Ex Parte Settimi

Patent Trial and Appeal Board

Nov 5, 2013

11561736 (P.T.A.B. Nov. 5, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte PHILIP DAVID SETTIMI
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Appeal 2011-010826
Application 11/561,736
Technology Center 3600
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Before MEREDITH C. PETRAVICK, NINA L. MEDLOCK, and
PHILIP J. HOFFMANN, Administrative Patent Judges.

MEDLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2011-010826
Application 11/561,736

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STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1, 3, 5-7, 9, 10, 15, 16, 18, and 20. We have jurisdiction
under 35 U.S.C. § 6(b).

STATEMENT OF THE DECISION
We AFFIRM-IN-PART.1

BACKGROUND
Appellant’s invention relates to identification and notification of
clinical study participants and investigators based on electronic medical
record data (Spec., para. [04]).
Claim 1, reproduced below with added bracketed notations, is
representative of the subject matter on appeal:
1. A system for clinical study notification, said system
comprising:
[a] a data storage to include:
search results including a pool of potential study
participants generated from electronic patient data; and
[b] at least one processor to generate:
[i] a first user interface facilitating identification
one or more healthcare providers associated with the pool
of potential study participants and communication with at
least one of the one or more healthcare providers and the
pool of potential study participants regarding
participation in a clinical study, wherein the pool of
potential study participants is anonymized, and wherein

1 Our decision will refer to the Appellant’s Appeal Brief (“Br.,” filed
November 22, 2010) and the Examiner’s Answer (“Ans.,” mailed April 5,
2011).
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said first user interface is authorized to re-identify at least
one of the pool of potential study participants; and
[ii] a second user interface allowing at least one of
the one or more healthcare providers and the pool of
potential study participants to join the clinical study,
wherein said second user interface comprises opt-in
functionality to allow at least one of the one or more
healthcare providers and the pool of potential study
participants to join the clinical study,
[iii] wherein at least one of said first user interface
and said second user interface operates via an electronic
medical record system.

THE REJECTIONS
The following rejections are before us for review:
Claims 9, 10, and 15 stand rejected under 35 U.S.C. § 101 as being
directed to non-statutory subject matter.
Claims 1, 3, 5-7, 9, 10, 15, 16, 18, and 20 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Michelson (US 2002/0002474
A1, pub. Jan. 3, 2002).

ANALYSIS
Non-Statutory Subject Matter
Appellant does not present any argument in the Appeal Brief in
response to the Examiner’s rejection of claims 9, 10, and 15 under 35 U.S.C.
§ 101. Therefore, we will summarily affirm the Examiner’s rejection.
Obviousness
Independent claim 1 and dependent claims 3 and 5-7
Appellant argues that the Examiner erred in rejecting claim 1 under
35 U.S.C. § 103(a) because Michelson fails to disclose or suggest any of
limitations [i], [ii], and [iii], as recited in claim 1 (Br. 11-13).
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The Examiner acknowledges that Michelson does not explicitly
disclose the argued features:
Michelson does not explicitly disclose wherein the pool of
potential study participants is anonymized and wherein said
first user interface is authorized to re-identify at least one of the
pool of potential study participants [as recited in limitation [i]];
wherein said second user interface comprises opt-in
functionality to allow at least one of the one or more healthcare
providers and the pool of potential study participants to join the
clinical study [as recited in limitation [ii]]; and wherein at least
one of said first user interface and said second user interface
operates via an electronic medical record system [as recited in
limitation [iii]].

(Ans. 6 and 12).
However, the Examiner concludes it would have been obvious to one of
ordinary skill in the art to expand Michelson to include these features “since
it was not only old and well known in the art at the time of the invention, but
since it would also provide a more reliable and efficient system and method
for clinical study notification” (Ans. 7).
It would have been obvious to one of ordinary skill in the art at
the time of the art at the time of the invention to expand
Michelson to include wherein the pool of potential study
participants is anonymized and wherein said first user interface
is authorized to re-identify at least one of the pool of potential
study participants; wherein said second user interface comprises
opt-in functionality to allow at least one of the one or more
healthcare providers and the pool of potential study participants
to join the clinical study; and wherein at least one of said first
user interface and said second user interface operates via an
electronic medical record system since it was not only old and
well known in the art at the time of the invention, but since it
would also provide a more reliable and efficient system and
method for clinical study notification.

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(Ans. 7 and 12).
The Examiner describes Michelson at length in the Answer, variously
pointing to the disclosure at paragraphs [0009], [0011], [0029], [0030],
[0080], [0082], [0086], and [0115] (see Ans. 6). But the Examiner does not
maintain that any of these paragraphs discloses the argued limitations; the
Examiner also denies any reliance on Official Notice (Ans. 15). Instead, the
Examiner observes that obviousness is determined not merely by what
references expressly state but rather by what they reasonably suggest to one
of ordinary skill in the art. With that, Examiner concludes that “[t]he
Michelson reference alone, either explicitly discloses, or seemingly suggests
any and all limitations as stated by the Appellant in the language of
independent Claim 1” (Ans. 16).
The Supreme Court made clear in KSR that an obviousness
determination “cannot be sustained by mere conclusory statements.”
KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007) (quoting In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Instead, an Examiner must
articulate “reasoning with some rational underpinning to support the legal
standard of obviousness.” Id.
Here, although the Examiner describes the Michelson disclosure at
length, the Examiner does not explain why a person of ordinary skill in the
art would have had an apparent reason to modify the Michelson system, as
the Examiner proposes, to arrive at the subject matter of claim 1. As such,
the Examiner has failed to establish a prima facie case of obviousness.
Therefore, we will not sustain the Examiner’s rejection of claim 1
under 35 U.S.C. § 103(a). We also will not sustain the Examiner’s rejection
of claims 3 and 5-7, which depend from claim 1. Cf. In re Fritch, 972 F.2d
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1260, 1266 (Fed. Cir. 1992) (“[D]ependent claims are nonobvious if the
independent claims from which they depend are nonobvious.”).
Independent claim 9 and dependent claims 10 and 15
Claim 9 is directed to a computer-implemented method for clinical
study notification and recites that the method comprises, inter alia,
“allowing at least one of the one or more healthcare providers and the pool
of potential study participants to join the clinical study via the electronic
medical record system” and “facilitating completion of the clinical study via
the electronic medical record system.”
Appellant argues that the Examiner erred in rejecting claim 9 under
35 U.S.C. § 103(a) because “Michelson merely discusses an on-line
interactive forum that promotes exchange of information, rather than the
electronic medical record system joining and completion recited in claim 9”
(Br. 13).
In the Answer, the Examiner does not specifically respond to
Appellant’s arguments with respect to claim 9. Instead, the Examiner states
that “the Examiner respectfully disagrees for the same, or substantially
similar, reasons presented above with respect to independent Claim 1” (Ans.
22).
We find that the Examiner has not established a prima facie case of
obviousness. Not only has the Examiner failed to respond to Appellant’s
specific contentions with respect to claim 9, but in rejecting claim 1, the
Examiner acknowledged that Michelson fails to explicitly disclose that at
least one of the first user interface and the second user interface (which
allows at least one of the one or more healthcare providers and the pool of
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potential study participants to join the clinical study) operates via an
electronic medical record system.
The Supreme Court made clear in KSR that when considering
obviousness, “the analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ.” KSR, 550 U.S. at 418. However, the Court also made clear
that there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness. Id.
Critically here, the Examiner does not articulate any reasoning with
rational underpinning for modifying Michelson to arrive at the method
recited in claim 9. Therefore, constrained by the record before us, we will
not sustain the Examiner’s rejection of claim 9 under 35 U.S.C. § 103(a).
For the same reasons, we also will not sustain the Examiner’s rejection of
claims 10 and 15, which depend from claim 9.
Independent claim 16 and dependent claims 18 and 20
Claim 16 is directed to a computer-readable medium having a set of
instructions for execution by a computer, the set of instructions comprising,
inter alia,
a second user interface routine allowing at least one of
the one or more healthcare providers and the set of potential
study participants to join the clinical study, wherein said second
user interface routine comprises opt-in functionality to allow at
least one of the one or more healthcare providers and the set of
potential study participants to join the clinical study,
and
wherein at least one of said first user interface routine
and said second user interface routine operates via an electronic
medical record system.
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Appellant argues that “Michelson merely discusses an on-line
interactive forum that promotes exchange of information, rather than the
electronic medical record system using opt-in functionality recited in
claim 16” and that the Examiner has failed to establish a prima facie case of
obviousness (Br. 14).2
As with claim 9, the Examiner does not specifically respond to
Appellant’s arguments with respect to claim 16. Instead, in the Answer, the
Examiner states, “Appellant presents the same, or substantially similar,
arguments as presented above with respect to independent Claim 1, the
Examiner respectfully disagrees for the same, or substantially similar,
reasons as presented above with respect to independent Claim 1” (Ans. 23).
As described above with respect to claim 1, the Examiner has
acknowledged that Michelson does not explicitly disclose the opt-in
functionality recited in the claims. The Examiner also has failed to articulate
any reasoning with rational underpinning for modifying Michelson to
include this functionality.
We find that the Examiner has failed to establish a prima facie case of
obviousness. Therefore, constrained by this record, we will not sustain the
Examiner’s rejection of claim 16 under 35 U.S.C. § 103(a). We also will not
sustain the Examiner’s rejection of dependent claims 18 and 20.

2 We treat, as inadvertent error, Appellant’s reference to “anticipation,”
rather than “obviousness,” at page 14 of the Appeal Brief.
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DECISION
The Examiner’s rejection of claims 9, 10, and 15 under 35 U.S.C.
§ 101 is affirmed.
The Examiner’s rejection of claims 1, 3, 5-7, 9, 10, 15, 16, 18, and 20
under 35 U.S.C. § 103(a) is 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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