Ex parte Augurt

Board of Patent Appeals and Interferences

Sep 11, 2001

08439602 (B.P.A.I. Sep. 11, 2001)

Application for patent filed May 12, 1995. According to appellant, this application1
is a divisional of application serial no. 08/121,072, filed September 14, 1993, now U.S.
Patent No. 5,447,868.
1
The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 18
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte
THOMAS A. AUGURT
___________
Appeal No. 1997-3805
Application No. 08/439,6021
__________
ON BRIEF
__________
Before WILLIAM F. SMITH, ROBINSON, and SCHEINER, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
Appeal No. 1997-3805
Application No. 08/439,602
2
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the final rejection of claims
24 through 26 and 30 through 43, all the claims remaining in the application.
Claims 24, 25 and 26 are representative of the claims on appeal and read as
follows:
24. A method for detecting occult blood in a specimen comprising combining the
specimen with
(a) hydrogen peroxide or a peroxide source;
(b) an oxidizable substrate that produces a colored product in the presence of
peroxide and hemoglobin; and
(c) an enhancer consisting of a composition selected from the group consisting of
tertiary and quaternary amines having a phenyl or substituted phenyl group attached to the
nitrogen in a liquid carrier, wherein the peroxide, oxidizable substrate and enhancer are
combined with the specimen in amounts effective to produce a visually detectable color
change if medically significant amounts of blood are present in the specimen.
25. A composition for use as a liquid developer in a test for fecal occult blood
based upon the oxidation of a substrate to a colored product comprising
(a) hydrogen peroxide or a peroxide source;
(b) an amount of an enhancer effective to enhance the amount of colored product
produced; and
(c) a carrier comprising water and ethanol, wherein the enhancer is selected from
the group consisting of tertiary and quaternary amines having a phenyl or substituted
phenyl group attached to the nitrogen.
26. A kit for the detection of occult blood comprising, in packaged combination,
(a) an oxidizable substrate which is converted to a colored product in the presence
of peroxide and hemoglobin; and
(b) a developer comprising a liquid carrier, hydrogen peroxide or a peroxide
source, and an enhancer in an amount effective to enhance the conversion of the
oxidizable substrate to the colored product, wherein the enhancer is selected from the
group consisting of tertiary and quaternary amines having a phenyl or substituted phenyl
group attached to the nitrogen.
Appeal No. 1997-3805
Application No. 08/439,602
3
The references relied upon by the examiner are:
Gantzer 4,556,640 Dec. 3, 1985
Eur. Pat. Spec. (Baker) 0 308 227 Jul. 22, 1992
Claims 24 through 26 stand rejected under the judicially-created doctrine of
obviousness-type double patenting as unpatentable over claims 4, 10 and 16 of U.S.
Patent No. 5,563,071, while claims 24 through 26 and 30 through 43 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Baker and Gantzer.
We affirm the obviousness-type double patenting rejection and reverse the
obviousness rejection.
DISCUSSION
The claims on appeal are drawn to methods, compositions and kits for detecting
occult blood. Each of the claims requires an enhancer in a liquid carrier, wherein the
enhancer is selected from the group consisting of tertiary and quaternary amines having a
phenyl or substituted phenyl group attached to the nitrogen.
Obviousness-type Double Patenting
In deciding this issue, we have considered the arguments made in appellant’s Brief
(paper no. 11) and in the Examiner’s Answer (paper no. 12). We have also considered the
prosecution histories of parent application serial no. 08/121,072 (now U.S. Patent
Appeal No. 1997-3805
Application No. 08/439,602
4
5,447,868); the present divisional application; and divisional application serial no.
08/439,603 (now U.S. Patent 5,563,071).
Claims 24 through 26 on appeal are directed to a method, composition and kit,
respectively, each requiring an enhancer selected from the group consisting of tertiary and
quaternary amines having a phenyl or substituted phenyl group attached to the nitrogen.
Patent No. 5,563,071 claims a similar method, composition and kit, but each independent
claim requires an enhancer selected from the group consisting of tertiary and quaternary
amines having a hydroxy alkyl or esterified hydroxy alkyl group attached to the nitrogen.
Patented claims 4, 10, and 16 limit the enhancer component to phenyl diethanolamine.
The examiner argues that patented claims 4, 10 and 16 are not patentably distinct from
claims 24 through 26 on appeal because phenyl diethanolamine is simultaneously a
tertiary amine having a phenyl group attached to the nitrogen, and a tertiary amine having a
hydroxy alkyl group attached to the nitrogen. Examiner’s Answer, page 5. That is, the
specific enhancer of the patented claims, phenyl diethanolamine, falls within the presently
claimed genus of enhancers comprising tertiary and quaternary amines having a phenyl
group attached to the nitrogen, as well as the patented genus of enhancers comprising
tertiary amines having a hydroxy alkyl group attached to the nitrogen. Accordingly, the
claims stand rejected under the doctrine of obviousness-type double patenting.
Appellant argues that the double patenting rejection is improper because the
present application and the application leading to the patent were filed in response to a
Appeal No. 1997-3805
Application No. 08/439,602
5
restriction requirement in parent application serial no. 08/121,072, and the generic
enhancers in the two divisional applications remain the same as they were at filing. Brief,
page 4.
The examiner points out that patented claims 4, 10 and 16 were not original claims
in the parent application that gave rise to the two divisional applications at issue here, but
were added by amendment. Thus, the examiner argues that “these claims are not
consonant with the restriction requirement made in the parent application since the claims
have changed in material respects from the claims at the time the requirement was made .
. . and the line of demarcation between the independent and distinct inventions identified
by the examiner in the parent application does not exist.” Examiner’s Answer, page 8.
Nevertheless, appellant argues “to claim the specific compound, Applicant could
and did place it in one (and only one) of the two applications” and “should not be penalized
or limited in the scope of his rights because the Examiner failed to appreciate that the
groups were not fully distinct at the time the restriction requirement was made.” Brief,
page 4. We note that appellant, despite being aware of the same facts as the examiner,
did not traverse the restriction requirement. Instead, appellant chose to place a claim in
one of the divisional applications that is simultaneously a species of the genuses claimed
in the two divisional applications. Be that as it may, we do not find that the confusion
surrounding the original restriction requirement, in and of itself, justifies an extension of the
Appeal No. 1997-3805
Application No. 08/439,602
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patent term for the presently claimed genus, which is not, in fact, separate and distinct from
the patented genus.
There is no dispute between appellant and the examiner that the presently claimed
genus is obvious over the patented species, but the patented species is not obvious over
the claimed genus. Examiner’s Answer, page 9. Thus, in our view, the dispositive issue is
whether one-way obviousness is sufficient basis for the examiner’s rejection of claims 24
through 26 under the doctrine of obviousness-type double patenting.
According to appellant, the examiner must apply the two-way obviousness analysis
described in In re Braat, 937 F.2d 589, 19 USPQ2d 1289 (Fed. Cir.1991) because the
two divisional applications were filed concurrently. Inasmuch as the patented claims are
directed to a species which falls within the scope of the generic claims of this application,
appellant argues that, in keeping with Braat, the examiner must determine not only whether
the genus is an obvious modification of the species, but whether the species is also an
obvious and trivial modification of the genus, and “submits that such a showing could not
be made.” Brief, pages 4 and 5.
Nevertheless, the examiner does not concede that a two-way test of obviousness is
required under the circumstances. In our judgment, the examiner is correct in applying the
one-way test.
Appeal No. 1997-3805
Application No. 08/439,602
7
In In re Berg, 140 F.3d 1428, 1432, 46 USPQ2d 1226, 1229 (Fed. Cir. 1998), the
court discussed circumstances under which a two-way test of obviousness would be
appropriate:
Generally, a “one-way” test has been applied to determine obviousness-type
double patenting. Under that test, the examiner asks whether the application
claims are obvious over the patent claims. In a recent case, with unusual
circumstances, however, this court instead applied a “two-way” test. See
Braat, 937 F.2d at 592, 19 USPQ2d at 1291-92. Under the two-way test,
the examiner also asks whether the patent claims are obvious over the
application claims. If not, the application claims later may be allowed. Thus,
when the two-way test applies, some claims may be allowed that would have
been rejected under the one-way test. . . The essential concern was to
prevent rejections for obviousness-type double patenting when the
applicants filed first for a basic invention and later for an improvement, but
through no fault of the applicants, the PTO decided the applications in
reverse order of filing, rejecting the basic application although it would have
been allowed if the applications had been decided in the order of their filing.
* * *
. . . Since Braat, many patent applicants facing an obviousness-type double
patenting rejection under the one-way test have argued that they actually are
entitled to the two-way test. The two-way test, however, is a narrow
exception to the general rule of the one-way test. . . Nevertheless, the notion
survives that in certain unusual circumstances, the applicant should receive
the benefit of the two-way test. The question then is: when?
According to the court, Id., 140 F.3d at 1435, 46 USPQ2d at 1232,
The two-way exception can only apply when the applicant could not avoid
separate filings, and even then, only if the PTO controlled the rates of
prosecution to cause the later filed species claims to issue before the claims
for a genus in an earlier application.
Assuming, for the sake of argument, that the first prong of the test has been
satisfied (since the separation of the “phenyl” genus and the “hydroxy alkyl” genus of
enhancer into two divisional applications was the direct result of a restriction requirement
Appeal No. 1997-3805
Application No. 08/439,602
8
in the parent application), the dispositive question is whether or not the second prong of
the test has been satisfied; that is, whether or not the PTO controlled the rate of
prosecution to cause the species claims to issue before the genus claims.
The actions taken by the PTO and by appellant are set forth in chronological order
in the following table and distinguished by different type fonts and columns:
Appeal No. 1997-3805
Application No. 08/439,602
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September Parent application 08/121,072 filed
14, 1993
January 26, Restriction requirement made in ‘072,
1994 separating “phenyl” genus (P) and
“hydroxy alkyl” genus (HA)
May 12, 1995 P divisional filed (08/439,602) HA divisional filed (08/439,603)
Concurrent preliminary amendment adds
phenyl diethanolamine species (PHA)
claims
September
20, 1995
PTO rejects on several grounds, including PTO rejects
provisional obvious-type double patenting
rejection over PHA claims
November 6,
1995
Applicant responds (about 1.5 months after
rejection)
January 5,
1996
Applicant responds (about 3.5 months
after rejection)
February 1,
1996
PTO finally rejects (about 3 months after
response)
April 5, 1996 PTO finally rejects (about 3 months after
response)
April 29, 1996 Applicant responds (about 3 months after
final rejection)
May 14, 1996 PTO allows
September
27, 1996
Applicant responds (about 5 months after
final rejection)
October 8,
1996
PTO issues patent
October 9,
1996
Applicant files notice of appeal
October 16,
1996
PTO sends advisory action
April 4, 1997 Applicant files appeal brief
Appeal No. 1997-3805
Application No. 08/439,602
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As shown in the table, the two divisional applications were filed on the same day.
Likewise, the PTO initiated prosecution of the two applications on the same day, imposing
the double patenting rejection from the start. On the other hand, appellant’s initial
response in the phenyl “genus” divisional was submitted approximately two months later
than the initial response in the phenyl diethanolamine “species” divisional, and this pattern
continued throughout prosecution of the two applications. Given this prosecution history,
we see no evidence that the PTO controlled the rate of prosecution in such a way as to
cause the phenyl diethanolamine species claims to issue before the phenyl genus claims.
Thus, we conclude that the second prong of the test has not been satisfied, and a two-way
obviousness analysis is not required in this instance. Inasmuch as there is no dispute that
one-way obviousness exists between the genus and species claims, the rejection of the
claims under the doctrine of obviousness-type double patenting, based on a one-way
analysis, is affirmed.
Obviousness
Claims 24 through 26 and 30 through 43 stand rejected under 35 U.S.C. § 103 as
unpatentable over Baker and Gantzer.
Baker describes a method, composition, and kit for determining occult blood in a
fecal sample. The sample is combined with an oxidizable substrate (guaiac) and a
developer solution comprising ethanol, water, a peroxide, and an enhancer. Hemoglobin
in the sample has peroxidative activity and catalyzes the oxidation of guaiac, resulting in a
Appeal No. 1997-3805
Application No. 08/439,602
11
blue color. Baker’s enhancer, which provides better color production, is phenol or a
“phenolic type compound[]” (page 2), rather than a tertiary or quaternary amine with a
phenyl or substituted phenyl group attached to the nitrogen, as required by the claims on
appeal.
Gantzer describes a method for determining substances, particularly occult blood,
in a test sample, comprising the steps of combining the test specimen with a peroxide
source, an oxidizable indicator, and a stabilizer, for example, an aniline compound that
serves to stabilize the reagents and enhance the overall sensitivity of the test. Aniline
compounds are tertiary or quaternary amines having a phenyl or substituted phenyl group
attached to the nitrogen. The reference also describes a composition, preferably applied
to a matrix strip as two separate solutions and then dried, wherein the first solution
comprises an enhancer such as aniline, and the second solution contains a peroxide and
an oxidizable indicator compound.
According to the examiner (Examiner’s Answer, pages 7 and 8),
Gantzer renders obvious the composition recited in [the instant claims] since
at the point at which both the first and second solutions are applied to the
dry-matrix test strip, all components of the composition are mixed together
including the enhancer, the peroxide, the indicator substrate and the water
and ethanol.
Thus,
[I]t would have been obvious to one of ordinary skill in the art . . . to substitute
the aniline compounds taught by Gantzer for the phenol compounds as the
enhancer in the method, composition and kit of [Baker] since Gantzer
teaches that aniline compounds enhance the stability of the reaction thus
Appeal No. 1997-3805
Application No. 08/439,602
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enabling the method to be more sensitive to the presence of occult blood.
Therefore, one . . . would have found the aniline compounds taught by
Gantzer to work equally as well as the phenol compounds in the method,
composition and kit taught by [Baker] as enhancers for detecting occult
blood.
We have no doubt that the prior art could be modified in a manner consistent with
appellant’s specification and claims. The fact that the prior art could be so modified,
however, would not have made the modification obvious unless the prior art suggested the
desirability of the modification. In re Gordon, 733 F.2d 900, 902, 221 USPQ 1125, 1127
(Fed. Cir. 1984). Here we find no reason stemming from the prior art which would have led
a person having ordinary skill to the claimed method.
In addition to producing “a more intense and readable blue color end point,”
Baker’s phenolic enhancer “degrades and inhibits the more labile peroxidases” which
often contaminate fecal samples and interfere with test results by causing false positive
reactions. Page 2.
Gantzer, on the other hand, is narrowly focused on improving the shelf-life of solid
phase “dip-and-read” devices impregnated with peroxidatively active substances. The
aniline stabilizer is dried onto the device along with, or in addition to, the a peroxide source
and a colorimetric indicator. According to Gantzer, the “anilines are believed to function
not only as inhibitors of chain decomposition of the organic hydroperoxides commonly
used in solid phase assays, but also are advantageous for diminishing or preventing
deleterious interactions between reagents.” Column 4, lines 55-58.
Appeal No. 1997-3805
Application No. 08/439,602
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In our view, the mere fact that both references are directed to test systems for
detecting occult blood would not have led one skilled in the art to substitute the aniline
stabilizer from Gantzer’s solid phase system for the phenolic enhancer/developer in
Baker’s liquid phase system, when the stated functions of those reagents in their
respective systems are different.
In our judgment, the only reason or suggestion to combine the references in the
manner proposed by the examiner comes from appellant’s specification. Accordingly, the
rejection of claims 24 through 26 and 30 through 43 as unpatentable over Baker and
Gantzer is reversed.
CONCLUSION
For the reasons set forth in the body of this opinion, we have affirmed the rejection
of claims 24 through 26 under the doctrine of obviousness-type double patenting, and
reversed the rejection of claims 24 through 26 and 30 through 43 under 35 U.S.C. § 103.
As a result of the action taken today, claims 30 through 43 are free of rejection.
Appeal No. 1997-3805
Application No. 08/439,602
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No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART
)
William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Douglas W. Robinson )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Toni R. Scheiner )
Administrative Patent Judge )
Appeal No. 1997-3805
Application No. 08/439,602
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Oppedahl & Larson
P.O. Box 5270
Frisco, CO 80443-5270