Ex Parte 8,088,097 B2 et al

Patent Trial and Appeal Board

Feb 11, 2015

95002142 (P.T.A.B. Feb. 11, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/002,142 09/06/2012 8,088,097 B2 25428-0018RX1 1180
123345 7590 02/12/2015
MEDTRONIC MINIMED, INC.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
02/12/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

GLYSURE LTD.
Respondent, Requester

v.

Patent of GLUMETRICS, INC.
Appellant, Patent Owner
1

________________

Appeal 2014-007070
Inter Partes Reexamination Control 95/002,142
Patent No. US 8,088,097 B2
2

Technology Center 3900
________________

Before STEVEN D.A. McCARTHY, DANIEL S. SONG and
BRETT C. MARTIN, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

1
The patent under reexamination was assigned by Glumetrics, Inc. to
Medtronic Minimed, Inc. of Northridge, California, in an assignment
recorded with the Patent and Trademark Office on July 3, 2014.
2
Issued January 3, 2012 to Williams H. Markle and David R. Markle
(the “’097 patent”). The ’097 patent issued from US Application
12/274,617, filed November 20, 2008. Application 12/274,617 claimed
the priority of US Provision Application 60/989,732, filed November 21,
2007. References in this opinion to the “filing date” of the ’097 patent will
be to the claimed priority date of November 21, 2007.
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STATEMENT OF THE CASE 1
The Appellant/Patent Owner appeals under 35 U.S.C. § 134(b) and 2
35 U.S.C. § 315(a) (2011) from a final rejection of claims 1–14, 19–31 and 3
33. Claims 15–18 and 32 are not subject to reexamination. Claim 34 has 4
been cancelled. (Right of Appeal Notice mailed June 20, 2013 (“RAN”) at 5
1.) Only those arguments actually made by the Patent Owner have been 6
considered. Arguments that the Patent Owner could have made, but chose 7
not to make, have not been considered and are deemed to be waived. See 37 8
C.F.R. § 41.67(c)(1)(vii) (2011); In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 9
2011). We have jurisdiction under § 134(b) and § 315(a). 10
The Patent Owner relies on an Appeal Brief dated September 19, 2013 11
(“Patent Owner’s Appeal Brief” or “App. Br. PO”). The Requester relies on 12
a Respondent Brief dated October 21, 2013 (“Resp. Br. Req’r”). The 13
Examiner’s findings and conclusions are set forth in the RAN.
3
The RAN 14
incorporates by reference “Third Party [Requester] Comments in 15
Accordance with 37 C.F.R. § 1.947” dated January 22, 2013 (“Requester 16
Comments” or “Req’r Comm.”). The Requester Comments includes as 17
appendices a “Declaration of Tony James, Ph.D. under 37 C.F.R. § 1.132” 18
(“James Declaration” or “James Decl.”) and a “Declaration of Dr. John 19
Pickup, D.Phil under 37 C.F.R. § 1.132” (“Pickup Declaration” or “Pickup 20
Decl.”). An untimely request for oral hearing was not entered. 21
Claims 1 and 33 are independent. Both independent claims were 22
amended during the course of the reexamination proceeding. The Examiner 23

3
The Examiner’s Answer mailed November 21, 2013 incorporates the
RAN by reference.
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rejects claims 1–14, 19–31 and 33 as indefinite under the second paragraph 1
of 35 U.S.C. § 112 (2011). 2
3
ISSUE 4
The dispositive issue in this appeal is: Does the limitation italicized 5
below, which was added in identical language to both independent claim 1 6
and independent claim 33 by amendment during the reexamination 7
proceeding, fail to particularly point out the standard of accuracy that the 8
equilibrium glucose sensor used in the claimed methods must satisfy? 9
We sustain the rejection under the second paragraph of § 112. 10
11
CLAIM 1 12
Independent claim 1, reproduced in its entirety with added italics, 13
recites: 14
1. A method for maintaining glycemic 15
control in a patient in need thereof, comprising: 16
deploying an equilibrium glucose 17
sensor within a blood vessel in the patient, 18
wherein the equilibrium glucose sensor 19
comprises a fluorophore and a glucose 20
binding moiety, which are configured to 21
generate a fluorescent signal related to the 22
blood glucose concentration; 23
determining the blood glucose 24
concentration from the fluorescent signal, 25
wherein the determination of blood glucose 26
concentration using the equilibrium glucose 27
sensor is at least as accurate as a 28
determination of blood glucose 29
concentration using a standard fingerstick 30
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test, even at blood glucose concentrations 1
below 100 mg/dl; 2
coupling the sensor to a monitor that 3
displays the patient’s blood glucose 4
concentration; and 5
manually administering a blood 6
glucose regulator when the blood glucose 7
concentration varies outside of a 8
predetermined concentration range, wherein 9
the blood glucose regulator is administered 10
in an amount sufficient to return the blood 11
glucose concentration to within the 12
predetermined concentration range, thereby 13
maintaining glycemic control. 14
15
OTHER GROUNDS OF REJECTION AND 16
PROCEDURAL ARGUMENTS NOT REACHED 17
Because the Patent Owner relies heavily on the italicized limitation 18
in its effort to distinguish the prior art rejections proposed by the Requester 19
and adopted by the Examiner, we decline to reach the rejections of the 20
appealed claims under 35 U.S.C. § 102(e) (2011) and 35 U.S.C. § 103(a) 21
(2011).
4
See In re Steele, 305 F.2d 859, 862-63 (CCPA 1962). Our decision 22
not to reach these grounds of rejection does not reflect on the adequacy of 23
the prior art evidence applied in support of the rejections. Furthermore, 24
because our decision sustaining the rejection of claims 1–14, 19–31 and 33 25
under the second paragraph of § 112 is dispositive of the issues on appeal, 26
see 37 C.F.R. § 41.77(a) (“The affirmance of the rejection of a claim on any 27
of the grounds specified constitutes a general affirmance of the decision of 28

4
These art rejections are detailed on pages 11–14 of the Patent Owner’s
Appeal Brief.
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the examiner on that claim, except as to any ground specifically reversed.”), 1
we decline to reach the rejection of claims 1–14, 19–31 and 33 for failure to 2
comply with the written description requirement under the first paragraph of 3
§ 112. 4
The Patent Owner argues that the Examiner erred in failing to enter 5
proposed amendments to the appealed claims first presented after the Action 6
Closing Prosecution. (See App. Br. PO 16 and 34). The Examiner’s 7
decision not to enter the amendment is a matter of discretion, which is not 8
appealable to this Board. In re Mindick, 371 F.2d 892, 894 (CCPA 1967); 9
see also 37 C.F.R. § 1.116; cf. 37 C.F.R. § 1.951(a) (amendments proposed 10
after an Action Closing Prosecution are subject to the same rules governing 11
amendments after final during original prosecution). We will not address 12
this argument further. 13
14
THE ’097 PATENT 15
The ’097 patent teaches a method for maintaining glycemic control in 16
a patient. The method uses an equilibrium glucose sensor implanted 17
intravascularly (that is, within a blood vessel) in the patient to monitor the 18
patient’s blood glucose concentration. (See ’097 patent, col. 3, ll. 41–47). 19
The preferred equilibrium glucose sensor includes a fluorophore material 20
operably coupled with a quenching agent having analytic binding moieties 21
for binding glucose molecules. When illuminated by light at one or more 22
excitation wavelengths characteristic of the fluorophore material, the 23
combination of the fluorophore material and the quenching agent fluoresces 24
at one or more emission wavelengths different than the one or more 25
excitation wavelengths. The intensity of the light fluoresced by the 26
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combination of the fluorophore material and the quenching agent at the one 1
or more emission wavelengths is dependent on the glucose concentration in 2
the blood sample in which the sensor is placed. (See ’097 patent, col. 5, ll. 3
49–55 and col. 23, l. 65 – col. 24, l. 11). 4
The patent teaches that “tight glycemic control [in intensive care unit 5
(“ICU”) patients] may significantly reduce complications, shorten ICU 6
stays, and improve outcome.” (’097 patent, col. 37, ll. 3–8; see also id., col. 7
37, ll. 25–32). Nevertheless, the patent recognizes that an existing problem 8
with monitoring patients, and particularly ICU patients, using intravascular, 9
fluorescence-based equilibrium sensors was that slight changes in blood pH 10
might cause inaccurate readings. (See ’097 patent, col. 3, ll. 22–35). The 11
patent addresses the risk of inaccurate readings due to changes in pH by 12
teaching the use of a fluorophore material including both acidic and basic 13
species. By exploiting differences in the excitation or emission wavelengths 14
of the two species, one might take readings indicative of both the blood 15
glucose concentration and the blood pH. (See ’097 patent, col. 5, l. 55 – col. 16
6, l. 3; col. 21, ll. 30–41 and col. 23, ll. 21–62). The blood pH reading is 17
then used to correct the reading of blood glucose concentration to obtain a 18
more accurate measurement of blood glucose concentration. (See ’097 19
patent, col. 5, l. 65 – col. 6, l. 3). 20
The ’097 patent teaches preferably maintaining the blood glucose 21
concentration in ICU patients within the range of 80 mg/dl to 110 mg/dl. 22
(See ’097 patent, col. 37, ll. 52–55). The patent states that the “lack of 23
accurate and reliable blood glucose sensing below 100 mg/dl has hampered 24
ICU attempts to maintain target blood glucose levels, because of the 25
significant clinical risk of going too low.” (’097 patent, col. 38, ll. 16–19). 26
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During the reexamination proceeding, the Patent Owner amended 1
claims 1 and 33 to recite, with italics added for emphasis: 2
determining the blood glucose concentration from 3
the fluorescent signal, wherein the determination 4
of blood glucose concentration using the 5
equilibrium glucose sensor is at least as accurate as 6
a determination of blood glucose concentration 7
using a standard fingerstick test, even at blood 8
glucose concentrations below 100 mg/dl. 9
The ’097 patent mentions the term “standard fingerstick test” only once, in a 10
paragraph at column 38, lines 20–29. (See Req’r Comm. 2). This paragraph 11
describes two graphs reproduced as Figures 18A and 18B of the ’097 patent. 12
The written disclosure describes Figure 18A as a Bland-Altman 13
graph
5
representing the accuracy
6
of a determination of blood glucose 14
concentration using a “standard fingerstick test.” The data recorded in 15

5
We take official notice that, in a Bland-Altman graph, each data point
maps the difference between the POC reading and a laboratory measurement
of the same sample (represented on the y-axis) against the mean value of the
two measurements (represented on the x-axis). The “bias” is the arithmetic
mean of the differences between the POC readings and the laboratory
measurements. The “limits of agreement” represent the range within which
95% of the differences between the POC readings and the corresponding
laboratory measurements are likely to fall. (See Bland et al., Measuring
Agreement in Method Comparison Studies, 8 STAT. METHODS IN MED. RES.
135, 140–42 (1999)). This fact is of background interest only and has not
affected the outcome of this appeal.
6
We adopt the Requester’s definition of “accuracy” as the “degree of
conformity of a measure to a standard or true value.” (Req’r Comm. 5,
citing “Merriam-Webster’s Dictionary”). Therefore, the accuracy of an
instrument or method can be determined by comparing measurements taken
by the instrument or method with more reliable measurements of the same
quantity. (See James Decl., para. 11).
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Figure 18A compares measurements taken by the “standard fingerstick test” 1
against measurements taken by a “clinical chemistry system.” (See ’097 2
patent, col. 38, ll. 20–26). The text appearing on the face of Figure 18A 3
identifies the “clinical chemistry system” as a Dimension Clinical Chemistry 4
System, model RxL. The text appearing on the face of Figure 18A also 5
indicates that the drawing figure reproduces a graph appearing on page 340 6
of Lacara et al., Comparison of Point-of-Care & Laboratory Glucose 7
Analysis in Critically Ill Patients, 16 AM. J. CRITICAL CARE 336 (2007) 8
(“Lacara”). 9
The written disclosure of the ’097 patent describes Figure 18B as a 10
Bland-Altman graph representing the accuracy of a determination of blood 11
glucose concentration using a GluCath continuous equilibrium fluorescence 12
glucose sensor implanted in the right jugular vein of a sheep. The data 13
recorded in Figure 18B compares measurements taken by the equilibrium 14
glucose sensor against measurements taken by a YSI lab analyzer. (See ’097 15
patent, col. 38, ll. 29–32 and Fig. 18B). The ’097 patent then compares the 16
accuracy of the “standard fingerstick test” as reflected in the data recorded in 17
Figure 18A to the accuracy of the GluCath continuous equilibrium 18
fluorescence glucose sensor as reflected in the data recorded in Figure 18B. 19
The patent finds that the differences between the readings taken by the 20
equilibrium glucose sensor and the YSI lab analyzer as recorded in Figure 21
18B are “much tighter” than the differences between the readings taken by 22
the “standard fingerstick test” and the Dimension Clinical Chemistry System 23
as recorded in Figure 18A. The ’097 patent also finds that the graph in 24
Figure 18B has many more data points below 100 mg/dl than the graph in 25
Figure 18A. (’097 patent, col. 38, ll. 32–34). 26
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FINDINGS OF FACT 1
The Requester has introduced extrinsic evidence in the form of the 2
James Declaration and the Pickup Declaration. We find the following 3
findings of fact (“FF”) by a preponderance of the evidence. 4
1. Both the James Declaration and the Pickup Declaration testify 5
that one of ordinary skill in the art would have understood the term 6
“standard fingerstick test” to refer to any fingerstick test on the market. 7
(Req’r Comm. 2 (citing James Decl., para. 7; Pickup Decl., para. 8–10)). 8
The Patent Owner has not introduced any testimony or documentary 9
evidence regarding how one of ordinary skill in the art would have 10
understood the term. The declarants’ testimony demonstrates that the term 11
“standard fingerstick test” did not identify any particular brand or design of 12
fingerstick test for use as a benchmark or basis of comparison for assessing 13
accuracy. 14
2. In particular, the Pickup Declaration states that “there was not 15
one ‘standard’ [fingerstick] test then (on Nov. 21, 2007), and there is not one 16
such test now.” (Id., para. 8; see also Req’r Comm. 2). The Patent Owner 17
has not identified any evidence contradicting this statement. In particular, 18
the Patent Owner has not identified any evidence that one of ordinary skill in 19
the art would have recognized any one fingerstick test (or any limited 20
number of identifiable fingerstick tests) as providing a basis for evaluating 21
the accuracy of other tests for blood glucose concentration. On the contrary, 22
the Patent Owner argues that its “amendment was intended to be broad and 23
not linked to any specific point of comparison.” (App. Br. PO 35). 24
3. As mentioned earlier, the text appearing on the face of 25
Figure 18A indicates that the drawing figure reproduces a graph appearing 26
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on page 340 of Lacara. The Requester introduced a copy of Lacara during 1
the reexamination proceeding as Appendix U to the Requester Comments. 2
Lacara describes the graph reproduced in Figure 18A as a Bland-Altman 3
graph comparing readings of blood glucose concentration in samples taken 4
from critically ill patients made using a point-of-care (“POC”) glucose 5
oxidase photometry device and a Dimension Clinical Chemistry System, 6
model RxL. (See Lacara 337-38). Lacara identifies the POC glucose 7
oxidase photometry device as a SURESTEP PRO hospital meter using 8
SURESTEP PRO test strips. (See id.; see also Pickup Decl., para. 9). 9
4. Lacara does not use the term “standard fingerstick test.” In 10
particular, Lacara does not describe the SURESTEP PRO hospital meter and 11
test strips as a “standard fingerstick test.” Although Lacara conducted 12
experiments to measure the accuracy of determinations of blood glucose 13
concentration made using SURESTEP PRO test strips, Lacara also refers to 14
articles discussing the accuracy of another POC test as compared with 15
laboratory tests (see Lacara 341; see also Pickup Decl., para. 9) without any 16
suggestion that one fingerstick test or the other was “standard.” 17
5. The James Declaration states that: 18
As one of ordinary skill in the art would [have] 19
know[n], as of Nov. 21, 2007 and even today, 20
various commercially available point-of-care 21
(POC) fingerstick tests are available on the market. 22
They have different accuracy characteristics, 23
depending on the specific measurement device and 24
manufacturing variability with those devices. The 25
accuracy of glucose sensing from one fingerstick 26
test type or model to another different model or 27
type is highly variable. Based upon my knowledge 28
and experience in this art and my study of the ’097 29
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patent, using the highly variable “standard 1
fingerstick test” as a point of comparison in 2
measuring the accuracy of a glucose sensor (as is 3
done in claims 1 and 33 of the ’097 patent) would 4
make the result essentially meaningless. 5
(Id., para. 7). The Pickup Declaration includes similar testimony. (Id., 6
para. 10). The Patent Owner has not identified any evidence contradicting 7
this statement. We accept this statement as true. 8
6. The James Declaration also states that 9
The accuracy of any sensor is dependent on the 10
environment in which the measurement is being 11
taken. The temperature, length of exposure, and 12
(most importantly for an equilibrium glucose 13
sensor) the chemical compounds present in the 14
environment can each impact a measured accuracy 15
of a glucose concentration. . . . Accordingly, the 16
specific environment in which an accuracy test is 17
being conducted must be defined with some level 18
of specificity in order for one having ordinary skill 19
in the art to be able to determine if an equilibrium 20
glucose sensor is ‘at least as accurate’ as a 21
fingerstick test. 22
(Id., para. 8). The Patent Owner has not identified any evidence 23
contradicting this statement. We also accept this statement as true. 24
25
PRINCIPLES OF LAW 26
“During reexamination, as with original examination, the PTO must 27
give claims their broadest reasonable construction consistent with the 28
specification. . . . Therefore, we look to the specification to see if it provides 29
a definition for claim terms, but otherwise apply a broad interpretation.” In 30
re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007). 31
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According to the second paragraph of § 112, each claim must 1
“particularly [point] out and distinctly [claim] the subject matter which the 2
[Patent Owner] regards as his [or her] invention.” Procedurally, 3
when the [Examiner] has initially issued a well-4
grounded rejection that identifies ways in which 5
language in [an amended] claim is ambiguous, 6
vague, opaque, or otherwise unclear in describing 7
and defining the claimed invention, and thereafter 8
the applicant fails to provide a satisfactory 9
response, the [Examiner] can properly reject the 10
claim as failing to meet the statutory requirements 11
of [the second paragraph of § 112]. 12
In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014); cf. 35 U.S.C. § 314(a) 13
(2011)(“Except as otherwise provided in this section, reexamination shall be 14
conducted according to the procedures established for initial examination 15
under the provisions of sections 132 and 133.”). Compliance with the 16
second paragraph of § 112 is determined from the viewpoint of one of 17
ordinary skill in the art as of the filing date. Howmedica Osteonics Corp. v. 18
Tranquil Prospects Ltd., 401 F.3d 1367, 1371 (Fed. Cir. 2005)(citing W.L. 19
Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1556-57 (Fed. Cir. 1983)). 20
21
ANALYSIS 22
The Examiner adopts reasoning proposed by the Requester on 23
pages 1–8 of the Requester Comments as the basis for rejecting claims 1–14, 24
19–31 and 33 under the second paragraph of § 112. (See RAN 9–10; see 25
also id. at 12–13). This reasoning establishes a well-grounded rejection of 26
independent claims 1 and 33 under the second paragraph of § 112. More 27
specifically, the Examiner correctly concludes that claims 1 and 33, as well 28
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as their dependent claims, are indefinite because they fail to particularly 1
point out to one of ordinary skill in the art how to assess whether “the 2
determination of blood glucose concentration using the equilibrium glucose 3
sensor is at least as accurate as a determination of blood glucose 4
concentration using a standard fingerstick test.” (See RAN 12–13). There 5
are three reasons for this. 6
First, the Requester correctly defines “standard fingerstick test” as 7
being sufficiently broad to encompass any fingerstick test on the market as 8
of the filing date. The ordinary meaning of the term “standard” may refer to 9
a benchmark or procedure for making a comparison; or merely to something 10
that is ordinary or usual. The Patent Owner does not identify any formal 11
definition or clear disclaimer that might require that the term be interpreted 12
more narrowly than its ordinary meaning. In particular, the ’097 patent uses 13
the term “standard fingerstick test” only once, in describing Figure 18A. 14
This description contains no language indicative of a formal definition or a 15
desire to limit the scope of the claims. 16
The extrinsic evidence forecloses the possibility that the term 17
“standard” refers to a benchmark for making a comparison. The term fails 18
to identify any such benchmark in a manner recognizable to one of ordinary 19
skill in the art. (See FF 1–4). In particular, there is no evidence that one of 20
ordinary skill in the art would have recognized a SURESTEP PRO hospital 21
meter using SURESTEP PRO test strips as a “standard” POC fingerstick test in 22
the sense of defining a benchmark for determining accuracy. (See, e.g., FF 23
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2–4).
7
Therefore, “standard fingerstick test” may reasonably be interpreted 1
as identifying an ordinary or usual fingerstick test—in other words, any 2
fingerstick test on the market as of the filing date of the ’097 patent. 3
The Requester points out that the accuracy of fingerstick tests on the 4
market as of the filing date varied over a wide range. (Req’r Comm. 2; see 5
FF 5). Therefore, the recitation “at least as accurate as a determination of 6
blood glucose concentration using a standard fingerstick test” does not 7
define a reasonably reliable benchmark for assessing whether the accuracy 8
of an equilibrium glucose sensor used in an accused method satisfies the 9
accuracy limitations of claims 1 and 33. Instead, the recitation defines a 10
range of accuracies, within which an arbitrary line would have to be drawn 11
in order to determine whether a particular method using a particular 12
equilibrium glucose sensor infringes. In other words, “[b]ecause a skilled 13

7
The Patent Owner does not argue in this appeal that the content of the
Bland-Altman graph reproduced in Figure 18A is itself a benchmark for
assessing how accurate “a determination of blood glucose concentration
using a standard fingerstick test” is. The Patent Owner mentions Figure 18A
only twice in its arguments addressing the rejection under the second
paragraph of § 112. (See generally App. Br. PO 33–36). The Patent Owner
argues that, “[w]hile no numerical evaluation of accuracy is given, it is clear
from the testing results, such as those in FIGS. 18A and 18B, so that a
person having ordinary skill in the art could determine what constitutes
accuracy.” (App. Br. PO 35). This argument addresses the statistical
method (that is, the numerical evaluation) used to calculate accuracy rather
than the benchmark against which the comparison is to be made. The Patent
Owner also argues that the “Examiner next asserts that as the data
evaluations discussed with respect to FIGS. 18A and 18B are indefinite for
lacking a common point of comparison.” This statement characterizes the
Examiner’s reasoning, not whether the drawing figures provide a benchmark
for assessing accuracy. The Patent Owner’s response to the Examiner’s
reasoning does not refer to Figure 18A.
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artisan would be able to identify many fingerstick tests, each having 1
different accuracy characteristics, that skilled artisan would not know which 2
one to use as a point of comparison and thus be unable to determine if a 3
given equilibrium glucose sensor has the claimed accuracy.” (Resp. Br. 4
Req’r 12). As such, the recitation “at least as accurate as a determination of 5
blood glucose concentration using a standard fingerstick test” fails to 6
particularly point out the metes and bounds of the claimed subject matter. 7
Second, the step of “determining the blood glucose concentration 8
from the fluorescent signal” provides an antecedent basis for “the 9
determination of blood glucose concentration using the equilibrium glucose 10
sensor.” Therefore, one may deduce that the accuracy of “the determination 11
of blood glucose concentration using the equilibrium glucose sensor” is to be 12
determined in the environment in which the step of “determining the blood 13
glucose concentration from the fluorescent signal” is carried out. 14
On the other hand, neither claim 1 nor claim 33 recites the 15
environment in which the accuracy of the “determination of blood glucose 16
concentration using a standard fingerstick test” is to be assessed. The 17
accuracy of even a single fingerstick test may vary depending on 18
environmental conditions such as temperature, length of exposure and 19
sample chemistry. (FF 6). As a consequence, one of ordinary skill in the art 20
might not know if a particular method using a particular equilibrium glucose 21
sensor infringes, even after one or more benchmark fingerstick tests were 22
identified, until the environment in which the accuracy of the “determination 23
of blood glucose concentration using a standard fingerstick test” is to be 24
assessed is identified. (See Resp. Br. Req’r 12; Req’r Comm. 4–5; see also 25
James Decl., para. 13). 26
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In fact, the claim is not limited so as to require that the accuracy of the 1
standard fingerstick test be measured in the environment in which the step of 2
“determining the blood glucose concentration from the fluorescent signal” is 3
carried out. Assuming that the term “accuracy” had any meaning to one of 4
ordinary skill in the art when comparing a determination made using an 5
equilibrium glucose sensor in one environment to a determination made 6
using a fingerstick test in a different environment (see James Decl., para. 7
13), the “accuracy” of a “determination of blood glucose concentration using 8
a standard fingerstick test” might vary over a range of values depending on 9
the environment chosen for measuring that accuracy. As such, claims 1 and 10
33 fail to particularly point out the metes and bounds of the claimed subject 11
matter. 12
Third, neither claim 1 nor claim 33 identifies the “true value” of blood 13
glucose concentration that is to be used to assess the accuracy of either the 14
recited equilibrium glucose sensor or the “standard fingerstick test.” Once 15
again, one of ordinary skill in the art might not know if a particular method 16
using a particular equilibrium glucose sensor infringes until system and 17
method for determining the “true value” is identified. (See Resp. Br. Req’r 18
13; Req’r Comm. 6; see also James Decl., para. 11). Even then, nothing in 19
claim 1 or claim 33 requires that the same “true value” be used to determine 20
the accuracies of both the equilibrium glucose sensor and the “standard 21
fingerstick test.” As such, claims 1 and 33 fail to particularly point out the 22
metes and bounds of the claimed subject matter. 23
The significance of this these three bases for uncertainty or ambiguity 24
becomes apparent when one attempts to read the language of claims 1 and 25
33 in view of the written disclosure and drawing figures of the ’097 patent. 26
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The only comparison between the accuracy of a “determination of blood 1
glucose concentration using the equilibrium glucose sensor” and a 2
“determination of blood glucose concentration using a standard fingerstick 3
test” which appears in the ’097 patent occurs in the text describing Figures 4
18A and 18B. (See generally ’097 patent, col. 38, ll. 20–34). More 5
specifically, Figure 18B represents data associated with a determination of 6
blood glucose concentration obtained using an equilibrium glucose sensor 7
implanted into the jugular vein of a sheep, compared against “true values” 8
obtained by a YSI lab analyzer. Figure 18A represents data associated with 9
a determination using a fingerstick test (of a type the patent itself does not 10
identify) performed on blood from critically ill, human patients, compared 11
against “true values” obtained by a Dimension Clinical Chemistry System. 12
(See id.; see also James Decl., para. 12; Pickup Decl., para. 13 and 14). The 13
’097 patent purports to compare the accuracy of the two determinations. 14
(’097 patent, col. 38, ll. 32–34). 15
In other words, the written description and drawing figures of the 16
’097 patent imply that one may determine whether a method using a 17
particular equilibrium glucose sensor satisfies the limitations of claims 1 and 18
33 by comparing the accuracy of a determination taken by the sensor in a 19
particular environment, assessed in terms of one set of “true values,” to the 20
accuracy of an arbitrarily chosen fingerstick test performed in a different 21
environment, assessed in terms of a different set of “true values,” which may 22
differ from each other. As such, the ’097 patent teaches comparing the 23
“accuracies” of the equilibrium glucose sensor and the “standard fingerstick 24
test” under precisely those arbitrary conditions which prompted the 25
Examiner to conclude that claims 1 and 33 are indefinite. 26
Appeal 2014-007070
Reexamination Control 95/002,142
Patent No. US 8,088,097 B2

18
The recitation that “wherein the determination of blood glucose 1
concentration using the equilibrium glucose sensor is at least as accurate as a 2
determination of blood glucose concentration using a standard fingerstick 3
test, even at blood glucose concentrations below 100 mg/dl,” further 4
obscures the scope of claims 1 and 33. As the Requester points out, it is not 5
reasonably clear from this recitation whether the determination of blood 6
glucose concentration using the equilibrium glucose sensor need only be at 7
least as accurate as a determination of blood glucose concentration using a 8
standard fingerstick test at blood glucose concentrations below 100 mg/dl; or 9
whether this must be true up to some greater concentration as well. (See 10
Req’r Comm. 8). 11
Therefore, the reasoning proposed by the Requester and adopted by 12
the Examiner establishes a well-grounded rejection of independent claims 1 13
and 33 under the second paragraph of § 112. The Patent Owner’s response 14
is not persuasive or satisfactory. The Patent Owner argues that claims 1 and 15
33 are merely broad rather than indefinite. More specifically, the Patent 16
Owner argues that its amendment: 17
was intended to be broad and not linked to any 18
specific point of comparison. A skilled person 19
would appreciate that the recited accuracy was 20
provided in general language, because all ICU 21
physicians and staff were accustomed to using 22
various point-of-care (finger stick) determinations 23
in order to titrate insulin dose in the ICU. . . . 24
Therefore, a precise point of comparison is not 25
needed for one skilled in the art to fully appreciate 26
the data and description of [the Patent Owner’s] 27
recited method. 28
(App. Br. PO 35–36). 29
Appeal 2014-007070
Reexamination Control 95/002,142
Patent No. US 8,088,097 B2

19
This argument fails to come to grips with the reasoning adopted by the 1
Examiner in sufficient detail to be persuasive of error. Although one of 2
ordinary skill in the art may appreciate the written description to support the 3
claimed subject matter, greater clarity and precision than appear in claims 1 4
and 33 are required to provide one of ordinary skill in the art fair notice of 5
the scope of the exclusive rights that the Patent Owner seeks. 6
7
CONCLUSION 8
We sustain the rejection of claims 1–14, 19–31 and 33 as indefinite 9
under the second paragraph of 35 U.S.C. § 112. We do not reach the other 10
grounds of rejection entered by the Examiner. 11
12
DECISION 13
We AFFIRM the Examiner’s decision rejecting claims 1–14, 19–31 14
and 33. 15
Requests for extensions of time in this inter partes reexamination 16
proceeding are governed by 37 C.F.R. § 1.956. 17
In the event neither party files a request for rehearing within the time 18
provided in 37 C.F.R. § 41.79, and this decision becomes final and 19
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must 20
timely serve notice on the Director of the United States Patent and 21
Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. 22
23
AFFIRMED 24
25
26
Appeal 2014-007070
Reexamination Control 95/002,142
Patent No. US 8,088,097 B2

20
Patent Owner: 1
2
KNOBBE MARTENS OLSON & BEAR LLP 3
2040 MAIN STREET 4
FOURTEENTH FLOOR 5
IRVINE, CA 92614 6
7
Third Party Requester: 8
9
FISH & RICHARDSON P.C. (TC) 10
P.O. BOX 1022 11
MINNEAPOLIS, MN 55440-1022 12