UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`
`_________________
`
`Case IPR2020-00084
`Patent 9,089,519
`
`_________________
`
`PATENT OWNER ALLERGAN INDUSTRIE, SAS’S
`PRELIMINARY RESPONSE
`
`
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`
`TABLE OF CONTENTS
`
`
`PATENT OWNER ALLERGAN INDUSTRIE, SAS’S PRELIMINARY
`RESPONSE ................................................................................................................ 1 
`I. 
`INTRODUCTION ............................................................................................. 1 
`II.  THE ’519 PATENT ........................................................................................... 2 
`III.  PROSECUTION HISTORY OF THE ’519 PATENT FAMILY .................... 5 
`A.  Prosecution of the ’795 Patent ...................................................................... 5 
`B.  Prosecution of the ’676 Patent .................................................................... 12 
`C.  Prosecution of the ’519 Patent .................................................................... 17 
`IV.  CLAIM CONSTRUCTION ........................................................................... 18 
`V.  PERSON OF ORDINARY SKILL IN THE ART .......................................... 19 
`VI.  ARGUMENT .................................................................................................. 21 
`A.  Claims 1-4 are Entitled to the August 4, 2008 Priority Date ...................... 21 
`1.  Law of Priority Entitlement ..................................................................... 21 
`2.  Claims 1-4 are Described in the Priority Applications ............................ 22 
`3.  The Disclosed Species Adequately Support the Claims .......................... 26 
`B.  Grounds 1-3 Should be Denied because the Supporting References Do
`Not Qualify as Prior Art to Claims 1-4 of the ’519 Patent .................................. 28 
`C.  Ground 5 Should be Denied because Petitioner Fails to Prove P050047
`is a Printed Publication ........................................................................................ 29 
`D.  The Board Should Deny Grounds 4 & 5 under Section 325(d) .................. 33 
`1.  Becton Dickinson factors (a)-(d) .............................................................. 35 
`2.  Becton Dickinson factor (e) ..................................................................... 41 
`3.  Becton Dickinson factor (f) ...................................................................... 46 
`VII.  CONCLUSION ........................................................................................... 50 
`
`
`
`
`
`
`
`i
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`
`EXHIBIT LIST
`Exhibit Description
`Juvéderm Ultra™ XC Label
`Juvéderm Ultra Plus™ XC Label
`Juvéderm Voluma®XC Label
`U.S. Patent Publication No. 2004/0101959 to Marko et al,
`published May 27, 2004
`Excerpts from U.S. 8,822,676 file history
`Excerpts from U.S. 9,089,519 file history
`About Juvéderm Ultra Plus™ XC
`About Juvéderm Volbella® XC
`About Juvéderm Voluma® XC
`
`
`
`
`
`
`Exhibit No.
`2001
`2002
`2003
`2004
`
`2005
`2006
`2007
`2008
`2009
`
`ii
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`
`I.
`
`INTRODUCTION
`U.S. Patent No. 9,089,519 (“the ’519 patent”) relates to lidocaine-containing
`
`dermal fillers that Allergan sells under the trade name “JUVÉDERM®.” After
`
`extensive prosecution of this application, the Examiner allowed the claims based
`
`on the Applicant’s evidence of unexpected results. In particular, the Examiner
`
`found that the Applicant unexpectedly found that the claimed hyaluronic acid soft
`
`tissue fillers did not result in instability, contrary to what those of ordinary skill in
`
`the art at the time of the invention would have expected.
`
`The present Petition, which challenges claims 1-8 of the ’519 patent on three
`
`anticipation and two obviousness grounds, should be denied.1 The anticipation
`
`challenges should be denied because the supporting references for Grounds 1-3
`
`(P050047/S005 (Ex. 1060), Weinkle (Ex. 1070), and U.S. 2010/0028438 (Ex.
`
`1072)) do not qualify as prior art under AIA § 102(a). In addition, Ground 5
`
`should be denied because Petitioner fails to prove that P050047 (Ex. 1074)
`
`qualifies as a printed publication under pre-AIA § 102(b). Finally, the Board
`
`should deny Grounds 4 and 5 under Section 325(d) because the Petition fails to
`
`provide new evidence or new arguments that are different from those considered
`
`during prosecution. Rather, the Petition uses references cited during prosecution of
`
`
`1 Petition at 1-2.
`
`1
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`the ’519 patent family, or replaces them with cumulative references, and then
`
`rehashes the same arguments that were presented and overcome during
`
`prosecution. The allegedly new evidence is merely unsupported and conclusory
`
`expert opinion.
`
`Critically, the Petition offers no new evidence that refutes the Examiner’s
`
`conclusion that the evidence of unexpected results submitted during prosecution
`
`made the claims patentable. Petitioner simply wants the Board to second-guess the
`
`Examiner. Such tactics waste party and Board resources, and should result in
`
`denial of all grounds under Section 325(d).
`
`II. THE ’519 PATENT
`The ’519 patent relates to injectable dermal, subdermal, and soft tissue filler
`
`compositions made from crosslinked hyaluronic acid (“HA”) that include an
`
`anesthetic agent (lidocaine).2 Allergan sells these compositions under the trade
`
`name “JUVÉDERM®.”3 These gels are used to fill voids in the patient’s skin,
`
`e.g., wrinkles in the patient’s face.4 As a result, it is desirable for the gel to
`
`maintain the filling effect for a long time, e.g., 26 weeks up to 2 years.5 But HA
`
`
`2 Ex. 1001 at 1:20-23; 2:40-53.
`3 Exs. 2001-2003.
`4 Ex. 1001 at 1:27-38.
`5 See e.g., Exs. 2007-2009.
`
`2
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`quickly degrades in the body.6 To overcome this problem and maintain the desired
`
`filling effect, the HA can be crosslinked in order to slow down the degradation.7
`
`
`
`Challenged claims 1-8 are all composition claims that recite BDDE-
`
`crosslinked HA and the anesthetic agent lidocaine. Claims 1 and 2 require that the
`
`BDDE-crosslinked HA lidocaine-containing composition “fills in facial lines and
`
`depressions substantially the same as” another dermal filler that does not include
`
`lidocaine, but is otherwise identical.8 Claims 3 and 4 require that the lidocaine-
`
`containing BDDE-crosslinked HA composition “restores fat loss-related tissue
`
`volume loss substantially the same” as another dermal filler that does not include
`
`lidocaine, but is otherwise identical.9 Claims 5-8 require that the lidocaine-
`
`containing BDDE-crosslinked HA composition “is substantially as stable during
`
`storage under ambient conditions for at least 3 months” as another dermal filler
`
`that does not include lidocaine, but is otherwise identical.10 Claims 2, 4, and 8
`
`further require the lidocaine in the first composition to be freely released in vivo.11
`
`
`6 Ex. 1001 at 2:3-18.
`7 Id. at 2:19-23.
`8 Id. at 19:16-25.
`9 Id. at 19:26-20:8.
`10 Id. at 20:9-26.
`11 Id at 19:24-25, 20:7-8, 20:25-26.
`
`3
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`Lidocaine is included in the compositions to minimize any pain when the
`
`compositions are injected, e.g., into a patient’s face.12 However, as the ‘519 patent
`
`explains, “[u]nfortunately, HA-based injectable compositions which incorporate
`
`lidocaine during the manufacturing process are prone to partial or almost complete
`
`degradation prior to injection, particularly during high temperature sterilization
`
`steps and/or when placed in storage for any significant length of time.”13
`
`Moreover, the lidocaine must quickly exit the gel upon injection, i.e. it is freely
`
`released, in order to minimize the short-term pain associated with the injection.14
`
`The inventor of the ‘519 patent solved the post-sterilization stability problem
`
`that previously afflicted lidocaine-containing, HA-based injectable compositions.15
`
`The ’519 patent provides experimental data demonstrating that the claimed
`
`compositions are stable to heat sterilization and prolonged storage.16 The ’519
`
`patent also provides experimental data demonstrating the free release of lidocaine
`
`from the claimed compositions.17 The ’519 patent states that “[i]t is a surprising
`
`discovery that formulations of crosslinked HA-based compositions including
`
`
`12 Id. at 1:39-45 and 6:41-61.
`13 Id. at 2:26-31.
`14 Id. at 17:8-30.
`15 Id. at 2:26-36.
`16 Id. at 2:40-53, 6:7-20, 7:16-50, 14:17-25, 15:21-17:2.
`17 Id. at 17:6-44.
`
`4
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`lidocaine can be manufactured in a manner to produce sterilization-stable,
`
`injectable HA/lidocaine compositions.”18
`
`III. PROSECUTION HISTORY OF THE ’519 PATENT FAMILY
`On February 26, 2009, Allergan filed two largely similar patent applications
`
`based on the inventions of Pierre Lebreton: U.S Application 12/393,884 (the ’884
`
`application), which issued as U.S. Patent No. 8,357,795 (the ’795 Patent), and
`
`Application 12/393,768 (the ’768 application), which issued as U.S. Patent No.
`
`U.S. Patent No. 8,450,475 (the ’475 patent).
`
`The ’519 patent is a continuation of U.S. Application No. 13/419,079 (the
`
`’079 application), which issued as U.S. Patent No. 8,822,676 (the ’676 patent).
`
`The ’676 patent is a continuation of the ’795 patent. The prosecution of these
`
`patent applications was extensive and exhaustive. Ultimately, the ’475, ’795,
`
`’676, and ‘519 patents were allowed based on the unexpected results from the
`
`claimed inventions.
`
`A.
`Prosecution of the ’795 Patent
`During the prosecution of the ’795 patent, in a non-final Office Action dated
`
`May 31, 2011, the Examiner rejected the pending claims on several grounds.
`
`Relevant here, the claims were rejected as obvious over Lebreton (Ex. 1029) in
`
`
`18 Id. at 7:47-50.
`
`5
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`view of Wang (Ex. 1047).19 The Examiner stated: “Lebreton teaches a method of
`
`forming mono[p]hase hydrogel” crosslinked with BDDE which is “packed into
`
`syringes and sterilized in an autoclave.”20 The Examiner further stated: “Lebreton
`
`lacks a teaching wherein the hydrogel further comprises lidocaine.”21 To
`
`overcome this deficiency, the Examiner relied upon Wang, a published patent
`
`application, for teaching “the formation of a crosslinked hyaluronic acid which
`
`further comprises preferably an anesthetic such as lidocaine.”22 The Examiner then
`
`concluded that “[i]t would have been obvious to one of ordinary skill in the art at
`
`the time of the instant invention to add lidocaine to the hydrogel of Lebreton in
`
`order to provide a therapeutic delivery of an anesthetic to the injectable
`
`formulation.”23
`
`With respect to the obviousness rejection in view of Lebreton and Wang,
`
`Applicant stated that “[a]ccording to Wang, ‘[b]ecause HA is a water-soluble
`
`polymer and is degraded and eliminated rapidly in vivo, the potential applications
`
`for HA in biomedical purposes have been somewhat limited.’”24 To solve this
`
`
`19 Ex. 1023 at 78.
`20 Id. at 79.
`21 Id.
`22 Id. at 80 (internal citations omitted).
`23 Id.
`24 Id. at 67.
`
`6
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`problem, Applicant stated “Wang ‘features a product containing hyaluron cross
`
`linked to chitosan’ that ‘can be for the delivery of an anesthetic such as
`
`lidocaine.’”25
`
`Thus, Applicant argued “[b]ased upon this, a person of ordinary skill in the
`
`art would understand that Wang teaches a crosslinked combination of HA and
`
`chitosan, and more specifically, teaches that HA alone is ineffective for delivery of
`
`anesthetics such as lidocaine.”26 Accordingly, “Wang teaches away from adding
`
`lidocaine to an HA that is not crosslinked to a non-HA biopolymer such as
`
`chitosan” and “Wang teaches away from a composition wherein the lidocaine is
`
`freely released in vivo.”27 With regard to the pH limitation of the claims, Applicant
`
`argued “[n]either Lebreton nor Wang teach or suggest adding lidocaine HCl to an
`
`HA component at a pH of about 7.5 to about 8.”28
`
`Applicant amended the claims by including limitations wherein the HA is
`
`not crosslinked to a non-HA biopolymer, the composition is sterile, and the
`
`lidocaine is freely released in vivo, as shown below in amended claim 23:
`
`23. (Currently Amended) A soft tissue filler composition comprising:
`a hyaluronic acid (HA) component crosslinked with a crosslinking
`agent selected from the group consisting of 1,4-butanediol diglycidyl
`
`
`25 Id. (emphasis in original).
`26 Id. at 67-68.
`27 Id. at 68 (emphasis in original).
`28 Id. at 70.
`
`7
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`1,4-bis(2,3-epoxypropoxy)butane,
`1,4-
`(BDDE),
`ether
`bisglycidyloxybutane, 1,2-bis(2,3-epoxypropoxy)ethylene and 1-(2,3-
`epoxypropyl)-2,3-epoxycyclohexane, and 1,4-butanediol diglycidyl
`ether; wherein the HA is not crosslinked to a non-HA biopolymer; and
`at least one anesthetic agent lidocaine combined with said crosslinked
`HA component; wherein the lidocaine is freely released in vivo; and
`wherein the composition is sterile.29
`
`In a final Office Action dated December 27, 2011, the Examiner withdrew
`
`the obviousness rejection over Lebreton in view of Wang in light of amendments
`
`to the claims.30 The Examiner issued new obviousness rejections over Lebreton
`
`(Ex. 1029) in view of Calias (Ex. 1048) and in further view of Marko (Ex. 2004).31
`
`The Examiner noted that Lebreton taught all of the claim elements except “a
`
`teaching wherein the hydrogel further comprises lidocaine.”32 The Examiner cited
`
`Calias for disclosing a “single phase gel formed from reacting hyaluronic acid with
`
`divinyl sulfone” and that the gel could further comprises a drug such as lidocaine.33
`
`The Examiner concluded:
`
`It would have been prima facie obvious to one of ordinary skill in the
`art at the time of the instant invention to add lidocaine to the hydrogel
`composition of Lebreton. One would have been motivated to do so in
`order to provide lidocaine, an anesthetic, to the tissue at the site of
`surgery. It would have been obvious to one [of] ordinary skill in the art
`at the time of the instant invention to add the lidocaine to the hydrogel
`
`29 Id. at 57.
`30 Id. at 43.
`31 Id. at 43, 46.
`32 Id. at 45.
`33 Id.
`
`8
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`during the homogenization in order to provide a hydrogel which [h]as
`a lidocaine homogeneously mixed throughout the gel.34
`
`The Examiner also stated “[w]ith regard to the limitation that the
`
`lidocaine is freely released in vivo, this limitation is taught because the prior
`
`art hydrogel and instant hydrogel are structurally indistinguishable and
`
`therefore it would necessarily result from the addition of lidocaine to the
`
`hydrogel.”35 With regard to those claims limiting the amount of lidocaine to
`
`0.2 to 1%, the Examiner cited Marko which “teach[es] a crosslinked collagen
`
`hydrogel composition that comprises 0.3% lidocaine.”36
`
`In its June 14, 2012 Response to Office Action, Applicant summarized the
`
`in-person interview conducted with the Examiner on April 3, 2012: “[I]n that []
`
`interview, the undersigned [Applicant] and the Examiner agreed that submitting a
`
`Declaration to show unexpected results of incorporating lidocaine into a hyaluronic
`
`acid gel that has been crosslinked, and has not been crosslinked to any other
`
`polymer, would be sufficient to overcome the prior art of record.”37
`
`In its Response, Applicant submitted evidence of unexpected results,
`
`including a declaration of Pierre Lebreton, on June 14, 2012:
`
`
`34 Id. at 45-46.
`35 Id. at 46.
`36 Id. at 47.
`37 Id. at 21-22.
`
`9
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`applicant offers evidence, in the form of the Declaration of the inventor,
`supported by examples and data in the specification, to show
`unexpected results, namely, that it was a surprising and unexpected
`discovery, not appreciated prior to the present invention, that certain
`hyaluronic acid gels, as defined in the application, when mixed with
`lidocaine, could be made to be heat stable and thus useful as dermal
`fillers. The Declaration shows that it was believed that adding lidocaine
`to hyaluronic acid gel compositions during manufacturing caused
`degradation of the hyaluronic acid prior to injection of the hyaluronic
`acid as a dermal filler. The Declaration further shows that at the time
`of the invention, it was not known whether a heat sterilized hyaluronic
`acid/lidocaine gel could be made to be stable. As will be explained
`hereinafter, the examples and data in the specification support these
`assertions in the Declaration by showing that, when tested, certain
`hyaluronic acid based gels degraded and lost viscosity when mixed with
`lidocaine and heat sterilized, as was expected.38
`
`
`Specifically, the Lebreton Declaration stated in relevant part:
`
`5. It was believed that adding lidocaine to hyaluronic acid gel
`compositions during manufacturing caused degradation of
`the
`hyaluronic acid prior to injection of the HA as a dermal filler.
`
`6. It was believed that lidocaine caused degradation of HA gel
`compositions during high temperature sterilization.
`
`7. It was not known whether HA compositions comprising lidocaine
`were stable or not after high temperature sterilization when placed in
`storage for any significant length of time.
`
`8. It was also believed that the instability of HA described above would
`have caused a viscosity reduction of the HA that would make it
`unsuitable for soft tissue filling applications.
`
`9. Based upon the facts set forth above, a person of ordinary skill in the
`art would have expected that a dermal filler comprising hyaluronic acid
`
`
`38 Id. at 23 (emphasis in original).
`
`10
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`and lidocaine would not have remained sufficiently stable to be useful
`as soft tissue filler.
`
`10. It was not appreciated that a dermal filler comprising a cohesive gel
`of hyaluronic acid makes it possible for lidocaine to be combined with
`hyaluronic acid in a gel that is sufficiently stable to be useful as a soft
`tissue filler.
`
`11. The enhanced stability properties of the inventive dermal fillers was
`evidenced by certain experiments performed under my direction by my
`research team prior to the application filing date.
`
`12. The experiments are generally set forth in the patent application in
`the Examples and Drawings.
`
` …
`
`
`
`
`15. To my knowledge, it was a surprising and unexpected discovery,
`not appreciated prior to the present invention, that certain cohesive HA
`gels, as defined in the application, when mixed with lidocaine, could be
`made to be heat and shelf stable.39
`
`
`With respect to the experiments referenced in the declaration, Applicant
`
`pointed to Example 4 and Figures 2-8 of the ’884 specification as showing
`
`unexpected results.40 In addition, Applicant submitted a publication by Cui et al
`
`(Ex. 1025) “in support of the non-obviousness of the presently claimed
`
`invention.”41 Cui et al. was offered to show “that HA gels crosslinked with BDDE
`
`
`39 Ex. 1024 at ¶¶ 5-12, 15.
`40 Ex. 1023 at 26-27.
`41 Id. at 28.
`
`11
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`are known to be especially sensitive to heat sterilization relative to gels crosslinked
`
`with other, i.e., non-BDDE, crosslinkers.”42
`
`After receiving this evidence, the Examiner allowed the claims.43 The ‘884
`
`application’s Notice of Allowance states: “Applicant unexpectedly found that a
`
`hyaluronic acid gel cross-linked, but not with a non-hyaluronic acid biopolymer,
`
`mixed with lidocaine and sterilized does not degrade.”44 The application issued as
`
`U.S. Patent No. 8,357,795.
`
`B.
`Prosecution of the ’676 Patent
`On March 13, 2012, Allergan filed the ’079 application as a continuation of
`
`the ’795 patent. During prosecution, Applicant submitted several information
`
`disclosure statements (IDS) that identified various publications and patent
`
`applications for the Examiner’s consideration.45 These IDS filings included the
`
`same references Petitioner relies on in support of its obviousness challenges,
`
`including Lebreton (Ex. 1029), Sadozai (Ex. 1030), and Kinney (Ex. 1012).46
`
`
`42 Id. (emphasis in original).
`43 Id. at 5.
`44 Id. at 9.
`45 Ex. 2005 at 30, 121.
`46 Id. at 32, 125, 128.
`
`12
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`During prosecution, the Examiner acknowledged consideration of all of these
`
`references.47
`
`On August 30, 2013, the Examiner issued a non-final rejection, rejecting the
`
`claims as obvious over Lebreton (Ex. 1029) and Wang (Ex. 1047).48 The
`
`Examiner stated: “Lebreton teach[es] a mixture of 90% 0.6 MDa HA and 2.8 MDa
`
`10% HA are hydrated in an alkaline solution, BDDE is added to cross-link the HA,
`
`the cross-linked HA is neutralized to a pH of 7.2, resulting in a monophase gel that
`
`is packed into syringes and sterilized (paragraphs 74-76 and 86-91).”49 The
`
`Examiner also stated: “Lebreton lacks a teaching wherein the composition
`
`comprises lidocaine” but noted that “Wang teaches the formation of cross-linked
`
`hyaluronic acid which further comprises preferably an anesthetic such as lidocaine
`
`(paragraph 011).”50 The Examiner concluded:
`
`It would have been obvious to one of ordinary skill in the art at the time
`of the instant invention to add lidocaine to the hydrogel of Lebreton in
`order to provide a therapeutic delivery of an anesthetic to the injectable
`formulation. One would have expected success since both Lebreton and
`Wang are directed to crosslinked hyaluronic acid formulations. With
`regard to the dermal filler being stable at about 25C for at least 6 months
`after sterilization of the dermal filler, such a property is implicit to the
`
`47 Id. 23, 94, 95.
`48 Id. at 70. The claims were also rejected for nonstatutory double patenting over
`US Patent Nos. 8,450,475; 8,357,795 and Application Nos. 13/314,075;
`13/419,079; and 13/746,170. Id. at 72-75.
`49 Id. at 71.
`50 Id.
`
`13
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`composition of the prior art since it is structurally indistinguishable
`from the instant composition, absent an unexpected finding. Therefore,
`the instant claims are rendered obvious by the teachings of the prior
`art.51
`
`In Remarks and Amendments filed on February 28, 2014, Applicant
`
`amended claim 1 as follows:
`
`1. (Currently Amended) A soft tissue dermal filler composition
`comprising[[:]]
`a-hyaluronic acid (HA) component crosslinked with a crosslinking
`agent selected from the group consisting of 1,4-butanediol diglycidyl
`ether
`(BDDE),
`1,4-bis(2,3-
`epoxypropoxy)butane,—1,4-
`bisglycidyloxybutane,—1,2-bis(2,3-epoxypropoxy)ethylene, and 1-
`(2,3-epoxypropyl)-2,3-epoxycyclohexane,
`and
`1,4-butanediol
`diglycidyl ether; the hyaluronic acid component comprising a mixture
`of high molecular weight HA and low molecular weight HA; and about
`0.3% lidocaine by weight, combined with said crosslinked HA
`component; wherein the lidocaine is freely released in vivo; and
`wherein the composition is sterile; and wherein the composition does
`not exhibit significant degradation when stored at ambient temperatures
`for a period of at least about 6 months.52
`
`Regarding the § 103 rejection, Applicant stated the claimed inventions are
`
`“not prima facie obvious at least because the combination of references [cited by
`
`the Examiner] teaches away from the claimed inventions, because the combination
`
`of references does not teach or suggest every limitation, and because the soft tissue
`
`filler of the claims has unexpected properties.”53 Specifically, Applicant argued:
`
`
`51 Id.
`52 Id. at 50.
`53 Id. at 54.
`
`14
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`Wang “features a product containing hyaluronan cross linked to
`chitosan” that “can be for the delivery of an anesthetic such as
`lidocaine.” According to Wang, “[b]ecause HA is a water-soluble
`polymer and is degraded and eliminated rapidly in vivo, the potential
`applications for HA in biomedical purposes have been somewhat
`limited.” Based upon this, a person of ordinary skill in the art would
`have inferred that Wang invented a crosslinked combination of
`hyaluronic acid (HA) and chitosan because HA alone was ineffective
`for delivery of anesthetics such as lidocaine, and would have been
`deterred from preparing a combination of HA and lidocaine, wherein
`lidocaine is freely released in vivo.54
`
`Applicant argued “Wang teaches away from the claimed limitation that ‘the
`
`lidocaine is freely released in vivo’” because “Wang suggests that HA degrades too
`
`rapidly in vivo to be useful ‘in biomedical purposes.’”55 Applicant further argued:
`
`“A person of ordinary skill would have understood this to refer to a product that
`
`provides sustained delivery of the lidocaine because stability over a period of
`
`weeks or months is generally required for sustained drug delivery systems. If
`
`lidocaine is freely released in vivo, a composition cannot provide sustained
`
`delivery because it would be released within a few hours rather than over a period
`
`of weeks or months.”56
`
`Applicant also argued “[t]he claimed sterile soft tissue filler has unexpected
`
`properties.”57 Applicant explained:
`
`
`54 Id. at 55 (internal citations omitted).
`55 Id. (emphasis in original).
`56 Id.
`57 Id.
`
`15
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`At the time of invention, it was believed that adding lidocaine to HA
`gel compositions during manufacturing caused degradation of the HA,
`especially when the combination was subjected to autoclaving. For
`example, it was believed that crosslinked HA compositions when
`combined with lidocaine were not capable of withstanding high
`temperature sterilization without a significant reduction in viscosity.
`Such a reduction of viscosity would make these compositions
`unsuitable for soft tissue filling applications.58
`
`Applicant also submitted Cui (Ex. 1025) “as evidence of unexpected
`
`results.”59 Applicant stated “Cui, et al. suggests that HA crosslinked with BDDE
`
`(as in all of the claimed embodiments) is one of the least stable of four different
`
`crosslinked hyaluronic acid gels tested, when subjected to heat sterilization.”60
`
`Applicant submitted this article as evidence suggesting “that one would not expect
`
`a BDDE-crosslinked hyaluronic acid gel to be stable, for example, maintain
`
`viscosity, after sterilization.”61
`
`The Examiner withdrew the pending obviousness rejection and issued a
`
`Notice of Allowance on July 18, 2014.62 The Notice of Allowance stated:
`
`Applicant argues that one of ordinary skill in the art would have
`expected degradation of the hyaluronic acid gel with addition of
`lidocaine during sterilization, as this was what was known in the prior
`art. Applicant unexpectedly found that a hyaluronic acid gel
`
`58 Id.
`59 Id. at 56.
`60 Id.
`61 Id.
`62 Id. at 3. Applicant also filed terminal disclaimers to overcome the double
`patenting rejections. Id. at 10.
`
`16
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`crosslinked, but not with a non-hyaluronic acid biopolymer, mixed with
`lidocaine and sterilized does not degrade. Therefore, claims 1 and 23-
`52 are allowed.63
`
`C.
`Prosecution of the ’519 Patent
`On April 1, 2014, Allergan filed the ’747 application as a continuation of the
`
`’676 Patent and ’795 Patent. On April 10, April 16, September 5, and September
`
`18, 2014, Applicant submitted a total of four information disclosure statements
`
`(IDS) that identified various publications and patent applications for the
`
`Examiner’s consideration.64 These IDS filings identified the same prior art
`
`Petitioner relies on in support of its obviousness challenges, including Lebreton
`
`(Ex. 1029), Sadozai (Ex. 1030), and Kinney (Ex. 1012).65 During prosecution, the
`
`Examiner again acknowledged consideration of all of these references.66
`
`On September 29, 2014, Applicant filed various terminal disclaimers,
`
`including terminal disclaimers over the ’475, ’795 and ’676 patents.67
`
`On June 22, 2015, the Examiner issued a Notice of Allowance.68 The Notice
`
`of Allowance stated:
`
`
`63 Id. at 11.
`64 Ex. 2006 at 118, 124, 134, 156.
`65 Id. at 135, 157, 159.
`66 Id. at 67, 69, 112.
`67 Id. at 114.
`68 Id. at 19. On October 10, 2014 the Examiner issued a first Notice of Allowance
`citing the same reasons for allowance of the claims. Id. at 49. This Notice was
`
`17
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`Applicant provided unexpected results when combining HA
`crosslinked with BDDE with lidocaine in a submission in the
`parent application 12/393,884 (now patent 8357795). Applicant
`argued that it was known by one of ordinary skill in the art at the
`time of the instant invention that HA gels formed by crosslinking
`HA with BODE is less stable when subjected to sterilization
`procedures such as autoclaving compared to HA gels formed
`from crosslinking HA with other classes of crosslinkers.
`Therefore, Applicant argued in the parent application that they
`unexpectedly found that when lidocaine was added and the HA
`crosslinked gel was sterilized it was stable (response filed on
`06/14/2012, pp. 14-18). Therefore, claims 1-8 are allowed.69
`
`IV. CLAIM CONSTRUCTION
`Petitioner offers constructions for a number of terms: “sterile,” “stable,” and
`
`“freely released in vivo.”70 Allergan does not concede that Petitioner’s proposed
`
`constructions are the correct interpretation of these claims under the Phillips
`
`standard. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).
`
`Nevertheless, even under Petitioner’s proposed constructions, Petitioner fails to
`
`establish a reasonable likelihood that the challenged claims are unpatentable.
`
`Accordingly, it is not necessary to construe any of these terms to deny institution.
`
`See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
`
`
`withdrawn in light of Applicant’s request for reconsideration in light of an IDS
`filed on November 24, 2014. Id. at 48. This IDS was considered by the Examiner
`prior to issuance of the second Notice of Allowance, issued on April 14, 2015. Id.
`at 38.
`69 Id. at 32.
`70 Petition at 15-17.
`
`18
`
`

`

`Attorney Docket No.: 13351-0081IP1
`Case No.: IPR2020-00084
`(“[C]laim terms need only be construed ‘to the extent necessary to resolve the
`
`controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`
`803 (Fed. Cir. 1999)).
`
`V.
`
`PERSON OF ORDINARY SKILL IN THE ART
`In IPR2017-01906, which involved the ’795 patent (the grandparent of the
`
`’519 patent), the Board adopted the following definition of a person of ordinary
`
`skill in the art (“POSITA”):
`
`[A] person of ordinary skill in the art at the time of the invention would
`have had a B.S. or M.S. in biochemistry, polymer chemistry, medicinal
`chemistry, pharmaceutical chemistry, or a related field with “several
`years” of practical experience. Alternatively according to Petitioner
`the ordinary artisan would have had less practical experience but a
`Ph.D. in one of those fields, or an M.D. in dermatology, plastic
`surgery, or a special