Ex Parte Mecklenburg

Patent Trial and Appeal Board

Oct 17, 2018

10592218 (P.T.A.B. Oct. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/592,218 07/11/2008 George A. Mecklenburg
71331 7590 10/19/2018
NIXON PEABODY LLP
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.
MSE-2699 2767
EXAMINER
70 West Madison, Suite 3500 SIMS, JASON M
CHICAGO, IL 60602
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
10/19/2018 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):
docketingchicago@nixonpeabody.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE A. MECKLENBERG 1
Appeal2017---001517
Application 10/592,218
Technology Center 1600
Before TONI R. SCHEINER, DEMETRA J. MILLS, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant states that the real party-in-interest is Bayer HeathCare LLC.
App. Br. 1.
Appeal2017---001517
Application 10/ 592,218
SUMMARY
Appellant files this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1--4, 8-11, 13-16, 18, 20-23 and 25-
27 as unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory
subject matter.
Claims 1-2, 8-11, 14--16, 18, 20-23 25, and 26 also stand rejected as
unpatentable under 35 U.S.C.§ I03(a) as being obvious over Bemer et al.
(US 2001/0016682 Al, August 23, 2001) ("Bemer").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to method and apparatus for
implementing threshold-based correction functions for biosensors. Abstr.
REPRESENTATIVE CLAIM
Appellant argues all of the claims together. App. Br. 4. Claim 1 is
representative of the claims on appeal and recites:
1. A method for determining an analyte value from a
sample by implementing threshold based correction functions for
a biosensor system including a biosensor, a processor, and a
memory, the method comprising the acts of:
applying the sample to the biosensor and obtaining a
primary measurement of an analyte value from the biosensor
responsive to a command from a processor;
obtaining a secondary measurement of a secondary effect
on the sample via a command from the processor;
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comparing said secondary measurement of the secondary
effect with a threshold value;
responsive to said compared values, the processor
identifying a correction function from a plurality of potential
correction functions stored in the memory based on said
compared values wherein said identified correction function is a
first correction function if the secondary measurement is less
than the threshold value, and said identified correction function
is a second different correction function if the secondary
measurement is greater than the threshold value; and
applying said identified correction function to said
primary measurement via the processor to provide a corrected
analyte value.
App. Br. 30.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings
and conclusions establishing that Appellant's claims are: ( 1) directed to
nonstatutory subject matter; and (2) primafacie obvious over the cited prior
art. We address the arguments raised by Appellant below.
A. Rejection of the claims under 35 U.S.C § 101
Issue 1
Appellant argues that the Examiner erred because, when viewed as a
whole, the claims do not seek to tie up any judicial exception such that
others cannot practice it. App. Br. 6.
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Analysis
Appellant points to Part I.B.3 of the 2014 Interim Guidance on Patent
Subject Matter Eligibility, 79(241) Federal Register 74618 (2014) (the
"Guidance," which states that:
For purposes of efficiency in examination, a streamlined
eligibility analysis can be used for a claim that may or may not
recite a judicial exception but, when viewed as a whole, clearly
does not seek to tie up any judicial exception such that others
cannot practice it. Such claims do not need to proceed through
the full analysis.
App. Br. 6 (quoting Guidance 74625). Appellant next points to Alice Corp.
Pty. Ltd. v. CLS Bank lnt'l, 134 S.Ct. 2347 (2014), which Appellant asserts:
"describes the purpose of the exclusion of abstract ideas as addressing
concerns of pre-emption and ensuring that patent law does not inhibit future
discovery by improperly tying up the use of laws of nature and the like by
granting patents on laws and principles that are "the basic tools of scientific
and technological work." Id. (quoting Alice, 134 S.Ct. at 2354). Appellant
argues that the claims on appeal are not "directed to" such abstract ideas
and, when viewed as a whole, do not seek to preempt an abstract idea such
that others cannot practice it. Id.
Appellant contends that the claims on appeal are directed to the
functioning of biosensor systems, such as those used by persons who suffer
from diabetes. App. Br. 7. According to Appellant, the claimed
measurement process is not for abstract data, rather, it is directed toward
measuring liquid samples ( e.g., blood) for a specific substance, an analyte
( e.g., glucose). Id. Appellant argues that measuring an analyte
concentration in a liquid sample is not an abstract process, and that, as
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explained by Appellant's Specification, the resulting testing data from the
sample assists, for example, in monitoring physiological abnormalities such
as diabetes, which requires accurate knowledge of blood glucose levels. Id.
( citing App. Br., Ex. A ,r 3). 2
Appellant asserts that the claims at issue are a particular inventive
embodiment of a biosensor measurement device having improved accuracy
and, when viewed as a whole, are not of a scope to broadly pre-empt
biosensors or measurements of analyte concentrations, in general. App. Br.
7. According to Appellant, when viewed as a whole, the claims are not
directed to an abstract idea and are not similar to, or analogous to, any of the
abstract ideas referenced in Alice. Id. Furthermore, argues Appellant, the
claims at issue do not seek to grant a monopoly on all biosensors, let alone
"basic tools of scientific and technological work." Id. (quoting Alice, 134
S.Ct. at 2354).
We do not find Appellant's argument persuasive. As an initial matter,
we note that Appellant omits from their quotation of the Guidance the
sentence immediately subsequent to the passage quoted above, viz.:
"However, if there is doubt as to whether the applicant is effectively seeking
coverage for a judicial exception itself, the full analysis should be conducted
to determine whether the claim recites significantly more than the judicial
exception." Guidance 74625. As we explain below, we are not persuaded
by Appellant's contention that the claims recite so much substantially more
than the judicially-created exceptions to Section 101 that the claims are self-
2 Appellant's Exhibit A is Mecklenburg (US 2008/0274447 Al, November
6, 2008), the published application of the claims on appeal.
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evidently directed to patent-eligible matter. To be sure, all inventions at
some level embody, use, reflect, rest upon, or apply laws of nature, natural
phenomena, or abstract ideas. Mayo Collaborative Serves. v. Prometheus
Labs. Inc., 566 U.S. 66, 71 (2012). However, "to transform an unpatentable
law of nature into a patent-eligible application of such a law, one must do
more than simply state the law of nature while adding the words 'apply it.'"
Mayo, 566 U.S. at 72 (citing, e.g., Gottschalkv. Benson, 409 U.S. 63, 71-72
(1972). The same holds true of the other judicial exceptions to Section 101,
i.e., "natural phenomena, and abstract ideas." Alice, 134 S.Ct. at 2354.
Moreover, we note that neither Alice nor Mayo instructs us to consider
in our analysis whether the claims attempt to preempt one of the judicial
exceptions. Rather, such preemption is an outcome to be avoided in any
such analysis, rather than an established step in the analytical framework
itself. See Mayo, 566 U.S.at 72-73.
The Examiner concludes that the claims on appeal are directed to
nonstatutory subject matter. Appellant contends that the claims on appeal do
not seek to preempt the judicial exception that the Examiner concludes they
fall within, i.e., an abstract idea. Taking Appellant's argument, arguendo,
on its face, the Guidance instructs us to tum to the full Mayo/Alice analysis.
We therefore so proceed.
Issue 2
Appellant argues that the Examiner erred in concluding that the claims
on appeal are directed to a judicially-created exception to Section 101, i.e.,
to an abstract idea. App. Br. 9.
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Analysis
We agree with Appellant that the claims are directed to a "process"
and therefore fall into one of the broad statutory categories of patent-eligible
subject matter under 35 U.S.C. § 101. See App. Br. 8-9. We consequently
next tum to determining whether this process is patent eligible or comes
under one of the nonstatutory exceptions to Section 101.
In performing such a patentability analysis under 35 U.S.C. § 101, we
follow the framework set forth by the Supreme Court in Mayo. As a first
step, we determine whether the claims at issue are directed to a 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 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.
Appellant argues that it is important to consider what the claims are
actually directed toward, not merely what may be involved. App. Br. 10.
Appellant contends that the proper interpretation is that the whole of the
identified steps are part of an analyte measurement process, a process that is
not abstract. Id. Appellant asserts that an abstract idea must be the type of
concept that constitutes a fundamental practice, building block, or basic tool
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of the relevant industry or society or a disembodied concept such as a motive
or result that is dissociated from a manner of accomplishment. Id. at 11
(citing Alice, 134 S.Ct. at 2354 and Internet Patents Corp. v. Active
Network, Inc., 790 F.3d 1343, 1348 (Fed. Cir. 2015)).
Appellant disagrees with the Examiner's finding that the steps of the
claim are drawn to an abstract process that only manipulates data or is
directed toward a mathematical function. App. Br. 12 (citing Final Act. 3-
6). Appellant asserts that the Examiner's conclusion improperly focuses on
individual elements of the claim such as the correction function in asserting
that the claim is directed to the abstract concept of manipulation of data. Id.
Appellant contends that the claims as a whole are directed toward an analyte
measurement process and are not directed toward mathematical algorithms
themselves or data manipulation. Id. According to Appellant, the correction
process is inherent to analyte measurement and cannot be separated from the
overall analyte measurement process. Id. Viewed as a concept, argues
Appellant, the claims relate to an analyte measurement method that provides
accurate readings of an analyte value via selection of different error
correction functions. Id.
Appellant argues further that the Examiner has cited a series of cases,
referenced by the July 2015 Update of the Guidance, as supporting the
principle that storing and comparing data constitute abstract ideas. App. Br.
12 (citing Final Act. 5---6). Appellant asserts that none of these cases is
applicable to Appellant's claims, as all of them involved claims focused on
the data itself and none of them relate to data in the context of measurement
instruments that obtain and correct data to produce a measurement. Id.
Appellant contends that the Examiner ignores the fact that subject-eligible
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devices, such as measurement devices, whose function is to gather data are
not rendered ineligible because their function relates to data gathering. Id.
Appellant asserts that such devices including the correction of the gathered
data in these devices have been traditionally found to be patent eligible by
the Patent Office and have their own classification system. Id.
We are not persuaded by Appellant's arguments. Appellant's claims
are expressly directed to a method, and thus are within the scope of patent-
eligible subject matter under 35 U.S.C. § 101. We must therefore determine
whether the claims fall, as the Examiner finds, within one of the judicially-
created exceptions to Section 101, viz., an abstract concept or idea, and if so,
whether the elements of the claim, individually or "as an ordered
combination" contain additional elements sufficient to "transform the nature
of the claim" into a patent-eligible application.
The Supreme Court "has not established a definitive rule to determine
what constitutes an 'abstract idea."' Enfzsh, LLC v. Microsoft Corp., 822
F.3d 1327, 1334 (Fed. Cir. 2016) (citing Alice, 134 S.Ct at 2357). Our
reviewing court has held that information, as such, is intangible, and the
collecting of information, including when limited to particular content
(which does not change its character as information), is within the realm of
abstract ideas. Electric Power Grp., LLC v. Alstom S.A., 830 F.3d 1350,
1353-54 (Fed. Cir. 2016) (collecting cases). The Federal Circuit has
similarly treated the analyzing of information by steps that a person is
capable of performing mentally, or via mathematical algorithms, without
more, as essentially mental processes falling within the abstract idea
category. Id. Furthermore, the court has held that the mere presentation of
the results of abstract processes of collecting and analyzing information,
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without more, is abstract, as an ancillary part of such collection and analysis.
Id.
Appellant's claims are directed to obtaining a first measurement
value, e.g., in the form of an electrical signal, from a biosensor and a second
value from a measurement of a secondary effect, e.g., temperature. A
processor compares the second value to a threshold value stored in the
processor and, depending upon whether the second value exceeds the
threshold a first correction factor is applied to the first value. If the second
value does not exceed the stored threshold value, a different, second
correction factor is applied to the first value.
We find that there is nothing in these processes that represents more
than the routine collection of data from a generic biosensor and the routine
manipulation of information according to an algorithm by a generic
processor, i.e., comparing the second measurement value against a stored
threshold value and performing an "if, then" decision process to select which
correction factor to apply to the first measurement value. Moreover, we find
that the comparison of a first measurement value against a stored threshold
value and then deciding which correction factor to apply to the first
measurement value is the sort of process that an individual could perform
mentally, or with a pencil and paper. Because, with the exception of the step
requiring acquisition of the signal from a biosensor, all of claim 1 's method
steps could be performed in the human mind, or by a human using pencil
and paper, the claims are directed to an abstract idea without significantly
more, and therefore, not patent eligible. See, e.g., CyberSource Corp. v.
Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011).
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Appellant contends that the claims are directed to significantly more
than merely an abstract idea. Reply Br. 2. First, Appellant asserts that the
claims at issue constitute improvements to another technology or technical
field. Id. at 3. According to Appellant, correcting for errors is crucial to
accurate measurement and as such is not a mere manipulation of data, rather
it is an improvement in the technical field of biosensor measurement
instruments. Id. Appellant contends that the Specification is evidence of the
technical improvement as the subject of a patent is, by definition, an
improvement in the art. Id. Specifically, Appellant argues that the
Specification discloses a new and improved biosensor and further discloses
that the invention improves the accuracy of diagnostic chemistry tests by
correcting for secondary effects. Id. ( citing Spec. ,r,r 16, 27).
Second, Appellant argues that the allegedly abstract idea of the claims
is applied to a particular machine. Reply Br. 4. Appellant contends that the
correction functions of the claims (the alleged abstract idea) are applied for a
specific analyte biosensor system that is a recognized type of particular
machine. Id. Appellant argues that a biosensor is a particular type of
machine that is not subject to the analysis for applications of a generic
computer. Id. at 5. Furthermore, argues Appellant, there is no requirement
that a particular claimed machine cannot be composed of known
components in a field that are used in a routine manner and that, in this
instance, the elements of the particular apparatus are the claim as a whole.
Id.
Third, Appellant argues that the claims include a specific limitation
other than what is well-understood, routine in the field, or add
unconventional steps that confine the claim to a particular useful application.
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Reply Br. 5. Appellant disputes the Examiner's finding that a generic
biosensor, a processor and a memory were well-known, routine and
conventional in the field. Id. ( citing Ans. 21 ). Appellant contend, rather,
that even if individual elements themselves are common, the combination
may provide meaningful limitations: in the case of Appellant's claimed
invention, the combination of claim elements (processor, biosensor, and
memory) with the selection of correction functions via the processor to
determine the correction of the measurement performed by the biosensor
provide such specific limitations. Id.
Finally, Appellant points to Diamond v. Diehr, 450 U.S. 175, 188
(1981) as supporting the patent eligibility of their claimed invention. Reply
Br. 6. According to Appellant, the Supreme Court held, in Diehr, that a
claim for a particular machine ( a rubber curing machine) combined with an
abstract concept (the curing algorithm) was patent eligible. Id. Similarly,
argues Appellant, in this case, the claims relate to a specific machine ( a
biosensor) in conjunction with an abstract concept (the corrective functions).
Id.
Appellant argues that the Examiner errs in analyzing the claims by
improperly separating out individual elements such as the processor,
biosensor and memory, rather than employing the proper approach of
viewing the claim as a whole, as in Diehr. Reply Br. 6 (citing Ans. 14).
Appellant asserts that the Examiner errs further by conflating inventive
concepts under 35 U.S.C. §§ 102 or 103 with eligibility under 35 U.S.C.
§ 101. Id. Appellant contends that there is no requirement that the
individual elements that are significantly more than the abstract concept
need be inventive. Id. Appellant notes that, in Diehr, the Court cautioned
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against such an approach when evaluating 35 U.S.C. § 101 subject matter
eligibility, because all inventions incorporate known elements, thus making
it essential to consider the claim as a whole. Id. ( citing Diehr, 450 U.S. at
188). Therefore, Appellant argues, focusing on individual elements of the
claim erroneously avoids the requirement that the pending claims must be
considered as a whole when conducting the analysis under 35 U.S.C. § 101.
Id. at 7.
We do not find Appellant's arguments persuasive. With respect to
Appellant's first point, that the claimed invention constitutes an
improvement to another technology or technical field, we find that the
application of a correction factor to a first measured value obtained from a
generic biosensor by a generic processor, the correction factor being
determined by a second measurement and a stored threshold value, could
improve the function of the measuring device. But the application of a
correction factor based on comparing an obtained measurement against a
stored threshold is an abstract principle which, as we have explained supra,
could be performed mentally, or with pencil and paper, by a person of
ordinary skill in the art.
Here we rely on the distinction between, on one hand, computer-
functionality improvements and, on the other, uses of existing computers as
tools in aid of processes focused on abstract ideas. Electric Power Grp., 830
F.3d at 1355 (citing Enfish, 822 F.3d at 1335-36; see also Alice, 134 S.Ct. at
2358-59). In this instance, the manipulations embodied in the abstract idea
are performed on a generic processor in a manner that would be a matter of
simple and routine programming, i.e., comparing a value against a stored
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threshold and performing an "if, then" decision. We do not find this to be an
inventive or patent eligible advance in the technology.
The same reasoning applies to Appellant's second and third points.
Appellant's claims require a generic biosensor, an unspecified second
measuring means, and a generic processor to perform a simple calculation.
The generic biosensor and the second measuring means do no more than
routine data-gathering, well known in the art, and supply the values to the
processor used in performing the recited application of a correction factor
based on a threshold comparison. As such, and coupled with the abstract
idea (i.e., the "if, then" steps) by routine computer processing activity, the
claims do not rise to significantly more than the abstract idea recited in the
claims. See OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363
(Fed. Cir. 2015) (Holding that claims reciting no more than an abstract idea
coupled with routine data-gathering steps and conventional computer
activity are unpatentable); see also Mayo, 566 U.S. at 72.
We can thus distinguish the appeal before us from the facts of Diehr,
which Appellant's fourth point argues is dispositive. In Diehr, the claims at
issue were directed to the transformation of raw, uncured synthetic rubber,
into a cured, molded product. Diehr, 450 U.S. at 184. The claims recited in
detail a step-by-step method for accomplishing such, beginning with the
loading of a mold with raw, uncured rubber and ending with the eventual
opening of the press at the conclusion of the cure. Id. The claims also
recited, in several of the steps, use of a mathematical equation and a
programmed digital computer. Id. The Court noted that such transformative
processes were of the type that were historically afforded the protection of
patent law. Id.
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The fact that several of these steps used an algorithm and a computer
did not change the Court's conclusion. Diehr, 450 U.S. at 185. The Court
noted that the respondents sought patent protection for a process of curing
synthetic rubber and that, although that process employed a well-known
mathematical equation, respondents sought only to foreclose from others the
use of the equation in question only in conjunction with all of the other steps
in their claimed process. Id. In concluding, the Court held that when a
claim containing a mathematical formula implements or applies that formula
in a structure or process which, when considered as a whole, is performing a
function which the patent laws were designed to protect ( e.g., transforming
or reducing an article to a different state or thing), then the claim satisfies the
requirements of Section 101. Id. at 192.
Appellant's argument to the contrary notwithstanding, we find that the
claims on appeal are distinguishable from those at issue in Diehr. The Diehr
claims were directed to a process for accurately curing synthetic rubber and
employed a computer driven algorithm to accurately direct the time required
for curing. Appellant's claims are directed to no more than gathering
information and then using a processor to determine which correction factor
to apply to the measured value. In essence, Appellant's claims are directed
to no more than the conversion of one measured value (i.e., a number; an
abstract idea) into another, corrected value. As we have noted, our
reviewing court's holding in OIP Technologies (citing Mayo) informs us that
claims reciting no more than an abstract idea coupled with routine data-
gathering steps and conventional computer activity are unpatentable is
dispositive of Appellant's claims. OIP Techs., 788 F.3d at 1363.
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At oral argument on September 26, 2018, counsel pointed additionally
to Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), as
further supporting the contention that Appellant's claims do not fall into an
exception to Section 101. 3 Oral Hearing Transcript, September 26, 2018,
("Transcript") at 8. Counsel argued that the improvement in the technology,
i.e., an improvement in the accuracy of measurement, is basically the same
improvement that Appellants were attempting to achieve in the claims. Id.
at 9. Counsel argued that, as in Thales, the elements from which the data is
obtained, i.e., the biosensor and the surrounding components including the
processor and the memory, as well as the output are all things that are not
abstract. Id. at 10. Counsel asserted that the combination of those elements
with the abstract idea removes the claim from the realm of an abstract idea.
Id.
We do not find Appellant's argument with respect to Thales
persuasive. In Thales, the court held that:
[T]he '159 patent claims at issue in this appeal are not
directed to an abstract idea. The claims specify a particular
configuration of inertial sensors and a particular method of using
the raw data from the sensors in order to more accurately
calculate the position and orientation of an object on a moving
platform. The mathematical equations are a consequence of the
arrangement of the sensors and the unconventional choice of
reference frame in order to calculate position and orientation.
Far from claiming the equations themselves, the claims seek to
protect only the application of physics to the unconventional
configuration of sensors as disclosed. As such, these claims are
3 Thales was decided by the Federal Circuit subsequent to the filing date of
Appellant's Reply Brief (November 7, 2016).
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not directed to an abstract idea and thus the claims survive Alice
step one.
Thales, 850 F.3d at 1349. We find the facts of Thales distinguishable from
the claims on appeal because the claims in Thales were directed to "a
particular [ and novel] configuration of inertial sensors and a particular
method of using the raw data from the sensors." Id. Furthermore, the
algorithms employed were a function or consequence of the arrangement of
the sensors and the unconventional choice of reference frame and the claims
sought protection only for the unconventional configuration of the sensors.
Id.
Appellant's claims, by contrast, recite no such inventive concept as an
unconventional arrangement of inertial sensors, but merely recite the routine
and well known gathering of data from a generic biosensor to a generic
processor and the application of a correction factor based on a second
external value. We conclude that there is nothing significantly more in
Appellant's claims beyond the abstract idea of applying a correction factor,
based on a threshold value, other than routine data gathering and generic
computer activity. OIP Techs., 788 F.3d at 1363. We consequently affirm
the Examiner's rejection of the claims on this ground.
B.
Issue
Rejection of claims 1--4, 8-11, 13-16, 18, 20-23 and 25-26 under
35 U.S.C § 103(a)
Appellant argues that the Examiner erred because Bemer neither
teaches nor suggests the limitation of claim 1 reciting: "identifying a
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correction function from a plurality of potential correction functions stored
in memory." App. Br. 21.
Analysis
Appellant argues that the teachings of Bemer are directed only to
single correction function during its operation. App. Br. 21-22 (citing
Bemer ,r 131 ). According to Appellant, there is no teaching or suggestion in
Bemer that multiple correction functions are stored in memory that would be
available to correct a measurement during operation of the device. Id. at 22.
Rather, Appellant argues, Bemer suggests that multiple corrective functions
are available, but does not teach or suggest that the device may select
between multiple corrective functions during the measurement operation.
Id. Appellant asserts that the storage of different correction functions in the
memory is directed to the use of different correction functions selected by
the processor in the operation of the biosensor. Id. This feature, argues
Appellant, allows the application of an appropriate correction function in
view of a secondary measurement during the operation of the biosensor
system, and is not obvious over the teachings of Bemer. Id.
Appellant argues further that Bemer teaches three different
temperature correction functions: (1) an Arrhenius-type function (Bemer ,r,r
132-138); (2) a K2 temperature correction (id. ,r,r 139-145); and (3) an
anodal subtraction (id. ,r,r 146-154 ), that may be selected by the device
designer to take advantage of a sampling system that includes an active
reservoir and a blank reservoir. App. Br. 22-23 (also citing Bemer ,r,r 109,
130-163). Appellant contends that none of the three temperature correction
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methods taught by Bemer is optimally selected based on a secondary
measurement, rather they each have different characteristics based on the
dual blank and active reservoirs. Id. at 23. Appellant argues further that
none of the example correction methods is selected based on the comparison
of a temperature measurement to a threshold value. Id. Rather, Appellant
asserts, all of the described correction functions taught by Bemer would be
used over the entire range of temperatures and are therefore not selected on
the basis of a secondary measurement as recited by the claims. Id.
Appellant argues that a person of ordinary skill in the art, understanding the
teachings of Bemer, would have used a single correction function based on
the designer's desire for the advantage offered by each of the correction
functions. Id.
Appellant disputes the Examiner's finding that paragraphs [0110]-
[0113] teaching comparing secondary measurements to threshold values and
that such measurements may be used for correcting measurements. App. Br.
24 ( citing Final Act. 12). According to Appellant, the threshold value in
Bemer is not used to determine a selection of a correction function to
produce a corrected analyte value. Id. Rather, argues Appellant, the
threshold value is used for another purpose: viz., to invalidate temperature,
perspiration or analyte measurements, as explained in paragraphs [O 110]-
[0112]. Appellant contends that paragraph [0113] of Bemer teaches only
that departure from expected values is indicative of an incorrect
measurement requiring correcting measurements, and that Bemer does not
teach or suggest that the solution to an incorrect measurement is to select
another correction function if the measurement is incorrect. Id.
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Appellant argues that the Examiner relies on paragraphs [0016] and
[0130] of Bemer as teaching that temperature correction functions may be
used to reduce temperature-related effects on the signal. App. Br. 24 ( citing
Final Act. 13-14). Appellant argues that nothing in paragraph [0130]
teaches or suggests what criteria are used to select the temperature function
to be used. Id. Appellant contends that the remainder of Bemer subsequent
to paragraph [0130] would have been understood by one of skill in the art to
mean that the temperature correction functions refer to a number of different
temperature correction functions that could be selected by a designer of the
monitoring system, and that Bemer does not disclose, teach or suggest tying
the selection to the comparison of a secondary measurement with the
threshold value as recited by the claims. Id.
Appellant argues that, contrary to the Examiner's findings, the
calibration parameters cited in paragraphs [0106], [0017] and [0110]
reinforce the Appellant's contention that Bemer does not store the correction
functions for selection. App. Br. 24. Appellant asserts that Bemer teaches
that these correction functions are selected based on calibration performed
on the system during manufacture and not during operation. Id. Appellant
also contends that paragraph [O 11 OJ also teaches the invalidation of a
measurement based on temperature. Id.
Appellant also argues that paragraph [0147], upon which the
Examiner also relies, teaches six related temperature correction functions,
but does not describe any criteria by which any one should be selected.
App. Br. 25. Appellant asserts that the only guidance provided by Bemer is
that the correction function may be used based on alternating anodal and
cathodal phases during the measurement cycle to produce a smooth signal.
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Id. According to Appellant, the functions taught by paragraph [0147] are
selected not based upon comparison to a threshold value, but on the method
of measurement used for the analyte sample. Id.
Finally, Appellant argues that the Examiner erroneously finds that use
of generally recited measurement values implies routine optimization based
on different conditions, and is a routine practice that would be obvious for
one of ordinary skill to apply, and that that determining a correction function
is routine optimization based on different conditions. App. Br. 26 ( citing
Final Act. 14, 20).
Appellant repeats the assertion that the correction functions in Bemer
are selected when the device is designed, and that the different conditions
that the Final Office Action relies upon for the different correction functions
are not derived from a secondary measurement, rather they are design
functions, such as smoothing the signal. App. Br. 26. Appellant further
asserts that the selection of different correction functions during the
operation of the device would not be routine optimization as it produces the
unexpected result of accurate measurements for different external conditions
such as varying temperatures. Id. Appellant argues that Bemer would only
allow a biosensor designer to select one correction function from multiple
correction functions for all external conditions. Id.
We are not persuaded by Appellant's arguments. The test for
obviousness is not "that the claimed invention must be expressly suggested
in any one or all of the references. Rather, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art." In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981).
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Bemer expressly teaches the use of a secondary measurement ( e.g.,
temperature) measured against a threshold value as a means of determining
whether a first measured value is acceptable or not:
Accordingly, a temperature sensor is used to monitor changes in
temperature over time. A maximum temperature change over
time ( d( temp)/ d( time)) threshold value can then be used in a data
screen to invalidate a measurement. Such a threshold value can,
of course, be set at any objective level, which in tum can be
empirically determined depending upon the particular
extraction/sensing device used, how the temperature
measurement is obtained, and the analyte being detected.
Absolute temperature threshold criteria can also be employed,
wherein detection of high and/or low temperature extremes can
be used in a data screen to invalidate a measurement.
Temperature monitoring can be carried out using a separate,
associated temperature sensing device, or, preferably using a
temperature sensor that is integral with the sensing device.
Bemer ,r 110; see also ,r,r 111-113. Bemer further teaches that:
Raw signal thresholds can also be used in the data screening
method of the present invention. For example, any sensor
reading that is less than some minimum threshold can indicate
that the sampling/sensing device is not operating correctly, for
example, where the biosensor electrode is disconnected. In
addition, any chemical sensor will have a maximum range in
which the device can operate reliably. A reading greater than
some maximal value, then, indicates that the measurement is off-
scale, and thus possibly invalid. Accordingly, minimum and
maximum signal thresholds are used herein as data screens to
invalidate or correct measurements. Such minimum and
maximum thresholds can likewise be applied to background
measurements
Bemer ,r 114. Bemer thus expressly teaches the limitations of claim 1
reciting: "obtaining a secondary measurement of a secondary effect on the
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sample via a command from the processor" and "comparing said secondary
measurement of the secondary effect with a threshold value."
Bemer further teaches correction factors as a means of correcting the
first measured value ( e.g., blood glucose) for the secondary effects ( e.g.,
temperature) caused by physical or chemical factors and measured as a
second value (see Bemer ,r,r 110-114) via various correction functions. See
Bemer ,r,r 130-138. Specifically, Bemer teaches that:
[T]he conversion step is used to correct for changing conditions
in the biological system and/or the biosensor system ( e.g.,
temperature fluctuations in the biological system, temperature
fluctuations in the biosensor element, or combinations thereof).
Temperature can affect the signal in a number of ways, such as
by changing background, reaction constants, and/ or diffusion
coefficients. Accordingly, a number of optional temperature
correction functions can be used in order to reduce these
temperature-related effects on the signal.
More particularly, to compensate for temperature
fluctuations, temperature measurements can be taken at each
measurement time point within the measurement cycle, and this
information can be used to base a temperature correction
algorithm which adjusts the background current at every time
point depending on the difference in temperature between that
time point and the temperature when the previous background
current was measured.
Bemer ,r,r 13 0-131. Bemer teaches that one such temperature correction
algorithm is based on an Arrhenius relationship: between the background
current and temperature:
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Where (ibkgn