`
`
`Filed on behalf of: American Regent, Inc.
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`
`
`
`
`
`PHARMACOSMOS A/S,
`Petitioner
`v.
`AMERICAN REGENT, INC.,
`Patent Owner
`______________________
`
`Case PGR2020-00009
`Patent No. 10,478,450
`______________________
`
`DECLARATION OF DR. TODD LOWARY, PH.D.
`
`
`
`PGR2020-00009
`Patent No. 10,478,450
`
`
`
`I.
`
`TABLE OF CONTENTS
`Contents
`INTRODUCTION........................................................................... 1
`A. QUALIFICATIONS .............................................................. 1
`B. MATERIALS CONSIDERED ............................................... 4
`THE ’450 PATENT......................................................................... 4
`A.
`The ’450 Patent Specification and Claims ............................... 4
`III. LEVEL OF ORDINARY SKILL IN THE ART................................ 7
`IV. CARBOHYDRATE CHEMISTRY.................................................. 8
`V.
`PROSECUTION HISTORY OF THE ’450 PATENT AND
`RELATED PATENTS .................................................................. 12
`A.
`Prosecution of the ’549 Patent .............................................. 13
`B.
`Prosecution of the ’450 Patent .............................................. 16
`VI. LEGAL STANDARDS ................................................................. 20
`VII. THE MEANING OF “IRON POLYISOMALTOSE COMPLEX”
`AS USED IN THE ’450 PATENT ................................................. 21
`A.
`Intrinsic Evidence of the ’450 Patent Clearly Defines “Iron
`Polyisomaltose Complex” .................................................... 22
`Intrinsic Evidence Clearly Shows that the “Iron
`Polyisomaltose Complex” Is Not Limited to Iron Complexed
`to Polysaccharides Consisting of at Least 20 Glucose Units ... 23
`Extrinsic Evidence Raised by Pharmacosmos Is Not
`Relevant or Persuasive ......................................................... 26
`1.
`There Was No Universally Accepted Definition of
`“Oligosaccharide” ...................................................... 27
`
`II.
`
`B.
`
`C.
`
`
`
`i
`
`
`
`
`
`PGR2020-00009
`Patent No. 10,478,450
`
`2.
`
`3.
`
`An Iron–Carbohydrate Complex Made with
`“Isomaltose Oligosaccharides” Could be Referred to
`as an “Iron Polyisomaltose” or an “Iron
`Oligosaccharide”........................................................ 28
`A POSA Would Have Understood that
`“Polyisomaltose” Does Not Mean “Dextran”............... 29
`VIII. A POSA WOULD HAVE RECOGNIZED AND VISUALIZED
`THE CLAIMED “IRON POLYISOMALTOSE COMPLEX” ......... 31
`IX. CONCLUSION ............................................................................. 33
`
`
`
`ii
`
`
`
`
`I.
`
`PGR2020-00009
`Patent No. 10,478,450
`
`INTRODUCTION
`I, Todd L. Lowary, Ph.D., have been retained by Finnegan,
`1.
`
`Henderson, Farabow, Garrett & Dunner, LLP on behalf of American Regent, Inc.
`
`(“Patent Owner”), as an independent expert in the field of chemistry.
`
`2.
`
`I have been asked to provide information and opinions on United
`
`States Patent No. 10,478,450 (“the ’450 patent”). This declaration sets forth my
`
`analyses and opinions based on the materials I have considered thus far, as well as
`
`the bases for my opinions.
`
`3.
`
`I am being compensated for the time I spend on this matter, but my
`
`compensation is not contingent upon my opinions or the outcome of this or any
`
`other proceeding.
`
`A. QUALIFICATIONS
`I am a Professor of Chemistry and the R.U. Lemieux Chair in
`4.
`
`Carbohydrate Chemistry at the University of Alberta, as well as Distinguished
`
`Research Fellow at the Institute of Biological Chemistry, Academia Sinica,
`
`Taiwan. I am also a Joint Appointment Professor at the Institute of Biochemical
`
`Sciences at National Taiwan University. I have specific expertise and more than
`
`thirty years of research experience in carbohydrate chemistry. My education,
`
`experience, and professional qualifications are summarized below and described in
`
`further detail in my curriculum vitae, which is Exhibit 2002.
`
`
`
`1
`
`
`
`5.
`
`I obtained a B.A. in Chemistry, with highest honors, from the
`
`PGR2020-00009
`Patent No. 10,478,450
`
`
`
`University of Montana in 1988 and a Ph.D. in Chemistry from the University of
`
`Alberta in 1993. After receiving my Ph.D., I completed two postdoctoral research
`
`fellowships in the area of carbohydrate chemistry: at the University of Alberta
`
`from 1993 to 1995, and at the Carlsberg Laboratory, Copenhagen, Denmark from
`
`1995 to 1996. During those fellowships, my research specifically focused on
`
`carbohydrate and glycopeptide chemistry.
`
`6.
`
`In 1996, I became an Assistant Professor of Chemistry at The Ohio
`
`State University, and I was promoted to Associate Professor with tenure in 2002.
`
`In 2003, I accepted a position as a tenured Associate Professor of Chemistry at the
`
`University of Alberta, and, in 2006, I was promoted to Professor. I still hold that
`
`position today. I have received many awards and recognition at the University of
`
`Alberta, including the Canada Research Chair in Carbohydrate Chemistry and the
`
`R.U. Lemieux Chair in Carbohydrate Chemistry. I have held the latter since 2015.
`
`In 2019, I expanded my research and teaching roles to the Institute of Biological
`
`Chemistry, Academia Sinica in Taiwan, where I am the Director and a
`
`Distinguished Research Fellow and the Institute of Biochemical Sciences at
`
`National Taiwan University where I am a Joint Appointment Professor.
`
`7.
`
`In 1996, I established my independent research group to study the role
`
`of carbohydrates in biology, with a particular focus on microbial diseases including
`
`
`
`2
`
`
`
`
`tuberculosis. Through my research, I have mentored more than 180 students on
`
`PGR2020-00009
`Patent No. 10,478,450
`
`research projects related to the use of synthetic chemistry to make molecules that
`
`can be used to probe the biological role of carbohydrates.
`
`8.
`
`I am an expert in carbohydrate chemistry, and I have experience with
`
`the formation and chemistry of carbohydrate–metal complexes. For example, in
`
`the course of directing syntheses of carbohydrates, I have instructed my group
`
`members in the use of transiently formed metal–carbohydrate complexes to
`
`achieve specific reactions. These processes utilize, and indeed require, an
`
`advanced understanding of the chemistry of carbohydrates and metals, individually
`
`and when complexed together. In addition, I teach this content in a graduate-level
`
`course on carbohydrate chemistry.
`
`9.
`
`I am also knowledgeable in the area of glycoimmunology. Much of
`
`my research is directed at understanding how carbohydrates interact with the
`
`immune system. For example, recent work in my group includes projects to
`
`develop diagnostics that detect antibodies that recognize carbohydrates.
`
`10. As a professor and principal investigator, I have particular experience
`
`in reviewing and publishing carbohydrate chemistry research. I served as an Editor
`
`for Carbohydrate Research from 2004 to 2016, and I have served on the editorial
`
`boards of several chemistry research journals. I have authored more than 200 peer-
`
`reviewed articles in leading scientific journals, including the Proceedings of the
`
`
`
`3
`
`
`
`
`National Academy of Sciences U.S.A., the Journal of the American Chemical
`
`PGR2020-00009
`Patent No. 10,478,450
`
`Society, Carbohydrate Research, the Journal of Organic Chemistry, the Journal of
`
`Biological Chemistry, and ACS Chemical Biology. In addition, I have given
`
`numerous presentations and invited lectures in my field at conferences and
`
`academic seminars, both in the U.S. and abroad.
`
`B. MATERIALS CONSIDERED
`In forming my opinions, I have considered the materials cited in this
`11.
`
`report, as well as those listed in Appendix A. In addition to these materials, I may
`
`consider additional documents and information in forming any supplemental
`
`opinions. To the extent I am provided with additional documents or information,
`
`including any expert declarations in this proceeding, I may offer further opinions.
`
`II. THE ’450 PATENT
`A. The ’450 Patent Specification and Claims
`12. The ’450 patent generally relates to methods of treating iron
`
`deficiency conditions by administering an iron polyisomaltose complex, which is a
`
`type of iron–carbohydrate complex.
`
`13.
`
`I understand from counsel that the ’450 patent claims priority (is
`
`entitled to rely on the filing date) through a series of continuation applications to
`
`provisional application no. 60/757,119, (“the ’119 application”), which was filed
`
`on January 6, 2006. I also understand that the ’450 patent shares a specification,
`
`
`
`4
`
`
`
`
`with a few differences, with three earlier-issued patents that also claim priority to
`
`PGR2020-00009
`Patent No. 10,478,450
`
`the ’119 application: U.S. Patent Nos. 7,754,702 (“the ’702 patent”); 8,431,549
`
`(“the ’549 patent”); and 8,895,612 (“the ’612 patent”). Like the ’450 patent, the
`
`’702, ’549, and ’612 patents describe methods of treating iron deficiency
`
`conditions by administering certain iron–carbohydrate complexes.
`
`14. The ’450 patent specification describes novel methods of treating iron
`
`deficiency conditions that were first described in the ’119 application. As
`
`disclosed in the specification, the inventors of the ’450 patent identified the
`
`characteristics of certain iron–carbohydrate complexes that would allow them to be
`
`safely administered to patients in a single, high dose. Based on that information,
`
`the specification teaches methods of treating iron deficiency conditions by
`
`administering a single, high dose of certain iron–carbohydrate complexes,
`
`including iron polyisomaltose complexes.
`
`15. The background section of the ’450 patent specification describes the
`
`limitations and drawbacks of the parenteral iron–carbohydrate treatments that were
`
`available at the time the patent application was filed. Specifically, the
`
`specification explains that so-called “iron dextran” products have been associated
`
`with anaphylactoid-type reactions that were “believed to be caused by the
`
`formation of antibodies to the dextran moiety.” Ex. 1001 at 1:51-59. It further
`
`describes the drawbacks of other parenteral iron formulations, like iron gluconate
`
`
`
`5
`
`
`
`
`and iron sucrose, which have physicochemical characteristics that require that they
`
`PGR2020-00009
`Patent No. 10,478,450
`
`be administered in low doses and over extended periods of time. Ex. 1001 at 1:59-
`
`2:4. As explained in the patent, using those prior art iron formulations to achieve
`
`iron repletion would generally require 5-10 separate visits to a healthcare provider.
`
`Ex. 1001 at 2:14-21.
`
`16. By contrast, the ’450 patent specification teaches that the iron
`
`deficiency can be treated according to the claimed methods by administering a
`
`single, high dose of certain iron–carbohydrate complexes. Ex. 1001 at 2:31-36.
`
`The specification indicates that the iron–carbohydrate complexes used in the
`
`methods may include, for example, “iron carboxymaltose, iron sucrose, iron
`
`polyisomaltose, iron polymaltose, iron gluconate, iron sorbitol, iron hydrogenated
`
`dextran.” Ex. 1001 at 10:65-11:1.
`
`17. The claims of the ’450 patent are directed to methods of treating iron
`
`deficiency conditions by administering an iron polyisomaltose complex having
`
`certain characteristics useful for high-dose administration. Ex. 1001 at 27:6-29:5.
`
`Specifically, independent claim 1 recites methods of treatment that involve
`
`administration of an “iron polyisomaltose complex” that is “substantially non-
`
`immunogenic” and has “substantially no cross reactivity with anti-dextran
`
`antibodies.” Ex. 1001 at 27:7-17. The dependent claims further describe
`
`
`
`6
`
`
`
`
`administration of an iron polyisomaltose complex with, for example, specific iron
`
`PGR2020-00009
`Patent No. 10,478,450
`
`core size, particle size, pH, osmolarity, and/or half-life. Ex. 1001 at 27:18-29:5.
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`I have been told that a person of ordinary skill is a legal construct that
`18.
`
`is used to assess patentability and other patent law standards. I understand that a
`
`person of ordinary skill in the art (“POSA”) is a fictional composite that is
`
`presumed to have a certain level of knowledge and expertise, including knowledge
`
`of all relevant prior art references at the time of invention.
`
`19.
`
`I understand that Pharmacosmos has defined a person of ordinary skill
`
`in the art as “[a] person of skill in the art of the ’450 patent would have held at
`
`least a bachelor’s degree in chemistry or biochemistry, with some related post-
`
`graduate experience (academic or industrial) in the area of carbohydrates and their
`
`metal complexes. The person of ordinary skill would be familiar with the
`
`chemistry of iron carbohydrate complexes and the related immunological issues.”
`
`Pet. at 9.
`
`20.
`
`I understand that Patent Owner has modified that definition, for
`
`purposes of this POPR, as follows: “A person of skill in the art of the ’450 patent
`
`would have at least a bachelor’s degree in chemistry, biochemistry, medicine, or a
`
`related degree, with some related post-graduate experience (academic, medical, or
`
`industrial) in the area of medical uses of carbohydrates and/or their metal
`
`
`
`7
`
`
`
`
`complexes. The person of ordinary skill would be familiar with, or know to
`
`PGR2020-00009
`Patent No. 10,478,450
`
`consult someone familiar with, the chemistry of iron carbohydrate complexes and
`
`the immunological issues related to the administration of iron carbohydrate
`
`complexes.”
`
`21.
`
`In my opinion, Patent Owner’s definition is more appropriate because
`
`it more expressly includes medical professionals, as the claims of the ’450 patent
`
`are directed towards methods of treating patients. In any event, I qualify as a
`
`POSA under either definition and therefore am qualified to provide an opinion as
`
`to what a POSA would have known and concluded as of the date of invention.
`
`However, my opinions below do not change depending on which definition is
`
`applied.
`
`IV. CARBOHYDRATE CHEMISTRY
`22. As background for my substantive analysis of the ’450 patent, I have
`
`delineated some basic elements of carbohydrate chemistry.
`
`23. Carbohydrates are composed of carbon, hydrogen, and oxygen, and
`
`have a general chemical formula that approximates CnH2nOn. The smallest
`
`carbohydrate building blocks are monosaccharides. Monosaccharides are often
`
`classified based on the number of carbons in the backbone (usually five or six) and
`
`the position of their carbonyl group.
`
`
`
`8
`
`
`
`24. Two monosaccharides can be joined by a covalent bond, referred to as
`
`PGR2020-00009
`Patent No. 10,478,450
`
`
`
`a glycosidic bond or glycosidic linkage, to form a disaccharide. Of relevance in
`
`this case, the disaccharide maltose is made up of two glucoses linked by an α-
`
`(1→4) glycosidic bond (see Figure 1(a), below), and the disaccharide isomaltose is
`
`two glucoses linked by an α-(1→6) glycosidic bond (see Figure 1(b), below).
`
`Glucose is the most abundant monosaccharide.
`
`
`
`
`
`
`
`Figure 1(b): Isomaltose, in which
`glucoses are linked by an α-(1→6)
`glycosidic bond
`
`Figure 1(a): Maltose, in which
`glucoses are linked by an α-(1→4)
`glycosidic bond. The rings are
`numbered to facilitate understanding
`the nomenclature
`
`
`
`The glycosidic bonds in these examples are referred to as “α-(1→4)” and “α-
`
`(1→6)” based on the carbon number of each of the two residues that form the
`
`glycosidic bond (carbon 1 in one residue and carbon 4 or 6 in another).
`
`25. Monosaccharides can also be repeatedly linked together by glycosidic
`
`bonds to form polysaccharides, like the one depicted in Figure 2 below.
`
`
`
`
`9
`
`
`
`
`
`PGR2020-00009
`Patent No. 10,478,450
`
`
`
`Figure 2: A polyisomaltose (polysaccharide of glucose monomers
`linked by α-(1→6) glycosidic linkages X ≥ 0)
`
`Like isomaltose, the glucose monomers in the polysaccharide in Figure 2 are
`
`linked entirely by α-(1→6) glycosidic linkages. The structure of this
`
`polysaccharide chain is linear.
`
`26. Many polysaccharides have “branches” that are connected to a linear
`
`“backbone,” as shown in Figure 3. These branches can either be single
`
`monosaccharide residues, or longer chains of monosaccharides connected via
`
`glycosidic linkages.
`
`
`
`10
`
`
`
`
`
`PGR2020-00009
`Patent No. 10,478,450
`
`
`Figure 3: “A fragment of the Dextran structure”
`adapted from Pharmacosmos’s website (see Ex. 2035)
`
`Figure 3 shows a dextran with a backbone of glucose monomers linked by α-
`
`(1→6) glycosidic linkages, and a branch (or side chain) connected via an α-(1→3)
`
`linkage. Depending on the configuration of the backbone, branches can start from
`
`different locations on a polysaccharide, and they can vary in length and frequency.
`
`27. Polysaccharides can range in size from three monomers to hundreds,
`
`and, in terms of nomenclature, short polysaccharides can be called
`
`oligosaccharides. I agree with Dr. Josephson that scientists have historically used
`
`the prefixes “poly,” meaning many, and “oligo,” meaning few, to refer to chain-
`
`
`
`11
`
`
`
`
`like molecules of different sizes. The term “oligosaccharides” describes short
`
`PGR2020-00009
`Patent No. 10,478,450
`
`chain “polysaccharides.”
`
`28. For simplicity, this portion of my declaration discusses only the
`
`compounds, and is limited to topics of carbohydrate chemistry, that I consider
`
`directly relevant to Patent Owner’s preliminary response. Here, I do not address
`
`aspects of Dr. Josephson’s declaration that purport to describe the state of the art
`
`with respect to iron dextran and iron polyisomaltose. However, I reserve the right
`
`to supplement my opinions to address those topics.
`
`V.
`
`PROSECUTION HISTORY OF THE ’450 PATENT AND RELATED
`PATENTS
`29. Counsel has informed me that the current proceeding is a “Post Grant
`
`Review” (“PGR”), which is an administrative proceeding conducted by the Patent
`
`Trial and Appeal Board (the “PTAB” or “Board”) to review the patentability of
`
`one or more claims of a recently issued patent. I understand from counsel that a
`
`PGR begins when a third party like Pharmacosmos files a petition alleging that a
`
`patent does not meet certain requirements for patentability. Counsel has also
`
`explained what an “Inter Partes Review” (“IPR”) is, and that certain patents related
`
`to the ’450 patent have been previously challenged by Pharmacosmos in IPRs.
`
`30.
`
`I understand from counsel that the written record of the patent
`
`application process conducted before the United States Patent and Trademark
`
`
`
`12
`
`
`
`
`Office (“PTO”) is called the “prosecution history” or “file history.” I also
`
`PGR2020-00009
`Patent No. 10,478,450
`
`understand that a formal communication from the PTO to the patent applicant that
`
`addresses the patentability of the pending claims is called an “Office Action.”
`
`Counsel has also informed me that the PTO official who examines a patent
`
`application and determines whether it contains a patentable invention is called an
`
`“examiner.”
`
`31.
`
`I have reviewed portions of the prosecution history of the ’450 patent,
`
`and I rely on the prosecution history to provide context and inform my analysis of
`
`the ’450 patent, including the meaning of the term “iron polyisomaltose.” I have
`
`also reviewed portions of the prosecution history of the ’549 patent, and statements
`
`made during that prosecution provide further support for my analysis. For those
`
`reasons, I have summarized portions of the prosecution history of the ’549 patent
`
`and ’450 patent that I consider particularly relevant to my analysis of the
`
`’450 patent.
`
`Prosecution of the ’549 Patent
`A.
`32. As previously noted, I understand that the ’450 patent descends from
`
`the same priority application as the ’702, ’549, and ’612 patents, which all issued
`
`before the ’450 patent. I have been informed that the ’549 patent is the
`
`“grandparent” of the ’450 patent, and similar to the ’450 patent, it claims methods
`
`
`
`13
`
`
`
`
`of treating iron deficiency conditions by administering certain iron–carbohydrate
`
`PGR2020-00009
`Patent No. 10,478,450
`
`complexes that include iron polyisomaltose.
`
`33. During prosecution of the ’549 patent, the Patent Owner and the
`
`inventor made clear statements about the meaning of the term “iron
`
`polyisomaltose” that are relevant to the analysis of the ’450 patent. In an Office
`
`Action dated June 6, 2012, the examiner raised questions as to the differences
`
`between dextrans and “polyisomaltoses.” Ex. 1007 at 82-84. In particular, the
`
`examiner stated that polyisomaltose is “synthetic dextran that reacts as a
`
`completely linear molecule.” Ex. 1007 at 82. In response, Patent Owner submitted
`
`to the PTO a declaration1 of Richard P. Lawrence, a co-inventor of the ’549 and
`
`’450 patents, which explained the meaning of the term iron polyisomaltose as
`
`follows: “[A]n iron polyisomaltose is a type of iron carbohydrate complex that
`
`includes isomaltose units in the carbohydrate component. An isomaltose is a
`
`disaccharide similar to maltose, but with a α-(1-6)-linkage between two glucose
`
`units instead of an α-(1-4)-linkage. One example of an iron polyisomaltose
`
`complex is an iron isomaltoside (e.g., Monofer®), where the carbohydrate
`
`component is a pure linear chemical structure of repeating α-1-6 linked glucose
`
`units.” Ex. 1007 at 111.
`
`
`1 Referred to hereinafter as the Lawrence Declaration.
`
`
`
`14
`
`
`
`34. The Lawrence Declaration incorporated by reference a scientific
`
`PGR2020-00009
`Patent No. 10,478,450
`
`
`
`publication by Markus Jahn and colleagues, which describes the physicochemical
`
`characteristics of Monofer. Jahn characterizes Monofer as an “iron oligo
`
`isomaltoside (1000)” and reports that “[t]he carbohydrate isomaltoside 1000 is a
`
`pure linear chemical structure of repeating α-l-6 linked glucose units, with an
`
`average size of 5.2 glucose units and an average molecular weight of 1000 Da.”
`
`Ex. 1007 at 115. Accordingly, I understand the Lawrence Declaration to clearly
`
`define the term “iron polyisomaltose” to include within its scope a complex of iron
`
`with a carbohydrate that has a linear structure of approximately five repeating α-l,6
`
`linked glucose units.
`
`35.
`
`In addition, co-inventor Richard Lawrence expressly contrasted the
`
`linear structure of the “polyisomaltose” with dextran, which has a branched
`
`structure. Specifically, his declaration explained: “In contrast [to polyisomaltose],
`
`a dextran is a branched glucan with straight chains having αl-6 glycosidic linkages
`
`and branches beginning from α1-3 linkages.” Ex. 1007 at 111-12.
`
`36. Relying on the Lawrence Declaration and additional claim limitations
`
`that further informed the meaning of “polyisomaltose,” Patent Owner, in a
`
`Response dated December 6, 2012, stated that an example of a polyisomaltose is
`
`the carbohydrate component in Monofer, which “is a pure linear chemical structure
`
`of repeating α1,6 linked glucose units.” Ex. 1007 at 99. Patent Owner also
`
`
`
`15
`
`
`
`
`explained that data related to one example of an iron polyisomaltose showed that it
`
`PGR2020-00009
`Patent No. 10,478,450
`
`was substantially non-immunogenic and had substantially no cross reactivity with
`
`anti-dextran antibodies. Ex. 1007 at 99-100. The examiner allowed the claims and
`
`credited Patent Owner’s explanation and the Lawrence Declaration in the reasons
`
`for allowance. Ex. 1007 at 141-46. The examiner specifically concluded that the
`
`evidence was “persuasive that one of ordinary skill in the art at the time of the
`
`instant invention would have been able to practice the invention for iron
`
`polyisomaltose complex having substantially non-immunogenic carbohydrate
`
`complex and substantially no cross-reactivity with anti-dextran antibodies.”
`
`Ex. 1007 at 142 (underlining in original).
`
`B.
`37.
`
`Prosecution of the ’450 Patent
`I understand that, before the ’549 patent issued, the inventors filed
`
`application no. 13/847,254 as a continuation of the ’549 patent. That application
`
`was ultimately abandoned, but, before it was, the inventors filed another
`
`continuation, application no. 14/683,415 (“the ’415 application”), which issued as
`
`the ’450 patent.
`
`38.
`
`I have been informed that the prosecution history of the ’450 patent
`
`includes one substantive office action, with the examiner issuing rejections based
`
`on certain provisions of U.S. patent law, namely 35 U.S.C. §§ 102, 103, and 112.
`
`
`
`16
`
`
`
`
`I have focused on the examiner’s rejection and Patent Owner’s responses
`
`PGR2020-00009
`Patent No. 10,478,450
`
`concerning § 112 only because they are relevant to my analysis of the ’450 patent.
`
`39.
`
`I understand from counsel that 35 U.S.C. § 112 requires that an
`
`inventor “particularly point out” the invention that is claimed in the patent.
`
`A person of ordinary skill must be able to understand the scope of the claims, when
`
`they are read in light of the patent specification and the teachings of the prior art.
`
`If a POSA cannot understand the scope of what is claimed in the patent, then the
`
`claim is deemed “indefinite.”
`
`40. The examiner issued a rejection under 35 U.S.C. § 112 stating that “it
`
`is unclear if the meaning of the term ‘polyisomaltose’ encompasses the meaning
`
`loosely “dextran” as used in the prior art.” Ex. 1002 at 188. The examiner noted
`
`that although “[t]he ordinary meaning of ‘polyisomaltose’ would have been
`
`interpreted by one of ordinary skill in the chemical arts to mean a polymer of
`
`isomaltose,” he considered two references cited by the Patent Owner, Muller et al.
`
`(US 3,100,202) and Helenek et al. (US 6,960,571), to be relevant to the meaning of
`
`“polyisomaltose.” Ex. 1002 at 187-88. The examiner referred to statements in
`
`Muller that “polyisomaltose is a term used loosely for dextran” and interpreted
`
`Helenek as using the terms “iron polyisomaltose” and “iron dextran”
`
`synonymously. Ex. 1002 at 187-88. For those reasons, the examiner determined
`
`
`
`17
`
`
`
`
`that “[f]or the purpose of examination, polyisomaltose will be interpreted as
`
`PGR2020-00009
`Patent No. 10,478,450
`
`meaning dextran based on Muller et al. and Helenek et al.” Ex. 1002 at 189.
`
`41. The Patent Owner responded to the examiner’s argument by providing
`
`evidence that contradicted the examiner’s interpretations and explaining that the
`
`term “iron polyisomaltose” did not mean “iron dextran.” Ex. 1002 at 206-213.
`
`Patent Owner stated that, because the patent application repeatedly and
`
`consistently distinguishes iron dextrans from the iron–carbohydrates used in the
`
`claimed methods, a POSA would understand that the term “polyisomaltose” as
`
`used in the ’450 patent does not refer to branched iron dextran. Id. Patent Owner
`
`reiterated the differences between “polyisomaltose” and “dextran”: “Hence,
`
`‘polyisomaltose’ is not the same as dextran, which is a branched glucan
`
`polysaccharide. Thus, the skilled person would understand polyisomaltose refers
`
`to a linear chemical structure of repeating α-1,6 linked glucose units that
`
`optionally is reduced.” Ex. 1002 at 206-207 (emphasis added).
`
`42. Addressing the examiner’s reference to Muller, Patent Owner pointed
`
`out that, rather than treating the two terms synonymously, Muller actually
`
`describes differences between dextran and polyisomaltose, as those terms were
`
`used in Muller. Citing Exhibit 1051 (Khalikova), Patent Owner explained that a
`
`POSA would understand that “dextran is a branched molecule whereas
`
`
`
`18
`
`
`
`
`polyisomaltose is a linear molecule,” and accordingly, polyisomaltose and
`
`PGR2020-00009
`Patent No. 10,478,450
`
`dextran are not synonymous. Ex. 1002 at 210 (emphasis added).
`
`43. Patent Owner also argued that the examiner had misinterpreted
`
`Helenek by concluding that the parenthetical “iron dextran” in the phrase “iron
`
`polyisomaltose (iron dextran)” amounted to equivalence. Patent Owner explained
`
`that the inclusion of “(iron dextran)” in Helenek was an inadvertent typographical
`
`error. Ex. 1002 at 208-209. Moreover, they noted that interpreting “iron dextran”
`
`to be equivalent to “iron polyisomaltose” would be inconsistent with the
`
`description in the Helenek specification and recitation in the Helenek claims,
`
`which clearly disparaged and distinguished iron dextrans. Ex. 1002 at 208.
`
`44. Beyond addressing the specific points in the examiner’s rejection,
`
`Patent Owner urged the examiner to follow the patent office’s prior determinations
`
`on the meaning of the term “iron polyisomaltose” with respect to related patents.
`
`Ex. 1002 at 210-212. Specifically, Patent Owner described the PTAB’s finding
`
`during inter partes review of the ’612 patent, which I understand is related to the
`
`’450 patent, that “in the context of the entire disclosure, the term ‘iron
`
`polyisomaltose’ does not include ‘iron dextran.’” Ex. 1002 at 210. In addition,
`
`Patent Owner explained that, during the inter partes review of the ’549 patent, the
`
`Board concluded that “polyisomaltose” would include “an essentially linear
`
`chemical structure of repeating α-1-6 linked glucose units, which is reduced
`
`
`
`19
`
`
`
`
`(hydrogenated) and has molecular weight of 1000 Da.” Ex. 1002 at 211-212.
`
`PGR2020-00009
`Patent No. 10,478,450
`
`Patent Owner argued that the term “iron polyisomaltose” as used in the ’450 patent
`
`claims should be construed the same way as in the ’612 and ’549 patents.
`
`45.
`
`In light of Patent Owner’s arguments, the examiner withdrew the
`
`rejection and issued a notice of allowance. The examiner’s reasons for allowance
`
`stated that “polyisomaltose as described in the instant application does not mean
`
`dextran and instead the term is given its regular meaning in the art which the cited
`
`Muller et al. acknowledges is different from dextran in that polyisomaltose is the
`
`degradation product of dextran consisting of polymerized glucose residues joined
`
`predominantly by 1,6 linkages.” Ex. 1002 at 237. Patent Owner subsequently
`
`submitted additional references for the examiner to consider, and the examiner
`
`issued further notices of allowance. In each subsequent notice of allowance, the
`
`examiner recognized that iron polyisomaltose and iron dextran are different
`
`complexes. Ex. 1002 at 239.
`
`VI. LEGAL STANDARDS
`I am not an attorney, but counsel has explained to me the legal
`46.
`
`standards and principles set forth below. I have been told that patent claims are
`
`usually given their “ordinary and customary meaning,” which is the meaning that
`
`the claims would have to a person of ordinary skill in the art at the time of
`
`invention. I have also been told that claim terms should not be interpreted in
`
`
`
`20
`
`
`
`
`isolation but must be interpreted in context of the patent specification and
`
`PGR2020-00009
`Patent No. 10,478,450
`
`prosecution history of the patent.
`
`47.
`
`I understand that if the inventor clearly defines a claim term in the
`
`patent specification or prosecution history, the inventor’s definition should govern,
`
`even if it is different from the ordinary meaning in the art. I have been told that,
`
`when multiple patents derive from the same initial application, the meaning of
`
`claim terms in one patent are informed by the inventors’ statements made during
`
`prosecution of other patents in the same family.
`
`48.
`
`I understand that, when patent claim terms are interpreted, intrinsic
`
`evidencethe patent specification and the prosecution history of the patentare
`
`considered first and given the most weight. I have been told that extrinsic
`
`evidence, such as dictionaries, scientific references, expert testimony, and other
`
`materials that were not included in the public record associated with the patent, are
`
`considered less reliable in determining the meaning of a claim term. I also
`
`understand that if the intrinsic evidence provides a clear indication of the meaning
`
`of the claim term, then extrinsic evidence should not be considered.
`
`VII. THE MEANING OF “IRON POLYISOMALTOSE COMPLEX” AS
`USED IN THE ’450 PATENT
`I understand that the parties disagree about the meaning of the term
`49.
`
`“iron polyisomaltose complex.” I have been told that Pharmacosmos’s proposed
`
`
`
`21
`
`
`
`
`construction is “iron complexed to a carbohydrate that is a polysaccharide
`
`PGR2020-00009
`Patent No. 10,478,450
`
`consisting of many (at lea
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
