UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Clark S. Cheney
`Administrative Law Judge
`
`
`Investigation No. 337-TA-1207
`
`In the Matter of
`
`CERTAIN PRE-FILLED SYRINGES
`FOR INTRAVITREAL INJECTION
`AND COMPONENTS THEREOF
`
`
`COMPLAINANTS’ OPENING MARKMAN BRIEF
`
` 
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`
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`
` 
`
`Regeneron Exhibit 1069.001
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

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`
`
`TABLE OF CONTENTS
`INTRODUCTION ................................................................................................................... 1
`
`I.
`
`II. BACKGROUND ..................................................................................................................... 3
`
`A. The Invention of the ʼ631 Patent ......................................................................................... 3
`
`B. The Disputed Claim Terms .................................................................................................. 6
`
`C. Relevant Prosecution History of the ʼ631 Patent ................................................................. 7
`
`D. Procedural History ............................................................................................................... 9
`
`III.
`
`LEGAL STANDARDS ..................................................................................................... 10
`
`A. Claim Construction ............................................................................................................ 10
`
`B.
`
`Indefiniteness ..................................................................................................................... 10
`
`IV. ARGUMENT ..................................................................................................................... 12
`
`A. The Term “About” Has a Clear Meaning in the Relevant Claims, Particularly Given the
`Specification’s Express Guidance. ............................................................................................ 12
`
`i. A Skilled Artisan Would Apply the ±10% Meaning of “About” to the Silicone Oil
`Claims. ................................................................................................................................... 14
`
`ii. A Skilled Artisan Would Apply the ±10% Meaning of “About” to the Force Claims. 16
`
`B. Regeneron’s Attempt To Manufacture Uncertainty as to the use of “About” in Certain
`Claims Is Baseless. .................................................................................................................... 18
`
`V. CONCLUSION ..................................................................................................................... 21
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`i
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`Regeneron Exhibit 1069.002
`Regeneron v. Novartis
`IPR2020-01317
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`

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`
`CASES:
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Acumed LLC v. Stryker Corp.,
`483 F.3d 800 (Fed. Cir. 2007)..................................................................................................11
`
`Allergan Sales, LLC v. Lupin Ltd.,
`No. 11-cv-530, 2013 WL 4519609 (E.D. Tex. Aug. 21, 2013) .................................................2
`
`Allergan, Inc. v. Teva Pharms. USA, Inc.,
`No. 15-cv-1455, 2016 WL 7210837 (E.D. Tex. Dec. 13, 2016) .......................................12, 18
`
`BJ Servs. Co. v. Halliburton Energy Servs., Inc.,
`338 F.3d 1368 (Fed. Cir. 2003)............................................................................................2, 13
`
`Cargill, Inc. v. Canbra Foods, Ltd.,
`No. 03-cv-1209, 2005 WL 8177016 (D. Or. Nov. 22, 2005) ....................................................2
`
`In re Certain Liquid Crystal Display Devices & Prods. Containing the Same, No.
`337-TA-631, Order No. 29, 2010 WL 5642163 (Dec. 2010) .....................................................2
`
`In the Matter of Certain Magnetic Tape Cartridges & Components Thereof,
`Inv. No. 337-TA-1036, Initial Determination, 2018 WL 4634919
`(Jan. 25, 2018)......................................................................................................................2, 20
`
`In the Matter of Certain Microelectromechanical Sys. (Mems Devices) & Prod.
`Containing the Same,
`Inv. No. 337-TA-876, Order No. 53, 2014 WL 507477 (Jan. 29, 2014) ...................................2
`
`In the Matter of Certain Reduced Ignition Proclivity Cigarette Paper Wrappers &
`Prod. Containing Same,
`Inv. No. 337-TA-756, Order No. 15, 2011 WL 3646182 (Aug. 18, 2011) ...............................2
`
`Cohesive Techs., Inc. v. Waters Corp.,
`543 F.3d 1351 (Fed. Cir. 2008)............................................................................................2, 13
`
`Cox Commc’ns, Inc. v. Sprint Commc’ns Co. LP,
`838 F.3d 1224 (Fed. Cir. 2016)................................................................................................11
`
`Duraflame, Inc. v. Hearthmark, LLC,
`No. 12-cv-1205, 2013 WL 594241 (N.D. Cal. Feb. 14, 2013) ............................................2, 19
`
`Eiselstein v. Frank,
`52 F.3d 1035 (Fed. Cir. 1995)..................................................................................................12
`
`ii
`
`Regeneron Exhibit 1069.003
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
`
`Exmark Manuf. Co. v. Birggs & Stratton Power Prods. Grp., LLC,
`879 F.3d 1322 (Fed. Cir. 2018)................................................................................................11
`
`Ferring B.V. v. Watson Labs., Inc.,
`No. 11-cv-481, 2013 WL 499158 (D. Nev. Feb. 6, 2013) .........................................................2
`
`General Hosp. Corp. v. Sienna Biopharms., Inc.,
`888 F.3d 1368 (Fed. Cir. 2018)..........................................................................................18, 19
`
`Glaxo, Inc. v. Novopharm, Ltd.,
`110 F.3d 1562 (Fed. Cir. 1997)................................................................................................10
`
`Guangdong Alison Hi-Tech Co. v. ITC,
`936 F.3d 1353 (Fed. Cir. 2019)................................................................................................11
`
`Kluhsman Mach., Inc. v. Dino Paoli SRL,
`No. 19-cv-20, 2020 WL 422740 (W.D.N.C. July 23, 2020) ...................................................12
`
`Laryngeal Mask Co. v. Ambu,
`618 F.3d 1367 (Fed. Cir. 2010)................................................................................................10
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995)....................................................................................................10
`
`Merck & Co. v. Teva Pharm. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005)..................................................................................2, 3, 12, 19
`
`Modine Mfg. Co. v. U.S. Int’ Trade Comm’n,
`75 F.3d 1545 (Fed. Cir. 1996)..............................................................................................2, 12
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ...........................................................................................................10, 11
`
`Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Lab, Ltd.,
`476 F.3d 1321 (Fed. Cir. 2007)................................................................................2, 12, 13, 18
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)................................................................................................10
`
`Sonix Tech. Co. v. Publ’ns Int’l, Ltd.,
`844 F.3d 1370 (Fed. Cir. 2017)..........................................................................................11, 21
`
`Telcorida Techs., Inc. v. Cisco Sys., Inc.,
`612 F.3d 1365 (Fed. Cir. 2010)................................................................................................11
`
`TransWeb, LLC v. 3M Innovative Properties Co.,
`No. 10-4413, 2011 WL 5825782 (D. N.J. Nov. 16, 2011) ..................................................2, 20
`
`iii
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`Regeneron Exhibit 1069.004
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
`
`Young v. Lumenis, Inc.,
`492 F.3d 1336 (Fed. Cir. 2007)............................................................................................2, 20
`
`STATUTES:
`
`35 U.S.C. § 112, ¶ 2 .......................................................................................................................10
`
` 
`
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`
`iv
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`Regeneron Exhibit 1069.005
`Regeneron v. Novartis
`IPR2020-01317
`
`

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` 
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`
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`Ex. #
`1
`2
`3
`4
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`5
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`6
`
`7
`8
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`9
`
`TABLE OF EXHIBITS
`
`Exhibit Description
`U.S. Patent No. 9,220,631 (“the ʼ631 patent”)
`Declaration of Dr. Karl Leinsing (“Leinsing Decl.”)
`Originally-Filed Application, ʼ631 Patent Prosecution History Excerpt
`Aug. 16, 2013 Preliminary Amendment, ʼ631 Patent Prosecution History
`Excerpt
`Nov. 24, 2014 Amendment and Response, ’631 Patent Prosecution History
`Excerpt
`July 17, 2015 Amendment and Response, ’631 Patent Prosecution History
`Excerpt
`May 14, 2014 Non-Final Rejection, ʼ631 Patent Prosecution History Excerpt
`Aug. 13, 2014 Amendment and Response, ʼ631 Patent Prosecution History
`Excerpt
`U.S. Patent Application Publication No. 2020/0155760 A1 (May 21, 2020)
`
`
`v
`
`Regeneron Exhibit 1069.006
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
`
`I.
`
`INTRODUCTION
`
`This investigation relates to the unlawful importation and sale by Respondent Regeneron
`
`Pharmaceuticals, Inc. (“Regeneron”) of certain pre-filled, terminally sterilized syringes that
`
`infringe the U.S. patent owned by the Novartis Complainants (“Novartis”), U.S. Patent No.
`
`9,220,631 (the “’631 patent”) (Ex. 1). The ’631 patent claims a novel prefilled-syringe that is used
`
`to inject medications called VEGF-antagonists into the vitreous chamber of the eye. The claimed
`
`prefilled syringe is terminally sterilized, has a low number of particulates, and low amounts of
`
`silicone oil, while at the same time achieving low break loose and glide forces (the forces required
`
`to make the stopper start moving from its resting place in the syringe barrel and to continue moving
`
`the stopper in the syringe barrel after movement has begun, respectively). This combination of
`
`characteristics had been considered unachievable prior to the inventions of the ’631 patent.
`
`The present dispute regarding construction of the ’631 patent is exceptionally narrow, as
`
`the Parties have identified just two sets of claim terms for construction. As to each set, the Parties’
`
`dispute turns entirely on the claims’ use of “about” as a qualifier to a numerical range. One set of
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`claim terms concerns the use of “about” to describe the amount of silicone oil present in the pre-
`
`filled, terminally sterilized syringe:
`
`“about 1 ug to 100 ug silicone oil” (claim 1); “about 3 ug to about
`100 ug silicone oil” (claim 3); and “about 1-50 ug silicone oil”
`(claim 22).
`
`See Ex. 1 at claims 1, 3, 22. The second set of claim terms at issue concerns the use of “about” in
`
`descriptions of the amount of force (break loose force and glide force) required to operate the
`
`syringe:
`
`“less than about 11N” (claim 1, 16), and “less than about 5N” (claim
`14).
`
`See Ex. 1 at claims 1, 14, 16. In each instance, respondent Regeneron has declined to offer a
`
`1
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`Regeneron Exhibit 1069.007
`Regeneron v. Novartis
`IPR2020-01317
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`

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` 
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`construction for the claim. Instead, Regeneron is using claim construction to effectively seek a
`
`summary determination of invalidity on the theory that the claim terms are indefinite merely
`
`because they use “about.”
`
`Regeneron bears the burden of proving all facts in support of its invalidity defense by clear
`
`and convincing evidence, and it falls well short of its burden. It is utterly commonplace for patent
`
`claims to use terms of degree like “about”— the Federal Circuit,1 district courts,2 and judges in
`
`ITC proceedings3 have routinely construed the term “about” and they have repeatedly rejected
`
`challenges based on indefiniteness. Indeed, the ’631 patent uses “about” in several claims that
`
`Regeneron has not challenged, belying its contention that the term as used in this patent somehow
`
`fails to provide sufficient objective boundaries to a person of ordinary skill in the art. See p. 12,
`
`infra.
`
` 
`1 See, e.g., Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1369–71 (Fed. Cir. 2008); Ortho-
`McNeil Pharm., Inc. v. Caraco Pharm. Lab, Ltd., 476 F.3d 1321, 1326–28 (Fed. Cir. 2007); Merck
`& Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1369–72 (Fed. Cir. 2005); BJ Servs. Co. v.
`Halliburton Energy Servs., Inc., 338 F.3d 1368, 1372–73 (Fed. Cir. 2003); Modine Mfg. Co. v.
`U.S. Int’ Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996); cf. Young v. Lumenis, Inc., 492
`F.3d 1336, 1345–47 (Fed. Cir. 2007) (holding that use of the term “near” did not make claims
`indefinite).
`2 See, e.g. Allergan Sales, LLC v. Lupin Ltd., No. 11-cv-530, 2013 WL 4519609, at *8–9 (E.D.
`Tex. Aug. 21, 2013); Duraflame, Inc. v. Hearthmark, LLC, No. 12-cv-1205, 2013 WL 594241, at
`*8 (N.D. Cal. Feb. 14, 2013); Ferring B.V. v. Watson Labs., Inc., Lead No. 11-cv-481, 2013 WL
`499158, at *10 (D. Nev. Feb. 6, 2013); TransWeb, LLC v. 3M Innovative Properties Co., No. 10-
`4413, 2011 WL 5825782, at *8 (D. N.J. Nov. 16, 2011); Cargill, Inc. v. Canbra Foods, Ltd., No.
`03-cv-1209, 2005 WL 8177016, at *3 (D. Or. Nov. 22, 2005).
`3 See, e.g., In the Matter of Certain Magnetic Tape Cartridges & Components Thereof, Inv. No.
`337-TA-1036, Initial Determination, 2018 WL 4634919, at *105–107 (Jan. 25, 2018); In the
`Matter of Certain Microelectromechanical Sys. (Mems Devices) & Prod. Containing the Same,
`Inv. No. 337-TA-876, Order No. 53, 2014 WL 507477, at *114–116 (Jan. 29, 2014); In the Matter
`of Certain Reduced Ignition Proclivity Cigarette Paper Wrappers & Prod. Containing Same, Inv.
`No. 337-TA-756, Order No. 15, 2011 WL 3646182, at *3–4 (Aug. 18, 2011); In re Certain Liquid
`Crystal Display Devices & Prods. Containing the Same, No. 337-TA-631, Order No. 29, 2010 WL
`5642163, at *96 (Dec. 2010).
`
`2
`
`Regeneron Exhibit 1069.008
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
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`Even absent express guidance from the intrinsic record about the meaning of “about,”
`
`courts have had no difficulty construing the term, as they generally apply “its ordinary meaning of
`
`‘approximately.’” Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1371 (Fed. Cir. 2005).
`
`Here, construction of “about” is particularly easy, because the specification provides further
`
`guidance on how to apply the term, stating that “[t]he term ‘about’ in relation to a numerical value
`
`x means, for example, x ±10%.” Ex. 1 at 10:28–29. As discussed below, a skilled artisan, as the
`
`of the effective filing date, would have read this statement to provide a benchmark for applying
`
`the term “about” in the patent claims. Such a person also would have concluded that the x±10%
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`range provides an appropriate framework for approximation with respect to the silicone oil and
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`force limitations that Regeneron has challenged.
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`Given the well-established ordinary meaning of “about,” the additional guidance provided
`
`by the ʼ631 patent’s specification, and the expert testimony put forward by Novartis regarding how
`
`a skilled artisan would apply these claims in the context of the invention, Regeneron cannot show
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`by clear and convincing evidence that claims using this common term of degree are indefinite.
`
`II. BACKGROUND
`A.
`
`The Invention of the ʼ631 Patent
`
`The ’631 patent is directed to the invention of a terminally-sterilized pre-filled syringe for
`
`injection of a class of biologic drugs called VEGF antagonists into the eye. In a prefilled syringe
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`presentation, the drug is sold already inside the syringe to be used for injection. Declaration of
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`Dr. Karl Leinsing ¶ 19 (“Leinsing Decl.”) (Ex. 2). Such a syringe is made up of several parts,
`
`including a barrel, stopper, plunger, and needle. Id. To work properly, a prefilled syringe for
`
`intravitreal injections must allow the physician to administer an easy, controlled injection without
`
`using too much force. Ex. 1 at 5:27–34.
`
`3
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`Regeneron Exhibit 1069.009
`Regeneron v. Novartis
`IPR2020-01317
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`

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`Many syringe barrels, particularly for sensitive biologic drugs like proteins, are made from
`
`glass, which is less likely than plastic to cause undesired interactions with a drug formulation. Ex.
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`2 ¶¶ 19, 24. Glass syringes, regardless of whether they are pre-filled, generally require lubrication
`
`to ensure that the stopper can move easily enough for use during injection. Id. ¶ 24. Silicone oil
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`is a lubricant used to coat the inside of syringe barrels and stoppers. Id. The oil reduces friction
`
`and enables the stopper to move smoothly within the syringe barrel as measured by break loose
`
`and glide forces. Id. Silicone oil can be sprayed onto the interior of the syringe barrel alone or as
`
`an emulsion with water and chemical emulsifiers.4 Id. ¶ 25.
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`As described in the patent specification, there was a long-felt need as of the priority date
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`to develop a terminally-sterilized, pre-filled syringe that maintains low injection forces (and thus
`
`ease of use) while using low levels of silicone oil. Decreasing the amount of silicone oil in a
`
`prefilled syringe has significant benefits. Ex. 1 at 4:50–5:50; Ex. 2 ¶¶ 27, 28, 34. When high
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`silicone oil, non-prefilled syringes are used for repeated intravitreal injections of VEGF
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`antagonists over long periods of time, a number of procedure-related side effects can result,
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`ranging from contamination by silicone oil droplets that can obscure the patient’s vision
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`(“floaters”) to increased intraocular pressure to eye infections. Ex. 1 at 4:50–57; Ex. 2 ¶¶ 27, 34.
`
`In addition to these undesired side effects arising during the injection procedure, silicone oil was
`
`also known to “cause proteins to aggregate,” threatening the stability of a VEGF antagonist drug
`
`formulation stored within a pre-filled syringe. Ex. 1 at 4:55–56; Ex. 2 ¶ 34. But as of the priority
`
`date, the “conventional thinking” in the art taught a skilled artisan that “if you decrease the silicone
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`oil level” used in a prefilled syringe, “the [injection] forces required would increase.” Ex. 1 at
`
`5:21–23; see Ex. 2 ¶ 34. That outcome would be undesirable, because “[h]aving too great a force
`
` 
`4 One such emulsion is DuPont’s Dow Corning 365 product.
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`4
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`Regeneron Exhibit 1069.010
`Regeneron v. Novartis
`IPR2020-01317
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`required to move the stopper” and keep the stopper in motion could make the prefilled syringe too
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`difficult to operate, risking serious adverse consequences for the patient including tissue damage
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`in the eye. Ex. 1 at 5:27–34; see Ex. 2 ¶ 34.
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`The novel design claimed by the ’631 patent fills this long-felt need by providing a pre-
`
`filled syringe including only low levels of silicone oil while maintaining low injection forces.
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`Specifically, the invention is able “to decrease the likelihood of silicone oil droplets being injected
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`into the eye” and of “proteins . . . aggregat[ing]” in the presence of silicone oil by reducing silicone
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`oil levels to as low as about 1 μg, while unexpectedly providing break loose and slide forces of
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`“less than about 11 N” to permit “[s]mooth dose delivery.” Ex. 1 at 4:50–5:50. Another important
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`aspect of the invention of the ʼ631 patent is the novel disclosure of a terminally-sterilized pre-filled
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`syringe, which was an extremely challenging prospect given known sterilization methods, in view
`
`of the particular sensitivity of biologic drugs like VEGF antagonists. Ex. 1 at 1:14–43, 3:2–42,
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`9:48–10:22; Ex. 2 ¶¶ 20, 33.
`
`The ’631 patent includes 26 claims, of which only claim 1 is independent. Claim 1
`
`describes:
`
`1. A pre-filled, terminally sterilized syringe for intravitreal injection, the
`syringe comprising a glass body forming a barrel, a stopper and a plunger and
`containing an ophthalmic solution which comprises a VEGF-antagonist, wherein:
`
`(a) the syringe has a nominal maximum fill volume of between about 0.5
`ml and about 1 ml,
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`(b) the syringe barrel comprises from about 1 μg to 100 ug silicone oil,
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`(c) the VEGF-antagonist solution comprises no more than 2 particles >50
`μm in diameter per ml and wherein the syringe has a stopper break loose force of
`less than about 11N.
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`The dependent claims are directed to limits on the properties of and amount of silicone oil that can
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`be present in the pre-filled syringe (claims 2–4, 10, 22, and 23); restrictions on the amount of
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`5
`
`Regeneron Exhibit 1069.011
`Regeneron v. Novartis
`IPR2020-01317
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`

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`particles that may be present (claims 5, 6, and 10); particular VEGF antagonists (claims 7–9 and
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`11–13); limitations on the break loose and glide force needed to move the stopper (claims 14–16),
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`details regarding sterilization (claims 17–21); and methods of treating patients with the VEGF
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`antagonist pre-filled syringe for intravitreal injection (claims 24–26).
`
`B.
`
`The Disputed Claim Terms
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`The Parties’ present dispute centers around the claim term “about” as it appears in two
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`contexts in the claims of the ʼ631 patent: first, in regard to the amount of silicone oil present (in
`
`micrograms (μg)) in the claimed pre-filled syringe, and second, in regard to the amount of force
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`(in Newtons (N)) required to start moving the stopper (break loose force) or to continue the stopper
`
`in motion (slide force). Claims 1, 3, and 22 respectively recite that the amount of silicone oil
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`present in the syringe barrel is “from about 1 μg to 100 μg,” “from about 3 μg to about 100 μg,”
`
`or “from about 1–50 μg.”5 Claims 1 and 16 respectively recite that the break loose force or slide
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`force of the pre-filled syringe is “less than about 11N.” Claim 14 recites that both the break loose
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`force and the slide force are “less than about 5N.”
`
`Although Regeneron has only challenged the patent’s use of “about” as to these specific
`
`claims, the term also appears in several additional claims. In particular, the ʼ631 patent’s claims
`
`use the term “about” to modify: (1) the “nominal fill volume” of the claimed syringe (“between
`
`about 0.5 ml and about 1 ml”), (2) the average thickness of the silicone oil layer applied to the
`
`interior of the claimed syringe (“about 450 nm or less”), and (3) the viscosity of the silicone oil
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`(“about 350 cP”). See Ex. 1 at claims 1, 2, 10, 23.
`
`The ’631 patent’s specification provides definitions for several claims at the end of the
`
`section disclosing the invention. In the definitional section, the specification provides specific
`
` 
`5 The Parties agree that “about” modifies both the low and high values in these ranges.
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`6
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`Regeneron Exhibit 1069.012
`Regeneron v. Novartis
`IPR2020-01317
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`

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` 
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`guidance on the meaning of “about,” stating that, as used in the patent, the “term ‘about’ in relation
`
`to a numerical value x means, for example, x±10%.” Ex. 1 at 10:28–29. As discussed below, pp.
`
`14–18, infra, a skilled artisan reading the specification would have understood that this x±10%
`
`illustration to provide a presumptive meaning for “about” that applies here. See Ex. 2 ¶¶ 43–44.
`
`C.
`
`Relevant Prosecution History of the ʼ631 Patent
`
`As originally drafted, the ʼ631 patent’s claims included “about” to modify the amount of
`
`silicone oil present and the magnitude of the stopper break loose and slide forces. See Originally-
`
`Filed Application, ʼ631 Patent Prosecution History Excerpt (Ex. 3) (original claims 1, 7–9, 20–
`
`23). The original claim language regarding the stopper break loose and slide forces is unchanged
`
`from the issued claims. Id. at 19 (original claims 20–23).6 As for silicone oil, the claims originally
`
`were directed not only to ranges (original claim 9), but also to amounts of silicone oil that were
`
`“at least about” certain low values (original claim 8) or, separately, “less than about” certain higher
`
`values (original claims 1 and 7). Id. at 17–18. Original claims 8 and 9 were modified in a
`
`preliminary amendment to recite ranges of silicone oil “from about” a low value “to less than
`
`about” a higher value. Aug. 16, 2013 Preliminary Amendment at 3, ʼ631 Patent Prosecution
`
`History Excerpt (Ex. 4). Original claims 1 and 7 were both amended but retained their structure
`
`as directed to an amount of silicone oil “less than about” a specific value. Id. at 2–3.
`
`The preliminarily amended claims 1 and 7–9 were rejected by the Examiner over a prior
`
`art reference (Scypinski) that was silent as to the amount of silicone oil content in the disclosed
`
` 
`6 The configuration of the claims changed during prosecution, such that the location of some of
`the limitations regarding break loose and slide forces moved among claims, but the language
`employed for the relevant claim phrases regarding forces—including in particular with respect to
`the term “about”—is identical in the original and issued claims. Compare Originally-Filed
`Application at 19 (original claims 20–23) (Ex. 3); Nov. 24, 2014 Amendment and Response at 2–
`3 (original claims 1, 21–23), ʼ631 Patent Prosecution History Excerpt (Ex. 5); and July 17, 2015
`Amendment and Response at 2 (original claims 1, 21–22), ʼ631 Patent Prosecution History Excerpt
`(Ex. 6) with Ex. 1 at claims 1, 14, 16.
`
`7
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`Regeneron Exhibit 1069.013
`Regeneron v. Novartis
`IPR2020-01317
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`

`

` 
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`syringe. See May 14, 2014 Non-Final Rejection at 4, 7, ʼ631 Patent Prosecution History Excerpt
`
`(Ex. 7). The Examiner interpreted this silence as meaning there was no silicone oil present in the
`
`syringe of Scypinski. See id. at 4 (“Scypinski teaches a barrel without any silicone oil[.]”); id. at
`
`7 (“Scypinkski [sic] . . . is silent to an internal silicone coating on the syringe barrel.”). The
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`Examiner also rejected original claim 10 as indefinite for lacking an antecedent basis, where the
`
`claim recited a particular kind of silicone oil (Dow Corning (“DC”) 365), but claim 1 from which
`
`it depended did not positively require silicone oil at all (by virtue of the absence of any lower
`
`boundary on the claimed amount of silicone oil). Id. at 2.
`
`In response to the rejection, the Applicant amended claim 1 to recite a claimed range with
`
`the addition of a lower bound, as follows:
`
`
`
`Aug. 13, 2014 Amendment and Response at 2, ʼ631 Patent Prosecution History Excerpt (Ex. 8).
`
`The Applicant retained original claim 9 (directed to a range of silicone oil “from about 3μg to
`
`about 200μg”), and cancelled original claims 7 and 8 in favor of new claims 33 and 34 that were
`
`respectively directed to “from about 1–100μg” or “from about 1–50μg” silicone oil. Id. at 2–4.
`
`The Applicant explained that the revision of the claims to include a lower bound in claim 1 and to
`
`otherwise be directed to ranges of amounts of silicone oil meant the “the claims have been amended
`
`to positively recite the presence of silicone oil in the barrel,” thereby avoiding Scypinski and
`
`resolving the indefiniteness rejection as to original claim 10. Id. at 5–6. Before the Examiner
`
`responded to these amended claims, the Applicant again revised them to lower the high end of the
`
`claimed ranges of silicone oil to 100 μg, and to cancel claim 33. See Nov. 24, 2014 Amendment
`
`and Response at 2, 4, ʼ631 Patent Prosecution History Excerpt (Ex. 5). The subsequent rejection,
`
`amendment, and allowance of the pending claims do not bear on the Parties’ claim constructions.
`
`8
`
`Regeneron Exhibit 1069.014
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
`
`D.
`
`Procedural History
`
`The Parties have agreed upon constructions for certain claim terms. See Joint Claim
`
`Construction Chart (“JCCC”) at 3. Pursuant to Ground Rule 7.2, Novartis identifies these agreed-
`
`upon constructions in the table below.
`
`Claim
`4
`
`1
`
`11
`
`Term for Construction
`“the silicone oil is DC365
`emulsion”
`“VEGF-antagonist”
`
`“non-antibody VEGF
`antagonist”
`
`Agreed-to Construction
`“the silicone oil is applied as a component of
`DC365 emulsion”
`“a substance capable of blocking or inhibiting
`the biological action of vascular endothelial
`growth factor”
`“a VEGF-antagonist that is not an antibody”
`
`
`Regeneron disputes several claim terms, but in each case its arguments are centered on the
`
`alleged indefiniteness of the word “about” with respect to claimed numerical values. See JCCC at
`
`2. Both Novartis and the Staff took the position that these claim terms employing the word “about”
`
`should be given their plain meaning. Id. The disputed claim terms are as follows:
`
`Novartis and Staff Proposed
`Construction
`Plain and ordinary meaning
`
`Regeneron Proposed
`Construction
`Indefinite
`
`Plain and ordinary meaning
`
`Indefinite
`
`Claim Terms
`“about 1 μg to 100 ug silicone
`oil” (claim 1)
`
`“about 3 μg to about 100 ug
`silicone oil” (claim 3)
`
`“about 1-50 μg silicone oil”
`(claim 22)
`
`“less than about 11N” (claim
`1, 16)
`
`“less than about 5N” (claim
`14)
`
`Following further correspondence between the parties, Novartis further explained that the plain
`
`meaning of the term “about” is approximately, and that, in the context of the ’631 patent, the
`
`9
`
`Regeneron Exhibit 1069.015
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
`
`specification further provides that about “means, in relation to a numerical value x, for example,
`
`x +/- 10%. Ex. 1 at 10:28–29.
`
`III. LEGAL STANDARDS
`A.
`
`Claim Construction
`
`“The words of a claim are generally given their ordinary and customary meaning as
`
`understood by a person of ordinary skill in the art in question at the time of the invention when
`
`read in the context of the specification and prosecution history.” Laryngeal Mask Co. v. Ambu,
`
`618 F.3d 1367, 1370 (Fed. Cir. 2010) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.
`
`Cir. 2005)). In this respect, “the person of ordinary skill in the art is deemed to read the claim term
`
`not only in the context of the particular claim in which the disputed term appears, but in the context
`
`of the entire patent, including the specification.” Phillips, 415 F.3d at 1313. Thus, the three
`
`primary sources considered in claim construction are: (1) the claim language, (2) the patent
`
`specification, and (3) the prosecution history. See Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562,
`
`1565 (Fed. Cir. 1997); Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995).
`
`B.
`
`Indefiniteness
`
`The Patent Act provides that “[t]he specification shall conclude with one or more claims
`
`particularly pointing out and distinctly claiming the subject matter which the applicant regards as
`
`his invention.” 35 U.S.C. § 112, ¶ 2. The Supreme Court has explained that this statutory provision
`
`requires “that a patent’s claims, viewed in light of the specification and prosecution history inform
`
`those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, Inc.
`
`v. Biosig Instruments, Inc., 572 U.S. 898, 909 (2014). This test strikes a balance between the “the
`
`inherent limitation of language” and the need for claims to “be precise enough to afford clear notice
`
`of what is claimed.” Id. at 909. In conducting the inquiry, “[o]ne must bear in mind . . . that
`
`10
`
`Regeneron Exhibit 1069.016
`Regeneron v. Novartis
`IPR2020-01317
`
`

`

` 
`
`patents are ‘not addressed to lawyers or even to the public generally,’ but rather to those skilled in
`
`the relevant art.” Id.
`
`“[A] patentee need not define his invention with mathematical precision in order to comply
`
`with the definiteness requirement.” Sonix Tech. Co. v. Publ’ns Int’l, Ltd., 844 F.3d 1370, 1377
`
`(Fed. Cir. 2017) (citation omitted). Patents often use “terms of degree,” and such claim language
`
`“has long been found definite where it provided enough certainty to one of skill in the art when
`
`read in the context of the invention.” Id. (quotation marks and citation omitted); accord Exmark
`
`Manuf. Co. v. Birggs & Stratton Power Prods. Grp., LLC, 879 F.3d 1322, 1346 (Fed. Cir. 2018)
`
`(explaining that “numerical precision” is not required “when using … terms of degree”). “Intrinsic
`
`evidence—such as the claims, figures, written description, or prosecution history of a patent—can
`
`provide the necessary objective boundaries” for a term of degree, and “[e]xtrinsic evidence can
`
`also help identify objective boundaries.” Guangdong Alison Hi-Tech Co. v. ITC, 936 F.3d 1353,
`
`1360 (Fed. Cir. 2019). Moreover, “a sound claim construction need not always purge every shred
`
`of ambiguity. The resolution of some line-drawing problems . . . is properly left to the trier of
`
`fact” when adjudicating infringement. Acumed LLC v. Stryker Corp., 483 F.3d 800, 806 (Fed. C