Ex Parte Antovich

Patent Trial and Appeal Board

Jan 19, 2018

13562004 (P.T.A.B. Jan. 19, 2018)

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.
13/562,004 07/30/2012 Zachary ANTOVICH 89799-847576/000130US 1016
20350 7590 01/23/2018
KILPATRICK TOWNSEND & STOCKTON LLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
SALMON, KATHERINE D
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
01/23/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ipefiling@kilpatricktownsend.com
KT S Docketing2 @ kilpatrick. foundationip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ZACHARY ANTOVICH1
Appeal 2016-004322
Application 13/562,004
Technology Center 1600
Before RICHARD J. SMITH, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of genotyping within a human leukocyte antigen (HLA) locus. A hearing
was held on December 4, 2017.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellant, the real parties in interest are Thermo Fisher
Scientific Inc. and Linkage Biosystems, Inc. (a wholly owned subsidiary).
(Communication Pursuant to Rule 41.8 Mandatory Notices dated Nov. 14,
2017; Appeal Br. 3.)
Appeal 2016-004322
Application 13/562,004
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—19 are on appeal. (Claims Appendix, Appeal Br. 47—50.)
Claim 1 is illustrative and reads as follows (emphasis added):
1. A method of genotyping within a human leukocyte antigen
(HLA) locus using a multiplex PCR system having a uniform
master PCR mixture and applying a uniform thermocycling
profile, the method comprising the steps of:
i. establishing a plurality of at least 25 PCR reaction
vessels each with an aqueous solution containing a PCR primer
pair for amplifying a control region of DNA, a different PCR
HLA allele specific primer pair for amplifying different HLA
alleles within the locus and a master PCR mixture having a
fluorescent dye able to bind to double stranded DNA wherein the
master PCR mixture is uniform in the at least 25 PCR reaction
vessels each having the same concentration of MgCf, the same
concentration of dNTPs, identical buffers, and wherein the
uniform master PCR mixture permits the detection of HLA allele
amplification using thermal melting points of amplified HLA
alleles;
ii. adding a biological sample containing HLA
encoding DNA and control encoding DNA to the reaction
vessels;
iii. amplifying the HLA encoding DNA and control
encoding DNA in the reaction vessels consisting essentially of
the aqueous solution of step i using a uniform thermocycling
profile across the plurality of reaction vessels to obtain solutions
containing amplified DNA comprising a control amplicon and
HLA amplicons, where the melting temperature of the control
amplicon is at least 10°C less than the melting temperature of
the HLA amplicons when the melting temperatures are
determined in the uniform master PCR mixture used in the at
least 25 PCR reaction vessels', and,
iv. determining the HLA type by the DNA melting
profile in the solutions.
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Examiner’s Rejections
1. Claims 1—6 and 8—19 stand rejected under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Tiemann,2 Gaffney,3 Akey,4 and Ponchel,5 as
evidenced by Knott6 and the Promega7 melting temperature calculation
page. (Ans. 3—7.)
2. Claim 7 stands rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Tiemann, Gaffney, Akey, and Ponchel, as evidenced by
Knott and the Promega melting temperature calculation page, and Bunce.8
2 C. Tiemann et al., RapidDNA Typing of HLA-B27 Allele by Real-Time
PCR Using LightCycler Technology, Clin. Lab. 47, 131—34 (2001)
(“Tiemann”).
3 D. Gaffney et al., A PCR based method to determine the Kalow allele of
the cholinesterase gene: the Ef allele frequency and its significance in the
normal population, J. Med. Genet. 31, 248—50 (1994) (“Gaffney”).
4 J.M. Akey et al., Melting Curve Analysis of SNPs (McSNP®): A Gel-Free
and Inexpensive Approach for SNP Genotyping, BioTechniques 30, 358—67
(2001) (“Akey”).
5 F. Ponchel et al., Real-time PCR based on SYBR-Green Ifluorescence: An
alternative to the TaqMan assay for a relative quantification of gene
rearrangements, gene amplifications and micro gene deletions, 3 BMC
Biotechnology 18, 1-13 (2003) (“Ponchel”).
6 T.J. Knott et al., Complete cDNA and derived protein sequence of human
apolipoprotein B-100, 14 Nucleic Acids Research 18, 7501-03 (1986)
(“Knott”).
7 BioMath—Tm Calculations for Oligos,
http://www.promega.com/biomath/calcll.htm, dated Sept. 8, 2009
(“Promega”).
8 M. Bunce et al., Phototyping: comprehensive DNA typing for HLA-A, B, C,
DRBl, DRB3, DRB4, DRB5 & DQB1 by PCR with 144 primer mixes
utilizing sequence-specific primers (PCR-SSP), Tissue Antigens 46, 355—
67 (1995) (“Bunce”).
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(Id. at 8—9.)9
FINDINGS OF FACT
The following findings are provided for emphasis and reference
purposes. Additional findings may be found in this Decision and in the
Examiner’s Answer.
FF 1. Tiemann teaches “a fast DNA typing of HLA-B27 by PCR and real­
time detection using LightCycler™ technology,” that the “PCR cycles were
monitored continuously using the SYBR Green I dye,” and that “P-globin
was used as an internal control.” (Tiemann 131 (Summary).) Tiemann
further teaches that “[a]n analysis of 32 samples with one PCR run was
completed within 40 minutes,” and that “[ajfter amplification a melting
curve analysis permitted the accurate identification of the PCR amplicons”
based on the mean melting temperature (Tm) characteristic “for HLA-B27
[90.5°C] and P-globin [87.3°C].” (Id.)
FF 2. The Examiner acknowledges that Tiemann “does not teach amplifying
different HLA alleles within the locus or using a control amplicon that is at
least 10[°C] less than the melting temperature of the HLA amplicons.”
(Ans. 4.) However, the Examiner finds that “[tjhese modifications appear to
be routine optimization of the light cycler per assay taught by Tiemann.”
(Id.)
FF 3. The Examiner finds that Gaffney teaches a PCR based method for
determining differences in a population, using a PCR control amplicon (a
9 We agree with Appellant that the Examiner’s rejection of claim 7
(dependent on claim 1) appears to be inadvertently based on certain
references cited in connection with a withdrawn rejection of claim 1. (Reply
Br. 2.) The rejection of claim 7 has been rephrased accordingly.
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region in the gene for apolipoprotein B) with a melting temperature (Tm)
calculated as below 75°C, which is at least 10°C less than the HLA amplicon
of Tiemann (90.5°C). (Ans. 4—5, citing Gaffney 248 (Abstract) and 249.)
The control DNA taught by Gaffney “is derived from the same gene target
as the preferred control DNA used by the Appellant.” (Reply Br. 3.)
FF 4. The Examiner finds that “it would be routin[e] optimization to design
controls and targets such that the melting peaks are distinguishable from one
another, including designs in which the melting temperatures differed by at
least 10[°C].” (Ans. 5.)
FF 5. The Examiner finds that Akey performs an assay on 7 different
alleles, and suggests that up to 96 genotypes can be assayed per PCR run.
(Ans. 5—6, citing Akey 367.) The Examiner further finds that Akey shows
that multiplexing can be performed and that “multiplex reactions in PCR are
very well known.” (Ans. 10.)
FF 6. The Examiner finds that Ponchel “teaches that primers can be
optimally designed for accurate and specific quantification using real time
PCR,” and that “optimization of primer[s] includes concentration, annealing
temperature, and length.” (Ans. 6, citing Ponchel 3.)
FF 7. The Examiner finds that
the art teaches optimization of assays in order to detect multiple
allelic positions. Designing primers and reaction conditions to
genotype HLA using a multiplex PCR system, would be
considered routine optimization of the art. The prior art teaches
the parameters and objectives involved in the selection of
primers, reaction components and concentrations, and assay
conditions (see Akey, Ponchel). Further the art teaches detection
of HLA alleles with a uniform master PCR mixture and applying
a uniform thermocycling profile (see Tiemann). As such the
prior art is replete with guidance and information necessary to
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permit the ordinary artisan in the field of uniform thermocycling
profile detection [, and] the ordinary artisan would be motivated
to have designed and tested new components (primers and
reaction conditions) that function to genotype HLA.
(Ans. 7.)
DISCUSSION
We adopt the Examiner’s findings, analysis, and conclusions,
including with regard to the scope and content of, and motivation to
combine, the prior art, as set forth in the Answer (Ans. 2—27). We discern
no error in the rejections of the claims as obvious.
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejections under pre-AIA 35 U.S.C. § 103(a).
Principles of Law
The test for obviousness is “what the combined teachings of the
references would have suggested to those of ordinary skill in the art” and not
“that the claimed invention must be expressly suggested in any one or all of
the references.” In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases).
An obviousness analysis “need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007).
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Rejection No. 1
Analysis
We limit our consideration to claims 1 and 19 because the claims
subject to this rejection were not argued separately.
Examiner’s Position
The Examiner concludes that
it would have been prima facie obvious to one of ordinary skill
in the art at the time of filing to modify the method of Tiemann
[] to examine at least 25 [] different HLA alleles by establishing
a plurality of at least 25 PCR reaction vessels each with a [] PCR
primer pair for amplifying a control region of DNA, a different
PCR HLA allele specific primer pair for amplifying different
HLA alleles within the locus, and a master mix.
(Ans. 6; see PL 1—7.)
Appellant characterizes the issue before the Board as “whether the
prima facie case set forth by multiplicity across 25 HLA targets is rebutted
by the evidence of record.” (Appeal Br. 43.) According to Appellant,
“[tjhis appeal. . . [is] diligently focused on providing objective and scientific
rebuttal evidence to the prima facie case of obviousness.” (Id.)
We agree that the Examiner has established a prima facie case of
obviousness, and address Appellant’s arguments and evidence below.
Appellant’s Arguments
Appellant argues that “[t]his invention multiplies the thermal melting
PCR assay of [] Tiemann [] with its single HLA allele target, across at least
25 different HLA alleles using a single reaction profile (uniform PCR master
mix and a single thermocycling profile).” (Appeal Br. 27.) That is,
according to Appellant, “this invention is the discovery that by optimizing
the sequence of primer pairs, one can develop a [] Tiemann assay across 25
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or more reaction vessels with different HLA targets using a single reaction
profile.” {Id. at 43.) In advancing that argument, Appellant discusses
individual distinctions of Tiemann, Akey, Gaffney, and Ponchel, but does
not persuasively address the combination of their respective teachings. {See,
e.g., Appeal Br. 29, 34—35, and 42-45.) See also Keller, 642 F.2d at 426
(one cannot show nonobviousness by attacking references individually
where the Examiner bases the rejection on a combination of references).
Tiemann
Appellant argues that Tiemann “provide[s] a single assay modality for
the amplification of a single HLA target,” and “does not change or
strengthen the Examiner’s prima facie case of obviousness.” {Id. at 29, 42—
43.) The Examiner responds that “[although Tiemann uses one set of
primers for HLA detection in combination with an internal control, it is
noted that the combination of the art teaches the use of multiple primers
using the same universal mastermix.” (Ans. 9, 23.)
Gaffney
Appellant states that “Gaffney teaches the control that melts 10°C
less than the amplicon of Tiemann but there is no express motivation in the
prior art nor implied motivation articulated by the Examiner to use that
specific control amplicon over the P-globin control amplicon of Tiemann.”
{Id. at 43.) However, claim 1 is not limited to a specific control amplicon
and the Examiner’s rejection is thus not based on a motivation to use a
specific control amplicon. Appellant also contends that “Gaffney does not
use their internal control in an assay requiring thermal melting temperature
detection of its amplimers.” {Id. at 29.) However, as the Examiner
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explains, “Tiemann already teaches the need for internal controls in thermal
melting temperature reactions.” (Ans. 10—11.)
Akey
Appellant argues that Akey “target[s] SNPs having no relationship to
each other and thus allow[s] for greater flexibility in selection of primers. In
addition, Akey does not use an internal control PCR amplification which
allows their assays more flexibility in both reaction conditions and primer
selection.” (Appeal Br. 43.) However, as the Examiner explains, “it is the
combination of all the references that suggest the method claimed.” (Ans.
12.) Appellant also argues that Akey uses a single reaction profile for only 6
of 7 targets, and thus “teaches away from Appellant’s invention because 1/7
reaction mixtures were different.” {Id. at 34—35.) But Akey does not teach
away because it does not “criticize, discredit, or otherwise discourage” the
use of more than six reaction vessels with a single reaction profile or the use
of the same reaction profile across all vessels. See In re Fulton, 391 F.3d
1195, 1201 (Fed. Cir. 2004).
Appellant also states that Gaffney and Akey “do little to strengthen
the Examiner’s prima facie case of obviousness.” (Appeal Br. 43.)
Ponchel
Appellant argues that “Ponchel is the only prior art cited by the
Examiner that used primer design to optimize their assays and they focused
solely on concentration and not on primer length and sequences,” and that
Ponchel “does not lend significant rebuttal to the objective evidence
presently before this Board.” {Id. at 43 44.) Moreover, according to
Appellant, “[t]he fact that primer optimization as a generic concept is one of
the many PCR variables that can be optimized by those of skill does not
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diminish from the non-obviousness of the claimed invention.” (Id. at 44; see
also Reply Br. 4.) Appellant further contends that
Ponchel does not mention running all of the target genes together
in a single assay. There is no mention of the use of a uniform
reaction profile across all of their targets. They do not expressly
suggest that primer optimization using length, sequence and
concentration will solve PCR related problems of the type solved
by Appellant, i.e., the problem of specifically amplifying and
detecting 25 or more related (i.e. HLA) targets by thermal
melting points analysis using a uniform master PCR mixture and
applying a uniform thermocycling profile.
(Reply Br. 5—6.)
However, Ponchel is cited for the optimization of primer design, and
the rejection of claim 1 is based on the combined teachings of the cited
references. See Keller, 642 F.2d at 425—26.
Melting Temperature
Appellant argues that the innovation of using a specific control
amplicon having a melting temperature at least 10°C less than the HLA
amplicon “was the result of the Appellant’s work after testing multiple HLA
targets and recognizing the benefit of the control having 10°C difference
from all the targets given the inherent limitations of the assay.” (Appeal Br.
43; see also Reply Br. 6.) Moreover, Appellant contests the Examiner’s
position that such melting temperature requirement “is a routine design
choice,” arguing that “Appellant empirically determined that even with
primer design optimization, inevitable melting point variations among the
different HLA targets is an issue that is preferably solved by the minimum of
10°C separation of the control amplicon from the target amplicons.”
(Appeal Br. 44^45.)
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We are not persuaded. As to the asserted melting temperature
differential being the result of Appellant’s work and testing, we do not find
any persuasive evidence that such work and testing was beyond the level of
one of ordinary skill in the art. KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007) (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”); In re Sovish, 769 F.2d 738, 743 (Fed. Cir.
1985) (skill is presumed on the part of one of ordinary skill in the art).
We also agree with the Examiner’s finding that the melting
temperature requirement was a matter of routine optimization of a result-
effective variable. (Ans. 7.) “[WJhere the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456
(CCPA 1955). Here, the general conditions are evidenced by Tiemann and
Gaffney using melting curve analysis, where the temperature differential is a
function of the particular control and test amplicons used. (See FF 1 4.)
Moreover, as the Examiner explains:
The design of control amplicons are well known in the prior art
[]. Further, it would be obvious to design control amplicons such
that the melting temperature of the control amplicon does not
overlap in any way with the test amplicons. As this method
measures the increasing fluorescence due to the incorporation of
Sybr Green during the synthesis of amplicons, the detection of
the target amplicons and that of the control must be distinct. As
such the melting temperatures of the control and the target must
be different in order to distinguish the melting peaks. As such it
would be routin[e] optimization to design controls and targets
such that the melting peaks are distinguishable from one another,
including designs in which the melting temperatures differed by
at least 10 [°C].
(Ans. 25—26.)
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Primer Optimization
Appellant argues that “[pjrior to Appellant’s work, most people of
skill in PCR did not address the problem of PCR optimization by optimizing
or tweaking the primer sequences or length,” and “the value of primer design
was underappreciated by those of skill.” (Appeal Br. 44; see also Reply Br.
6.) We are not persuaded. Ponchel teaches the optimization of primer
design (FF 6), and claim 1 is not limited to any method or technique for
optimizing primers. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(rejecting arguments “not based on limitations appearing in the claims”).
Moreover, Appellant acknowledges that “primer optimization as a generic
concept is one of the many PCR variables that can be optimized by those of
skill.” (Appeal Br. 44.)
Appellant’s Evidence
Unexpected Results
Appellant relies on the Ginzinger Declaration10 as evidence that the
claimed “invention was surprising and unexpected.” (Appeal Br. 37 40;
Reply Br. 8.) Appellant contends that “Dr. Ginzinger identifies 10 variables
related to PCR that led him to conclude that the Appellant’s claimed assays
are non-obvious.” (Id.)
The focus of the Ginzinger Declaration is that Appellant’s work
required optimizing multiple interrelated variables, and the result was
unpredictable. (See, e.g., Ginzinger Decl. 1 6 (“variables for optimizing are
many”) and 9-11,16.) But the mere fact that multiple result-effective
variables were combined does not render their combination nonobvious or
10 Rule 132 Declaration of David Ginzinger PhD, dated Feb. 17, 2010
(“Ginzinger Declaration” or “Ginzinger Deck”).
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beyond the capability of a person having ordinary skill in the art. See In re
Applied Materials, 692 F.3d 1289, 1297—98 (Fed. Cir. 2012). Here, we are
not persuaded that either the recognition of, or the ability to optimize, the
multiple variables at issue would have been beyond the capability of a
person having ordinary skill in the art. (See Ans. 16—19.)
Moreover, “obviousness cannot be avoided simply by a showing of
some degree of unpredictability in the art so long as there was a reasonable
probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364
(Fed. Cir. 2007) (“[A] rule of law equating unpredictability to patentability,
applied in this case, would mean that any new salt. . . would be separately
patentable, simply because the formation and properties of each salt must be
verified through testing.”).
The Ginzinger Declaration also posits the “reasonable expectation of
success” requirement in the context of Appellant rather than a person of
ordinary skill in the art. (Ginzinger Decl. |10 (“As I understand the law, the
question is whether before Mr. Zantovich began his work, there was a
reasonable expectation that he could successfully develop a HLA genotyping
system that used thermal melting points for detection, a single PCR master
mix and uniform thermocycling across 25 or more reaction vessels.”); see
also id. \ “my initial expectation of his success was less than 50%” (emphasis
added).) But the reasonable expectation of success requirement is assessed
from the perspective of the person of ordinary skill in the art rather than the
inventor. See Pfizer, 480 F.3d at 1364 (“[t]he evidence would convince a
reasonable finder of fact that the skilled artisan would have had [a]
reasonable expectation of success”); see also Life Techs. Inc. v. Clontech
Labs. Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000) (“That the inventors were
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ultimately successful is irrelevant to whether one of ordinary skill in the art,
at the time the invention was made, would have reasonably expected
success.”).
For the foregoing reasons, we find that the Ginzinger Declaration does
not rebut the Examiner’s finding of a reasonable expectation of success, or
otherwise provide persuasive evidence of unexpected results.
Commercial Success
Appellant argues that he has “marketed a commercially successful
diagnostic assay with a loyal customer base,” relying on the Frome
Declaration.11 (Appeal Br. 40-41; Reply Br. 8—9.) The Frome Declaration
includes a statement regarding sales data, and third party statements
regarding cost savings, related to test kits sold under the name Linkage
Biosciences LinkSeq kits. (Frome Deck 5—14.)
The Frome Declaration makes the following statement regarding sales
of test kits:
6. The test kits were introduced into the market mid-2010. The
increase in sales from the first to the second year was in excess
of 10 fold. From the second to third year, sales increased 5 fold.
Our expected increase from the 4th years sales will be 3 fold.
Current sales are now several million dollars per year.
(Frome Decl. | 6.)
The foregoing statement is limited to year over year increase in sales
(without identifying the number of kits sold) and sales of “several million
dollars per year,” but does not identify the number of kits sold or market
share. (Id.) Moreover, the limited sales data “provides no indication of
11 Rule 132 Declaration of Matthew Frome: Regarding Commercial Success
as Evidence of Non-obviousness, dated Sept. 10, 2013 (“Frome Declaration”
or “Frome Deck”).
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whether this represents a substantial quantity in this market.” In re Huang,
100 F.3d 135, 140 (Fed. Cir. 1996); see also Applied Materials, 692 F.3d at
1300 (“An important component of the commercial success inquiry ... is
determining whether [Appellant] had a significant market share relative to
all competing [products] based on the merits of the claimed invention.”).12
We also agree with the Examiner that the required nexus between the
claimed method and the test kits is deficient, particular with respect to the
third party statements regarding cost savings. (Ans. 20—21.) Commercial
success “is relevant in the obviousness context only if there is proof that the
sales were a direct result of the unique characteristics of the claimed
invention—as opposed to other economic and commercial factors unrelated
to the quality of the patented subject matter.” Huang, 100 F.3d at 140. “In
other words, a nexus is required between the sales and the merits of the
claimed invention.” Id.
Here, the Frame Declaration states that the test kits “utilize the
claimed invention,” referring to a four page product brochure (Exhibit 1).
(Frame Decl. | 5.) The Frame Declaration then provides information about
sales data and cost savings without persuasively establishing that the sales or
cost savings were “the direct result of the unique characteristics of the
[method of claim 1],” rather than other factors. See Huang, 100 F.3d at 140.
During ex parte prosecution, the PTO must rely upon the Appellant to
provide hard factual evidence of a nexus between sales and the claimed
12 We note Appellant’s argument that “the market for treating transplant
patients does not significantly grow from year to year.” (Reply Br. 9.)
However, the Frome Declaration provides no evidence of market share for
any year.
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invention (see id. at 139-40), such as might be achieved by “an affidavit
from the purchaser explaining that the product was purchased due to the
claimed features.” Id. at 140. Contrary to Appellant’s argument (Reply Br.
9), we do not find that the “three email testimonies from customers []
expressly support the nexus between the invention and product success,”
including because they do not specify whether or how the specific methods
steps employed by the customer correspond to the method of claim 1. Stated
another way, it is not clear from the evidence presented that purchasing and
using Appellant’s test kit necessarily involved practicing the steps
specifically recited in claim 1.
Summary
In weighing the proffered evidence and arguments of unexpected
results and commercial success with the evidence of obviousness, we find
that the balance favors the Examiner’s conclusion of obviousness as to claim
1. In particular, we find that the Ginzinger Declaration and the Frome
Declaration are entitled to limited weight for the reasons stated above.
Appellant’s arguments do not persuade us of any error in the
Examiner’s prima facie case, and Appellant’s evidence is insufficient to
rebut that prima facie case. Accordingly, we find that Appellant’s evidence
and arguments of unexpected results and commercial success do not
outweigh the Examiner’s findings and conclusion of obviousness of claim 1.
Claim 19
Appellant requests separate consideration of claim 19 (Appeal Br. 50),
which is similar to claim 1 but does not include the limitation regarding
melting temperatures of the control and target amplicons (see italicized
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wording in claim 1 above). (Appeal Br. 45^46; Reply Br. 7—8.) Appellant
advances essentially the same arguments and evidence as advanced in
connection with claim 1, and they are unpersuasive for the reasons set forth
above.
Accordingly, for the reasons of record and as set forth above, we
affirm the rejections of claims 1 and 19. Claims 2—6 and 8—18 were not
argued separately and fall with claim 1.
Rejection No. 2
Appellant relies on the same arguments and evidence advanced in
connection with claim 1. (Appeal Br. 45; Reply Br. 7.) Accordingly, for the
reasons of record and as set forth above, we affirm the rejection of claim 7.
Conclusions of Law
A preponderance of evidence of record supports the Examiner’s
rejections of claims 1—19 under pre-AIA 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejections of all claims on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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