Trials@uspto.gov
`571-272-7822
`
` Paper 9
`
`Date: April 14, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EVERGREEN THERAGNOSTICS, INC.,
`Petitioner,
`
`v.
`
`ADVANCED ACCELERATOR APPLICATIONS SA,
`Patent Owner.
`____________
`
`PGR2021-00002
`Patent 10,596,278 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 325(d)
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
` Paper 9
`
`Date: April 14, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`EVERGREEN THERAGNOSTICS, INC.,
`Petitioner,
`
`v.
`
`ADVANCED ACCELERATOR APPLICATIONS SA,
`Patent Owner.
`____________
`
`PGR2021-00002
`Patent 10,596,278 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 325(d)
`
`
`
`
`
`
`
`
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`
`INTRODUCTION
`Evergreen Theragnostics, Inc. (“Petitioner”) filed a Petition (Paper 2
`(“Pet.”)), requesting a post-grant review of claims 1–25 of U.S. Patent
`No. 10,596,278 B2 (Ex. 1002, “the ’278 patent”). Advanced Accelerator
`Applications SA (“Patent Owner”) filed a Preliminary Response (Paper 7
`(“Prelim. Resp.”)).
`We review the Petition under 35 U.S.C. § 324, which provides that a
`post-grant review may not be instituted unless “it is more likely than not that
`at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C.
`§ 324(a). For the reasons provided below, we exercise our discretion to deny
`institution of post-grant review under 35 U.S.C. § 325(d).
`Related Matters
`Petitioner also filed PGR2021-00001, challenging the same claims of
`the ’278 patent. 1 Pet. 80. Petitioner further filed PGR2021-00003,
`challenging the claims of U.S. Patent No. 10,596,276, a patent in the same
`family as the ’278 patent. Id.
`Background of the Technology and the ’278 Patent
`The ’278 patent relates to “radionuclide complex solutions of high
`concentration and of high chemical stability, [which] allows their use as
`drug product for diagnostic and/or therapeutic purposes.” Ex. 1002,
`Abstract.
`
`
`1 The parties filed separate papers, addressing the issue of parallel petitions.
`Papers 3, 8. Because we deny the instant Petition for different reasons, we
`do not discuss that issue.
`
`2
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`
`The targeted drug delivery concept has been used in radiomedicine to
`deliver radionuclides selectively to the target cells for diagnostic or
`therapeutic purposes. Id. at 1:35–37. In a radiomedicine application, a target
`cell receptor binding moiety is linked to a chelating agent that is able to form
`a strong complex with the metal ions of a radionuclide. Id. at 1:38–41. When
`the radiopharmaceutical drug is delivered, the decay of the radionuclide
`affects only the target cells. Id. at 1:41–44.
`Specifically, peptide receptor radionuclide therapy (PRRT) was
`developed because “[n]early all cancers have overexpression of specific
`receptors on the tumor surface.” Ex. 1016, 2951. 2 “The most widely
`employed modality of PRRT uses somatostatin analogues for targeting
`somatostatin receptors, which are overexpressed in neuroendocrine cancer.”
`Id. 177Lu is a therapeutic radionuclide (id. at 2939), and DOTA is one of the
`most widely used chelating agent for Lu (id. at 2940). Thus, 177Lu-labeled-
`DOTA-somatostatin analogues, including 177Lu-DOTA-TATE and
`177Lu-DOTA-TOC have been used in PRRT. Id. at 2952.
`The ’278 patent explains that,
`One technical problem with those radiopharmaceutical drug
`products is that the decay of the radionuclide occurs constantly,
`e.g. also during the manufacturing and during storage of the drug
`product, and the released high energy emissions induce the
`cleavage of the chemical bonds of the molecules which form part
`of the drug product. This is often referred to as radiolysis or
`radiolytic degradation. The radiolytic degradation of the receptor
`
`
`2 Unless otherwise noted, we cite the original page numbers of the exhibits.
`3
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
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`
`binding moiety of the drug may lead to a decrease in its efficacy
`to act as a diagnostic and/or therapeutic.
`Ex. 1002, 1:45–54.
`The ’278 patent states that, before its invention, the usage of
`radiopharmaceutical drugs was limited due to their poor stability and the
`lack of any significant shelf-life. Id. at 1:55–2:8. Although prior art taught
`various ways to reduce radiolysis and improve stability of
`radiopharmaceutical drugs, each of those strategies has its own drawbacks.
`Id. at 2:9–39.
`According to the ’278 patent,
`It remains therefore a challenge to design a ready-to-use
`radiopharmaceutical drug product which can be produced at
`commercial scale and delivered as a sufficiently stable and sterile
`solution in a high concentration which leads to a for patient
`convenient small infusion volume and which has a composition
`of high physiological tolerability (e.g. a composition which does
`not contain ethanol).
`Id. at 2:40–47.
`The ’278 patent states that its inventors “found a way to design and
`produce a highly concentrated radionuclide complex solution which is
`chemically and radiochemically very stable even if stored at ambient or short
`term elevated temperatures so that it can be produced on commercial scale
`and supplied as ready-to-use radiopharmaceutical product.” Id. at 2:50–55.
`
`
`
`4
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`
`Illustrative Claim
`Independent claim 1 is illustrative of the challenged claims and
`is reproduced below:
`1. A pharmaceutical aqueous solution comprising:
`(a) a complex formed by
`(ai) the radionuclide 177Lu (Lutetium-177), and
`(aii) a somatostatin receptor binding peptide linked to the
`chelating agent DOTA; and
`(b) at least two different stabilizers against radiolytic degradation
`comprising
`(bi) gentisic acid or a salt thereof; and
`(bii) ascorbic acid or a salt thereof;
`wherein
`said radionuclide is present in a concentration that it provides
`a volumetric radioactivity of from 250 to 500 MBq/mL;
`said stabilizers are present in a total concentration of from 1.0
`to 5.0 mg/mL; and the pharmaceutical aqueous solution
`has less than 1% ethanol, and the radiochemical purity
`(determined by HPLC) of the solution is maintained at
`≥95% for at least 72 h when stored at 25 ℃.
`
`
`
`
`5
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`
`Asserted Grounds of Unpatentability
`
`Claim(s)
`Challenged
`1, 8–17, 19
`1, 8–194
`2–4
`15
`
`35 U.S.C. §
`102(a)
`103
`103
`103
`
`5–7
`
`103
`
`Reference(s)/Basis
`Maus3
`Maus, Kwekkeboom5
`Maus, Kwekkeboom, Scott6
`Maus, Kwekkeboom, de Blois, 7
`SEC Statement8
`Maus, Kwekkeboom,
`De Leon-Rodriguez, 9 Banerjee10
`
`
`3 Maus et al., Aspects of Radiolabeling of 177Lu-DOTA-TATE: After C18
`Purification Re-Addition of Ascorbic Acid Is Required to Maintain
`Radiochemical Purity, 1 Int. J. Diagnostic Imaging 5–12 (2014) (Ex. 1009).
`4 Petitioner separately challenges claim 18 as obvious over Maus,
`Kwekkeboom, and the general knowledge of an ordinarily skilled artisan.
`Pet. 39–40. Because the general knowledge of an artisan is always part of
`the obviousness analysis, we do not list this ground separately.
`5 Kwekkeboom et al., [177Lu-DOTA0,Tyr3]octreotate: Comparison with
`[111In-DTPA0]octreotide in Patients, 28 Eur. J. Nucl. Med. 1319–25 (2001)
`(Ex. 1010).
`6 Scott et al., Studies into Radiolytic Decomposition of Fluorine-18 Labeled
`Radiopharmaceuticals for Positron Emission Tomography, 67 Appl.
`Radiation and Isotope 88–94 (2009) (Ex. 1015).
`7 de Blois et al., Application of single-vial ready-for-use formulation of
`111In- or 177Lu-labelled somatostatin analogs, 85 Applied Radiation
`and Isotopes 28–33 (2014) (Ex. 1017).
`8 United States Security and Exchange Commission Form F-1 for Advanced
`Accelerator Applications S.A. (2014) (Ex. 1018).
`9 De Leon-Rodriguez et al., The Synthesis and Chelation Chemistry of
`DOTA−Peptide Conjugates, 19 Bioconjugate Chem. 391–402 (2008)
`(Ex. 1014).
`10 Banerjee et al., Lutetium-177 Therapeutic Radiopharmaceuticals: Linking
`Chemistry, Radiochemistry, and Practical Applications, 115 Chem. Rev.
`2934−74 (2015) (Ex. 1016).
`
`6
`
`
`
`20
`
`20–2512
`
`8, 11–14
`9, 10
`
`17
`
`103
`
`103
`
`103
`103
`
`103
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`
`Claim(s)
`Challenged
`5–7
`
`35 U.S.C. §
`103
`
`Reference(s)/Basis
`Maus, Kwekkeboom, ’536 patent, 11
`De León-Rodríguez, Banerjee
`Maus, Kwekkeboom, Scott,
`De León-Rodríguez, Banerjee
`Maus, Kwekkeboom, Scott,
`’536 patent, De León-Rodríguez,
`Banerjee
`Maus, Kwekkeboom, ’536 patent
`Maus, Kwekkeboom, ’536 patent,
`Scott
`Maus, Kwekkeboom,
`Luna-Gutiérrez13
`Enablement
`112
`1–25
`In support of its positions, Petitioner relies on the declarations of
`Stephan Maus (Ex. 1007) and Ingrid Hsieh-Yee, Ph.D. (Ex. 1008).
`ANALYSIS
`Patent Owner asks us to exercise our discretion under 35 U.S.C.
`§ 325(d) and deny this Petition. Prelim. Resp. 19–35. Patent Owner argues
`that Maus was overcome during prosecution, many of the other references
`cited in the Petition were either cited during prosecution or are cumulative to
`
`
`11 Zamora et al., US 6,261,536 B1, issued Jul. 17, 2001 (Ex. 1013).
`12 Petitioner challenges claim 20 and claims 21–25 under two grounds, with
`the difference being that, for the latter ground, the ’536 patent is included as
`optional. Pet. 11. We do not list these two grounds separately.
`13 M. Luna-Gutiérrez et al., Freeze-Dried Multi-Dose Kits for the Fast
`Preparation of 177Lu-Tyr3-Octreotide and 177Lu-PSMA(Inhibitor)
`under GMP Conditions, J. Radioanal. Nucl. Chem., pp. 2181–88 (2017)
`(Ex. 1025).
`
`7
`
`
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`PGR2021-00002
`Patent 10,596,278 B2
`
`those that were cited, and Petitioner fails to identify material error. Id. We
`find Patent Owner’s arguments persuasive.
`Under § 325(d),
`In determining whether to institute or order a proceeding under
`. . . chapter 31, the Director may take into account whether, and
`reject the petition or request because, the same or substantially
`the same prior art or arguments previously were presented to the
`Office.
`In evaluating whether to exercise our discretion under § 325(d), we
`weigh the following non-exclusive factors (“BD factors”):
`(a) the similarities and material differences between the
`asserted art and the prior art involved during examination;
`(b) the cumulative nature of the asserted art and the prior
`art evaluated during examination;
`(c) the extent to which the asserted art was evaluated
`during examination, including whether the prior art was the basis
`for rejection;
`(d) the extent of the overlap between the arguments made
`during examination and the manner in which Petitioner relies on
`the prior art or Patent Owner distinguishes the prior art;
`(e) whether Petitioner has pointed out sufficiently how the
`Examiner erred in its evaluation of the asserted prior art; and
`(f) the extent to which additional evidence and facts
`presented in the Petition warrant reconsideration of prior art or
`arguments.
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586,
`Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first
`paragraph).
`Factors (a), (b), and (d) relate to whether the art and arguments
`presented in the petition are the same or substantially the same as those
`
`8
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`previously presented to the Office. Advanced Bionics, LLC v. Med-El
`Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB
`Feb. 13, 2020) (precedential). Factors (c), (e), and (f) “relate to whether the
`petitioner has demonstrated a material error by the Office” in its prior
`consideration of that art or arguments. Id. Only if the same or substantially
`the same art or arguments were previously presented to the Office do we
`then consider whether petitioner has demonstrated error. Id.
`BD Factors (a), (b), and (d)
`We first consider whether Petitioner asserts the same or substantially
`the same prior art or arguments that previously were presented to the Office.
`We conclude that Petitioner does so.
`Petitioner asserts Maus as the primary reference in all 13 art based
`grounds. Pet. 9–12. It is undisputed that “Maus is identified on the face of
`the ’278 patent and was considered during prosecution.” Id. at 16. Petitioner
`also asserts several other references, including Kwekkeboom, Banerjee,
`Luna-Gutierrez, and de Blois in various art based grounds. Id. at 10–12. It is
`undisputed that these references are identified on the face of the ’278 patent,
`and the Examiner explicitly discussed de Blois during prosecution. Id. at 17–
`21. Petitioner further cites Breeman 2003, 14 Das 2, 15
`
`
`14 Breeman et al., Optimizing Conditions for Radiolabeling of DOTA-
`Peptides with 90Y, 111In and 177Lu at High Specific Activities, 30 Eur. J, Nuc.
`Med. and Molecular Imaging 917–20 (2003) (Ex. 1020).
`15 Das et al., Preparation of DOTA-TATE and DOTA-NOC Freeze-Dried
`Kits for Formulation of Patient Doses of 177lu-Labeled Agents and
`
`9
`
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`PGR2021-00002
`Patent 10,596,278 B2
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`Liu, 16 and Breeman 2016, 17 for teaching background of the technology. Id.
`at 2–3 (citing Ex. 1020, 1022, 1023, 1027). These references were also
`identified on the face of the ’278 patent. Ex. 1002, code (56). Thus, many of
`the same references Petitioner relies on here were previously presented to
`the Office.
`Patent Owner argues that additional references Petitioner relies on are
`cumulative to references cited during prosecution. Prelim. Resp. 30–34. For
`example, Petitioner asserts the ’536 patent in Challenges 7 and 9–12, as
`numbered in the Petition. Pet. 10–12. Patent Owner contends that the
`’536 patent is cumulative to Liu, which was before the Office. Prelim.
`Resp. 32. According to Patent Owner, Petitioner relies on the ’536 patent “as
`disclosing that AA [ascorbic acid] is preferably added after chelation.” Id.
`(citing Pet. 47). “The potential advantage of adding AA after chelation,”
`Patent Owner argues, “was disclosed in other references of record before the
`Examiner,” such as Liu. Id. We find Patent Owner’s argument persuasive.
`Petitioner argues that, in view of the teachings of the ’536 patent, “[a]
`POSA would have been motivated to add the sodium ascorbate after the
`radiolabeling reaction was completed based on a reasonable expectation that
`
`
`Their Comparison for Peptide Receptor Radionuclide Therapy Application,
`299 J. Radioanal. Nucl. Chem. 1389–98 (2014) (Ex. 1022).
`16 Liu et al., Stabilization of 90Y-Labeled DOTA-Biomolecule Conjugates
`Using Gentisic Acid and Ascorbic Acid, 12 Bioconjugate Chem. 554–58
`(2001) (Ex. 1023).
`17 Breeman et al., Overview of Development and Formulation of 177Lu-
`DOTA-TATE for PRRT, 9 Current Radiopharmaceuticals 8–18 (2016)
`(Ex. 1027).
`
`10
`
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`PGR2021-00002
`Patent 10,596,278 B2
`
`such a process would provide a superior product.” Pet. 47 (citing Ex. 1013,
`5:29–40). Liu teaches the use of ascorbic acid and gentisic acid as stabilizers
`that can be added into a radiopharmaceutical formulation either before or
`after radiolabeling. Ex. 1023, 557. According to Liu:
`For the post-labeling addition, the stabilizer is not exposed to
`the heating process; thereby it may have a longer stabilizing
`effect and higher stabilizing efficiency. The post-labeling
`approach is particularly useful when the addition of a large
`amount of stabilizer in the radiopharmaceutical formulation
`interferes with the radiolabeling of the DOTA-biomolecule
`conjugate.
`Id. Therefore, like the ’536 patent, Liu teaches adding ascorbic acid after
`chelation to increase stability and provides an example in which this is done.
`See id. at 556. Indeed, Petitioner acknowledges this disclosure by citing to
`Liu for the proposition that an ordinarily skilled artisan would have known
`that ascorbic acid was “preferably added after the complexation reaction is
`completed.” Pet. 47 (citing Ex. 1023, 557). Thus, we find the ’536 patent is
`cumulative to Liu, which was previously presented to the Office.
`Patent Owner also contends that De Leon-Rodriguez is cumulative.
`Prelim. Resp. 33. In its Challenges 6–10, as numbered in the Petition,
`Petitioner argues that the challenged claims would have been obvious over
`various references, and further in view of De Leon-Rodriguez or Banerjee.
`Pet. 10–11. Thus, we agree with Patent Owner that Petitioner “relies on
`De Leon-Rodriguez as an alternative to Banerjee (Ex. 1016) to teach the pH
`range for chelation.” Prelim. Resp. 33 (citing Pet. 3, 18, 40, 43–45, 48–51).
`As Petitioner acknowledges, “Banerjee is identified on the face of the
`
`11
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`PGR2021-00002
`Patent 10,596,278 B2
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`’278 patent.” Pet. 18. Thus, we find De Leon-Rodriguez is cumulative to
`Banerjee, which was previously presented to the Office.
`Patent Owner further asserts that Scott is cumulative. Prelim.
`Resp. 33. In its Challenges 3, 8, 9, 10, and 12, as numbered in the Petition,
`Petitioner argues that an ordinarily skilled artisan would have understood
`that “ascorbic acid and sodium ascorbate are interchangeable as radiolytic
`stabilizers, as evidenced by Scott.” Pet. 10–12. We agree with Patent Owner
`that other references before the Office, such as Maus, Kwekkeboom,
`Breeman 2003, and Breeman 2016, teach using sodium ascorbate as a
`stabilizer. See, e.g., Ex. 1010, 1320; Ex. 1020, 918; Ex. 1027, 11. Thus, we
`find Scott is cumulative to other references that were previously presented to
`the Office.
`The last reference Petitioner relies on is the SEC Statement, asserted
`in Challenge 4 to support the proposition that an ordinarily skilled artisan
`would have understood that “a shelf life of at least 72 hours was necessary
`for a commercially viable product.” Pet. 38 (citing Ex. 1018, 2). During
`prosecution, the Examiner stated:
`It would have been obvious to one ordinarily skilled in the art
`before the effective filing date of the claimed invention that the
`177Lu-DOTA-TATE has a shelf life of at least 72 h when stored
`at ≤ 25 ℃ as RCM meeting18 discloses that the 177L u-DOTA-
`TATE is stable up to 4 d as it retained its radiochemical purity
`
`
`18 RCM meeting (Development and preclinical evaluation of therapeutic
`radiopharmaceuticals based on 177Lu- and 90Y-labelled monoclonal
`antibodies and peptides: Stip, Republic of Macedonia Oct. 1–5, 2012) is a
`reference cited by the Examiner. Ex. 1002, code (56).
`
`12
`
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`PGR2021-00002
`Patent 10,596,278 B2
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`>98% when stored at room temperature, as determined via
`HPLC.
`Ex. 1004, 243 (footnote added). 19
`Relying on this passage, Patent Owner argues that the SEC Statement
`is cumulative because the Examiner “discussed teachings concerning a
`72-hour shelf life during prosecution.” Prelim. Resp. 33–34 (citing Ex. 1004,
`243). We do not need to address Patent Owner’s argument here, because in
`Challenge 4, Petitioner relies on Maus, Kwekkeboom, de Blois, and the SEC
`Statement. Pet. 10. As discussed above, all but the SEC Statement were
`before the Examiner during prosecution. See supra at 10.
`In sum, because all but one of the references Petitioner relies on were
`previously presented to the Office, or are cumulative to references that were
`before the Office, we move on to the second part of the Advanced Bionics
`framework.
`
`BD Factors (c), (e), and (f)
`Because we find that the “same or substantially the same prior art or
`arguments previously were presented to the Office,” we turn to whether
`Petitioner demonstrates that the Office erred in a manner material to the
`patentability of the challenged claims. Advanced Bionics, Paper 6 at 8, 10;
`see Becton, Dickinson, Paper 8 at 24. We conclude that Petitioner has failed
`to do so.
`Petitioner summarizes the prosecution history of the ’278 patent
`(Pet. 5–8) and acknowledges that several references cited in the Petition
`were previously before the Office (id. at 16–21). Petitioner, however, fails to
`
`19 For Exhibit 1004, we cite the page numbers added by Petitioner.
`13
`
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`PGR2021-00002
`Patent 10,596,278 B2
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`sufficiently address how the Office erred in a manner material to the
`patentability of the challenged claims. Indeed, Petitioner states in a single
`sentence that “the Examiner did not appear to appreciate the formulation of
`the Kwekkeboom kit used in Maus and did not appear to appreciate the
`specific ingredients of that kit.” Id. at 16–17. Patent Owner counters that,
`during prosecution, the applicant discussed the Kwekkeboom formulation,
`and the Examiner acknowledged that discussion. Prelim. Resp. 29 (citing
`Ex. 1004, 162 n.1, 238). We agree with Patent Owner.
`During prosecution, the Examiner specifically cited Section 2.2 of
`Maus, the “Manual radiolabeling procedure,” in issuing an obvious
`rejection. Ex. 1004, 119. Section 2.2 of Maus refers to use of the
`DOTA-TATE kit formulation of Kwekkeboom for the radiolabeling
`procedure. Ex. 1009, 7 (citing Kwekkeboom as ref. 13).
`In response to the rejection, the applicant argued that Maus, using the
`Kwekkeboom formulation, “refers to a noticeably higher total concentration
`of gentisic acid and ascorbic acid (equivalent to 5–10 mg/mL at a volumetric
`radioactivity of 6.8-13.5 mCi/mL 177Lu and up to 15.4 mg/mL gentisic acid
`or 17.6 mg/mL ascorbic acid sodium salt at a volumetric radioactivity of
`13.5 mCi/mL 177Lu).” Ex. 1004, 162. The applicant argued that, therefore,
`Maus “teaches away from using lower concentrations of gentisic acid and
`ascorbic acid.” Id.
`The applicant also specifically discussed Kwekkeboom in stating:
`Maus refers to ref. 13 for the DOTA-TATE kit formulation, in
`which the final concentration of gentisic acid in the final solution
`is 15 mg/mL and that of ascorbic acid is 70 mg/mL at a
`volumetric radioactivity of 4.44 GBq/mL or 120 mCi/mL 177Lu.
`
`14
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`PGR2021-00002
`Patent 10,596,278 B2
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`
`See ref. 13 cited in Maus at page 1320, left column in “Methods”
`section.
`Id. at 162 n.1.
`The Examiner “fully considered” the applicant’s arguments, found
`them “persuasive” and withdrew the original rejection. Ex. 1004, 238. The
`Examiner issued a new obviousness rejection over Maus in combination
`with additional references, and again cited the radiolabeling procedure of
`Maus Section 2.2. Id. at 238–44. This rejection was maintained in the final
`rejection by the Examiner; but after an Examiner Interview, the Examiner
`issued a Notice of Allowance along with an Examiner’s Amendment. Id. at
`273–277, 297–300.
`In sum, during prosecution, the applicant described the components
`and amounts of the DOTA-TATE kit formulation from Kwekkeboom, and
`this information was considered by the Examiner. Petitioner neither
`addresses the applicant’s statements made during prosecution regarding
`Maus and Kwekkeboom, nor asserts that the Examiner’s responses to these
`statements are incorrect. A single sentence stating the Examiner “did not
`appear to appreciate” the Kwekkeboom formulation does not amount to a
`showing of a material error by the Office.
`Conclusion
`Weighing the BD factors, we conclude that the Petition relies on the
`same and substantially the same references, and presents arguments that are
`substantially the same as those the Examiner considered during prosecution.
`Petitioner has not demonstrated that the Examiner materially erred in that
`consideration. Thus, on the record presented, the circumstances of this case
`
`15
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`warrant exercise of our discretion under § 325(d) to deny institution of all art
`based grounds. 20
`Under the Office Guidance, “if the PTAB institutes a trial, the PTAB
`will institute on all challenges raised in the petition.” Guidance on the
`Impact of SAS on AIA Trial Proceedings (April 26, 2018). 21 In addition, the
`Board “will evaluate the challenges and determine whether § 325(d) is
`sufficiently implicated that its statutory purpose would be undermined by
`instituting on all challenges” and, if so, “evaluate whether the entire petition
`should be denied.” SAS Q&A’s, Part D, Effect of SAS on Future Challenges
`that Could Be Denied for Statutory Reasons, answer to Question D1 (June 5,
`2018). 22
`Here, Petitioner advances 14 challenges against the claims of the ’278
`patent. Pet. 9–12. As discussed above, we deny institution of 13 of the 14
`challenges under § 325(d). Supra at 7–15. Furthermore, we determine that
`§ 325(d) is sufficiently implicated that instituting on the remaining one
`ground would undermine the statutory purpose of § 325(d). Accordingly,
`we deny institution of the entire Petition. 23
`
`
`20 Patent Owner argues that Petitioner has not met its burden in showing
`anticipation and obviousness of the challenged claims. Prelim. Resp. 35–48.
`Because we deny institution of the art based grounds under § 325(d), we do
`not reach those additional arguments.
`21 Available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-
`sas-aia-trial.
`22 Available at https://www.uspto.gov/sites/default/files/documents/
`sas_qas_20180605.pdf.
`23 See SAS Q&As, D1 (June 5, 2018), available at https://www.uspto.gov/
`sites/default/files/documents/sas_qas_20180605.pdf.
`16
`
`
`
`PGR2021-00002
`Patent 10,596,278 B2
`
`
`ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied and no post-grant review is
`instituted.
`
`
`
`
`
`
`FOR PETITIONER:
`
`C. Kyle Musgrove
`Paul Dietze
`Scott Cunning
`Elizabeth Crompton
`PARKER POE ADAMS & BERNSTEIN LLP
`kylemusgrove@parkerpoe.com
`pauldietze@parkerpoe.com
`scottcunning@parkerpoe.com
`elizabethcrompton@parkerpoe.com
`
`
`
`
`FOR PATENT OWNER:
`
`Jane Love
`Kyanna Sabanoglu
`GIBSON, DUNN & CRUTCHER LLP
`jlove@gibsondunn.com
`ksabanoglu@gibsondunn.com
`
`17
`
`
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