`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`––––––––––––––––––
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`––––––––––––––––––
`
`Merck Sharp & Dohme LLC,
`Petitioner,
`
`v.
`
`Halozyme Inc.,
`Patent Owner.
`
`––––––––––––––––––
`
`Case No. PGR2025-00024
`U.S. Patent No. 12,060,590
`
`––––––––––––––––––
`
`Declaration of Jeffrey P. Kushan
`
`
`
`Petitioner Merck
`Ex. 1068, p. 1
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`I, Jeffrey P. Kushan, make the following Declaration pursuant to 28 U.S.C.
`
`§ 1746:
`
`1.
`
`2.
`
`I am a partner at the law firm of Sidley Austin LLP.
`
`I provide this declaration in connection with the above-identified post
`
`grant review proceeding before the United States Patent and Trademark Office and
`
`initiated by Merck Sharp & Dohme LLC (“Merck”) against Halozyme Inc. under
`
`35 U.S.C. § 321. Unless otherwise stated, the facts stated in this Declaration are
`
`based on my personal knowledge.
`
`3.
`
`For each of the exhibits addressed below, an exhibit label and page
`
`numbers have been added, but no other alterations have been made. Where the
`
`exhibit is a PDF generated from a webpage displayed in a web browser, the PDF
`
`may contain information in the header and footer (e.g., the URL, the title of the
`
`page being displayed, or similar items), which was generated automatically by the
`
`web browser displaying the page.
`
`4.
`
`EX1015 is a document mapping citations in Merck’s Petition to U.S.
`
`Patent No. 12,060,590 (“the ’590 Patent”) to corresponding text in U.S. Patent
`
`Application No. 13/694,731 (“the ’731 Application”). This mapping was prepared
`
`by staff at my law firm working under my supervision, and is true and accurate to
`
`the best of my knowledge.
`
`Petitioner Merck
`Ex. 1068, p. 2
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`5.
`
`Exhibit 1016 is a true and correct copy of a publication by Boris
`
`Steipe titled “Consensus-Based Engineering of Protein Stability: From Intrabodies
`
`to Thermostable Enzymes” (“Steipe”). This paper was published as a chapter in
`
`“Methods in Enzymology,” Vol. 388, on pages 176-186. As the Steipe paper itself
`
`does not include the year in which it was published, I have appended the
`
`publication information at the end of Exhibit 1016, as pages 187-192. Pages 187-
`
`192 of Exhibit 1016 are a true and correct copy of the web page available from the
`
`following URL:
`
`https://www.sciencedirect.com/science/article/abs/pii/S0076687904880169
`
`6.
`
`Exhibit 1045 is a true and correct copy of a redline that I had created
`
`for U.S. Patent Application No. 13/694,731 and U.S. Patent No. 12,060,590 using
`
`Litera Compare in Microsoft Word. To create this redline, the text of U.S. Patent
`
`Application No. 13/694,731 (as published in U.S. Patent Application Publication
`
`2013-0302275) was copied and compared to the text of U.S. Patent No.
`
`12,060,590, both obtained from the USPTO’s Patent Center website. The text of
`
`both documents was pasted into separate Word documents. Any text that appeared
`
`before the “Background/Summary” heading and the claim language was deleted.
`
`The Word document with the text from U.S. Patent Application No. 13/694,731
`
`was designated as the original file and the Word document with the text from U.S.
`
`Patent No. 12,060,590 was designated as the modified file. I saved the redline as a
`
`Petitioner Merck
`Ex. 1068, p. 3
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`PDF and included it here as Exhibit 1045. The redline shows certain differences as
`
`a result of formatting changes (principally in the presentation of tables). In my
`
`review of the redline (with one exception1), I have not identified any substantive
`
`differences between U.S. Patent Application No. 13/694,731 and U.S. Patent No.
`
`12,060,590, and I believe them to be substantively identical.
`
`a.
`
`The text file that I copied for the ’731 Application is available from
`
`the following URL: https://image-ppubs.uspto.gov/dirsearch-
`
`public/patents/html/20130302275?source=US-
`
`PGPUB&requestToken=eyJzdWIiOiI2ODY2MWZjNy1mODMzLTQ
`
`0YTItYmJkNy00MmZkN2M2ZjdlYTMiLCJ2ZXIiOiIyYjBhM2VjN
`
`S04MTRjLTRhMTUtYTI2Ni0wODExZmRlZWUwY2QiLCJleHAiO
`
`jB9
`
`b.
`
`The text file that I copied for the ’590 Patent is available from the
`
`following URL: https://image-ppubs.uspto.gov/dirsearch-
`
`public/patents/html/12060590?source=USPAT&requestToken=eyJzd
`
`
`The ’590 Patent alters the list of mutations that should be avoided in
`
`1
`
`enzymatically active PH20 proteins by removing positions 282, 298, and
`
`431 from the list in the ’731 Application. See EX1045, 78; also EX1001,
`
`80:14-26; EX1026, 91:30-92:1.
`
`Petitioner Merck
`Ex. 1068, p. 4
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`WIiOiI0OTFiMTRkNi1jYTFjLTQ2NmQtYjI5OS1mMDc2ZGY4NT
`
`hmYzIiLCJ2ZXIiOiIyMDZhNTQ2My1hNGMxLTQyNGMtODUwY
`
`S0xZjEwYjZjMzljYzIiLCJleHAiOjB9
`
`7.
`
`Exhibit 1064 is a true and correct copy of a set of web pages available
`
`from the Internet Archive at the URLs listed below:
`
`a.
`
`Pages 1-2 of Exhibit 1064 (“Basic Local Alignment Search Tool”) are
`
`a true and correct copy of the web page available from the following
`
`URL:
`
`https://web.archive.org/web/20110721055636/http://blast.ncbi.nlm.ni
`
`h.gov/Blast.cgi?CMD=Web&PAGE_TYPE=BlastHome
`
`b.
`
`Page 3 of Exhibit 1064 (“Help”) is a true and correct copy of the web
`
`page available from the following URL:
`
`https://web.archive.org/web/20110721055521/http://blast.ncbi.nlm.ni
`
`h.gov/Blast.cgi?CMD=Web&PAGE_TYPE=BlastDocs
`
`c.
`
`Pages 4-22 of Exhibit 1064 (“Blast Program Selection Guide”) are a
`
`true and correct copy of the web page available from the following
`
`URL:
`
`https://web.archive.org/web/20110721055500/http://blast.ncbi.nlm.ni
`
`h.gov/Blast.cgi?CMD=Web&PAGE_TYPE=BlastDocs&DOC_TYPE
`
`=ProgSelectionGuide
`
`Petitioner Merck
`Ex. 1068, p. 5
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`d.
`
`Pages 23-28 of Exhibit 1064 (“BLASTP Suite”) are a true and correct
`
`copy of the web page available from the following URL:
`
`https://web.archive.org/web/20110728070830/http://blast.ncbi.nlm.ni
`
`h.gov/Blast.cgi?PROGRAM=blastp&BLAST_PROGRAMS=blastp&
`
`PAGE_TYPE=BlastSearch&SHOW_DEFAULTS=on&LINK_LOC=
`
`blasthome
`
`8.
`
`Exhibit 1065 is a true and correct copy of a set of web pages available
`
`from the Internet Archive at the URLs listed below:
`
`a.
`
`Pages 1-3 of Exhibit 1065 (“Clustal Omega”) are a true and correct
`
`copy of the web page available from the following URL:
`
`https://web.archive.org/web/20111022151531/http://www.clustal.org/
`
`omega/
`
`b.
`
`Pages 4-13 of Exhibit 1065 (“Introduction”) are a true and correct
`
`copy of the web page available from the following URL:
`
`https://web.archive.org/web/20120110130931/http://www.clustal.org/
`
`omega/README
`
`9.
`
`Exhibit 1066 is a true and correct copy of a set of web pages available
`
`from the Internet Archive at the URLs listed below:
`
`a.
`
`Pages 1-2 of Exhibit 1066 (“SWISS-MODEL”) are a true and correct
`
`copy of the web page available from the following URL:
`
`Petitioner Merck
`Ex. 1068, p. 6
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`https://web.archive.org/web/20110519141121/http://swissmodel.expa
`
`sy.org/?pid=smh01&uid=&token=
`
`b.
`
`Pages 3-4 of Exhibit 1066 (“Introduction to SWISS-MODEL
`
`Workspace”) are a true and correct copy of the web page available
`
`from the following URL:
`
`https://web.archive.org/web/20110519140410/http://swissmodel.expa
`
`sy.org/?pid=smd11&uid=&token=
`
`c.
`
`Pages 5-12 of Exhibit 1066 (“Help – Introduction to SWISS-MODEL
`
`Workspace”) are a true and correct copy of the web page available
`
`from the following URL:
`
`https://web.archive.org/web/20110519144707/http://swissmodel.expa
`
`sy.org/?pid=smd02&uid=&token=
`
`d.
`
`Pages 13-24 of Exhibit 1066 (“Tutorial – Introduction”) are a true and
`
`correct copy of the web page available from the following URL:
`
`https://web.archive.org/web/20110519144916/http://swissmodel.expa
`
`sy.org/?pid=smd03&uid=&token=
`
`e.
`
`Pages 25-26 of Exhibit 1066 (“SwissModel Automatic Modelling
`
`Mode”) are a true and correct copy of the web page available from the
`
`following URL:
`
`Petitioner Merck
`Ex. 1068, p. 7
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`https://web.archive.org/web/20110519141354/http://swissmodel.expa
`
`sy.org/workspace/index.php?func=modelling_simple1
`
`f.
`
`Pages 27-28 of Exhibit 1066 (“Protein Structure & Model Assessment
`
`Tools”) are a true and correct copy of the web page available from the
`
`following URL:
`
`https://web.archive.org/web/20110519144444/http://swissmodel.expa
`
`sy.org/workspace/index.php?func=tools_structureassessment1&userid
`
`=USERID&token=TOKEN
`
`g.
`
`Pages 29-38 of Exhibit 1066 (“Template Library – Introduction to
`
`SWISS-MODEL Workspace”) are a true and correct copy of the web
`
`page available from the following URL:
`
`https://web.archive.org/web/20110925072951/http://swissmodel.expa
`
`sy.org/workspace/index.php?func=special_help&=#QMEAN6
`
`h.
`
`Pages 39-42 of Exhibit 1066 (“QMEAN Server – Quick Help”) are a
`
`true and correct copy of the web page available from the following
`
`URL:
`
`https://web.archive.org/web/20110924165101/http://swissmodel.expa
`
`sy.org/qmean/cgi/index.cgi?page=help
`
`i.
`
`Pages 43-44 of Exhibit 1066 (“Visualisation”) are a true and correct
`
`copy of the web page available from the following URL:
`
`Petitioner Merck
`Ex. 1068, p. 8
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`https://web.archive.org/web/20110519144341/http://swissmodel.expa
`
`sy.org/repository/?pid=smd08
`
`10. Exhibit 1067 is a true and correct copy of a set of web pages available
`
`from the Internet Archive at the URLs listed below:
`
`a.
`
`Page 1 of Exhibit 1067 (“PyMol”) is a true and correct copy of the
`
`web page available from the following URL:
`
`https://web.archive.org/web/20110701072314/http://pymol.org/
`
`b.
`
`Pages 2-3 of Exhibit 1067 (“Support”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110709092136/http://www.pymol.org/
`
`support
`
`c.
`
`Pages 4-5 of Exhibit 1067 (“PyMOL Wiki”) are a true and correct
`
`copy of the web page available from the following URL:
`
`https://web.archive.org/web/20110716184103/http://www.pymolwiki.
`
`org/index.php/Main_Page
`
`d.
`
`Pages 6-7 of Exhibit 1067 (“Commands”) are a true and correct copy
`
`of the web page available from the following URL:
`
`https://web.archive.org/web/20110714225113/http://www.pymolwiki.
`
`org/index.php/Category:Commands
`
`Petitioner Merck
`Ex. 1068, p. 9
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`e.
`
`Page 8 of Exhibit 1067 (“Center”) is a true and correct copy of the
`
`web page available from the following URL:
`
`https://web.archive.org/web/20110529094111/http://www.pymolwiki.
`
`org/index.php/Center
`
`f.
`
`Pages 9-12 of Exhibit 1067 (“Color”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110529095125/http://www.pymolwiki.
`
`org/index.php/Color
`
`g.
`
`Pages 13-14 of Exhibit 1067 (“Create”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110404080403/http://www.pymolwiki.
`
`org/index.php/Create
`
`h.
`
`Page 15 of Exhibit 1067 (“Disable”) is a true and correct copy of the
`
`web page available from the following URL:
`
`https://web.archive.org/web/20110809113427/http://www.pymolwiki.
`
`org/index.php/Disable
`
`i.
`
`Page 16 of Exhibit 1067 (“Enable”) is a true and correct copy of the
`
`web page available from the following URL:
`
`https://web.archive.org/web/20110809113452/http://www.pymolwiki.
`
`org/index.php/Enable
`
`Petitioner Merck
`Ex. 1068, p. 10
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`j.
`
`Pages 17-18 of Exhibit 1067 (“Extend”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20111013065541/http://www.pymolwiki.
`
`org/index.php/Extend
`
`k.
`
`Pages 19-21 of Exhibit 1067 (“Get Area”) are a true and correct copy
`
`of the web page available from the following URL:
`
`https://web.archive.org/web/20110515092633/http://www.pymolwiki.
`
`org/index.php/Get_Area
`
`l.
`
`Pages 22-23 of Exhibit 1067 (“Get Model”) are a true and correct
`
`copy of the web page available from the following URL:
`
`https://web.archive.org/web/20071024002140/http://www.pymolwiki.
`
`org/index.php/Get_Model
`
`m.
`
`Pages 24-25 of Exhibit 1067 (“Hide”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110523082224/http://www.pymolwiki.
`
`org/index.php/Hide
`
`n.
`
`Pages 26-27 of Exhibit 1067 (“Select”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110714221710/http://www.pymolwiki.
`
`org/index.php/Select
`
`Petitioner Merck
`Ex. 1068, p. 11
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`o.
`
`Pages 28-29 of Exhibit 1067 (“Set”) are a true and correct copy of the
`
`web page available from the following URL:
`
`https://web.archive.org/web/20101006204019/http://www.pymolwiki.
`
`org/index.php/Set
`
`p.
`
`Page 30 of Exhibit 1067 (“Set Name”) is a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110426091639/http://www.pymolwiki.
`
`org/index.php/Set_Name
`
`q.
`
`Pages 31-32 of Exhibit 1067 (“Show”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110714224117/http://www.pymolwiki.
`
`org/index.php/Show
`
`r.
`
`Pages 33-39 of Exhibit 1067 (“Cartoon”) are a true and correct copy
`
`of the web page available from the following URL:
`
`https://web.archive.org/web/20110728104502/http://www.pymolwiki.
`
`org/index.php/Cartoon
`
`s.
`
`Pages 40-41 of Exhibit 1067 (“Lines”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110522111856/http://www.pymolwiki.
`
`org/index.php/Lines
`
`Petitioner Merck
`Ex. 1068, p. 12
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`t.
`
`Pages 42-44 of Exhibit 1067 (“Spheres”) are a true and correct copy
`
`of the web page available from the following URL:
`
`https://web.archive.org/web/20110809121448/http://www.pymolwiki.
`
`org/index.php/Spheres
`
`u.
`
`Pages 45-46 of Exhibit 1067 (“Sticks”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110522120033/http://www.pymolwiki.
`
`org/index.php/Sticks
`
`v.
`
`Pages 47-51 of Exhibit 1067 (“Surface”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110607231738/http://www.pymolwiki.
`
`org/index.php/Surface
`
`w.
`
`Page 52 of Exhibit 1067 (“Plugins”) is a true and correct copy of the
`
`web page available from the following URL:
`
`https://web.archive.org/web/20110728104325/http://www.pymolwiki.
`
`org/index.php/Category:Plugins
`
`x.
`
`Pages 53-57 of Exhibit 1067 (“APBS”) are a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110728103647/http://www.pymolwiki.
`
`org/index.php/APBS
`
`Petitioner Merck
`Ex. 1068, p. 13
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`y.
`
`Page 58 of Exhibit 1067 (“TOPTOC”) is a true and correct copy of
`
`the web page available from the following URL:
`
`https://web.archive.org/web/20110606042538/http://www.pymolwiki.
`
`org/index.php/TOPTOC
`
`z.
`
`Page 59 of Exhibit 1067 (“Biochemical Properties”) is a true and
`
`correct copy of the web page available from the following URL:
`
`https://web.archive.org/web/20110610033151/http://www.pymolwiki.
`
`org/index.php/Category:Biochemical_Properties
`
`aa.
`
`Page 60 of Exhibit 1067 (“Nonstandard Amino Acids”) is a true and
`
`correct copy of the web page available from the following URL:
`
`https://web.archive.org/web/20101129073634/http://www.pymolwiki.
`
`org/index.php/Nonstandard_Amino_Acids
`
`bb. Pages 61-62 of Exhibit 1067 (“Mutagenesis”) are a true and correct
`
`copy of the web page available from the following URL:
`
`https://web.archive.org/web/20101121002000/http://www.pymolwiki.
`
`org/index.php/Mutagenesis
`
`
`
`
`
`
`
`Petitioner Merck
`Ex. 1068, p. 14
`
`
`
`PGR2025-00024
`
`Declaration of Kushan
`
`I, Jeffrey P. Kushan, do hereby declare and state, 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, under Section 1001 of Title 18 of the United
`
`States Code.
`
`
`
`Dated: February 21, 2025
`
`
`Respectfully Submitted,
`
`
`/Jeffrey P. Kushan
`
` Jeffrey P. Kushan
`Reg. No. 43,401
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington D.C. 20005
`
`
`Petitioner Merck
`Ex. 1068, p. 15
`
`
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