Ex Parte Blumenfeld

Board of Patent Appeals and Interferences

Sep 8, 2008

10118369 (B.P.A.I. Sep. 8, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte TRACY HARMON BLUMENFELD
____________

Appeal 2008-3771
Application 10/118,369
Technology Center 3600
____________

Decided: September 8, 2008
____________

Before WILLIAM F. PATE, III, HUBERT C. LORIN, and
JOSEPH A. FISCHETTI, Administrative Patent Judges.

LORIN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Tracy Harmon Blumenfeld (Appellant) seeks our review under 35
U.S.C. § 134 of the final rejection of claims 1, 3-12, 14-21, and 28-31.
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Claims 2 and 13 have been cancelled and claims 22-27 have been
withdrawn. We have jurisdiction under 35 U.S.C. § 6(b) (2002).

SUMMARY OF DECISION
We AFFIRM. 1

THE INVENTION
The invention is directed to a system and method for evaluating the
performance and progress of research trials and more specifically to
providing benchmark metrics in real time. (Specification 1:3-5.)

Currently no electronic mechanism exists that
systematically and automatically provides
clinicians and/or pharmaceutical sponsors with the
ability to obtain interactive, real-time benchmarks
and with those benchmarks better assess physician
capabilities for matching physicians and research
sites and with those data better assess physician
capabilities for matching physicians and research
sites for future clinical trials.

(Specification 1:15-2:2.)
Claim 1, reproduced below, is illustrative of the subject matter on
appeal.
1. A method for permitting a sponsor of an activity
to contact a plurality of potential participants in the
activity and for monitoring progress of the activity,

1 Our decision will make reference to the Appellant’s Appeal Brief (“App.
Br.,” filed Jun. 15, 2007) and Reply Brief (“Reply Br.,” filed Dec. 10, 2007),
and the Examiner’s Answer (“Answer,” mailed Oct. 9, 2007).
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the method comprising:
(a) storing, on a database server, information
concerning the plurality of potential participants
to allow the sponsor to access the information
concerning the plurality of potential participants;
(b) storing, on the database server, information
submitted by the sponsor concerning the activity to
allow the plurality of potential participants to
access the information concerning the activity;
(c) providing contact between the sponsor and at
least one of the plurality of potential participants
concerning the activity to allow selection of at
least one participant from the plurality of potential
participants;
(d) selecting said at least one participant;
(e) storing, on the database server, information
concerning the progress of the activity and
displaying some or all of the information at least to
the at least one participant selected in step (d);
(f) automatically calculating, from the information
stored in step (e), benchmarks concerning the
progress of the activity once said at least one
participant is selected; and
(g) displaying some or all of the benchmarks at
least to the at least one participant.

THE REJECTION
The Examiner relies upon the following as evidence of
unpatentability:
Benigno
Knight
US 2002/0087361 A1
US 2002/0099570 A1
Jul. 4, 2002
Jul. 25, 2002

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The following rejection is before us for review:
1. Claims 1, 3-12, 14-21, and 28-31 are rejected under 35 U.S.C. §103(a)
as being unpatentable over Benigno and Knight.

ISSUE
The issue before us is whether the Appellant has shown that the
Examiner erred in rejecting claims 1, 3-12, 14-21, and 28-31 under 35
U.S.C. §103(a) as being unpatentable over Benigno and Knight. The issue
turns on whether the prior art would have led one of ordinary skill in the art
to conduct claim steps (d) and (g) using the same participant.

FINDINGS OF FACT
We find that the following enumerated findings of fact (FF) are
supported by at least a preponderance of the evidence. Ethicon, Inc. v.
Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general
evidentiary standard for proceedings before the Office).
The scope and content of the prior art
1. Benigno relates to “systems useful for analyzing medical data
related to clinical pathways and performing actions based upon the
analyses.” [0003].
2. Benigno [0025] describes its system as one which allows a
caregiver, such as a doctor or nurse, to review a proposed clinical
pathway.
3. Benigno [0113] describes it system as one which can determine
optimal clinical pathways based on various criteria developed from
a patient’s history.
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4. Knight describes techniques for recruiting patients into a clinical
trial.
Any differences between the claimed subject matter and the prior art
5. The claimed method combines Benigno’s benchmarking system
with Knight’s patient selection process but instead of displaying
the benchmarks to the caregiver, as Benigno suggests, displaying
them to the selected patient.
The level of skill in the art
6. Neither the Examiner nor the Appellant has addressed the level of
ordinary skill in the pertinent arts of benchmarking and medical
care. We will therefore consider the cited prior art as
representative of the level of ordinary skill in the art. See Okajima
v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)(“[T]he absence
of specific findings on the level of skill in the art does not give rise
to reversible error ‘where the prior art itself reflects an appropriate
level and a need for testimony is not shown’”) (Quoting Litton
Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163
(Fed. Cir. 1985)).
7. One of ordinary skill in the art of medical care would have known
that most, if not all, caregivers share health-related information
they have gathered on a patient with that patient herself.
Secondary considerations
8. There is no evidence on record of secondary considerations of non-
obviousness for our consideration.

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PRINCIPLES OF LAW
Obviousness
“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., 127 S.Ct. 1727,
1734 (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, and (3) the level of skill in the art. Graham v. John Deere Co., 383
U.S. 1, 17-18 (1966). See also KSR, 127 S.Ct. at 1734 (“While the sequence
of these questions might be reordered in any particular case, the [Graham]
factors continue to define the inquiry that controls.”) The Court in Graham
further noted that evidence of secondary considerations “might be utilized to
give light to the circumstances surrounding the origin of the subject matter
sought to be patented.” 383 U.S. at 17-18.

ANALYSIS
The Appellant argued claims 1, 3-12, 14-21, and 28-31 as a group
(App. Br. 4-6; Reply Br. 1-3). We select claim 1 as the representative claim
for this group, and the remaining claims 3-12, 14-21, and 28-31 stand or fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii) (2007).
Benigno describes a system for analyzing medical data related to
clinical pathways. (FF 1.) The Examiner argued that Benigno describes
automatically calculating benchmarks concerning the progress of an activity
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of a participant (citing [0025] and [0113]-[0115]) and displaying the
benchmarks to the participant; the activity being care of a patient and the
participant being a nurse. (Ans. 4-5.) The Examiner conceded that
“Benigno fails to teach … [claim step] (d) selecting said at least one
participant.” (Ans. 5.) To meet this limitation, the Examiner relied on
Knight. According to the Examiner, Knight
teaches recruitment of patients into clinical trials
(Knight: [0005]) and includes acquiring patient
data (Knight: [0050]) and providing sponsor
contact information to the patient (Knight: Fig 13;
[0083]) if a match exists between the patient and
the requirements of a clinical trial (Knight:
[0017]).
In an embodiment of Knight, a
pharmaceutical company can access patient
information to pre-enroll (Knight: [0130]); read on
by select) patients in a trial. If a patient is selected
for participation in the trial as a result of the
system having matched the patient to the trial,
patient data can be sent to the system’s server via
the clinical trial.

(Answer 5.) The Examiner concluded:
[i]t would have been obvious to one of ordinary
skill in the art at the time of the invention to
combine the teachings of Benigno and Knight with
the motivation of providing highly current patient
data collected by a clinician (Benigno: [0038]),
thus further accelerating the patient recruitment
process into a clinical trial (Knight: [0130]).
(Ans. 6.)
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The Appellant disagreed arguing that “[t]here is no teaching or
suggestion to display the benchmarks to the patient.” (App. Br. 6.)
According to the Appellant
The system for determining optimal pathways
taught in [Benigno] is not taught as displaying
benchmarks to a patient. With regard to the claim
limitation directed to selecting said at least one
participant (claim 1, step (d)), the Final Rejection
reads that limitation on the selection of a patient in
Knight. If that is the case, then with regard to the
claim limitation directed to displaying some or all
of the benchmarks at least to the at least one
participant (claim 1, step (g)), the at least one
participant ought to be the patient as well, since the
meaning of the term cannot shift within a single
claim. However, the Final Rejection reads the
limitation of step (g) on paragraphs of [Benigno]
that do not teach or even vaguely suggest
displaying any benchmarks to the patient. Rather,
the cited paragraphs of [Benigno] teach displaying
such benchmarks to the caretaker or the nurse, or
to unspecified parties.
(App. Br. 5.)(See also Reply Br. 2-3.)
If we understand the Appellant’s argument correctly, the Appellant is
saying that Benigno, which describes displaying benchmarks to a nurse or
doctor and Knight, which describes selecting a patient, would lead one of
ordinary skill in the art to display the benchmarks to the nurse or doctor but
not to the patient. We are not persuaded as to error in the rejection by this
argument. In our view, the argument falls in the face of common sense.
Benigno describes a method for determining the clinical pathways that
are optimal for a patient depending on that patient’s history. (FF 3.) Patient
information is gathered and evaluated according to criteria for determining
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an optimal clinical pathway for the patient and that optimal clinical pathway
is then communicated. Benigno does not limit communication of the
optimal clinical pathway to nurses and doctors, although Benigno mentions
nurses and doctors as the caregivers who communicate with the system that
determines the optimal clinical pathways. (FF 2 and 3.) Clearly, the optimal
clinical pathway for a patient must be communicated to a caregiver so that
the patient may be cared for consistent with the determined optimal clinical
pathway. But there is nothing in Benigno that limits display of the
determined optimal clinical pathway to a caregiver. Most if not all
caregivers share health-related information they have gathered on a patient
with that patient herself. That is notoriously well known in the field of
medical care. (FF 7.) One of ordinary skill in the art reading Benigno alone
would understand its scope and content to be such that it would cover
displaying the optimal clinical pathways to the patient involved. That
Benigno should be read to suggest that benchmarks be displayed only to
nurses and doctors, and not to patients, even where a nurse or doctor may be
the very patient being monitored, presumes one of ordinary skill in the art
lacks the common sense to understand that caregivers share patient
information with their patients. That is not a presumption we believe can be
supported by objective evidence, especially given that “[a] person of
ordinary skill is also a person of ordinary creativity, not an automaton.”
KSR, 127 S.Ct. at 1742.
On the question of whether the cited prior art describes or discloses
selecting a participant whose activity will be monitored, there is no dispute
that Benigno is drawn to clinical trials. It is generally well known that
patients are selected to be in clinical trials. This is evidenced by Knight.
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Accordingly, given the cited prior art which describes determining
optimal clinical pathways for a patient (Benigno) and selecting a patient for
a clinical trial (Knight), and that caregivers normally share medical results
with their patients, it would have been obvious to select a participant whose
activity will be monitored and benchmarked and to display some or all of the
benchmarks to the selected participant.

CONCLUSIONS OF LAW
We conclude that the Appellant has not shown that the Examiner
erred in rejecting claims 1, 3-12, 14-21, and 28-31 under 35 U.S.C. §103(a)
as being unpatentable over Benigno and Knight.

DECISION
The decision of the Examiner to reject claims 1, 3-12, 14-21, and 28-
31 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2007).
AFFIRMED

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