the same date as the HTML file.
`Likewise, if a website is designed with "frames," the date assigned by the lntemet
`Archive applies to the frarneset as a whole. and not the individual pages within each
`frame.
`
`6. Attached hereto as Exhibit A are true and accurate copies of printouts of the
`Internet Archive's records of the HTML. files for the URLs and the dates specified in the
`footer of the printout.
`7. I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE: 0/1
`
`"3/'1’
`
`Christopher Butler
`
`
`
`PAR1 O28
`
`CBM of U.S. Patent No. 7,668,730
`Page 1 of 362
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`

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`CALIFORNIA JURAT WITH AFFIANT STATEMENT
`
`See Attached Document.
`
`State of California
`
`County ofSan Francisco
`
`
`
`Subscribed and swam-to-{-er affinncd) before me this
`
`\c’_Mflday of 3”“ 9'
`
`, 7-«‘’‘7--', by
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`__C_--\»\r1_s+_uE\n2-r
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`’?>\Mrh or
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`
`proved to me on the basis of satisfactory
`evidence to be the person who appeared
`before me.
`
`Signature:
`
`
`
`PAR1028
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`CBM of U.S. Patent No. 7,668,730
`Page 2 of 362
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`Exhibit A
`
`
`
`PAR1028
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`CBM of U.S. Patent No. 7,668,730
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`PAR1028
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`PAR1 O28
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`CBM of U.S. Patent No. 7,668,730
`Page 5 of 362
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`PAR1 O28
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`CBM of U.S. Patent No. 7,668,730
`Page 6 of 362
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`PAR1028
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`CBM of U.S. Patent No. 7,668,730
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`CBM of US. Patent No. 7,668,730
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`CBM of U.S. Patent No. 7,668,730
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`PAR1028
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`CBM of U.S. Patent No. 7,668,730
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`PAR1028
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`CBM of U.S. Patent No. 7,668,730
`Page 14 of 362
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`CBM of US. Patent No. 7,668,730
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`PAR1028
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`CBM of Us. Patent No. 7,668,730
`Page 16 of 362
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`PAR1028
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`CBM of Us. Patent No. 7,668,730
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`CBM of U.S. Patent No. 7,668,730
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`CBM of U.S. Patent No. 7,668,730
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`CBM of U.S. Patent No. 7,668,730
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`CBM of U.S. Patent No. 7,668,730
`Page 21 of 362
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`CBM of US. Patent No. 7,868,730
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`PAR1028
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`CBM of US. Patent No. 7,668,730
`Page 23 of 362
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