Ex Parte Keys

Board of Patent Appeals and Interferences

Feb 28, 2011

10225684 (B.P.A.I. Feb. 28, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PHILIP KEYS
____________

Appeal 2010-002319
Application 10/225,684
Technology Center 3600
____________

Before MURRIEL E. CRAWFORD, JOSEPH A. FISCHETTI, and BIBHU
R. MOHANTY, Administrative Patent Judges.

CRAWFORD, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-002319
Application 10/225,684

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STATEMENT OF THE CASE
Appellant seeks our review under 35 U.S.C. § 134 of the Examiner’s
final decision rejecting claims 1, 2, 4 to 17, 28, 29, and 31 to 44. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.
Appellant’s invention is directed to computer-based system and
method for monitoring, dosing, and managing patients. (Spec. 1).
Claim 1 is illustrative:
1. A system for monitoring and managing a
patient within a therapeutic range for at least one
medication, the system comprising:
means for receiving and storing at least one
set of medication-specific data about the at least
one medication, wherein said medication-specific
data includes data relating to said therapeutic range
for said at least one medication;
means for receiving and storing at least one
set of patient-specific data about the patient using
said at least one medication, wherein said patient-
specific data includes data relating to said
therapeutic range;
means for analyzing the patient-specific data
and the medication-specific data by applying at
least one set of patient management rules to said
patient-specific data and said medication-specific
data and by facilitating analysis of the patient-
specific data and the medication-specific data,
wherein the applying and facilitating assist a
clinician at a location remote from a health care
provider who is attendant the patient in providing
at least one patient- specific management
recommendation;
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means for storing, displaying and
communicating said patient-specific management
recommendations to the health care provider who
is attendant the patient at a location remote from
the system and the clinician.

Appellant appeals the following rejection:
Claims 1, 2, 4 to 17, 28, 29 and 31 to 44 under 35 U.S.C. § 103(a) as
unpatentable over Surwit (US Pat. 6,024,699, iss. Feb. 15, 2000) in view of
Rosenfeld (US Pat. 6,804,656 B1, iss. Oct. 12, 2004).

ISSUES
Did the Examiner err in rejecting the claims because Rosenfeld does
not disclose utilizing a centralized expert clinician who is remote from the
health care provider who is attendant the patient at clinical sites?
Did the Examiner err in rejecting the claims because there is no
suggestion, teaching, or motivation in Surwit to modify the Surwit system
according to the teachings of Rosenfeld?
Has the Appellant established that the claimed invention has had
commercial success and solved an unsolved need in the pharmacy field?

FACTUAL FINDINGS
We adopt the Examiner’s findings as our own. (Ans. 3 to 5).

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ANALYSIS
We are not persuaded of error by the Examiner by Appellant’s
argument that Rosenfeld does not disclose utilizing a centralized expert
clinician who is remote from the health care provider who is attendant the
patient at clinical sites. We note at the outset that claim 1 does not recite a
centralized expert clinician but recites only a clinician. As such, the
argument that Rosenfeld does not disclose a centralized expert clinician is
not commensurate with the scope of claim 1 and thus is not persuasive. This
is also the case in regard to Appellant’s argument that neither reference
discloses an expert clinician that communicates patient-specific management
recommendations for high risk medications to health care providers.
Appellant also argues that Surwit and Rosenfeld relate to the
treatment of patients remotely. We do not find this argument persuasive
because Rosenfeld discloses that the Intensivist can be present or remote
(col. 1, ll. 20 to 21; 53 to 54) and that when the Intensivist is remote from
the patient, a nurse is the primary caregiver and this nurse, is not remote
from the patient (col. 1, ll. 29 to 30).
We are also not persuaded of error by the Examiner by Appellant’s
argument that the clinician in the present invention is never remotely or
directly managing a patient because this argument is not commensurate with
the recitations in claim 1. In this regard, claim 1 does not recite that the
clinician never remotely or directly manages a patient.
We do not find the Appellant’s argument that the Examiner erred in
rejecting the claims because there is no suggestion, teaching, or motivation
in Surwit to modify the Surwit system according to Rosenfeld. To the extent
Appellant is looking for an explicit motivation, suggestion, or teaching in the
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art, this rigid test has been foreclosed by the Supreme Court's recent holding
in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). In KSR, the Court
characterized the teaching, suggestion, motivation test as a “helpful insight”
but found that when it is rigidly applied, it is incompatible with the Court's
precedents. KSR, 550 U.S. at 418-19. The holding in KSR makes clear that
it is no longer absolutely necessary to find motivation in the references
themselves. See KSR, 550 U.S. at 418-19. The Supreme Court explained
that “the principles laid down in Graham reaffirmed the ‘functional
approach’ of Hotchkiss, 11 How. 248.” KSR, 550 U.S. at 415 (citing
Graham v. John Deere Co., 383 U.S. 1, 12 (1966)), and reaffirmed
principles based on its precedent that “[t]he combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” Id. at 416. The Court explained:
When a work is available in one field of endeavor,
design incentives and other market forces can
prompt variations of it, either in the same field or a
different one. If a person of ordinary skill can
implement a predictable variation, § 103 likely
bars its patentability. For the same reason, if a
technique has been used to improve one device,
and a person of ordinary skill in the art would
recognize that it would improve similar devices in
the same way, using the technique is obvious
unless its actual application is beyond his or her
skill.
Id. at 417. The operative question in this “functional approach” is thus
“whether the improvement is more than the predictable use of prior art
elements according to their established functions.” Id.
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In the present case, it is our view that the use of the expert care
network of Rosenfeld in the Surwit system of data gathering and analysis
would be no more than the use of prior art elements according to their
established functions to achieve predictable results.
Appellant has also argued that the invention achieved commercial
success and satisfied a long felt need. As evidence of these secondary
considerations, the Appellant filed a declaration by the Inventor. The
Appellant directs our attention to paragraphs 19 to 21 of this declaration to
support the commercial success and the satisfaction of long felt need.
We do not believe that the declaration persuasively establishes
commercial success of the claimed invention. In that regard, the declaration
provides no data concerning the amount of sales. The declaration points to
two situations in which the system is used. In fact the declaration does not
assert that the invention is a commercial success but rather that the invention
has been used successfully and represents a substantial share in this market.
On the basis of the limited information provided by the declarant, we
conclude that the Appellant has failed to persuasively establish commercial
success.
Even assuming that the Appellant had sufficiently demonstrated
commercial success, that success is relevant in the obviousness context only
if it is established that the sales were a direct result of the unique
characteristics of the claimed invention, as opposed to other economic and
commercial factors unrelated to the quality of the claimed subject matter.
See Cable Elec. Products, Inc. v. Genmark, Inc., 770 F.2d 1015, 1027 (Fed.
Cir. 1985). In other words, a nexus is required between the sales and the
merits of the claimed invention. In ex parte proceedings before the Patent
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and Trademark Office, an applicant must show that the claimed features
were responsible for the commercial success of an article if the evidence of
nonobviousness is to be accorded substantial weight. Merely showing that
there was commercial success of an article which embodied the invention is
not sufficient. See Ex parte Remark, 15 USPQ2d 1498, 1502-03 (BPAI
1990). Compare Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851
F.2d 1387, 1394 (Fed. Cir.), cert. denied, 488 U.S. 956 (1988). See also
Pentec, Inc. v. Graphic Controls Corp., 776 F.2d 309, 315 (Fed. Cir. 1985)
(commercial success may have been attributable to extensive advertising and
position as a market leader before the introduction of the patented product);
In re Fielder, 471 F.2d 640, 646 (CCPA 1973) (success of invention could
be due to recent changes in related technology or consumer demand; here
success of claimed voting ballot could be due to the contemporary drive
toward greater use of automated data processing techniques).
The declaration asserts that the system disclosed in the instant
application is in use commercially. The declaration does not tie the system
in use to the recitations in the claims. This alone is insufficient to establish
the required nexus. Claims are not technical descriptions of the disclosed
inventions, but are legal documents like the descriptions of lands by metes
and bounds in a deed which define the area conveyed but do not describe the
land. Because of this characteristic of claims, the commercial success of a
machine “claimed” may be due entirely to improvements or modifications
made by others to the invention disclosed in the application for patent. Such
success is not pertinent to the nonobviousness of the advantages inherent in
what is specifically disclosed in the application are not to be considered in
determining nonobviousness. In re Vamco Machine and Tool, Inc., 752 F.2d
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1564, 1577 (Fed. Cir. 1985). In sum, the Appellant simply has not carried
his burden to persuasively establish that a nexus existed between any
commercial success and the novel features claimed in the application.
Establishing the secondary consideration of long-felt need requires
objective evidence that an art-recognized problem existed in the art for a
long period of time without solution. In particular, the evidence must show
that the need was a persistent one that was recognized by those of ordinary
skill in the art. In re Gershon, 372 F.2d 535, 539 (CCPA 1967). The
relevance of long-felt need and the failure of others to the issue of
obviousness depend on several factors. First, the need must have been a
persistent one that was recognized by those of ordinary skill in the art.
Orthopedic Equipment Co. v. All Orthopedic Appliances, Inc., 707 F.2d
1376, 1379 (Fed. Cir. 1983). Second, the long-felt need must not have been
satisfied by another before the invention by Applicant. Newell Companies v.
Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another
supplied the key element, there was no long-felt need or, indeed, a problem
to be solved.”) Third, the invention must in fact satisfy the long felt need.
In re Cavanagh, 436 F.2d 491, 496 (CCPA 1971).
Upon review of all of the evidence of long-felt need submitted by
the Appellant, we have no idea of exactly when the articulated problem was
first identified. The declaration states that a report issued in 2006 stated that
medication errors harm 1.5 million patients and kill several thousand each
year. However, the declaration does not state when the problem was first
identified, or how long it has existed. As such, we have no way of knowing
just how long the need for a solution to the problem existed. “[L]ong-felt
need is analyzed as of the date of an articulated identified problem and
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evidence of efforts to solve that problem.” Texas Instruments, Inc. v.U.S.
Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
Further, the declarant has proffered no persuasive evidence that
others in the industry had made attempts to solve the articulated problem and
failed.
Thus, the evidence of long-felt need proffered by the Appellant is not
sufficient to show the duration of the problem and the efforts and/or
resources expended during that time to solve the problem. As such, the
evidence of long felt need is not sufficient to out weigh the evidence of
obviousness.
In view of the foregoing, we will sustain the Examiner’s rejection of
claim 1. We will also sustain the rejection as it is directed to claims 2, 4 to
17, 28, 29 and 31 to 44 because the Appellant has not argued the separate
patentability of these claims.

DECISION
We affirm the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1).

AFFIRMED
Appeal 2010-002319
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hh

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