Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper: 7
`
` Date: January 29, 2020
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PROGENICS PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`MAX-PLANCK-GESELLSCHAFT ZUR FOERDERUNG DER
`WISSENSCHAFTEN E.V.
`AND
`UNIVERSITAT ZU KOLN,
`Patent Owners.
`____________
`
`PGR2019-00052
`Patent 10,112,974 B2
`____________
`
`
`Before GEORGIANNA W. BRADEN, J. JOHN LEE, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Granting Institution of Post-Grant Review
`35 U.S.C. § 324
`
`
`
`
`
`
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`
` INTRODUCTION
`Progenics Pharmaceuticals, Inc. (“Petitioner”) filed a Petition to
`institute a post-grant review of claims 1–15 and 31 of U.S. Patent No.
`10,112,974 B2 (Ex. 1001, “the ’974 patent”). Paper 2 (“Pet.”). Max-Plank-
`Gesellschaft Zur Foerderung Der Wissenschaften E.V. and Universtitat Zu
`Koln, (collectively “Patent Owner”) did not file a Preliminary Response to
`the Petition.
`We have authority to determine whether to institute a post-grant
`review under 35 U.S.C. § 324, which provides that a post-grant review may
`not be instituted unless the information presented in the petition, if “not
`rebutted, would demonstrate that 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).
`Upon considering the Petition, and based on the current record, we
`determine Petitioner has demonstrated that it is more likely than not that at
`least one of the claims challenged in the Petition is unpatentable.
`Accordingly, we institute a post-grant review of all challenged claims based
`upon all grounds raised in the Petition.
`Related Proceedings
`A.
`Both parties represent they are “not aware of any other judicial or
`administrative proceedings involving the ’974 patent.” Pet. 94; see Paper 6,
`2.
`
`The ’974 Patent
`B.
`1. Eligibility for Post-Grant Review
`Petitioner certifies that the ’974 patent is available for post-grant
`review. Pet. 95. We agree. Post-grant review is available for patents
`“described in section 3(n)(1)” of the Leahy-Smith America Invents Act
`
`2
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`(“AIA”), Pub L. No. 112-29, 125 Stat. 284 (2011). AIA § 6(f)(2)(A).1
`Those are patents that issue from applications “that contain[] or contained
`at any time . . . a claim to a claimed invention that has an effective filing
`date as defined in section 100(i) of title 35, United States Code, that is on
`or after” “the expiration of the 18-month period beginning on the date of
`the enactment of” the AIA. See AIA § 3(n)(1). The AIA was enacted on
`September 16, 2011; therefore, post-grant review is available for patents
`that, at one point, contained at least one claim with an effective filing date,
`as defined by 35 U.S.C. § 100(i), on or after March 16, 2013. The ’974
`patent claims priority to a PCT application filed August 24, 2015, as well
`as two foreign applications filed August 24, 2014 and September 4, 2014.
`See Ex. 1001, 1. Accordingly, the ’974 patent is eligible for post-grant
`review.
`
`2. Patent Disclosure
`The ’974 patent describes methods and chemical precursors for
`making “18F-labelled active esters via nucleophilic substitution of the
`corresponding onium precursors with 18F-. . . .” Ex. 1001, Abstr. The
`Specification indicates that such compounds are “useful for positron
`emission tomography (PET) imaging, especially imaging prostate tumor.”
`Id. at 1:14–18. According to the Specification,
`In recent years imaging of prostate carcinoma (PCa) with PET
`isotope labelled PSMA ligands has become of considerable
`importance in clinical diagnosis. This can mainly be attributed
`
`
`1 The AIA also requires the petition to be filed within nine months of the
`issue date of the challenged patent. 35 U.S.C. § 321(c). The ’974 patent
`issued on October 30, 2018. Ex. 1001. The Petition has been accorded a
`filing date of July 29, 2019, Paper 3, 1, which is within the nine-month
`window. Thus, Petitioner has timely filed the Petition.
`3
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`to the high expression of the extracellular localized prostate
`specific membrane antigen (PSMA) in PCa. Ligands bearing
`the syL-C(O)-Glu-binding motif exhibit high binding affinity to
`PSMA.
`Id. at 5:60–66.
`The 18F-labelled compounds taught in the Specification exhibit a
`“syL-C(O)-Glu” motif and correspond to general formula (I), which is
`reproduced below.
`
`
`Id. at 7:40–55.2 The compounds in formula (II) and formula (III), shown
`below, are described in the Specification as precursors used to make
`compounds of formula (I) according to the methods therein.
`
`
`
`
`2 The Specification’s descriptions for the variables depicted in formulas (I),
`(II), and (III) are not reproduced here for sake of brevity.
`4
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`
`
`
`
`
`
`The Specification provides numerous examples of compounds
`
`corresponding to general formula (I) that may be made with the disclosed
`methods. See generally id. at 26:11–28:10; 45:45–59:60 (listing
`compounds). One of these examples “[18F]DCFPyL” or compound 1-10 in
`the Specification is shown below.
`
`
`
`5
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`The Specification acknowledges that a method for making [18F]DCFPyL
`was known in the prior art, but describes certain “disadvantages” to that
`method. See id. 5:66––7:20 (citing “Pomper et al. (WO2010/01493; Clin.
`Cancer Res. 2011, 17, 7645-7653)” (“Pomper”)). According to the
`Specification, the methods described therein involve the use of compounds
`corresponding to formula (II) and formula (III) as precursors and provide
`advantages over the prior art method in Pomper. See id. at 62:54–64:10
`(describing “Scheme 6: The novel method for the preparation of
`[18F]DCFPyL 1–10” and comparing it to “the published radiosynthesis of
`[18F]DCFPyL 1–10 by Pomper et al.”).
`Illustrative Claim
`C.
`Petitioner challenges claims 1–15 and 31. Claims 1–15 are directed to
`a compound of formula (II). Claim 1 is illustrative of these claims and reads
`as follows:
`1. A compound of formula (II)
`
`
`
`
`wherein, E represents a covalent bond or
`
`
`
`
`
`
`
`6
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2019-00052
`
`PGR2019-00052
`Patent 10,112,974 B2
`Patent 10,112,974 B2
`
`II}
`
`{5
`
`n
`
`CI
`
`
`
`U
`
`I.
`
`JVJ'I'H (in.
`
`{TLH
`
`CI
`
`Ell-1
`
`{I
`
`."I'.
`
`
`
`1:-
`
`: n_n
`
`E]
`
`Cl
`
`i“
`
`“112.
`
`0
`
`.I
`1.x!“
`
`U
`
`r:
`
`3.
`
`LI
`“\jL
`.
`. am ‘ 1.
`é
`5{H1
`EJ'L'I
`
`[II
`
`L_'IZJ
`
`I
`
`'
`rm,
`blip-um H
`
`-_
`E
`H‘T'H
`
`n
`
`c}: I
`_
`
`El
`:4
`
`El
`K
`
`1]
`
`HI
`
`n
`I’ll
`
`<1
`
`I’ll
`
`U
`
`I’ll
`
`{J
`
`2H
`
`7
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`
`
`
`
`
`
`
`
`
`wherein
`
`n is an integer selected from 0 to 10;
`
`n1 is an integer selected from 0 to 10;
`n2 is an integer selected from 0 to 10;
`
`
`m is an integer selected from 1 to 18;
`
`p is an integer selected from 0 to 10;
`
`q is an integer selected from 1 to 18;
`
`X, Y, W, and Z represent independently of each other
` ––CH2––, ––CH––, ––NH–– or ––N––;
`
`
` represents a single or double bond;
`and diastereomers, entantiomers, hydrates, and salts
`thereof.
`
`
`Ex. 1001, 101:25–103:25.
`Claim 31 is directed to a kit comprising containers containing
`compounds of formula (II) and (III). It reads as follows:
`31. A kit for carrying out the method of claim 18 comprising
`one or more containers containing the compounds of formula
`
`8
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`(II) and (III), optionally a packaged pharmaceutical
`compositions comprising a pharmaceutically acceptable carrier,
`further optionally comprising instructions for preparing
`compounds according to the invention from supplied precursors
`and/or instructions for using the composition to image cells or
`tissues.
`Id. at 118:15–22.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–15 and 31 of the
`’974 patent on the following nine grounds (Pet. 29–30):
`Claim(s) Challenged
`
`35 U.S.C. §
`Reference(s)/Basis
`1, 3–15, 31
`112(b)
`Indefiniteness
`
`Indefiniteness
`
`112(b)
`
`2
`
`3, 4, 15
`
`1–4, 9, 13, 15
`
`1–5, 7, 9, 11, 12, 15
`
`1–4, 9, 13, 15
`
`5–8, 10–12, 14
`
`31
`
`112(d)
`
`
`
`102
`
`102
`
`102
`
`103
`
`103
`
`’192 publication3
`
`Shallal4
`
`’529 publication5
`
`’529 publication
`
`’933 publication6
`
`
`3 WO2008/058192 A2, published May 15, 2008 (“’192 publication”)
`(Ex. 1004).
`4 Hassan M. Shallal et al., Heterobivalent Agents Targeting PSMA and
`Integrin-αvβ3, Bioconjugate Chem., Vol. 25, 393–405 (2014) (“Shallal”) (Ex.
`1005).
`5 WO2009/002529 A2, published Dec. 31, 2008 (“’529 publication”)
`(Ex. 1006).
`6 WO2010/014933 A2, published Feb. 4, 2010 (“’933 publication”)
`(Ex. 1007).
`
`9
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`1–12, 14, 15
`
`112(a)
`
`Enablement
`
`Petitioner also relies on the Declaration of Stephen G. DiMagno,
`Ph.D. (Ex. 1002).
`
` ANALYSIS
`Claim Construction
`A.
`In a post-grant review, the claims are construed “using the same claim
`construction standard that would be used to construe the claim in a civil
`action under 35 U.S.C. § 282(b).” 37 C.F.R. § 42.200(b) (2019). Therefore,
`we construe the challenged claims under the framework set forth in Phillips
`v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under
`this framework, claim terms are given their ordinary and customary
`meaning, as would be understood by a person of ordinary skill in the art at
`the time of the invention, in light of the language of the claims, the
`specification, and the prosecution history of record. Id.
`Variable “p” (claims 1–15, 31)
`1.
`In its first two grounds, Petitioner asserts the challenged claims are
`unpatentable under 35 U.S.C. § 112(b) because the variable “p” as recited in
`those claims is indefinite. See Pet. 30–35. To the extent those arguments
`raise claim construction issues, we address those issues within our analysis
`of Petitioner’s indefiniteness grounds below.
`Preamble Language (claim 31)
`2.
`The preamble of claim 31 recites a kit “for carrying out the method of
`claim 18.” Ex. 1001, 118:15. Petitioner argues that this preamble “should
`not be considered a limitation, or given patentable weight” because it is “not
`essential to understand the limitations or terms in the claim” and “simply is
`an intended purpose” of the recited kit. Pet. 81. Patent Owner has not yet
`
`10
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`provided its position regarding the construction of the preamble language in
`claim 31.
`At this stage of the proceeding, we agree with Petitioner’s position,
`which is currently unrebutted, that the preamble language does not limit
`claim 31. Our reviewing court has long held that “a preamble is not limiting
`where a patentee defines a structurally complete invention in the claim body
`and uses the preamble only to state a purpose or intended use for the
`invention.” Artic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1328
`(Fed. Cir. 2019) (quoting Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801, 808 (Fed. Cir. 2002)) (internal quotations omitted). Here, the
`body of claim 31 defines a structurally complete invention, that is, a kit
`comprising “one or more containers containing the compounds of formula
`(II) and (III)” as well as several “optional[]” components. Ex. 1001,
`118:15–23. There is no reliance on the preamble for antecedent basis, nor
`does it appear that the applicant expressly relied on this preamble language
`to distinguish prior art during prosecution. See Catalina, 289 F.3d at 808
`(identifying instances in which the preamble may limit the scope of a claim).
`Instead, it appears the preamble merely recites an intended use for the
`claimed kit, i.e., “carrying out the method of claim 18.” Accordingly, based
`on the current record and for purposes of this decision, we determine that
`claim 31 is not limited by the language of its preamble.
`Remaining Claim Terms
`3.
`At this stage of the proceeding and for purposes of this decision, we
`determine that it is unnecessary to expressly construe the remaining claim
`terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co.,
`868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to
`“construe terms ‘that are in controversy, and only to the extent necessary to
`
`11
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
`Level of Ordinary Skill in the Art
`B.
`Petitioner describes a person having ordinary skill in the art as having
`“a Ph.D. degree and training in organic chemistry, medicinal chemistry,
`radiopharmaceutical chemistry, or a related field with at least two years of
`post-doctoral experience.” Pet. 18–19.
`At this stage in the proceeding, we find Petitioner’s description of the
`level of ordinary skill in the art is sufficiently supported by the record.
`Moreover, we note that the applied prior art reflects the appropriate level of
`skill at the time of the claimed invention. See Okajima v. Bourdeau, 261
`F.3d 1350, 1355 (Fed. Cir. 2001). Thus, for purposes of this decision, we
`adopt Petitioner’s description of a person of ordinary skill in the art.
`Indefiniteness (claims 1, 3–15, and 31)
`C.
`Petitioner asserts that claims 1, 3–15, and 31 are indefinite because
`“[v]ariable p . . . appears at multiple locations on compounds of formula
`(II)” as recited in claim 1 and it is unclear whether: (1) “p is the same at each
`instance it appears in formula (II), or (2) “p is independently selected each
`time it appears in formula (II).” Pet. at 31. Petitioner urges that it “is not
`evident from the face of the claims” which of these two interpretations
`applies and that nothing in the intrinsic record of the ’974 patent “resolve[s]
`the ambiguity in the claim language.” Id. at 33. Thus, Petitioner argues
`claim 1 is indefinite under both the “reasonable certainty” standard set forth
`in Nautilus Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014), and
`the “amenable to two or more plausible claim constructions” analysis
`employed in Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008)
`(precedential). Id. at 33. Petitioner additionally argues, “[b]ecause 3–15 and
`
`12
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`31 all depend from claim 1, claims 3–15 and 31 also are indefinite.” Id. at
`34. Patent Owner did not file a preliminary response to these contentions.7
`Based on the current record, we are not persuaded by Petitioner’s
`indefiniteness argument concerning the interpretation of the variable “p” in
`claims 1, 3–15, and 31. Phillips makes clear that the surrounding claim
`language should be considered in determining the proper construction of a
`claim term. See Phillips, 415 F.3d at 1314. Here, both the context provided
`by the surrounding claim language and well-established claim construction
`principles support interpreting “p” to be the same integer each time it
`appears in these claims.
`Claim 1 recites express definitions for the variables in the recited
`formula. See Ex. 1001, 103:15–25. According to that claim language, “p is
`an integer selected from 0 to 10.” Id. But p is not the only variable given
`that definition. Claim 1 also defines “n,” “n1,” and “n2” as “an integer
`selected from 0 to 10.” Id. If p were “independently selected each time it
`appears,” according to Petitioner’s “second interpretation,” the same
`variable “p” could be used throughout the recited formula. Pet. 31. Thus,
`the fact that claim 1 recites four different variables (i.e., p, n, n1, and n2)
`with the same definition cuts against interpreting p to be independently
`selected each time it appears in the recited formula because such an
`interpretation would render the other identically-defined variables
`redundant. See, e.g., Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d
`1334, 1340 (Fed. Cir. 2016) (quoting Power Mosfet Techs., L.L.C. v.
`
`
`7 While Petitioner did not exercise its right to file a preliminary response
`under 35 U.S.C. § 323, the burden of persuasion for each of the alleged
`grounds remains on Petitioner. 35 U.S.C. § 326(e); see Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`13
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`Siemens AG, 378 F3d 1396, 1410 (Fed. Cir. 2004) (“Interpretations that
`render some portion of the claim language superfluous are disfavored.”).
`In addition, claim 1 defines other variables in the recited formula as
`follows: “wherein . . . X, Y, W, and Z represent independently of each
`other . . . .” Ex. 1001, 103:15–22 (emphasis added). The fact that claim 1
`expressly recites the term “independently” to define the selection of some of
`the variables in the recited formula, but not “p,” evidences that independent
`selection is not within the plain meaning of “p” and must be separately
`recited. See, e.g., Phillips, 415 F.3d at 1314 (explaining, by way of
`example, that the claim’s reference to “‘steel baffles’ . . . strongly implies
`that the term ‘baffles’ does not inherently mean objects made of steel.”).
`In addition, as a matter of general claim construction principles, there
`is a “presumption that the same terms appearing in different portions of the
`claims should be given the same meaning unless it is clear from the
`specification and prosecution history that the terms have different meanings
`at different portions of the claims.” Paragon Sol., LLC v. Timex Corp, 566
`F.3d 1075, 1087 (Fed. Cir. 2009) (quoting PODS, Inc. v. Porta Stor, Inc.,
`484 F.3d 1359, 1366 (Fed. Cir. 2007)). Petitioner’s first interpretation is
`consistent with this presumption because it interprets “p” to be the same
`integer at each instance of “p” in recited formula. On the other hand,
`Petitioner’s second interpretation runs contrary to the presumption because,
`as Petitioner points out, that interpretation allows “p” to have different
`meanings at each instance of “p” in the recited formula. See Pet. 32–33
`(giving an example where “p is 1 on the lysine-like moiety” and p is “6 on
`the linker”). Petitioner acknowledges that “nothing within the specification
`provides context” for selecting one interpretation over the other and Patent
`Owner “did not comment on the interpretation of p during prosecution.”
`
`14
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`Pet. 33. Thus, there is nothing in the Specification or prosecution history
`that provides the clear evidence typically necessary to depart from the
`presumption that “p” has the same meaning each time it appears in claim 1.
`Moreover, as explained above, the surrounding claim language affirmatively
`supports that “p” should be construed to be the same integer throughout
`claim 1.
`For these reasons, at this stage of the proceeding, we do not agree that
`variable “p” is reasonably amenable to Petitioner’s second interpretation.
`Thus, we are not persuaded by Petitioner’s argument that claim 1 is
`indefinite according to the analysis in Mizyaki. We also are unpersuaded by
`Petitioner’s argument that claim 1 fails to meet the “reasonable certainty”
`standard in Nautilus. For purposes of this decision, we construe “p” to be
`limited to the same integer selected from 0 to 10 at each instance within the
`formula recited in claim 1. Accordingly, at this stage of the proceeding,
`Petitioner has not shown that it is more likely than not that claim 1 is
`unpatentable under 35 U.S.C. § 112(b).
`Petitioner’s indefiniteness challenge of claims 3–15 and 31 is
`premised on the same arguments as claim 1. Therefore, we are likewise
`unpersuaded that Petitioner has met its burden with respect to those claims.
`Indefiniteness (claim 2)
`D.
`Claim 2 is an independent claim that, like claim 1, recites a compound
`of formula (II) that includes the variable “p.” Ex. 1001, 103:26–104:46. But
`unlike claim 1, claim 2 does not recite a definition for “p.” Petitioner argues
`“[b]ecause the scope of p is not defined [claim 2] fails the requirements of
`35 U.S.C. § 112(b).” Pet. 34 (citing cases). Petitioner additionally urges
`that the specification and prosecution history do not resolve this ambiguity
`because “[v]ariable p has multiple definitions throughout the specification”
`
`15
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`and “no guidance” was provided during to prosecution “as to which of the
`stated values of p should be applied in claim 2.” Id. at 35. Patent Owner did
`not file a preliminary response to these contentions.
`Based on the information in the Petition, which is currently
`unrebutted, we are persuaded that it is more likely than not that claim 2 is
`unpatentable under 35 U.S.C. § 112(b). Claim 2 recites definitions for some
`of the variables in the claimed formula, but it does not recite a definition for
`“p.” See Ex. 1001, 104:40–46. As Petitioner points out, the Specification
`describes multiple definitions of varying scope for the variable p in formula
`(II). The broadest of these is “an integer selected from 0 to 10.” See, e.g.,
`id. at 14:37. But the Specification also describes other embodiments of
`compound (II) where p is more narrowly described as “an integer selected
`from 0 to 6, and preferably p is an integer selected from 0, 2 to 4 in any
`possible combination.” Id. at 19:47–50. There is nothing in the language of
`claim 2 that favors one of these definitions over the others when attempting
`to understand the scope of that claim. Moreover, Petitioner’s contention that
`neither the specification, nor prosecution history, resolves this ambiguity
`appears to have merit based on our review of the information in the Petition.
`Accordingly, at this stage of the proceeding and based on the current record,
`Petitioner has shown it is more likely than not that claim 2 is indefinite
`under both the Nautilus and Miyzaki standards.
`35 U.S.C. § 112(d) (claims 3, 4, and 15)
`E.
`Petitioner asserts that claims 3, 4, and 15 are “invalid under 35 U.S.C.
`§ 112(d)” because “the purported limitations of claims 3, 4, and 15 are not
`limiting at all; rather they are reiterations of claim 1.” Pet. 37–38.
`Specifically, Petitioner contends each of these claims “depend, directly or
`indirectly on claim 1, and each recites that said compound is a ‘direct
`
`16
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`precursor’ of a compound of formula (I).” Pet. 37. But Petitioner urges
`these claims do not “specify a further limitation” as required by 35 U.S.C.
`§ 112(d) because “all compounds according to claim 1 are direct precursors
`of a compound of formula (I) according to the specification.” Id. (internal
`quotations omitted). With respect to claim 15, Petitioner makes the same
`argument for the “capable of being coupled to a compound of formula
`[(III)]” language. Petitioner further argues the “optionally in an anhydrous
`protic solvent” language of claim 15 “do[es] not narrow the claim because
`[optional language] can always be omitted.” In re Johnston, 435 F.3d 1381,
`1384 (Fed. Cir. 2006). For these reasons, Petitioner contends “each of
`claims 3, 4, and 15 encompasses the same scope as claim 1, and is invalid
`under 35 U.S.C. § 112(d) for failing to further narrow the scope of the claim
`from which it depends.” Id. at 38. Patent Owner did not file a preliminary
`response to these contentions.
`
`Based on the information in the Petition, which is currently
`unrebutted, we are persuaded that it is more likely than not that claims 3, 4,
`and 15 are unpatentable under 35 U.S.C. § 112(d). The Specification
`teaches that compounds of formula (I) are made by reacting a compound of
`formula (II), as recited in claim 1, with a compound of formula (III).
`Ex. 1001, 28:15–30:65. Thus, Petitioner’s contention that the Specification
`teaches that “all” compounds of formula (II) are “direct precursors” to
`compounds of formula (I) is supported by the current record. Petitioner’s
`additional contentions regarding claim 15 are also supported by the
`information in the Petition and the current record. To the extent Patent
`Owner disagrees with these contentions, it may explain in what regard
`claims 3, 4, and 15 “specify a further limitation of the subject matter
`
`17
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`claimed” in the claims from which they depend, and provide any evidence
`supporting that argument, in Patent Owner’s Response. 35 U.S.C. § 112(d).
`Anticipation by the ’192 Publication (claims 1–4, 9, 13, and 15)
`F.
`Petitioner asserts that claims 1–4, 9, 13, and 15 are anticipated by the
`disclosure of the compound “MIP 1033” in the ’192 publication. See
`Pet. 39–44. Petitioner contends the ’192 publication, which was published
`on May 15, 2008, is prior art to the ’974 patent under 35 U.S.C. § 102(a)(1).
`Pet. 13. Patent Owner did not file a preliminary response to these
`contentions.
`The ’192 publication discloses compounds with “glutamate-urea-
`lysine PSMA-binding moieties” that may be radiolabeled and used “in
`diagnostic and therapeutic treatment.” Ex. 1004, 4. One of these
`compounds is “(S,S)-2-[3-(5-Amino-1-carboxy-pentyl)-ureido]-pentanedioic
`acid” or “MIP 1033,” which has the chemical structure shown below.
`
`
`
`Id. at 14–15.
`
`Based on the information in the Petition, which is currently
`unrebutted, we are persuaded that it is more likely than not that claims 1, 3,
`4, 9, 13, and 15 are anticipated by the disclosure of MIP 1033 in the ’192
`publication. MIP 1033 corresponds to the formula recited in claim 1
`wherein p is 1 and E is a covalent bond. Accordingly, based on the current
`record, Petitioner has shown that it is more likely than not that MIP 1033 is a
`species within the genus of chemical compositions recited in claim 1 and,
`
`18
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`therefore, that claim 1 is anticipated by the ’192 publication.8 See Atlas
`Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999) (“In
`chemical compounds, a single prior art species within the patent’s claimed
`genus reads on the generic claim and anticipates.”) (citing In re Gosteli, 872
`F.2d 1008, 1010 (Fed. Cir. 1989).
`As explained above in our analysis of Petitioner’s ground under
`35 U.S.C. § 112(d), based on the information in the Petition, which is
`presently unrebutted, claims 3, 4, and 15 fail to “specify a further limitation”
`on the scope of claim 1. 35 U.S.C. § 112(d). As such, at this stage of the
`proceeding, we interpret claims 3, 4, and 15 to have the same scope as
`claim 1. Because the information in the Petition demonstrates that it is more
`likely than not that claim 1 is anticipated by the disclosure of MIP 1033 in
`the ’192 publication, we are likewise persuaded that Petitioner has met its
`burden for this ground with respect to claims 3, 4, and 15.9
`Claim 9 depends from claim 1 and further specifies that “p is an
`integer selected from 0 to 6.” As explained above, MIP 1033 corresponds to
`the recited formula where p is 1. Thus, based on the current record, we are
`
`
`8 As Petitioner acknowledges, the ’192 publication was cited during
`prosecution and was the basis for an anticipation rejection that the applicant
`overcame. Pet. 39–40. That rejection was not premised on the disclosure of
`MIP 1033 specifically, but instead the Examiner cited to other pages of the
`’192 publication. See Ex. 1022, 3. Moreover, Petitioner has sufficiently
`pointed out “how the Examiner erred in its evaluation of” the ’192
`publication. See Becton, Dickson and Company v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (informative). Accordingly,
`we do not exercise discretion to decline institution under 35 U.S.C. § 325(d).
`9 As explained above, claim 2 fails to define variable “p” and, based on the
`information in the Petition, is more likely than not indefinite. Because the
`scope of “p” in claim 2 is undefined, it is not clear whether MIP 1033 reads
`on the formula recited there.
`
`19
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`persuaded that it is more likely than not that the ’192 publication anticipates
`this claim.
`Claim 13 depends from claim 1 and further specifies that the
`compound is “selected from” a series of compounds designated “compounds
`2a-2p.” The chemical structure for MIP 1033 as disclosed in the ’192
`publication is the same as that recited for compound 2b in claim 13.
`Compare Ex. 1003, 15 (MIP 1033), with Ex. 1001, 109:5–10 (compound
`2b). Thus, based on the current record, we are persuaded that it is more
`likely than not that the ’192 publication anticipates this claim.
`Anticipation by Shallal (claims 1–5, 7, 9, 11, 12, and 15)
`G.
`Petitioner asserts that claims 1–5, 7, 9, 11, 12, and 15 are anticipated
`by the disclosure of the compound “EUKL-NH2” in Shallal. See Pet. 45–54.
`Petitioner contends that Shallal was published on January 11, 2014, and is,
`therefore, prior art to the ’974 patent under 35 U.S.C. § 102(a)(1). Pet. 13–
`14. Patent Owner did not file a preliminary response to these contentions.
`Shallal discloses the synthesis of a “PSMA Targeting Agent” in the
`synthetic pathway shown in scheme 1. Ex. 1005, 397. EUKL-NH2 is
`disclosed as an intermediate in that pathway with the chemical structure
`shown below.
`
`
`Id.; see also id. at 394 (explaining that EUKL-NH2 “was obtained from the
`corresponding protected NHS ester 1”).
`
`20
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`Based on the information in the Petition, which is currently
`unrebutted, we are persuaded that it is more likely than not that claims 1, 3–
`5, 7, 9, and 15 are anticipated by the disclosure of EUKL-NH2 in Shallal.
`EUKL-NH2 corresponds to the formula recited in claim 1, wherein p is 1, E
`has the structure shown below, m is 6, and n is 3.
`
`
`Ex. 1001, 102:50. Thus, the information in the Petition, which is currently
`unrebutted, demonstrates that it is more likely than not that EUKL-NH2 is a
`species within the genus of chemical compositions of claim 1 and, therefore,
`Shallal’s disclosure of that species anticipates claim 1. See Atlas Powder,
`190 F.3d at 1346.
`As explained above, based on the current record and for purposes of
`this decision, we interpret claims 3, 4, and 15 to have the same scope as
`claim 1. Because, based on the current record, Petitioner has shown it is
`more likely than not that claim 1 is anticipated by the disclosure of EUKL-
`NH2, we likewise are persuaded that Petitioner has met its burden for this
`ground with respect to claims 3, 4, and 15.10
`
`Claim 5 depends from claim 1 and further specifies that “either of n or
`n1 or n2 is an integer selected from 1 to 4.” Ex. 1001, 108:36–37. As
`explained above, EUKL-NH2 corresponds to the recited formula where n is
`
`
`10 As explained above, claim 2 fails to define variable “p” and, based on the
`information in the Petition, is more likely than not indefinite. Because the
`scope of “p” in claim 2 is undefined, it is not clear whether EUKL-NH2
`reads on the formula recited there.
`
`21
`
`

`

`PGR2019-00052
`Patent 10,112,974 B2
`3. Thus, based on the current record, Petitioner has shown it is more likely
`than not that Shallal anticipates this claim.
`
`Claim 7 depends from claim 1 and further specifies that “m is an
`integer selected from 1 to 10.” Ex. 1001, 108:41–42. As explained above,
`EUKL-NH2 corresponds to the recited formula where m is 6. Thus, based
`on the current record, Petitioner has shown it is more likely than not that
`Shallal anticipates this claim.
`Claim 9 depends from claim 1 and further specifies that “p is an
`integer selected from 0 to 6.” As explained above, EUKL-NH2 corresponds
`to the recited formula where p is 1. Thus, based on the current record,
`Petitioner has shown it is more likely than not that Shallal anticipates this
`claim.
`Claims 11 and 12 each depend from claim 1 and further limit “q” to
`an integer selected from “1 to 10” and “1 to 3” respectively. Ex. 1001,
`108:50–54. Petitioner contends EUKL-NH2 discloses these limitations
`because it corresponds to the formula recited in claim 1, wherein E has the
`structure shown below. Pet. 47–48.
`
`
`Acco