`
`Trials@uspto.gov Paper 166
`571-272-7822 Entered: September 2, 2014
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`ARIOSA DIAGNOSTICS,
`Petitioner,
`v.
`ISIS INNOVATION LIMITED,
`Patent Owner.
`____________________
`
`Case IPR2012-000221
`Patent 6,258,540
`___________________
`
`Before LORA M. GREEN, FRANCISCO C. PRATS, and
`JEFFREY B. ROBERTSON, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`I. INTRODUCTION
`A. Background
`Petitioner, Ariosa Diagnostics (“Ariosa”), filed a Petition for inter
`partes review of claims 1, 2, 4, 5, 8, 19–22, 24, and 25 of U.S. Patent No.
`6,258,540 (“the ’540 Patent”) pursuant to 35 U.S.C. §§ 311–319. Paper 1
`(“Pet.”). Patent Owner, Isis Innovation Limited (“Isis”), filed a Preliminary
`
`1 This Case has been joined with IPR2013-00250.
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`Response. Paper 18 (“Prelim. Resp.”). On March 19, 2013, we instituted
`trial as to all of the challenged claims. Paper 24 (“Dec. Institute”).
`After institution of trial in IPR2012-00022, Ariosa filed a second
`Petition for inter partes review of claims 3, 8, 12, 13, 15, and 18 of the ’540
`patent. IPR2013-00250, Paper 1. Ariosa also filed a Motion for Joinder,
`seeking joinder of that proceeding with IPR2012-00022. IPR2013-00250,
`Paper 4. On September 3, 2013, we instituted trial as to all of the claims
`challenged in the second Petition (IPR2013-00250, Paper 26), and joined the
`proceeding with IPR2012-00022 (IPR2013-00250, Paper 25). Thus, claims
`1–5, 8, 12, 13, 15, 18–22, 24, and 25 are subject to inter partes review in the
`joined proceeding.
`Isis filed a Patent Owner Response in the joined proceeding. Paper 89
`(“PO Resp.”). Isis filed also a contingent Motion to Amend by submitting
`proposed substitute new claims 28–30, or substitute new claims 31–33, for
`claims 1, 24, and 25, respectively. Paper 88 (“Mot. to Amend”). Ariosa
`filed a Reply to the Patent Owner Response (Paper 114; “Reply”), and also
`an opposition to Isis’s Motion to Amend (Paper 115; “Opp.”). Isis then filed
`a Reply in support of its Motion to Amend. Paper 130 (“Reply Mot. to
`Amend”).
`Isis filed a Motion to Exclude. (Paper 135; “Isis’s Motion to
`Exclude”); and Ariosa filed an Opposition to that Motion (Paper 155). Oral
`hearing was held on January 24, 2014. Paper 1652 (“Tr.).
`
`
`2 We note that the pages of the oral hearing transcript are not numbered.
`We, thus, designate the first page on which argument appeared, entitled
`“PROCEEDINGS,” as page 1, and number the remaining pages sequentially
`therefrom.
`
`2
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`The Board has jurisdiction under 35 U.S.C. § 6(c). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Ariosa has demonstrated, by a preponderance of the evidence of
`record, the unpatentability of claims 1, 2, 4, 5, 8, 19, 20, 24, and 25 under 35
`U.S.C. § 102(b). Ariosa, however, has not met its burden to show by a
`preponderance of the evidence of record that claims 3, 12, 13, 15, 18, 21,
`and 22 are unpatentable under 35 US.C. § 103(a).
`Isis’s Motion to Amend is denied.
`
`B. Related Proceedings
`Claims 1, 2, 4, 5, 8, 19–22, 24, and 25 of the ’540 patent were
`declared invalid in Ariosa Diagnostics v. Sequenom, Civ. No. 12-00132-SI
`(N.D. Cal.). Paper 107, 1 (citing Ex. 2224). The district court granted
`summary judgment on the basis that the claims were drawn to patent
`ineligible subject matter under 35 U.S.C. § 101. Ex. 2224, 20. The district
`court’s decision is currently on appeal to the Court of Appeals for the
`Federal Circuit in Ariosa Diagnostics, Inc. v. Sequenom, Inc., Appeal Nos.
`14-1139, 14-1142, and 14-1144. Paper 163, 1.
`
`C. The ’540 Patent
`The ’540 patent issued on July 10, 2001, with Yuk-Ming Dennis Lo
`and James Stephen Wainscoat as the listed co-inventors. The ’540 patent is
`drawn to “prenatal detection methods using non-invasive techniques,” and,
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`in particular, “to prenatal diagnosis by detecting foetal nucleic acids in
`serum or plasma from a maternal blood sample.” Ex. 1001,3 col. 1, ll. 6–9.
`
`According to the ’540 patent, it was unexpected that fetal DNA “is
`detectable in maternal serum or plasma samples.” Id. at col. 1, ll. 50–51.
`The concentration of fetal DNA in serum or plasma samples has been
`measured from 0.39% (early pregnancy) to 11.4% (late pregnancy), whereas
`the concentration of fetal cells in the cellular fraction is generally from
`0.001% to 0.025%. Id. at col. 1, ll. 59–64. The ’540 patent thus “provides a
`detection method performed on a maternal serum or plasma sample from a
`pregnant female, which method comprises detecting the presence of nucleic
`acid of foetal origin in the sample.” Id. at col. 2, ll. 1–4. “[P]renatal
`diagnosis” is defined by the ’540 patent as covering the “determination of
`any maternal or foetal condition or characteristic which is related to either
`the foetal DNA itself or to the quantity or quality of the foetal DNA in the
`maternal serum or plasma.” Id. at col. 2, ll. 6–10.
`
`The ’540 patent also teaches that the “preparation of serum or plasma
`from the maternal blood sample is carried out by standard techniques,” and
`that “[s]tandard nucleic acid amplification systems can be used.” Id. at col.
`2, ll. 26–27 and ll. 43–47. Polymerase chain reaction (“PCR”) is one of the
`standard nucleic acid amplification systems disclosed by the ’540 patent. Id.
`at col. 2, ll. 44–48. According to the ’540 patent, “[s]ex determination has
`successfully been performed on pregnancies from 7 to 40 weeks of
`gestation.” Id. at col. 3, ll. 60–62.
`
`
`3 Throughout the decision, quotations to the ’540 patent (Ex. 1001) include
`the British spelling of several words. We, otherwise, use the American
`spelling; for example, “foetal” versus “fetal.”
`
`4
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`The ’540 patent teaches further that the plasma or serum-based
`
`prenatal diagnostic method may be used to determine fetal rhesus D status in
`rhesus negative mothers, such that the detection of the rhesus D gene in the
`negative mother is indicative of a rhesus D positive fetus. Id. at col. 2, l. 57–
`col. 3, l. 3. The diagnostic methods may be used also to detect
`haemoglobinopathies or other paternally-inherited DNA polymorphisms. Id.
`at col. 3, ll. 4–24.
`
`According to the ’540 patent, the non-invasive methods may be used
`also to screen for Down’s syndrome and other chromosomal aneuploidies.
`Id. at col. 3, ll. 25–28. The ’540 patent teaches that it was known that the
`level of circulating fetal cells is higher in pregnancies with chromosomal
`aneuploidies, such as Down’s syndrome, and it was further determined that
`the level of fetal DNA in maternal plasma and serum is also higher. Id. at
`col. 3, ll. 30–40. Thus, the ’540 patent teaches that quantitative detection of
`fetal DNA in maternal plasma or serum may be used to screen for fetal
`aneuploidies. Id. at col. 3, ll. 40–43. Another method disclosed by the ’540
`patent for use in screening fetal aneuploidies is quantifying fetal DNA
`markers on different chromosomes, such as quantification of fetal
`chromosomal 21-derived DNA. Id. at col. 3, ll. 44–51.
`
`Example 2 of the ’540 patent describes quantitative analysis of fetal
`DNA in maternal serum, wherein the pregnancy is an aneuploidy pregnancy.
`Id. at col. 5, ll. 55–57. Plasma and serum samples were obtained from
`pregnant women undergoing prenatal testing, and DNA was extracted from
`those samples. Id. at col. 6, ll. 14–34. The DNA then was amplified using
`real time quantitative PCR using primers for the SRY gene. Id. at col. 6,
`l. 35–col. 7, l. 3. The inventors report that the concentration of fetal DNA is
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`elevated in aneuploid pregnancies. Id. at col. 8, ll. 33–36. The same test,
`using the same primers, was used to screen for pre-eclampsia, wherein the
`concentration of fetal DNA is higher in patients with pre-eclamptic
`pregnancies. Id. at col. 11, l. 38–col. 12, l. 49, Example 4.
`
`The SRY gene is male specific, being found on the Y chromosome.
`Id. at col. 25, ll. 6–7, claim 7. The ’540 patent teaches that the “[r]eal time
`quantitative SRY system was insensitive to the existence of background
`female DNA from 0 to 12,800 female genome-equivalents.” Id. at col. 14,
`ll. 46–48. In addition, samples from women bearing female fetuses did not
`provide a positive SRY signal. Id. at col. 15, ll. 63–67.
`
`According to the ’540 patent,
`For selected disorders, foetal genetic information could
`be acquired more economically and rapidly from maternal
`plasma or serum than by using foetal cells isolated from
`maternal blood. We envisage that foetal DNA analysis in
`maternal plasma and serum would be most useful in situations
`where the determination of foetal-derived paternally inherited
`polymorphisms/mutations or genes would be helpful in clinical
`prenatal diagnosis. Examples include foetal sex determination
`for the prenatal diagnosis of sex-linked disorders, foetal rhesus
`D status determination in sensitized rhesus negative pregnant
`women, autosomal dominant disorders in which the father
`carries the mutation and autosomal recessive genetic disorders
`in which the father and mother carry different mutations, e.g.,
`certain hemoglobinopathies and cystic fibrosis. Due to the
`much reduced maternal background and high foetal DNA
`concentration in maternal plasma and serum, we predict that
`this type of analysis would be much more robust compared with
`their application for detecting unsorted foetal cells in maternal
`blood. The ability for allelic discrimination allows the
`homogeneous TaqMan assay to be used for this purpose.
`Id. at col. 17, ll. 32–54 (citations omitted).
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`As for the application of the method to female fetuses, the ’540 patent
`
`teaches:
`
`[I]t has been demonstrated (Example 2) that the foetal
`DNA concentration in maternal plasma and serum is . . .
`elevated in [aneuploid] pregnancies. This provides a new
`screening test for foetal chromosomal disorders. For this
`application, foetal DNA quantitation systems can be developed
`for polymorphic markers outside the Y chromosome so that
`quantitation can be applied to female foetuses. Autosomal
`polymorphic systems which may be used for this purpose have
`already been described.
` However, foetal cell
`isolation
`techniques would still be necessary for a definitive cytogenetic
`diagnosis. Similarly, foetal cell isolation would also be
`required for direct mutational analysis of autosomal recessive
`disorders caused by a single mutation. It is likely that foetal
`cell
`isolation and analysis of foetal DNA
`in maternal
`plasma/serum would be used as complementary techniques for
`non-invasive prenatal diagnosis.
`Id. at col. 17, l. 59–col. 18, l. 8 (citations omitted).
`
`
`D. Illustrative Claim
`Claims 1, 21, 24, and 25 of the ’540 patent are independent. Claim 1
`is illustrative, and is reproduced below:
`1.
`A method for detecting a paternally inherited nucleic acid
`of fetal origin performed on a maternal serum or plasma sample
`from a pregnant female, which method comprises
`
`amplifying a paternally inherited nucleic acid from the
`serum or plasma sample and
`
`detecting the presence of a paternally inherited nucleic
`acid of fetal origin in the sample.
`
`
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`§ 103(a) Lo and Simpson5
`
`E. Instituted Challenges
`References
`Claims
`Basis
`1–5, 12, 13, 15, 18–22,
`§ 102(a) Lo4
`24, and 25
`8
`1, 2, 4, 5, 8, 19, 20, 24,
`and 25
`3, 12, 13, 15, and 18
`1, 2, 4, 5, 19–22, 24, and
`25
`3, 12, 13, 15, and 18
`
`§ 102(b) Kazakov6
`
`§ 103(a) Kazakov and Bianchi7
`§ 103(a) Simpson, Schallhammer,8 and
`Kazakov
`§ 103(a) Simpson, Schallhammer, Kazakov,
`and Bianchi
`
`
`In regard to the challenge of claims 1–5, 12, 13, 15, 18–22, 24,
`
`and 25 as being anticipated under 35 U.S.C. § 102(a) by Lo, as well as
`the challenge of claim 8 as being rendered obvious under 35 U.S.C.
`§ 103(a) over the combination of Lo and Simpson, we note that
`Ariosa stated during oral argument that it is no longer pursuing those
`challenges. Tr., 10:9–20. Without a further developed record, we
`decline to address those challenges further in this Decision.
`
`4 Lo et al., Presence of Fetal DNA in Maternal Plasma and Serum, 350
`LANCET 485–487 (1997) (Ex. 1016).
`5 Simpson et al., Isolating Fetal Cells in Maternal Circulation for Prenatal
`Diagnosis, 14 PRENATAL DIAGNOSIS 1229–1242 (1994) (Ex. 1025).
`6 Kazakov et al., Extracellular DNA in the Blood of Pregnant Women, 37(3)
`CYTOLOGY (TSITOLOGIA) 232–236 (1995) (Ex. 1014).
`7 Bianchi et al., Fetal Cells in Maternal Blood: Determination of Purity and
`Yield by Quantitative Polymerase Chain Reaction, 171 AM. J. OBST.
`GYNECOL. 922–26 (1994) (Ex. 1043).
`8 Schallhammer et al., Phenotypic Comparison of Natural Killer Cells from
`Peripheral Blood and from Early Pregnancy Decidua, 3 EARLY
`PREGNANCY: BIOLOGY AND MEDICINE 15–22 (1997) (Ex. 1022).
`
`8
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`II. ANALYSIS
`
`
`A. 35 U.S.C. § 315(a)(1)
`Isis argues that Ariosa lacks standing on the basis of Ariosa’s filing of
`a civil action challenging the validity of the ’540 patent before filing of the
`Petition for Inter Partes Review. PO Resp. 59 (citing IPR2012-00022,
`Prelim. Resp.). In the Preliminary Response, Isis asserted that Ariosa, prior
`to filing its Petition, filed a civil action against Sequenom, the exclusive
`licensee of the ’540 patent, seeking a declaration that it did not infringe any
`claim of the ’540 patent. Prelim. Resp. 3–4. Sequenom counterclaimed for
`infringement, and Ariosa answered by raising the affirmative defense of
`invalidity of the ’540 patent. Id. at 4. We responded to that argument before
`institution of the IPR2021-00022 proceeding. See generally Paper 20. As
`this proceeding is at Final Decision, we summarize our Decision that
`addressed the issue of whether Ariosa lacked standing to bring to bring the
`IPR2012-00022 proceeding under 35 U.S.C. § 315(a)(1).
`
`Specifically, in its Preliminary Response in IPR2012-00022, Isis
`argued that it “is of no moment” that Ariosa’s challenge of the validity of the
`’540 patent in civil litigation is in the form of an affirmative defense.
`Prelim. Resp. 6. Isis asserted that the bar in § 315 does not require that the
`challenge be placed in the complaint, but “is directed to a petitioner-initiated
`‘civil action’—in other words the entire civil lawsuit—that challenges patent
`validity.” Id. at 6–7.
`
`Isis argued further that the exception in § 315(a)(3) does not apply, as
`that exception is limited to a counterclaim. Id. at 7. According to Isis,
`Ariosa only could have brought a counterclaim for invalidity if Isis and
`Sequenom had initiated the civil action. Id. Isis cited Leatherman v.
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`Tarrant County Narcotics Intelligence & Coordination Unit, 507 U.S. 163,
`168 (U.S. 1993) (“Expressio unius est exclusio alterius”) for the “canon of
`statutory interpretation ‘the express mention of one thing excludes all
`others,’” arguing that canon excludes additional exceptions, such as the
`filing of an affirmative defense of patent invalidity. Id. at 7–8.
`Isis also asserted that to allow Ariosa to file an inter partes review
`
`proceeding would thwart the intent of Congress. Id. at 5–6. According to
`Isis, § 315 was enacted to “avoid patent-owner harassment and to further the
`central purpose of IPRs to provide a cost-effective alternative to district-
`court patent validity litigation.” Id. at 5. Thus, Isis asserted, a “key
`directive” of the statute is that the party that wishes to challenge the validity
`of a patent “must choose a single forum,” with the only narrow exception
`being if the challenge is in the form of a counterclaim in a patent owner-
`initiated civil action. Id. at 5–6.
`The issue we thus addressed before instituting inter partes review in
`IPR2012-00022 was
`whether filing a Declaratory Judgment of non-infringement in
`District Court bars Ariosa from later filing a petition for Inter
`Partes Review under 35 U.S.C. § 315(a), and whether the
`express mention of a counterclaim of invalidity in 35 U.S.C.
`§ 315(a)(3) mandates interpreting the statute such that raising
`an affirmative defense of invalidity in response to a compulsory
`counterclaim of infringement deprives Ariosa of standing to file
`for inter partes review.
`
`Paper 20, 3–4.
`We noted in our Decision that statutory construction “‘begins with
`‘the language of the statute.’ And where the statutory language provides a
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`clear answer, it ends there as well.’” Id. at 4 (quoting Hughes Aircraft Co. v.
`Jacobson, 525 U.S. 432, 438 (1999) (citations omitted)).
`“Beyond the statute’s text, [the ‘traditional tools of statutory
`construction’]
`include
`the statute’s structure, canons of
`statutory construction, and legislative history.” Timex V.I. v.
`United States, 157 F.3d 879, 882 (Fed.Cir.1998) (quoting
`Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467
`U.S. 837, 843 n. 9, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984)). “If
`a court, employing traditional tools of statutory construction,
`ascertains that Congress had an intention on the precise
`question at issue, that intention is the law and must be given
`effect,” Chevron, 467 U.S. at 843 n. 9, 104 S.Ct. 2778.
`
`
`Bull v. U.S., 479 F.3d 1365, 1376 (Fed. Cir. 2007).
`
`We first addressed the issue of what is meant by “the petitioner or real
`party in interest filed a civil action challenging the validity of a claim of the
`patent” in § 315(a)(1) of the statute. Paper 20, 4. Under Isis’s interpretation
`of the statute, “filing” extends beyond the commencement of the civil action
`and includes raising the affirmative defense of invalidity. Id. We looked to
`the Federal Rules of Civil Procedure as a guide to interpreting the plain
`meaning of the statute. Id.
`We noted that Rule 2 of the Federal Rules of Civil Procedure9 states
`
`that “[t]here is one form of action—the civil action,” and Rule 3 states that
`“[a] civil action is commenced by filing a complaint with the court.” Id. at
`5. Defenses are raised in answer to the complaint or in answer to a
`counterclaim. Id. (citing Fed. R. Civ. P. 12). We concluded, therefore, that
`when the statute refers to filing a civil action, it refers to filing a complaint
`with the court to commence the civil action. Id.; see, e.g., Baldwin Cnty.
`Welcome Ctr. v. Brown, 466 U.S. 147, 149 (1984) (citing Fed. R. Civ. P. 3
`
`9 As amended December 1, 2010.
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`for the proposition that a civil action is brought upon the filing of a
`complaint with the court).
`
`The next issue we addressed was whether the above interpretation of
`what constitutes filing a civil action for purposes of § 315(a)(1) can be
`reconciled with the explicit exception of filing a counterclaim for invalidity
`in § 315(a)(3). Paper 20, 5.
`In our Decision addressing this issue, we noted that the Supreme
`Court has distinguished an affirmative defense of invalidity from a
`counterclaim of invalidity in Cardinal Chem. Co. v. Morton Int’l, Inc., 508
`U.S. 83 (1993). Paper 20, 5–6. The question before the Court in that case
`was whether the Court of Appeals for the Federal Circuit properly vacated a
`declaratory judgment of invalidity after finding that there was no
`infringement. Cardinal Chem., 508 U.S. at 85. Quoting Altvater v.
`Freeman, 319 U.S. 359, 363–364 (1943), the Court stated:
`“To hold a patent valid if it is not infringed is to decide a
`hypothetical case. But the situation in the present case is quite
`different. We have here not only bill and answer but a
`counterclaim.
` Though the decision of non-infringement
`disposes of the bill and answer, it does not dispose of the
`counterclaim which raises the question of validity . . . . [T]he
`issue of validity may be raised by a counterclaim in an
`infringement suit. The requirements of case or controversy are
`of course no less strict under the Declaratory Judgments Act
`(48 Stat. 955, 28 U.S.C. § 400) than in case of other suits. But
`we are of the view that the issues raised by the present
`counterclaim were justiciable and that the controversy between
`the parties did not come to an end on the dismissal of the bill
`for non-infringement, since their dispute went beyond the single
`claim and the particular accused devices involved in that suit.”
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`Cardinal Chem. Co., 508 U.S. at 94. The Court noted, however, that
`Altvater did not answer the question of whether, in the absence of an
`ongoing infringement dispute between the parties, an adjudication of
`invalidity would be moot. Id. at 95.
`
`In answering that question, the Court observed that “[a] party seeking
`a declaratory judgment of invalidity presents a claim independent of the
`patentee’s charge of infringement.” Id. at 96. The Court also emphasized
`that there are public policy reasons to resolve questions of patent validity.
`Id. at 100–101. The Court, thus, rejected the Federal Circuit’s practice of
`vacating a declaratory judgment of invalidity after a finding of
`noninfringement. Id. at 102.
`Thus, it is clear from Cardinal Chem. Co. that there is a fundamental
`
`difference between an affirmative defense of invalidity and a counterclaim
`of invalidity. The affirmative defense of invalidity is tied to the claim of
`infringement, whereas a counterclaim of invalidity is independent from the
`claim of infringement and survives a finding of noninfringement. Section
`315(a)(3) makes clear that if a party is faced with a claim of infringement, it
`can bring the independent claim of invalidity as a counterclaim and still
`avail itself of inter partes review.
`
`Given the above analysis as a backdrop, we concluded that the
`statutory language provides a clear answer to the issue of whether filing a
`civil action for a declaratory judgment of noninfringement by a party
`deprives that party of standing to file an inter partes review as a result of
`raising the affirmative defense of invalidity in response to a counterclaim of
`infringement. Paper 20, 6.
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`As discussed above, the statute clearly defines which civil actions,
`when filed, bar a party from filing an inter partes review—civil actions
`challenging the validity of a patent. A civil action for a declaratory
`judgment of non-infringement is not a civil action challenging the validity of
`a patent. Moreover, as discussed above, asserting an affirmative defense of
`invalidity is treated differently than a counterclaim for invalidity, and thus
`for the purposes of § 315(a)(1) cannot be considered a filing of a civil action
`for invalidity. And as also discussed above, that interpretation of
`§ 315(a)(1) does not conflict with the explicit exclusion in § 315(a)(3) of
`filing a counterclaim for invalidity.
`
`We considered Isis’s argument that to allow Ariosa to file a
`declaratory judgment action for noninfringement and also file a Petition for
`inter partes review allows Ariosa to thwart the intent of Congress, but it did
`not convince us otherwise.
`In reviewing the legislative history of the America Invents Act10
`
`(“AIA”) (Paper 20, 7–8), we noted that Senator Kyl stated in discussing the
`Act:
`
`Another set of changes made by the House bill concerns
`the coordination of inter partes and postgrant review with civil
`litigation. The Senate bill, at proposed sections 315(a) and
`325(a), would have barred a party or his real party in interest
`from seeking or maintaining an inter partes or postgrant review
`after he has filed a declaratory-judgment action challenging the
`validity of the patent. The final bill will still bar seeking IPR or
`PGR after a declaratory-judgment action has been filed, but will
`allow a declaratory-judgment action to be filed on the same day
`or after the petition for IPR or PGR was filed. Such a
`declaratory-judgment action, however, will be automatically
`
`10 Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011).
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`stayed by the court unless the patent owner countersues for
`infringement. The purpose of allowing the declaratory-
`judgment action to be filed is to allow the accused infringer to
`file the first action and thus be presumptively entitled to his
`choice of venue.
`
`157 Cong. Rec. S5429 (daily ed. Sept. 8, 2011)).
`
`Thus, as made clear by Senator Kyl, § 315(a) was amended to allow a
`petitioner to file an inter partes review, and still have a choice of venue by
`allowing the petitioner to file a declaratory judgment action that same day.
`
`Moreover, a party cannot bring a declaratory judgment action of
`noninfringement without any basis for doing so.
`Although there is no bright line rule to determine whether
`a declaratory judgment action satisfies Article III’s case-or-
`controversy requirements, the dispute must be “definite and
`concrete, touching the legal relations of parties having adverse
`legal interests,” “real and substantial,” and “admi[t] of specific
`relief
`through a decree of a conclusive character, as
`distinguished from an opinion advising what the law would be
`upon a hypothetical state of facts.” “Basically, the question in
`each case
`is whether
`the facts alleged, under all
`the
`circumstances, show that there is a substantial controversy,
`between parties having adverse legal interests, of sufficient
`immediacy and reality to warrant the issuance of a declaratory
`judgment.” Id..
`
`3M Co. v. Avery Dennison Corp., 673 F.3d 1372, 1376 (Fed. Cir. 2012)
`(citations omitted). And even when there is a case or controversy, the
`district court still has discretion in deciding whether it will entertain the
`declaratory judgment action. Id.
`We concluded, therefore, that allowing a party to file both a
`declaratory judgment action for noninfringement and an inter partes review
`does not constitute harassment of a patent owner, because in order to bring
`
`15
`
`
`
`IPR2012-00022
`Patent 6,258,540
`
`the declaratory judgment action for noninfringement, a party must still
`satisfy Article III’s case-or-controversy requirements. Paper 20, 8.
`
`We, thus, concluded that 35 U.S.C. § 315(a) does not deprive Ariosa
`of standing to bring the instant inter partes review. Id.
`
`
`B. 35 U.S.C. § 315(b)
`Isis argues further that this inter partes review is barred under
`35 U.S.C. § 315(b). PO Resp. 59 (citing IPR2013-00250, Prelim. Resp.). In
`its Preliminary Response filed in IPR2013-00250, Isis contended that under
`35 U.S.C. § 315(b), the “Office may not institute inter partes review if the
`petitioner filed its petition more than one year after being served with a
`complaint alleging infringement of the patent.” IPR2013-00250, Prelim.
`Resp. 42. According to Isis, Aria Diagnostics, Inc., now Ariosa, accepted
`service of a complaint alleging infringement of the ’540 patent, more than a
`year before the IPR2013-00250 Petition filing date of April 19, 2013. Id.
`
`Isis acknowledged that the parties later agreed to dismissal of the civil
`action without prejudice. Id. Isis argued, however, that § 315(b) leaves no
`room for discretion, as it states that “inter partes review ‘may not be
`instituted if the petition requesting the proceeding is filed more than 1 year
`after the date on which the petitioner . . . is served with [the] complaint’” Id.
`(alteration in original). According to Isis, the fact that the infringement suit
`was dismissed without prejudice was immaterial to whether or not Ariosa
`was barred from bringing the instant inter partes review against Isis. Id. at
`42–44.
`
`In the Decision to Institute in IPR2013-00250, we noted that that
`argument had already been considered by the Board in Macauto U.S.A. v.
`
`16
`
`
`
`IPR2012-00022
`Patent 6,258,540
`
`BOS GMBH & KG, Case IPR2012-00004 (PTAB January 24, 2013) (Paper
`18). IPR2013-00250, Paper 26, 4. In that proceeding, the panel noted that
`the bar of filing an inter partes review under 35 U.S.C. § 315(b) did not
`attach to a complaint of infringement that was voluntarily dismissed without
`prejudice. See Macauto, slip. op. at 14–16. We agree with that reasoning,
`discussed below.
`
`Specifically, the panel in that case looked to the Federal Rules of Civil
`Procedure in making its determination. Id. at 15. As to the requirement of
`service, the panel noted that the infringement suit was voluntarily dismissed
`without prejudice under Fed. R. Civ. P. 41(a). Id. The panel noted further
`that the Court of Appeals for the Federal Circuit has consistently interpreted
`the effect of such dismissals as leaving the parties as though the action had
`never been brought. Id. (citing Graves v. Principi, 294 F.3d 1350, 1356
`(Fed. Cir. 2002) (“The dismissal of an action without prejudice leaves the
`parties as though the action had never been brought”); Bonneville
`Associates, Ltd. Partnership v. Baram, 165 F.3d 1360, 1364 (Fed. Cir. 1999)
`(“The rule in the federal courts is that ‘[t]he effect of a voluntary dismissal
`without prejudice pursuant to Rule 41(a) is to render the proceedings a
`nullity and leave the parties as if the action had never been brought.’”)
`(citations and internal quotes omitted.)); Accord, Wright, Miller, Kane, and
`Marcus, 9 Federal Prac. & Proc. Civ. § 2367 (3d. ed.) (“[A]s numerous
`federal courts have made clear, a voluntary dismissal without prejudice
`under Rule 41(a) leaves the situation as if the action never had been filed.”)
`(footnote omitted).
`As in the Macauto case, we agreed that the dismissal without
`
`prejudice leaves the parties as if the action had never been brought, and
`
`17
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`IPR2012-00022
`Patent 6,258,540
`
`concluded that Ariosa was not barred from filing its Petition in IPR2013-
`00250 under 35 U.S.C. § 315(b). IPR2013-00250, Paper 26, 3. As a result,
`we did not address Isis’s arguments (IPR2013-00250, Prelim. Res. 44–46)
`regarding joinder in the context of the bar under § 315(b). Id.
`
`
`C. 35 U.S.C. § 315(c)
`Isis also argues the joinder statute only allows joinder of parties, not
`joinder of issues. PO Resp. 60 (citing IPR2013-00250, Prelim. Resp. 44–
`46).
`
`Ariosa’s Motion for Joinder under 37 C.F.R. § 42.122(b) requested
`that proceeding IPR2013-00250, involving the same parties and patent as
`IPR2012-00022, be joined with that proceeding. IPR2013-00250, Paper 4.
`The Joinder Motion was timely filed within one month after institution of
`this trial in accordance with § 42.122(b). Isis opposed the Motion on the
`ground that the enabling joinder statute, 35 U.S.C. § 315(c), allows only
`joinder of parties, not joinder of issues. IPR2013-00250, Prelim. Resp. 44–
`45; IPR2012-00022, Paper 72, 6–8.
`The statute governing joinder of inter partes review proceedings,
`35 U.S.C. § 315(c), provides:
`(c) JOINDER.—If the Director institutes an inter partes
`review, the Director, in his or her discretion, may join as a party
`to that inter partes review any person who properly files a
`petition under section 311 that the Director, after receiving a
`preliminary response under section 313 or the expiration of the
`time for filing such a response, determines warrants the
`institution of an inter partes review under section 314.
`
`In its Response to the Petition, Isis maintains that the language in
`§ 315(c) addresses joinder of a “party” to a proceeding, rather than the
`
`18
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`IPR2012-00022
`Patent 6,258,540
`
`situation present in this case, where Ariosa essentially seeks the “joinder” of
`additional grounds by the same party. PO Resp. 60.
`In addressing that argument previously (IPR2013-00250, Paper 25, 4),
`we no
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