throbber
Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Paper 10
`Entered: April 14, 2021
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EVERGREEN THERAGNOSTICS, INC.,
`Petitioner,
`v.
`ADVANCED ACCELERATOR APPLICATIONS SA,
`Patent Owner.
`
`PGR2021-00003
`Patent 10,596,276 B2
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`WISZ, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 325(d)
`
`
`
`
`
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`
`INTRODUCTION
`I.
`Evergreen Theragnostics, Inc. (“Petitioner”) filed a Petition (Paper 2,
`“Pet.”) requesting a post-grant review of claims 1–24 of U.S. Patent
`No. 10,596,276 B2 (Ex. 1001, “the ’276 patent”). Advanced Accelerator
`Applications SA (“Patent Owner”) filed a Preliminary Response (Paper 6,
`“Prelim. Resp.”). With our authorization, Petitioner filed a Reply (Paper 7,
`“Reply”), and Patent Owner filed a Sur-Reply (Paper 9, “PO Sur-Reply”).
`Under 35 U.S.C. § 324(a), a post-grant review may not be instituted
`“unless . . . the information presented in the petition . . . , if such information
`is not rebutted, would demonstrate that it is more likely than not that at least
`1 of the claims challenged in the petition is unpatentable.” Upon
`considering the arguments and evidence, we exercise our discretion to deny
`institution of post-grant review under 35 U.S.C. § 325(d).
`
`II. BACKGROUND
`A. Real Parties-in-Interest
`Petitioner identifies Evergreen Theragnostics, Inc. as the real party-in-
`interest. Pet. 86. Patent Owner states that “Advanced Accelerator
`Applications SA is the assignee of [the ’276 patent]” and that “Novartis AG
`and other Novartis subsidiaries may also have an interest.” Paper 4, 2.
`
`B. Related Proceedings
`The parties indicate that Petitioner has filed two petitions for post-
`grant review for a related patent in the following proceedings: PGR2021-
`00001 (U.S. Patent No. 10,586,278) (“the ’278 patent”); and PGR2021-
`00002 (the ’278 patent). See Pet. 86–87; Paper 4, 2.
`The parties also identify the following pending applications and
`patents that claim priority to the same patent application as the ’276 patent:
`
`2
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`Application No. 16/140,962; Application No. 16/045,484; Application
`No. 16/175,239, now the ’278 patent; and Application No. 16/827,606.
`Pet. 86; Paper 4, 2.
`
`C. The ’276 Patent
`The ’276 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. 1001,
`code (57).
`The targeted drug delivery concept has been used in radiomedicine to
`deliver radionuclides selectively to target cells for diagnostic or therapeutic
`purposes. Ex. 1001, 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.
`The ’276 patent explains that
`[o]ne 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 binding moiety of the drug may lead to a decrease in
`its efficacy to act as a diagnostic and/or therapeutic.
`Ex. 1001, 1:45–54.
`The ’276 patent states that, before its invention, the usage of
`radiopharmaceutical drugs was limited due to their poor stability and the
`
`3
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`lack of any significant shelf-life. Ex. 1001, 1:55–2:8. The ’276 patent
`further states that, although the 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 ’276 patent,
`[i]t 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
`convenient small infusion volume for patients and which has a
`composition of high physiological tolerability (e.g. a
`composition which does not contain ethanol).
`Ex. 1001, 2:40–47.
`The ’276 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.” Ex. 1001, 2:50–
`55. The ’276 patent also states that the use of two stabilizers — one during
`complex formation and another after complex formation — was found to be
`particularly advantageous for shelf-life. Id. at 3:67–4:6.
`
`D. Illustrative Claim
`Petitioner challenges claims 1–24 of the ’276 patent. Claim 1, which
`is the only independent claim of the ’276 patent, is illustrative of the
`challenged claims, and is reproduced below:
`1. A process for manufacturing a pharmaceutical aqueous
`solution, comprising:
`providing a solution comprising a complex of the radionuclide
`177Lu (Lutetium-177) and a somatostatin receptor binding
`
`4
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`peptide linked to the chelating agent DOTA; a first stabilizer
`against radiolytic degradation, and optionally a second
`stabilizer against radiolytic degradation different from the first
`stabilizer; and diluting the solution comprising the complex
`with an aqueous dilution solution comprising at least one
`stabilizer against radiolytic degradation to obtain the
`pharmaceutical aqueous solution;
`wherein if the solution comprising the complex comprises only
`the first stabilizer as an stabilizer against radiolytic degradation
`and not the second stabilizer, then the aqueous dilution solution
`comprises at least one stabilizer against radiolytic degradation
`that is different from the first stabilizer, and in the obtained
`pharmaceutical aqueous solution, the radionuclide 177Lu is
`present in a concentration that it provides a volumetric
`radioactivity of from 250 to 500 MBq/mL and the stabilizers
`are present in a total concentration of from 1.0 to 5.0 mg/mL,
`and ethanol is present in a concentration of less than 1%.
`Ex. 1001, 37:18–41. Challenged claims 2–24 depend from claim 1, either
`directly or indirectly.
`
`5
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`E. The Asserted Grounds of Unpatentability
`Petitioner contends claims 1–24 of the ’276 patent are unpatentable in
`view of the following grounds. Pet. 10–12.
`Ground Claim(s)
`35 U.S.C. § Reference(s)/Basis
`Challenged
`1–9, 12–14
`10, 11, 17
`
`1
`2
`
`103
`103
`
`Maus,1 ’536 patent2
`Maus, ’536 patent, De León-
`Rodríguez,3 Banerjee4
`Maus, ’536 patent,
`Kwekkeboom,5 de Blois6, 7
`
`3
`
`16
`
`103
`
`
`1 Maus et al., Aspects of radiolabeling of 177Lu-DOTA-TATE: After C18
`purification re-addition of ascorbic acid is required to maintain
`radiochemical purity, Int. J. Diagnostic Imaging, 1(1):5–12, 2014 (Ex. 1009,
`“Maus”).
`2 Zamora et al., US 6,261,536 B1, issued Jul. 17, 2001 (Ex. 1013, “the
`’536 patent”).
`3 De León-Rodríguez et al., The Synthesis and Chelation Chemistry of
`DOTA−Peptide Conjugates, Bioconjugate Chem., 19(2):391–402, Feb. 2008
`(Ex. 1014, “De León-Rodríguez”).
`4 Banerjee et al., Lutetium-177 Therapeutic Radiopharmaceuticals: Linking
`Chemistry, Radiochemistry, and Practical Applications, Chem. Rev.,
`115:2934−2974, 2015 (Ex. 1016, “Banerjee”).
`5 Kwekkeboom et al., [177Lu-DOTA0,Tyr3]octreotate: comparison with
`[111In-DTPA0]octreotide in patients, Eur. J. Nucl. Med., 28(9):1319–1325,
`Sept. 2001 (Ex. 1010, “Kwekkeboom”).
`6 de Blois et al., Application of single-vial ready-for-use formulation
`of 111In- or 177Lu-labelled somatostatin analogs, Applied Radiation
`and Isotopes, 85:28–33, 2014 (Ex. 1017, “de Blois”).
`7 The Petition describes this challenge as obviousness by Maus, in view of
`the ’536 patent, further in view of Kwekkeboom “or other prior art
`disclosing the use of 177LuCl3 in an HCl solution for complexation.” Pet. 10,
`43–44. Because de Blois is the other reference cited for such disclosure, we
`list it here. Id. at 45.
`
`6
`
`

`

`35 U.S.C. § Reference(s)/Basis
`
`PGR2021-00003
`Patent 10,596,276 B2
`Ground Claim(s)
`Challenged
`18
`
`4
`
`5
`
`6
`7
`8
`9
`
`15, 19
`
`20–24
`24
`20–24
`1–19
`
`103
`
`103
`
`102(a)
`103
`103
`103
`
`Maus, ’536 patent, Scott8
`
`Maus, ’536 patent, de Blois,
`’365 publication9, Chen10, 11
`Maus
`Maus
`Maus, ’536 patent
`Protocol,12 Maus, ’536 patent,
`De León-Rodríguez, Banerjee,
`Scott
`Protocol, Maus, ’536 patent,
`Kwekkeboom, De León-
`Rodriguez, Banerjee, Scott
`
`10
`
`16
`
`103
`
`
`8 Scott et al., Studies into Radiolytic Decomposition of Fluorine-18 Labeled
`Radiopharmaceuticals for Positron Emission Tomography, Appl. Radiat.
`Isot., 67(1): 88–94 Jan. 2009 (Ex. 1015, “Scott”).
`9 Chen at al., US 2012/0065365 A1, published Mar. 15, 2012 (Ex. 1019, “the
`’365 publication”).
`10 Chen et al., Synthesis, stabilization and formulation of [177Lu]Lu-AMBA,
`a systemic radiotherapeutic agent for Gastrin Releasing Peptide receptor
`positive tumors, Applied Radiation and Isotopes, 66(4):497–505, Apr. 2008
`(Ex. 1029, “Chen”).
`11 The Petition describes this challenge as obviousness by Maus, in view of
`the ’536 patent, “further in view of prior art disclosing routine storage of
`radiolabeled pharmaceuticals in a stoppered vial.” Pet. 11, 46–47. Because
`the Petition cites to de Blois, the ’365 publication, and Chen as disclosing
`that “vials were a routine, art-recognized container for pharmaceutical
`solutions,” we list those references here. Id. at 48.
`12 Protocol associated with Strosberg et al., Phase 3 Trial of 177Lu-Dotatate
`for Midgut Neuroendocrine Tumors, 376 N. Engl. J. Med. 125–35 (2017)
`(Ex. 1012, “Protocol”).
`
`7
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`Ground Claim(s)
`Challenged
`20–24
`24
`20–24
`
`11
`12
`13
`
`14
`
`24
`
`35 U.S.C. § Reference(s)/Basis
`
`102(a)
`103
`103
`
`112
`
`Protocol
`Protocol
`Protocol, Maus, ’536 patent,
`Scott
`Enablement
`
`Petitioner submits the Declarations of Stephan Maus (Ex. 1005),
`Ingrid Hsieh-Yee, Ph.D. (Ex. 1008), and Paul E. Dietze, Ph.D., Esq.
`(Ex. 1037) in support of institution of post-grant review.
`
`III. DENIAL UNDER 35 U.S.C. § 325(d)
`Patent Owner asserts that we should deny the Petition under 35 U.S.C.
`§ 325(d) because Maus was overcome during prosecution, many of the other
`references cited in the Petition were either cited during prosecution or are
`cumulative to those that were cited, and Petitioner fails to identify material
`error. See Prelim. Resp. 20–36. We find Patent Owner’s arguments
`persuasive.
`We have discretion to deny review when “the same or substantially
`the same prior art or arguments previously were presented to the Office.”
`35 U.S.C. § 325(d). In that respect, section 325(d) provides that the Director
`may elect not to institute a proceeding if the challenge to the patent is based
`on matters previously presented to the Office.13 Advanced Bionics, LLC v.
`Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7
`(PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”).
`
`
`13 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a).
`
`8
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`In evaluating the exercise of discretion to deny institution under
`§ 325(d), the Board uses the following two-part framework: (1) determining
`whether the same or substantially the same art previously was presented to
`the Office or whether the same or substantially the same arguments
`previously were presented to the Office; and (2) if either condition of the
`first part of the framework is satisfied, determining whether the petitioner
`has demonstrated that the Office erred in a manner material to the
`patentability of challenged claims. Advanced Bionics, Paper 6 at 8.
`In applying the two-part framework, we consider several non-
`exclusive factors, including:
`(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 the 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 Section III.C.5,
`first paragraph) (“Becton, Dickinson”).
`
`9
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`Factors (a), (b), and (d) of the Becton, Dickinson factors relate to
`whether the art or arguments presented in the Petition are the same or
`substantially the same as those previously presented to the Office. Advanced
`Bionics, Paper 6 at 10. 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 a material error by the
`Office. Id. “At bottom, this framework reflects a commitment to defer to
`previous Office evaluations of the evidence of record unless material error is
`shown.” Id. at 9.
`
`A. Same or Substantially the Same Art or Arguments Previously
`Presented to the Office
` We first consider whether Petitioner asserts the same or substantially
`the same art or arguments that previously were presented to the Office.
`Advanced Bionics, Paper 6 at 8. We conclude that Petitioner does so.
`Patent Owner asserts that Maus was overcome during prosecution and
`that many of the other references cited in the Petition were either cited
`during prosecution or are cumulative to those that were cited. See Prelim.
`Resp. 21–36. It is undisputed that Maus, the primary reference for many of
`Petitioner’s grounds, was the subject of obviousness rejections issued by the
`Examiner during prosecution of the ’276 patent. See Ex. 1003, 125–131,
`248–258, 292–300;14 Pet. 16. In addition, numerous other references cited
`
`
`14 The cited pages numbers in Ex. 1003 refer to the numbers added by
`Petitioner in the bottom-right corner of the page.
`
`10
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`in the Petition grounds were also cited during prosecution. For instance,
`Kwekkeboom, Banerjee, and de Blois15 were submitted on an Information
`Disclosure Statement (“IDS”) and were considered by the Examiner. Id. at
`79, 80, 138, 139. Also, the ’375 publication,16 which is the parent to the
`’365 publication cited in the Petition, was cited by the Examiner in
`obviousness rejections. See id. at 126–128, 132, 251–257, 293–297. All of
`these references are listed under the “References Cited” section of the ’276
`patent. See Ex. 1001, code (56). “Previously presented art includes art
`made of record by the Examiner, and art provided to the Office by an
`applicant, such as on an [IDS], in the prosecution history of the challenged
`patent.” Advanced Bionics, Paper 6 at 7–8. Therefore, many of the same
`references cited by Petitioner were previously presented to the Office.
`Patent Owner further argues that additional references cited in the
`Petition are cumulative to references that were cited during prosecution. See
`Prelim. Resp. 32–35. Specifically, Patent Owner contends that the
`’536 patent, cited by Petitioner, is cumulative to Liu,17 which was before the
`Office. Id. at 32–33. According to Patent Owner, Petitioner relies on the
`’536 patent “as disclosing that AA [ascorbic acid] is preferably added after
`chelation.” Id. at 33 (citing Pet. 26). “The potential advantage of adding
`
`
`15 De Blois was also cited in obviousness rejections by the Examiner. See
`Ex. 1003, 251–257, 293–297.
`16 Chen et al., US 2007/0269375 A1, published Nov. 22, 2007 (Ex. 2003,
`“the ’375 publication”).
`17 Liu et al., Stabilization of 90Y-Labeled DOTA-Biomolecule Conjugates
`Using Gentisic Acid and Ascorbic Acid, Bioconjugate Chem., 12:554–558,
`2001 (Ex. 1023, “Liu”).
`
`11
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`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 person of ordinary skill in the
`art would have known “that adding ascorbate after complexation resulted in
`improved product.” Pet. 26 (citing Ex. 1013, 5:29–40, 7:22–28, 7:34–48).
`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. See Ex. 1023, 557.18 According to Liu,
`[f]or 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 a person of ordinary skill in the art
`would have known that “[ascorbic] acid was preferably added after
`complexation.” See Pet. 26 (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 León-Rodríguez is cumulative to
`Banerjee because Petitioner “relies on De León-Rodríguez as an alternative
`
`
`18 The cited pages numbers in Ex. 1023 refer to the original page numbers at
`the top of the page.
`
`12
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`to Banerjee (Ex. 1016) to teach the pH range for chelation” and Banerjee
`was before the Examiner. Prelim. Resp. 34 (citing Pet. 3, 17, 40–43, 46).
`We agree with Patent Owner that Petitioner relies on De León-Rodríguez
`and Banerjee as alternative references for disclosing optimal pH. See, e.g.,
`Pet. 40 (“De León-Rodríguez and Banerjee (amongst other references)
`disclosed that the optimal pH for the complexation reaction was between 5
`and 6.” (citing Ex. 1014 ¶ 213; Ex. 1016; Ex. 1022)). Thus, we find that
`De León-Rodríguez is cumulative to Banerjee, which was previously
`presented to the Office.
`
`Patent Owner further contends that Scott is cumulative to other
`previously presented references such as Maus, Kwekkeboom, Breeman
`2003,19 and Breeman 2016.20 Prelim. Resp. 34. According to Patent Owner,
`Petitioner “relies on Scott to assert that sodium ascorbate (NaAsc) was
`known to be an alternative to ascorbic acid (AA)” and other references
`before the Examiner “likewise discussed using NaAsc.” Id. (citing Pet. 23–
`24, 46; Ex. 1009; Ex. 1010; Ex. 1020; Ex. 1027). We agree with Patent
`Owner that other references before the Office teach the use of sodium
`ascorbate as a stabilizer. See, e.g., Ex. 1010, 1320; Ex. 1020, 918;
`Ex. 1027, 11. Thus, we find that Scott is cumulative to other references that
`were previously presented to the Office.
`
`19 Breeman et al., Optimizing conditions for radiolabeling of DOTA-
`peptides with 90Y, 111In and 177Lu at high specific activities, Eur. J, Nuc.
`Med. and Molecular Imaging, 30(6):917–920, June 2003 (Ex., 1020,
`“Breeman 2003”)
`20 Breeman et al., Overview of Development and Formulation of 177Lu-
`DOTA-TATE for PRRT, Current Radiopharmaceuticals, 9:8–18, 2016
`(Ex. 1027, “Breeman 2016”)
`
`13
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`
`Petitioner also cites to Chen as disclosing that “vials were a routine,
`art-recognized container for pharmaceutical solutions.” Pet. 48. Because
`the Petition also cites to de Blois and the ’365 publication for this disclosure
`(id.), we find that Chen is cumulative to these references, which were
`previously presented to the Office.
`
`In sum, we find that all but one of the references relied on in the
`Petition grounds were previously presented to the Office or are cumulative
`to references that were previously cited to the Office. The remaining
`reference, the Protocol, was not previously cited, and Patent Owner does not
`appear to argue that it is cumulative to references that were before the
`Office.21 However, three of the grounds that list the Protocol as the primary
`reference for obviousness (i.e., grounds 9, 10, 13), combine the Protocol
`with art that was previously cited or is cumulative to art that was previously
`cited to the Office. For example, grounds 9, 10, and 13 all rely on the
`Protocol in combination with Maus and other references. In these grounds,
`Petitioner relies on the disclosure of Maus for all of the process steps for
`creating the pharmaceutical solutions disclosed in the Protocol because the
`“Protocol does not disclose how the pharmaceutical aqueous solution
`disclosed therein was prepared.” Pet. 57; see also Pet. 57–73, 78–80
`(discussing the obviousness combinations including the Protocol and Maus).
`Thus, Petitioner relies heavily on the disclosure of Maus to show
`obviousness even for the grounds that list the Protocol as the primary
`
`
`21 Patent Owner argues that Petitioner fails to show that the Protocol is prior
`art (see, e.g., Pet. 42–61); however, because we exercise our discretion to
`deny institution of post-grant review under 35 U.S.C. § 325(d), we do not
`need to address the prior art status of the Protocol in this Decision.
`
`14
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`reference. As discussed in more detail below, Maus was cited and discussed
`by the Examiner in three rejections during prosecution of the ’276 patent.
`Therefore, because all but one of the references cited in grounds 1–10
`and 13 of the Petition were previously presented to the Office or are
`cumulative to references that were before the Office, we find that the same
`or substantially the same art was previously presented to the Office and we
`move on to the second part of the Advanced Bionics framework.
`
`B. Whether the Office Erred in a Manner Material to Patentability
`Because we find that the same or substantially the same art previously
`was 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 does not expressly address exercising discretion to deny
`institution of post grant review under 35 U.S.C. § 325(d), but does address
`the prosecution history of the ’276 patent. See Pet. 6–8, 16. Petitioner
`acknowledges that the Examiner rejected pending claims during prosecution
`of the ’276 patent as obvious over Maus in combination with other
`references in three separate rejections and that Patent Owner eventually
`overcame these rejections. Id. at 6–8. According to Petitioner, the
`“Examiner cited Maus for teaching the use of ascorbic and gentisic acids as
`stabilizers and the advantage of adding DTPA to complex non-incorporated
`177Lu.” Id. at 16. Petitioner further acknowledges that the “Examiner also
`cited Maus for teaching addition of one of the stabilizers during complex
`formation and one of the stabilizers after the complex formation.” Id.
`
`15
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`Petitioner also recognizes that other references cited in the Petition were
`previously before the Office. See id. at 17–18, 20.
`Despite the acknowledgment that the same art was previously cited
`(and in some cases, discussed) during prosecution, Petitioner does not
`expressly address how the Office erred in a manner material to the
`patentability of the challenged claims. The only reference to a possible
`misunderstanding by the Office is in the Declaration of Mr. Maus (rather
`than in the Petition itself), which states that the Examiner “appears not to
`have appreciated the formulation of the Kwekkeboom kit to which the Maus
`article cited and did not appear to appreciate the specific ingredients of that
`kit.” Ex. 1005 ¶ 84.
`Patent Owner contends that Petitioner does not “identify a single error
`in how the Examiner evaluated the references.” Prelim. Resp. 29. Patent
`Owner further asserts that Petitioner “relies on the same portions of Maus as
`did the Examiner for the same propositions concerning both the components
`of the claimed pharmaceutical solutions and the stability characteristics the
`claims require.” Id. In response to the statement by Mr. Maus regarding the
`Examiner’s failure to appreciate the formulation of the Kwekkeboom kit,
`Patent Owner asserts that the contents of the Kwekkeboom kit were
`discussed by Patent Owner during prosecution of the ’276 patent and
`acknowledged by the Examiner. Id. at 30 (citing Ex. 1003, 228 n.1, 250).
`We agree with Patent Owner.
`During prosecution, the contents of the Kwekkeboom kit, as disclosed
`in Maus, were discussed. First, the Examiner specifically cited the “Manual
`radiolabeling procedure” of Section 2.2 of Maus in issuing an obviousness
`rejection. Ex. 1003, 128. Section 2.2 of Maus, which is relied on by
`
`16
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`Petitioner for its obviousness grounds (see, e.g., Pet. 24–29), refers to use of
`the DOTA-TATE kit formulation of Kwekkeboom for the radiolabeling
`procedure. See Ex. 1009, 722 (citing Kwekkeboom as ref. 13). In response
`to the Examiner’s obviousness rejection, the applicant argued that the
`disclosure in Maus, using the formulation from the Kwekkeboom kit:
`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. 1003, 228 (citing Kwekkeboom). 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. See ref. 13 cited in Maus at page 1320, left column in
`“Methods” section.
` Id. at 228 n.1.
`In response, the Examiner acknowledged that the applicant’s
`arguments were “fully considered and [] persuasive” and withdrew the
`rejection. Ex. 1003, 250. 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 251–257. This rejection
`
`
`22 The cited pages numbers in Ex. 1009 refer to the original page numbers at
`the bottom of the page.
`
`17
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`was maintained in a Final Rejection by the Examiner; however, after an
`Examiner Interview, the Examiner issued a Notice of Allowance along with
`an Examiner’s Amendment. Id. at 293–297, 321–325.
`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 these statements made during prosecution regarding Maus and
`Kwekkeboom, nor asserts that the Examiner’s responses to these statements
`are incorrect. “[I]f the alleged error is a disagreement with a specific finding
`of record by the Office, then ordinarily the petitioner’s required showing of
`material error must overcome persuasively that specific finding of record.”
`Advanced Bionics, Paper 6 at 10–11.
`Therefore, we find that Petitioner has not sufficiently pointed out how
`the Examiner erred in its evaluation of Maus and Kwekkeboom (or any other
`previously cited art). In fact, Petitioner fails to mention any error by the
`Examiner in the Petition, and the closest reference to error is a vague
`statement by Mr. Maus that the Examiner “appears not to have appreciated
`the formulation of the Kwekkeboom kit.” Ex. 1005 ¶ 84. This single
`sentence in the Declaration of Mr. Maus is not sufficient to show a material
`error by the Office here. Because Petitioner fails to sufficiently point out
`any material error, we find that Petitioner has not persuasively shown that
`the Office erred in a manner material to the patentability of the challenged
`claims.
`
`C. Conclusion as to § 325(d)
`For the reasons set forth above, we do not institute review of
`claims 1‒24 under grounds 1–10 and 13 because, under 35 U.S.C. § 325(d),
`
`18
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`the same or substantially the same art previously was presented to the
`Office, and Petitioner has not shown that the Office erred in a manner
`material to patentability.
`Furthermore, we determine that 35 U.S.C. § 325(d) is sufficiently
`implicated that instituting on the remainder of the Petition would undermine
`the statutory purpose of 35 U.S.C. § 325(d). Accordingly, we deny
`institution of the entire Petition.23
`
`IV. CONCLUSION
`For the foregoing reasons, we exercise discretion not to institute post-
`grant review under 35 U.S.C. § 325(d).
`
`V. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Petition is denied and no post-grant review is
`instituted.
`
`
`
`
`
`
`
`
`
`
`
`
`
`23 See SAS Q&As, D1 (June 5, 2018) (available at https://www.uspto.gov/
`sites/default/files/documents/sas_qas_20180605.pdf)
`
`19
`
`

`

`PGR2021-00003
`Patent 10,596,276 B2
`PETITIONER:
`C. Kyle Musgrove
`Paul E. Dietze
`Scott A. Cunning
`Elizabeth M. Crompton
`PARKER POE ADAMS & BERNSTEIN LLP
`kylemusgrove@parkerpoe.com
`pauldietze@parkerpoe.com
`scottcunning@parkerpoe.com
`elizabethcrompton@parkerpoe.com
`
`PATENT OWNER:
`Jane M. Love
`Kyanna Sabanoglu
`GIBSON, DUNN & CRUTCHER LLP
`jlove@gibsondunn.com
`ksabanoglu@gibsondunn.com
`
`20
`
`

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