Ex Parte Walsh et al

Board of Patent Appeals and Interferences

Jun 28, 2012

10605125 (B.P.A.I. Jun. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte FRANCIS MICHAEL WALSH and
BRUCE A. FRIEDMAN
____________________

Appeal 2010-006899
Application 10/605,125
Technology Center 3600
____________________

Before: MURRIEL E. CRAWFORD, HUBERT C. LORIN, and
ANTON W. FETTING, Administrative Patent Judges.

CRAWFORD, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2010-006899
Application 10/605,125

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STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-28. We have jurisdiction under 35
U.S.C. § 6(b).

SUMMARY OF THE DECISION
We AFFIRM-IN-PART.

BACKGROUND
Appellants’ invention is directed to a computer based clinical
laboratory ordering and reporting system with embedded consultation
function (Spec., para. [0002]). Claims 1 and 16 are illustrative of the
claimed subject matter:
1. A system for providing clinical laboratory test ordering and
results reporting with an embedded consultation service,
comprising:
an order entry subsystem for submitting orders for at
least one diagnostic test;
a laboratory for receiving said orders and for managing
patients to fill said orders, thereby generating test results;
a data storage subsystem for receiving and retaining test
results from said laboratory;
a triage subsystem for comparing test results downloaded
from said data storage subsystem with a predetermined
reference range specific to such results, with said triage
subsystem setting an abnormal results flag in the event that the
test results are outside of said reference range; and
a reporting-consulting subsystem for receiving the results
of said comparison from said triage subsystem, with said
reporting-consulting subsystem transmitting the processed test
results, comprising at least the results of said comparison, to the
person requesting said at least one diagnostic test, and with the
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reporting-consulting subsystem further transmitting results
bearing an abnormal results flag to an embedded consultant,
with said reporting-consulting subsystem providing at least one
template for selection by said consultant to generate a
consultative report concerning the test results.

16. A method for providing clinical laboratory services,
comprising the steps of:
submitting an order to a laboratory for a diagnostic test
by means of a networked terminal device;
managing a patient to fill said test order, thereby
generating test results;
loading said test results into a data storage subsystem;
comparing said test results contained within said data
storage subsystem with predetermined reference range values,
and thereafter causing the test results to be transmitted directly
to the test requestor, using a networked terminal device, in the
event that the test results are within said reference range, but
causing the test results to be transmitted by a networked
terminal device to a consulting physician via a consultative
reporting-consulting subsystem in the event that the test results
are outside said reference range;
receiving said test results lying outside of said reference
range in a reporting consulting subsystem, and using said
reporting-consulting subsystem to provide at least one
selectable report template;
using said report template and said consulting physician
to generate a consultative report based at least in part upon the
test results; and
communicating said consultative report, bearing an
electronic signature, to the test requester by means of a
networked terminal device.

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The following rejections are before us for review.
Claims 1-21 are rejected under 35 U.S.C. § 101 because the claimed
invention is directed to non-statutory subject matter, because claims 1, 14
and 16 claim an "imbedded consultant" (i.e., potentially a human being).
Claims 18 and 22-28 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
Claims 1, 3, 9, 11, and 13-15 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Atlas (Atlas LabWorks (www.atlasdev.com) web pages
dated Aug. 2, 2002, retrieved from the Web Archive
(http://www.atlasdev.com/Labworks/visual_labworks/LWPortal.htm)) and
Bladen (US 2002/0099586 A1, pub. Jul. 25, 2002).
Claims 2, 4, 5, 12, 22, 26, and 27 are rejected under 35 U.S.C. §
103(a) as unpatentable over Atlas, Bladen, and Edelson (US 5,737,539, iss.
Apr. 7, 1998).
Claim 28 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Atlas, Bladen, Edelson, and Ross (US 5,823,948, iss. Oct. 20, 1998).
Claims 6-8 are rejected under 35 U.S.C. § 103(a) as unpatentable over
Atlas, Bladen, and Dworkin (US 2002/0071540 A1, pub. Jun. 13, 2002).
Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Atlas, Bladen, and Matsuoka (US 5,819,242, iss. Oct. 6, 1998).
Claims 16 and 18 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Atlas, Bladen, and Smith (US 2003/0069759 A1, pub.
Apr. 10, 2003).
Claim 17 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Atlas, Bladen, Smith, and Edelson.
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Claims 19 and 20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Atlas, Bladen, Smith, and Dworkin.
Claim 21 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Atlas, Bladen, Smith, and Ross.
Claims 23-25 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Atlas, Bladen, Edelson, and Smith.

ANALYSIS
Patentable Subject Matter
We are not persuaded by the Appellants’ arguments that the Examiner
erred in the rejection of claims 1-15 under 35 U.S.C. § 101. App. Br. 9,
Rep. Br. 1. Independent claim 1 recites a system with an “embedded
consultant,” and independent claim 14 recites a system with an “embedded
consulting physician.” Both claims thus claim a human as part of the
system, because “the consultants, who are associates of the laboratory itself,
are an integral component ...” (Spec., para. [0008]). See, Manual of Patent
Examining Procedure (MPEP) § 2105 (8th Ed., Rev. 8, Jul. 2010) (“If the
broadest reasonable interpretation of the claimed invention as a whole
encompasses a human being, then a rejection under 35 U.S.C. [§] 101 must
be made indicating that the claimed invention is directed to nonstatutory
subject matter.”) For these reasons we affirm the rejection of claims 1 and
14, as well as dependent claims 2-13 and 15 that were not separately argued,
because they claim ineligible subject matter under 35 U.S.C. § 101.
Independent claim 16, however, is directed to a method. Even though
claim 16 recites “using ... said consulting physician to generate a
consultative report.” This language is not claiming a human being, but
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instead is claiming only the use of a human in a process. Therefore, we do
not sustain the rejection of claim 16, or dependent claims 17-21, under 35
U.S.C. § 101.
Indefiniteness
We are not persuaded by the Appellants’ argument of error by the
Examiner for rejecting claim 18 as indefinite because of the term
“desirable.” App. Br. 10. Claim 18 recites “performing additional reflexive
tests in the event that said test results indicate that such testing is desirable.”
The term “‘desirable’” is not defined by the Specification, expressly or
inherently, and its meaning cannot be precisely determined by the claims.
Reflexive testing, in which additional tests are performed not as a result of a
direct order but instead as a result of initial test results, is an area prone to
inefficiency and arguably unnecessary testing. Therefore, reflexive testing is
regulated as to which tests may be performed reflexively and which may not
without additional direct orders. It is not clear if the term “desirable” relates
to what is permissible under a variety of regulations, or “desirable” for
reasons outside the scope of the regulations. As a result, one of ordinary
skill would not be able to ascertain the precise boundaries of the claim.
We are also not persuaded of error by the Examiner for rejecting
claims 22-28 as indefinite because of the term “‘remarkable’” in claim 22.
App. Br. 10. Claim 22 recites causing the test results to be transmitted to a
reporting-consulting subsystem in the event that the test results are
remarkable. The Appellants argue the term “is defined as abnormal test
results” at paragraph [0043] of the Specification (App. Br. 10). However,
paragraph [0043] says “results that are flagged as remarkable for any reason
by the triage engine” are forwarded. But the “triage engine,” in addition to
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comparing results “with predetermined reference ranges to determine which
of the test results are abnormal” (Spec., para. [0043]), also may rely on
another indefinite reason, because “in a more sophisticated manner,
knowledge about how groups of test results are altered [is] on the basis of
disease conditions.” The particular disease conditions that make a result
“remarkable” is unclear, so the meaning of “remarkable” is thus not entirely
clear. As a result, one of ordinary skill would not be able to ascertain the
precise boundaries of independent claim 22.
For these reasons we affirm the rejections of claims 18 and 22, as well
as dependent claims 23-28 that were not argued separately, under 35 U.S.C.
§ 112, second paragraph, as indefinite.
Obviousness
We reverse the rejections under 35 U.S.C. § 103(a) for failure to
present a prima facie case of obviousness. We note that the Examiner bears
the initial burden of presenting a prima facie case of obviousness. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “[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.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006) (quoted with approval in KSR Int'l Co. v.
Teleflex, Inc., 550 U.S. 398, 418 (2007)).
We do not find the Examiner has provided sufficient evidence to
support a prima facie case of obviousness of the claimed subject matter,
because large sections of claim language of independent claims 1, 14, 16,
and 22 are rejected over general reference to several LabWorks web pages,
without specific page or element citation. Ans. 6-10, 12, 17-18. The
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Appellants argue numerous features not found in LabWorks (App. Br. 12,
13, 15, 17). However, it is not clear from the Answer where the Examiner
finds any of the claimed features within Atlas LabWorks. In particular, at
least as to the “triage system setting an abnormal results flag,” and
“comparing test results” (Ans. 7, 12), “template,” “triage subsystem [that]
causes archival test results ... to be transferred” (Ans. 9), “comparing said
test results” (Ans. 12, 18), “causing the test results to be transmitted directly
to the test requestor ... [if] results are with said reference range,” and
“causing test results to be transmitted ... to a consulting physician” (Ans.
18), we are unable to determine from the record particularly where such
disclosures or suggestions are in the reference. For this reason, we must
conclude that a prima facie case has not been made and that the rejections
cannot stand in their current form. Therefore, we reverse the rejections of
independent claims 1, 14, 16, and 22, as well as dependent claims 2-13, 15,
17-21, and 23-28, under 35 U.S.C. § 103(a).

CONCLUSIONS OF LAW
The Examiner did not err in rejecting claims 1-15 under 35 U.S.C. §
101.
The Examiner erred err in rejecting claims 16-21 under 35 U.S.C. §
101.
The Examiner did not err in rejecting claims 18 and 22-28 under 35
U.S.C. § 112, second paragraph.
The Examiner erred in rejecting claims 1-28 under 35 U.S.C. §
103(a).

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DECISION
For the above reasons, the Examiner’s rejection of claims 1-15 under
35 U.S.C. § 101, and the rejection of claims 18 and 22-28 under 35 U.S.C. §
112, second paragraph, are AFFIRMED. The Examiner’s rejection of
claims 16-21 under 35 U.S.C. § 101, and the rejections of claims 1-28 under
35 U.S.C. § 103(a) are REVERSED.
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).

AFFIRMED-IN-PART

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