Ex Parte WU

Patent Trials and Appeals Board

Mar 26, 2019

12329698 - (D) (P.T.A.B. Mar. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/329,698 12/08/2008
71331 7590
NIXON PEABODY LLP
70 West Madison, Suite 3500
CHICAGO, IL 60602
03/28/2019
FIRST NAMED INVENTOR
Huan-Ping WU
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.
07DC03 l US01/247082-433USP 9388
EXAMINER
WHALEY, PABLO S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/28/2019 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):
docketingchicago@nixonpeabody.com
ipairlink@nixonpeabody.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RUAN-PING WU 1
Appeal2017-007857
Application 12/329,698
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant identifies Ascensia Diabetes Care Holdings AG as the real party-
in-interest. App. Br. 1.
Appeal2017-007857
Application 12/329,698
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-5, 72-13, 16, 18-27, 83, and 84 as
unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory subject
matter.
Claims 1-5, 7-13, 16, 18-27, 83, and 84 also stand rejected as
unpatentable under 35 U.S.C. § 112, second paragraph, as being indefinite.
Claims 1, 4, and 5 stand rejected as unpatentable under the
nonstatutory doctrine of obviousness-type double patenting over claims 1, 4,
5, 6, 18, and 24 of Huang et al. (US 9,164,076 B2, October 20, 2015) (the
"'07 6 patent").
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to a biosensor system that adjusts a
relation for determining analyte concentrations in a biological sample from
output signals with one or more index functions responsive to one or more
errors that could bias the determined analyte concentrations. Spec. ,r 20.
2 Independent claim 7 is not listed as a claim on appeal in the Examiner's
Final rejection, or otherwise addressed by the Examiner. See Final Act. 1.
However, claims 8-12, which depend from claim 7, were included in the
Examiner's rejections under 35 U.S.C. §§ 101 and 112, second paragraph.
Id. We therefore include independent claim 7 in our analyses with respect
to these rejections.
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REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method for determining an analyte concentration in a
fluid sample via a biosensor system comprising:
providing an analyte measurement device and a sensor
strip, the analyte measurement device including a storage device,
a sensor interface, and a processor, the processor coupled to
storage device and the sensor interface, the sensor interface for
receiving the sensor strip, the sensor strip including an electrode
that contacts the sensor interface of the measurement device
when the sensor strip is placed in the sensor interface;
applying an electrical input signal to the sample via the
electrode of the sensor strip when the sensor strip is placed in the
sensor interface of the analyte measurement device and a fluid
sample is applied to the sensor strip;
generating at least one output signal value from an analysis
of the fluid sample via the sensor interface of the analyte
measurement device, the at least one output signal value
responsive to the analyte concentration in the sample;
determining at least one L'iS value from at least one error
parameter via the processor of the analyte measurement device,
where the at least one L'iS value is a value of slope deviation or a
value of normalized slope deviation in relation to at least one
previously determined reference correlation relating previously
determined reference output signal values to reference sample
analyte concentration values, the previously determined
reference sample analyte concentration values obtained from a
reference instrument, the previously determined reference
correlation stored in the storage device of the analyte
measurement device, and where the at least one error parameter
causes one or more errors in the at least one output signal value;
and
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determining the analyte concentration in the sample from
the at least one output signal value, the at least one L'iS value, and
the at least one previously determined reference correlation
relating the at least one output signal value to one of the reference
sample analyte concentration values via the processor of the
analyte measurement device,
where the determining the analyte concentration in
the sample comprises adjusting the at least one previously
determined reference correlation with the at least one L'iS
value, and
where the determining the at least one L'iS value
from at least one error parameter and the determining the
analyte concentration in the sample from the at least one
output signal value are performed by the processor of the
analyte measurement device using computer readable
software code.
App. Br. 27-28.
ISSUES AND ANALYSIS
We decline to adopt the Examiner's findings, reasoning, and
conclusion that Appellant's claims 1-5, 7-13, 16, 18-27, 83, and 84 are
directed to nonstatutory subject matter or indefinite. However, we adopt the
Examiner's conclusion that claims 1, 4, and 5 are obvious under the
nonstatutory doctrine of obviousness-type double patenting. We address the
arguments raised by Appellant below.
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A. Rejection of claims 1-5, 8-13, 16, 18-27, 83, and 84 under 35 U.S.C.
§ 101
Issue
Appellant argues that the Examiner erred in finding that the claims
recite no more than an abstract concept and are therefore directed to
nonstatutory subject matter. App. Br. 9.
Analysis
In performing an analysis of patentability under Section 101, we
follow the framework set forth by the Supreme Court in Mayo Collaborative
Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). We are also
mindful of, and guided by, the USPTO's 2019 Revised Patent Subject
Matter Eligibility Guidance, 84(4) Fed. Reg. 50-57 (January 7, 2019) (the
"2019 Guidance").
Appellant's claim 1 recites: "A method for determining an analyte
concentration in a fluid sample via a biosensor system comprising .... "
Following the first step of the Mayo analysis, we agree with the Examiner
that the claims are directed to a method or "process" and therefore fall into
one of the broad statutory categories of patent-eligible subject matter under
35 U.S.C. § 101. Final Act. 2.
In the next step of the Mayo analysis, we determine whether the
claims at issue are directed to a nonstatutory, patent-ineligible concept, i.e., a
law of nature, a phenomenon of nature, or an abstract idea. Mayo, 566 U.S.
at 70-71. If the claims are so directed, we next consider the elements of
each claim both individually and "as an ordered combination" to determine
whether additional elements "transform the nature of the claim" into a
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patent-eligible application. Id. at 78-79; see also Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir. 2015). Specifically, the
Supreme Court considered this second step as determining whether the
claims recite an element or combination of elements that is "sufficient to
ensure that the patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself." Mayo, 566 U.S. at 72-73.
More specifically, in this second step of the Mayo analysis, we look to
whether the claim recites one of the judicially-created exceptions to Section
101, i.e., an abstract idea, a law of nature, or a natural phenomenon. See
2019 Guidance 54 ( step 2A, prong 1 ). In the case of claims reciting an
abstract idea, these exceptions comprise mathematical concepts, certain
methods of organizing human activity, and mental processes. Id. If we
determine that the claim is directed to a judicial exception, we then
determine whether the limitations of the claim reciting the judicial exception
are integrated into a practical application. Id. (step 2A, prong 2).
Finally, if we determine that the claim is directed to a judicially-
created exception to Section 101, we evaluate assess the claims under step
two of the Mayo analysis, considering the elements of each claim both
individually and "as an ordered combination" to determine whether
additional elements "transform the nature of the claim" into a patent-eligible
application. Mayo, 566 U.S. at 78-79; 2019 Guidance at 56 (Step 2B).
Claim 1 recites, in relevant part:
[D]etermining at least one L'iS value from at least one error
parameter via the processor of the analyte measurement device,
where the at least one L'iS value is a value of slope deviation or a
value of normalized slope deviation in relation to at least one
previously determined reference correlation relating previously
determined reference output signal values to reference sample
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analyte concentration values, the previously determined
reference sample analyte concentration values obtained from a
reference instrument, the previously determined reference
correlation stored in the storage device of the analyte
measurement device, and where the at least one error parameter
causes one or more errors in the at least one output signal value;
and
determining the analyte concentration in the sample from
the at least one output signal value, the at least one L'iS value, and
the at least one previously determined reference correlation
relating the at least one output signal value to one of the reference
sample analyte concentration values via the processor of the
analyte measurement device,
where the determining the analyte concentration in
the sample comprises adjusting the at least one previously
determined reference correlation with the at least one L'iS
value, and
where the determining the at least one L'iS value
from at least one error parameter and the determining the
analyte concentration in the sample from the at least one
output signal value are performed by the processor of the
analyte measurement device using computer readable
software code.
The Examiner finds that these "determining" limitations recited in
claim 1 are directed to an ineligible mathematical concept. Final Act. 2.
Specifically, the Examiner finds the limitations recite determining the slope
differential (L'iS) between a measured analyte concentration function and a
reference function, and then using the L'iS to determine the actual analyte
concentration by removing possible sources of error, such as temperature,
hematocrit levels, etc. Final Act. 2-3; see also, e.g., Spec. Fig. 5; ,r,r 88-94.
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We agree with the Examiner's conclusion at this step of the analysis.
Claim 1 recites: "generating at least one output signal value." The
"determining" steps of the analysis relate to a comparison of the measured
output signal value (i.e., the slope function derived from measurements of
the actual test analyte) and comparing the derived slope values to a set of
reference values stored previously to arrive at a slope deviation, L'iS. This
L'iS value is then used to correct for possible error parameters that can cause
differences between the measured slope function and the stored reference
slope function, and to arrive at a corrected and accurate analyte
concentration value. Although the claims do not expressly recite
mathematical formulae for determining L'iS, the Specification discloses
algorithms for the determination of L'iS, and for using L'iS in correcting the
measured analyte slope function to obtain an accurate analyte concentration
value, which are fairly characterized as mathematical relationships. See
Spec. ,r,r 84, 92, 104, 107, 111.
Furthermore, claim 1 also recites a "processor" upon which these
quantitative values may be determined and a "storage device" from which
the reference values may be retrieved for comparison with the measured
values. Claim 1 additionally recites that: "the at least one output signal
value [is] performed by the processor of the analyte measurement device
using computer readable software code." Claim 1 thus relates to the
manipulation of mathematical data ( comparing derived values to stored
values to correct for measurement error) by a processor using computer-
readable software code. We therefore conclude that the claims recite a
mathematical relationship, which is a category of an "abstract idea" and an
exception to Section 101. See Mayo 566 U.S. at 89.
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Our analysis, however, does not end there. We next look to evaluate
whether the claim recites additional elements that integrate the exception
into a practical application. 2019 Guidance 54. We perform this evaluation
by: (1) identifying whether there are any additional elements recited in the
claim beyond the judicial exception(s); and (2) evaluating those additional
elements individually and in combination to determine whether they
integrate the exception into a practical application. Id. at 54--55.
Claim 1 also recites:
[ A ]n analyte measurement device and a sensor strip, the analyte
measurement device including a storage device, a sensor
interface, and a processor, the processor coupled to storage
device and the sensor interface, the sensor interface for receiving
the sensor strip, the sensor strip including an electrode that
contacts the sensor interface of the measurement device when the
sensor strip is placed in the sensor interface.
This device is then employed by:
[ A ]pp lying an electrical input signal to the sample via the
electrode of the sensor strip when the sensor strip is placed in the
sensor interface of the analyte measurement device and a fluid
sample is applied to the sensor strip
The end result of the ensuing "determining" steps recited in the claim is the
determination of: "the analyte concentration in the sample."
Claim 1 is thus directed to a specific analyte measurement device,
comprising: (1) a storage device; (2) a sensor interface; (3) a processor
coupled to the storage device; and ( 4) a sensor interface for receiving a
sensor strip including an electrode. This device is used in a specific
application or method as recited in claim 1, i.e., the accurate measurement of
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an analyte (i.e., blood glucose concentration; see, e.g., Spec. ,r 14). The
recited mathematical concept described supra is employed within the device
to ensure an accurate reading of the analyte by correcting for possible errors.
The mathematical processes recited in the claims are thus
incorporated into a specific device that is recited in the claim and used in a
specific application: viz., the accurate, corrected measurement of an analyte.
We therefore conclude that the claims recite additional elements that
implement the judicial exception with, and uses a judicial exception in
conjunction with, a particular machine or manufacture that is integral to the
claim. See, e.g., Eibel Process Co. v. Minnesota & Ontario Paper Co., 261
U.S. 45, 64---65 (1923).
We note that the claims on appeal differ from those at issue in
Diamond v. Diehr, 450 U.S. 175 (1981), in that they are not directed to a
transformation or reduction of a particular article to a different state or thing.
Diehr, 450 U.S. at 184. Nevertheless, we conclude that the claims are
directed to a sufficiently specific and non-abstract application, i.e.,
determining the concentration of an analyte. Furthermore, we note that the
measurement of a defined substance or property is the very essence of a
measurement device.
We therefore conclude that, although the claims may recite a
mathematical concept, the claim also recites additional elements that
integrate the exception into a practical application. As such, the claims are
not directed solely to a judicial exception to Section 101, and our eligibility
analysis concludes there. See 2019 Guidance 54. We consequently reverse
the Examiner's rejection of the claims upon this ground.
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B. Rejection of claims 1-5, 8-13, 16, 18-27, 83, and 84 under 35 U.S.C.
§ 112, second paragraph as being indefinite
Issue 1: "reference correlation "
Appellant argues that the Examiner erred in finding that the claim
term "one previously determined reference correlation" is indefinite. App.
Br. 20.
Analysis
The Examiner finds that claim 1 does not set forth any previous steps
whereby a "reference correlation" is previously determined or provided.
Final Act. 6. The Examiner also finds that the claim does not set forth any
previous steps by which "reference sample analyte concentration values" are
determined or provided. Id. The Examiner therefore contends that the claim
is incomplete because it omits essential steps. Id.
The Examiner further finds with respect to the claim language reciting
"relating ... output signal values to reference sample analyte concentration
values," it is unclear what positive process limitation(s) is/are intended.
Final Act. 6. The Examiner finds that this feature does not impart any active
method steps (i.e. relating two things), but merely describes the nature of the
reference correlation (i.e., the nature of the data). Id.
Appellant responds that the reference correlation is a predetermined
( e.g., calculated in advance) set of values and is stored in the measurement
device for use in the measurement process. App. Br. 20. Appellant argues
that a person of ordinary skill in the art would have understood "reference
correlation" to mean a standard or reference relationship between output
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current and analyte concentration. Id. Appellant contends, by way of
example, that a 100 nA analytic output signal may correspond to a
50 mg/dL analyte concentration in the reference correlation. Id. Therefore,
argues Appellant, when a 100 nA analytic output signal is received, the
sensor would output an analyte concentration of 50mg/dL, based on the
reference correlation. Id. Appellant asserts that the term "reference
correlation obtained from a reference instrument" is explained in paragraph
[0086] of Appellant's Specification, and refers to previous test data of
analyte concentrations and corresponding output currents that are used to
assemble the correlation. Id.
According to Appellant, a person of ordinary skill in the
contemporary art would not have found this term indefinite, as explained in
the Declaration of the inventor, Dr. Ruan-Ping Wu (the "Wu Declaration").
App. Br. 20 ( citing Wu Deel. ,r 7). Furthermore, contends Appellant, a
person of ordinary skill in the art would have understood that the previous
steps recited in claim 1 involved obtaining reference sample analyte
concentration values from a reference instrument and assembling a reference
correlation table for storage and use in the method in claim 1. Id.
We agree with Appellant. Paragraph [0086] of Appellant's
Specification discloses, in relevant part:
Thus, the output signal preferably has a linear relationship with
the analyte concentration in the sample and may originate from
a redox reaction, light-identifiable species, or other process. The
reference correlation equation describes a function relating the
output signals from a biosensor system to analyte concentration
values determined from a reference instrument. For example, the
output signal from a biosensor system for a specific sample may
be related to the analyte concentration values determined from a
YSI reference instrument for the same sample.
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With respect to the last sentence quoted supra, paragraph [0012] of
Appellant's Specification further discloses that: "Accepted reference values
may be obtained with a reference instrument, such as the YSI 2300 STAT
PLUSâ„¢ available from YSI Inc., Yellow Springs, Ohio." We agree with
the Appellant that a person of ordinary skill, having read the language of the
claims in light of the Specification, would have understood that the claim
term "reference correlation" refers to a set of previously or concurrently
determined reference values obtained by a standard reference measurement
instrument, e.g., a YSI 2300 STAT PLUSâ„¢.
Furthermore, Dr. Wu opines that:
It is known in the art that a reference correlation can be
determined by a reference instrument such as a glucose analyzer
manufactured by YSI. To obtain the reference correlation,
different samples of varying analyte concentrations are measured
and the corresponding output currents are recorded. After
sufficient testing samples are taken, a reference correlation may
be obtained that correlates different current values with
corresponding analyte concentrations. This reference correlation
is stored and used by a processor in the actual instrument to
output the analyte concentration corresponding to a generated
output current.
Wu Deel. ,r 7. We are persuaded by Appellant that the storage of previously
collected reference data from a standard instrument, for the purposes of
comparison with test measurements, is an ordinary practice in the art of
analyte sensing that would have been reasonably understood by a skilled
artisan. We therefore reject the Examiner's findings and conclusion.
Issue 2: "error parameter"
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Appellant argues that the Examiner erred in finding that the claim
language reciting: "where the at least one error parameter causes one or
more errors in the output signal," is indefinite with respect to how error
parameters cause one or more errors in the output signal. App. Br. 20.
Analysis
The Examiner finds that the claim term "causes" appears to be
nothing more than an intended use recitation of the error parameter, and it is
unclear to the Examiner in what way an error parameter "causes" errors in
the output signal. Final Act. 6. Consequently, the Examiner finds, it is
unclear as to what the limiting effect of the claimed error parameter is
intended by this phrase such that one of ordinary skill in the art would know
how to avoid infringement. Id. The Examiner further finds that a review of
Appellant's Specification does not provide any limiting definition or
clarifying examples. Id.
Appellant responds that claim 1 is directed to a method for
compensating for an actual error by adjusting the reference correlation.
App. Br. 21. Appellant asserts that a person of ordinary skill in the art
would understand that errors are present in measuring an analyte, due to
factors such as temperature or hematocrit content, that will distort the
reading as explained in paragraph [0013] of the Specification. Id. (also
citing Wu Deel. ,r 8). According to Appellant, compensating for such errors
to produce a more accurate analyte concentration reading is the inventive
feature of Appellant's claims. Id.
Appellant argues further that the term "error parameter" is also
explained in paragraph [0094] of the Specification as being any value
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responsive to one or more errors in the output signal. App. Br. 21.
Appellant explains that these errors are not measured or determined from the
signal separately. Id. For example, Appellant contends, temperature or
hematocrit content can result in error in the output signal, but the output
signal does not have a separate component that is measured for this error.
Id. Appellant contends that, because such errors are known to be in the
output signal value, and because these error parameters cause such errors,
the claimed process corrects such errors by employing the correction
function based on slope deviation for such conditions. Id. Appellant argues
that a person of ordinary skill in the art would have understood that the
claimed method corrects the error caused by the error parameters. Id.
We are persuaded by Appellant's argument. Appellant's
Specification discloses:
Biosensor systems may provide an output signal during the
analysis of the biological fluid that includes one or multiple
errors. These errors may be reflected in an abnormal output
signal, such as when one or more portions or the entire output
signal is non-responsive or improperly responsive to the analyte
concentration of the sample. These errors may be from one or
more contributors, such as the physical characteristics of the
sample, the environmental aspects of the sample, the operating
conditions of the system, interfering substances, and the like.
Physical characteristics of the sample include hematocrit (red
blood cell) concentration and the like. Environmental aspects of
the sample include temperature and the like. Operating
conditions of the system include underfill conditions when the
sample size is not large enough, slow-filling of the sample,
intermittent electrical contact between the sample and one or
more electrodes in the sensor strip, degradation of the reagents
that interact with the analyte, and the like. Interfering substances
include ascorbic acid, uric acid, acetaminophen, and the like.
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There may be other contributors or a combination of contributors
that cause errors.
Spec. ,r 13. The Specification further discloses that such errors are well
known in the art and that various techniques have been employed as a means
of correcting those errors so as to provide accurate analyte measurement.
Spec. ,r,r 14--17.
Dr. Wu further attests that factors causing errors in analyte
measurement are well known to those of skill in the art:
A problem with using a reference correlation is that the
concentration values may be subject to errors based on external
factors such as temperature or hematocrit content that differ from
those when the testing was conducted to determine the reference
correlation. For example, if the reference correlation was taken
at a hematocrit content of 42% and an analytic output signal is
taken from a sample with a hematocrit content of 60%, the
biosensor will inaccurately report a different analyte
concentration value at the higher hematocrit content of 60%
using the reference correlation. One skilled in the art would
understand that such an error will occur as it is well understood
that such external factors distort the readings.
Wu Deel. ,r 8.
Appellant's Specification further discloses that:
An index function may be responsive to an error parameter, such
as temperature, which is measurable by another means. An index
function may be a calculated number that correlates with an error
parameter such as hematocrit and represents the influence of this
error parameter on the slope deviation L'iS. Thus, error parameters
may be any value responsive to one or more errors in the output
signal and may be measured, calculated, or determined through
other means. Index functions may be experimentally determined
as a regression equation of the plot between L'iScal and an error
parameter.
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Other methods may be correlated with error parameters, such as
the %-hematocrit level of whole blood samples. For example, US
Patent No. 7,338,639 describes using AC phase angle
measurements to determine the hematocrit level and temperature
errors associated with whole blood samples. EP 1,742,045 Al
describes the determination of the hematocrit by an independent
electrode and the correlation of the hematocrit level with output
currents.
Spec. ,r,r 94--95 (paragraph numbers omitted).
The combined evidence thus teaches that it was well known in the art
that a number of factors can cause quantitative errors in analyte
measurement and that it is of concern of those in the art to devise methods of
correcting for such error parameters. We therefore agree with Appellant that
a person of ordinary skill in the art, upon reading the claims in light of the
Specification, would have understood what is meant by the language of
claim 1 reciting "at least one error parameter causes one or more errors in
the at least one output signal."
Issue 3: "reference sample analyte concentration"
Appellant argues that the Examiner erred in finding the language of
claim 1 reciting: "reference sample analyte concentration" is indefinite and
"appears from out of nowhere." App. Br. 21 (quoting Final Act. 6).
Analysis
The Examiner finds that claim 1 recites: "determining the analyte
concentration ... where the determining the analyte concentration in the
sample comprises adjusting the at least one previously determined reference
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correlation with the at least one L'iS value." Final Act. 6. The Examiner
finds that it is unclear what positive process limitations are intended by the
above phrase. Id. On one hand, the Examiner finds, the claim requires
"determining" the analyte concentration, apparently by comparison to a
reference sample analyte concentration. Id. On the other hand, the
Examiner finds, the claim recites a "where" phrase that appears to require
adjusting a reference correlation. Id. The Examiner states that, if
Appellant's invention is a method of correcting the output signal using a
correlation equation, this is not clear. Id.
Appellant repeats the argument presented supra, that the determined
reference correlation is described in claim 1 as "relating the at least one
output signal value to reference sample analyte concentration values." App.
Br. 21. Appellant contends that the sample analyte concentration values are
determined by adjusting the previously determined reference correlation
with the L'iS value that represents the slope deviation due to error. Appellant
contends that a person of ordinary skill in the art would have understood that
this element of claim 1 is a description of the process of eliminating error in
the measured analyte concentration by determining the L'iS value ( slope
deviation due to error) and applying that value to correct the error to produce
a corrected output. Id. at 20-21.
We agree with Appellant. As we have explained supra, Appellant's
Specification discloses that the reference sample analyte concentration is
determined by a reference set of concentration values compared to a
reference set of sensor outputs that are derived from a standardized source
and are stored in memory for comparison to the sensor output from a test
source. These concentration values reflect the concentration in the reference
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standard in the absence of error-causing factors. Specifically, Appellant's
Specification discloses that:
Accuracy may be expressed in terms of bias of the sensor
system's analyte reading in comparison to a reference analyte
reading, with larger bias values representing less accuracy ....
Accepted reference values may be obtained with a reference
instrument, such as the YSI 2300 STAT PLUSâ„¢ available from
YSI Inc., Yellow Springs, Ohio.
Spec. ,r 12. We consequently agree with Appellant that a person of ordinary
skill would have understood from the disclosures of the Specification that a
"reference sample analyte concentration," as recited in claim 1 is the basis
for the stored "a reference analyte reading," disclosed in the Specification.
Issue 4: "index function"
Appellant argues that the Examiner erred in finding that the claim
term "index function" recited in claims 7, 18, and 19 is indefinite. App. Br.
22.
Analysis
The Examiner notes that the claims recite: "where ... the
predetermined index function being determined by a regression equation .... "
Final Act. 7. The Examiner points to MPEP § 2111.04, noting that the
following are examples of language that may raise a question as to the
limiting effect of the language in a claim: ( 1) statements of intended use or
field of use; (2) "adapted to" or "adapted for" clauses; (3) "wherein" clauses;
or ( 4) "whereby" clauses. Id. The Examiner finds that, in the claims at
issue, the quoted limitation merely describes the environment in which the
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data was obtained, i.e., a product-by-process type limitation, and does not
impose any additional positive process limitations of the method as claimed
and is therefore indefinite. Id.
The Examiner further finds that it is unclear as to the metes and
bounds of the term "index function" such that a skilled artisan would have
understood what mathematical function is intended. Final Act. 7. The
Examiner again notes that the phrase has been described in terms of how it is
obtained, i.e., a product-by-process type limitation, but not what actually
comprises this function. Id. The Examiner finds that paragraphs [0061] and
[0071] suggest that index functions could be represented as the %-bias, but
finds that these disclosures do not amount to a limiting definition for index
functions. Id.
Appellant responds that the claim term "index function" is recited to
further define the step of determining at least one L'iS value from a
predetermined index function that is part of the error parameter. App. Br. 22
( citing Wu Deel. ,r,r 10-12 ). Appellant asserts that index functions may be
used for any error parameter and, therefore, claim 7 is a general process for
any error parameter. Id. at 23.
Appellant argues that, based upon the disclosures of the Specification,
a person of ordinary skill in the art would have understood that an index
function is a function relating intermediate values of an output signal to the
error in determined analyte concentrations to provide a value of slope
deviation from a reference correlation as explained in paragraphs [0056] and
[0057] of the Specification. App. Br. 23 (also citing Wu Deel. ,r 12).
According to Appellant, a skilled artisan would have understood the
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mathematical functions that fall within the metes and bounds of the "index
function" term recited in these claims. Id.
Appellant argues that claim 7 recites that the "predetermined index
function" is "determined by a regression equation of a plot between the
deviation in a slope of the reference correlation in response to the at least
one error parameter." App. Br. 23 (citing Spec. ,r,r 91, 94). Appellant
argues that regression analysis is a well understood statistical method to
determine variables for inclusion in mathematical functions. Id.
We are not persuaded by the Examiner's reasoning. Appellant's
Specification discloses that:
The present invention provides a biosensor system that adjusts a
relation for determining analyte concentrations in a biological
sample from output signals with one or more index functions
responsive to one or more errors that could bias the determined
analyte concentrations. The bias may be represented by slope
deviations, L'iS values, and normalized slope deviations obtained
from one or more error parameters. The L'iS values represent
slope deviations determined with one or more index functions
from the error parameters. The index functions are extracted
from the output signals.
Spec. ,r 20. The Specification further discloses:
In a method for determining index functions from error
parameters, at least one error parameter responsive to the percent
bias in a determined analyte concentration in a sample is
determined. The at least one error parameter is related to at least
one L'iS value with at least one index function, the at least one L'iS
value representing the difference in slope between the slope from
a reference correlation and a hypothetical slope of a line for the
output signal value that would provide an analyte concentration
in the sample without bias.
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Id. at ,r 22. In other words, the Specification discloses that an index function
is a mathematical function derived from the effect of an error parameter on a
measured analyte sample and relating that error parameter to a L'iS value (the
slope deviation between test and reference measurements (see Spec. Fig. 5)).
Appellant's Specification further discloses:
Index functions compensate the measured analyte concentration
for one or more errors in the analyte concentration analysis. One
or more index functions may be used. An index function that
correlates with the total slope deviation L'iS would provide an
ultimate total error compensation of the analyte concentration
since this index function could be used to compensate for the
total error in the analysis without having to know the exact cause
of the slope deviation L'iS and thus the bias of the measured
analyte concentration. An index function may be responsive to
an error parameter, such as temperature, which is measurable by
another means. An index function may be a calculated number
that correlates with an error parameter such as hematocrit and
represents the influence of this error parameter on the slope
deviation LIS. Thus, error parameters may be any value
responsive to one or more errors in the output signal and may be
measured, calculated, or determined through other means. Index
functions may be experimentally determined as a regression
equation of the plot between LI Seal and an error parameter.
Spec. ,r 94 ( emphases added). Dr. Wu explains that:
One skilled in the art would clearly understand, based on reading
[Appellant's Specification], the process of determining an index
function based on test data and application of statistical methods.
The published application describes throwing out potential error
parameters to select those with the most influence on error. The
selected error parameters are then incorporated into the
determined index function. The determined index function is
stored in the medical device for use to predict error (slope
deviation value L'iS) in the measurement environment. It is my
opinion that one skilled in the art therefore would not find the
term "index function" indefinite as used in claims 7, 18 and 19.
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One skilled in the art would also understand that the L'iS value
( compensation for error) would be influenced by the error
parameter and would be expressed by the index function based
on the claimed language.
Wu Deel. i112.
Appellant's Specification further discloses that:
Index functions correspond to the %-bias in the correlation
between the analyte concentrations and the output signals due to
one or more errors in the analysis. The %-bias in the correlation
may be represented by one or more LIS values obtained from one
or more error parameters. The L'iS values represent slope
deviations of the correlation between analyte concentrations and
output signals determined from one or more error parameters.
Index functions corresponding to the slope or change in slope
may be normalized to reduce the statistical effect of changes in
the output signals, improve the differentiation in variations of the
output signals, standardize the measurements of the output
signals, a combination thereof, or the like.
Spec. ,r 57 (emphasis added). Paragraphs [0060]-[0070] of the Specification
provide a mathematical example of determining the relationship between the
%-bias and an index function.
We agree with Appellant that a person of ordinary skill in the art
would have understood, from both the disclosures of the Specification and
the knowledge of those skilled in the art, that an index function serves to
relate the slope deviation (i.e., the L'iS) between test and reference samples to
reflect the effect of the error parameter upon the actual analyte
measurement.
Issue 5: "peifect correlation"
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Appellant argues that the Examiner erred in finding that the limitation
of claim 11 reciting: "the L'iScal value representing the difference between the
reference correlation and a hypothetical perfect correlation having an R2
value of at least 0.3" is indefinite. App. Br. 23.
Analysis
The Examiner finds that Appellant's Specification does not provide
any limiting definition or clarifying examples for the term "having an R2
value of at least 0.3 correlation." Final Act. 8. The Examiner also finds that
it is unclear as to what way this claim further limits the subject matter of
parent claims 1 and 7, as these claims do not set forth any previous steps by
which a "L'iScai" having R2 values are determined or even explicitly
calculated for a reference correlation. Id.
Appellant first points to paragraphs [0082], [0088], and Figure 5 of
the Specification as explaining the concept of a hypothetical perfect
correlation between an analyte concentration and the output signal obtained
from applying an electrical signal to the biological sample. App. Br. 23.
Appellant argues that the use of such a perfect correlation would result in a
completely accurate determination of the analyte concentration from the
output signal. Id.
Appellant further asserts that a person of ordinary skill in the art
would have understood that R2 is a coefficient of determination that is well
known in the art of statistical measurement, and used to describe how close
the data is to the fitted regression line correlation, as explained in paragraph
[0060] of Appellant's Specification. According to Appellant, a person of
ordinary skill in the art would have therefore understood how the R2 value is
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determined to describe how closely the L'iScal term should be as applied to the
method in claim 1.
We agree with Appellant. R2 is known in the art as a statistical
measurement as measuring the "fit" of a regression to the data. See
"Coefficient of Determination" available at:
https://stattrek.com/statistics/dictionary.aspx (last visited March 21, 2019).
Claim 11 expressly recites that a "perfect correlation" is one "having an R2
value of at least 0.3." This is not the traditional understanding of a perfect
correlation (where R2 approaches 1.0) but Appellant may define claim terms
to suit his own purpose, as long as they are clearly defined. See Phillips v.
AWH Corp., 415 F.3d 1303, 1319 (Fed. Cir. 2005) (holding that Appellants
may act as their own lexicographer as long as they have clearly set forth an
explicit definition of the term). We agree with Appellant that a person of
ordinary skill in the art would understand Appellant's use of the term to
mean that a perfect correlation is one having an R2 of at least 0.3. We
consequently reverse the Examiner's rejection of the claims upon this
ground.
C.
Issue
Rejection of claims 1, 4, and 5 under the nonstatutory doctrine of
obviousness-type double patenting.
Appellant argues that the Examiner erred because the claims are not
obvious over claims 1, 4, 5, 6, 18, and 24 the '076 patent. App. Br. 24.
Analysis
The Examiner finds that claims 1 and 18 of the '07 6 patent both teach
all aspects of instant claim 1 except determining a L'iS values from an error
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parameter and compensating the output signal based L'iS values. Final Act.
8. However, the Examiner finds, claim 6 of the '076 patent teaches
compensating analyte concentration with a slope compensation equation,
which is effectually teaching L'iS values, and claims 13 and 24 of the '076
patent both teach index functions equivalent to slope deviations, which also
reads on L'iS values, since they represent deviation of test and reference
slopes. Id. The Examiner therefore concludes that the claims are obvious
over the cited claims of the '076 patent, because it would have been obvious
to a person of ordinary skill in the art, and because it would have been
obvious to combine the limitations taught in the cited claims of the '076
patent. Id.
Appellant responds that claims 1 and 18 of the '07 6 patent recite an
index function that relies on error parameters based on a first secondary
measurement and a second secondary measurement to assist in correction.
App. Br. 24. According to Appellant, these secondary measurements are
taken from external means other than the analyte concentration and assist in
error correction. Id. In contrast, argues Appellant, the claims on appeal are
directed toward the general process of determining a single error parameter
from a slope deviation from the reference correlation to perform the
corrective process. Id. Appellant therefore argues that the claims on appeal
are patentably distinct from those of the '076 patent since they do not
include the extra step of obtaining a secondary output and determining an
index function from the secondary output. Id.
We are not persuaded by the Appellant's arguments. Claim 1 of the
'07 6 patent, which is representative, recites:
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1. A method for determining an analyte concentration in a
biological sample using a biosensor system comprising a sample
interface having a working electrode and a counter electrode, a
processor, and a signal generator connected to the processor,
compnsmg:
generating by the processor, a command to direct the
signal generator to provide an electrical input signal;
applying the electrical input signal provided by the signal
generator to the biological sample through the working electrode
and the counter electrode of the sample interface;
generating from the electrical input signal at least one
output signal in response to a redox reaction of an analyte from
the biological sample;
generating using the processor a second command to
direct the signal generator to provide a second electrical input
signal;
applying the second electrical input signal to the biological
sample through an electrochemical or optical sensor system;
in response to the second command, generating multiple
secondary output signals using the electrochemical or optical
sensor system from the biological sample independently from the
at least one output signal and redox reaction of the analyte from
the biological sample;
determining by the processor at least one index function
responsive to at least one error parameter from the at least one
output signal and at least two error parameters from the multiple
secondary output signals; and
determining by the processor, the analyte concentration in
the biological sample from the at least one output signal and a
slope compensation equation responsive to the at least one index
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function, where the slope compensation equation includes at
least one reference correlation and at least one slope deviation,
where the at least one index function represents the
influence of the error parameters on the slope deviation, and
where the at least one index function is responsive to at
least one of a slope deviation of the error parameters and an
intercept deviation of error parameters.
Claim 1 of the '076 patent thus requires, as Appellant argues,
generating a command for, and applying, a second electrical input signal, to
the biological sample through an electrochemical or optical sensor system.
However, claim 1 of the claims on appeal recites: "A method for
determining an analyte concentration in a biological sample ...
comprising .... " (emphasis added). As such, the claims can include other,
unrecited elements, including the generation of a second command to apply
a second electrical signal. See Crystal Semiconductor Corp. v. TriTech
Microelectronics Int'!, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001) (holding
that: "In the parlance of patent law, the transition 'comprising' creates a
presumption that the recited elements are only a part of the device, that the
claim does not exclude additional, unrecited elements"). The fact that claim
1 of the '076 patent recites additional elements, i.e., the second electrical
input signal to generate additional error parameters does not preclude claim
1 of Appellant's claims from comprising that additional element.
Furthermore, we note that claim 1 of the '076 patent further recites:
[D]etermining by the processor at least one index function
responsive to at least one error parameter from the at least one
output signal ... and
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determining by the processor, the analyte concentration in
the biological sample from the at least one output signal and a
slope compensation equation responsive to the at least one index
function, where the slope compensation equation includes at
least one reference correlation and at least one slope deviation
[i.e., LiS],
where the at least one index function represents the
influence of the error parameters on the slope deviation, and
where the at least one index function is responsive to at
least one of a slope deviation of the error parameters and an
intercept deviation of error parameters.
Claim 1 of the '07 6 patent thus recites the same processing steps involving
generating: "at least one index function responsive to at least one error
parameter from the at least one output signal" and then, using the at least one
index function as a measurement of the slope deviation and intercept
deviation, comparing it to a reference correlation.
Claim 1 of Appellant's claims recites these same steps:
determining at least one LiS value from at least one error
parameter via the processor of the analyte measurement device,
where the at least one LiS value is a value of slope deviation or a
value of normalized slope deviation in relation to at least one
previously determined reference correlation ...
and
determining the analyte concentration in the sample from the at
least one output signal value, the at least one LiS value.
In other words, the multiple error parameters derived from the second
electrical input signal in claim 1 of the '076 patent is not essential to the
"determining" steps recited in that claim, which requires only determining:
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"at least one index function" derived from "at least one error parameter from
the at least one output signal." Therefore, the second electrical signal, and
the error parameters generated from it, are not essential to the "determining"
steps required in claim 1 of the '076 patent.
Because claim 1 of the '07 6 patent recites additional steps that are not
essential to the "determining" steps of either the '076 patent or the claims on
appeal, and because the inclusion of a second electric input signal is within
the scope of the "comprising" language of Appellant's claims, we affirm the
Examiner's rejection upon this ground.
DECISION
The Examiner's rejection of claims 1-5, 7-13, 16, 18-27, 83, and 84
as unpatentable under 35 U.S.C. § 101 is reversed.
The Examiner's rejection of claims 1-5, 7-13, 16, 18-27, 83, and 84
as unpatentable under 35 U.S.C. § 112, second paragraph, is reversed.
The Examiner's rejection of claims 1, 4, and 5 as unpatentable under
the nonstatutory doctrine of obviousness-type double patenting is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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