Ex Parte Wainwright et al

Patent Trial and Appeal Board

Apr 17, 2018

13095390 (P.T.A.B. Apr. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/095,390 04/27/2011
51414 7590 04/19/2018
GOODWIN PROCTER LLP
PATENT ADMINISTRATOR
100 Northern A venue
FIRST NAMED INVENTOR
Norman R. Wainwright
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
CHR-004Cl 2510
EXAMINER
HOBBS, LISA JOE
BOSTON, MA 02210 ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
04/19/2018 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):
PA TENTBOS@GOODWINPROCTER.COM
PSOUSA-ATWOOD@GOODWINPROCTER.COM
GLENN .WILLIAMS@GOODWINPROCTER.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NORMAN R. WAINWRIGHT
and FOSTER T. JORDAN
Appeal2016-005388 1
Application 13/095,3902
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 77, 78, and 80-
99 (Final Act. 1)3. Examiner entered a rejection under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellants' disclosure "relates generally to methods and compositions
using a hemocyte lysate for detecting and/or quantifying microbial
1 Oral Hearing was held April 3, 2018.
2 Appellants identify the real party in interest as "Charles River
Laboratories, Inc." (App. Br. 2).
3 Examiner's Final Office Action mailed July 16, 2014.
Appeal2016-005388
Application 13/095,390
contamination in a sample" (Spec. 1: 6-8). Independent claims 77 and 86
are representative and reproduced below:
77. A manufacture comprising a solid support having dried
thereon a composition comprising a mixture of a hemocyte
lysate and (i) an anti-frothing agent, (ii) a resolubilizing agent,
(iii) an anti-flaking agent and an anti-frothing agent, (iv) an
anti-flaking agent and a resolubilizing agent, (v) an anti-
frothing agent and a resolubilizing agent, or (vi) an anti-flaking
agent, an anti-frothing agent and a resolubilizing agent, wherein
said lysate is capable of being solubilized or reconstituted by a
sample.
86. A manufacture comprising a solid support comprising glass
or plastic having dried thereon a composition comprising
mixture of a hemocyte a lysate and (i) an anti-flaking agent, (ii)
an anti-frothing agent, (iii) a resolubilizing agent, (iv) an anti-
flaking agent and an antifrothing agent, (v) an anti-flaking agent
and a resolubilizing agent, (vi) an anti-frothing agent and a
resolubilizing agent, or (vii) an anti-flaking agent, an anti-
frothing agent and a resolubilizing agent, wherein said lysate is
capable of being solubilized or reconstituted by a sample.
(App. Br. 28.)
The claims stand rejected as follows:
Claims 77, 78, and 80-99 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Mahiout, 4 Takaoka, 5 Jordan, 6 and
Helmenstein. 7
4 Mahiout, WO 99/53322, published Oct. 21, 1999.
5 Takaoka et al., US 5,637,474, issued June 10, 1997.
6 Jordan et al., US 6,270,982 Bl, issued Aug. 7, 2001.
7 Anne Marie Helmenstein, Ph.D., Name 3 Disaccharides, List of
Dis accharides, http://chemistry.about.com/ od/biochemistry I a!N ame-3-
Disaccharides.htm (accessed July 9, 2014). We note that Examiner refers to
this document as "Disaccharides" (see Final Act. 3).
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Application 13/095,390
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Takaoka discloses that endotoxin, "a substance present in cell walls
of Gram-negative bacteria," and B-glucan, "a substance ... known to exist
as a skeleton constituent of cell walls of yeasts and molds," "is known to
react with a solution containing amebocyte lysate of horseshoe crabs
(referred to hereinafter as the AL solution) to activate an enzyme and cause
[a] gelation reaction" (Takaoka 1: 11-12, 21-22, and 31-34; see also
Mahiout 1: 19-22 ("Horseshoe crab (limulus) amoebocyte lysate provokes
together with endotoxin from gram-negative bacteria a gelatination induced
by a stepwise activation of several coagulation factors contained in the
lysate")).
FF 2. Mahiout discloses that "[t]he most available method to qualitatively
and quantitatively detect endotoxin in biological or aqueous solutions is
based on the limulus amoebocyte lysate (LAL) test," which "involves the
gelatination of the sample (gelation method, turbidimetry assay) in the
reagent glass or a more sensitive method based on a chromogenic substrate
and measurement by optical absorption" (Mahiout 1: 16-18 and 25-28; see
also Takaoka 1: 5-10 (Takaoka relates to a solution based LAL test, which
Takaoka refers to as "a kinetic turbidimetric method")).
FF 3. Appellants explain that
the kinetic turbidimetric assay includes the steps of (i)
solubilizing a hemocyte lysate with a sample to be analyzed, (ii)
incubating the resulting mixture at a temperature of about 0 to
about 40QC, preferably about 25Q to about 40QC, over a
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Application 13/095,390
predetermined time range, and (iii) measuring a time required
for either a turbidity change caused by coagulation to reach a
pre-selected value or a ratio in change of the turbidity, using a
conventional coagulometer, nepherometer, or
spectrophotometer.
(Spec. 27: 13-18.)
FF 4. Mahiout discloses that
[a]ll commercialized LAL testing methods based on a
chromogenic substrate are liquid-phase assays. The principle is
that in a reagent glass containing a lysate and sample, bacterial
endotoxin contained in the sample initiates activation of a
cascade of serine protease (Factor B, Factor C, Proclotting
enzyme, Coagulin) enzymes in LAL that cleave the end product
coagulogen into a peptide coagulin which produces clotting[ or
gelation]. The use of a synthetic chromogenic or fluorogenic
substrate increases the sensitivity of the testing and makes the
quantification of endotoxin possible. . . . [A] synthetic peptide
is used having an amino acid sequence in common with the
hydrolysis sites of coagulogen, namely the chromogenic
substrate Boc-Leu-Gly-Arg-p-nitroanilide (pNA) or the fluoro-
geni c substrate Boe-Leu-G 1 y-Arg-4-methy lcoumary 1-7 -amide.
In the presence of LAL and endotoxin, the colourless substrate
is rapidly cleaved to form the chromophore p-nitroaniline or the
fluorogenic 4-methylcoumaryl-7-amide.
(Mahiout 2: 3-15.)
FF 5. Takaoka discloses that the measurement sensitivity and
reproducibility of a nephelometric method of "determining endotoxin [can
be improved and enhanced, respectively,] by allowing both ionic surfactant
and suspending agent or a polymer having simultaneously the properties of
the two to be present during the reaction between the AL solution and the
endotoxin (or B-glucan)" (Takaoka 2: 4--10; see id. at 11. 11-14 ("an ionic
surfactant is added so as to stop the coagulation of Limulus protein, and a
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suspending agent is added to stabilize pharmaceutical or food emulsions and
colloidal solutions")).
FF 6. Takaoka discloses, however, that in its kinetic turbidimetric method
the gelation reaction can be effectively accelerated by making a
specific water-soluble polymer present without co-using an
ionic surfactant in the reaction system during the reaction of the
AL solution with the endotoxin (or B-glucan). In other words,
[] both the shortening of the reaction time in the kinetic
turbidimetric method and the enhancement of the measurement
sensitivity of the kinetic turbidimetric method are achieved by
using only the specific water-soluble polymer without using an
ionic surfactant.
(Takaoka 3: 11-20.)
FF 7. Takaoka discloses that the addition of a water-soluble polymer, such
as polyethylene glycol or polyvinyl alcohol, to the kinetic turbidimetric
method will both shorten the gelation reaction time and enhance "the
measurement sensitivity of the ... method" (Takaoka 3: 15-20 and 35-37;
see id. at 4: 6-8 ("water-soluble polymers have a sufficient effect even when
each thereof is used alone; however, they may be used in appropriate
combination of two or more"); see also Ans. 4).
FF 8. Mahiout discloses that
[t]he test strip provides a dry analytical element for endotoxin
which comprises an absorbent carrier divided in four portions
impregnated with: 1) a reagent system of limulus factors; 2)
synthetic chromogenic substrate derivatized with p-nitroaniline;
3) a buffer system containing chloride acid and sodium nitrite;
4) a buffer system containing chloride acid and ammonium.
The test also includes a solution containing
Nl-naphtylethylenediamine which is added at the top of the test
trip to develop a coloration by coupling the derivatized p-NA to
Nl-napthylethylenediamine as positive results.
(Mahiout 3: 12-19.)
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FF 9. Mahiout' s Figure 2 is reproduced below:
PAPER TEST STfUP
5
ENDOTOX~N
TEST PAPER 3
~.,.~.,.. ..~/ '---·-.
\
STEHR£ AND
PRYOGEN FREE
TUBE
• z
• 1
Mahiout's "Fig. 2 shows a schematic representation of a paper test strip"
(Mahiout 8: 1 ).
FF 10. Mahiout's "strip can [be] prepared from any matrix material through
which[] test fluid can vertically flow by capillarity" (Mahiout 9: 13-14; see
also id. at 5: 21-22 ("Examples of suitable supports [for Mahi out's strip] are
chromatographic papers, nitrocellulose, dextran and glass fibres"); id. at 7:
18-23 ("Suitable materials for chromatographic strips are paper,
nitrocellulose and hydrophilic polymers," wherein Mahiout discloses that "it
is desirable to use hydrophilic polymers which allow vertical capillary flow
excluding a bibulous lateral flow such as polyethylene sheet material"); see
generally Final Act. 3--4)).
FF 11. Mahi out's "polystyrene dipstick[, as illustrated in Mahi out's figure
2,] was constructed to be fitted in a sterile bottle," wherein the
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Application 13/095,390
active surface of the test strip was ... separated every 0.5 cm
between the first portion and the third portion with 0.5 cm x
0.2[ ]cm dry Sephadex ....
Portion 1: consisted of0.5[ ]cm x 0.5 cm ultra[-]high
molecular weight polyethylene sheet material ... which was
incubated for 10 min under pyrogen free conditions in 0.5
IU/ml ... of limulus amoebocyte lysate ... [dried and] applied
to the bottom of the test strip. A neutral 0.5 cm x 0.1 cm
portion was added above the neutral sephadex.
Portion 2: consisted of 0.5[ ]cm x 0.5 cm ultra[-]high
molecular weight polyethylene sheet material ... which was
spotted with 1/5 µmol/ml of chromogenic substrate ... for
endoxin. . . . The strip was applied just above the neutral
sephadex portion.
Between portions 2 and 3: consisted of 0.5[ ]cm x 0.5 cm
sephadex and Tris-HCl at a concentration of 0.025 mmol/l.
Portion 3: consisted of a 0.5 cm x 0.5 cm strip of filter paper
... which was submerged [in a] solution of 1 N HCl containing
0/1 % (w/v) sodium nitrite, dried and applied above the neutral
sephadex portion.
Portion 4: consisted of a 0.5 cm[]x 0.5 cm strip of filter paper
... which was submerged[] in [a] solution of 1 N HCl
containing 0.5 % ([w]v) ammonium sulfate, dried and applied
above the third portion.
Portion 5: consisted of a 0.5 cm[] [ x] 0.5 cm strip of filter
paper ... applied above the fourth portion.
(Mahiout 9: 14-10: 14 (emphasis omitted); see generally id. at 3: 10-19;
see Spec. 16: 20-22 (Appellants discloses that "the term, 'hemocyte lysate'
is understood to mean any lysate or a fraction or component thereof,
produced by the lysis and/or membrane permeabilization of hemocytes, for
example, amebocytes and hemolymph cells"); Final Act. 3.)
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FF 12. Mahiout's Figure 3 is reproduced below:
FIG.3
TEST STRIP REACTION PROCEDUFlE
5
DERIVATIZAT!mJ
P·~JHROAN!UNE . DIA.ZONllltvl
ENDOTOXI~~ COAGULOGEN
PROENZY'l>-~E ~--·······--·----................ ,. CLEAVAGE
PR.OOUCT
ENZYME
Mahiout's "Fig. 3 shows [the] mode of operation of [Mahiout's] test strip"
(Mahiout 8: 2).
FF 13. Mahiout's
solid support which is employed in [its] test strip is one which
is capable of absorbing endotoxin from the sample. When
wetted, the sample containing endotoxin reacts with reagents in
the first portion and the reaction products are transported by
flow to the dry region of the first support and thus to the second
portion of the test strip. In addition, the solid support is one
which is capable of absorbing both sample and binder. In order
to achieve a flow communication between the portion, it is
preferable to use an hydrophillic polymers solid support.
Examples of suitable supports are chromatographic papers,
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Appeal2016-005388
Application 13/095,390
nitrocellulose, dextran and glass fibres. Preferably,
chromatographic hydrophobic polymers are used though if
using chromatography papers, it is important to use reagents
which do not react with B-glucan ....
The second portion contains a solid support and a synthetic
substrate. A typical substrate to be immobilized in the second
portion is t-butoxycarbonyl-leucyl-glycyl-arginine-
paranitroanilide (Boc-Leu-Gly-Arg-pNA) to release
paranitroanilide. . . . Possible methods of immobilization of the
chromogenic substrate to the solid support are: 1) absorption; 2)
adsorption by ionic forces or/and hydrophobic interaction, and
3) covalent binding. Preferably, the support is absorbed with
the substrate. The solid support is typically made with the same
material as the first support and it is one which is capable of
absorbing the liquid and reactants flowing from the first
support, and which when wetted is this way, provides for flow
and analyte by capillary attraction from the first portion, and
through the second portion into the third portion. Upon contact
with the liquid and reactants flowing from the first support,
solution should react with immobilized chromogenic substrate.
Like the first portion, examples of suitable supports are
chromatographic papers, nitrocellulose, dextran and glass
fibres. Preferably, chromatographic papers are used. The solid
support absorbed with the chromogenic substrate is one which
is capable of absorbing reactants flowing from the first support.
When wetted, the so-called reactants are capable of reacting
with the second portion and the reactants with the new reaction
products being transported to the dry regions and thus to the
third portion of the test strip. The solid support is so
manufactured (with attention to the amount of absorbed
synthetic chromogenic substrate, size of the portion, material of
the solid support) that activated clotting enzyme and/or factor B
flowing from the lower portion reacts with substrate in the
second portion and the chromophore p-nitroaniline is cleaved.
The cleaved p-nitroaniline is then transported to the next
portion.
The third portion contains a solid support and a buffer
containing 1 N HCl and 0.1 % (w/v) sodium nitrite. Preferably,
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Application 13/095,390
to make the support; it is impregnated with the buffer system,
dried and is made with the same material as the second support.
When dried, the solid support is also one which is capable of
absorbing the liquid and the chromophore p-nitroaniline
flowing from the second support, and which when wetted is this
way, provides for flow from the second portion, and through
the third portion into the fourth portion.
The fourth portion contains a solid support and a buffer
containing N HCl containing 0.5% ammonium. Preferably, to
make the support, it is impregnated with the buffer system, and
dried. When absorbed with the buffer system and dried, the
solid support is also one which is capable of absorbing the
liquid and the chromophore p-nitroaniline flowing from the
third support, and which when wetted is this way, provides for
flow from the third portion, and through the dried region.
The third and fourth portions are those through which when the
flowing free p-nitroaniline released by the action of enzymes is
derivatized to its diazanium salt, typically formed in the fourth
portion.
The fifth portion is a neutral portion in which a drop of 0.05 %
N 1-naphtylethylenediamine in 40-50% (v/v) is added to form a
highly visible red colour by coupling of the derivatized p-NA to
N 1-napthylethylenediamine.
The test strip described in this invention can suitably be
prepared from any matrix material through which an aqueous
solution can flow by capillarity. Suitable materials for
chromatographic strips are paper, nitrocellulose and hydrophilic
polymers. Because of the presence of B-glucan in cellulosic
material, paper is not usually suitable without special treatment
as it induces false positive results. In this invention, it is
desirable to use hydrophillic polymers which allow vertical
capillary flow excluding a bibulous lateral flow such as
polyethylene sheet material.
(Mahiout 5: 14- 7: 23; see generally id. at 3: 10-19, 4: 12-22, and
10: 15-25; Final Act. 3.)
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Application 13/095,390
FF 14. Examiner finds that Mahiout's "solid state test device (test strip)
compris[ es] ... various salts and stabilizing components" (Final Act. 3
(citing Mahiout 8-9)).
FF 15. Examiner finds that "Mahiout does not specifically include an anti-
frothing agent" and "is silent on the hemocyte lysate and the other agent
(anti-frothing, resolubilizing, anti-flaking) being specifically mixed
together" (Final Act. 3--4).
FF 16. Jordan discloses "amebocyte lysate preparations having reduced
Factor G activity, methods of making such lysate preparations, and methods
of using such lysate preparations in the detection and/or quantitation of one
or more bacterial endotoxins in a sample of interest" (Jordan 2: 59-63).
FF 17. Jordan's
method is based upon a protocol for reducing or preferably
depleting amebocyte lysate of Factor G activity, with the
resulting lysate being less reactive to (1 ~3)-B-D glucan than
untreated amebocyte lysate. In addition, the invention is based,
in part, upon the discovery that (1 ~3)-B-D glucan, when
exogenously added to an amebocyte lysate preparation depleted
of Factor G activity ... can enhance the sensitivity of the
resulting amebocyte lysate preparation to endotoxin. The
invention, therefore, provides an endotoxin specific amebocyte
lysate preparation for use in reliably detecting and/or
quantitating a bacterial endotoxin in a sample of interest.
(Jordan 5: 45-51.)
FF 18. Jordan uses
the term, "(1 ~3)-B-D glucan" ... to mean any water soluble
polysaccharide, disaccharide or derivative thereof that is (i)
capable of inducing formation of a coagulin clot in crude
Limulus amebocyte lysate, and (ii) contains at least two B-D
glucosides, as defined in formula I below, connected by a
(1 ~3)-B-D glycosidic linkage. It is contemplated that such a
polysaccharide or derivative thereof, in addition to containing a
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(1 ~3)-B-D glycosidic linkage may also contain glucoside
moieties connected by a variety of other glycosidic linkages, for
example, via a (1 ~4)-B-D glucan glycosidic linkage and/or by
a (1 ~6)-B-D glycosidic linkage. It is contemplated that such
(1 ~3)-B-D glucan may be isolated from a variety of sources
including, without limitation, plants, bacteria, yeast, algae, and
fungi, or alternatively may be synthesized using conventional
sugar chemistries.
(Jordan 6: 33--48.)
FF 19. Examiner relies on Helmenstein to disclose that "maltose, trehalose
and sucrose are disaccharides" (Final Act. 4).
ANALYSIS
Based on the combination ofMahiout, Takaoka, Jordan, and
Helmenstein, Examiner concludes that, at the time Appellants' invention
was made, it would have been prima facie obvious to include, inter alia, "a
water soluble polymer such as polyethylene glycol and/or polyvinyl alcohol
in combination[, i.e. mixed,] with the amebocyte lysate of Mahi out because
Takaoka ... teach[ es] that this will provide the advantage of enhanced
sensitivity and shortening of reaction time" (Final Act. 4; see id. at 3; see
also Ans. 2 ("Mahiout specifically teaches that the hemocyte lysate (also
called amebocyte lysate) is placed on/with dextran, which would be a
combination of both the hemocyte lysate and an anti-flaking agent")). In
this regard, Examiner reasons that the reactions set forth in each of Mahiout
and Takaoka, "whether performed in solution or in a solution as it goes up
[a] solid support (such as that of Mahiout) the endotoxin in solution is still
reacting with the water soluble components (hemocyte lysate, salt etc.) that
are immobilized on the solid support, but would still be water soluble" (Final
Act. 5-6; see Ans. 4). According to Examiner, "[t]he important take away
here is that the water-soluble polymer increases the speed at which this
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Application 13/095,390
reaction (lysate with endotoxin) takes place .... Therefore one of ordinary
skill in the art would [have been] motivated to and have a reasonable
expectation of increasing the sensitivity (by the decrease of this reaction
time) of their assay by adding a water-soluble polymer" (Final Act. 6; see
Ans. 3-5). We are not persuaded.
As Appellants explain, "Mahiout teaches an assay system in which the
lysate and other elements, such as a salt, are placed at distinct, spatially
separated locations in the system" (App. Br. 6; see FF 8-14). "Mahiout uses
this arrangement so that the sample and resulting 'reaction products can flow
from one portion to the next' by capillary flow, and so that the reaction
products arriving in the last portion can 'develop a red coloration as a
positive result"' (App. Br. 6; see FF 8-14).
[T]he separation ofMahiout's reagents along the test strip is
essential for the functionality of his assay because it allows the
sample to flow from one end through the various reagents
creating the necessary reaction products that ultimately result in
a color change at the second end if a result is positive. In other
words, Mahi out's test strip is designed to permit the reaction to
proceed with the appropriate reagent reacting with the sample at
the appropriate time. There is no reason to believe that mixing
all of the reagents together would facilitate the detection of
endotoxin on Mahiout's test strip, especially since the color
change indication at the end relies on the presence of a
particular reagent with a particular reaction product at that
location.
(App. Br. 6; see FF 8-14.)
In contrast to Mahiout's test strip based assay method, Takaoka
discloses a solution-based assay (see e.g., FF 2). Takaoka discloses that
those of ordinary skill in this art understood that in assays of the type
disclosed by Takaoka, it was conventional to include "both [an] ionic
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surfactant and suspending agent or a polymer having simultaneously the
properties of the two [are] ... present during the reaction between the AL
solution and the endotoxin" (FF 5). In this regard, Takaoka discloses that it
was understood by those of ordinary skill in this art that "an ionic surfactant"
is added to the reaction "to stop the coagulation of Limulus protein, and
[the] suspending agent is added to stabilize pharmaceutical or food
emulsions and colloidal solutions" (id.). Takaoka, however, disclosed that
in its kinetic turbidimetric method, "the gelation reaction can be effectively
accelerated by making a specific water-soluble polymer present without co-
using an ionic surfactant in the reaction system during the reaction of the AL
solution with the endotoxin (or B-glucan)" (FF 6). By "using only [a]
specific water-soluble polymer without using an ionic surfactant," Takaoka
observed "both [a] shortening of the reaction time" and "the enhancement of
the measurement sensitivity" in its solution-based "kinetic turbidimetric
method" (id.).
Examiner now concludes, that the same effects observed in Takaoka' s
solution-based assay can be achieved in Mahiout's test strip assay, by
including Takaoka's polymer on Mahiout's test strip (see Final Act. 4).
Examiner, however, failed to establish an evidentiary basis on this record to
support this conclusion (see, e.g., App. Br. 8 ("there is simply no reason to
introduce a polyvinyl alcohol or polyethylene glycol as taught by Takaoka
into the amebocyte lysate of Mahiout"); id. at 9-10 ("there is no reason or
motivation to modify the teachings of Mahiout in view of the teachings of
Takaoka in order to arrive at the present invention")). Specifically,
Examiner failed to establish that Takaoka's polymer would have the same
effect observed in a solution-based assay, when applied to a test strip-based
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assay (see generally App. Br. 10-11). Further, although Mahiout makes
reference to the use of a "binder" and a "chromatographic hydrophobic
polymer" (see FF 14), Examiner failed to establish an evidentiary basis on
this record that a person of ordinary skill in this art would have recognized
that Takaoka's polymer would have satisfied either of these functionalities.
To the contrary, Examiner has, at best, established that a person of ordinary
skill in this art may have considered including Takaoka's polymer in the
sample solution into which Mahiout's test strip is placed, which does not,
however, meet the requirements of Appellants' claimed invention.
To be complete, for the reasons set forth by Appellants, we are not
persuaded by Examiner's unsupported assertion that the dextran or
polyethylene structural materials of Mahiout's test strip "would be mixed
with the hemocyte lysate when the hemocyte lysate is added" to the test strip
(Final Act. 3; see also Ans. 3; cf App. Br. 7-8).
Further, Examiner failed to establish that Jordan and Helmenstein,
alone or in combination, make up for the foregoing deficiencies in the
combination of Mahout and Takaoka (see generally App. Br. 9).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 77, 78, and
80-99 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Mahiout, Takaoka, Jordan, and Helmenstein is reversed.
REVERSED
15