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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
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`v.
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`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner
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`U.S. Patent No. 8,394,406
`_____________________
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`IPR2013-00372
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`_____________________
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`DECLARATION OF JOHN DOLL
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`TABLE OF CONTENTS
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`Introduction ..................................................................................................... 1
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`I. My Background and Qualifications ................................................................ 2
`II. Summary of Opinions ..................................................................................... 8
`III. Person of Ordinary Skill in the Art ............................................................... 13
`IV.
`Incorporation by reference ............................................................................ 14
`V. The Ashley '932 publication provides sufficient details for a POSA to
`unambiguously identify the Ashley '854 application. .................................. 15
` The Ashley '854 application was available to the public prior to the April 7,
`2003 asserted priority date for the ‘406 patent. ............................................ 21
` A person of ordinary skill in the art, having read the incorporation by
`for the ‘406 patent ......................................................................................... 25
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`VI.
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`VII.
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`VIII.
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`reference statement in the Ashley '932 publication, could have located the
`Ashley '854 application long before the April 7, 2003 asserted priority date
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`I.
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`I, John Doll, hereby declare as follows.
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`Introduction
`I am over the age of eighteen (18) and otherwise competent to make
`1.
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`this declaration.
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`2.
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`I have been retained as an expert witness on behalf of AMNEAL
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`PHARMACEUTICALS, LLC for the above-captioned inter partes review (IPR). I am
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`being compensated for my time in connection with this IPR at my standard
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`consulting rate, which is $750 per hour. I understand that the petition for inter
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`partes review involves U.S. Patent No. 8,394,406 ("the '406 patent"), AMNEAL
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`1009, which resulted from U.S. Application No. 12/926,934 ("the
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`'934
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`application"), filed on December 17, 2010. The '406 patent names Rong-Kun
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`Chang, Arash Rauofinia and Niraj Shah as inventors. The '406 patent issued on
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`March 12, 2013, from the '934 application. I understand that, according to the
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`USPTO records, the '406 patent is currently assigned to Supernus Pharmaceuticals,
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`Inc. ("the patentee").
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`3.
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`In preparing this Declaration, I have reviewed the '406 patent and
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`considered each of the documents cited herein, in light of general knowledge in the
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`art. In formulating my opinions, I have relied upon my experience, education and
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`knowledge in the relevant art of drug development and formulation. In
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`formulating my opinions, I have also considered the knowledge and skills of a
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`1
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`person of ordinary skill in the art ("POSA") (i.e., a person of ordinary skill in the
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`field of drug delivery and formulation).
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` My Background and Qualifications
`II.
`As described in more detail below, I had a 35-year career at the
`4.
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`USPTO and served in various capacities ranging from Patent Examiner to
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`Commissioner for Patents to Acting Under Secretary of Commerce for Intellectual
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`Property and Acting Director of the United States Patent and Trademark Office. I
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`served as an Assistant and Primary Patent Examiner at the USPTO for nine years,
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`during which time I was responsible for examining patent applications some of
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`which had compound claims having pharmaceutical utilities, composition claims,
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`and pharmaceutical methods of use claims. I later became the Director of
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`Technology Center 1600, which is responsible for examining applications covering
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`Biotechnology and Organic Chemistry (including pharmaceuticals). This is the
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`same Technology Center 1600 that examined the ‘406 patent. Having served as a
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`patent examiner and as the Director of Technology Center 1600, I am experienced
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`in determining what a person of ordinary skill in the art (POSA) in the field of drug
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`delivery and formulation would have understood, known or would have done in
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`view of the prior art, and I routinely made such factual determinations on behalf of
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`the USPTO. Likewise, I am experienced in reviewing references and determining a
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`reference’s prior art date from the facts available.
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`2
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`5. My experience in having served as a fact finder regarding prior art is
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`consistent with Federal Circuit decisions and The Manual of Patent Examining
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`Procedure (MPEP). For instance, the Federal Circuit has stated that examiners and
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`administrative patent judges on the Board are “person[s] of scientific competence
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`in the fields in which they work” and that their findings are “informed by their
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`scientific knowledge, as to the meaning of prior art references to persons of
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`ordinary skill in the art.” In re Berg, 320 F.3d 1310, 1315 (Fed. Cir. 2003).
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`Similarly, MPEP 2141(II) 8th edition, rev. 9 (2012) (Ex1099) recognizes Office
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`Personnel as Fact finders [Ex1099, 2100-113
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`to 2100-115.] and MPEP
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`2141(II)(C), (2012) explains that an examiner “may rely on their own technical
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`expertise to describe the knowledge and skills of a person of ordinary sill in the
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`art." [Ex1099, 2100-114.] Likewise, MPEP 2141.03(III) 8th edition, rev. 9 (2012)
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`(Ex1100) states that “[t]he examiner must ascertain what would have been obvious
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`to one of ordinary skill in the art at the time the invention was made” citing
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`Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 218 USPQ 865 (Fed.
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`Cir. 1983), cert denied, 464 U.S. 1043 (1984). [Ex1100, 2100-123.]
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`6. My educational and professional background is detailed in my
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`curriculum vitae. [Ex1050] I received a B.S. in Chemistry and Physics from
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`Bowling Green State University in 1971. I received a M.S. in Physical Chemistry
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`3
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`from The Pennsylvania State University in 1974. And I am registered to practice
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`before the USPTO (Registration No. 65,756).
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`7.
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`From September 1974 to August 1992, I served in various examining
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`capacities at the USPTO: Assistant and Primary Patent Examiner, Supervisory
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`Patent Examiner, and Quality Assurance Specialist. I examined, supervised and
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`reviewed the examination of patent applications encompassing pharmaceuticals,
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`herbicides, pesticides, dyestuffs, inorganic chemistry, hydrometallurgy, zeolite
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`catalysts, buckministerfullerenes, proteins, and peptides. The applications that I
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`examined, and for which I supervised examination, included applications having
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`compound claims, composition claims, and methods of use claims encompassing
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`pharmaceuticals.
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`8.
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`From August 1992 to January 2005, I served as a Group Director in
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`Groups 1100, 2900 and 1800 and in Technology Center 1600. During this time, I
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`was responsible for all patent examination issues in the chemistry, chemical
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`engineering, design, pharmaceutical, and biotechnology art areas. I was the
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`Director of Group 1100 (which was responsible for the patent examinations of
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`chemistry applications) and 2900 (which was responsible for the patent
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`examinations of design applications) from August 1992 to March 1995. In March
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`1995, I became Director of Group 1800, which was responsible for the patent
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`examinations of biotechnology applications. In 1998, Group 1800 (biotechnology),
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`4
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`Group 1200 (organic chemistry and pharmaceuticals), and part of Group 1500
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`(polymers) combined to form Technology Center 1600, which was response for the
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`patent examinations of biochemistry and organic chemistry applications. I was one
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`of 3 Directors of Group 1600 until January 2005. Additionally, in 1995, I directed
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`the development and implementation of the 35 U.S.C. § 101 Utility Guidelines,
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`and in 1996, I directed the development and implementation of the 35 U.S.C.
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`§ 112, paragraph 1, Enablement Examiner Training Materials.
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`9.
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`From March 2004 to January 2005, I served as the Special Assistant
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`to the Director of the United States Patent and Trademark Office. In this position,
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`I provided technical, examination and legal advice on all patent-related issues.
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`10. From January 2005 to August 2005, I served as the Deputy
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`Commissioner for Patent Resources and Planning. As the Deputy Commissioner
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`for Patent Resources and Planning, I was responsible for the formulation and
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`execution of the $1.3 billion budget as well as strategic planning for the Patent
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`Office.
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`11. From April 2005
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`to August 2005, I served as
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`the Acting
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`Commissioner for Patents. I was appointed by the Under Secretary of Commerce
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`for Intellectual Property and the Director of the United States Patent and
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`Trademark Office to perform the duties of the Commissioner for Patents until the
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`Secretary of Commerce appointed a new Commissioner for Patents.
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`5
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`12. From August 2005 to October 2009, I served as the Commissioner for
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`Patents. As the Commissioner for Patents, I was appointed by the Secretary of
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`Commerce and served as the Chief Operating Officer for all aspects of patent
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`related operations, planning and policy with the mission of properly applying the
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`patent laws and regulations of the United States in the examination of patent
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`applications. As the Commissioner, I oversaw a budget of $1.3 billion and a staff
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`of over 7000 employees. I was responsible for the USPTO's strategic planning and
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`execution, budget formulation and execution, information technology systems,
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`staffing, employee development, labor management relations, customer outreach,
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`congressional relations, public advisory committee relations, and patent policy
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`formulation.
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`13. From November 2008 to September 2009, I also served as the Deputy
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`Under Secretary of Commerce for Intellectual Property and Deputy Director of the
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`United States Patent and Trademark Office. In my role as the Deputy Under
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`Secretary of Commerce for Intellectual Property and Deputy Director of the United
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`States Patent and Trademark Office, I assisted the Under Secretary in developing
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`and promoting Administration positions on all Patent, Trademark and Copyright
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`issues domestically and internationally. Additionally, I served as the Chief
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`Operating Officer in planning, measuring and improving the mission performance
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`and achievement of the USPTO. I was also responsible for maintaining and
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`6
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`growing domestic and international leadership roles in intellectual property rights
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`policy by strengthening Intellectual Property protection. I was responsible for
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`providing customers with the highest levels of quality and service in all aspects of
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`USPTO operations.
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`14. From January 2009 to August 2009, I also served as the Acting Under
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`Secretary of Commerce for Intellectual Property and Acting Director of the United
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`States Patent and Trademark Office. As the Acting Under Secretary, I advised the
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`President, the Secretary of Commerce, and the Administration about all intellectual
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`property matters. As Acting Director, I administered the laws of granting Patents
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`and Trademarks, and was responsible for the day-to-day management of a $2.1
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`billion agency and for over 10,000 employees. I developed and articulated
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`administration positions on all Patent, Trademark and Copyright issues while
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`promoting strong intellectual property policy globally, including strategies to
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`thwart the theft of U.S. intellectual property around the world.
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`15. From October 2009 to the present, I have worked as an expert witness
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`and a consultant on U.S. Patent and Trademark Office (USPTO) practice and
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`procedure.
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`16.
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`I have received several honors in my career, including a Department
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`of Commerce Bronze Medal for examination and supervisory accomplishments; a
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`second Bronze Medal for the implementation of Patent Application Location and
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`7
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`Monitoring (PALM) system; a Department of Commerce Silver Medal for the
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`development of automated examiner office action tools; the Vice Presidential
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`Hammer Award for establishing the Biotechnology Customer Partnership; and a
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`Department of Commerce Gold Medal for implementation of the Image File
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`Wrapper system.
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` Summary of Opinions
`III.
`I have been asked by Counsel for Amneal to consider and respond to
`17.
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`the testimony of Supernus's declarant, Stephen Kunin [Ex2145]. In formulating
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`my opinions, I have drawn upon my experience in examining and in supervising
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`examination of patent applications in the drug development and formulation. And
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`I have provided my opinions from the vantage point of an experienced fact finder
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`with scientific competence and knowledge of a person of ordinary skill in this art.
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`18.
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`In his declaration and at deposition, Mr. Kunin questioned the
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`effectiveness of
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`the
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`incorporation-by-reference of
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`the Ashley 60/281,854
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`application into the Ashley WO 2002/080932publication. [Ex2145, ¶¶ 27-34.] He
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`also raised questions regarding the public availability of the Ashley '854
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`application. [Ex2145, ¶¶ 23-26.] I disagree with Mr. Kunin's conclusions.
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`19. Mr. Kunin seeks to cast doubt on whether the Ashley '932 publication
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`identified the Ashley '854 application with sufficient particularity to incorporate it
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`by reference. Yet, Mr. Kunin stated on cross-examination that whether a document
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`8
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`is incorporated by reference is a question of law on which he offered no opinion.
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`[See Ex1051, page 31, lines 12-17.] To the extent that Mr. Kunin purports to offer
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`factual testimony relevant to this question of law from the vantage point of a
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`person of ordinary skill in the art, I note that Mr. Kunin readily acknowledges that
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`he is not a POSA in this art:
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`Q Earlier you mentioned that you're not serving as a technical expert
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`in this case, correct?
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`A That's right. I -- if you look in my declaration in paragraph 6 on
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`page 3 of the declaration, you'll see that my technical background is
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`in electrical engineering, not pharmaceutical chemistry. I would
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`not be a person of ordinary skill in the pharmaceutical chemistry
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`technology.
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`Q Is it -- would you agree that you're not a person of ordinary skill in
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`the art with respect to the patents challenged in these IPRs?
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`A Yes, I think that's fair.
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`[Ex1051, page 29, line 15 to page 30, line 3 (emphasis added).]
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`20.
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`I note that Mr. Kunin, with an electrical engineering background, has
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`not examined patent applications from the vantage point of an experienced fact
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`finder with scientific competence and knowledge of a person of ordinary skill in
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`9
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`this art, which relates to drug development and formulation. [See Ex2145, Exhibit
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`A.]
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`21. During cross-examination, Mr. Kunin also stated that he did not read
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`the declaration of Amneal's expert in this case, Dr. Van Buskirk. [Ex1051, page
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`28, lines 6-12.] Therefore, not only is Mr. Kunin not a POSA, he cannot testify
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`from the perspective of a POSA. I have read the portions of Dr. Van Buskirk's
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`deposition and declarations that relate to his professional and educational
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`background and his opinions on incorporation by reference. [Ex1022, ¶¶ 11-20,
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`40-41 and footnote 3; Ex1066, ¶¶ 14, 106-108; Ex2015, pages 60-61, 63, 68-73,
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`and 85.]
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`22. And though Mr. Kunin questions whether the incorporation by
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`reference was effective, the Ashley '932 publication’s incorporation statement
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`refers to the incorporated application with sufficient particularity such that a POSA
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`could identify the Ashley '854 application without ambiguity. Even Mr. Kunin
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`identified only a single application with the April 5, 2001 filing date- the Ashley
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`'854 application when conducting a search using the identifying information
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`provided in the Ashley '932 publication’s incorporation statement. [See Ex1051,
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`page 64, line 4- page 66, line 9; Ex2145, Exhibit N.] Thus, Mr. Kunin and
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`Supernus do not establish that a POSA would have been confused as to which
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`application was incorporated into the Ashley '932 publication.
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`10
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`23. Mr. Kunin’s declaration also contains a lengthy discussion regarding
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`the USPTO’s procedures and processing times for retrieving and providing a copy
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`of an abandoned patent application to a member of the public. And in his
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`declaration and deposition testimony, Mr. Kunin implies that an abandoned patent
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`application becomes prior art only once a member of the public actually obtains a
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`copy of the application or actually inspects the application once the USPTO has
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`retrieved it. [See Ex1051, page 36, line 19-page 37, line 1; EX2145, ¶ 74.] But if
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`the USPTO’s retrieval procedures and delivery process impacted when an
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`abandoned application becomes prior art, two applications filed on the same day
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`could have different prior art dates depending on variables such as (i) when a
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`member of the public first requested access to the abandoned application, (ii) how
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`efficiently the PTO processed the request for access, (iii) whether the application
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`was stored electronically or only in hard copy, (iv) in which PTO warehouse a
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`paper copy of the application was stored, and (iv) how long it takes the U.S. Postal
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`Service to deliver a copy of the application to the party requesting the application,
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`which of course would depend on the delivery address of the requesting party [See
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`Ex2145, ¶ 84 and Exhibit P, stating that delivery times may range from 2-3 days.]
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`If such variables were considered in determining when an abandoned patent
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`application becomes prior art, inconsistent results would be obtained, and it would
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`11
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`virtually be impossible for the public to determine the effective date of many
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`references.
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`24.
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`In formulating my opinions, I have considered
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`the following
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`documents:
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`Paper # or
`Exhibit #
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`Description
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`Paper 2
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`Paper 1
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`Paper 2
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`Paper 8
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`Paper 11
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`Paper 8
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`Paper 40
`Paper 41
`Paper 39
`1009
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`1002
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`1003
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`1004
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`1022
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`Amneal's petition for inter partes review of US Patent No.
`8,206,740;
`Amneal's petition for inter partes review of US Patent No.
`8,394,405
`Amneal's petition for inter partes review of US Patent No.
`8,394,406
`Patent Trial & Appeal Board, Decision to Institute, Case
`IPR2013-00368 ;
`Patent Trial & Appeal Board, Decision to Institute, Case
`IPR2013-00371;
`Patent Trial & Appeal Board, Decision to Institute, Case
`IPR2013-00372;
`Patent Owner Response, Case IPR2013-00368;
`Patent Owner Response, Case IPR2013-00371;
`Patent Owner Response, Case IPR2013-00372
`Chang, U.S. Pat. No. 8,394,406, "Once Daily
`Formulations of Tetracyclines" (filed December 17, 2010;
`issued March 12, 2013) ("the '406 patent")
`Ashley, WO 2002/080932, “Method of Treating Acne”
`(filed April 5, 2002; published October 17, 2002) ("the
`Ashley '932 publication")
`Ashley, U.S. Prov. Appl. No. 60/281,854 " Controlled
`Delivery of Tetracycline and Tetracycline Derivatives"
`(filed April 5, 2001) ("the Ashley '854 application")
`Ashley, WO 02/083106, "Controlled Delivery of
`Tetracycline Compounds and Tetracycline Derivatives"
`(filed April 5, 2002; published October 24, 2002) ("the
`'106 publication")
`Declaration of Glenn A. Van Buskirk, Ph.D. (¶¶ 11-20,
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`12
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`
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`
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`
`
`1031
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`1033
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`1034
`1051
`
`1058
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`1066
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`1090
`1099
`1100
`1101
`1102
`1103
`1104
`2015
`
`2145
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`
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`40-41 and footnote 3)
`Ashley, U.S. Prov. Appl. No. 60/281,916, "Methods of
`Treating Acne" (filed April 5, 2001) ("the '916 application)
`Advanced Display Systems, Inc. v. Kent State University,
`212 F. 3d 1272 (Fed. Cir. 2000)
`Hollmer v. Harari, 681 F.3d 1351 (Fed. Cir. 2012)
`Transcript of Deposition of Stephan G. Kunin, Esq., Case
`IPR2013-00368; IPR2013-00371; and IPR2013-00372,
`April 18, 2014
`Kyocera Wireless Corporation v. ITC, 545 F.3d 1340
`(Fed. Cir. 2008)
`Second Declaration of Glenn A. Van Buskirk, Ph.D. (¶¶
`14 and 106-108)
`In re Wyer, 655 F.2d 221 (C.C.PA. 1981)
`MPEP 2141(II), 8th edition, rev. 9 (2012)
`MPEP 2141.03 (III) 8th edition, rev. 9 (2012)
`MPEP 901.02, 8th edition (2001)
`MPEP 2126, 8th edition (2001)
`MPEP 608.01(p)(I)(A)(1), 8th edition (2001)
`Espacenet Keyword Search Results
`Transcript of Deposition of Glenn A. Van Buskirk, Ph.D.,
`Case IPR2013-00368; IPR2013-00371; and IPR2013-
`00372, February 12, 2014 (pages 60-61, 63, 68-73, and 85)
`Declaration of Stephen G. Kunin, Esq. and Appendices A-
`P.
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` Person of Ordinary Skill in the Art
`IV.
`I understand that a POSA is a hypothetical person who is presumed to
`25.
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`be aware of all pertinent art, thinks along conventional wisdom in the art, and is a
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`person of ordinary creativity. A POSA would have had education and experience
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`in drug delivery and formulation as of 2003. The education and experience levels
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`may vary between persons of ordinary skill, with some persons holding a
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`Bachelor's degree with many years of experience and others holding higher degrees
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`13
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`but having less work experience. A POSA would have knowledge and skill
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`relating to the use, function, and formulation of pharmaceutical excipients;
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`knowledge and training regarding the equipment, processes and techniques used to
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`analyze and test formulation materials; and an understanding of pharmacokinetic
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`principles and how they relate to drug development. Such a person would have
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`specific experience with modified release drug systems.
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`26. A POSA typically would work as part of a multi-disciplinary team
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`and draw upon not only his or her own skills, but also take advantage of certain
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`specialized skills of others in the team, to solve a given problem. For example, a
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`clinician may be part of the team. I understand that when considering the prior art,
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`a POSA can rely on disclosures in the prior art as well as recourse to logic,
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`judgment, and common sense. I understand that a POSA does not necessarily
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`require explicit explication in any reference to understand the teachings therein.
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`V.
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`Incorporation by reference
`I understand that whether one document is incorporated by reference
`27.
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`into another document is a question of law. [See Advanced Display Systems, Inc.
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`v. Kent State University, 212 F. 3d 1272, 1283 (Fed. Cir. 2000) (Ex1033).] I also
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`note that Mr. Kunin agrees that the question of whether a document is properly
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`incorporated by reference is a question of law. In his deposition, when asked
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`whether the Ashley '932 publication's incorporation by reference of the Ashley
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`14
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`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
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`'854 application was effective, Mr. Kunin stated that "I think that's a question of
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`law, and that's really for the PTAB to decide, not me." [See Ex1051, page 31, lines
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`15-17.]
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`28.
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`I understand that the material to be incorporated by reference must be
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`described in the host document with "detailed particularity" as viewed from the
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`vantage point of a person of ordinary skill. [See Advanced Display Systems, 212 F.
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`3d at 1282-83 (Ex1033) ("the standard of one reasonably skilled in the art should
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`be used to determine whether the host document describes the material to be
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`incorporated by reference with sufficient particularity."); see also Hollmer v.
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`Harari, 681 F.3d 1351, 1356, 1358 (Fed. Cir. 2012) (Ex1034).]
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` The Ashley '932 publication provides sufficient details for a POSA to
`VI.
`unambiguously identify the Ashley '854 application.
`I agree with the Patent Trial and Appeal Board (PTAB) that the facts
`29.
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`surrounding the incorporation by reference support the conclusion that the "Ashley
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`'932 incorporates by reference Ashley '854 in its entirety." [Decision on Institution
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`of Inter Partes Review, IPR2013-00372, at 8 (Paper 8, December 17, 2013).] A
`
`POSA who considered the Ashley '932 publication’s incorporation statement
`
`would have understood that it described the incorporated application with such
`
`detailed particularity that it unambiguously referred to the Ashley '854 application.
`
`15
`
`
`
`
`
`
`
`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
`
`30. Though the Ashley '932 publication does not refer to the Ashley '854
`
`application by number, it uses the following language, which is sufficient for a
`
`POSA to identify the Ashley '854 application:
`
`Further description of methods of delivering tetracycline compounds
`by sustained release can be found in the patent application,
`"Controlled Delivery
`of Tetracycline
`and Tetracycline
`Derivatives," filed on April 5, 2001 and assigned to CollaGenex
`Pharmaceuticals, Inc. of Newtown Pennsylvania. The aforementioned
`application is incorporated herein by reference in its entirety.
`[Ex1002, page 15, lines 26-30 (emphasis added).]
`the Ashley
`'932 publication states
`31. Thus,
`
`that
`
`the referenced
`
`application is incorporated by reference in its entirety, and it references the
`
`application by (1) title, (2) application filing date, and (3) assignee. The title and
`
`application filing date provide sufficient information for a POSA to identify the
`
`Ashley '854 application without ambiguity, as the searching I conducted shows
`
`there is only a single application having this title and filing date. [Ex1104] Even
`
`Supernus's declarant, Mr. Kunin, identified only a single application having such a
`
`title and filing date. [See Ex1051, page 64, line 4- page 66, line 9; Exhibit 2145,
`
`Exhibit N.] Thus, a POSA would have found the Ashley '932 publication to be
`
`unambiguous in its incorporation of the Ashley '854 application by reference.
`
`Accordingly, I agree with the PTAB's previous determination that "there is no
`
`evidence of record to suggest that the identification was ambiguous." [Decision on
`
`16
`
`
`
`
`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
`
`
`
`Institution of Inter Partes Review, IPR2013-00372, fn 1 (Paper 8, December 17,
`
`2013)]
`
`32. Supernus asserts that "a person reading Ashley '932 would have
`
`reasonably assumed that this 'patent application' was U.S. Provisional No.
`
`60/281,916 [“the ‘916 application”], also filed on April 5, 2001, which is shown on
`
`the front of Ashley '932 under "Priority Data." [Patent Owner Response, page 54
`
`(Paper 39, March 10, 2014; emphasis omitted).] I disagree, and I note that
`
`Supernus's argument is not substantiated by any testimony from a POSA or from
`
`the vantage point of an experienced fact finder with scientific competence and
`
`knowledge of a person of ordinary skill in this art, which relates to drug
`
`development and formulation.
`
`33. For several reasons, a POSA would have believed
`
`that
`
`the
`
`incorporation statement in the Ashley '932 publication referred to the Ashley '854
`
`application, not the '916 provisional application (Ex1031).
`
`34. First, a keyword search using the assignee's name and terms from the
`
`application title provided in the Ashley '932 publication’s incorporation-by-
`
`reference statement leads to only a single application having the April 5, 2001
`
`filing date identified in the Ashley '932 publication. This single application is the
`
`Ashley '854 application. I conducted a search of the European Patent Office’s
`
`(EPO’s) Espacenet database using the key words "Controlled Delivery of
`
`17
`
`
`
`
`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
`
`
`
`Tetracycline and Tetracycline Derivatives" (searched in the title section) and
`
`"Collagenex" (searched in the applicant section). Quotation marks were not used
`
`around the keywords while searching. My search led to a single application having
`
`an April 5, 2001 filing date – the Ashley '854 application. My search results are
`
`consistent with Mr. Kunin’s similar search, as his search also led to single
`
`application filed on April 5, 2001 – the same Ashley '854 application. Mr. Kunin’s
`
`search results uniquely identify U.S. Appl. No. 60/281,854, having the title
`
`“Controlled Delivery of Tetracycline and Tetracycline Derivatives” and a filing
`
`date of April 5, 2001, just as described in the Ashley '932 publication. [Exhibit
`
`2145, Exhibit N, pages 000129-130.]
`
`35. Second, contrary to Supernus’s assertions, a POSA would not have
`
`concluded that the Ashley '932 application’s incorporation statement referred to the
`
`‘916 application. Even if a POSA were inclined to consider the possibility that the
`
`Ashley '932 publication’s incorporation statement referenced the ‘916 application,
`
`a POSA would have quickly dismissed such a notion. The Ashley '932
`
`publication’s incorporation statement refers to a patent application have a
`
`completely different title than the title of the '916 application. The incorporation
`
`statement identifies an application having the title "Controlled Delivery of
`
`Tetracycline and Tetracycline Derivatives," whereas the ‘916 application has the
`
`title "Methods of Treating Acne." [See Ex1031 page 1, line 1 and page 7, lines 28-
`
`18
`
`
`
`
`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
`
`
`
`30; Ex1002, page 15, lines 26-30.] A POSA would not overlook such a stark
`
`dissimilarity in application titles. Nor would a POSA find any ambiguity given the
`
`completely dissimilar titles. In contrast, Mr. Kunin, who concedes he is not a
`
`POSA and lacks a background in this art, acknowledged on cross-examination that
`
`he did not even review the ‘916 application before signing his declaration. [See
`
`Ex1051, page 26, lines 7-9.] When asked if he had "read the priority document for
`
`the '932 application," Mr Kunin replied "I did not . . . ." [See Ex1051, page 26,
`
`lines 7-9.] So, Supernus's attorneys' arguments, regarding the '916 application, are
`
`completely unfounded.
`
`36. Third, a POSA also wouldn’t have believed that the Ashley '932
`
`publication’s incorporation statement referred to the '916 application because the
`
`‘916 application contains the identical incorporation-by-reference statement that’s
`
`included in the Ashley '932 publication. The ‘916 application states:
`
`Further description of methods of delivering tetracycline compounds
`
`by sustained release can be found in the patent application,
`
`"Controlled Delivery
`
`of Tetracycline
`
`and Tetracycline
`
`Derivatives," filed on April 5, 2001 and assigned to CollaGenex
`
`Pharmaceuticals, Inc. of Newtown Pennsylvania. The aforementioned
`
`application is incorporated herein by reference in its entirety.
`
`[Ex1031, page 7, lines 27-31 (emphasis added).]
`
`19
`
`
`
`
`
`
`
`Inter Partes Review of USPN 8,394,406
`Declaration of John Doll (Exhibit 1049)
`
`37. Given the identical incorporation statements in the Ashley '932
`
`publication and the ‘916 application, a POSA would have understood that the
`
`incorporated application was a different application that the '916 application. And
`
`it would have been redundant for the drafters of the Ashley '932 publication to
`
`claim the benefit of the ‘916 application in the first paragraph of the Ashley '932
`
`publication and then again incorporate the ‘916 application by reference on page
`
`15 of the specification.
`
`38. Fourth, the Ashley '932 publication claims priority benefit to the '916
`
`application and incorporates it by referenc
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