Ex Parte Kovatchev et al

Patent Trial and Appeal Board

Jan 31, 2013

10524094 (P.T.A.B. Jan. 31, 2013)

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.
10/524,094 02/09/2005 Boris P. Kovatchev 3057.128.US 4378
26474 7590 01/31/2013
NOVAK DRUCE CONNOLLY BOVE + QUIGG LLP
300 NEW JERSEY AVENUE NW
FIFTH FLOOR
WASHINGTON, DC 20001
EXAMINER
CLOW, LORI A
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
01/31/2013 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
__________

Ex parte BORIS P. KOVATCHEV and DANIEL J. COX
__________

Appeal 2011-003312
Application 10/524,094
Technology Center 1600
__________

Before TONI R. SCHEINER, ERICA A. FRANKLIN, and JOHN G. NEW,
Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods and systems for evaluating the glycosylated hemoglobin (HbA1c) of
a patient based on blood glucose data. The Patent Examiner rejected the
claims as being directed to non-statutory subject matter, as being indefinite,
and as anticipated. We have jurisdiction under 35 U.S.C. § 6(b)(1). We
affirm-in-part.

Appeal 2011-003312
Application 10/524,094

2
STATEMENT OF THE CASE
“The invention includes a data analysis method and computer-based
system for the simultaneous evaluation, from routinely collected SMBG
[self-monitoring blood glucose] data, of the two most important components
of glycemic control in diabetes: HbA1c and the risk of hypoglycemia.”
(Spec. 7, ll. 3-5.)
Claims 1-39, 112-158, 160-178, 180-218, 220-224, and 226 are on
appeal.
1
Claims 1 and 6 are representative and read as follows:
1. A method for evaluating the glycosylated hemoglobin (HbA1c) of a
patient based on blood glucose (BG) data collected over a first
predetermined duration, said method comprising:

pre-processing the collected BG data to convert the collected BG data
into derived BG data derived from said collected BG data,

estimating HbA1c by applying at least one predetermined formula to
said derived BG data,

validating the estimate via sample selection criteria;

electronically transforming the estimate into a visual depiction; and

outputting the visual depiction of the estimate to a user.

1
Appellants state that claims 1-39 and 112-226 are on appeal. (App. Br. 2;
Reply Br. 10.) However, in the Answer, the Examiner withdrew the
rejection of claims 1, 5, 19, 23, 37, 38, 135, 139, 155, 159, 175, 179, 195,
199, 215, 219, 221 and 225 under 35 U.S.C. § 102(b). (Ans. 3.) None of the
remaining rejections includes claims 159, 179, 219, and 225 that were
included among the claims in the withdrawn rejection. Thus, claims 159,
179, 219, and 225 do not stand rejected and are not considered on appeal.
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6. The method of claim 1, wherein the preprocessing of the data
comprises:

conversion of plasma to whole blood BG mg/dl via BG=PLASBG
(mg/dl) /1.12;

conversion of BG measured in mg/dl to units of mmol/I via BGMM=BG/18;
and computing Low Blood Glucose Index (RL01) and High Blood Glucose
Index (RHI1) using a predetermined mathematical formula defined as:

Scale=[ln(BG)]
1.0845
- 5.381, wherein BG is measured in units of
mg/dl,
Risk1 = 22.765(Scale)
2
, wherein
RiskLO=Risk1 if (BG is less than about 112.5) and therefore risk of
LBGI exists, otherwise RiskLO=0, and
RiskHI=Risk1 if (BG is greater than about 112.5) and therefore risk of
HBGI exists, otherwise RiskHI=0,
BGMM1 = average of BGMM per patient,
RLO1 = average of RiskLO per patient,
RHI1 = average of RiskHI per patient,
L06 = average of RiskLO computed only for readings during the
night, otherwise missing if there are no readings at night,
N06, N12, N24 are percentage of SMBG readings in time intervals,
NC1 = total number of SMBG readings in the first predetermined
duration; and
NDAYS = number of days with SMBG readings in the first
predetermined duration.

The Examiner rejected the claims as follows:
• claims 1-18, 112, 113, 135-154, and 195-214 under 35 U.S.C. § 101
as being directed to non-statutory subject matter;
• claims 6, 8-10, 24, 26-28, 120, 122-124, 140, 142-144, 160, 162-
164, 180, 182-184, 200, 202-204, 220, and 226 under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter regarded as the invention;
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Application 10/524,094

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• claims 1, 19, 37, 38, 135, 155, 175, 195, 215, and 221 under 35
U.S.C. § 102(e) as anticipated by Heinonen.
2

NON-STATUTORY SUBJECT MATTER
The Examiner‟s position is that the rejected claims are directed to an
abstract idea. (Ans. 5.) Specifically, the Examiner found that: (a)
“the claims do not include an express or inherent recitation of a specific
machine to perform the method of evaluating the HbAlc of a patient;” b)
“the claims merely recite mathematical concepts of manipulating data by
pre-processing data to convert it to a derived data, estimating the HbAlc
from a predetermined formula, and validating the estimate without the
recitation of a machine in which to perform such steps;” c)
the recitation of „electronically transforming the estimate into a
visual depiction‟ is not material to or central to the purpose of
the claimed subject matter and does not constitute a
transformation to a different state or thing. The recitation is
tangentially related to the performance of the evaluation of
HbA1c, which is calculated by conversion of the collected BG
data, and estimated by applying a predetermined formula.

(Id. at 5-6.)
Appellants contend that the claims are not directed to abstract
intellectual concepts or mental processes, but are instead directed to a
specific method of estimating the glycosylated hemoglobin of a patient and
communicating the estimate to a user, involving analysis of quantitative
physical characteristics of a physical patient, and having a practical
application in the prevention or treatment of an adverse physical condition of

2
Patent No. US 6,421,633 B1 issued to Pekka Heinonen et al., Jul. 16, 2002.
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the patient. (App. Br. 14-15.) Appellants assert that the claimed method
meets the “transformation” test discussed in In re Bilski, 545 F.3d 943 (Fed.
Cir. 2008) because (a) “it converts SMBG data representative of blood
glucose, to an estimate of HbA1c data representative of glycosylated
hemoglobin” (id. at 15) and (b) “the claims all set forth electronic
transformation of the estimate data into a visual depiction that is presented to
a user” (id. at 16).
The test for patent eligible subject matter involves weighing factors to
evaluate the claim as to whether the claim represents an abstract idea or is
tailored narrowly enough to encompass only a particular application of a
fundamental principle. While we understand that the Federal Circuit's
“machine or transformation test” is not the sole test, as asserted by
Appellants (see App. Br. 14-15; Reply Br. 2) the Supreme Court did
acknowledge, based on the Court's precedent, that the test is a “useful and
important clue, an investigative tool, for determining whether some claimed
inventions are processes under § 101.” Bilski v. Kappos, 130 S.Ct. 3218,
3227 (2010); see also Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
132 S.Ct. 1289, 1296 (2012). Thus, the Examiner appropriately assessed
patent eligibility under the machine-or-transformation test.
We have considered the claimed methods taken as a whole and agree
with the Examiner that the claims are directed to an abstract idea, and
therefore recite patent ineligible subject matter under 35 U.S.C. § 101.
Appellants do not allege that the claims satisfy the machine arm of the
Bilski “machine or transformation test.” Rather, Appellants assert that the
claims satisfy the “transformation” arm of the test. (App. Br. 16-17.)
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However, we agree with the Examiner that the method claims at issue are
not transformative for the following reasons.
We do not find that the claimed method meets the “transformation”
test by “convert[ing] SMBG data representative of blood glucose, to an
estimate of HbA1c data representative of glycosylated hemoglobin.” (See
App. Br. 15.) The conversion of this data does not involve transforming an
article into a different state or thing, but instead converting one number to
another. See Bilski, 545 F.3d at 962-963. Indeed, as claim 1 recites, such
conversion involves merely “applying at least one predetermined formula to
said derived BG data.” (App. Br. 24, Claims App‟x.)
We also do not find that the claims meet the “transformation” test by
“set[ting] forth electronic transformation of the estimate data into a visual
depiction that is presented to a user.” (See id. at 16.) In particular, the
“estimate data” is not “raw” data “represent[ing] physical and tangible
objects,” such as the structure of bones, organs, and other body tissues as
discussed in Bilski. See Bilski, 545 F.3d at 962-963. Rather, the estimate
data of the claimed method represents processed data, i.e., BG data
converted into derived BG data, from which a numerical estimate was
formulated by applying at least one predetermined formula. Thus, the
claimed step of “electronically transforming the estimate into a visual
depiction” did not comprise a visual depiction of a physical or tangible
object. Rather, this visual depiction merely involved an electronic
communication of the numerical estimate to a user.
Moreover, to the extent that Appellants assert that collecting blood
glucose from a patient is an inherent step of the claimed method and that
such step provides additional evidence that the claims are not directed to
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abstract ideas (App. Br. 17) we disagree. The collection of a blood sample
from a patient is a “well-understood, routine, conventional activity
previously engaged in by researcher in the field” that is insufficient to
transform an abstract idea into an eligible concept. See Mayo Collaborative
Servs. v. Prometheus Labs, Inc., 132 S.Ct. at 1294-1298 (“Purely
„conventional or obvious‟ „[pre]-solution activity‟ is normally not sufficient
to transform an unpatentable law of nature into a patent-eligible application
of such a law.”); accord Perkinelmer, Inc. v. Intema Ltd., 2012 WL
5861658, *5 (Fed. Cir. 2012) (purely conventional “measuring” steps
insufficient to make the claims reciting mental processes and natural laws
patent-eligible).
Accordingly, we conclude that the method of independent claim 1 is
patent ineligible subject matter under 35 U.S.C. § 101. Claims 2-18, 112,
113, 135-154, and 195-214 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

INDEFINITENESS
The Examiner‟s position is that the claims recite “using a
predetermined mathematical formula defined as,” but fail to recite any such
mathematical formula. (Ans. 6.) According to the Examiner, the claims
merely define certain criteria, such as “scale” and “risk” without any
association to an actual formula. (Id.) Therefore, the Examiner found that it
is unclear as to what is being computed. (Id.)
Appellants contend that “actual mathematical formulae are in fact set
forth in the claims under rejection.” (App. Br. 18.) For example, Appellants
assert that claim 6 requires computing Low Blood Glucose Index (RLO1)
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and High Blood Glucose Index (RHI1) using a predetermined mathematical
formula defined as RLO1=average of Risk LO per patient, and
RHI1=average of Risk HI per patient, which are actual mathematical
formulae. (Id.)
We agree with Appellants that the claims specifically recite
predetermined mathematical formula for computing RLO1 and RHI1.
Accordingly, we reverse the indefiniteness rejection.

ANTICIPATION
The Examiner found that Heinonen taught a method and system
whereby levels of HbA1c are predicted using a mathematical model which is
derived to predict the behavior of HbA1c relative to blood glucose, therefore
meeting the limitations of converting BG data and estimating HbA1c and
providing an output of the data. (Ans. 7-8.)
Appellants contend that Heinonen does not disclose the claimed
method, in particular Heinonen does not disclose a step of validating the
estimate via sample selection criteria. (App. Br. 21; Hearing Transcript 9, ll.
4-10.)
The Examiner‟s position is that in Heinonen, “[t]he data are validated
by recalculation of modeling coefficients based on levels attained
previously.” (Ans. 12.)
Appellants note that the Examiner has not provided any citation to
Heinonen to support this finding. (Hearing Trans. 9, l. 22- 10, l. 3.) Further,
Appellants assert that Heinonen‟s disclosure of “updating the model when a
new glycosylated haemoglobin component level is measured using that new
measurement and recent new blood glucose level measurements” (Heinonen
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col. 2, ll. 30-33) is not validating the estimate, as it is not an estimate, but a
model matrix that is being updated (Hearing Trans. 10, l. 5- 11. l. 3).
We agree with Appellants that the Examiner has not established that
Heinonen disclosed validating the estimated HbA1c via sample selection
criteria. The Specification sets forth the parameters for achieving such
validation, which requires that the first predetermined duration sample meets
at least one of the listed criteria. (See Spec. 13, ll. 10-25.) Not only does
Heinonen not address the sample selection criteria disclosed in the instant
Specification, Heinonen also does not disclose validating its estimate by any
means. Rather, as Appellants have correctly asserted, Heinonen merely
updates the model that is applied to predict the HbA1c level.
Accordingly, we reverse the anticipation rejection.

SUMMARY
We affirm the rejection of claims 1-18, 112, 113, 135-154, and 195-
214 under 35 U.S.C. § 101 as being directed to non-statutory subject matter;
we reverse the rejection of claims 6, 8-10, 24, 26-28, 120, 122-124,
140, 142-144, 160, 162-164, 180, 182-184, 200, 202-204, 220, and 226
under 35 U.S.C. § 112, second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter regarded as the
invention;
we reverse the rejection of claims 1, 19, 37, 38, 135, 155, 175, 195,
215, and 221 under 35 U.S.C. §102(e) as anticipated by Heinonen.

Appeal 2011-003312
Application 10/524,094

10
TIME PERIOD FOR RESPONSE
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-IN-PART

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