Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01215/USCOURTS-ca13-15-01215-0/pdf.json

Parties Involved:
Ariosa Diagnostics
Appellant
Verinata Health, Inc.
Appellee

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

ARIOSA DIAGNOSTICS,

Appellant

v.

VERINATA HEALTH, INC.,

Appellee

______________________ 

2015-1215, 2015-1226

______________________ 

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. 

IPR2013-00276, IPR2013-00277. 

______________________ 

Decided: November 16, 2015 

______________________ 

MARK A. LEMLEY, Durie Tangri LLP, San Francisco, 

CA, argued for appellant. Also represented by DARALYN 

JEANNINE DURIE, ALEXANDRA HELEN MOSS; GREG

GARDELLA, Oblon, Spivak, McClelland, Maier & Neustadt, 

LLP, Alexandria VA. 

EDWARD R. REINES, Weil, Gotshal & Manges LLP, 

Redwood Shores, CA, argued for appellee. Also represented by DEREK C. WALTER, ANANT N. PRADHAN; MICHAEL T.

ROSATO, Wilson, Sonsini, Goodrich & Rosati, PC, Seattle, 

WA. 

______________________ 

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2 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

Before PROST, Chief Judge, WALLACH, and TARANTO,

Circuit Judges.

TARANTO, Circuit Judge.

Verinata Health, Inc. owns U.S. Patent No. 8,318,430, 

which describes and claims methods of noninvasive prenatal testing for the presence of fetal chromosomal abnormalities. In particular, the methods may identify

“aneuploidy,” i.e., the presence of an abnormal number of

copies of a chromosome—say, three rather than the 

normal two for chromosome 21, an abnormality that 

characterizes Down Syndrome. The methods involve

obtaining blood samples from several pregnant women; 

isolating from the samples genomic DNA molecules not 

contained in cells; choosing particular DNA sequences—

some on a chromosome of concern, some not; indexing by 

maternal source the chromosomes or regions containing 

those sequences; amplifying (making many copies of) the 

group of chromosomes or regions; performing massively 

parallel sequencing on the resulting pool; using the indexing to count, for a particular maternal source, the number 

of sequences from chromosomes of concern versus the 

number from reference chromosomes or regions; and 

determining based on the comparison whether there are

fetal chromosomal abnormalities, such as an extra copy of 

a chromosome of concern. 

Ariosa Diagnostics, Inc. petitioned the Patent Trial 

and Appeal Board for inter partes review of claims 1–18 

and, in a separate petition, claims 19–30, challenging the 

claims for obviousness under 35 U.S.C. § 103. The Board

concluded that Ariosa had not met its burden of proving 

that claims 1–18 and 19–30 would have been obvious. 

Ariosa Diagnostics v. Verinata Health, Inc., IPR2013-276, 

2014 WL 5454541 (PTAB Oct. 23, 2014); Ariosa Diagnostics v. Verinata Health, Inc., IPR2013-277, 2014 WL 

5454542 (PTAB Oct. 23, 2014). We vacate the decisions 

and remand for further consideration because of one 

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ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 3

matter that the Board’s language suggests it did not 

sufficiently consider.1

BACKGROUND

Verinata and Ariosa are competitors in the relatively 

new field of noninvasive prenatal diagnostics, which 

includes testing for fetal chromosomal abnormalities. For 

many years, prenatal chromosomal testing required 

invasive, high-risk procedures, such as amniocentesis. 

Noninvasive tests, based on the combination of ultrasound observation and measurement of biochemical 

markers in blood samples drawn from the pregnant 

woman, suffered from low accuracy—in a matter where 

accuracy is very important. The 1997 discovery of cellfree fetal DNA circulating in maternal blood suggested 

the possibility of superior noninvasive tests, but turning 

the possibility into a reality presented significant challenges. 

One challenge involved the proportion of the total 

amount of cell-free DNA in maternal blood that came 

from the fetus. That proportion is typically less than 10 

percent. Some scientists seeking to use the 1997 discovery focused on distinguishing fetal DNA from maternal 

DNA in a blood sample. By separating fetal from maternal DNA, or determining the particular fetal/maternal 

ratio of cell-free DNA, certain counting methods could try 

to discern which fetus-specific chromosomes had an 

abnormal number of copies.

Verinata’s ’430 patent, with a priority date of January 

2010, does not rely on separating fetal from maternal cellfree DNA or, even, determining the fetal/maternal ratio of 

cell-free DNA. ’430 patent, col. 5, lines 63–65. Rather, 

1 The Board’s decisions are the same in all respects 

material to this opinion. Instead of providing duplicative 

citations, we cite only the decision in IPR2013-276, which 

we call simply “Ariosa.” 

 

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4 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

the ’430 patent describes a counting technique applied to 

an overall pool of DNA segments, selected for comparing a 

chromosome of concern (say, chromosome 21) with a 

reference chromosome (or chromosomal region), making 

the comparison by identifying the respective DNA sequences. Fetal aneuploidy (in the case of, for example,

three versus two copies of a chromosome) may be determined by comparing the number of sequences generated 

from the chromosome of concern with the number of 

sequences generated from a reference chromosome—

counting copies from all cell-free DNA, whether fetal or 

maternal. Id., col. 13, lines 59–64. But because cell-free 

fetal DNA is such a small proportion of total cell-free 

DNA, the elevation in the target-sequence count will be 

small in an overall sample; and for the numerical elevation to be significant and sufficiently reliable for prenatal 

testing, a large sample must be created and sequenced. 

The ’430 patent describes doing so by amplifying the 

target and reference sequences, pooling samples from 

several women and indexing them for later identification, 

and using massively parallel sequencing. ’430 patent, col. 

1, lines 41–48; id., col. 6, lines 20–27; id., col. 12, lines 56–

63. 

Claim 1 of the patent states:

1. A method for determining a presence or absence of a fetal aneuploidy in a fetus for each of a 

plurality of maternal blood samples obtained from 

a plurality of different pregnant women, said maternal blood samples comprising fetal and maternal cell-free genomic DNA, said method 

comprising: 

(a) obtaining a fetal and maternal cell-free genomic DNA sample from each of the plurality 

of maternal blood samples;

(b) selectively enriching a plurality of nonrandom polynucleotide sequences of each fetal 

and maternal cell-free genomic DNA sample 

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of (a) to generate a library derived from each 

fetal and maternal cell-free genomic DNA 

sample of enriched and indexed fetal and maternal non-random polynucleotide sequences, 

wherein each library of enriched and indexed 

fetal and maternal non-random polynucleotide sequences includes an indexing nucleotide sequence which identifies a maternal 

blood sample of the plurality of maternal 

blood samples,

wherein said plurality of non-random polynucleotide sequences comprises at least 100 different non-random polynucleotide sequences 

selected from a first chromosome tested for 

being aneuploid and at least 100 different 

non-random polynucleotide sequences selected from a reference chromosome, wherein the 

first chromosome tested for being aneuploid 

and the reference chromosome are different, 

and wherein each of said plurality of nonrandom polynucleotide sequences is from 10 

to 1000 nucleotide bases in length,

(c) pooling the libraries generated in (b) to produce a pool of enriched and indexed fetal and 

maternal non-random polynucleotide sequences;

(d) performing massively parallel sequencing of 

the pool of enriched and indexed fetal and 

maternal non-random polynucleotide sequences of (c) to produce sequence reads corresponding to enriched and indexed fetal and 

maternal non-random polynucleotide sequences of each of the at least 100 different 

non-random polynucleotide sequences selected from the first chromosome tested for being 

aneuploid and sequence reads corresponding 

to enriched and indexed fetal and maternal 

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6 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

non-random polynucleotide sequences of each 

of the at least 100 different non-random polynucleotide sequences selected from the reference chromosome;

(e) based on the indexing nucleotide sequence, 

for each of the plurality of maternal blood 

samples, enumerating sequence reads corresponding to enriched and indexed fetal and 

maternal non-random polynucleotide sequences selected from the first chromosome 

tested for being aneuploid and sequence reads 

corresponding to enriched and indexed fetal 

and maternal non-random polynucleotide sequences selected from the reference chromosome; and

(f) for each of the plurality of maternal blood 

samples, determining the presence or absence 

of a fetal aneuploidy comprising using a number of enumerated sequence reads corresponding to the first chromosome and a number of 

enumerated sequence reads corresponding to 

the reference chromosome of (e).

’430 patent, col. 63, lines 8–67. Claims 2–18 depend on 

claim 1 and add various limitations, such as the number 

of non-random DNA sequences selected, the length of the 

non-random DNA sequences, and the chromosomes to be 

tested. Id., col. 64, line 8 through col. 65, line 11. Claim 

19, the only other independent claim, differs from claim 1 

in that claim 19 requires comparing the tested chromosome region to a chromosome control region, rather than 

comparing a tested chromosome to a reference chromosome. Id., col. 65, lines 35–36, 55–56, 65, and col. 66, line 

7. Claims 20–30 depend on claim 19 and are largely 

analogous to claims 2–18. Id., col. 66, lines 1–62.

Ariosa petitioned for inter partes review of claims 1–

18 and 19–30. It argued that the claimed methods would 

have been obvious to a relevant skilled artisan in January 

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2010 in light of three prior-art references: Shoemaker, 

Dhallan, and Binladen. 

U.S. Patent Application No. 2008/0090239, filed in 

2008 by Shoemaker et al., discloses a method of determining fetal aneuploidy by isolating fetal cells, not cell-free 

DNA. A maternal blood sample, known to include a very 

small number of fetal blood cells, is enriched for blood 

cells and then dispersed into wells, each well receiving at 

most one blood cell. Shoemaker ¶¶ 7, 8, 219. A polymerase chain reaction (PCR) technique is used to tag and 

amplify specific regions of chromosomes in those cells—

regions being tested as well as control regions. Id. ¶¶ 7, 

9. All amplified products are then pooled for sequencing. 

Id. ¶ 121. Non-maternal sequences are identified and 

used to distinguish wells containing fetal cells from those 

containing maternal cells. Id. ¶ 138. For the wells that 

contain fetal cells, the ratio of maternal to non-maternal 

alleles is then compared: certain disparities will indicate 

the presence of extra copies of fetal chromosomes. Id.

¶ 140.

U.S. Patent No. 7,332,277, issued in 2003 to Dhallan, 

discloses a method of detecting fetal genetic disorders. 

Dhallan describes using a maternal blood sample to 

obtain a mixture of cell-free fetal and maternal DNA. 

’277 patent, col. 31, lines 32–34. Specific DNA sequences 

are amplified and sequenced. Id., col. 47, lines 38–39. 

After sequencing, maternal and fetal alleles are distinguished, id., col. 67, lines 28–34, the percentage of fetal 

DNA in the original sample is calculated, id., col. 67, lines 

18–27, and the calculated ratio of fetal to maternal alleles 

is used to identify chromosomal abnormalities, id., col. 68, 

lines 56–60. 

An article published in 2007 by Jonas Binladen et al.

describes a study that involved tagging and sequencing 

DNA samples from multiple sources simultaneously. The 

study isolated DNA samples from thirteen species (human, wolf, cheetah, lion, hippopotamus, zebra, mouse, 

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8 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

etc.) using a commercially available extraction kit, then 

amplified and indexed targeted sequences from those 

samples by methods of polymerase chain reaction that 

already were known. The amplified products were then 

pooled for sequencing, which was performed using a 

massively parallel sequencing machine.

In its Petitions, Ariosa argued for obviousness based 

on combinations of Dhallan’s teachings about cell-free 

fetal DNA with Binladen’s indexing and sequencing 

techniques and Shoemaker’s method of determining 

aneuploidy. Specifically, Ariosa argued that “a scientist 

in this field would have known that Dhallan could be 

enhanced through use of the PCR amplification techniques utilizing sample indices and massively parallel 

sequencing of pooled samples as discussed in Binladen.” 

J.A. 208–09. It added “that a skilled artisan would have 

readily understood that Shoemaker’s methods for determining the presence of fetal abnormalities could be carried out with the use of cell-free DNA described in 

Dhallan and the multiplexed detection techniques taught 

in Binladen.” J.A. 209.

The Board instituted reviews under 35 U.S.C. § 314(a)

upon finding a reasonable likelihood that the methods of 

the ’430 patent’s claims were unpatentable because they 

would have been obvious. But after receiving the Patent 

Owner’s Response and accompanying submissions, then 

Ariosa’s Reply and accompanying submissions, and then 

counsel’s oral arguments, the Board upheld all of the 

claims. The Board concluded that Ariosa did not carry its 

burden of showing that the claims would have been 

obvious. 35 U.S.C. § 316(e).

The Board’s central point was that Ariosa’s Petitions 

were lacking because “virtually no effort [wa]s made to 

explain how or where the references differ from the challenged claims, how one of ordinary skill in the art would 

go about combining their disparate elements, or what 

modifications one of ordinary skill in the art would necesCase: 15-1215 Document: 54-2 Page: 8 Filed: 11/16/2015
ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 9

sarily have made in order to combine the disparate elements.” Ariosa, at *10. The Board discussed all three 

references—including, repeatedly, Shoemaker. Id. at *5, 

6, 7, 9, 10, 11. It pointed to concessions of Ariosa’s experts, Drs. Morton and Nussbaum, made in depositions 

after the Institution Decisions, that various modifications 

would have to be made to combine Dhallan and Binladen, 

including “that one ‘would do a different process to incorporate the tags’ . . . and Binladen’s ‘tagging would not be 

the way that that was done, because the method of inserting the tag, the way it’s done now was not known at that 

time.’” Id. at *9. The Board found unpersuasive Dr. 

Morton’s assertion that “‘one of ordinary skill . . . would 

be able to easily apply the teachings of Binladen to optimize the tags to decrease the error rate and increase the 

accuracy,’” given that Binladen’s tagging method displayed a high error rate and detection of fetal aneuploidy 

requires “‘highly precise methods for quantification.’” Id.

(citing Dr. Morton’s declarations). The Board further 

noted that Dr. Morton, in her deposition, “was unable to 

recall describing ‘a synthesis of how to put [Shoemaker, 

Dhallan, and Binladen] together’ anywhere in her Declaration.” Id.

The Board summarized: 

What is lacking in the Petition and accompanying 

Declarations is an “articulated reason[ ] with some 

rational underpinning to support the legal conclusion of obviousness.” [In re] Kahn, 441 F.3d [977,

988 (Fed. Cir. 2006)]. The inadequacy of the obviousness analysis in the Petition and accompanying Declarations is readily apparent when the 

disparate elements of the references are scrutinized closely, as in Patent Owner’s response, and 

we decline to search through the record and piece 

together those teachings that might support Petitioner’s position. Cf. DeSilva v. DiLeonardi, 181 

F.3d 865, 866–67 (Fed. Cir. 1999) (“A brief must 

make all arguments accessible to the judges, raCase: 15-1215 Document: 54-2 Page: 9 Filed: 11/16/2015
10 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

ther than ask them to play archeologist with the 

record.”). 

Ariosa, at *10.

At the end of its analysis, the Board addressed Ariosa’s attempt, through a second declaration of Dr. Morton

accompanying its Reply, to bolster the reliance placed in 

the Petitions on a brochure that describes indexing and 

massively parallel sequencing using the commercially 

available Illumina Genome Analyzer System (Exhibit 

1010). Id. at *10–11. The Board stated: 

This testimony, in effect, replaces the tagging and 

sequencing techniques of Dhallan and Binladen 

with the Illumina indexing kit and sequencing 

platform, but neither Petitioner nor Dr. Morton 

explains why Exhibit 1010 could not have been 

presented as part of the asserted ground of unpatentability in the first instance with the Petition.4 Therefore we accord this aspect of Dr. 

Morton’s testimony no weight.

Id. at *11. In the footnote to that passage, the Board 

quoted the PTO regulation declaring that “[a] reply may 

only respond to arguments raised in the corresponding . . . 

patent owner response,” 37 C.F.R. § 42.23(b), and the 

related explanation that “[r]eply evidence . . . must be 

responsive and not merely new evidence that could have 

been presented earlier to support the movant’s motion,”

Rules of Practice for Trials before the Patent Trial and 

Appeal Board, 77 Fed. Reg. 48,612, 48,620 (Aug. 14, 

2014). Ariosa, at *11 n.4.

Ariosa appeals the Board’s determinations of nonobviousness as to claims 1–18 and 19–30. The appeal is 

authorized by 35 U.S.C. § 319. This court has jurisdiction 

under 28 U.S.C. § 1295(a)(4)(A). 

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DISCUSSION

This court reviews the Board’s ultimate determinations of obviousness de novo. Randall Mfg. v. Rea, 733 

F.3d 1355, 1362 (Fed. Cir. 2013). It reviews for substantial evidence the underlying factual findings, which 

include findings as to the scope and content of the prior 

art, the differences between the prior art and the claimed 

invention, the level of ordinary skill in the art, the presence or absence of a motivation to combine or modify with 

a reasonable expectation of success, and objective indicia 

of non-obviousness. See, e.g., id.; PAR Pharm., Inc. v. 

TWI Pharms., Inc., 773 F.3d 1186, 1196–97 (Fed. Cir. 

2014); Tri-Med, Inc. v. Stryker Corp., 608 F.3d 1333, 1341

(Fed. Cir. 2010). A petitioner in an inter partes review 

has the burden of proving a claim’s invalidity by a preponderance of the evidence. 35 U.S.C. § 316(e).

A 

Ariosa’s principal challenge is to the Board’s treatment of Exhibit 1010, the Illumina brochure. Pointing to 

the Board’s language about Exhibit 1010, quoted supra, 

Ariosa argues that the Board erred in refusing to consider 

Exhibit 1010 for what it showed about the background 

knowledge that a skilled artisan would have possessed, 

particularly about DNA indexing, in January 2010. We 

agree with Ariosa up to a point: the Board’s language 

leaves open the distinct possibility that the Board incorrectly limited its consideration of Exhibit 1010.

The Board’s language on its face supports Ariosa’s interpretation of what the Board meant—that the Board 

was declining to consider Exhibit 1010, even as evidence 

of the background understanding of skilled artisans as of 

January 2010, simply because the brochure had not been 

identified at the petition stage as one of the pieces of prior 

art defining a combination for obviousness. If that is 

what the Board meant, the Board erred. Art can legitimately serve to document the knowledge that skilled 

artisans would bring to bear in reading the prior art 

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12 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

identified as producing obviousness. Randall, 733 F.3d at 

1362–63. Ariosa’s Petitions and opening declarations 

invoked Exhibit 1010 in that way.

Ariosa included Exhibit 1010 in its Petitions as an exhibit to Dr. Nussbaum’s expert declaration. Dr. Nussbaum, in discussing the state of the art of indexing and 

sequencing technology, stated that “as of 2008, indexed 

multiplexing was so widespread as a technique that the 

company Illumina, Inc. offered a commercially available 

kit for production and analysis of indexed libraries from 

different samples of origin,” and the indexed libraries 

could have been “analyzed on a commercially-available 

massively parallel sequencing platform sold by the same 

vendor.” J.A. 876. Ariosa’s second expert, Dr. Morton, 

also named the Illumina sequencing system when discussing the state of the art of massively parallel sequencing, 

although she did not specifically refer to Exhibit 1010. 

The Petitions then cited portions of Dr. Nussbaum’s and 

Dr. Morton’s declarations for the same proposition—that 

“[m]assively parallel sequencing methods were in routine 

use by 2008.” J.A. 179. Given those references in the 

Petitions and supporting declarations, Exhibit 1010 had 

to be considered by the Board even though it was not one 

of the three pieces of prior art presented as the basis for 

obviousness.

That the language of the Board regarding Exhibit 

1010 is readily susceptible of being read to rest on an 

incorrect legal proposition, by itself, does not require 

setting aside the Board’s decisions. We may affirm an 

agency ruling if we may reasonably discern that it followed a proper path, even if that path is less than perfectly clear. Bowman Transp., Inc. v. Arkansas-Best Freight 

System, Inc., 419 U.S. 281, 285–86 (1974). We also may 

affirm if an erroneous portion of an agency’s ruling is 

ultimately non-prejudicial, i.e., not material to the bottom-line result given other portions of the agency’s ruling. 

5 U.S.C. § 706; 28 U.S.C. § 2111; In re Chapman, 595 F.3d 

1330, 1338 (Fed. Cir. 2010); In re Watts, 354 F.3d 1362, 

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1369 (Fed. Cir. 2004). But we must not ourselves make 

factual and discretionary determinations that are for the 

agency to make. In re Lee, 277 F.3d 1338, 1342 (Fed. Cir. 

2002); ICC v. Bhd. of Locomotive Eng’rs, 482 U.S. 270, 283 

(1987); SEC v. Chenery Corp., 332 U.S. 194, 196–97 

(1947). 

Here, we cannot confidently discern whether the 

Board, in its consideration of Exhibit 1010, was actually 

relying on a legally proper ground rather than the erroneous ground just noted. The Board might have been saying 

only that the development of the argument invoking 

Exhibit 1010 in the Petitions was not adequate. This 

court in Randall did not dispense with the need for parties to provide adequately developed explanations when 

relying on background knowledge based on cited art; the 

adequacy of the challenger’s explanation in that regard 

was unquestioned in Randall. 733 F.3d at 1360. And a 

PTO regulation provides: “[t]he Board may exclude or give 

no weight to the evidence where a party has failed to state 

its relevance.” 37 C.F.R. § 42.104(b)(5). In the present 

case, other than stating that massively parallel sequencing was known by 2008, the Petitions and supporting 

declarations say little about the relevance of Exhibit 1010, 

such as how a skilled artisan would have used what it 

showed about background knowledge in combining or 

modifying the prior-art references or how it tended to 

show that a skilled artisan would have had a reasonable 

expectation of success in achieving the suggested combination and modification. 

Giving the inadequate-explanation reading to the 

Board’s statement about Exhibit 1010, though straining

the words somewhat, would fit two related aspects of the 

Board’s decisions. First, the Board’s statement followed 

its quotation of Dr. Morton’s Reply declaration, which 

contains little if any more explanation of Exhibit 1010’s 

role than appeared in her original declaration: “[O]ne of 

ordinary skill in January 2010 would be motivated to 

index individual samples and pool them for sequencing to 

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maximize sequencing capacity and to minimize sequencing cost. For example, the Illumina, Inc. product flyer 

from 2008 states, ‘[h]arnessing this sequencing power in a 

multiplexed fashion increases experimental throughput 

while reducing time and cost.’” Ariosa, at *11 (quoting 

J.A. 1485). Thus, while Dr. Morton’s Reply declaration

identifies Exhibit 1010 as evincing a motivation to “index 

individual samples and pool them for sequencing,” it does 

not address whether Exhibit 1010 would have motivated a 

skilled artisan to replace the quantification methods of 

Dhallan, see, e.g., ’277 patent, col. 63, line 55 through col. 

65, line 28, with the technique of massively parallel 

sequencing described by Binladen. Second, at the heart of 

the Board’s analysis in the rest of its decisions is its 

finding that Ariosa provided inadequate explanation: the 

Petitions did not “explain how or where the references 

differ from the challenged claims, how one of ordinary 

skill in the art would go about combining their disparate 

elements, or what modifications one of ordinary skill in 

the art would necessarily have made in order to combine 

the disparate elements.” Ariosa, at *10. 

Yet the Board did not sufficiently articulate the foregoing grounds for its rejection of Ariosa’s reliance on 

Exhibit 1010 or other grounds independent of the incorrect ground suggested by the Board’s language. Perhaps 

the Board could have done so. But it did not, and we 

cannot do so for the Board where, as here, the matter is 

not purely legal. 

We likewise are not prepared to find that the error we 

cannot rule out was non-prejudicial. We will not here 

draw our own conclusion about whether Exhibit 1010, if 

considered for what the Petitions (and supporting declarations) adequately presented about it, could have filled the 

explanatory gap that was the heart of the Board’s reason 

for finding Ariosa’s case unproved. Given the complexity 

of this area, and how seemingly small differences might 

be significant, we will not undertake to determine whether a proper assessment of Exhibit 1010 should lead to a 

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reassessment of the explanatory gap. The Board is in a 

better position to do so. We will therefore vacate the 

decisions and remand.

We do not direct the Board to take new evidence or, 

even, to accept new briefing. The Board may control its 

own proceedings, consistent with its governing statutes, 

regulations, and practice. 37 C.F.R. § 42.5(a). Those 

statutes, regulations, and practices embody expeditionand efficiency-based policies that the Board must consider 

in determining the scope of the remand proceedings. 

Congress generally directed that inter partes review 

proceedings be completed within one year of institution. 

35 U.S.C. § 316(a)(11). Reflecting that timing constraint, 

and the statutory goal of providing a relatively quick and 

low-cost alternative to litigation over validity, the PTO 

has established rules that, while necessarily respecting 

constitutional and statutory guarantees of procedural 

fairness, are designed generally to require that the parties make their cases in a very small number of filings—

with the challenger obliged to make an adequate case in 

its Petition and the Reply limited to a true rebuttal role. 

37 C.F.R. §§ 42.104(b)(5), 42.23(b). Within this structure, 

even while providing for an estoppel effect on the challenger, 35 U.S.C. § 315(e), Congress assigned to the 

challenger the burden of persuasion in the dispute, id.

§ 316(e). That burden, together with the procedural rules 

impartially applied, means that, in some cases, a challenge can fail even if different evidence and arguments 

might have led to success. We leave to the Board the 

determination of what remand proceedings are appropriate given the governing policies. 

B 

Ariosa also challenges the Board’s decision on a distinct ground. The Board determined that teachings of 

Binladen and Dhallan could not be combined because 

“Binladen’s indexing (i.e., tagging) scheme could not be 

used with Dhallan’s restriction-digestible amplification 

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16 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 

primers.” Ariosa, at *10. Ariosa argues that the Board 

erred in failing to consider some embodiments of Dhallan—those which do not require a restriction-enzyme 

digestible primer—embodiments that, they argue, could 

be combined with Binladen. The Board declined to consider those embodiments because the cited “portions of 

Dhallan were not identified or discussed in the Petition or 

the accompanying Declarations.” Ariosa, at *10. In any 

event, the Board added, Ariosa’s explanation was lacking 

even as to those portions. Id.

We see no error in the Board’s rejection of Ariosa’s reliance, in its Reply submissions, on previously unidentified portions of a prior-art reference to make a 

meaningfully distinct contention. Ariosa’s Petitions quote

a portion of Dhallan that states: “Any method that provides information on the sequence of a nucleic acid can be 

used . . . .” ’277 patent, col. 36, lines 6–19; see J.A. 189, 

215. The supporting declarations state that Dhallan 

teaches that the sequencing step can be performed using 

any method. J.A. 360–61 (quoting ’277 patent, col. 6, lines 

26–34); J.A. 919 (quoting ’277 patent, col. 36, lines 6–19). 

The Petitions and declarations, however, do no more than 

point to a generic statement in Dhallan that any sequencing method can be used; they make no mention of how the 

choice of sequencing method influences the use of a restriction-enzyme digestible primer, which occurs in the 

amplification step. ’277 patent, col. 36, lines 6–19. Not 

until Dr. Morton’s Reply declaration did Ariosa identify

specific embodiments of Dhallan that do not use restriction-enzyme digestible primers. J.A. 1479 (citing

embodiments at ’277 patent, col. 11, line 61 through col. 

12, line 17; id., col. 12, lines 40–47; id., col. 13, line 66 

through col. 14, line 5; id., col. 13, lines 36–42; id., col. 14, 

lines 15–25). 

A governing regulation states that a Petition must 

identify “[t]he supporting evidence relied upon to support 

the challenge and the relevance of the evidence to the 

challenge raised, including identifying specific portions of 

Case: 15-1215 Document: 54-2 Page: 16 Filed: 11/16/2015
ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 17

the evidence that support the challenge.” 37 C.F.R. 

§ 42.104(b)(5). Further, “[t]he Board may exclude or give 

no weight to the evidence where a party has failed to state 

its relevance or to identify specific portions of the evidence 

that support the challenge” in the Petition. Id. That 

regulation reflects the combination of efficiency and 

fairness interests also embodied in the regulation limiting 

Reply submissions to matter responsive to the Patent 

Owner’s Response. Id. § 42.23(b). The Board must make 

judgments about whether a Petition identified the specific 

evidence relied on in a Reply and when a Reply contention 

crosses the line from the responsive to the new. The 

Board reasonably made those judgments here. 

C 

Ariosa challenges the adequacy of the Board’s consideration of Shoemaker—even though, as we have noted, 

the Board addressed Shoemaker throughout its analysis. 

We need not decide, however, whether there are any 

deficiencies in the Board’s consideration of arguments 

about Shoemaker made and supported in a timely manner 

by Ariosa. We are remanding the matter regardless. On 

remand, the Board may decide whether its treatment of 

Shoemaker should be left as is, supplemented, or revised. 

CONCLUSION

For the foregoing reasons, we vacate the Board’s finding of nonobviousness and remand.

No costs.

VACATED AND REMANDED

Case: 15-1215 Document: 54-2 Page: 17 Filed: 11/16/2015