Ex parte LILJA et al.

Board of Patent Appeals and Interferences

Feb 27, 1998

07768255 (B.P.A.I. Feb. 27, 1998)

Application for patent filed October 16, 1991.1
-1-
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 23
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte JAN E. LILJA and SVEN-ERIK L. NILSSON
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Appeal No. 95-0635
Application 07/768,2551
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ON BRIEF
________________
Before WINTERS, JOHN D. SMITH and GRON, Administrative Patent
Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting
claims 1, 3, 4, 7, 8 and 12, which are all of the claims
remaining in the application.
Claims 1 and 8 are representative:
Appeal No. 95-0635
Application 07/768,255
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1. A method for determining the glucose content in whole
blood, in which a sample of undiluted whole blood is contacted
with a dye-containing reagent system which undergoes chemical
reaction with the glucose in the whole blood sample, the method
consisting essentially of the steps of:
introducing the undiluted whole blood sample in a
microcuvette having at least one cavity for receiving the sample,
said cavity being internally pretreated with the reagent in a dry
form and said chemical reaction then taking place in said cavity,
the reagent being comprised of a hemolyzing agent and agents
used in the glucose dehydrogenase method, said agents being
comprised of glucose dehydrogenase and a redox indicator dye, the
hemolyzing agent exposing the glucose contained in the blood
cells of the whole blood sample permitting a quantitative total
glucose determination in a whole blood hemolysate, the agents
which participate in the chemical reaction ensure that a dye
concentration change takes place in a wavelength range above
650 nm and,
performing an absorption measurement at said wavelength
range directly on the sample in the cuvette, and further
conducting a secondary absorption measurement to compensate for
background interference in a wavelength range above 700 nm.
8. A disposable cuvette for carrying out a determination of
the glucose content of undiluted whole blood where a sample of
undiluted whole blood is contacted with a dye-containing reagent
system undergoes chemical reaction with the glucose in the
undiluted whole blood sample, the cuvette being comprised of at
least one cavity for receiving the undiluted whole blood sample,
said cavity being internally pretreated with a reagent in dry
form and said chemical reaction occurring in said cavity after
introduction of the sample in undiluted form, the reagent being
comprised of a hemolyzing agent and agents used in the glucose
dehydrogenase method, said agents being comprised of glucose
dehydrogenase and a redox indicator dye, the hemolyzing agent
exposing the glucose contained in the blood cells of the whole
blood sample permitting a quantitative total glucose
determination in a whole blood hemolysate, the agents which
participate in the chemical reaction ensure that the dye
concentration change takes place in a wavelength range above
650 nm and that the cuvette is at least partly transparent for
Appeal No. 95-0635
Application 07/768,255
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permitting an absorption measurement directly on the sample in
the cavity of the cuvette in said wavelength range.
The prior art references relied on by the examiner are:
Banauch et al. (Banauch) 3,964,974 June 22, 1976
Lilja et al. (Lilja) 4,088,448 May 9, 1978
Pierre et al. (Pierre) 4,120,755 Oct. 17, 1978
Draeger et al. (Draeger) 4,551,427 Nov. 5, 1985
Tanaka et al. (Tanaka) 4,990,457 Feb. 5, 1991
(filed Apr. 4, 1989)
Claim 8 stands rejected under 35 U.S.C. § 102(b) as
described by or, in the alternative, under 35 U.S.C. § 103 as
unpatentable over Lilja. Claims 1, 3, 4, 7 and 12 stand rejected
under 35 U.S.C. § 103 as unpatentable over Pierre, Banauch,
Draeger, or Tanaka, either of those references considered alone
or further considered in view of Lilja. We shall reverse these
rejections.
DISCUSSION
The examiner's finding, that Lilja describes the disposable
cuvette of claim 8, is clearly erroneous. We summarily reverse
the rejection of claim 8 under 35 U.S.C. § 102(b) as described by
Lilja.
With respect to the rejection of claim 8 under 35 U.S.C.
§ 103 as unpatentable over Lilja, the examiner bears the initial
burden of presenting a prima facie case of unpatentability. In
re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed.
Appeal No. 95-0635
Application 07/768,255
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Cir. 1992). This the examiner has not done. The examiner does
not provide an adequate evidentiary basis to sustain a prior art
rejection of claim 8 drawn to a cuvette having at least one
cavity,
said cavity being internally pretreated with a reagent
in dry form . . . the reagent being comprised of a
hemolyzing agent and agents used in the glucose
dehydrogenase method, said agents being comprised of
glucose dehydrogenase and a redox indicator dye.
In an effort to reach the hemolyzing agent and other "agents
used in the glucose dehydrogenase method," recited in claim 8,
the examiner refers to "references" and to "reagents . . . taught
by the prior art" and to acknowledged prior art. See the
Examiner's Answer, page 5, lines 11 through 23. However, the
rejection before the Board is predicated on 35 U.S.C. § 103, and
the only evidence included in the statement of that rejection is
Lilja. In the statement of rejection, the examiner does not
include any other prior art references or acknowledged prior art.
As stated in In re Hoch, 428 F.2d 1341, 1342 n.3, 166 USPQ 406,
407 n.3 (CCPA 1970):
Where a reference is relied on to support a rejection,
whether or not in a "minor capacity," there would
appear to be no excuse for not positively including the
reference in the statement of rejection.
In conclusion, the Lilja patent alone is insufficient to support
a conclusion of obviousness of claim 8 which includes the
Appeal No. 95-0635
Application 07/768,255
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above-quoted limitations. Accordingly, we reverse the rejection
of claim 8 under 35 U.S.C. § 103 as unpatentable over Lilja.
Independent method claims 1 and 12 recite a reagent
containing more than conventional agents used in the glucose
dehydrogenase method for determining the glucose content of
blood. Each of those claims additionally requires a "hemolyzing
agent" in the reagent. Furthermore, claim 1 recites the steps of
(1) "performing an absorption measurement at said wavelength
range [above 650 nm] directly on the sample in the cuvette;" and
(2) "further conducting a secondary absorption measurement to
compensate for background interference in a wavelength range
above 700 nm." By the same token, claim 12 recites the steps of
(1) "determining by transmission photometry the concentration
change of the dye at a wavelength that is in an absorption range
above 650 nm., the dye being selected so that the dye
concentration change takes place at least in a wavelength range
above 650 nm. which is outside the absorption range of the blood
hemoglobin;" and (2) "further conducting a secondary absorption
measurement to compensate for background interference in a
wavelength range above 700 nm."
Manifestly, the examiner has not established a prima facie
case of obviousness of claims containing those limitations. We
have carefully reviewed the examiner's discussion of Pierre,
Appeal No. 95-0635
Application 07/768,255
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Banauch, Draeger, Tanaka and Lilja (Answer, pages 6 through 11).
In our judgment, however, the examiner does not adequately
explain how the cited prior art would have led a person having
ordinary skill from "here to there," i.e., from the disclosures
of the cited references to appellants' claimed method containing
the limitations outlined above. Ex parte Tanksley, 37 USPQ2d
1382, 1386 (Bd. Pat. App. & Int. 1994). We therefore reverse the
rejection of claims 1, 3, 4, 7 and 12 under 35 U.S.C. § 103 as
unpatentable over Pierre, Banauch, Draeger or Tanaka, either of
those references considered alone or further considered in view
of Lilja.
The examiner's prior art rejections are reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
JOHN D. SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
TEDDY S. GRON )
Administrative Patent Judge )
Joseph C. Sullivan
Kane, Dalsimer, Sullivan, Kurucz, Levy
Eisele and Richard
Appeal No. 95-0635
Application 07/768,255
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