Ex Parte Aigner et al

Patent Trials and Appeals Board

May 6, 2019

14744971 - (D) (P.T.A.B. May. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/744,971 06/19/2015
73630 7590 05/08/2019
Quarles & Brady LLP (Roche)
Attn: IP Docket
411 East Wisconsin Ave
Milwaukee, WI 53202
FIRST NAMED INVENTOR
Simon Aigner
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.
P30937US.157321.00005 7741
EXAMINER
MUI, CHRISTINE T
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
05/08/2019 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):
pat-dept@quarles.com
pair_roche@firsttofile.com
meg.ward@roche.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SIMON AIGNER, GABRIELE CHEMNITIUS, CARINA HORN,
BERND LIMBURG, TIMO OTTENSTEIN, WOLFGANG PETRICH,
MARKUS PLUM, CHRISTIAN RINGEMANN, and MARKUS SERR
Appeal2018-001078
Application 14/7 44,971
Technology Center 1700
Before MICHAEL P. COLAIANNI, A VEL YN N. ROSS,
and MICHAEL G. McMANUS, Administrative Patent Judges.
McMANUS, Administrative Patent Judge.
DECISION ON APPEAL
The Examiner rejected claims 1-21 of Application 14/7 44,971 under
35 U.S.C. §§ 101, 102, and 103. Non-Final Act. (Feb. 21, 2017) 3-19.
Appellant1 seeks reversal of these rejections pursuant to 35 U.S.C. § 134(a).
We have jurisdiction under 35 U.S.C. § 6(b).
For the reasons set forth below, we AFFIRM.
1 The Appellant is the Applicant, Roche Diabetes Care, Inc., which is also
identified as the real party in interest. Appeal Br. 1.
Appeal2018-001078
Application 14/7 44,971
BACKGROUND
The present application "relates generally to medicine/medical
diagnostics and mathematics, and more particularly, it relates to methods of
detecting an analyte concentration in a body fluid sample." Spec. 2. The
Specification further states that it relates to "methods of characterizing a
body fluid sample, as well a computer programs and devices that incorporate
the same." Id.
Claim 1 is illustrative of the subject matter on appeal and is
reproduced below:
1. A method for detecting an analyte in a body fluid sample,
the method comprising the steps of:
a) providing at least one optical measurement curve,
wherein the optical measurement curve contains a plurality of
measurement values recorded by monitoring a time
development of at least one measurement value indicating a
progress of a detection reaction of at least one test substance
and the body fluid sample, wherein the measurement values
contained in the optical measurement curve are acquired at
differing points in time, and wherein the detection reaction is
influenced by a set of state variables, each state variable
characterizing at least one of a state of the body fluid sample
and a condition of the detection reaction;
b) providing a set of at least two different evaluation
rules, each evaluation rule adapted to derive a characteristic
value from the optical measurement curve, thereby deriving a
set of characteristic values X= {Xi}i = 1. .. N from the optical
measurement curve, the set of characteristic values comprising
at least one first characteristic value being derived from the
optical measurement curve by using at least one first evaluation
rule from the set of evaluation rules and at least one second
characteristic value being derived from the optical measurement
curve by using at least one second evaluation rule from the set
of evaluation rules, the second evaluation rule being different
from the first evaluation rule;
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c) performing at least one multivariate analysis of the
at least one first characteristic value and of the at least one
second characteristic value by using at least one predetermined
multivariate evaluation algorithm, the at least one multivariate
evaluation algorithm adapted to derive at least one result from
at least two variables, wherein the at least one first
characteristic value and the at least one second characteristic
value are used as the at least two variables, thereby deriving at
least one estimate value for at least one target variable Y of the
state variables; and
d) determining at least one analyte concentration by
using the at least one target variable Y.
Appeal Br. (Claims App. A-1 to A-2).
REJECTIONS
The Examiner maintains the following rejections:
1. Claims 1-21 are under 35 U.S.C. § 101 as directed to patent
ineligible subject matter. Final Act. 3-5.
2. Claims 1, 20, and 21 are rejected under 35 U.S.C. § 102(a) (pre-
AIA) as anticipated by Dartmann2. Id. at 5-8.
3. Claims 1-19 are rejected under 35 U.S.C. § 102(b) (pre-AIA) as
anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as
obvious over, Schafer et al. 3 Id. at 10-17.
4. Claims 20 and 21 are rejected under 35 U.S.C. §103(a) as obvious
over Schafer in view of Dartmann. Id. at 18-19.
2 WO 2011/131490 A2, published Oct. 27, 2011 ("Dartmann").
3 US 5,420,042, issued May 30, 1995 ("Schafer").
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DISCUSSION
Rejection 1. The Examiner rejected claims 1-21 as directed to
ineligible subject matter.
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. See, e.g., Alice Corp. v. CLS Bankint'l, 573 U.S.
208,216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
we first determine what concept the claim is "directed to." See Alice, 573
U.S. at 219 ("On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and
mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 192
( 1981) ); "tanning, dyeing, making waterproof cloth, vulcanizing India
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rubber, smelting ores" (id. at 184 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267---68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that "a claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula." Diehr, 450 U.S. at 187; see also id. at 191 ("We
view respondents' claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula."). That
said, the Supreme Court also indicated that a claim "seeking patent
protection for [a] formula in the abstract ... is not accorded the protection of
our patent laws,[] and this principle cannot be circumvented by attempting to
limit the use of the formula to a particular technological environment." Id.
at 191 ( citing Benson and Flook); see, e.g., id. at 187 ("It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.") ( emphasis in original).
If the claim is "directed to" an abstract idea, we tum to the second step
of the Alice and Mayo framework, where "we must examine the elements of
the claim to determine whether it contains an 'inventive concept' sufficient
to 'transform' the claimed abstract idea into a patent eligible application."
Alice, 573 U.S. at 221 (quotation marks omitted). "A claim that recites an
abstract idea must include 'additional features' to ensure 'that the [claim] is
more than a drafting effort designed to monopolize the [ abstract idea].'" Id.
(quoting Mayo, 566 U.S. at 77). "[M]erely requir[ing] generic computer
implementation[] fail[ s] to transform that abstract idea into a patent-eligible
invention." Id.
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The United States Patent and Trademark Office recently published
revised guidance on the application of 35 U.S.C. § 101. USPTO's 2019
Revised Patent Subject Matter Eligibility Guidance ("Guidance"). 4 Under
the Guidance, in determining what concept the claim is "directed to," we
first look to whether the claim recites:
(1) any judicial exceptions, including certain
groupings of abstract ideas (i.e., mathematical concepts, certain
methods of organizing human activity such as a fundamental
economic practice, or mental processes); and
(2) additional elements that integrate the judicial
exception into a practical application (see MPEP § 2106.05(a}-
(c), (e}-(h)).
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim contains an "'inventive concept' sufficient to 'transform"'
the claimed judicial exception into a patent-eligible application of the
judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82).
In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial
exception that is not "well-understood, routine and
conventional in the field" (see MPEP § 2106.05(d)); or
( 4) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception.
See Guidance, 84 Fed. Reg. at 54--56.
4 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg.
50-57 (January 7, 2019).
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Guidance Step 2(a), Prong 15
Pursuant to the Guidance, we begin by determining whether the
claims recite any judicial exception(s) to patent eligibility. In this regard,
the Examiner determined as follows:
Claim 1 recites a method for detecting an analyte in a body
fluid sample that includes steps of a) providing an optical
measurement curve, b) providing a set of at least two evaluation
rules, c) performing at least one multivariate analysis and d)
determining at least one analyte concentration value. These steps
describe a concept that is well known in the art for determining
the concentration of an analyte in a sample that can be performed
mentally or by any well-known generic computer and computer
program and includes the use of mathematical techniques and
relationships by manipulating existing information to generate
additional information by evaluation rules. This idea is similar to
the basic concept of manipulating information using
mathematical relationships by converting numerical
representation by Benson, Gottschalkv. Benson, 409 U.S. 63, 70,
175 USPQ 673, 676 (1972), which has been found by the courts
to be an abstract idea. Therefore, the claim is directed to an
abstract idea.
Non-Final Act. 3--4. We consider each limitation in tum. Step a) of claim 1
requires as follows:
a) providing at least one optical measurement curve, wherein
the optical measurement curve contains a plurality of
measurement values recorded by monitoring a time development
of at least one measurement value indicating a progress of a
detection reaction of at least one test substance and the body fluid
sample, wherein the measurement values contained in the optical
measurement curve are acquired at differing points in time, and
wherein the detection reaction is influenced by a set of state
5 Appellant presents argument regarding the patent eligibility of claim 1
under Step 2A and further asserts that "[ c ]laims 2-21 are patent eligible, at
least because of the chain of dependency." Appeal Br. 6.
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variables, each state variable characterizing at least one of a state
of the body fluid sample and a condition of the detection reaction.
Appeal Br. (Claims App. A-1 ). This claim element concerns providing an
optical measurement curve. The optical measurement curve is indicated to
contain a number of values recorded over time. That is, an optical
measurement curve is a graphic representation of certain mathematical data
recorded in sequence. See Spec. ,r 7 5 ("the monitoring of the time
development may include acquiring the respective measurement times,
thereby generating the measurement curve, especially the optical
measurement curve, including data pairs (Ri, ti) and/or (ti, Ri(ti))."). The
Guidance indicates that "[ m ]athematical concepts- mathematical
relationships, mathematical formulas or equations, mathematical
calculations" fall within the abstract idea exception. Guidance at 52. The
optical measurement curve of the claim indicates the mathematical
relationship of certain measured data. Accordingly, we discern no error in
the Examiner's determination that claim element a) recites abstract subject
matter (mathematical relationships).
Step b) of claim 1 requires as follows:
b) providing a set of at least two different evaluation rules,
each evaluation rule adapted to derive a characteristic value from
the optical measurement curve, thereby deriving a set of
characteristic values X={Xi}r=1...N from the optical measurement
curve, the set of characteristic values comprising at least one first
characteristic value being derived from the optical measurement
curve by using at least one first evaluation rule from the set of
evaluation rules and at least one second characteristic value
being derived from the optical measurement curve by using at
least one second evaluation rule from the set of evaluation rules,
the second evaluation rule being different from the first
evaluation rule.
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Appeal Br. (Claims App. A-1).
The Specification indicates that "[t]he evaluation rule generally may
be an arbitrary mathematical algorithm or may be an arbitrary combination
of algorithms for deriving one or more numeric values from the optical
measurement curve and/or from the measurement curve." Id. ,r 88. The
Specification further teaches that "[a]s used herein, 'different evaluation
rules' means that an algorithm of the first evaluation rule may differ from
the algorithm of the at least one second evaluation rule in at least one
coefficient and/or in at least one parameter and/or in at least one other
component defining the algorithm." Id. ,r 87. Thus, claim element b) recites
mathematical concepts considered to be abstract.
Step c) of claim 1 requires as follows:
c) performing at least one multivariate analysis of the at least
one first characteristic value and of the at least one second
characteristic value by using at least one predetermined
multivariate evaluation algorithm, the at least one multivariate
evaluation algorithm adapted to derive at least one result from at
least two variables, wherein the at least one first characteristic
value and the at least one second characteristic value are used as
the at least two variables, thereby deriving at least one estimate
value for at least one target variable Y of the state variables.
Appeal Br. (Claims App. A-1 ). Claim element c) requires a multivariate
analysis using at least one multivariate evaluation algorithm. The
Specification indicates that the "multivariate analysis may include at least
one mathematical operation." Spec. ,r 123. Accordingly, claim element c)
recites a mathematical concept considered to be abstract.
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Step d) of claim 1 requires "determining at least one analyte
concentration by using the at least one target variable Y." Appeal Br.
(Claims App. A-1 ). In regard to this step, the Specification teaches that
The target variable Y may be or may include a target variable Y
being independent from the at least one analyte concentration.
For example, the target variable Y being derived in step c) may
be the at least one analyte concentration or if the target variable
Y derived in step c) includes the analyte concentration, nothing
may have to be done in step d), or just a simple calculation.
Spec. ,r 137 (emphasis added). Thus, the Specification teaches that step d)
may be "nothing" or "a simple calculation." Id. The Specification further
teaches that, in some cases, step d) may require a correction algorithm
and/or a transformation algorithm. Id. ,r 138. The calculations and
algorithms of step d) are mathematical concepts. Accordingly, step d) of
claim 1 recites abstract subject matter.
In view of the foregoing, we do not discern error in the Examiner's
determination that claim 1 recites abstract subject matter.
Guidance Step 2(a), Prong 2
Under Prong Two of the Revised Guidance, we must determine if the
claims integrate the judicial exception into a practical application. That is,
we determine whether a meaningful limit is imposed on the judicial
exception, such that the claims are more than a drafting effort that
monopolizes the judicial exception. This determination is made by
identifying any additional claim limitations beyond the judicial exception
and evaluating the additional limitations individually and in combination for
determining whether they integrate the judicial exception into a practical
application.
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Appellant argues that the claims are to improvements in computer
related technology. Appeal Br. at 11-16. Appellant asserts that "[t]he
instant claims, when read in light of the specification, provide a robust
analysis of improvements to the computer functionality itself." Id. at 12.
This is firmly contradicted by the Specification. The Specification provides
that "one of the steps or a plurality of the steps or even all of the steps may
be performed by using a data processing device such as a computer,
preferably a microcomputer and/or an application-specific integrated circuit
(ASIC)." Spec. ,r 70. The Specification further teaches that "[t]he [data]
structures, which, after loading into a computer or computer network, such
as into a working memory or main memory of the computer or computer
network, may execute the methods as disclosed herein." Id. ,r 174. That is,
the Specification teaches a method "for which computers are invoked merely
as a tool." Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327, 1336 (Fed. Cir.
2016); see also MPEP § 2106.0S(a), 9th Ed. (Rev. 08.2017).
Appellant additionally argues that the claims are to concepts
inextricably tied to computer technology and, therefore, not abstract (id. at
16-1 7) and that the claims are directed to a solution to a problem in the
software arts and are therefore not abstract (id. at 17-18). The same analysis
applies to these arguments. It is apparent that the present claims concern
analysis of a detection reaction where "computers are invoked merely as a
tool."
Appellant further argues that gathering and combining data from a
medical device is not abstract as it requires inputs from a physical device.
Id. at 18-19. Appellant asserts that "claims 1-21 include input in the form of
'a sample analysis device ... at least one measuring unit ... [and] at least one
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evaluation device,' and 'detecting an analyte in a body fluid sample' through
the use of these input devices." Id. at 19.
Claim 1 requires "the optical measurement curve contains a plurality
of measurement values recorded by monitoring a time development of at
least one measurement value indicating a progress of a detection reaction of
at least one test substance and the body fluid sample." This is mere pre-
solution activity. See Parker v. Flook, 437 U.S. 584, 590 (1978) ("[t]he
notion that post-solution activity, no matter how conventional or obvious in
itself, can transform an unpatentable principle into a patentable process
exalts form over substance. A competent draftsman could attach some form
of post-solution activity to almost any mathematical formula."); see also
MPEP § 2106.05(g), 9th Ed. (Rev. 08.2017). Such detection reactions have
long been known in the art. See Spec. 3-24.
The remaining limitations referred to by Appellant are recited in claim
20 (and claim 21 by dependency). Claim 20 is to a "sample analysis device"
that includes a "measuring unit" that measures a detection reaction of a test
substance and a sample so that an optical measurement curve is recorded.
Appeal Br. (Claims App. A-6 to A-7). Claim 21 depends from claim 20 and
further requires a "test element" that includes a "test substance" that
"perform[s] the detection reaction." Id. (A-7). The Guidance instructs to
identify "additional elements recited in the claim beyond the judicial
exception( s )" and to determine if such additional elements "integrate the
exception[s] into a practical application." Guidance at 54--55. Claims 20
and 21 recite such additional elements in such a manner that the recited
abstract ideas are used "in conjunction with, a particular machine or
manufacture that is integral to the claim." See id. at 55.
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Appellant also argues that claim 1 and its dependents are not directed
to an idea "of itself' or mathematical relationships or formulae. Appeal Br.
19--20. These arguments are addressed above.
We discern no additional elements ( or combination of elements)
recited in Appellants' claim 1 that integrate the judicial exceptions into a
practical application. See 2019 Revised Guidance, Revised Step 2A, Prong
Two. For example, Appellant's claimed additional elements (e.g.,) recited in
claim 1 do not: (1) improve the functioning of a computer or other
technology; (2) are not applied with any particular machine ( except for
generic computers and devices); (3) do not effect a transformation of a
particular article to a different state; and ( 4) are not applied in any
meaningful way beyond generally linking the use of the judicial exception to
a particular technological environment, such that the claim as a whole is
more than a drafting effort designed to monopolize the exception. See
MPEP § 2106.0S(a}-(c), (e}-(h), 9th Ed. (Rev. 08.2017).
In view of the foregoing, we determine that Appellant has not shown
error in the Examiner's determination that claims 1-19 are directed to a
judicial exception. We further determine that Appellant has shown error
with regard to the Examiner's determination that claims 20 and 21 are
directed to a judicial exception.
Guidance Step 2 (b)
Appellant argues that claim 1 and its dependent claims recite
additional elements that amount to "significantly more" than an abstract
idea. Appeal Br. 20-24. Appellant asserts that "the claims in light of
the specification represent an improvement in the functioning of the
computer, as well as an improvement to the analyte detection technologies."
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Id. at 21. This argument is similar to Appellant's argument above
considered in regard to Prong 2 of Step 2(a) and is rejected for the same
reasons. The Specification's teaching that "one of the steps or a plurality of
the steps or even all of the steps may be performed by using a data
processing device such as a computer, preferably a microcomputer and/or an
application-specific integrated circuit (ASIC)" (Spec. ,r 70) indicates that
one may practice the method of the invention on a generic computer. See
also Dartmann, 22:23-23:3 (describing use of a computer program to
mathematically fit a curve to signal measurements and thereby determine
concentration of an analyte ).
Appellant further argues that claim 1 includes additional claimed
elements effecting a transformation or reduction of a particular article to a
different state or thing. Appeal Br. 22. In support, Appellant asserts that
"[t]he claims in the instant application include multiple required concrete
steps transforming the original input parameters or other data." Id. at 23.
Such argument carries little weight. See DDR Holdings, LLC v. Hotels.com,
L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) ("[I]n Mayo, the Supreme Court
emphasized that satisfying the machine-or-transformation test, by itself, is
not sufficient to render a claim patent-eligible, as not all transformations or
machine implementations infuse an otherwise ineligible claim with an
'inventive concept."').
Nor does our review of claim 1 reveal additional elements recited in
the claims that provide significantly more than the abstract idea exception.
Each step of claim 1 (a through d) requires an abstract mathematical step.
Step a) may be seen as requiring the reaction of a test substance and a body
fluid sample as well as some type of measuring device. Such steps are,
however, well understood, routine, conventional activity in this field. See
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Non-Final Act. 4; Spec. ,r,r 11, 14, 16; Schafer 1:8---61. Accordingly,
Appellant has not shown that there are additional elements recited in the
claims that provide significantly more than the abstract idea exception.
In view of the foregoing, Appellant has not shown error in the
Examiner's rejection of claim 1 and dependent claims 2-19 as directed to
ineligible subject matter.
Rejection 2. The Examiner rejected claims 1, 20, and 21 as
anticipated by Dartmann. Non-Final Act. 5-8. In support of the rejection,
the Examiner determined that Dartmann teaches two different evaluation
rules adapted to derive a characteristic value from the optical measurement
curve and performing a multivariate analysis of the first and second
characteristic values. Id. at 6-7 ( citing Dartmann, 18:29-19:2, 20: 16-29,
79:1---6 (claim 8), and 80:16-27 (claim 12)). In the Answer, the Examiner
indicated that "[i]n particular, one evaluation rule interpreted by the
Examiner is the 'regularization on parameter a,' page 18 line 29-page 19 line
2. The other evaluation rule interpreted by the Examiner is the decision
made by the decision tree of another parameter (yO, r, b, or nO), page 20 line
16-29." Answer 19. The Examiner further determined that Dartmann
teaches the "multivariate analysis" limitation where it discloses "parameters
are constrained during fitting to ensure robust and confident estimation of
parameters for curves showing no amplification behavior or amplification
behavior in the very end only. Constraints may be uni- or multivariate, linear
or non-linear." Id. (citing Dartmann 19).
In its Appeal Brief, Appellant largely addresses the Examiner's
findings from a previous Office Action. Appeal Br. 25-26. Appellant
further provides a brief summary of its view of Dartmann but does not
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specifically articulate error in the Examiner's analysis. Id. at 27. Appellant
submitted a Reply Brief but does not address Dartmann therein. See Reply
Br., generally.
Appellant argues that the rejection of claims 20 and 21 is procedurally
deficient. Appeal Br. 28-29. As above, "the PTO carries its procedural
burden of establishing a prima facie case when its rejection satisfies 35
U.S.C. § 132, in 'notify[ing] the applicant ... by stating the reasons for [its]
rejection, or objection or requirement, together with such information and
references as may be useful in judging of the propriety of continuing the
prosecution of [the] application."' In re Jung, 637 F.3d 1356, 1362 (Fed.
Cir. 2011) (quoting 35 U.S.C. § 132). Here, the Examiner informed
Appellant of the basis of the rejection (35 U.S.C. § 102) and the specific
portion of the reference (Dartmann) stated to anticipate. While the Rejection
could have been more informative, the Examiner satisfied the procedural
burden to establish a prima facie case.
Appellant does not put forward any substantive argument in
opposition to the rejection of claims 20 and 21 apart from a general
allegation that Dartmann does not teach the elements of claim 21. Appeal
Br. 29. Accordingly, Appellant has not shown error in this regard. See 37
C.F.R. § 4I.37(c)(l)(iv) (2012); Hyattv. Dudas, 551 F.3d 1307, 1313-14
(Fed. Cir. 2008); see also Manual of Patent Examining Procedure (MPEP) §
1205.02, 9th ed. (Rev. 08.2017) ("If a ground of rejection stated by the
examiner is not addressed in the appellant's brief, appellant has waived any
challenge to that ground of rejection and the Board may summarily sustain
it, unless the examiner subsequently withdrew the rejection in the
examiner's answer.").
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In view of the foregoing, Appellant has not shown reversible error in
the Examiner's rejection of claims 1, 20, and 21 as anticipated by Dartmann.
Rejection 3. The Examiner rejected claims 1-19 as anticipated by or,
in the alternative, obvious over, Schafer. As a preliminary matter, we
reverse the Examiner's rejection on the basis of anticipation in view of the
Examiner's concession that Schafer does not teach a process "wherein the at
least one first characteristic value and the at least one second characteristic
value are used as the at least two variables, thereby deriving at least one
estimate value for at least one target variable Y of the state variables" as
required by claim 1. Answer 20. We consider the rejection on the basis of
obviousness below.
Schafer teaches that both a training run and an analysis run are
performed. Abstract. In a training run ( or multiple training runs), a sample
with a known concentration of a given analyte is used to calibrate certain
measurements. See, e.g., Schafer 10:66-11:68, 13:4--14:21 (claim 1).
Subsequently, an analysis run is performed and information learned from the
training run is used to interpret the results of the analysis run. Id.
Claim 1 requires providing evaluation rules and performing
multivariate analysis as follows:
b) providing a set of at least two different evaluation rules,
each evaluation rule adapted to derive a characteristic value from
the optical measurement curve, thereby deriving a set of
characteristic values X={Xi}r=1. .. N from the optical measurement
curve, the set of characteristic values comprising at least one first
characteristic value being derived from the optical measurement
curve by using at least one first evaluation rule from the set of
evaluation rules and at least one second characteristic value
being derived from the optical measurement curve by using at
least one second evaluation rule from the set of evaluation rules,
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the second evaluation rule being different from the first
evaluation rule
c) performing at least one multivariate analysis of the at
least one first characteristic value and of the at least one
second characteristic value by using at least one predetermined
multivariate evaluation algorithm, the at least one multivariate
evaluation algorithm adapted to derive at least one result from at
least two variables, wherein the at least one first characteristic
value and the at least one second characteristic value are used as
the at least two variables, thereby deriving at least one estimate
value for at least one target variable Y of the state variables.
Appeal Br. (Claims App. A-1) (emphasis added).
Appellant argues that Schafer "does not teach or suggest that one
could use multiple discriminator sets as variables in a single multivariate
statistical technique." Id. at 33. Rather, Appellant contends, it teaches to
apply multivariate statistical techniques to each discriminator set
individually. Id.
As noted above, this is conceded by the Examiner. Non-Final Act.
11; Answer 20. In this regard, the Examiner states as follows:
However, it would be obvious to one having ordinary skill in
the art at the time the invention was made to modify the
multivariate evaluation algorithm of Schaefer with a computer
program adapted to derive at least one result from at least two
variables, wherein the at least one first characteristic value and
the at least one second characteristic value are used as the at
least two variables thereby deriving at least one estimate value
for at least one target variable Y of the state variables to
manipulate the values obtained into a one dimensional space for
deriving a single estimate value.
Non-Final Act. 11-12. Appellant does not address this finding.
Accordingly, Appellant has not shown error in the foregoing and the
rejection of claim 1 as obvious over Schafer is affirmed.
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Appellant separately appeals the rejection of claims 2-21 over
Schafer. Appeal Br. 34--45.
Appellant argues that the Examiner failed to establish a prima facie
case of invalidity of claim 2. Id. at 35. Claim 2 is a Markush claim listing a
number of "state variables." Id. (Claims App. A-2). In the rejection, one
such state variable, "alterations of the body fluid sample or of certain
properties of the body fluid sample caused by pharmacological
treatment of a donor of the body fluid sample" is in bold text and
followed by a citation to Schafer. Non-Final Act. 12. While a more
thorough explanation may be desirable, the rejection as issued fairly notified
the applicant of the reason for the rejection and the reference relied upon.
See In re Jung at 1362.
Appellant does not provide substantive argument against the rejection.
Accordingly, Appellant has not shown error in this regard. See 37 C.F.R. §
4I.37(c)(l)(iv) (2012).
Appellant additionally argues that claim 3 was rejected in error.
Appeal Br. 36. Claim 3 depends from claim 2 and further requires that "the
particulate component of the body fluid sample is a hematocrit." Id. ( Claims
App. A-2). The Examiner conceded that Schafer does not teach that the
particulate component of the body fluid is a hematocrit (red blood cell
content). Non-Final Act. 17. The Examiner found, however, that Schafer
teaches analysis of urine and "it is well known that chemical analysis on
biological sample include blood and urine." Id. The Examiner additionally
cited to a portion of Schafer that teaches that "[i]n chemical analysis, in
particular with the analysis of body fluids such as blood and urine,
methods are commonly used which are based on a specific binding
reaction of two binding partners exhibiting biological affinity." Schafer,
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1 :22-26 ( emphasis added). On this basis, the Examiner concluded that
claim 3 would have been obvious to one of ordinary skill in the art. Schafer
further teaches that "the invention has as its aim the creation of a method
with which the analysis is possible in the case of an ambiguous evaluation
curve C=f(X) with high reliability and for a broad spectrum of different
tests." Schafer, 3:60-65 (emphasis added).
Appellant argues that the examples of Schafer, which concern the
testing of urine for albumin (Examples 1 and 3) and the testing of serum for
ferritin (Example 2), would not provide sufficient reason to modify the
teachings of Schafer. Appeal Br. 36. This argument is insufficient to show
error in the Examiner's determination. Schafer teaches that it is applicable
to a "broad spectrum of different tests" and that blood tests are known in the
art. In view of such teachings, the Examiner's finding that one of skill in the
art would have had reason to apply the teachings of Schafer in the context of
hematocrit testing is sufficiently supported. Accordingly, Appellant has not
shown error in regard to the rejection of claim 3 as obvious over Schafer.
Appellant additionally argues that claim 4 was rejected in error.
Appeal Br. 3 6-7. Claim 4 depends from claim 1 and further requires that
"the first evaluation rule may not be transformed into the second evaluation
rule by a time transformation." Id. (Claims App. A-2).
The Examiner conceded that Schafer "does not specifically disclose
wherein the first evaluation rule may not be transformed into the second
evaluation rule by a time transformation." Non-Final Act. 12. The
Examiner finds, however, that "it would be obvious to one having ordinary
skill in the art so that one of the evaluation rules are not transformed to
maintain unaltered values to be observed for a point of reference, See
Schafer et al, Column 13 line 10 - Column 14 line 2, Claim 1." Id.
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This is inadequate analysis to support an obviousness rejection.
"[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Here,
the Examiner merely cited to a lengthy portion of Schafer's claim 1. It is not
apparent from review of the cited portion of Schafer how the Examiner
proposes to modify the claim so that "the first evaluation rule may not be
transformed into the second evaluation rule by a time transformation." This
falls short of the "articulated reasoning" required of the rejection.
Appellant additionally challenges the rejection of claim 5. Appeal Br.
3 7. Claim 5 depends from claim 1 and further requires that "the second
evaluation rule differs from the first evaluation rule in at least one of: in at
least one coefficient, in at least one parameter, and in at least one component
related to the at least one predetermined multivariate evaluation algorithm."
In rejecting claim 5, the Examiner repeated the claim language and then
stated "See Schafer et al, Column 13 line 10 - Column 14 line 2, Claim 1,
different discriminator sets." Non-Final Act. 12-13.
The cited portion of Schafer includes the claim element "wherein the
generating step ( 1 )( c) for the at least one additional training run further
includes generating a different discriminator set from the measurements of
S(t) by at least one of a different discriminator generation method and a
different multivariate statistical technique." Schafer 13:54--58 (emphasis
added). Here, it is possible to determine the portion of Schafer relied upon,
but the Examiner fails to provide even minimal analysis linking the
reference to the claim at issue. Accordingly, the rejection of claim 5 falls
short of the requisite "articulated reasoning."
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Appellant additionally argues that claim 6 was rejected in error.
Appeal Br. 37-38. Claim 6 depends from claim 1 and further requires that
"a third evaluation rule is provided, wherein in step c ), the at least one first
characteristic value is derived from the first evaluation rule, and wherein in
the at least one multivariate evaluation algorithm, the second evaluation rule
or the third evaluation rule is used depending on the at least one first
characteristic value." Id. (Claims App. A-2). In the rejection, the Examiner
repeats the claim language then states that one of skill in the art would make
such modification "to compare the target value of Y, taking into account
different conditions of the sample." Non-Final Act. 13. This does not
directly address the limitations at issue and is an inadequate explanation as
to why one of skill in the art would have been motivated to make such a
modification.
Appellant additionally argues that claim 7 was rejected in error.
Appeal Br. 38. Claim 7 depends from claim 1 and further requires that
the first characteristic value is determined by using a first time
interval of the optical measurement curve, wherein the second
characteristic value is determined by using a second time
interval of the optical measurement curve, and wherein the first
time interval of the optical measurement curve is different from
the second time interval of the optical measurement curve.
Id. (Claims App. A-3). In support of the rejection, the Examiner repeats the
claim's language then states "See Schafer et al, Schafer et al, Column 13 line
10 - Column 14 line 2, Column 7 line 26-66, Claim 1." Non-Final Act. 13.
This does not directly address the limitations at issue and is an inadequate
explanation as to how Schafer teaches the limitation. Accordingly, the
rejection of claim 7 is reversed. This applies equally to the rejection of
claim 8 which depends from claim 7.
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Appellant additionally argues that claim 9 was rejected in error.
Appeal Br. 3 9. Claim 9 depends from claim 1 and further requires that "the
at least two evaluation rules are adapted to derive the characteristic values
from at least two derivatives of the optical measurement curve." Id. (Claims
App. A-3). In support of the rejection, the Examiner repeats the claim's
language then states "[ s Jee Schafer et al, Column 13 line 10 -Column 14 line
2, Claim 1, Figure 1." Non-Final Act. 13. This does not directly address the
limitations at issue and, given the complexity of the claim, is an inadequate
explanation as to how Schafer teaches the limitations at issue. Accordingly,
the rejection of claim 9 is reversed.
Appellant additionally argues that claim 10 was rejected in error.
Appeal Br. 3 9. Claim 10 depends from claim 1 and further requires that "the
target variable Y comprises the at least one analyte concentration in the body
fluid sample." Id. (Claims App. A-3). In support of the rejection, the
Examiner repeats the claim's language then states "[s]ee Schafer et al,
Column 14 line 17-21." Non-Final Act. 13. This does not directly address
the limitations at issue and is an inadequate explanation as to how Schafer
teaches the limitations at issue. Accordingly, the rejection of claim 10 over
Schafer is reversed.
Appellant additionally argues that claim 11 was rejected in error.
Appeal Br. 40. Claim 11 depends from claim 1 and further requires that "in
step d), in addition to the at least one target variable Y, at least one
electrochemical measurement value is used for determining the at least one
analyte concentration, and wherein the electrochemical measurement value
is determined by using at least one electrochemical measurement." In
support of the rejection, the Examiner repeats the first clause of claim 11 and
then cites to "Schafer et al, Column 14, line 17-21." Non-Final Act. 13-14.
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The Examiner then recites the remainder of the claim and the following
citation and limited analysis: "[s]ee Schafer et al, Column 4 line 23-43,
Column 6 line 4-14, kinetic of the reaction and concentration, Figure 1." Id.
at 14.
Appellant argues that the rejection of claim 11 is both procedurally
and substantively defective. Appeal Br. 40. Appellant argues that the
rejection is procedurally defective as the "Examiner did not provide any
explanation of the rejection or how teachings of Shafer et al. were applied to
these specifically-claimed elements." Id. Appellant argues that the rejection
is substantively in error as Schafer lacks any teaching regarding
electrochemical measurement. Id.
Appellant's assertion regarding the absence of any explicit teaching
regarding electrochemical measurement is corroborated by review of the
sections cited by the Examiner. The Examiner does not further address this
rejection in the Answer. Accordingly, Appellant has shown that this
rejection lacks a proper basis and is therefore reversed. Claim 12 depends
from claim 11 and is rejected on the same basis. Non-Final Act. 14.
Accordingly, the rejection of claim 12 over Schafer is reversed for the same
reasons as claim 11.
Appellant additionally argues that claim 13 was rejected in error.
Appeal Br. 41. Claim 13 depends from claim 1 and further requires that "the
predetermined multivariate evaluation algorithm comprises at least one
polynomial algorithm selected from:
Y =A ·X, (1);
Y = XT · A · X, (2); and
y = XT · (XT · A · X), (3),
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wherein A is a one-dimensional, a two-dimensional or a three-dimensional
evaluation tensor." Id. (Claims App. A-4).
In support of the rejection, the Examiner determined that "it would be
obvious to one having ordinary skill in the art at the time the invention was
made to modify the method ... to optimally quantify the target variable."
Non-Final Act. 14. This is insufficient to articulate a reason to modify the
teachings of Schafer. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
("[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.").
Appellant additionally argues that claim 14 was rejected in error.
Appeal Br. 41--4 2. Claim 14 depends from claim 1 and further requires that
the predetermined multivariate evaluation algorithm comprises
at least one algorithm selected from:
Y = Liai ·Xi, (4);
Y = Li ai · Xi+ Li,j aij · Xi · Xj, ( 5); and
Y = Liai · Xi + Li,j aij · Xi · Xj + Li,j,k aijk · Xi · Xj · Xk, ( 6),
wherein ai, aij, are predetermined coefficients, and wherein i, j
and k are, mutually independently, integers from 1 to N.
Id. (Claims App. A-4).
In support of the rejection of claim 14, the Examiner determined that
"it would be obvious to one having ordinary skill in the art at the time the
invention was made to modify the method ... to take into account specific
circumstances and different conditions of the method." Non-Final Act. 14--
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15. This is insufficient to articulate a reason to modify the teachings of
Schafer. See In re Kahn, 441 F.3d at 988.
Appellant additionally argues that claim 15 was rejected in error.
Appeal Br. 42--43. Claim 15 depends from claim 1 and further requires that
"the at least one multivariate evaluation algorithm comprises a function
involving at least one decision tree, and wherein the decision tree comprises
at least one decision branch that allows selecting one out of at least two
alternative procedures based on an assessment whether a predetermined
condition may be fulfilled." Id. (Claims App. A-4).
In support of the rejection of claim 15, the Examiner determined that
"it would be obvious to one having ordinary skill in the art at the time the
invention was made to modify the method ... to offer a decision between
performing or not performing a specific procedure under a specific
parameter with a specific parameter set or within a specific parameter range,
under specific circumstances." Non-Final Act. 15. This is insufficient to
articulate a reason to modify the teachings of Schafer. See In re Kahn, 441
F.3d at 988. Accordingly, the rejection of claim 15 is reversed.
Appellant also argues that claim 16 was rejected in error. Appeal Br.
43--44. Claim 16 is reproduced below:
16. The method of Claim 1, wherein at least one of the two
different evaluation rules is selected from the group consisting
of:
a) using a specific measurement value of the optical
measurement curve or a derivative of the optical measurement
curve at a predetermined point in time as the characteristic value;
b) using a mean value of the optical measurement curve or
a derivative of the optical measurement curve over a
predetermined period of time as the characteristic value;
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c) using a characteristic point in time of the optical
measurement curve or of a derivative of the optical measurement
curve as the characteristic value;
d) using a characteristic parameter of the optical
measurement curve or of a derivative of the optical measurement
curve as the characteristic value;
e) using a fit parameter derived by at least one fitting
process as the characteristic value, wherein the fitting process
implies a fitting of at least one predetermined fit curve to at least
a section of the optical measurement curve or of a derivative of
the optical measurement curve; and
[ fJ) using at least one value derived from a phase plot of at
least two derivatives of different order of the optical
measurement curve as the characteristic value, wherein the phase
plot comprises at least one phase space curve.
Id. (Claims App. A-4 to A-5).
In support of the rejection of claim 16, the Examiner repeated the
claim then cited to "Schafer et al, Column 4 line 4-44, Column 7 line 26-66,
Claim 4-9." Non-Final Act. 15-16. The Examiner did not specify which
two of the six possibilities is believed to be taught by Schafer. The rejection
does not directly address the limitations at issue and is an inadequate
explanation as to how Schafer teaches such limitations. The rejection of
claim 16 is not addressed in the Examiner's Answer. Accordingly, the
rejection of claim 16 is reversed.
Appellant also argues that claim 17 was rejected in error. Appeal Br.
44--45. Claim 17 depends from claim 1 and further requires that step b) of
claim 1 include four recited substeps. Id. (Claims App. A-5 to A-6). For
each substep of claim 1 7, the Examiner identified a portion of Schafer found
to teach the substep. Non-Final Act. 16. Appellant, referring to a previous
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Final Office Action, asserts that "Appellant cannot reasonably determine
which feature of Schafer et al. is believed to correspond with which feature
recited in claim 17." Appeal Br. 44. Appellant additionally includes a
general denial that Schafer teaches the claimed elements. Id. at 44--45. As
this does not address the citations to evidence in the operative Non-Final
Rejection, it is insufficient to show error in the rejection.
Appellant additionally argues that claim 18 was rejected in error.
Appeal Br. 45. Claim 18 requires the following steps:
A) bringing the body fluid sample into contact with at
least one test substance, thereby initiating a detection reaction of
the test substance and the body fluid sample, wherein the
detection reaction is influenced by a set of state variables, each
state variable characterizing at least one of a state of the body
fluid sample and a condition of the detection reaction;
B) monitoring a time development of at least one
measurement value indicating a progress of the detection
reaction, thereby recording an optical measurement curve
containing a plurality of the measurement values acquired at
differing points in time;
C) evaluating the optical measurement curve by using
the method of Claim 1.
Id. (Claims App. A-6).
In the Non-Final Action, the Examiner repeated the claim then stated
"[s]ee Schafer et al, Rejection of Claim 1, Example 1, Columns 10 and 11."
Non-Final Act. 17. This is a succinct rejection to be sure. Given the nature
of the limitations at issue, however, and the description of Example 1 in
Schafer, one can readily ascertain the teachings intended by the Examiner.
Accordingly, Appellant has not shown error in this regard.
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Appellant additionally argues that claim 19 was rejected in error.
Appeal Br. 45. Claim 19 requires "[a] computer program comprising
computer-executable instructions for performing the method of Claim 1
when the program is executed on a computer or a computer network." In
support of the rejection, the Examiner cited to a portion of Schafer which
teaches as follows:
Central determination by the manufacturer has the
advantage that a particularly powerful computer facility may
be used. If the optimized discrimination algorithm is
independent of the manufacturing batch of the reagent kit, one
data transfer of the information to the analytical unit, for
example by means of a diskette, is sufficient. However if
different manufacturing batches of the reagents vary to such an
extent that the same optimized discrimination algorithm cannot
be used for different batches, it is advisable that the optimized
discrimination algorithm be determined separately for each
batch and be dispatched to the clinical laboratory on a
suitable storage medium with the packing of the test kit.
Schafer, 9:27--40. Appellant argues that "[t]he Examiner did not provide
any explanation of the rejection or how teachings of Shafer et al. were
applied to these specifically-claimed elements" but does not present
substantive argument regarding the claim. Appeal Br. 45. Given the nature
of the limitations at issue and Schafer's straightforward teachings regarding
a computer facility and computer program storage, one can readily ascertain
the teachings intended by the Examiner. Accordingly, Appellant has not
shown error in this regard.
Rejection 4. The Examiner rejected claims 20 and 21 as obvious over
Schafer in view ofDartmann. Non-Final Act. 18-19. In support of the
rejection of claim 20, the Examiner found that Schafer teaches each element
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"except for wherein the method is performed on a sample analysis device."
Id. at 18. The Examiner finds that Dartmann teaches the claimed analysis
device and cites to "Dartmann et al, page 22 line 1-22, Rejection of Claim 1,
under 102(a)" in support thereof. Id.
The rejection lacks any statement as to why one of ordinary skill in
the art would have had reason to combine the teachings of Schafer and
Dartmann. Id. Appellant argues that this is inadequate to state a rejection
on the basis of obviousness. Appeal Br. 46. We accept such argument. See
In re Kahn, 441 F.3d at 988.
Accordingly, the rejection of claims 20 and 21 as obvious over
Schafer in view of Dartmann is reversed.
CONCLUSION
The rejection of claims 1-19 as directed to ineligible subject matter is
affirmed. The rejection of claims 20 and 21 as directed to ineligible subject
matter is reversed. The rejection of claims 1, 20, and 21 as anticipated by
Dartmann is affirmed. The rejection of claims 1-3, and 17-19 as obvious
over Schafer is affirmed. The rejection of claims 4--16 as obvious over
Schafer is reversed. The rejection of claims 20 and 21 as obvious over
Schafer in view of Dartmann is reversed.
As at least one rejection applicable to each claim at issue is affirmed,
the Office Action as a whole is affirmed.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
31