Ariosa Diagnostics v. Verinata Health, Inc.

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 Trade-

mark 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 represent-

ed by DEREK C. WALTER, ANANT N. PRADHAN; MICHAEL T.

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

WA.

______________________

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 pre-

natal testing for the presence of fetal chromosomal ab-

normalities. 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 index-

ing 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 Diagnos-

tics 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

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 ultra-

sound 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 cell-

free fetal DNA circulating in maternal blood suggested

the possibility of superior noninvasive tests, but turning

the possibility into a reality presented significant chal-

lenges.

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 discov-

ery focused on distinguishing fetal DNA from maternal

DNA in a blood sample. By separating fetal from mater-

nal 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 cell-

free 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.”

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 se-

quences. Fetal aneuploidy (in the case of, for example,

three versus two copies of a chromosome) may be deter-

mined 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 eleva-

tion 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 ab-

sence 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 ma-

ternal blood samples comprising fetal and mater-

nal cell-free genomic DNA, said method

comprising:

(a) obtaining a fetal and maternal cell-free ge-

nomic DNA sample from each of the plurality

of maternal blood samples;

(b) selectively enriching a plurality of non-

random polynucleotide sequences of each fetal

and maternal cell-free genomic DNA sample

ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 5

of (a) to generate a library derived from each

fetal and maternal cell-free genomic DNA

sample of enriched and indexed fetal and ma-

ternal non-random polynucleotide sequences,

wherein each library of enriched and indexed

fetal and maternal non-random polynucleo-

tide sequences includes an indexing nucleo-

tide sequence which identifies a maternal

blood sample of the plurality of maternal

blood samples,

wherein said plurality of non-random polynu-

cleotide sequences comprises at least 100 dif-

ferent non-random polynucleotide sequences

selected from a first chromosome tested for

being aneuploid and at least 100 different

non-random polynucleotide sequences select-

ed 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 non-

random polynucleotide sequences is from 10

to 1000 nucleotide bases in length,

(c) pooling the libraries generated in (b) to pro-

duce a pool of enriched and indexed fetal and

maternal non-random polynucleotide se-

quences;

(d) performing massively parallel sequencing of

the pool of enriched and indexed fetal and

maternal non-random polynucleotide se-

quences of (c) to produce sequence reads cor-

responding to enriched and indexed fetal and

maternal non-random polynucleotide se-

quences of each of the at least 100 different

non-random polynucleotide sequences select-

ed from the first chromosome tested for being

aneuploid and sequence reads corresponding

to enriched and indexed fetal and maternal

6 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC.

non-random polynucleotide sequences of each

of the at least 100 different non-random poly-

nucleotide sequences selected from the refer-

ence chromosome;

(e) based on the indexing nucleotide sequence,

for each of the plurality of maternal blood

samples, enumerating sequence reads corre-

sponding to enriched and indexed fetal and

maternal non-random polynucleotide se-

quences selected from the first chromosome

tested for being aneuploid and sequence reads

corresponding to enriched and indexed fetal

and maternal non-random polynucleotide se-

quences selected from the reference chromo-

some; and

(f) for each of the plurality of maternal blood

samples, determining the presence or absence

of a fetal aneuploidy comprising using a num-

ber of enumerated sequence reads correspond-

ing 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 chromo-

some region to a chromosome control region, rather than

comparing a tested chromosome to a reference chromo-

some. 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

ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 7

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 determin-

ing 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 polymer-

ase 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 distin-

guished, 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 (hu-

man, wolf, cheetah, lion, hippopotamus, zebra, mouse,

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 tech-

niques 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 deter-

mining the presence of fetal abnormalities could be car-

ried 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 chal-

lenged 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 neces-

ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 9

sarily have made in order to combine the disparate ele-

ments.” 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 ex-

perts, 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 incor-

porate the tags’ . . . and Binladen’s ‘tagging would not be

the way that that was done, because the method of insert-

ing 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 opti-

mize the tags to decrease the error rate and increase the

accuracy,’ ” given that Binladen’s tagging method dis-

played 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 Decla-

ration.” 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 conclu-

sion of obviousness.” [In re] Kahn, 441 F.3d [977,

988 (Fed. Cir. 2006)]. The inadequacy of the obvi-

ousness analysis in the Petition and accompany-

ing Declarations is readily apparent when the

disparate elements of the references are scruti-

nized closely, as in Patent Owner’s response, and

we decline to search through the record and piece

together those teachings that might support Peti-

tioner’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, ra-

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 Ari-

osa’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 un-

patentability in the first instance with the Peti-

tion.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 nonobvi-

ousness 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).

ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 11

DISCUSSION

This court reviews the Board’s ultimate determina-

tions of obviousness de novo. Randall Mfg. v. Rea, 733

F.3d 1355, 1362 (Fed. Cir. 2013). It reviews for substan-

tial 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 pres-

ence 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 pre-

ponderance of the evidence. 35 U.S.C. § 316(e).

A

Ariosa’s principal challenge is to the Board’s treat-

ment 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 incor-

rectly limited its consideration of Exhibit 1010.

The Board’s language on its face supports Ariosa’s in-

terpretation 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 legiti-

mately serve to document the knowledge that skilled

artisans would bring to bear in reading the prior art

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 ex-

hibit to Dr. Nussbaum’s expert declaration. Dr. Nuss-

baum, 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 discuss-

ing 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 fol-

lowed a proper path, even if that path is less than perfect-

ly 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 bot-

tom-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,

ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 13

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 errone-

ous 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 par-

ties 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 sequenc-

ing 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 combi-

nation 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

14 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC.

maximize sequencing capacity and to minimize sequenc-

ing 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 fore-

going grounds for its rejection of Ariosa’s reliance on

Exhibit 1010 or other grounds independent of the incor-

rect 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 declara-

tions) 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 wheth-

er a proper assessment of Exhibit 1010 should lead to a

ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC. 15

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 expedition-

and 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 par-

ties 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 chal-

lenger, 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 chal-

lenge 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 appropri-

ate given the governing policies.

B

Ariosa also challenges the Board’s decision on a dis-

tinct 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

16 ARIOSA DIAGNOSTICS v. VERINATA HEALTH, INC.

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

erred in failing to consider some embodiments of Dhal-

lan—those which do not require a restriction-enzyme

digestible primer—embodiments that, they argue, could

be combined with Binladen. The Board declined to con-

sider 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 re-

liance, in its Reply submissions, on previously unidenti-

fied 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 pro-

vides 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 sequenc-

ing method can be used; they make no mention of how the

choice of sequencing method influences the use of a re-

striction-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 re-

striction-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

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 consid-

eration 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 find-

ing of nonobviousness and remand.

No costs.

VACATED AND REMANDED