Ex Parte 7534584 et al

Patent Trial and Appeal Board

Dec 23, 2016

95001294 (P.T.A.B. Dec. 23, 2016)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/001,294 04/05/2010 7534584 0066090-008US2 1914
22504 7590 04/18/2018
DAVIS WRIGHT TREMAINE, LLP/Seattle
IP Docketing Dept.
Davis Wright Tremaine LLP
1201 Third Avenue, Suite 2200
SEATTLE, WA 98101-3045
EXAMINER
TURNER, SHARON L
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
04/18/2018 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

BIOMÉRIEUX, INC.
Requester and Respondent

v.

INSTITUTE FOR ENVIRONMENTAL HEALTH INC.
Patent Owner and Appellant
____________

Appeal 2017-001150
Reexamination Control 95/001,294
Patent 7,534,584 B2
Technology Center 3900
____________

Before ROMULO H. DELMENDO, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
This is a Decision on a Request for Rehearing under 37 C.F.R.
§ 41.77(b) (“Req. Reh’g”) by the Requester of the final Decision entered
Jan. 23, 2017 (“41.77f Dec.”).1 The 41.77f Decision reversed new grounds

1 Requester submitted two new declaration in the Request for Rehearing.
However, as recognized by Requester, new evidence is not permitted under
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of rejection 1–4 based on Patent Owner’s narrowing of the independent
claims and reconsideration of the relied-upon evidence as a whole, including
entered new evidence and evidence of secondary considerations.
Requester contends that the 41.77f Decision misapprehended or
overlooked the evidence of secondary considerations and that the Board
erred in reversing all rejections, particularly in reversing its conclusion in the
original Decision on Appeal that the claims are unpatentable under 35
U.S.C. § 103(a). Req. Reh’g 1–3.
We have considered Requester’s arguments, but decline to modify the
41.77f Decision.
Claim 1 is directed to a method of sampling, testing, and validating a
plurality of operationally-linked test lots of beef for release into commerce.
See 41.77f Dec. 2–4. Claim 17 is the same, but recited meat or poultry
instead of being limited to only beef. Id. at 5. The samples are tested for
microbial agents or microorganism.
In the original Decision on Appeal (“7983 Decision” or “7983 Dec.”),
we found that in presenting the evidence of secondary considerations, Patent
Owner had not provided an adequate explanation of the classical industry
method to which the claimed method had been compared. 7983 Dec. 24.
For this and other reasons, the 7983 Decision concluded that a nexus had not

37 C.F.R. § 41.79(b)(1) unless the conditions of (b)(2) or (b)(3) are met.
Requester attempts to establish under (b)(2) that a new Federal Circuit
decision warrants consideration of the new evidence, but such new evidence
relates to “secondary considerations” which have been at issue throughout
the appeal and thus do not constitute “a showing of good cause” as required
by 37 C.F.R § 41.79(b)(2). Accordingly, the new evidence has not been
entered into the record or considered.
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been established between the claims and the evidence of secondary
considerations. As it turns out, Patent Owner’s original Appeal Brief had
contained two Exhibits, A and B (labeled Figs. 1 and 2, respectively) that
illustrated the differences between the claimed method and the industry
method, but we had overlooked these exhibits in reaching the decision in the
Decision on Appeal. In the subsequent 4177f Decision, we recognized that
Figs. 1 and 2 contained the information we had believed to be deficient in
the record. 41.77f Dec. 4, 6. This evidence, while being part of the original
record, provided additional clarity as to the differences between the prior art
and the claimed subject matter, and led, along with other evidence in the
record and the accompanying narrowing of the claims, to conclude that a
“nexus” had been established between the claims and the secondary
considerations. 41.77f Dec. 15, 16. Requester now objects:
Both Figure 1 and Figure 2 were included in the Patent Owner’s
Appeal Brief, and were before the Board for the 7983 Decision.
The Decision does not explain why or how the information
contained in those Figures alters its previous conclusion that the
Patent Owner had failed to establish a nexus between
commercial success and the claimed invention.
Req. Reh’g 6.
The simple fact is that this information had been overlooked, and
when Patent Owner drew attention to Figs. 1 and 2 (PO Response under
41.77b at 20), it prompted reconsideration of the evidence in the record, as
we are required to do. Cf. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992) (“After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the record, by a
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preponderance of evidence with due consideration to persuasiveness of
argument.”).

The claimed invention
Claim 1 is reproduced in the 41.77f Decision at 2–3. In steps a and b,
the claim requires collecting portions from separate test lots and combining
the portions to produce separate test lot samples for each test lot. The
samples are incubated and enriched in step c “to allow levels of a target
microbial agent or organism that is present in one or more of the separate
test lot samples to reach detectable levels and become uniform.” Portions
are removed from the enriched samples and combined in step d to form a
modular inter-lot sample and then are tested in step e. Fig. 2 illustrates the
claimed method (step 1 corresponds to steps a and b of the claim; step 2
corresponds to claimed step c; step 3 to claimed step d; step 4 to claimed
step e). Fig. 1 illustrates the “industry art,” which we found to be
representative of the cited prior art. As explained in the 41.77 Dec. with
references to Figs. 1 and 2:
The first key difference between the two methods is that the
portions (samples) from all combo bins are combined into one
container for culture in the Present Industry Art (Fig. 1),
whereas in the claimed invention (Fig. 2), the portions from
each combo bin are separately cultured. The second key
difference is that, in the Present Industry Art, a cultured sample
from the single same container, containing portions from all the
combo bins, is directly tested for the presence of
microorganisms, while in the claimed invention, cultured
samples from the different culture containers are combined into
a “modular composite sample” (step d1 of the claimed method)
and then tested for the presence of microorganisms. In other
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words, the sample combining step is done before culture in the
Present Industry Art, and after culture in the claimed method.
These are the same differences between the claimed invention
and the cited prior art.
41.77f Dec. 7. Thus, the testing for microorganisms is performed at
different times in the claimed invention and in the prior art industry method.
The Request for Rehearing contends that the original 7983 Decision
was correct in finding that there was a strong evidence of obviousness:
It is “commonsense,” the Board pointed out, “to combine
samples from the same bin and subject them to enrichment,
since each bin represents a discrete unit of the production run
and results obtained from the enriched sample could be
attributed to the bin from which the sample was obtained.” Id.
[7983 Decision] at 16.
Req. Reh’g 3.
While we made such a statement in the 7983 Decision, upon
reconsideration, we determined in the 41.77f Decision that the obviousness
rejections had been overcome in light of considering the evidence anew,
including the newly presented evidence. In the 7983 Decision, it was stated
that it would have been obvious to have composited samples after
enrichment to reduce the number of test necessary to perform. 7983 Dec.
18. We found a reason to composite after enrichment because “Jarvis
describes compositing both pre-enrichment samples and enrichment samples
(141, method 3).” 7983 Dec. 18.
The statement from Jarvis we relied upon is as follows: “5 samp1es
are composited at pre-enrichment stage and aliquots of the duplicate pre-
enrichment media are composited at the stage of inoculating the enrichment
medium.” Jarvis 141. In other words, the duplicative pre-enrichment
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samples that are subsequently enriched are obtained from different
containers—as shown in step 1 of attached Figure 1. The claims, however,
combine samples from the same container, perform enrichment on them, and
then composite samples from different containers and test for bacteria. The
original reasoning that we found the claimed step d to have been obvious
was based on the obviousness of reducing sample number. However, Jarvis
was combining pre-enrichment samples and provides no sufficient reason for
deviating from its method to reduce sample number by compositing after
enrichment has been performed. The difference between Jarvis and the
claimed method is not insignificant because steps d and e of claim 1 involve
diluting the enrichment samples and then testing for microbial
contamination, while Jarvis tests directly on undiluted enriched samples.
As discussed in the 41.77f Decision, there was skepticism that a sample after
enrichment was as reliable as an undiluted one. 41.77f Dec. 5–6.
Consequently, we do not agree that the reason for arriving at the claimed
order of steps is as compelling and “strong” as Requester asserts and as we
had previously (and erroneously) believed. Req. Reh’g 5. We do not agree
that it would have been obvious to a person of ordinary skill in the art to
reverse the order in which the steps are performed because reversing the
order as claimed would have resulted in testing diluted samples for the
presence of microorganisms, rather than an undiluted sample.
Requester contends that we have upended the 7983 Decision because
it had been stated that even if direct enrichment was “inferior,” an inferior
step would still have been obvious. Req. Reh’g 9. However, Requester has
misconstrued this statement in the 7983 Decision. The Decision was
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referring to the obviousness of performing “direct enrichment” without a
pre-enrichment step. 7983 Dec. 16–17. We have not changed our stance on
this analysis. Nonetheless, it is not pertinent to the obviousness
determination because pre-enrichment is not required by the claim and does
not serve as the nexus to commercial success.

Secondary considerations
Commercial Success
To determine whether the claimed product has achieved commercial
success, it must first be determined whether a product that embodies the
claimed invention has been sold in the marketplace. In the 7983 Decision,
the Board did not challenge Patent Owner’s contention that the claimed
process was embodied in the marketed process. However, the 7983
Decision found it had not been established that the success was a result of
the order of the enrichment and testing steps and that the alleged success for
beef would be representative of other food products. 7983 Dec. 23–24. In
other words, we found a nexus had not been established between the
evidence and the claimed subject matter. A nexus is established when the
secondary consideration is attributed to a feature of the claimed invention.
Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311–12 (Fed. Cir. 2006).
Patent Owner responded by limiting claim 1 to beef and claim 17 to
meat or poultry. Patent Owner also made clear to us that the difference
between the claimed invention and the prior art, as practiced in the industry
method, is that the claimed method composites enriched samples and then
tests them. 41.77f Dec. 6–7. This step was not performed in the prior art,
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and the articulated reason for a person of ordinary skill in the art to do so
was based strictly on reducing sample number, a step which was already
carried out by the Jarvis, Price, and industry methods. But upon
reconsideration, it is our opinion that such steps (particularly steps d and e of
claim 1) were not readily available in the prior art and appropriately
constituted a “nexus” between the sales data and the claims. For these
reasons, we do not agree with Requester that the conclusion that a nexus has
been established is not supported by the evidence in the record. Req. Reh’g
5.
Requester characterizes the 41.77f Decision as a “factual about-face
from the 7983 Decision” (Req. Reh’g 7). We find this irrelevant. The 7983
Decision was not a final decision, but rather afforded the Patent Owner to
address the concerns and Requester with the opportunity to respond. The
fact that the rule states that “Board . . . shall reconsider the matter and issue a
new decision” necessarily implies that the Board is authorized, and required,
to modify its earlier rulings in any respect based on such reconsideration, if
warranted.
Requester contends that “Patent Owner has not pointed to any
authority suggesting that the limited success purportedly achieved by its
product-at most, a 30% market share in the United States-should be given
dispositive weight in the face of strong evidence of obviousness” and that
the evidence of commercial success “supports only a ‘chain of inferences’
leading to a finding of nonobviousness,” which is broken if “Patent Owner
cannot establish that the supposedly novel features of the invention that
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motivated those sales were not already available to the public.” Req. Reh’g
5.
First, the sales of 30% in the US and 40% in Canada of the market
cannot be ignored as evidence that the process was commercially successful.
Indeed, in Classco, Inc. v. Apple, 838 F.3d 1214, 1219 (Fed. Cir. 2016), the
Federal Circuit found error in the Board dismissing evidence of commercial
success when the marketed product, as here, embodied all the features of the
claimed invention. Requester appears to be arguing that the features were
readily available in the prior art, but as already stated, there is inadequate
evidence in this record that the recited enrichment and testing steps had been
performed in the prior art, and we have not been pointed to a persuasive
reason to have composited and tested samples for microorganisms after the
enriching step had been performed. For completeness, we address this once
again.
In their comments dated March 20, 2015, Requester stated:
Patent Owner did not address the DOA’s finding that Price also
teaches testing pooled enrichment samples. (DOA at 18).
Figure l of Price clearly teaches compositing samples at the
enrichment stage, and subsequently testing them. (Price at Fig.
1). Accordingly, the Price reference further buttresses the
conclusion that step (d)(l) was obvious.
Requester’s 41.77c Comments 16.
We do not agree. Figure 1 of Price is reproduced below:
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Fig. 1 of Price shows the pre-enrichment samples as being
composited, but not the enrichment samples. The enrichment samples are
tested directly by plating on selective media and then testing. Requester’s
statement that Price describes compositing enrichment samples in Figure 1 is
not supported by the figure drawing.
The Examiner stated that “two-tiered compositing were well
understood and practiced by the artisan at the time of the invention,
particularly for the noted advantages of reducing workload, increasing
testing capacity and preserving portions from different sample lots for repeat
testing.” Examiner’s 41.77d Determination 12. However, the so-called two
tier testing of Price refers to pooling samples in the pre-enrichment and
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enrichment steps, not enriching samples separately from the same container
and then pooling for the purpose of testing as required by the claims.
Despite Requester’s objections to the data, we have not been pointed
to an error in determining that the 30% market share is strong evidence of
commercial success.2 While Requester characterized the data as “weak,” the
only apparent identified weakness was an alleged lack of nexus. However,
because Patent Owner’s process embodies all the claimed features, and
recited steps d and e were not readily available to one of ordinary skill in the
art, we do not find this argument to be persuasive.
With regard to Requester’s complaint that there was no explained
reason that the data from beef is extrapolatable to poultry and other meats as
recited in claim 17, the 41.77f Decision relied upon testimony by Dr.
Samadpour and we had not been “directed to a persuasive deficit in this
reasoning.” 41.77f Dec. 16.

Skepticism
In the 41.77f Decision, we found the evidence of skepticism
compelling because it was tied to features of the commercial process
embodying the claimed invention. 41.77f Dec. beginning on page 11.
Requester contends that the reliance on skepticism was an error:
Skepticism evidence cannot overcome a prima facie case of
obviousness unless it establishes that the claimed invention

2 “Denso argues that this [sales] evidence is insufficient because Tec Air
failed to provide market share data. Although sales figures coupled with
market data provide stronger evidence of commercial success, sales figures
alone are also evidence of commercial success.” Tec Air, Inc. v. Denso Mfg.
Mich., Inc., 192 F.3d 1353, 1361-62 (Fed. Cir. 1999).
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"was not viewed as technically feasible" by persons of ordinary
skill. Arkie Lures, Inc. v. Gene Larew Tackle, Inc., 119 F.3d
953, 955, 958 (Fed. Cir. 1997) (crediting experts' fear of
"violent explosions" when mixing the chemicals required to
make the claimed invention). The Patent Owner’s new evidence
of skepticism – again consisting entirely of Dr. Samadpour's
uncorroborated statements – did not and could not possibly
satisfy that standard. To the contrary, as the 7983 Decision
recognized, far from considering the method steps technically
infeasible, everyone knew how to perform them.
Req Reh’g 10-11.
To being with, Arkie Lures did not equate skepticism with the
requirement for technical feasibility. As held in Arkie Lures:
It is insufficient to establish obviousness that the separate
elements of the invention existed in the prior art, absent some
teaching or suggestion, in the prior art, to combine the
elements. Indeed, the years of use of salty bait and of plastic
lures without combining their properties, weighs on the side of
unobviousness of the combination. Mr. Larew persisted against
the accepted wisdom, and succeeded. The evidence that the
combination was not viewed as technically feasible must be
considered, for conventional wisdom that a combination should
not be made is evidence of unobviousness.
Arkie Lures, 119 F.3d at 957–58.
In Arkie Lures, there was evidence of skepticism that a salty bait
could be combined with a plastic lure. Id. at 957. The court did not make it
a rule that skepticism required technical feasibility to be considered evidence
of nonobviousness. As discussed in MPEP § 716.05 “‘Expressions of
disbelief by experts constitute strong evidence of nonobviousness.’” Here,
the skepticism evidence indicated that persons skilled in the art would have
expected diluting samples after culture would lead to false negatives but
testing of the invention proved the contrary. 41.77f Decision 12–13.
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Requester attempted to disparage the evidence of skepticism by only
citing to Dr. Samadpour’s declarations. However, the 41.77f Decision cited
corroborating declarations by Warren Mirtsching and James Byron as
evidence of skepticism by experts, in addition to Dr. Samadpour’s
testimony. 41.77f Dec. 11. Although the 7983 Decision may have stated
that the method was adopted over skepticism in the industry (Req. Reh’g
12), Mr. Warren Mirtsching explained that he had to carry out detailed
testing to be convinced that the method had the requisite sensitivity to be
used for meat testing. 41.77f Dec. 12.

Bailey Declaration
Requester states that the Board erred in the 41.77f Decision because it
“overlooked contrary testimony from Requester's declarant, Dr. Bailey” and
“does not even cite it.” Req. Reh’g 7. Requester contends that Dr. Bailey’s
testimony “thoroughly undermines the Patent Owner's evidence” and the
Decisions does not “explain why . . . the self-serving declarations of the
patent inventor and his employees on commercial success should be
considered more credible.” Id.
We considered the Bailey declaration (dated Jan. 13, 2010; “Bailey
Decl.”), but as discussed below in detail, simply did not find that it had
probative value to the obviousness issue, let alone effective to “undermine”
the evidence of commercial success as alleged by Requester. Indeed, there
is no discussion of commercial success in Dr. Bailey’s declaration.
Paragraph 9 of Dr. Bailey’s declaration is a discussion of the Jarvis
publication. Dr. Bailey describes Jarvis’s pre-enrichment steps and
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enrichment steps. Bailey Decl. ¶¶ 9d, 9e. Dr. Bailey also describes
compositing pre-enrichment broth, after culture, into enrichment media. Id.
at ¶ 9f. However, the claims require pooling of enrichment broth, a step
which was interpreted in the 7983 Decision to be different from pre-
enrichment. 7983 Dec. 6–8.
Dr. Bailey also discussed Price. Bailey Decl. ¶ 10. In paragraph 10b
of his declaration, Dr. Bailey explained why one of ordinary skill would
have had reason to composite samples from the same lot to ensure that a
representative sample is obtained. Dr. Bailey testified that such samples are
subjected to pre-enrichment and then pooled to form a single enrichment
broth. Id. However, these steps differ from claim 1 because claim 1 does
not pool the samples into a single enrichment broth. Rather, pooling is
accomplished after enrichment. Dr. Bailey did not explain in this paragraph
why compositing the enrichment broth for testing purposes would have been
obvious to one of ordinary skill in the art.
Paragraphs 10c–10e, 10h, 10i of the Bailey Declaration further
address the meaning of “pre-enrichment” and the reasons for performing
pre-enrichment steps. Pre-enrichment is not required by the claims. The
meaning of pre-enrichment was an issue in the interpretation of claim 1,
where we interpreted the pre-enrichment step to be different from the
enrichment step and accomplished for a different purpose. 7983 Dec. 6.
Dr. Bailey also discusses enrichment and microorganism in his
declaration with respect to Price. Bailey Decl. ¶¶ 10f, 10g, 11–16. Dr.
Bailey cited additional prior art not cited in the rejections for teaching
compositing samples as in steps a and b of the claims. Id. at ¶¶ 16–19.
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However, this discussion does not provide a rationale for compositing
enrichment broths after enrichment has been accomplished as required by
the claims.
Dr. Bailey discusses the Silliker and Gabis publications:
Each of these publications described taking multiple samples
from the lot of food product being tested, compositing those
samples in pre-enrichment media, incubating those media,
transferring aliquots to a selective enrichment media and testing
for the presence of Salmonella. In my opinion, each of these
publications described the sample-compositing and incubation
steps a), b) and c) of the claims of the '584 patent.
Bailey Decl. ¶ 20.
We do not agree with Dr. Bailey that these publications describes
steps a, b, c of the claims. Firstly, the claimed steps have been interpreted to
require enrichment, not pre-enrichment as discussed in Silliker and Gabis.
Silliker 475; Gabis 663; 7983 Dec. 8. Secondly, even if Silliker and Gabis
were understood to disclose or suggest enrichment steps, Silliker expressly
refers to lumping “samples from individual lots” (Silliker 479) and Gabis
discloses directly enriching “lumped samples” (Gabis 657), but does not
indicate the samples are from the same lot. In contrast, the claims combine
samples from the same test lot (claim 1, step b). Dr. Bailey did not address
the relevance of this prior art to steps d and e of claim 1 in which
compositing and testing after enrichment is performed or why Silliker and
Gabis would have rendered these steps obvious.

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Apple v Samsung
Requester contends that rehearing is warranted because of changes in
the law decided after submission Requester’s response to Patent Owner’s
comments. Req. Reh’g 12–13. Requester states, citing Apple Inc. v.
Samsung Elec. Co., 839 F. 3d 1034 (Fed. Cir. 2016):
For the first time, the Federal Circuit held in Apple that, in
every case, “[a] determination of whether a patent claim is
invalid as obvious ... requires consideration of all four Graham
factors,” including the secondary considerations. Id. at 1048
(majority op.).
Req. Reh’g 13.
We agree that Judge Dyk in his dissent criticized the majority for
holding that secondary considerations must “always” be considered.
However, Requester’s argument is not well taken as we properly considered
all aspects of the obviousness inquiry. Chief Judge Prost, in her dissent,
opined that the majority had “elevated” the evidence of secondary
considerations because “when the prima facie case of obviousness is strong,
secondary considerations carry little weight.” Id. at 1080. Judge Prost was
not stating that the factors should not be considered, but rather that they
carry less weight in view of the strong case of obviousness. Our reviewing
court has long cautioned the Board that when evidence is properly
submitted, it must be considered.3 Properly read in light of other precedents
that have not been overruled, Apple cannot be read to say that the Board can

3 See, e.g., In re Sullivan, 498 F.3d 1345, 1351 (Fed. Cir. 2007) (“When a
patent applicant puts forth rebuttal evidence, the Board must consider that
evidence.”).
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now dismiss or ignore submitted evidence. Apple, 839 F.3d at 1039 (“We
have applied existing obviousness law to the facts of this case.”).
The weighing of secondary factors along with the other evidence of
obviousness or non-obviousness is a factual matter that, as illustrated in
Apple v Samsung, may cause reasonable minds to differ on how much
import each factor is to be afforded. We only reiterate that, upon
reconsideration of the evidence in this case, that a “strong” case of
obviousness based on the cited prior art has not been established because
there is a lack of a persuasive reason to have combined enrichment broths
after culturing them and then to have tested the composited and diluted
enriched sample. This view is buttressed by declarations of two experts in
the field who attested to being skeptical that a method utilizing this claimed
step would have sufficient sensitivity to be reliable, let alone to have
achieved a 30% market share in the United States.

REHEARING DENIED

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CC:

Patent Owner:

DAVIS WRIGHT TREMAINE, LLP/Seattle
IP Docketing Dept.
Davis Wright Tremaine LLP
1201 Third Avenue, Suite 2200
Seattle, WA 98101-3045

Third Party Requester:

ROTHWELL, FIGG, ERNST, & MANBECK, P.C
607 14th Street, N.W.
Suite 800
Washington, DC 20005

lb