Trials@uspto.gov
`571-272-7822
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`Paper 171
`Date: March 24, 2015
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`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.
`
`DECISION
`Request for Rehearing
`37 C.F.R. § 42.71
`
`I.
`
`SUMMARY
`
`
`
`Isis Innovation Limited (“Patent Owner”), requests rehearing of the
`
`Final Decision (“Dec.”), dated September 2, 2014 (Paper 166). Paper 168.
`
`Ariosa Diagnostics (“Petitioner”), also requests rehearing of the Final
`
`1 This Case has been joined with IPR2013-00250.
`
`
`571-272-7822
`
`
`
`
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`
`
`Paper 171
`Date: March 24, 2015
`
`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.
`
`DECISION
`Request for Rehearing
`37 C.F.R. § 42.71
`
`I.
`
`SUMMARY
`
`
`
`Isis Innovation Limited (“Patent Owner”), requests rehearing of the
`
`Final Decision (“Dec.”), dated September 2, 2014 (Paper 166). Paper 168.
`
`Ariosa Diagnostics (“Petitioner”), also requests rehearing of the Final
`
`1 This Case has been joined with IPR2013-00250.
`
`
`
`IPR2012-00022
`Patent 6,258,540
`
`
`Decision. Paper 167. In the Final Decision, we determined that claims 1, 2,
`
`
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`4, 5, 8, 19, 20, 24, and 25 were unpatentable under 35 U.S.C. § 102(b), but
`
`that claims 3, 12, 13, 15, 18, 21, and 22 were not shown to be unpatentable.
`
`See Dec. 56. We determined further that the joinder statute allows joinder of
`
`issues by the same party, as well as joinder of parties. Id. at 22.
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`
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`Patent Owner requests rehearing on a single issue. Specifically,
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`Patent Owner argues that we must reconsider our determination that the
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`joinder statute allows joinder of issues by the same party, as well as joinder
`
`of parties, in view of the expanded panel decision in Target Corp. v.
`
`Destination Maternity Corp., IPR2014-00508, slip. op. 7, 11 (PTAB Sept.
`
`25, 2014) (Paper 18).
`
`
`
`Petitioner requests rehearing of our determination that the
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`combination of Simpson (Ex. 1025) and Kazakov (Ex. 1014) does not render
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`unpatentable claims 1, 2, 4, 5, 19–22, 24, and 25 under 35 U.S.C. § 103(a).
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`In particular, Petitioner contends that determination “was erroneously
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`premised on the factual finding that the combined method of Kazakov . . .
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`and Simpson . . . was limited to quantitative testing for chromosomal
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`abnormalities, e.g., aneuploidy,” whereas the combination of those
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`references would have rendered obvious a method of testing for fetal gender.
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`Paper 167, 1.
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`II.
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`DISCUSSION
`
`
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`A party challenging a Final Written Decision by way of request for
`
`rehearing must identify specifically all matters the party believes the Board
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`misapprehended or overlooked. 37 C.F.R. § 42.71(d). The challenging
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`party bears the burden of showing that the decision should be modified.
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`2
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`IPR2012-00022
`Patent 6,258,540
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`PATENT OWNER’S REQUEST FOR REHEARING
`
`A.
`
`
`
`
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`We have carefully considered Patent Owner’s Request for Rehearing
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`based on the panel decision in Target Corp. v. Destination Maternity Corp.,
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`IPR2014-00508, slip. op. 7, 11 (PTAB Sept. 25, 2014) (Paper 18), but do not
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`find it persuasive. First, that decision is not a precedential decision, and thus
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`is not binding. Second, an expanded panel of the Board granted rehearing of
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`that decision, and agreed with our determination that the joinder statute
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`allows joinder of issues by the same party, as well joinder of parties. See
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`IPR2014-00508 (PTAB Feb. 12, 2015) (Paper 28).
`
`
`
`
`
`
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`We, therefore, deny Patent Owner’s Request for Rehearing.
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`B.
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`PETITIONER’S REQUEST FOR REHEARING
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`Petitioner contends that, as set forth in the Petition filed in IPR2013-
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`00250 (Paper 1, “the ’250 Petition”), “it would have been obvious to use the
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`Y chromosome fetal sequence specific primers of Simpson or Bianchi to
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`amplify fetal DNA of paternal origin in a male fetus for the purpose of
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`identifying the sex of a male fetus.” Paper 167, 2. Petitioner points also to
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`the claim chart as to claim 5 in the Petition filed in IPR2012-00022 (Paper 1,
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`“the ’022 Petition”), which notes that Simpson taught the use of PCR to
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`amplify Y sequences, and the experiments conducted by Kazakov would
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`have resulted in the amplification of Y-specific sequences that were
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`contained in Y-specific sequences. Paper 167, 2. (citing Ex. 1007
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`(“Mansfield Declaration”), ¶¶ 51–69, 74)). According to Petitioner, such
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`methods are qualitative rather than quantitative. Id.
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`
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`Petitioner contends further that our determination was premised on the
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`finding that “in the combined method the objective was solely to test for
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`3
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`IPR2012-00022
`Patent 6,258,540
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`fetal aneuploidy.” Paper 167, 6–7 (citing Dec. 43–45). That erroneous fact
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`
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`finding, Petitioner asserts, led to the conclusion that Petitioner failed to
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`demonstrate that the combination of Simpson and Kazakov rendered the
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`claimed method obvious by a preponderance of the evidence. Id. at 7–8
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`(citing Dec. 46). That is, Petitioner argues, the rarity of fetal DNA in
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`maternal serum would not have been an issue as PCR is able to detect the
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`equivalent of a single male cell. Id. at 9.
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`
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`Petitioner’s contentions do not persuade us that we overlooked or
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`misapprehended any evidence or argument in the Final Decision. The claim
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`chart as to claim 5 filed in the ’022 Petition states:
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`Simpson teaches that PCR was used to amplify Y
`sequences from fetal cells in women to confirm the sex of a
`male fetus (Mansfield Decl. ¶74).
`Additionally, the experiments conducted by Kazakov
`would have resulted in the amplification of Alu repeats that
`contained Y-specific sequences, as demonstrated in the in silico
`genomic data provided in the Kazakov declaration as well as
`the scientific data provided in the Mansfield declaration
`(Mansfield Decl. ¶¶51-69).
`
`’022 Petition, 51. The ’022 Petition provides no further analysis as to that
`
`claim. In particular, we note that the claim chart does not state that such
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`methods would have been qualitative, rather than quantitative. Paragraphs
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`51–69 of the Mansfield Declaration were cited to demonstrate that the
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`primers used in the Kazakov reference would have resulted in amplification
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`of sequences from the Y chromosome. Paragraph 74 cites the Simpson
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`reference for its teaching of primers specific for the Y chromosome. Thus,
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`those portions of the Mansfield Declaration also do not state that such
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`methods would have been qualitative rather than quantitative.
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`4
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`IPR2012-00022
`Patent 6,258,540
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`Moreover, the issue of whether detecting fetal Y chromosomal
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`
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`sequences is qualitative rather than quantitative is irrelevant to our Decision,
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`as we determined that the preponderance of the evidence did not support that
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`the combination of Simpson and Kazakov provided a reasonable expectation
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`of success that the fetal DNA would have been present in maternal serum in
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`sufficient quantities for detection using amplification methods such as PCR.
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`Dec. 43. In particular, as noted in the Final Decision, Petitioner relied on
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`Simpson for its teaching that fetal cells, or at least fetal DNA, are present in
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`maternal blood. Dec. 39 (citing ’022 Petition, 49). Kazakov was relied
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`upon for its teaching that the level of extracellular DNA increases in the
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`blood of pregnant females. Id. (citing ’022 Petition, 50). We noted that
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`although Simpson suggested that DNA would be found in levels sufficient to
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`be determined using amplification reactions, such as PCR, by teaching that
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`Y chromosome specific signals were seen in women carrying a male fetus,
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`we determined that a preponderance of the evidence supported the finding
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`that the source of that DNA was fetal cells, and not cell-free DNA. Id. at 40.
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`Thus, we considered specifically Simpson’s teaching of using PCR to detect
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`Y-chromosome specific signals.
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`
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`In concluding that Petitioner had not established that the combination
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`of Simpson and Kazakov rendered obvious challenged claims 1, 2, 4, 5, 19–
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`22, 24, and 25, we noted that the evidence supported that the occurrence of
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`fetal cells in maternal blood was a rare event. Id. at 42. The Decision noted
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`also that Kazakov did not consider fetal DNA to be the only source of the
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`increased DNA in maternal serum during the first trimester, but also
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`considered maternal sources, and did not rule out the possibility that the
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`DNA being amplified was only from maternal sources. Id. Those findings
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`5
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`IPR2012-00022
`Patent 6,258,540
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`support our conclusion that the ordinary artisan would not have had a
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`
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`reasonable expectation of success of using maternal serum or plasma, as
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`taught by Kazakov, as the source of fetal DNA in the fetal DNA analysis
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`methods of Simpson. Id. at 43. Stated differently, as any fetal cells, if
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`present, would have been removed in the samples of Kazakov, and as
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`Simpson teaches that it is the fetal cells that are the source of fetal DNA, the
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`ordinary artisan would not have reasonably expected that the samples of
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`Kazakov would have contained sufficient levels of fetal DNA, such that
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`PCR-based methods could be used detect fetal DNA, including Y-
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`chromosome specific signals, in view of Kazakov’s uncertainty as to the
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`source of the DNA being amplified.
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`
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`Petitioner contends further that the overwhelming evidence of record
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`demonstrates that “the use of the Simpson gender detection technique on an
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`alternative source suggested by Kazakov—maternal serum—‘would require
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`at most only routine adjustments to the PCR protocols.’” Paper 167, 8
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`(quoting Ex. 1215 ¶ 43). In particular, Petitioner argues that that the “a
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`person of ordinary skill would have understood that the ability to detect
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`fetal-specific sequences from cell-free DNA present in maternal DNA
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`present in maternal serum or plasma did not require fetal cell-free DNA to
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`be any more prevalent than fetal cells.” Id. at 9–10 (citing Ex. 1008, ¶ 63).
`
`
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`Petitioner argues that although Kazakov does not confirm the origin of
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`cell-free DNA, Kazakov does teach that the overall level of extracellular
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`DNA in maternal blood increases during pregnancy. Id. at 10. Thus,
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`Petitioner argues, the ordinary artisan would have expected that there would
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`be sufficient levels of cell-free DNA from fetal cells to allow for the
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`detection of Y-chromosomal sequences. Id. (citing Ex. 1008 ¶ 63).
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`6
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`IPR2012-00022
`Patent 6,258,540
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`
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`Although we do not disagree with Petitioner’s contention that it would
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`have only required routine experimentation to analyze maternal serum or
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`plasma, as taught by Kazakov, that does not address the question as to
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`whether the ordinary artisan would have expected there to be sufficient
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`quantities of cell-free DNA in maternal DNA for the detection of fetal
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`chromosomes, such as fetal chromosomal abnormalities, as taught by
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`Simpson. See Dec. 45. Moreover, as already discussed, Petitioner did not
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`demonstrate by a preponderance of the evidence that the ordinary artisan
`
`would have had a reasonable expectation of success of using maternal serum
`
`or plasma as a source for fetal DNA in the methods of testing fetal DNA,
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`including determination of chromosome specific sequences, as taught by
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`Simpson. The mere fact that Kazakov teaches that the overall level of
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`extracellular DNA in maternal blood increases during pregnancy at best begs
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`the question of whether that increase reflects increases in fetal DNA, given
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`Kazakov’s uncertainty as to the source of that DNA.
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`We, therefore, deny Petitioner’s Request for Rehearing.
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`III. CONCLUSION
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`For the foregoing reasons, it is hereby ORDERED that both Patent
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`Owner’s and Petitioner’s Requests for Rehearing are denied.
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`7
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`IPR2012-00022
`Patent 6,258,540
`
`For PETITIONER:
`
`Greg Gardella
`cpdocketgardella@oblon.com
`
`Scott McKeown
`cpdocketmckeown@oblon.com
`
`Kevin Laurence
`klaurence@oblon.com
`
`Dianna DeVore
`DDeVore@ariosadx.com
`
`Sarah Brashears
`sbrashears@convergentlaw.com
`
`Amir Naini
`anaini@irell.com
`
`
`
`For PATENT OWNER:
`
`Eldora Ellison
`eellison@skgf.com
`
`Helene Carlson
`hcarlson@skgf.com
`
`
`
`8
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