Ex Parte 5582989 et al

Board of Patent Appeals and Interferences

Jun 15, 2012

90009495 (B.P.A.I. Jun. 15, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
90/009,495 06/18/2009 5582989 067456-5123-US 5573
21089 7590 06/15/2012
VYSIS, INC
PATENT DEPARTMENT
1350 E TOUHY AVENUE
DES PLAINES, IL 60018
EXAMINER
PONNALURI, PADMASHRI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
06/15/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte BAYLOR COLLEGE of MEDICINCE and ABBOTT
LABORATORIES
Appellant
____________

Appeal 2012-005140
Reexamination Control
90/009495
Patent 5,582,989
Technology Center 3900
____________

Before SALLY G. LANE, RICHARD M. LEBOVITZ, and
RAE LYNN P. GUEST, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal by the Patent Owner, Baylor College of
Medicine, from the Patent Examiner’s rejections of claims 1-5, 7, and 11 in an
ex parte reexamination of U.S. Patent No. 5,582,989, issued December 10,
1996. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6 and
134. We affirm.
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STATEMENT OF THE CASE
A request for ex parte reexamination of U.S. Patent 5,582,989
(hereinafter, “the ‘989 patent) was made by a Third Party Requester on June
18, 2009, pursuant to 37 C.F.R. § 1.510. The claims were amended during
the reexamination proceeding before the Examiner. A Final Rejection
rejecting all pending and amended claims was mailed by the Examiner on
April 27, 2011. The Patent Owner appealed the Examiner’s decision to the
Board of Patent Appeals and Interferences (Notice of Appeal, dated July 26,
2011). An oral hearing was held on April 18, 2012.1 This is the decision on
the appeal.
The claims in the ‘989 patent are directed to methods of simultaneously
detecting at least three different DNA sequences by performing a DNA
amplification reaction in a single reaction vessel using at least three pairs of
oligonucleotide primers. Each oligonucleotide pair is specific for a different
DNA sequence. The primers are annealed to target DNA in the same reaction
vessel, and then simultaneously extended using a DNA polymerase to produce
DNA products corresponding to the three different DNA sequences. The
latter reaction is referred to as DNA amplification. The products are
identified in the mixture.
The claimed method is basically drawn to polymerase chain reaction
(“PCR”)2 using three pairs of DNA primers in the same reaction vessel.
According to the ‘989 patent, standard PCR “is adequate for one and possibly

1 A transcript of the Oral Hearing will be entered into the record in due course.
2 PCR was known at the time of the claimed invention as a method to amplify
a specific DNA sequence using an oligonucleotide primer pair.
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two pair of primers, but when greater than two pairs of primers are used the
procedure will not adequately amplify all the appropriate sequences.” ‘989
patent, col. 7, ll. 52-56. Using multiple primer pairs in the same reaction
vessel is referred to as “multiplexing.”3 Example 1 of the ‘989 patent
describes conditions to perform its method on the human DMD gene using
three primer pairs. ‘989 patent, col. 8, ll. 43-61. The patent describes
adjusting extension time, reaction temperature, primer length, and percentage
of GC bases in the primer pairs. ‘989 patent, col. 8, ll. 43-61. “The
advantages of the multiplex amplification system are that numerous diseases
or specific DNA sequence alterations can be detected in the same assay.”
‘989 patent, col. 7, ll. 21-23. Thus, rather than using one reaction vessel for
each primer pair, the claimed method involves using the same common
reaction vessel for all primer pairs used in the PCR reaction.
The grounds of rejection on review are as follows:
A. Whether claims 1 and 11 would have been obvious under 35 U.S.C.
§ 103(a) in view of U.S. Patent No. 4,965,188 (“the ‘188 patent”), Diaz-
Chico,4 and Weier,5 and further in view of Kogan, Gelfand, and Gitschier
Declarations as evidence.
B. Whether claims 2-5 and 7 would have been obvious under 35 U.S.C.
§ 103(a) in view U.S. Patent No. 4,965,188, Diaz-Chico, and Weier, and

3 We use the term “multiplex” to mean two or more primer pairs.
4 Biochim. Biophys. Acta 949:43-48 (1988).
5 Abstracts for XII International Meeting of Society for Analytical Cytology,
Aug. 9-15, Cambridge, England, UK, Cytometry, Suppl. 1, page 20, #113
(1987).
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further in view of Kogan, Gelfand, and Gitschier Declarations as evidence and
further in view of Kogan.6
C. Whether claims 1 and 11 would have been obvious under 35 U.S.C.
§ 103(a) over U.S. Patent No. 4,889,818 (“the ‘818 patent”), Diaz-Chico, and
Weier, and further in view of Kogan, Gelfand, and Gitschier Declarations as
evidence.
D. Whether claims 2-5 and 7 would have been obvious under 35
U.S.C. § 103(a) over U.S. Patent No. 4,889,818, Diaz-Chico, and Weier, and
further in view of Kogan, Gelfand, and Gitschier Declarations as evidence,
and further in view of Kogan.
E. Whether claims 1-5 and 11 would have been obvious under 35
U.S.C. § 103(a) over Kogan or Saiki,7 Diaz-Chico, and Weier, and further in
view of Kogan, Gelfand, and Gitschier Declarations as evidence.
F. Whether claim 7 is unpatentable under 35 U.S.C. § 103(a) over
Kogan or Saiki, Diaz-Chico, and Weier, and further in view of Kogan,
Gelfand, and Gitschier Declarations as evidence, and further in view of
Chehab.8
Claim 11 is representative and reads as follows (underlining and
brackets added to show amendments relative to the original claims):
A method for simultaneously detecting at least three DNA
sequences, comprising the steps of:
adding to a common reaction vessel containing a sample
mixture of at least three distinct, target sequences in single-
stranded form, at least three pairs of oligonucleotide primers,

6 New England J. Med. 317:985-990 (1987).
7 Science, 239:487-491 (1988)
8 Nature 329: 293-294 (1987).
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each pair specific for a different sequence, one primer of each
pair substantially complementary to a part of the sequence in the
sense-strand and the other primer of each pair substantially
complementary to a different part of the same sequence in the
complementary anti-sense strand;
annealing the at least three pairs of primers to their
complementary sequences, all primers being subject to the same
reaction conditions;
simultaneously extending said at least three pairs of
annealed primers from each primer’s 3’ terminus to synthesize an
extension product complementary to the strands annealed to each
primer, said extension products, after separation from their
complement, [being capable of] serving as templates for the
synthesis of an extension product from the other primer of each
pair;
separating said extension products from said templates to
produce single-stranded molecules;
amplifying said single stranded target sequences by
repeating, at least once, said annealing, extending and separating
steps; and
identifying, differentially, whether amplified extension
products have been synthesized from each different sequence, as
a result of the presence or absence of each target sequence.

OBVIOUSNESS REJECTIONS
Rejections
All six rejections are based on similar facts and reasoning. While
different publications were cited in the different rejections, Patent Owner’s
arguments were substantially the same for each. Consequently, we shall
consider all the rejections together.
The claims are drawn to a method of amplifying at least three DNA
sequences in the same reaction vessel using three pairs of oligonucleotide
primers, each primer pair targeted to a different DNA sequence. The
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Examiner cited several primary publications which describe the polymerase
chain reaction (“PCR”), a DNA amplification method which the Examiner
found met substantially all steps of the claimed method (Answer 5, 8, & 9).
The primary difference between the prior art PCR methods and the claims is
that the former did not describe using three primer pairs as claimed. Rather,
the PCR publications cited by the Examiner teach one (the ‘188 patent and the
‘818 patent) or two primer pairs (Kogan; Weier; Chehab). However, the prior
art suggested using multiple primer pairs in a single reaction vessel (Kogan;
Diaz-Chico), including three primer pairs (Diaz-Chico9). Based on these
disclosures, the Examiner concluded that the prior suggested and enabled a
method of performing DNA amplification in a single reaction vessel
employing three primer pairs as claimed.

Multiplexing prior art
For convenience, we quote several of the most pertinent prior art
disclosures which describe multiplexing:
• The prior art had suggested simultaneously amplifying DNA segments using
multiple primer pairs in a single reaction
Kogan described a PCR amplification method using two primer pairs
and Taq polymerase to amplify two different segments of DNA in the same
reaction mixture.

9 Diaz-Chico disclosed using PCR with three primer pairs, but did not give the
details of the experiment nor describe identifying the reaction products in the
mixture as required by the claims.
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In addition, this method allows multiple sequences of interest to
be amplified and examined simultaneously, and is adaptable to
nonradioactive probes.
Kogan 990 (citing Saiki).
Diaz-Chico described a PCR amplification method using two primer
pairs and Klenow fragment (a DNA polymerase) to amplify two different
segments of DNA in the same reaction mixture.
It is possible to employ multiple primer sets in a single
amplification experiment, and we have been able to amplify three
primer set regions simultaneously. However, the conditions
require more Klenow fragment, an increased concentration of
deoxynucleotide triphosphates, and an increased reaction time.
The results obtained thus far are rather variable and we are
currently working to improve the technique.
Diaz-Chico 48.
Weier teaches:
The polymerase chain reaction (pcr), an oligonucleotide primed,
repeated, in vitro DNA synthesis procedure is used to
simultaneously amplify two or more nucleic acid sequences to
the point were [sic, where] they produce visible bands in EB
stained gels following electrophoresis.
Weier (Abstract 20, ¶ 113; emphasis added)

• Two pairs of primers had been used in PCR amplification in a single
reaction
Figure 1 shows pedigree analysis and carrier detection with this
approach. For the analysis of the large pedigree S1, the BclI and
XbaI target sequences were amplified simultaneously with Taq
polymerase. For this experiment, primers 8.1, 8.2, 7.7, and 7.10
were used (Table 1) [i.e., two primer pairs] . . . Although some
background bands are present, heterozygotes (Lanes 4, 5, 6 and
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9) are clearly distinguishable from persons who are hemizygous
or homozygous for the site (3 and control 4X).
Kogan 987 (paragraph spanning columns 1-2).
The polymerase chain reaction (pcr) . . . is used to simultaneously
amplify two or more nucleic acid sequences to the point were
[sic, where] they produce visible bands in EB stained gels
following electrophoresis . . . The fifth exon of the superoxide
dismutase gene (SOD-1), on human chromosome 21, and a
sequence from the glycophorin A (GPA) gene on chromosome 4
have been amplified.
Weier (Abstract 20, ¶ 113).
To detect this deletion, we primed DNA synthesis in the PCR
with a pair of oligonucleotides that produce amplification of a
136-base-pair (bp) region of the α-globin gene cluster between
the ψα and α2-globin genes. . . . We also added to the reaction
mixture two primers that amplify a 110-bp segment of the β-
globin gene, which served as a control.
Chehab 293.

• Three pairs of primers had been used in PCR amplification in a single
reaction
It is possible to employ multiple primer sets in a single
amplification experiment, and we have been able to amplify three
primer set regions simultaneously. However, the conditions
require more Klenow fragment, an increased concentration of
deoxynucleotide triphosphates, and an increased reaction time.
The results obtained thus far are rather variable and we are
currently working to improve the technique.
Diaz-Chico 48.

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No reasonable expectation of success
To decide whether a process would have been obvious in light of the
prior art, it must be determined whether, at the time of invention, “a person of
ordinary skill in the art would have had reason to attempt to . . . carry out the
claimed process, and would have had a reasonable expectation of success in
doing so.” PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342,
1360 (Fed. Cir. 2007). “Obviousness does not require absolute predictability
of success.” In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Patent
Owner contends that a person of ordinary skill in the art would not have
reasonably expected PCR amplification to have succeeded with three primer
pairs.
To support its arguments, Patent Owner provided declarations by Drs.
Kary Mullis and Jeffrey Chamberlain. Dr. Mullis is the inventor of PCR for
which he was awarded the 1993 Nobel Prize in Chemistry (Mullis Decl. ¶ 2).
Dr. Chamberlain is a co-inventor of the ‘989 patent and a Professor of
Neurology, Medicine and Biochemistry at the University of Washington
School of Medicine (Chamberlain Decl. ¶ 3).
The Third Party Requester provided declarations by Drs. David
Gelfand, Jane Gitschier, and Scott Kogan to support the opposite position
(Request for Reexamination, June 18, 2009; Exhibits 17-19). Dr. Gelfand is a
scientist who worked on the development of PCR with Kary Mullis and other
scientists. Gelfand Decl. ¶ 2. Drs. Gitschier and Kogan are scientists and co-
authors of the Kogan publication. All three are qualified as experts in the
technology at issue in this appeal.

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While Kogan observed “background bands” when two primer pairs
were utilized to simultaneously amplify two different target sequences, Kogan
also observed “specific bands” produced using the primers. Kogan expressly
stated that “heterozygotes (Lanes 4, 5, 6, and 9) are clearly distinguishable
from persons who are hemizygous or homozygous for the site (3 and control
4X).” Kogan 987 (paragraph spanning columns 1 and 2). Thus, Dr. Mullis’s
statement that the reaction with two primer pairs did not appear to be
“specific” is directly contradicted by Kogan’s conclusion, supported by
experimental data, that the Kogan method produced specific DNA fragments
that distinguished heterozygotes from hemizygotes or homozygotes.
In view of the background observed by Kogan when two primer pairs
were observed, Dr. Mullis stated that “[r]amping up the reaction to more than
two primer pairs would have increased the number of non-specific PCR
products lending to at best unreliable and uninterpretable results.” Mullis
Decl. p. 3, ¶ 8. Dr. Mullis supports his testimony with Diaz-Chico who
described using multiple primer pairs in a single amplification experiment.
DiazChico 48. Dr. Mullis testified that “it appears as if Daiz-Chico [sic] had
problems using multiple primer pairs, stating that ‘the results obtained thus far
are rather variable . . .’” Mullis Decl. p. 3, ¶ 8.
Dr. Mullis’s testimony captures the crux of the issue in this appeal.
Given that background is observed when two primer pairs were used to
simultaneously amplify DNA fragments, and Diaz-Chico’s statements about
the results being “rather variable” when three primers were used, would it
have been reasonable for one of ordinary skill in the art to expect successful
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amplification of DNA fragments using three primers pairs in the PCR
amplification method? We answer that question in the affirmative.
First, as discussed above, despite background bands, Kogan’s method
succeeded in amplifying two different target DNAs using two primers in the
same single reaction. Thus, the presence of background non-specific bands
did not deter Kogan from detecting the specific, desired, bands on the gel.
Because the products in the mixture were separated on the gel, the skilled
worker would readily discern specific from non-specific DNA bands as did
Kogan.
Second, while Diaz-Chico observed “variable” results, that observation
did not discourage the authors from stating it was “possible to employ
multiple primer sets in a single amplification experiment.” Diaz-Chico 48.
Moreover, Diaz-Chico concluded that the three primer pairs worked in a
single reaction: “we have been able to amplify three primer set regions
simultaneously.” Id. Thus, despite Dr. Mullis’s reservations expressed about
twenty years after Diaz-Chico was published and the ‘989 patent application
was filed, the authors of Diaz-Chico themselves did not appear to have any
doubt their method worked with three primer pairs as claimed.
As acknowledged by Dr. Mullis, Diaz-Chico utilized Klenow fragments
to polymerize the DNA in the amplification method. Kogan instead employed
Taq polymerase which they stated “markedly improves the specificity of
amplification.” Kogan 985-86. Kogan stated that an advantage of its
technique of using Taq polymerase in PCR amplification was that the
“method allows multiple sequences to be amplified and examined
simultaneously.” Kogan 990. Kogan also recognized, as quoted in the
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passage reproduced below, that additional heterogeneous fragments were
observed when Klenow fragment was employed, but that Taq polymerase was
highly specific. Kogan 987.
At the outset, the reason for using this heat-stable [Taq]
polymerase was to avoid adding enzyme at each round of DNA
synthesis after the 90°C denaturation step. However, an
unexpected benefit was that although amplification with Klenow
yields the desired sequence together with a heterogeneous
mixture of fragments, amplification with Taq polymerase is
highly specific. That is, the vast majority of fragments are of the
correct size and sequence. It appears that raising the temperature
of the reaction mixture from 37°C (with Klenow) to 63°C (with
Taq polymerase) is responsible for this specificity.
Kogan 987 (under “Results”).
Saiki also concluded that PCR specificity was improved when Taq
polymerase was used in PCR. Saiki 487 (Abstract).
Thus, thirdly, it was recognized at the time of the claimed invention that
the use of Taq polymerase avoided some of the pitfalls of Klenow fragment
when used in PCR as described by Diaz-Chico. As testified by Dr. Gelfand
and supported by factual evidence, persons of ordinary skill in the art would
therefore have reasonably expected, based on Kogan’s and Saiki’s teachings,
that the results obtained with Klenow fragment by Diaz-Chico could be
improved with Taq polymerase. Gelfand Decl. ¶ 5.
Dr. Mullis stated that “Kogan offers no explanation as to the
background problem nor any suggestions as to overcome the [background]
problem.” Mullis Decl. p. 3, ¶ 8. Dr. Mullis has not provided sufficient
evidence that the so-called “background problem” would have interfered with
“identifying said amplified extension products [of the claimed amplification
process] by differentiating each extension product from each different
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sequence in a mixture” as recited in claim 1. Kogan reported success with
two primer pairs, and Diaz-Chico stated they were “able to amplify three
primer set regions simultaneously.” Thus, the evidence indicates that despite
background and variability, a method employing three primers would have
been reasonably expected to work. Dr. Mullis offered his opinion that it
would not work, but did not provide evidence that outweighed the expressed
statements of success in the cited publications, including Dr. Gelfand’s
testimony to the contrary and publications cited by Dr. Gelfand which Dr.
Gelfand said described and enabled the use of two or more primers to
simultaneously amplify different segments of DNA. Gelfand Decl. ¶¶ 7 & 8.

Chamberlain declaration
We also do not find Dr. Chamberlain’s testimony persuasive. After
discussing the Kogan and Diaz-Chico publications, Dr. Chamberlain, who is
also a co-inventor of the claimed invention, testified that “these manuscripts
did nothing to teach multiplex DNA amplification simultaneously.”
Chamberlain Dec. p. 6, ¶ 7. To the contrary, Kogan described and showed
data in which two primer pairs – and therefore a multiplex DNA amplification
– were used to amplify DNA. Diaz-Chico did not provide data, but reported
that they had been able to achieve amplification with three primers. Thus, Dr.
Chamberlain’s statement that the publications taught “nothing” about
multiplex amplification is neither credible nor supported by the evidence of
record.

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Enablement
Patent Owner contends that the cited prior art does not enable an
amplification method which employs three primer pairs as claimed. Both Drs.
Mullis and Chamberlain contend that the conditions for carrying out the
claimed method with three PCR primers were not described in the prior art.
Mullis Decl. ¶ 9; Chamberlain Decl. ¶ 8. Dr. Mullis stated that Diaz-Chico
did not identify the reaction conditions utilized to carry out the amplification
process. Mullis Decl. ¶ 8. Dr. Mullis contends that “[w]ithout knowledge of
the particular conditions, one of ordinary skill in the art would have no idea of
the starting conditions and would have to explore unknown parameters to
speculate on the reaction conditions.” Id. In the Appeal Brief, Patent Owner
identified a number of experimental variables (polymerase concentration,
temperature, extension time, etc.) in a PCR reaction which Patent Owner
characterized as “obstacles to overcome to obtain amplification and specificity
of multiple sequences.” App. Br. 9.
As already discussed, Kogan established that PCR could succeed with
two primer pairs. While background and variability was observed in Kogan
and Diaz-Chico, successful multiplexing was reported in each. Both Kogan
and Diaz-Chico also suggested that multiple sequences could be amplified in a
single reaction, providing concrete evidence that the ordinary skilled worker
believed that multiplexing was enabled by the prior art and expected to work.
Kogan, in particular, described reaction conditions for two oligonucleotide
primer pairs, and suggested these conditions for multiple pairs, giving the
Examiner basis to conclude that prior art was enabled for performing PCR
with three primer pairs as claimed.
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Additional evidence of enablement was provided by Drs. Gitschier and
Kogan, coauthors of the Kogan publication. Both Drs. Gitschier and Kogan
testified in their declarations that the conditions which controlled PCR
specificity were known at the time of the ‘989 invention. Gitschier Decl. ¶¶ 5,
9, & 10; Kogan Decl. ¶¶ 4 & 5. Dr. Gitschier stated that oligonucleotide
length and GC content were known prior to the claimed invention to be
important considerations in designing PCR primers to obtain DNA annealing
specificity.10 Gitschier Decl. 10. Dr. Gitschier cited the Woods publication to
support her testimony. Id. We have reviewed Woods and find it consistent
with Dr. Gitschier’s testimony.
Saiki also identified conditions that controlled PCR specificity when
using Taq polymerase, such as extension time, enzyme concentration, and
temperature. Saiki 488, col. 3. Patent Owner cited this disclosure of Saiki as
evidence of lack of enablement and unpredictability. However, to the
contrary, such disclosure provides guidance to the skilled worker as to what
parameters can be varied with routine skill to optimize the PCR reaction when
using Taq polymerase. In fact, the conditions cited by Dr. Gitschier and Saiki
are the same variables identified in the ‘989 patent that would be modified to
optimize the PCR reaction for three primer pairs (‘989 patent, col. 8, ll. 43-

10 In the Oral Hearing held on April 18, 2012, Patent Owner’s representative
Mr. Thomas D. Paul identified GC-AT ratio and primer length as criteria to
select primers that would work in the claimed multiplex PCR method. Oral
Hearing Transcript 23. However, Dr. Gitschier’s testimony, factually
supported by the Woods publication, established that the role of such factors
in optimizing oligonucleotide binding specificity were known prior to the
filing date of the claimed invention.
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61). Thus, the prior art provided the same level of enablement described in
the ‘989 patent.

Summary
In sum, for the foregoing reasons, we conclude that the prior art
described and enabled a method of simultaneously amplifying three DNA
sequences using three oligonucleotide primer pairs. Based on the
preponderance of the evidence, we also conclude that that the ordinary skilled
worker would have reasonably expected the claimed method to have
succeeded.

Secondary considerations
Patent Owner contends that the Examiner improperly ignored evidence
of long felt need and commercial success. App. Br. 25. We have considered
this evidence and conclude that it does not overcome the strong case of
obviousness.11

11 There are numerous cases in which objective considerations of non-
obviousness, including unexpected results, substantial evidence of commercial
success, praise, copying, and licensing were inadequate to overcome a strong
case of prima facie obviousness. See e.g., Leapfrog Enters. Inc. v. Fisher-
Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007); Iron Grip Barbell Co., Inc.
v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2004); Richardson-Vicks
Inc. v. Upjohn Co., 122 F.3d 1476, 1483-1484 (Fed. Cir. 1997) (Asyst Techs.,
Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) (“[E]vidence of
secondary considerations does not always overcome a strong prima facie
showing of obviousness.”).
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Long felt need
Patent Owner provided declarations from five different skilled artisans
stating that there was a need in the art for multiplex amplifications involving
more than two set of primers. The declarants stated that the ‘989 patent’s
multiplex assay would save time and money by eliminating the need for a
number of separate assays for each sequence.
While the declarants gave plausible reasons as to why the ‘989 method
would save time and money, their opinions did not take into consideration that
multiplexing was strongly suggested and enabled by the prior art. Thus, while
we have considered the declarants’ testimony, we conclude that the
declarations do not outweigh the strong case of obviousness.

Licensing
Patent Owner submitted a declaration under 37 C.F.R. § 1.132 by Mr.
George Maliekal, Senior Director Business Development and Licensing of
Abbott Molecular Inc. (“Abbott Molecular”), a wholly owned Abbott
Laboratories, which is the exclusive licensee of the ‘989 patent. Maliekal
Decl., ¶ 1. Mr. Maliekal testified in his declaration that Abbott Laboratories
has granted sublicenses under the ‘989 Patent to nineteen (19) other firms and
obtained approximately 19 million and three-hundred thousand dollars in fees
“for the sublicense granted and continues to receive royalties from several of
its sublicensees.” Maliekal Decl., ¶ 2.
The mere existence of licenses is insufficient to overcome the
conclusion of obviousness without a showing of nexus. Iron Grip Barbell
Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2004).
Appeal 2012-005140
Reexamination Control 90/009495
Patent 5,582,989

19
“For objective evidence to be accorded substantial weight, its proponent must
establish a nexus between the evidence and the merits of the claimed
invention.” In re GPAC, Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). In this
case, Mr. Mr. Maliekal did not establish that the ‘989 patent licensing was due
to the merits of the claimed invention, rather than for business or other
reasons.
SUMMARY
We affirm the Examiner’s determination that claims 1-5, 7, and 11 are
unpatentable in view of the prior art cited in Rejections A through F. Claims
not separately argued fall together with claim 11. 37 C.F.R. 41(c)(1)(vii).

TIME PERIOD FOR RESPONSE
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

AFFIRMED

ack

Appeal 2012-005140
Reexamination Control 90/009495
Patent 5,582,989

20
cc:

Patent Owner
VYSIS, INC.
Patent Department
1300 E. Touhy Ave
Des Plaines, IL 60018

Third Party
Robin M. Silva
MORGAN, LEWIS & BROCKIUS LLP
One Market Square
Spear Street Tower
San Francisco, CA 94105