Ex Parte Heller

Board of Patent Appeals and Interferences

Aug 24, 2010

11199488 (B.P.A.I. Aug. 24, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte ZINDEL HERBERT HELLER
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Appeal 2009-011094
Application 11/199,488
Technology Center 1700
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Before TERRY J. OWENS BEVERLY A. FRANKLIN, and
KAREN M. HASTINGS, Administrative Patent Judges.

OWENS, Administrative Patent Judge.

DECISION ON APPEAL1
STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 59-112, which are all of the pending claims. We have
jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-011094
Application 11/199,488

The Invention
The Appellant claims a method and apparatus for determining the
concentration of a medically significant component of a biological fluid or a
control. Claim 59 is illustrative:
59. A method for determining the concentration of a first, medically
significant component of a biological fluid or a control, the biological fluid
or control including a second component which affects the determination of
the concentration of the first component, the method including performing a
first measurement of a time-varying function i1(t) on the biological fluid or
control which first measurement varies with both the concentration of the
first component and at least one of the presence and concentration of the
second component, i1(t) having the general form

i1(t) = M/sqrt(t) + B

where t is time from initiating the measurement, M is the slope of a
graph of the function and B is a value the function approaches as t becomes
very large, performing a second measurement on the biological fluid or
control which second measurement has the form of a time-varying function
i2(t), where t is time, t < some arbitrarily established time, i2(t) varying
primarily only with the at least one of the presence and concentration of the
second component to develop an indication of the at least one of the
presence and concentration of the second component, and removing an
amount representative of the indicated presence or concentration of the
second component from the concentration of the first component indicated
by the first measurement.

The Rejection
Claims 59-112 stand rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the enablement requirement.
OPINION
We reverse the rejection.

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Appeal 2009-011094
Application 11/199,488

Issue
Has the Appellant indicated reversible error in the Examiner’s
determination that the Appellant’s original disclosure would have failed to
enable one of ordinary skill in the art to determine the concentration of a
first, medically significant component of a biological fluid or a control by
performing a first measurement of a time varying function and using a
second measurement having the form of a time varying function to remove
an amount representative of the presence or concentration of a second
component from the concentration of a first component indicated by the first
measurement of a time varying function?2
Analysis
The Examiner argues that
the specification, while being enabling for the determination of
glucose as the first component in a blood sample in the presence of
hematocrit as a second component, does not reasonably provide
enablement for the determination of any and all analytes found in any
biological fluid. . . . The specification does not provide evidence that
the concentration of any and all components (i.e. bilirubin, albumin,
etc.) in any biological sample (i.e. saliva, spinal fluid, etc[.]) is
affected by the presence or concentration of a second component, and
that the concentrations of all components in a biological fluid sample

2 The Appellant’s exemplified biological fluid is blood or a blood fraction
and the exemplified first and second components are, respectively, glucose
and blood cells (Spec. (copy filed Oct. 31, 2005) 5:31-36). The Appellant
discloses that the principal interference to wet chemistry measurement of
total glucose in blood is from the red and white blood cells (Spec. 4:5-15).
The Appellant teaches that the greater the hematocrit, i.e., the percentage of
the blood’s volume that is cells, the less glucose is available for the glucose
oxidase reaction (Spec. 10:21, 30-31). The Appellant corrects the indicated
glucose concentration for the effect of the hematocrit to provide a more
accurate indication of glucose concentration (Spec. 10:21-27).
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Appeal 2009-011094
Application 11/199,488

can be determined by the functions i1(t) and i2(t) as defined in the
claims. [Ans. 2-3]
. . . .
Analytes other than glucose may require other functions for their
determination in a biological sample in the presence of an interfering
substance. [Ans. 6-7]

The Appellant argues that “the claims do not cover ‘any and all
analytes,’ nor any and all interferents, nor any and all biological fluids or
controls” (Reply Br. 2), and do not cover an analyte and a biological fluid or
control unless the time varying functions in the Appellant’s claims are
applicable. See id. The Appellant argues that “[w]hether an analyte, an
interferent and a biological fluid or control conform to these relationships
(and thus can even be the analyte, interferent, and biological fluid or control
to which the present claims are directed) can straightforwardly be
determined using standard laboratory testing equipment and standard testing
methods” (Reply Br. 3). The Appellant describes a technique for making
that determination (Reply Br. 3-4).
Regarding enablement, a predecessor of our appellate reviewing court
stated in In re Marzocchi, 439 F.2d 220, 223-24 (CCPA 1971):
[A] specification disclosure which contains a teaching of
the manner and process of making and using the invention in
terms which correspond in scope to those used in describing
and defining the subject matter sought to be patented must be
taken as in compliance with the enabling requirement of the
first paragraph of § 112 unless there is reason to doubt the
objective truth of the statements contained therein which must
be relied on for enabling support. . . .
. . . [I]t is incumbent upon the Patent Office, whenever a
rejection on this basis is made, to explain why it doubts the truth or
accuracy of any statement in a supporting disclosure and to back up
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Appeal 2009-011094
Application 11/199,488

assertions of its own with acceptable evidence or reasoning which is
inconsistent with the contested statement. Otherwise, there would be
no need for the applicant to go to the trouble and expense of
supporting his presumptively accurate disclosure.

Contrary to the Examiner’s argument (Ans. 3), the Appellant’s claims
do not require that the concentration of every component of any biological
sample is affected by the presence or concentration of a second component
or that the recited time varying functions apply to all components of all
biological samples. The claims merely require use of a second measurement
having the form of a time varying function to remove an amount
representative of the indicated presence or concentration of a second
component from the concentration of a first component indicated by a first
measurement of the recited time varying function i1(t). The Examiner has
not provided the required evidence or reasoning which shows that one of
ordinary skill in the art could not have determined, through no more than
routine experimentation, the components and biological fluids to which that
concentration adjustment applies.
Conclusion of Law
The Appellant has indicated reversible error in the Examiner’s
determination that the Appellant’s original disclosure would have failed to
enable one of ordinary skill in the art to determine the concentration of a
first, medically significant component of a biological fluid or a control by
performing a first measurement of a time varying function and using a
second measurement having the form of a time varying function to remove
an amount representative of the presence or concentration of a second
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Appeal 2009-011094
Application 11/199,488

component from the concentration of a first component indicated by the first
measurement of a time varying function.
DECISION/ORDER
The rejection of claims 59-112 under 35 U.S.C. § 112, first paragraph,
as failing to comply with the enablement requirement is reversed.
It is ordered that the Examiner’s decision is reversed.
REVERSED

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