conformance and not considered. Include copyof this form with next communication to applicant.
`
`
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`G I K
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`03/18/1997
`5,612,460
`06/02/1995
`468
`424
`Oshlack et al.
`06/17/1997
`5,639,476
`B
`
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` 5,643,575 424 10/27/1993 B
`194.1
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`07/01/1997
`;
`525
`408
`09/30/1997
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`10/02/1995
`Cc
`B
`5,672,662
`
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`Santuset al.
`10/07/1997
`D
`536
`22.1
`02/24/1998
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`10/21/1991
`B
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`424 42603/31/1998 10/30/1995 Lewis
`
`B
`5,733,566
`85.1
`06/16/1998
`03/30/1995
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`
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`
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`02/23/1998
`
`E F G I J
`B B
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`
`Examiner Signature
`
`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/C.A.M./
`
`18/068,418 ~ GAU: 1656
`
`Sheet _1 of _25_
`
`Substitute Form PTO-1449
`(Modified)
`
`U.S. Department of Commerce
`Patent and Trademark Office
`
`Attomey Docket No.
`33320.03087.US2E/3087K
`
`Application No.
`18/068,418
`
`List of Patents and Publications for Applicant’s
`Information Disclosure Statement
`
`Inventor(s)
`Wei et al.
`
`-
`Filing Date
`December 19, 2022
`
`Group Art Unit
`Not yet assigned
`
`Examiner
`Initial
`
`Document
`Number
`
` A
`
`Patentee
`
`Publication
`Filing Date
`Subclass
`Date
`If Appropriate
`28
`02/17/1969
`10/27/1970
`A
`Applezweig
`3,536,809
`
`Zaffaroni
`08/10/1971
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`12/28/1971
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`11/08/1983
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`4,414,209
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`09/06/1988
`493
`02/24/1987
`4,952,496
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`08/28/1990
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`91
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`435
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`12/25/1990
`371
`01/03/1989
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`53
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`425
`07/30/1990
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`5,033,252
`206
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`10/01/1991
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`439
`07/27/1990
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`5,052,558
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`10/22/1991
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`4,364,923
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`12/21/1982
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`5,059,595
`5,073,543
`5,120,548
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`12/17/1991
`06/09/1992
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`5,122,614
`5,323,907
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`5,324,844
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`06/16/1992
`06/28/1994
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`

`

`conformance and not considered. Include copyof this form with next communication to applicant.
`
`
`
`
`
`
`18/068,418 ~ GAU: 1656
`
`Sheet _2 of _25_
`
`Substitute Form PTO-1449
`(Modified)
`
`U.S. Department of Commerce
`Patent and Trademark Office
`
`Attomey Docket No.
`33320.03087.US2E/3087K
`
`Application No.
`18/068,418
`
`List of Patents and Publications for Applicant’s
`Information Disclosure Statement
`
`Inventor(s)
`Wei et al.
`
`-
`Filing Date
`December 19, 2022
`
`Group Art Unit
`Not yet assigned
`
`Publication
`Document
`Examiner
`Filing Date
`
`Initial
`Number
`Date
`Patentee
`Class
`Subclass
`If Appropriate
`42
`4
`178.1
`07/06/1999
`Greenwaldet al.
`03/20/1997
`
`B
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`L
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`5,919,455
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`435
`188
`05/17/1995
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`5,932,462
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`012 07/03/1996
`435
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`B
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`09/28/1999
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`424
`85.2
`12/19/1997
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`5,985,263
`11/16/1999
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`05/20/1998
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`05/02/2000
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`435
`6
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`6,113,906
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`424
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`
`Examiner Signature
`
`Date Considered
`
`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/C.A.M./
`
`

`

`04/28/2006 2007/0067855
`
` 2009/0028829
`
`
`
`
`Sheet 3 of _25_
`
`Substitute Form PTO-1449
`(Modified)
`
`U.S. Department of Commerce
`Patent and Trademark Office
`
`Attomey Docket No.
`33320.03087.US2E/3087K
`
`Application No.
`18/068,418
`
`18/068,418 ~ GAU: 1656
`
`List of Patents and Publications for Applicant’s
`Information Disclosure Statement
`
`Inventor(s)
`Weief al.
`
`Filing Date
`December 19, 2022
`
`Group Art Unit
`Not yet assigned
`
`U.S. Patent Documents
`Publication
`Document
`Examiner
`Filing Date
`
`Initial
`Number
`Date
`Patentee
`Subclass
`If Appropriate
`201
`04/30/2013
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`02/20/2009
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`03/17/2020
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`06/22/2021 03/19/2020 Wei et al. 069.100
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`
`523
`
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`
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`Bentley et al.
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`31410/24/2002 01/22/2002 Zhao 58
`
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`2002/0156047
`424
`01/23/2003
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`001.490
`04/30/2002
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`2003/0017108
`530
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`06/19/2003
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`2003/0114647
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`
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`
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`08/16/2007
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`424G
`093.7
`05/17/2004
`Gruskin et al.
`01/29/2009
`E
`
`
`
`Examiner Signature
`
`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in conformance and not considered. Include copyof this form with next communication to applicant.
`
`Date Considered
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/C.A.M./
`
`DJ
`
`K L I
`
`N
`
`D
`D
`
`

`

`conformance and not considered. Include copyof this form with next communication to applicant.
`
`
`
`
`
`2009/0214505
`
`08/27/2009
`
`Bookbinderatal.
`
`2009/0253 175
`2009/0304665
`
`10/08/2009
`12/10/2009
`
`Bookbinderat al.
`Frost et al.
`
`2009/0305982
`2009/0311237
`
`12/10/2009
`12/17/2009
`
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`
`Jensen et al
`Frost
`
`94.1
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`69.1
`94.5
`
`04/16/2009
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`04/28/2009
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`069.100
`094.620
`
`06/11/2009
`04/14/2009
`
`424
`
`435
`424
`
`a
`
`2010/0143457
`06/10/2010
`Wei etal.
`E
`2010/0172892
`07/08/2010
`Uvarkina et al
`94.62
`12/15/2009
`S
`424
`E
`
`435
`E
`2011/0053247
`03/03/2011
`Bakeretal.
`201
`11/09/2010
`
`09/16/2010
`183
`314
`Teschneret al.
`03/17/2011
`2011/0066111
`E
`
`200
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`2011/0152359
`06/23/2011
`Bookbinderetal.
`435
`12/21/2010
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`07/15/2011
`130.1
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`Shepardet al.
`01/26/2012
`2012/0020951
`EW
`
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`2012/0093770
`04/19/2012
`Bookbinderetal.
`424
`094.620
`12/15/2011
`06/14/2012
`Bookbinderet al.
`435
`200
`12/28/2011
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`LZ
`
`A B C
`
`c D E
`
`G H
`
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`11/22/2012
`
`F
`2013/0011378
`01/10/2013
`Yangctal.
`424
`094.300
`06/15/2012
`FF
`2013/0022588
`01/24/2013
`Yanget al.
`424
`094.300
`06/15/2012
`
`
` F 2013/0022592|01/24/2013 Vaughn etal. 424 094.620 06/15/2012
`
`
`
`03/07/2013
`Bookbinderet al.
`435
`200
`10/18/2012
`
`10/04/2012
`
`Bookbinderetal.
`
`424
`
`I J
`F F
`
`K L M
`
`12/28/2012
`094.620
`424
`Weietal.
`11/14/2013
`
`
`
`FN 2013/0302400|11/14/2013 Manevalet al. 435 195 03/15/2013
`
`
`
`02/06/2014
`Bookbinderet al.
`424
`094.620
`09/25/2013
`
`P
`
`
`F 2014/0105824|04/17/2014 Shepard etal. 009.200 10/16/2013
`
`
`
`
`FO 2014/0135682|05/15/2014 Frostet al. 094.500 09/24/2013
`
`
`
`
`FR 2014/0199282|07/17/2014 Bookbinderet al. 200 02/26/2014
`
`
`
`Examiner Signature
`
`Date Considered
`
`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
`
`ALL, REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/C.A.M./
`
`Filing Date
`Publication
`Document
`.
`Examiner
`
`Initial Subclass_|If AppropriateNumber Date Patentee
`
`
`
`
`H
`2009/0042785
`02/12/2009
`Matschineret al.
`E
`012
`04/28/2008
`
`2009/0123367
`05/14/2009
`Bookbinderetal.
`001.490
`10/09/2008
`424
`2009/0181032
`07/16/2009
`Bookbinderat al.
`424
`141.1
`02/20/2009
`424
`435
`
`Sheet _4 of _25_
`
`18/068,418 ~ GAU: 1656
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`Inventor(s)
`“£1 ¢# al.
`-
`Filing Date
`December 19, 2022
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`
`.
`Group Art Unit
`Not yet assigned
`
`I J
`E E
`
`O
`
`K L M N O P Q R T U V
`
`E
`
`E
`E
`
`E
`E
`
`E
`
`

`

`
`
`5 ofSheet 25
`
`
`
`18/068,418 ~ GAU: 1656
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`Inventor(s)
`“£1 ¢# al.
`-
`Filing Date
`December 19, 2022
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`
`.
`Group Art Unit
`Not yet assigned
`
`Filing Date
`Publication
`Document
`.
`Examiner
`
`Initial Subclass_|If AppropriateNumber Date Patentee
`
`
`
`
`2015/0010529
`01/08/2015
`Wei
`FS
`94.62
`07/03/2014
`424
`FT
`2016/0362670
`12/15/2016
`Weiet al.
`094.620
`08/02/2016
`
`10/12/2017
`Manevaletal.
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`
`Examiner
`Initial
`
`ig.
`
`Document Number
`
`Publication
`Date
`
`Country or
`Patent Office
`
`CN 1020658864
`05/18/11
`X* (Item GR)
`EP 0400472 12/05/90
`EP 0822199
`09/22/04
`
`
`
`EP 1064951
`
`EP 3130347
`
`08/22/07
`
`09/18/19
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`X (Item GG)
`KR
`02/18/20
`KR 10-2020-00 17538
`
`
`WO 1992/16640
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`10/01/92
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`WIPO
`
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`WO 1994/028024 12/08/94
`WO 2000/002017
`01/13/00
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`GN**
`
`WO2001/087925
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`11/22/01
`
`[Fao|woromnsssrs|worm[|wino|«iPS
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`GP**
`
`WO 2004/056312
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`07/08/04
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`01/06/05
`WO 2005/000360
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`
`WO 2009/128917
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`WO 2009/134380
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`10/22/09
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`WO 2010/077297
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`07/08/10
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`/C.A.M./
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`Sheet _6 of _25_
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`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
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`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
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`18/068,418 ~ GAU: 1656
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`Not yet assigned 37 CER §1.98(b
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`List of Patents and Publications for Applicant's
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`Foreign Patent Documents or Published Foreign Patent Ap plications
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`Examiner|Desig. Publication Country or
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`aaoe]NomaNumber = Patent Office|Yes|...=No.|||cues||wo2010/149772|2010/149772|reno|WIPOa
`
`[fave|worirnerse|won[wo|
`[Jaws|wo2onee[eam[wre|si
`[Foxe[worms[orm|wro|Si
`
`ek
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`
`GY**
`WO 2015/003167
`01/08/15
`WIPO
`
`** = Copies not provided herewith as they have been previously provided in connection with U.S. Patent Application Serial
`No. 13/694,731, 15/226,489, 16/824,572, 17/327,568 and/or 17/327,586, whichare relied uponfor an earlier filing date in
`accordance with 35 U.S.C. §120.
`X* = An English language equivalent has been previously provided in connection with U.S. Serial No. 13/694,731.
`X** = An English Abstract (Item IM) for Japancse Publication No. JP 2007-153797 has been previously provided in
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`X= An English language equivalent has been previously provided in connection with U.S. Serial No. 15/226,489.
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`ID
`Document
`GZ
`Letter/Written Disclosure of the Information Disclosure Statement for the above-referenced
`application, filed herewith on March16, 2023, 2 pages.
`Ae Adams, G.E. and IJ. Stratford, "Bioreductive drugs for cancer therapy: the search for tumor
`specificity," Int. J. Radiat. Oncol. Biol. Phys., 29(2): 231-238 (1994).
`Alexanderet al., “Expression of the c-mvc oncogene under control of an immunoglobulin enhancerin
`Ep-myc transgenic mice,” Mol. Cell. Biol. 7(4):1436-1444 (1987).
`Ansel, H. C., Introduction to Pharmaceutical Dosage Forms, Lea & Febiger, Philadelphia, PA, Fourth
`HCe*
`Edition, p.126 (1985).
`“
`Anttila et al., "High levels of stromal hyaluronan predict poor disease outcome in epithelial ovarian
`HD**
`
`cancer," Cancer Res. 60(1):150-155 (2000).
`Arminget al., “Jn vitro mutagenesis of PH-20 hyaluronidase from human sperm,” Eur. J. Biochem.
`247(3):810-814 (1997).
`Atkinson, M.and E. Leiter, “The NOD mouse modelof type 1 diabetes: as good asit gets?” Nature
`Med. 5:601-604 (1999).
`HG««|Auvinen et al., "Hyaluronan in Peritumoral Stroma and Malignant Cells Associates with Breast
`Canccr Spreading and Predicts Survival," Am. J. Pathol. 156(2):529-536 (2000).
`Baumgartneret al., “Phase I study in chemoresistant loco-regional malignant disease with
`hyaluronidase,” Reg. Cancer Treat. 1:55-58 (1988).
`Beckenlehneret al., “Hyaluronidase enhancesthe activity of adriamycin in breast cancer models in
`vitro and in vivo,” J. Cancer Res. Oncol. 118:591-596 (1992).
`Benhar et al., “Pseudomonas exotoxin A mutants. Replacement of surface-exposed residues in domain
`HJ**|III with cysteine residues that can be modified with polyethylene glycol in a site-specific manner,” J.
`Biol. Chem. 269:13398-13404 (1994).
`Bianchiet al., “Synthetic depsipeptide substrates for the assay of humanhepatitis C virus protease,”
`Anal. Biochem. 237: 239-244 (1996).
`HL**|Bitter ct al., “Expression and sccrction vectors for ycast,” Mcthods in Enzymol. 153:516-544 (1987).
`
`HH**
`
`HIt#
`
`HK**
`
`
`
`

`

`Sheet _7_ of _25_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`
`18/068,418 ~ GAU: 1656
`
`Not yet assigned 37 CER §1.98(b
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`
`“£1 ¢# al.
`-
`Filing Date
`December 19, 2022
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`Group Art Unit
`
`Other Documents (include Author, Title, Date, and Place of Publication
`Examiner|Desig.
`
`Initial
`ID
`Document
`
` Pharmazie 45(9):693-694 (1990).
`
`
`
`
`
`HM™*
`HN**
`
`Hs**
`
`HT**
`
`HU**
`
`HwWw**
`
`Hx**
`
`Hy**
`
`Hz**
`
`IA«*
`
`IDt#
`
`Bonner, W. and E. Cantey, “Colorimetric method for determination of serum hyaluronidaseactivity,”
`Clin. Chim. Acta 13:746-752 (1966).
`Bookbinderet al., “A recombinant human enzyme for enhancedinterstitial transport of therapeutics,”
`J. Control. Release, 114:230-241 (2006).
`HO**
`Bordier, C., “Phase separation of integral membraneproteins in Triton X-114 solution,”J. Biol.
`Chem. 256(4):1604-1607 (1981).
`Hp** Aoos et al., “An invitro assay for hepatitis C virus NS3 serine proteinase,” Virology 209:52-59
`HO**
`Brinsteret al., “Regulation of metallothionein-thymidine kinase fusion plasmids injected into mouse
`
`eggs,” Nature 296:39-42 (1982).
`HR**
`Brownet al., "Codon utilisation in the pathogenic yeast, Candida albicans," Nucleic Acids Res.
`19(15):4298 (1991).
`Brumeanuet al., “Derivatization with monomethoxypolyethylene glycol of Igs expressing viral
`epitopes obviates adjuvant requirements,” J. Immunol. 154:3088-3095 (1995).
`Caliceti, P. and Veronese, F. M., “Pharmacokinetic and biodistribution properties of poly(ethylene
`elycol)-protein conjugates,” Adv. Drug Deliv. Rev. 55(10):1261-1277 (2003).
`Carrillo, H. and Lipman, D., “The multiple sequence alignment problem in biology,” SIAM J.
`Applied Math. 48(5):1073-1082 (1988).
`Cefalu, W., “Animal models of type 2 diabetes: clinical presentation and pathophysiological relevance
`HV«#
`
`to the human condition,” ILAR Journal 47(3): 186-198 (2006).
`Chapmanet al., “Therapeutic antibody fragments with prolonged in vivo half-lives,” Nature Biotech.
`17:780-783 (1999).
`
`Chenget al., “PEGylated adenoviruses for gene delivery to the intestinal epithelium by the oral
`route,” Pharm. Res. 20(9):1444-1451 (2003).
`Cherr et al., “The dual functions of GPI-anchored PH-20: hyaluronidase and intracellular signaling,”
`Matrix Biol., 20(8):515-525 (2001).
`Cherr etal., “The PH-20 protein in cynomolgus macaque spermatozoa: identification of two different
`forms exhibiting hyaluronidase activity,” Dev. Biol. 175:142-153 (1996).
`Choetal., “Construction of hepatitis C-SIN virus recombinants with replicative dependency on
`hepatitis C virus serine protease activity,” J. Virol. Meth. 65:201-207 (1997).
`Chowpongpanget al., "Cloning and characterization of the bovine testicular PH-20 hyaluronidase
`
` Ibs core domain," Biotechnol. Lett. 26(15):1247-52 (2004).
`Ice
`Colbere-Garapinet al., “A new dominant hybrid selective marker for higher eukaryotic cells,” J. Mol.
`Biol. 150:1-14 (1981).
`Conserved domain search from US Application No. 10/795,095 of SEQ ID NO:6, Primakoff et al. US
`5,721,348, performed on the NCBI website on August 5, 2008.
`IE#*|Csokaet al., “Hyaluronidasesin tissue invasion,” Invasion Metastasis 17:297-311 (1997).
`
`Csokaet al., “Purification and microsequencing of hyaluronidase isozymes from human urine,” FEBS
`i Lett., 417(3):307-3 10 (1997).
`IG**
`Csokaet al., “The six hyaluronidase-like genes in the human and mouse genomes,” Matrix Biol.
`20:499-508 (2001).
`Czejkaet al., “Influence of hyaluronidase on the blood plasma levels of 5-fluorouracil in patients,”
`
`Tt
`
`Examiner Signature
`
`Date Considered
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`conformance and not considered. Include copyof this form with next communication to applicant.
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`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/C.A.M./
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`

`

`Sheet 8 of _25_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`
`18/068,418 ~ GAU: 1656
`
`Not yet assigned 37 CER §1.98(b
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`
`“£1 ¢# al.
`-
`Filing Date
`December 19, 2022
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`Group Art Unit
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`Other Documents (include Author, Title, Date, and Place of Publication
`Examiner|Desig.
`
`Initial
`ID
`Document
`
`IL**
`
`De Maeyer, E. and J. De Maeyer-Guignard, “The growth rate of two transplantable murine tumors,
`Il**|3LL lung carcinoma and B16F 10 melanoma,is influenced by Hyal-1, a locus determining
`hyaluronidase levels and poly morphism,” Int. J. Cancer 51:657-660 (1992).
`DeSaleguiet al., “A Comparison of Serumand Testicular Hyaluronidase,” Arch. Biochem. Biophys.
`121:548-554 (1967).
`uv
`Ix««|De Boer etal., “The ‘ac promoter: a functional hybrid derived from the ép and /ac promoters,”Proc.
`Natl. Acad. Sci. USA 80:21-25 (1983).
`Delpechet al., “Enzyme-linked hyaluronectin: a unique reagent for hyaluronan assay and tissue
`location and for hyaluronidase activity
`detection,” Anal. Biochem. 229:35-41 (1995).
`Derwent English abstract for Japanese Publication No. JP 2007-153797, published Jun. 21, 2007,
`IM**|entitled "Therapeutic Agent And Preventive Agent Of AutoimmuneDisease, Inflammation, And
`NervousDisease," 3 pages.
`Dorfman, A. and M.Ott, “A turbidimetric method for the assay of hyaluronidase,” J. Biol. Chem.
`172:367-375 (1948).
`D'Souzaet al., “In vitro cleavage of hepatitis C virus polyprotein substrates by purified recombinant
`NS3 protease,” J. Gen. Virol. 76:1729-1736 (1995).
`Duttaroy ct al., "Developmentof a long-acting insulin analog using albumin fusion technology,"
`Diabetes 54(1):251-258 (2005).
`1Q**
`Elderet. al, “Intra-arterial hyaluronidase in severe peripheral arterial disease,” Lancet 1(8169):648-
`
`649 (1980).
`IR**
`Ernstet al., “Enzymatic degradation of glycosaminoglycans,” Crit. Rev. Biochem. Mol. Biol.
`30(5):387-444 (1995).
`
`ee
`
`IN
`10**
`
`Ip**
`
`Eskenset al., "Enzymatic glycocalyx treatment impairs insulin-mediated recruitment of microvascular
`IS**|blood volumeand decreasesinsulin sensitivity in rats," FASEB Journal 25: 1023.13 (2011)
`(Abstract).
`
`re boo Pharmacopocia, Chapter 5.1.3, "Efficacy of antimicrobial prescrvation," pp. 447-449
`lue*
`Fankhauser, N. and Maser, P., “Identification of GPI anchor attachment signals by a Kohonenself-
`
`organizing map,” Bioinformatics 21(9):1846-1852 (2005).
`Felix et al., “Pegylated peptides IV. Enhanced biological activity of site-directed pegylated GRF
`analogs,” Int. J. Peptide Protein Res. 46:253-264 (1995).
`Few, B., “Hyaluronidase for treating intravenous extravasations,” MCN Amer. J. Matern. Child Nurs.
`12(1):23 (1987).
`Filocamoet al., “Chimeric Sindbis viruses dependent on the NS3 protease of hepatitis C virus,”J.
`Virology 71:1417-1427 (1997).
`ry#*|Forsburg, S.L., "Codon usage table for Schizosaccharomyces pombe," Yeast 10(8):1045-1047 (1994).
`
`vex
`
`rwe*
`
`Ix##
`
`ize
`JAe*
`
`IBe*
`
`JC#*
`
`Franssonet al., "Solvent effects on the solubility and physical stability of human insulin-like growth
`factor I," Pharm. Res. 14(5):606-12 (1997).
`Frost, G. I. and Stern, R., “A microtiter-based assay for hyaluronidase activity not requiring
`specialized reagents,” Anal. Biochem. 251:263-269 (1997).
`Gardneret al., “The complete nucleotide sequence of aninfectious clone of cauliflower mosaic virus
`by M13mp7 shotgun sequencing,” Nucleic Acids Res. 9(12):2871-2888 (1981).
`GenBank Accession No. AAC60607, PH-20 [Homosapiens], published on 06-05-2000 [online]
`|retrieved on Dec. 12, 2012]|retrieved from the Internet: URL:<ncbi.nlm.nih. gov/protein/AAC60607],
`1 page.
`
`conformance and not considered. Include copyof this form with next communication to applicant.
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`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/C.A.M./
`
`

`

`Sheet _9 of _25_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`
`18/068,418 ~ GAU: 1656
`
`Not yet assigned 37 CER §1.98(b
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`
`“£1 ¢# al.
`-
`Filing Date
`December 19, 2022
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`Group Art Unit
`
`Other Documents (include Author, Title, Date, and Place of Publication
`Examiner|Desig.
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`Initial
`ID
`Document
`
` U.S. A. 99(17):11393-11398 (2002).
`
`
`
`
`
`JD**
`JEe*
`
`JFe*
`
`JH**
`
`JT**
`
`Gilbert, W. and Villa-Komaroff, L., “Useful Proteins from Recombinant Bacteria,” Scientific
`American 242(4):74-94 (1980).
`Girish etal., “Hyaluronidase inhibitors: a biological and therapeutic perspective,” Curr. Med. Chem.
`16(18):2261-2288 (2009).
`Gmachlet al., “The humansperm protein PH-20 has hyaluronidaseactivity,” FEBS 336(3):545-548
`(1993).
`jGe*|Good et al., "Hydrogen ion buffers for biological research," Biochemistry 5(2):467-477 (1966).
`
`Gribskov, M. and Burgess, R. R., “Sigma factors from £. coli, B. subtilis, phage SPO1, and phage T4
`are homologousproteins,” Nucl. Acids Res. 14(16):6745-6763 (1986).
`Grosschedet al., “Introduction of a Uy immunoglobulin gene into the mouse germ line: specific
`expression in lymphoid cells and synthesis of functional antibody,” Cell 38:647-658 (1984).
`Guiotto et al., “An improved procedure for the synthesis of branched polyethylene glycols (PEGs)
`JJ**|with the reporter dipeptide Met-BAla for protein conjugation,” Bioorg. Med. Chem. Lett. 12:177-180
`(2002).
`JK**|Guntenhoneretal., “A substrate-gel assay for hyaluronidase activity,” Matrix 12:388-396 (1992).
`
`Guoet al., “Protein tolerance to random amino acid change,” Proc. Nat’l. Acad. Sci. USA, 101:9205-
`9210, 2004.
`Hahmetal., “Generation of a novel poliovirus with a requirement of hepatitis C virus protease NS3
`activity,” Virology 226:3 18-326 (1996).
`Haller et al., “Escaping the Interstitial Matrix With Enzyme-Mediated Drug Delivery,” Drug Delivery
`Technology, 5(5):1-6 (2005).
`Hamatakeet al., “Establishment of an in vitro assay to characterize hepatitis C virus NS3-4A protease
`Jor#
`
`trans-processing activity,” Intervirology 39:249-258 (1996).
`Hammeret al., “Diversity of alpha-fetoprotein gene expression in mice is generated by a combination
`of separate enhancer elements,” Science 235:53-58 (1987).
`Hanahan,D., “Heritable formation of pancreatic B-cell tumours in transgenic mice expressing
`recombinant insulin/simian virus 40 oncogenes,” Nature 315(6015):115-122 (1985).
`Harris, J. and R. Chess, “Effect of pegylation on pharmaceuticals,” Nat. Rev. Drug Discov. 2(3):214-
`221 (2003).
`Hartman S. and R. Mulligan, “Two dominant-acting selectable markers for gene transferstudies in
`mammalian cells,” Proc. Natl. Acad. Sci. 85:8047-8051 (1988).
`Have et al., "Cloning and characterization of the cDNA encoding the PH20 protein in the European
`Te
`
`red fox Vulpes vulpes," Reproduct. Fertil. Dev. 10:165-172 (1998).
`Herrera-Estrella et al., “Expression of chimaeric genes transferred into plant cells using a Ti-plasmid-
`derived vector,” Nature 303:209-213 (1983).
`Herrera-Estrella et al., “Light-inducible and chloroplast-associated expression of a chimaeric gene
`introduced into Nicotiana tabacumusing a Ti plasmid vector,” Nature 310(5973):115-120 (1984).
`Hibi et al., “Chondroitinase C activity of Streptococcus intermedius," FEMS Microbiol. Lett.
`57(2):121-124 (1989).
`Hofingeret al., “Isoenzyme-specific differences in the degradation of hyaluronic acid by mammalian-
`type hyaluronidases,” Glycocony. J. 25:101-109 (2008).
`yye«|Holash et al.. "VEGF-Trap: a VEGF blocker with potentantitumoreffects." Proc. Natl. Acad. Sci.
`
`JL**
`
`JM**
`
`IN®*
`
`ype
`
`Jo**
`IR**
`
`yge*
`
`Jue
`
`vex
`
`Jwee
`
`Ixe*
`
`Examiner Signature
`
`conformance and not considered. Include copyof this form with next communication to applicant.
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`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
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`Date Considered
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/C.A.M./
`
`

`

`Sheet _10 of _25_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`
`18/068,418 ~ GAU: 1656
`
`Not yet assigned 37 CER §1.98(b
`
`List of Patents and Publications for Applicant's
`Information Disclosure Statement
`
`“£1 ¢# al.
`-
`Filing Date
`December 19, 2022
`
`.
`Group Art Unit
`
`Other Documents (include Author, Title, Date, and Place of Publication
`Examiner|Desig.
`
`Initial
`ID
`Document
`zee
`Hooper, N. M., "Determination of glycosyl-phosphatidylinositol membrane protein anchorage"
`Proteomics 1:748-755 (2001
`
`Horn etal., “Intravesical chemotherapy of superficial bladder tumorsin a controlled trial with cis-
`platinum versuscis-platinumplus hyaluronidase,” J. Surg. Oncol. 28:304-307 (1985).
`Huanget al., "Recombinant Human Hyaluronidase PH20 Does Not Stimulate an Acute Inflammatory
`Response and Inhibits Lipopolysaccharide-Induced Neutrophil Recruitment in the Air Pouch Model
`of Inflammation," (2014) J. Immunol. 192(11):5285-5295.
`Huang, X. and W. Miller., "A time-efficient, linear-space local similarity algorithm,” Adv. Appl.
`Kc™ Math. 12:337-357 (1991).
`KD**
`Hunnicutet al., “Structural relationship of sperm soluble hyaluronidase to the sperm membrane
`protein PH-20,” Biol. Reprod. 54(6):1343-1349 (1996).
`Infante et al., "Phase 1 trials of PEGylated recombinant human hyaluronidase PH20 in patients with
`advanced solid tumours," Br. J. Cancer 118(2):153-161 (2018).
`Ito et al., “Cultivation of hepatitis C virus in primary hepatocyte culture from patients with chronic
`hepatitis C results in release of high titre infectious virus,” J. Gen. Virol. 77:1043-1054 (1996).
`IUPAC-IUB Commission on Biochemical Nomenclature, “A One-Letter Notation for Amino Acid
`Sequences: Tentative Rules,” J. Biol. Chem. 243(13):3557-3559 (1968).
`IUPAC-IUB Commission on Biochemical Nomenclature, "Abbreviated nomenclature of synthetic
`poypeptides-polymerized amino acids-revised recommendations," The Journal of Biological
`KH**
`
`Chemistry 247(2):323-325 (1972).
`Jadin et al., "A comprehensive model of hyaluronan turnover in the mouse,” Matrix Biol. 31(2):81-89
`2012),
`
`KA**
`
`KB**
`
`KE**
`
`KF*#
`
`KG**
`
`KI**
`
`
`
`
`
` Reprod. 65(2):628-636 (2001).
`
`Jay et al., “Construction of a general vector for efficient expression of mammalian proteins in
`KJ**|bacteria: use of a synthetic ribosome bindingsite,” Proc. Natl. Acad. Sci. USA 78(9):5543-5548
`(1981).
`Karvinenct al., "Hyaluronan, CD44 and versican in cpidcrmal kcratinocyte tumours," British Journal
`of Dermatology 148: 86-94 (2003).
`KK"
`KL** Kelsey et al., “Species- and tissue-specific expression of human oj-antitrypsin in transgenic mice,”
`
`Genes And Devel. 1:161-171 (1987).
`KM««|Mimetal., "Sperm penetration through cumulus mass and zona pellucida,"Int. J. Dev. Biol. 526-
`6):677-682 (2008).
`KN** Kodukulaet al., "Biosynthesis of Phosphatidylinositol Glycan-anchored Membrane Proteins," J. Biol.
`Chem. 266:4464-4470 (1991).
`
`Kohnoetal., “Effects of hyaluronidase on doxorubicin penetration into squamous carcinoma
`KO**|multicellular tumor spheroids andits cell lethality,” J. Cancer Res. Clin. Oncol. 120(5):293-297
`1994).
`
`Kollias et al., “Regulated expression of human “y-, B-, and hybrid yB-globin genes in transgenic mice: Ke manipulation of the developmental expression patterns,” Cell 46:89-94 (1986).
`Ko* Krumlauf et al., “Developmental regulation of a-fetoprotein genes in transgenic mice," Mol. Cell.
`Biol. 5(7):1639-1648 (1985).
`KR*# Kruperset al., “Complexation of poly(ethylene oxide) with poly(acrylic acid-co-hydroxyethyl
`methacrylate)s,” Eur. Polym J. 32(6):785-790 (1996).
`KS** Kyte et al., "A Simple Method for Displaying the Hydropathic Character of a Protein" J. Mol. Biol.
`157:105-132 (1982).
`KT#s|Lalancette et al, “Characterization of an 80-kilodalton bull sperm protein identified as PH-20,” Biol.
`
`conformance and not considered. Include copyof this form with next communication to applicant.
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`EXAMINER:Initial if citation considered, whetheror not citation is in conformance with MPEP 609; Drawline through citation if not in
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`Date Considered
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/C.A.M./
`
`

`

`Sheet 11 of _25_
`
`Substitute Form PTO-1449 U.S. Department of Commerce|Attomey Docket No. Application No.
`
`
`
`
`(Modified) Patent and Trademark Office|33320.03087.US2E/3087K 18/068,418
`
`18/068,418 ~ GAU: 1656
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`Not yet assigned 37 CER §1.98(b
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`List of Patents and Publications for Applicant's
`Information Disclosure Statement
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`“£1 ¢# al.
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`Filing Date
`December 19, 2022
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`Group Art Unit
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`Other Documents (include Author, Title, Date, and Place of Publication
`Examiner|Desig.
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`Initial
`ID
`Document
`Kuex|Lamet al., "The effect of benzyl alcohol on recombinant humaninterferon-gamma," Pharm. Re