`Tel: 571-272-7822
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`
`
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`Paper 7
`Entered: June 28, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`SANOFI-AVENTIS U.S. LLC and
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Petitioners,
`
`v.
`
`ASTRAZENECA PHARMACEUTICALS LP and
`AMYLIN PHARMACEUTICALS, LLC,
`Patent Owners.
`____________
`
`Case IPR2016-00354
`Patent 8,445,647 B2
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
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`IPR2016-00354
`Patent 8,445,647 B2
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`I. INTRODUCTION
`
`Sanofi-Aventis U.S. LLC and Sanofi-Aventis Deutschland GMBH
`(“Petitioner”) filed a Petition (Paper 3; “Pet.”) to institute an inter partes
`review of claims 1–6 of US 8,445,647 B2 (Ex. 1001; “the ’647 patent”).
`AstraZeneca Pharmaceuticals LP and Amylin Pharmaceuticals, LLC
`(“Patent Owner”) did not file a Patent Owner Preliminary Response. We
`apply the threshold for review under 35 U.S.C. § 314.
`Upon consideration of the above-mentioned Petition, we conclude that
`Petitioner has established that there is a reasonable likelihood that it will
`prevail with respect to at least one of the challenged claims. We institute an
`inter partes review as to claims 1–6 of the ’647 patent.
`
`A. Related Proceedings
`Patent Owner identifies the following co-pending case involving the
`’647 patent: Sanofi-Aventis U.S. LLC, et al. v. AstraZeneca Pharmaceuticals
`LP, et al., Civil Action No. 15-cv-00662-GMS (D. Del.). Paper 6.
`Concurrent with the present inter partes review, Petitioner also
`requested review of claims in related patents, including: U.S. Patent No.
`7,297,761 (Case IPR2016-00348); U.S. Patent No. 7,691,963 (Case
`IPR2016-00353); and U.S. Patent No. 8,951,962 (Case IPR2016-00355).
`
`B. The ’647 patent (Ex. 1001)
`The ’647 patent discloses “modified exendins and exendin agonists
`having an exendin or exendin agonist linked to one or more molecular
`weight increasing compounds, of which polyethylene glycol polymers (or
`other molecular weight increasing agents), and related products and
`methods.” Ex. 1001, 3:64–4:2. The ’647 patent discloses exendin-4 as a
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`peptide that has the sequence set forth in SEQ ID NO: 2. Id. at 1:38–48,
`31:33–39, Figure 2. The “molecular weight increasing compounds” are
`described as follows:
`
`A “molecular weight increasing compound” is one that can be
`conjugated to an exendin or exendin agonist and thereby increase
`the molecular weight of the resulting conjugate. Representative
`examples of molecular weight increasing compounds, in addition
`to PEG, are polyamino acids (e.g., poly-lysine, poly-glutamic
`acid, and poly-aspartic acid; see Gombotz, et al. (1995),
`Bioconjugate Chem., vol. 6: 332-351; Hudecz, et al. (1992),
`Bioconjugate Chem., vol. 3, 49-57; Tsukada, et al. (1984), J.
`Natl. Cancer Inst., vol 73: 721-729; Pratesi, et al. (1985), Br. J.
`Cancer, vol. 52: 841-848), particularly
`those of the L
`conformation, pharmacologically
`inactive proteins
`(e.g.,
`albumin; see Gombotz, et al. (1995) and the references cited
`therein), gelatin (see Gombotz, et al. (1995) and the references
`cited therein), succinyl-gelatin (see Gombotz, et al. (1995) and
`the references cited therein), (hydroxypropyl)-methacrylamide
`(see Gombotz, et al. (1995) and the references cited therein), a
`fatty acid, a polysaccaride, a lipid amino acid, and dextran.
`Id. at 4:36–57.
`The ’647 patent discloses that “[t]he polyethylene glycol polymers (or
`other molecular weight increasing agents) are preferably linked to an amino,
`carboxyl, or thio group, and may be linked by N or C termini of side chains
`of lysine, aspartic acid, glutamic acid, or cysteine, or alternatively, the
`polyethylene glycol polymers or other molecular weight increasing agents
`may be linked with diamine and dicarboxylic groups.” Id. at 5:20–39.
`
`C. Challenged claims
`Claim 1 is the only independent claim of the ’647 patent. Claim 1 is
`illustrative of the challenged claims and is reproduced below:
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`1. A compound comprising exendin-4, or agonist analog of
`exendin-4, linked to a polyamino acid through the C-terminal
`amino acid of the exendin-4 or agonist analog of exendin-4 and
`wherein the polyamino acid is selected from the group consisting
`of poly(L-lysine), poly-glutamic acid, and poly-aspartic acid.
`
`Challenged claims 2–6 depend from claim 1, either directly or
`
`indirectly.
`
`D. Asserted Grounds of Unpatentability
`Petitioner challenges claims 1–6 of the ’647 patent on the following
`grounds. Pet. 31–56.
`Ground
`Reference[s]
`1
`Larsen PCT1
`
`Claim[s] Challenged
`1–4
`
`Basis
`§ 102(e)
`
`2
`
`3
`
`4
`
`5
`
`Larsen ’1072
`
`Larsen ’486 3
`
`RE ’3134
`
`Larsen PCT
`
`§ 102(e)
`
`1–4
`
`§ 102(e)
`
`1, 2, 5, 6
`
`§ 102(e)
`
`1, 2, 5, 6
`
`§ 103(a)
`
`1–4
`
`
`1 International Application No. PCT/DK99/00118 to Bjarne Due Larsen,
`filed March 9, 1999, published in English as International Publication No.
`WO 99/46283 on September 16, 1999. Ex. 1009 (“Larsen PCT”).
`2 U.S. Patent No. 7,414,107 to Bjarne Due Larsen, issued August 19, 2008.
`Ex. 1010 (“Larsen ’107”). Larsen ’107 Patent is a continuation of Larsen
`’118 PCT.
`3 U.S. Patent No. 6,528,486 to Bjarne Due Larsen et al., issued March 4,
`2003. Ex. 1011 (“Larsen ’486”).
`4 U.S. Patent No. RE45,313 to Bjarne Due Larsen et al., issued December
`30, 2014. Ex. 1012 (“RE ’313”). RE ’313 Patent is a reissue of Larsen
`’486 Patent.
`
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`Reference[s]
`Larsen ’107
`
`Ground
`6
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`Petitioner relies also on the Declaration of Dr. S. Russ Lehrman (Ex.
`1002).
`
`Basis
`§ 103(a)
`
`Claim[s] Challenged
`1–4
`
`II. ANALYSIS
`A. Claim Interpretation
`In an inter partes review, the Board interprets a claim term in an
`unexpired patent according to its broadest reasonable construction in light of
`the specification of the patent in which it appears. 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, No. 15-446, 2016 WL 3369425 (U.S.
`June 20, 2016). Under that standard, and absent any special definitions, we
`assign claim terms their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art at the time of the invention, in
`the context of the entire patent disclosure. In re Translogic Tech., Inc., 504
`F.3d 1249, 1257 (Fed. Cir. 2007). Only terms that are in controversy need to
`be construed, however, and then only to the extent necessary to resolve the
`controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999).
` We interpret the following terms of the challenged claims as part of
`our analysis. Based upon the facts presented, we determine that the explicit
`construction of any other specific claim term is unnecessary to reach our
`decision that Petitioner has established that there is a reasonable likelihood
`that it will prevail with respect to at least one of the challenged claims. See,
`e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir.
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`2011) (“[C]laim terms need only be construed ‘to the extent necessary to
`resolve the controversy.’”) (quoting Vivid Techs., 200 F.3d at 803)). At this
`stage of the proceeding, the Board has not made a final determination as to
`the construction of any claim term.
`
`1. “exendin-4”
`
`The ’647 patent discloses that “[t]he amino acid sequence of exendin-
`4 is shown in FIG. 2.” Ex. 1001, 1:38–48; see also id. at 31:33–39. Using
`the standard three-letter codes for amino acids, Figure 2 shows the 39-amino
`acid polypeptide sequence for exendin-4 terminating in an amide:
`
`
`
`Exendin-4 is also identified as SEQ ID NO: 2, which does not show
`the polypeptide terminating in an amide. Petitioner directs us to SEQ ID
`NO: 2 and contends that the broadest reasonable interpretation of “exendin-
`4” to a person of ordinary skill in the art would be SEQ ID NO: 2, which
`does not require exendin-4 terminating in an amide. Pet. 26–27 (citing Ex.
`1002 ¶¶ 57–62).
`We are not persuaded. Patent applications that contain a disclosure of
`an unbranched sequence of four or more amino acids must comply with the
`requirements of 37 C.F.R. §§ 1.821–1.825 (“Sequence Rules”). The
`sequence listing presents the polypeptide sequence of exendin-4 as SEQ ID
`NO: 2 in compliance with the Sequence Rules. Petitioner argues that the
`mere compliance of the Sequence Rules is sufficient to lead a person of
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`ordinary skill in the art to understand that exendin-4 does not terminate in an
`amide, despite the clear disclosure of the terminating amide in the
`specification of the ’647 patent. Ex. 1001, 1:38–48, 31:33-39. The evidence
`presented by Petitioner does not persuade us that a person of ordinary skill in
`the art would understand that the specific chemical structure disclosed for
`exendin-4 should be altered because of the inventor’s compliance with the
`formalities of the Sequence Rules.
`We find “exendin-4” to be expressly defined in the ’647 patent as the
`amino acid sequence shown in FIG. 2.
`Petitioner contends further that
`
`The “exendin-4” must also include a C-terminal amino acid that
`is able to covalently link to a polyamino acid. A person of
`ordinary skill in art would understand that an exendin-4 “linked
`to a polyamino acid through the C-terminal amino acid” would
`most likely be linked at the terminal carboxyl group. Ex. 1002, ¶
`61. The amide that is normally found on this amino acid in
`exendin-4 would need to be absent for the peptide to link to the
`polyamino acid in that manner. Id.
`Pet 26. Here, we distinguish between “exendin-4” and exendin-4 “linked to
`a polyamino acid through the C-terminal amino acid.” Petitioner has
`presented sufficient evidence for us to find, at this stage of the proceeding,
`that the chemical structure of exendin-4 would need to be modified in order
`to be successfully linked to a polyamino acid through the C-terminal amino
`acid to form an exendin-4–polyamino acid conjugate. Ex. 1002 ¶¶ 57–61.
`
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`2. “agonist analog of exendin-4”
`
`The term “agonist analog of exendin-4” is not expressly defined in the
`’647 patent. However, the term “exendin agonist” is expressly defined as
`follows:
`
`a compound which mimics the effects of exendins, e.g., on gastric
`motility and gastric emptying (namely, a compound which
`effectively binds to the receptor at which exendins exert their
`action on gastric motility and gastric emptying, preferably an
`analog or derivative of an exendin) or a compound, e.g., that
`mimics the effects of exendin on the reduction of food intake by
`binding to the receptor or receptors where exendin causes this
`effect.
`Id. at 6:42–49 (emphasis added).
`The ’647 patent further discloses that “[e]xendin agonists include
`exendin peptide analogs in which one or more naturally occurring amino
`acids are eliminated or replaced with another amino acid(s).” Id. at 11:34–
`36 (emphasis added).
`Petitioner directs our attention to the above passages of the ’647
`patent and contends as follows:
`
`From this perspective and in view of the specification’s use of
`the terms “exendin agonist” and “exendin peptide analogs,” a
`person of ordinary skill in the art would understand the broadest
`reasonable interpretation of “agonist analog of exendin-4” to be
`“a compound which is structurally substantially similar to
`exendin-4 and mimics the effects of exendin-4.”
`Pet. 28 (citing Ex. 1002, ¶ 66; Ex. 1001, 6:42–49, 11:34–36).
`We are persuaded by Petitioner’s analysis and adopt Petitioner’s claim
`construction for the phrase “agonist analog of exendin-4.” For the purposes
`of this Decision, “agonist analog of exendin-4” means “a compound which
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`is structurally substantially similar to exendin-4 and mimics the effects of
`exendin-4.”
`
`B. Priority Claim of the ’647 patent
`Petitioner contends that the claims of the ’647 patent are not entitled
`to the benefit of priority claim to U.S. Provisional Application No.
`60/132,018, filed April 30, 1999 (“the ’018 Provisional”) (Ex. 1003). Pet.
`21–23. Specifically, Petitioner contends that the ’018 Provisional does not
`provide adequate support for the “polyamino acids” limitation recited in the
`challenged claims, but rather is “limited to peptides linked to PEG polymers
`and two other ‘molecular weight increasing agents’ (specifically albumin
`and gelatin).” Id. at 21 (citing Ex. 1003, 10).
`Petitioner notes that during prosecution and reexamination of the ’963
`patent, Patent Owner argued that “the incorporation by reference of the non-
`patent Gombotz & Pettit5 article provides sufficient support for the
`polyamino acids limitation.” Id. at 22 (citing Ex. 1054, 6; Ex. 1044, 6–8).
`Petitioner contends, however, that the ’018 Provisional cites Gombotz &
`Pettit only for its discussion of PEG, albumin and gelatin and that it would
`be improper to incorporate essential material from other, uncited parts of the
`Gombotz & Pettit article. Id. at 22–23 (citing Ex. 1002 ¶ 48); see also
`Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1326-27 (Fed. Cir.
`2000) (“[O]ne cannot disclose a forest in the original application, and then
`later pick a tree out of the forest and say here is my invention. In order to
`
`
`5 Wayne R. Gombotz & Dean K. Pettit, Biodegradable polymers for protein
`and peptide drug delivery, 6 Bioconj. Chem. 332 (1995). Ex. 1004
`(“Gombotz & Pettit”).
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`satisfy the written description requirement, the blaze marks directing the
`skilled artisan to that tree must be in the originally filed disclosure.”).
`Petitioner further contends that our “Rules do not permit the
`incorporation by reference of essential material from non-patent
`publications.” Pet. at 23; see 37 C.F.R. § 1.57(d) (“‘Essential material’ may
`be incorporated by reference, but only by way of an incorporation by
`reference to a U.S. patent or U.S. patent application publication, which
`patent or patent application publication does not itself incorporate such
`essential material by reference.”).
`The challenged disclosure in the ’018 Provisional states that:
`
`The present invention also provides for conjugation of an
`exendin or exendin agonist to one or more polymers other than
`polyethylene glycol which can regulate kidney clearance in a
`manner similar to polyethylene glycol. Examples of such
`polymers include albumin and gelatin. See, Gombotz and Pettit,
`Bioconjugate Chern., 6:332–351, 1995, which is incorporated
`herein by reference in its entirety.
`The ’018 Provisional, 59:1–8. After consideration of the above cited portion
`of the ’018 Provisional, we are persuaded by Petitioner’s argument and
`evidence that the “polyamino acids” limitation appears to be essential
`material and that reliance on the disclosure of Gombotz and Pettit for
`adequate written description support for the “polyamino acids” limitation
`recited in the challenged claims is improper. See 37 C.F.R. § 1.57(d).
`In view of the above, at this stage of the proceeding, we conclude that
`the claims of the ’647 patent are not entitled the benefit of priority to the
`’018 Provisional.
`
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`C. Petitioner’s Asserted Grounds of Unpatentability
`
`1. Anticipation of Claims 1−4 by Larsen PCT
`
`Petitioner contends that claims 1−4 are anticipated by Larsen PCT.
`Pet. 33–35. Petitioner contends that Larsen PCT discloses exendin-4 as a
`pharmacologically active peptide to which a “stabilising peptide sequence”
`may be linked. Id. at 34 (citing Ex. 1009, 9:20–10:20–22). Petitioner
`contends that Larsen PCT discloses that exendin-4 can be conjugated to the
`“stabilising peptide sequence” at the C-terminal amino acid residue. Id.
`(citing Ex. 1009, 4:29–5:1, 18:5–7). Petitioner further contends that Larsen
`PCT discloses that the “stabilising peptide sequence” may be a “polyamino
`acid” such as poly(L-lysine), poly-glutamic acid, or poly-aspartic acid. Id. at
`36–37 (citing Ex. 1009, 5:10–15, 14:1–2, 14:14–15:16); see Ex. 1009, 5:10–
`15 (“Thus, in a first aspect the invention relates to a pharmacologically
`active peptide conjugate having a reduced tendency towards enzymatic
`cleavage, said peptide conjugate comprises: a pharmacologically active
`peptide sequence (X) and a stabilising peptide sequence (Z) of 4–20 amino
`acid residues covalently bound to X, each amino acid residue in said
`stabilising peptide sequence (Z) being independently selected from the group
`consisting of Ala, Leu, Ser, Thr, Tyr, Asn, Gln, Asp, Glu, Lys, Arg, His,
`Met, Orn . . . .”).
`Petitioner further provides a detailed claim chart explaining how each
`limitation of challenged claims 1–4 is disclosed by Larsen PCT. Pet. 35–37.
`At this stage of the proceeding, we determine that Petitioner has
`offered sufficient evidence and argument to institute trial. We conclude,
`based on the current record, that Petitioner has established a reasonable
`
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`likelihood of prevailing on its assertion that claims 1–4 are unpatentable as
`anticipated by Larsen PCT.
`
`2. Anticipation of Claims 1, 2, 5, and 6 by Larsen ’486
`Petitioner contends that claims 1, 2, 5, and 6 are anticipated by Larsen
`’486. Pet. 43–55. Petitioner contends that Larsen ’486 discloses “several
`exendin variants that have at least about 90–95% homology to exendin-4 and
`demonstrate exendin-4-like activity, such as being able to lower blood
`glucose levels in mammals and bind GLP-1 receptors.” Pet. 43 (citing Ex.
`1011, 5:27–37). Petitioner contends that Larsen ’486 discloses that the
`“exendin variants are conjugated to a polyamino acid (“peptide sequence
`Z”), which is typically between 4-20 amino acid residues in length.” Id.
`(citing Ex. 1011, 7:16–23, 8:1–6). The “peptide sequence Z” can be a
`polylysine, polyglutamic acid, or polyaspartic acid. Id. (citing Ex. 1011,
`8:1–16, 8:23–9:16, 10:26–33).
` Larsen ’486 claims the benefit of priority to U.S. Provisional
`Application 60/143,591, filed July 12, 1999 (Ex. 1014) (“Larsen
`Provisional”). Petitioner contends that Larsen Provisional “contains
`sufficient – nearly verbatim – support for both the claims and the
`specification of the Larsen ’486.” Pet 44. Petitioner provides a detailed
`discussion and claim charts explaining how each limitation of challenged
`claims 1, 2, 5, and 6 is disclosed in Larsen ’486 and Larsen Provisional.
`At this stage of the proceeding, we determine that Petitioner has
`offered sufficient evidence that Larsen ’486 is entitled to the benefit of
`priority to Larsen Provisional. Accordingly, Larsen ’486 qualifies as prior
`art to the ’647 patent. We further conclude, based on the current record, that
`
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`Petitioner has established a reasonable likelihood of prevailing on its
`assertion that claims 1, 2, 5, and 6 are unpatentable as anticipated by Larsen
`’486.
`
`3. Obviousness of Claims 1−4 by Larsen PCT
`
`Petitioner contends that claims 1−4 are obvious in view of Larsen
`PCT. Pet. 33–35. Specifically, Petitioner contends as follows:
`
`The Larsen [] PCT specifically discloses exendin-4 – including
`the C-terminal amide – as a peptide that can be linked to a
`stabilising peptide through solid-phase peptide synthesis. One of
`skill in the art would have understood that the exendin-4 peptide
`would not retain the amide functional group at the C terminus of
`exendin-4 if it were linked to a stabilising peptide through that
`methodology. Ex. 1002, ¶¶ 89-91. . . .
`The only difference between the primary structures of
`exendin-4 on its own and the same peptide conjugated to the
`stabilising peptide is the amide group. However, one skilled in
`the art would have had a reasonable expectation of success at
`creating the conjugate because the Larsen ‘118 PCT teaches how
`to synthesize it. Ex. 1002, ¶ 90. In fact, the Larsen ‘118 PCT
`discloses a method of synthesizing such a peptide conjugate on a
`solid support one amino acid at a time, and therefore a
`deamidation step would not even be required. Ex. 1009, p. 27, ll.
`9-11; Ex. 1002, ¶ 90.
`Pet. 53–54.
`In view of the above, we determine that Petitioner has offered
`sufficient evidence and argument to institute trial on this ground. We
`conclude, based on the current record, that Petitioner has established a
`reasonable likelihood of prevailing on its assertion that claims 1–4 are
`unpatentable as obvious over the Larsen PCT.
`
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`4. Petitioner’s Remaining Grounds
`
`The patent rules promulgated for AIA post-grant proceedings,
`including those pertaining to institution, are “construed to secure the just,
`speedy, and inexpensive resolution of every proceeding.” 37 C.F.R.
`§ 42.1(b); see also 35 U.S.C. § 316(b) (regulations for AIA post-grant
`proceedings take into account “the efficient administration of the Office”
`and “the ability of the Office to timely complete [instituted] proceedings”).
`Therefore, we exercise our discretion and, for reasons of administrative
`necessity to ensure timely completion of the instituted proceeding, do not
`institute a review on any ground other than those specifically instituted in
`the Order below. See 37 C.F.R. § 42.108(a).
`
`III. CONCLUSION
`
`We conclude that Petitioner has established a reasonable likelihood of
`prevailing on its assertions that claims 1–6 of the ’647 patent are
`unpatentable as anticipated and/or obvious.
`At this stage of the proceeding, the Board has not made a final
`determination as to the patentability of any challenged claim or the
`construction of any claim term. Thus, our view with regard to any
`conclusion reached in the foregoing could change upon consideration of
`Patent Owner’s merits response and upon completion of the record.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is granted with regard to the following
`asserted grounds:
`
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`A. Claims 1−4 of the ’647 patent under 35 U.S.C. § 102 as
`anticipated by Larsen PCT;
`B. Claims 1, 2, 5, and 6 of the ’647 patent under 35 U.S.C. § 102
`as anticipated by Larsen ’486; and
`C. Claims 1−4 of the ’647 patent under 35 U.S.C. § 103(a) as
`obvious over Larsen PCT.
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`partes review of the ʼ647 patent is hereby instituted commencing on the
`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`§ 42.4, notice is hereby given of the institution of a trial.
`FURTHER ORDERED that the trial is limited to the grounds listed in
`the Order. No other grounds are authorized.
`
`PETITIONER:
`Paul Berghoff
`berghoff@mbhb.com
`
`Joshua Rich
`rich@mbhb.com
`
`Andrew Williams
`williams@mbhb.com
`
`PATENT OWNER:
`David Berl
`dberl@wc.com
`
`Dov Grossman
`dgrossman@wc.com
`
`
`
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