UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN HUMAN MILK
`OLIGOSACCHARJDES AND METHODS
`OF PRODUCING THE SAME
`
`Inv. No. 337-TA-1129
`
`INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
`RECOMMENDED DETERMINATION ON REMEDY AND BOND
`
`Administrative Law Judge Cameron Elliot
`
`(September 9, 2019)
`
`Pursuant to the Notice of Investigation and Rule 2i0.42(a) of the Rules of Practice and
`
`Procedure of the United States International Trade Commission. this is my Initial Determination
`
`in the matter of Certain Human Milk Oligosaccharides and Methods 0_fPr0dt.-cing the Same,
`
`Investigation N0. 337-TA-1120.
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`l.
`
`INTRODUCTION ............................................................................................................. I
`
`A.
`B.
`C.
`D.
`
`Procedural Background .......................................................................................... ..l
`The Parties ............................................................................................................. ..3
`The Asserted Patent and Claims ............................................................................ ..4
`Products at Issue .................................................................................................... ..6
`
`Domestic Industry Products........
`l.
`Accused Product ........................................................................................ ..7
`2.
`STANDARDS OF LAW ................................................................................................... 7
`
`II.
`
`A.
`
`Claim Construction ................................................................................................ ..7
`
`III.
`
`IV.
`
`D.
`
`B.
`C.
`
`Infringement ......................................................................................................... ..l 1
`Domestic Industry ................................................................................................ ..I2
`1.
`Technical Prong ....................................................................................... .. l2
`2.
`Economic Prong ....................................................................................... ..l3
`Invalidity.......................................................................................................... ..l5
`1.
`35 U.S.C. § l02.........
`........l5
`2.
`35 U.S.C.
`I03 ........................................................................................ ..l6
`3.
`35 U.S.C. § 112........................................................................................
`..1S
`Unenforceability .................................................................................................. ..20
`E.
`JURISDICTION AND IMPORTATION ..................................................................... 22
`
`U.S. PATENT NO. 9,970,018 ...................................................................
`
`................... 24
`
`A.
`B.
`C.
`
`D.
`
`Level of Ordinary Skill in the Art ........................................................................ .24
`Claims-at-Issue
`........24
`Claim Construction .............................................................................................. ..26
`
`Infringement ......................................................................................................... ..27
`l.
`Regarding the Jenncwein TTFLIZ Strain .................................................28
`2. DirectInfringementbytheJcnncwein#1540—
`........................................................................................................35
`_
`
`a.
`Undisputed Claim Limitations ..................................................... ..36
`
`b.
`
`Disputed Claim I Limitation “an exogenous functional [3­
`galactosidase gene comprising a detectable level of B~
`galactosidase activity that is reduced compared to that of a
`wild-type E. colt bacterium" .........................................................38
`
`i
`
`

`

`c.
`
`d.
`
`e.
`
`Disputed Claim I Limitation “wherein the level of [3­
`galactosidase activity comprises between 0.05 and 200 units”
`
`.....45
`
`Disputed Claim S “the method of claim 1, wherein Said
`exogenous functional |3-galactosidase gene comprises an E.
`coir lacZ.gene" ....................................................................... ..
`
`......57
`
`Disputed Claim 23 “the method ofclaim l, wherein said
`exogenous functional |3-galaetosidase gene is inserted into an
`endogenous gene” .................................................................. ..
`
`E.
`
`F.
`
`1.
`
`2.
`
`..
`Domestic Industry —Technical Prong............................................................
`Undisputed Claim Limitations ........................................................... ..
`Disputed Claim I Limitation “wherein the level of [3-galactosidase
`activity comprises between 0.05 and 200 units" ................................ ..
`Disputed Claim 9 “the method of claim 8, wherein the lacZ gene is
`inserted into an endogenous Ion gene” .............................................. ..
`Disputed Claim 23 “the method of claim I, wherein said exogenous
`functional Ii-galactosidase gene is inserted into an endogenous gene"
`Validity and Enforceability ............................................................................ ..
`Asserted Prior Art .............................................................................. ..
`I.
`
`3.
`
`4.
`
`......60
`
`......6l
`
`......62
`
`.... ..65
`
`......67
`
`67
`
`......68
`
`......68
`
`2.
`
`3.
`
`35 U.S.C. § I03 (Obviousness) .......................................................... ..
`35 U.S.C. § ll2,1l
`I (Enablement) .................................................... ..
`4.
`35 U.S.C. § 112,1] I (Written Description) .......................................
`..
`5.
`Inequitable Conduct ................................................................................. ..9U
`DOMESTIC INDUSTRY - ECONOMIC PRONG .................................................. 96
`
`......69
`
`...."82
`......89
`
`Qualifying Investments ........................................................................................ ..97
`A.
`"Significant" or “Substantial”.........................................................................
`..l l l
`B.
`CONCLUSIONS OF LAW .........................
`............................................................ 114
`
`V.
`
`VI.
`
`VII.
`
`RECOMMENDED DETERMINATION ON REMEDY AND BOND ................... 114
`
`LIMITED EXCLUSION ORDER..................................................................... ..l I6
`A.
`................................................................................................................ ..l I8
`BOND
`B.
`PUBLIC INTEREST ......................................................................................... ,,l I9
`C.
`INITIAL DETERMINATION AND ORDER ........................................................... 121
`
`VII].
`
`ii
`
`

`

`TABLE OF ABBREVIATIONS
`
`Complainant’s Demonstrative Exhibit
`
`Cornplainanfs Revised Initial Post-Hearing Brief
`
`Cornplainant’s Prc-Hearing Brief
`
`C-ornplainant‘s Physical Exhibit
`
`Comp1ainant’s Reply Post-Hearing Brief
`
`Cornplainant’s Exhibit
`
`CDX
`
`CIB
`
`CPB
`
`CPX
`
`CRB
`
`CX
`
`Dep. Tr.
`
`Deposition Transcript
`
`i Hr’g Tr.
`i]X
`
`Hearing Transcript
`
`Joint Exhibit
`
`RDX
`
`RIB
`
`RPB
`
`RPX
`
`RRB
`
`RX
`
`SDX
`
`SIB
`
`SPB
`
`SPX
`
`SRB
`
`SX
`
`Respondents’ Demonstrative Exhibit
`
`Respondents’ Initial Post-Hearing Brief
`
`Respondents’ Pre-Hearing Brief
`
`Respondents’ Physical Exhibit
`
`Respondents’ Reply Post-Hearing Brief
`
`Respondents‘ Exhibit
`
`Staffs Demonstrative Exhibit
`
`Staff’s Initial Post-Hearing Brief
`
`Staff s Pre-Hearing Brief
`
`Staffs Physical Exhibit
`
`Staffs Reply Post-Hearing Brief
`
`Staffs Exhibit
`
`iii
`
`

`

`I.
`
`INTRODUCTION
`
`A.
`
`Procedural Background
`
`Complainant Glycosyn LLC (“Glycosyn” or “Comp1ainant") filed the complaint
`
`underlying this Investigation on April 2, 2018, and then filed an amended complaint on May 16,
`
`2018.
`
`'I'he complaint alleged respondent Jennewein Biotechnologie GrnbH (“Jennewein” or
`
`“Respondent”) imports certain products that infringe one or more claims of U.S. Patent Nos,
`
`9,453,230 (the ‘"230 patent”) and 9,970,018 {_the ‘"018 patent” also referred to as JX-0003).
`
`By publication of a notice in the Federal Register on June 21, 2018. the U.S. International
`
`Trade Commission ordered that:
`
`Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as
`amended, an investigation be instituted to determine whether there is a
`violation of subsection (a)(l)(B) of section 337 in the importation into the
`United States, the sale for importation, or the sale within the United States
`after importation of products identified in paragraph (2) by reason of
`infringement of one or more of claims 1-40 of the ’230 patent; and claims
`1-28 of the ‘O18patent; and whether an industry in the United States exists
`as required by subsection (a)(2) of section 337[.]
`
`83 Fed. Reg. 23,865 (June 21, 2018). On July 16, 2018, the presiding administrative law judge set
`
`a target date of October 21, 2019 for completion of this investigation and set the evidentiary
`
`hearing for February 22, 2019. (Order No. 4.) On August 20, 2018, the administrative lawjudge
`
`issued the procedural schedule.
`
`(Order N0. 6.) On September 4, 2018, and due to the retirement
`
`of the presiding administrative law judge,
`
`the investigation was reassigned to the Chief
`
`Administrative Law Judge. (EDIS Doc. ID 654642.)
`
`In accordance with the issued procedural schedule, on October
`
`I6, 2018, the Chief
`
`Administrative Law Judge held a technology tutorial and Markman hearing, and on December 18,
`
`2018, issued Order No. 22, construing certain terms of the asserted patents.
`
`

`

`At times throughout the investigation, Glycosyn moved for the termination of certain
`
`asserted claims from those identified in the complaint. Specifically, on July 27, 2018, Glycosyn
`
`moved to terminate claims 4-7, 9-12, 14, 23-26, 28-31, 33, and 30-40 ofthe ’230 patent and claims
`
`6, 7, 9, 11, 13-17, 19, and 22 of the ’018 patent. The presiding administrative law judge at the
`
`time granted Glycosyn’s motion on August 9, 2018 with Order No. 5. The Commission
`
`determined not to review Order No. 5 on August 29. 2018. (EDIS Doc. l.D654274.) On October
`
`18, 2018, Glycosyn moved to terminate claims 1-3, 8, 13, and 15-20 ofthe ’230 patent. The Chief
`
`Administrative Law Judge granted G1ycosyn‘s motion on October 30, 2018 with Order No. 15.
`
`The Commission determined not to review Order No. 15 on November 29, 2018. (_EDISDoc. ID
`
`662881.) On November 9, 2018, Glycosyn moved to terminate claim 27 of the ’230 patent and
`
`claims 4, 20, and 21 ofthe ’0l8 patent. The Chief Administrative Law Judge granted G1ycosyn‘s
`
`motion on November 19, 2018 vfitb Order No. 17. The Commission determined not to review
`
`Order No. 17 on December 12, 2018.
`
`(EDIS Doc. 1D 663942.) Lastly, on January 30, 2019,
`
`Glycosyn moved to terminate claims 21, 22, 32, and 34-38 of the ’230 patent. The Chief
`
`Administrative Law Judge granted G1ycosyn‘s motion on February 8, 2019 with Order No. 25.
`
`The Commission determined not to review Order No. 25 on February 28, 2019.
`
`(EDIS Doc. ID
`
`668665.)
`
`lmportantly, Order No. 25 terminated the last remaining asserted claims of the ’230
`
`patent, thereby tenninating that patent
`
`in its entirety fi'on1 the investigation. Thus, the sole
`
`remaining patent in this investigation is the T113patent.
`
`Also during the investigation, Jennewein filed two summary determination motions of non­
`
`infringement with respect to certain of their processes for the manufacture of its accused product.
`
`The Chief Administrative Law Judge denied both motions on March 8, 2019 with Order Nos. 27
`
`and 28.
`
`2
`
`

`

`With respect to the procedural schedule, the govemment shutdown occurring between
`
`December of 2018 and January 0f2019 necessitated an extension of all deadlines and the target
`
`date in this investigation. At the completion of the shutdown, on January, 29, 2019, the Chief
`
`Administrative Law Judge issued Order No. 23 which moved the start of the evidentiary hearing
`
`to May l3, 2019. Accordingly, the Chief Administrative Law Judge set a new procedural schedule
`
`for all remaining deadlines on February 7, 2019 with Order No. 24 and also extended the target
`
`date of the investigation approximately eleven weeks to January 9, 2020 with Order No. 26, issuing
`
`on February 21, 2019. The Commission determined not to review Order No. 26 on March 14,
`
`2019. (EDIS D00. ID 670060.)
`
`Finally, on April 2, 2019 the investigation was reassigned a second time from the Chief
`
`Administrative Law Judge to me.
`
`(EDIS Doc. ID 671950.)
`
`I then conducted an evidentiary
`
`hearing between May I4, 2019 and May 17, 2019.
`
`Following the evidcntiary hearing, and pursuant to the procedural schedule, the parties
`
`submitted initial and reply post-hearing briefs on June 3, 2019 and June 17, 2019 respectively,
`
`Further, on June 10, 2019, Jertnewein moved to strike certain portions of Glycosyn’s initial post­
`
`hearing brief-—-amotion which I granted-in-part on June I4, 2019 with Order No. 38. On June l7.
`
`2019, Glycosyn submitted a revised initial post-hearing brief in accordance with that order.
`
`As of the date of this initial determination. no motions remain pending.
`
`B.
`
`The Parties
`
`Complainant Glycosyn LLC is organized and exists under the laws of Massachusetts. (SIB
`
`at .2.)
`
`ll was founded in 2002 to pursue research and development “of commercially-viable
`
`methods for synthesizing and producing human milk oligosaccharides, commonly known as
`
`HMOs. (CIB at 7.) While Glycosyn conducts its research and development in the United States,
`
`3
`
`

`

`it
`
`is currently linked with a Dutch production partner, Royal FrieslandCampina N.V.,
`
`to
`
`manufacture and distribute the 2‘-FL HMO for the infant formula market. (Id. at T-3; see RlB at
`
`3 (citing RX-0056).}
`
`Respondent Jennewein Biotechnologie GmbH is based in Germany, and founded in 2005
`
`for the similar purpose of researching means of manufacture for HMOs. (CIB at 8.) Jennewein
`
`claims it “is the true innovator and market leader for 2‘-FL in the United States" as “[n]o other
`
`company, including Glycosyn or its partner, is supplying Z‘-FL to American consumers.” (RIB at
`
`4 (citing Hr’g Tr. at 57:3-4; RX-0385C at Q1813);see SIB at 3.)
`
`in this investigation, and as
`
`described further below, Glycosyn has alleged Jenncwein‘s methods of producing 2‘-FL imported
`
`into the United States infringe the ’018 patent. Ud.)
`
`C.
`
`The Asserted Patent and Claims
`
`The asserted patent relates to compositions and methods for providing engineered bacteria
`
`to produce certain HMOs. The following claims remain at issue in this investigation:
`
`Patent Number
`
`Infringement Claims
`
`DomesticIndustry Claims
`
`"U18 patent
`
`l~3, 5, S, l0, 12, 18, 23—2S
`
`l-3, 5, 8-I4,
`
`l8, 22~28
`
`(See CIB at l5-16.)
`
`The ’O]8 patent is entitled, “Biosynthesis of Human Milk Oligosaccharides in Engineered
`
`Bacteria." (JX-0003.)
`
`It was tiled on September 2], 2017, and claims priority as a continuation
`
`application of an application filed on February 24, 2017, itself a continuation of an application
`
`filed on September 23, 2013, which was a division of an application filed on February I6. 2012.
`
`4
`
`

`

`(10/.) Through these applications,
`
`the ‘U18 patent also claims liirther priority to a provisional
`
`application filed on February 16, 2011.
`
`(1d.) ' The ‘O18patent issued on May 15, 2018.
`
`The ‘O18patent generally describes “compositions and methods for engineering bacteria
`
`to produce fueosylated oligosaeeharides, and the use thereof‘ in the prevention or treatment of
`
`infection." (See id. at Abstract.) The patent explains:
`
`Human milk contains a diverse and abundant set of neutral and acidic
`oligosaceharides (human milk oligosaceharides, HMOS). Many of these
`molecules are not utilized directly by infants for nutrition, but
`they
`nevertheless serve critical roles in the establishment of a healthy gut
`microbiome, in the prevention of disease, and in immune function. Prior to
`the invention described herein, the ability to produce HMOS inexpensively
`at large scale was problematic. For example, HMOS production through
`chemical synthesis was limited by stereo-specificity issues, precursor
`availability, product impurities, and high overall cost. As such, there is a
`pressing need for new strategies to inexpensively manufacture large
`quantities of HMOS for a variety ofeommercial applications.
`
`(Id. at 1:34-47.)
`
`In some methods disclosed in the patent, an E. colt‘ bacterium is used. The
`
`bacterium is engineered in several ways that assist the production and collection of the desired
`
`oligosaceharide. For example, the bacterium may be engineered by the addition, deletion, or
`
`inactivation of genes to: create the desired oligosaceharide from first and second basic sugar
`
`building blocks (ve.g.,fueosyltranslerase gene, GDP-fucose synthesis pathway); improve the ability
`
`to intake the sugar building b1ock(s) from an outside medium (e.g., lactose pcrmease gene);
`
`inactivate certain pathways that compete with oligosaeeharide production (e.g., colonic acid
`
`synthesis gene); and produce certain enzymes which compete with oligosaccharide production but
`
`otherwise assist later steps of purification and retrieval of the oligosaccharide (e.g., functional 13­
`
`galaetosidase gene). (See id. at 1:51-60, 3:44-50.)
`
`The effective date of the asserted patents pre-dates the America lnvents Act (“ALA”)
`'
`enacted by Congress on September 16, 2011.
`
`5
`
`

`

`This last purpose,
`
`involving [3-galaetosidase activity,
`
`is pointedly in dispute in this
`
`investigation. The ’0l 8 patent describes one particularly relevant example of E. coli engineering
`
`and culturing:
`
`Also described herein are bacterial host cells with tl1eability to accumulate
`a[n]
`intracellular
`lactose pool while simultaneously possessing low,
`functional
`levels of cytoplasmic B-galactosidase activity, for example as
`provided by the introduction of a functional rccombinantE. coli laeZ gene,
`or by a B-galactosidase gene from any of a number of other organisms . . ..
`Low,
`functional
`levels of
`cytoplasmic B-galactosidase
`include
`[3­
`galactosidase activity levels, of between 0.05 and 200 units, e.g., between
`0.05 and 5 units. between 0.05 and 4 units, between 0.05 and 3 units, or
`between 0.05 and 2 units (for unit definition see: Miller J H, Laboratory
`CSH. Experiments in molecular genetics. Cold Spring Harbor Laboratory
`Cold Spring Harbor, N.Y.; I972; incorporated herein by reference). This
`low level of cytoplasmic B-galactosidase activity, while not high enough to
`significantly diminish the intracellular lactose pool. is nevertheless very
`useful for tasks such as . . . the facile removal ofundesired residual lactose
`at the end of fennentations.
`
`(‘O18 patent at 7:22-45.)
`
`In this art, and as used throughout this initial determination, genes are
`
`normally identified with a starting lower-ease letter and in italics (e._g.,lm;'Z), and the peptide
`
`created from that gene starts in upper case with no italics (e.g., LaCZ). (RX-0384C at Q1511;(IX­
`
`0004C at Q6l.)2
`
`Glycosyn contends it owns the ‘O18patent, which is reflected in the assignment filed with
`
`its prosecution history (CIB at 31 (citing JX-0006 at -4790; ’0l 8 patent)) and neither Jennewein
`
`nor the Staffdisputes ownership (see SIB at 3; see generalfiz RIB; RRB).
`
`D.
`
`Products at Issue
`
`I.
`
`Domestic Industry Products
`
`The domestic industry products in this investigation consist of certain non comn1ercial~
`
`level amounts of 2’-FL produced by Glycosyn within the United States as part of its research and
`
`The ‘O18 patent does not itself necessarily follow the italics scheme for genes.
`2
`e.g., ’0l8 patent at T126.)
`
`(See,
`
`6
`
`

`

`development efforts. (CIB at 92 (citing CX-0059C; CX-0131C; CX-0064C); CX-0004C at Q124­
`
`l25.) Glycosyn identifies its E997 bacterial strain as practicing at least one claim of the ‘O18
`
`patent. and contends many other strains are fairly represented by E997 with respect to this issue.
`
`(CIB at 15-16 (citing CX-0004 at Q99, 123), 126 n.8, 9.) Glycosyn claims the following strains,
`
`developed since 2015, are represented by its E997 strain as patent practicing:
`
`Products at Issue
`
`| Representative Product
`E997
`
`(C-[Bat 126 n.9 (citing CXJJOUZC at Q10"/A108; CX~l)06UC; CX~OO5SC;CX~OO59C; CX-0130(1).)
`
`2.
`
`Accused Product
`
`The accused product
`
`in this case is 2‘-FL which Jennewein has imported or sold for
`
`importation into the United States (“Accused Product”) using methods claimed in the ‘O18 patent.
`
`In this investigation, Glycosyn has accused Jennewein’s 2’-FL production methods based on an E.
`
`mam-1Th==#154@
`
`Jenneweinseeksadjudicationof-
`
`knownas TTFL]2. For reasonsdiscussedbelow,I do not
`
`find adjudication ofTTFL12 is warranted at this time.
`
`ll.
`
`STANDARDS OF LAW
`
`A.
`
`Claim Construction
`
`“The construction of claims is simply a way of elaborating the normally terse claim
`
`language in order to understand and explain, but not to change, the scope of the claims.” Emlirex,
`
`Inc. v. Serv. Engjg Corp, 216 F.3d 1343, 1347 (Fed. Cir. 2000). Although most of the disputed
`
`7
`
`

`

`claim terms were construed in an earlier order, some of the issues presented below are only
`
`resolvable with additional claim construction. (See Order No. 22.)
`
`Claim construction focuses on the intrinsic evidence, which consists of the claims
`
`themselves, the specification, and the prosecution history. See Pfiillips v. AWH Corp., 415 F.3d
`
`I303, I314 (Fed. Cir. 2005) (en bane); see also Marlcrnan v. Westview Instri, Inca, 52 F.3d 967,
`
`979 (Fed. Cir. 1995) (en bane). As the Federal Circuit in Phillips explained, courts must analyze
`
`each of these components to determine the “ordinary and customary meaning of a claim term” as
`
`understood by a person of ordinary skill in art at the time of the invention. 415 F.3d at 1313.
`
`“Such intrinsic evidence is the most significant source of the legally operative meaning of disputed
`
`claim language.” Bel! Ail. Network Servs., Inc. v. Comd Coimrtdns Grp., IPILZ,262 F.3d 1253,
`
`1267 (Fed. Cir. 2001).
`
`"lt is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to
`
`which the patentee is entitled the right
`
`to exclude?”
`
`Phillips, 41.5 F.3d at 1312 (quoting
`
`lrmova/Pure Water. Inc". v. Sajiari Water Filtration S_}’S.,Ina, 38] F.3d llll,
`
`lll5
`
`(Fed. Cit‘.
`
`20l)4')). “Quite apart from the written description and the prosecution history,
`
`the claims
`
`themselves provide substantial guidance as to the meaning ofpaiticular claims terms.” Id. at 1314;
`
`see Interactive Gift Fbrpress, Inc. v. Conrpuserve Ina, "256F.3d l323, I331 (Fed. Cir. 2001) (“In
`
`construing claims, the analytical focus must begin and remain centered on the language of the
`
`claims themselves, for it is that language that the patentee chose to use to ‘particularly point [ ] out
`
`and distinctly claim [ ] the subject matter which the patentee regards as his invention.”). The
`
`context i.nwhich a term is used in an asserted claim can be “highly instructive.” Phillips, 415 F.3d
`
`at l3|4. Additionally, other claims in the same patent, asserted or unasserted, may also provide
`
`guidance as to the meaning of a claim term. hi “Courts do not rewrite claims; instead, we give
`
`8
`
`

`

`effect to the terms chosen by the patentcc.” K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1364 (Fed.
`
`Cir. 1999).
`
`“[T]he specification ‘is always highly relevant to the claim construction analysis. Usually
`
`it is dispositive; it is the single best guide to the meaning ofa disputed term.’” Phillips, 415 F.3d
`
`at I315 (quoting V.r'rrom'csCorp. 11.Conceptromic, Inc, 90 F.3d 1576, ISSZ (Fed. Cir. 1996)).
`
`“[T]he specification may reveal a special definition given to a claim term by the patentee that
`
`differs from the meaning it would otherwise possess. In such cases, the inventor‘s lexicography
`
`governs.” Id. at I316. “ln other cases, the specification may reveal an intentional disclaimer, or
`
`disavowal, of claim scope by the inventor.” Id. As a general rule, however, the particular examples
`
`or embodiments discussed in the specification are not to be read into the claims as limitations. Id.
`
`at I323.
`
`In the end, “[t]he construction that stays true to the claim language and most naturally
`
`aligns with the patent’s description ofthe invention will be
`
`the correct construction." Id. at 1316
`
`(quoting Renishaw PLC v. Morposs S0ciela'per Azioni, 158 F.3d I243, l25D (Fed. Cir. 1998)).
`
`lu addition to the claims and the specification, the prosecution history should be examined,
`
`iI'in evidence.
`
`Id. at 1317; see Liebe!~FIai'she1‘mC0. 1/.Medrad, Inc, 358 F.3d 893, 913 (Fed. Cir.
`
`2004). The prosecution history can “often inform the meaning of the claim language by
`
`demonstrating how the inventor understood the invention and whether the inventor limited the
`
`invention in the course of prosecution. making the claim scope narrower than it would otherwise
`
`be.” Piwillips,415 F.3d at 1317; see Chimie v. PPG Indus. Int-., 402 F.3d I371, I384 (Fed. Cir.
`
`2005) (“The ptupose of consulting the prosecution history in construing a claim is to exclude any
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`interpretation that was disclaimed during prosecution”).
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`When the intrinsic evidence does not establish the meaning of a claim, then extrinsic
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`evidence (i‘.e., all evidence external
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`to the patent and the prosecution history,
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`including
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`9
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`

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`dictionaries,
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`inventor testimony, expert testimony, and learned treatises) may be considered.
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`Phillips, 4l5 F.3d at I317. Extrinsic evidence is generally viewed as less reliable than the patent
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`itself and its prosecution history in determining how to define claim tem-ts. Id. “The court may
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`receive extrinsic evidence to educate itself about the invention and the relevant technology, but the
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`court may not use extrinsic evidence to arrive at a claim constmction that is clearly at odds with
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`the construction mandated by the intrinsic evidence.” Elkay Mfg. C0. v. Ebco Mfg. Co., I92 F.3d
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`973, 977 (Fed. Cir. 1999).
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`The construction of a claim term is generally guided by its ordinary meaning. However,
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`courts may deviate from the ordinary meaning when: (1) “the intrinsic evidence shows that the
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`patentee distinguished that term from prior an on the basis of a particular embodiment, expressly
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`disclaimed subjeet matter, or described a particular embodiment as important to the invention;” or
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`(2) “the patentee acted as his own lexieographer and clearly set forth a definition of the disputed
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`claim term in either the specification or prosecution history.” Edwards LzfesciencesLLC v. Cook
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`inch, 582 F.3d 1322, i329 (Fed. Cir. 2009); see GE Lighting Sols., LLC v. Agilight, 11:13.,750 F.3d
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`I304, 1309 (Fed. Cir. 2014) (“the specification and prosecution history only compel departure
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`from the plain meaning in two instances: lexicography and disavowal”); Omega Eng ‘g, Inc, it
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`Raytek Corp, 334 F.3d l3l4, 1324 (Fed. Cir. 2003) ("[W]here the patentee has unequivocally
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`disavowed a certain meaning to obtain his patent, the doctrine ofprosecution disclaimer attaches
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`and narrows the ordinary meaning of the claim congruent with the scope of the surrenden”); Rheox.
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`Inc. v. Entact, Inc, 276 F.3d 1319, 1325 (Fed. Cir. 2002) (“The prosecution history limits the
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`interpretation of claim terms so as to exclude any interpretation that was diselaimed during
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`prosccution.”). Nevertheless, there is a “heavy presumption that a claim term carries its ordinary
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`and customary meaning." CCS F itness, Inc. v. Br:-mswickCorp, 288 F.3d 1359, 1366 (Fed. Cir.
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`I0
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`

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`2002) (citations omitted). The standard for deviating from the plain and ordinary meaning is
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`“exacting” and requires “a clear and unmistakable disclaimer.“ Thor-tierv. Sony Computer Emm ‘t
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`Am. LLC, 669 F.3d 1362, 1366-67 (Fed. Cir. 2012); see Epistar Corp. v. In! '1Trade Comm '12,566
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`F.3d 1321, 1334 (Fed. Cir. 2009) (requiring “expressions of manifest exclusion or restriction,
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`representing a clear disavowal of claim scope” to deviate from the ordinary meaning) (citation
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`omitted).
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`B.
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`Infringement
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`"An infringement analysis entails two steps. The first step is detemiining the meaning and
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`scope of the patent claims asserted to be infringed. The second step is comparing the properly
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`construed claims to the device accused of infringing." Markmari, 52 F.3d at 976.
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`A patentee may prove infiingement either literally or under the doctrine of equivalents.
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`Infringement of either Sort must be proven by a preponderance of the evidence. Smi'thK1ine
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`Diagnostics, Inc. v. Helena Labs. Corp, 859 F.2d S78, 889 (Fed. Cir. 1988). A preponderance of
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`the evidence standard “requires proving 1.l1atinfringement was more likely than not
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`to have
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`occurred.” Warner-Lambert Co. v. Teva Pharm. USA, Inc-.,418 F.3d 1326, 1341 n.l5 (Fed. Cir.
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`2005)
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`Literal infringement, a form of direct infringement, is a question of fact. Fittisar Corp. 1*.
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`DirecTV Group, [rtc., 523 F.3d 1323, 1332 (Fed. Cir. 2008). “To establish literal infringement,
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`every limitation set forth in a claim must be found in an accused product. exactly." Microsqfi
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`Corp. V. GeoTag, Ina, S17 F.3d I305, 1313 (Fed. Cir. 2016) (quoting Scmtltwal! Techs., Inc. v.
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`Cardina!1G Ct;-.,54 F.3d I570, I575 (Fed. Cir. 1995). If any claim limitation is absent, there is
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`no literal infringement of that claim as a matter of law. Bayer AG v.Elan Piiarm. Research C0rp.,
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`2.12 F.3d 1241, 1247 (Fed. Cir. 2000).
`
`ll
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`

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`Doctrine of equivalents is also a form of direct infringement. One rubric Forevaluating if
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`a claimed feature is not literally, but nonetheless equivalent to, a claimed feature is known as the
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`fimction-way-result test. Under this test, the accused feature is equivalent to the claim limitation
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`when “it performs substantially the same fimction in substantially the same way to Obtain the same
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`result.” Duncan Parking Techs, Inc. v. IPS Grp.. Ina, 914 F.3d 1347, I362 (Fed. Cir. 2019)
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`(quoting Graver Tank & Mfg. Co. v. Linda Afr Prods. Ca, 339 U.S. 605, 608 (1950)). Another
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`test is known as in the insubstantial differences test, where “[a]n element in the accused device is
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`equivalent to a claim limitation if the only differences between the two are insubstantial." Veda
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`v. Gordie Corp, 536 F.3d 131l, l 139 (Fed. Cir. 2003). The Supreme Court has further instructed,
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`"the proper time for evaluating equivalency . . . is at the time of infringement, not at the time the
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`patent was issued." Warner‘-Jenkinson Ca,
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`inc. v. Hilton Davis Chem. C0., 520 U.S. I7, 37
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`( I997).
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`C.
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`Domestic Industry
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`ln an investigation based on a claim of patent infringement, Section 337 requires that an
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`industry in the United States, relating to the articles protected by the patent, exist or be in the
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`process of being established. I9 U.S.C. § l337(a)(2). Under Commission precedent, the domestic
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`industry requirement has been divided into (i) a “technical prong” ” (which requires articles
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`covered by the asserted patent) and (ii) an “economic prong” (which requires certain levels of
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`activity with respect to the protected articles or patent itself). See Certain Video Game i511/stems
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`and C0m'r0Ner'.s',lnv. No. 337-TA-743, Co'mm’n Op. at 6-7 (April 14, 2011) (“Video Game
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`Systems“).
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`l.
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`Technical Prong
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`The technical prong of the domestic industry requirement is satisfied when the complainant
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`in a patent-based section 337 investigation establishes that it is practicing or exploiting the patents
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`I2
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`

`

`at issue. See 19 U.S.C. §§ 1337 (a)(2), (3); Certain Mir-rospiiere Adhesives, Pracessjbr Making
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`Same and Prods. Containing Same, Incliiding Sei;'¥.S‘iickRepositionable Notes, lnv. No. 337-TA­
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`366, C0mm’n Op. at 8 (U.S.l.T.C. Jan. 16, 1996). “In order to satisfy the technical prong of the
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`domestic industry requirement, it is sufficient to show that the domestic industry practices any
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`claim of that patent, not necessarily an asserted claim of that patent.” Certain Ammonium
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`Ocfarnuivbdaie isomers, lnv. No. 337-TA-477, Comofn Op. at S5 (U.S.l.T.C. Aug. 28, 2003).
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`The test for claim coverage for the purposes of the technical prong of the domestic industry
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`requirement is the same as that for infiingement. See Certain Doxoriibicin and Preparations
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`Containing Same, Inv. No. 337-TA-300, initial Determination at 109 (U.S.l.T.C. May 21, 1990),
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`affd, Views of the Commission at 22 (U.S.l.T.C. Oct. 31, 1990); Aiioc, Inc. v. Int’! Trade
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`Comm ‘ii, 342 F.3d 1361. 1375 (Fed. Cir. 2003). “First. the claims of the patent are construed.
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`Second, the complainant‘s article or process is examined to determine whether it falls within the
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`scope of the claims.” Certain Doxorabicin and Preparations Containing Same, Inv. N0. 337'-TA­
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`300, Initial Detennination at 109. As with infringement, the technical prong of the domestic
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`industry can be satisfied either literally or under the doctrine of equivalents. Certain Dynamic‘
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`Sequential Gradient Devices and Componen