Ex Parte Surwit et al

Board of Patent Appeals and Interferences

Oct 29, 2009

11115824 (B.P.A.I. Oct. 29, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte RICHARD S. SURWIT, LYLE M. ALLEN, III, JAMES J. MORRIS, JR.
and THOMAS LEE ORTEL
____________
Appeal 2009-004608
Application 11/115,824
Technology Center 3600
____________

Decided: October 30, 2009
____________

Before, ANTON W. FETTING, JOSEPH A. FISCHETTI, and BIBHU R.
MOHANTY, Administrative Patent Judges.

FISCHETTI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s final
rejection of claims 44-55 and 60-73. We have jurisdiction under 35 U.S.C. § 6(b).
(2002).

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SUMMARY OF DECISION
We REVERSE.

THE INVENTION
Appellants claim data processing apparatus and methods related to medical
monitoring apparatus and systems. (Spec. 1:3-5).
Claim 44 is representative of the subject matter on appeal.
44. A method of monitoring disease therapy of a patient, wherein the
disease therapy includes a patient-administered medication regimen and a patient-
administered regimen for a test that monitors efficacy of the medication regimen,
wherein the test is administered by the patient according to a first schedule, the
method comprising the following steps:
receiving test results from a patient-administered test at a portable, hand-
held apparatus that is configured to receive and analyze information regarding
patient compliance with the patient-administered medication and test regimens,
and wherein the apparatus is configured to modify the patient-administered
medication and test regimens;
directing the patient, via the portable, hand-held apparatus, to administer
future tests according to a second schedule different from the first schedule in
response to determining that the received test results are within or not within a
desired range, wherein the second schedule has a frequency of administration that
is lower in value than a frequency of administration of the first schedule when the
received test results are within a desired range, and wherein the second schedule
has a frequency of administration that is higher in value than a frequency of
administration of the first schedule when the received test results are not within a
desired range;
receiving non-medication related data from a patient at the portable, hand-
held apparatus, wherein the non-medication related patient data includes at least
one of physiological data, pathophysiological data, biological data, psychological
data, neuropsychological data, and behavioral data; and
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analyzing the received non-medication related data via the portable, hand-
held apparatus to determine if a change is necessary to the patient-administered
medication regimen and/or to the patient-administered test regimen.

THE REJECTION
The Examiner relies upon the following as evidence of unpatentability:
Worthington 5,822,715 Oct. 13, 1998
Lloyd 6,080,106 Jun. 27, 2000
Brown 6,161,095 Dec. 12, 2000
Hennessy 6,277,071 Aug. 21, 2001
Valenta, “How to achieve balance in your diabetes management program”
Ames Center for Diabetes Education, vol. 12, no. 1, Jan (1993) p. 6

The following rejections are before us for review.
The Examiner rejected claims 44-53, 55 and 60-69 under 35 U.S.C. § 103
(a) as being unpatentable over Worthington in view of Valenta and further in view
of Hennessy.
The Examiner rejected claims 54 and 70 under 35 U.S.C. § 103(a) as being
unpatentable over Worthington, Valenta, Hennessy, and further in view of Lloyd.
The Examiner rejected claims 71-73 under 35 U.S.C. § 103 (a) as being
unpatentable over Worthington, Valenta, Hennessy, Lloyd, and further in view
Brown.
ISSUE
Have Appellants shown that the Examiner erred in rejecting claims 44-53,
55 and 60-69 under 35 U.S.C. § 103 (a) as being unpatentable over Worthington in
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view of Valenta and further in view of Hennessy on the grounds that a person with
ordinary skill in the art would understand that Worthington’s disclosure of “dose
value, dose type, and time of injection in apparatus 10” is non-medication related
data and thus meets the limitations of claims 44 and 60?

PRINCIPLES OF LAW
“Section 103 forbids issuance of a patent when ‘the differences between the
subject matter sought to be patented and the prior art are such that the subject
matter as a whole would have been obvious at the time the invention was made to a
person having ordinary skill in the art to which said subject matter pertains.’” KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is
resolved on the basis of underlying factual determinations including (1) the scope
and content of the prior art, (2) any differences between the claimed subject matter
and the prior art, (3) the level of skill in the art, and (4) where in evidence, so-
called secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966). See also KSR, 550 U.S. at 407 (“While the sequence of these questions
might be reordered in any particular case, the [Graham] factors continue to define
the inquiry that controls.”)

FINDINGS OF FACT

We find the following facts by a preponderance of the evidence:
1. The Examiner found that Worthington discloses

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(c) receiving measurements of a blood glucose value at
the apparatus (an example of "physiological or biological
data") (col. 4 lines 1-12, col. 15 lines 36-45) (reads on
"receiving non-medication related data from a patient at
the portable, hand-held apparatus, wherein the non-
medication related patient data includes at least one of
physiological data, pathophysiological data, biological
data, psychological data, neuropsychological data and
behavioral data"); (Ans. 5).
2. Worthington discloses at col. 15 lines 36-45:
… patient eats a late dinner at 8:40 PM. Before eating,
the patient estimates that the meal requires 15 units of
bolus insulin and injects 15 units of lispro at 8:30 PM.
The patient records the dose value, dose type, and time of
injection in apparatus 10. At bedtime, 11:00 PM, the
patient uses apparatus 10 to measure his or her blood
glucose value. Apparatus 10 produces and displays to
the patient a current blood glucose value of 480 mg/dl.
The patient then requests apparatus 10 to predict a future
blood glucose value at the ultimate time point.
(Worthington, col. 15, ll. 36-46).
3. The Examiner found that “…Worthington discloses a method for assisting
a patient having diabetes in controlling blood glucose by measuring a blood sample
of the patient (col. 4 ll. 2-11) ….” (Ans. 3).
4. Worthington discloses at col. 4. , lines 2-11:
[t]he invention presents a system and method for
assisting a patient having diabetes mellitus in controlling
blood glucose. The system includes a patient-operated
apparatus having a blood glucose meter for measuring a
blood sample of the patient and for producing from a
measurement of the blood sample a blood glucose value
G(td) representative of a blood glucose concentration of
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the patient at time td. The apparatus also includes a user
interface for entering in the apparatus an insulin dose
value Ik representative of an insulin dose administered to
the patient prior to time td. (Worthington, col. 4, ll. 2-11).
5. The Specification describes non-medication related patient data in the
context of
… the CPM prompts the patient as to whether the patient
has undergone any behavioral or non-medication related
changes (Block 1500). For example, has the patient
changed his/her diet and/or intake of vitamins and/or
other medications. Behavioral and non-medication
related changes include all signs, symptoms, conditions
and behavior (changed or otherwise of concern) that
could affect a patient's disease state, and which are not
directly attributable to too much medication (supra-
therapeutic) or too little medication (sub-therapeutic).
According to the present invention, behavioral and non-
medication related changes may be divided into those
that are serious (thus requiring a call to a healthcare
provider immediately) and those that bear watching.
Behavioral and non-medication related changes that only
bear watching may become significant if they are deemed
to alter the patient's medication schedule or schedule for
transmitting data to a healthcare provider.
(Spec. 61:10-29).

ANALYSIS
Appellants assert error in the 35 U.S.C. § 103(a) rejections before us, each
based on Worthington, because allegedly the Examiner uses the same element in
Worthington to meet two different claim limitations. Specifically, Appellants
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argue:
the Final Action argues that blood glucose value
measurement [in Worthington] is "non-medication
related data." (Final Action, p. 4). However, the Final
Action also takes the position that "blood glucose value
measurement" is the same as Appellants' recited
"receiving test results." (Final Action, p. 4). Blood
glucose value measurements described in Worthington et
al. cannot be two separate recited elements of Appellants'
independent Claims 44 and 60 (i. e., "test results" and
"non-medication related data"). Appellants' specification
makes clear that "test results" and "non-medication
related data" are different. (Appeal Br. 7).
Each of independent claims 44 and 60 require:
a. receiving test results from a patient-administered test;
b. receiving non-medication related data from a patient at the portable,
hand-held apparatus, wherein the non-medication related patient data includes at
least one of physiological data, pathophysiological data, biological data,
psychological data, neuropsychological data, and behavioral data.
The Examiner found that Worthington at col. 4, ll. 1-12 discloses limitation
(a.) (FF 3), and that Worthington, at col. 4 ll. 10-12, and at col. 15, ll. 36-45
discloses limitation (b.). Worthington at column 4, ll. 1-12 discloses “a patient-
operated apparatus having a blood glucose meter for measuring a blood sample of
the patient and for producing from a measurement of the blood sample a blood
glucose value G(td) representative of a blood glucose concentration of the patient at
time t.” (FF4). We agree with the Examiner that Worthington meets the limitation
(a.) supra of independent claims 44 and 60.
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With respect to limitation (b) supra however, the Specification describes
non-medication related data from a patient in the context of “…has the patient
changed his/her diet and/or intake of vitamins and/or other medications.
Behavioral and non-medication related changes include all signs, symptoms,
conditions and behavior (changed or otherwise of concern) that could affect a
patient's disease state….”(FF 5).
Given that the Examiner offers two different excerpts from Worthington to
meet claim limitation (b.) (FF 1), and since the Examiner found that one of which,
Worthington’s disclosure at col. 4, ll. 1-12 already meets the receiving tests results
limitation (a.), we are thus left to apply the remaining excerpt of Worthington at
col. 15, ll. 36-45 to limitation (b.), supra.
This section of Worthington discloses receiving or recording of patient
“dose value, dose type, and time of injection in apparatus 10.” (FF 2). Such data
falls squarely within medication related data as opposed to non-medication related
data and thus cannot meet the claim limitations. The difference in content of the
testing information and the non-medication related data has functional significance
because the claims require that the received non-medication related data is
analyzed to determine if a change is necessary to the patient-administered
medication regimen and/or to the patient-administered test regimen.
Since claims 45-53, 55 and 61-69 depend from claims 44 and 60, and since
we cannot sustain the rejection of claims 44 and 60, the rejection of the dependent
claims likewise cannot be sustained.
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For the above reasons we will not sustain the rejection of claims 44-53, 55
and 60-69. As the rejection of claims 54 and 70-73 fails to cure the deficiency of
the rejection of claims 44 and 60, we will also not sustain the rejection of these
claims.

CONCLUSIONS OF LAW
We conclude the Appellants have shown that the Examiner erred in rejecting
claims 44-53, 55 and 60-69 under 35 U.S.C. § 103 (a) as being unpatentable over
Worthington in view of Valenta and further in view of Hennessy.
We conclude the Appellants have shown that the Examiner erred in rejecting
claims 54 and 70 under 35 U.S.C. § 103(a) as being unpatentable over
Worthington, Valenta, Hennessy, and further in view of Lloyd.
We conclude the Appellants have shown that the Examiner erred in rejecting
claims 71-73 under 35 U.S.C. § 103 (a) as being unpatentable over Worthington,
Valenta, Hennessy, Lloyd, and further in view Brown.

DECISION
The decision of the Examiner to reject claims 44-55 and 60-73 is
REVERSED.
REVERSED

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JRG

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