Medidata Solutions, Inc.

Patent Trials and Appeals Board

Jun 12, 2020

2018008613 (P.T.A.B. Jun. 12, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/140,734 12/26/2013 Glen de Vries 20622.0046 (IDF-46) 3641
127350 7590 06/12/2020
Steptoe & Johnson LLP
1330 Connecticut Avenue NW
Washington, DC 20036
EXAMINER
NILFOROUSH, MOHAMMAD A
ART UNIT PAPER NUMBER
3685
NOTIFICATION DATE DELIVERY MODE
06/12/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
hfox@steptoe.com
ipdocketing@steptoe.com
rgreenfeld@steptoe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GLEN DE VRIES and MICHELLE MARLBOROUGH
Appeal 2018-008613
Application 14/140,734
Technology Center 3600
Before JASON J. CHUNG, JOYCE CRAIG, and STEPHEN E. BELISLE,
Administrative Patent Judges.
CRAIG, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING

STATEMENT OF THE CASE
Appellant filed a Request for Rehearing (hereinafter “Request”) dated
May 26, 2020, seeking reconsideration of our Decision, mailed March 25,
2020 (“Decision”), in which we affirmed the rejection of claims 1–4, 7, 9,
11–14, and 20–23 under 35 U.S.C. § 101.

ANALYSIS
Appellant in the Request contends the Board overlooked several of
Appellant’s points, any one of which supports reversal of the Examiner’s
§ 101 rejection. Appellant asks the Board to address Appellant’s arguments
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Application 14/140,734

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directed to Koninklijke KPN N.V. v. Gemalto M2M GmbH, 942 F.3d 1143
(Fed. Cir. Nov. 15, 2019) (“KPN”) and Example 38 of the PTO’s 2019
Eligibility Examples. Request 3–6. Appellant also asks the Board to address
Appellant’s argument that the claimed invention does not recite a “certain
method of organizing human activity” as contemplated by the 2019 Revised
Guidance, including the subgroup of “commercial or legal interactions.” Id.
at 6.
Turning first to Appellant’s argument that the claimed invention does
not recite a “certain method of organizing human activity,” we reiterate our
agreement with the Examiner that it does. See Decision 7–8. To the extent it
is not clear from our Decision (see Decision at 7), claim 1 describes steps
that would be performed by people involved in submitting a clinical study
for regulatory approval, which is a commercial activity. Appellant’s
Specification describes that:
[d]uring the course of a clinical study, a large amount of clinical
data and information may be gathered at various investigator
sites, such as hospitals and clinics, by personnel such as
doctors, patients, nurses, and technicians. These data may be
inputted into a system where they may be recorded and stored.
These data may then be transmitted by the sites to, for example,
[contract research organizations “CROs”], sponsors, and/or
regulatory agencies. In some cases, an investigator site may
transmit the data to a CRO, which may in turn forward that data
to a sponsor that may finally submit the data to a regulatory
agency, such as the FDA or [European Medicines Agency
“EMA”].
Spec. ¶ 2. The Specification further describes that:
Regulatory agencies also often require site personnel to certify
at the end of a study or when a patient completes his or her
participation in a study that the data transmitted from the site to
the sponsor are the same as the data that were entered by site
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personnel into various eClinical systems during the course of
the study, i.e., that the site has been in control of its data
throughout the process of data capture, cleaning, and
submission to the agency.
Id. at ¶ 11. Moreover, claim 1 describes activity that involves multiple
parties, i.e., a commercial interaction or business relations. For
example, claim 1 recites that information is received from an eClinical
system, information is transmitted to a data provider, and other
information is transmitted to a data checker. The Specification
describes that “data providers are not limited to just sponsors, but may
include providers, CROs, and other third parties.” Spec. ¶ 24.
Similarly, “not only may a regulatory agency be a data checker, but
any entity downstream from where the data are collected may be a
data checker, including a provider, a CRO, a patient, a sponsor, or
another third party.” Id. The problem of verifying data is one that
existed prior to the Internet. The recited processors are generic and
operate in their normal capacities to receive, generate, transmit, and
compare information. See, e.g., Spec. ¶ 10. Therefore, the claim
recites a commercial interaction, which is a method of organizing
human activity, and an abstract idea. See 2019 Revised Guidance,
48 Fed. Reg. at 52.
Appellant argues that the decision in KPN “dictates” that
Appellant’s invention does not recite an abstract idea. Supp. Br. 3.
Appellant proceeds to compare the language of the pending claims
with that of the KPN claims. As we explained in our Decision, the
2019 Revised Guidance “extracts and synthesizes key concepts
identified by the courts as abstract ideas” (84 Fed. Reg. at 52) and
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does not require comparing claims to those already found to recite an
abstract idea. Decision at 8.
Nevertheless, claim 1 is distinguishable from the claims in
KPN. KPN’s claim 1, for example, is directed to a device comprising
other devices. From the plain language of KPN claim 1, no recited
element can be construed reasonably as a party or commercial entity.
In contrast, as explained above, Appellant’s claim 1 recites a
commercial interaction.
For these reasons, we make no change to our Decision with
regard to whether representative claim 1 recites an abstract idea.
We next turn to Appellant’s argument that claim 1 is not
directed to an abstract idea in light of the KPN decision. The KPN
court reiterated that, in cases involving software innovations, the
inquiry as to whether a claim is directed to an abstract idea “often
turns on whether the claims focus on ‘the specific asserted
improvement in computer capabilities ... or, instead, on a process that
qualifies as an abstract idea for which computers are invoked merely
as a tool.’” KPN, 942 F.3d at 1150 (quoting Finjan, Inc. v. Blue Coat
System, Inc., 879 F.3d 1299, 1303 (Fed. Cir. 2018) (quoting Enfish,
LLC v. Microsoft Corp., 822 F.3d 1327, 1335–36 (Fed. Cir. 2016)
(internal quotation marks omitted)). As we determined in the
Decision, this case is the latter.
The KPN court determined that the claims are not directed to an
abstract idea because they are directed to a non-abstract improvement
in an existing technological process (i.e., error checking in data
transmissions). Id. The court explained that, by requiring that a
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permutation applied to original data be modified “in time,” the claims
recite a specific implementation of varying the way check data is
generated that improves the ability of prior art error detection systems
to detect systematic errors. Id. The court determined that “the claims
sufficiently capture the inventors’ asserted technical contribution to
the prior art by reciting how the solution specifically improves the
function of prior art error detection systems.” Id. at 1151.
Appellant points to no such improvement in the claims on appeal.
Rather, Appellant argued in a conclusory manner that “the claims in both
cases ‘recite a specific means or method that solves a problem in an existing
technological process.’” Supp. Br. 4. Appellant, however, does not explain
how the improvement in the KPN claims—that a permutation applied to
original data be modified “in time”—applies to the claims at issue here.
Nor does Appellant direct our attention to anything in the
Specification to indicate that claim 1 provides a technical improvement to
the functioning of a computer or to another technology. See Alice Corp. Pty.
Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2359 (2014); see also MPEP
2106.05(a). Appellant points to paragraph 11 of the Specification, which
describes the data verification needs of a regulatory agency. Request at 4;
Spec. ¶ 11. Appellant further identifies paragraph 13 of the Specification,
which describes using a generic hashing algorithm on a generic computer to
verify data. Request at 4; Spec. ¶ 13. Neither paragraph articulates an
improvement in sufficient detail that one of ordinary skill would have
recognized that the claimed invention improves the relevant existing
technology.
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For these reasons, we are not persuaded that we overlooked anything
in the KPN decision in determining claim 1 is directed to an abstract idea.
Appellant next argues that Example 38 of the 2019 Eligibility
Examples necessitates a different outcome in this appeal. Request at 5; see
Subject Matter Eligibility Examples: Abstract Ideas, Examples 37 to 42, 6–7
(Jan. 7, 2019). The 2019 Eligibility Examples are not binding on this panel.
But even assuming arguendo that the 2019 Eligibility Examples were
binding, the claim in Example 38 is different than claim 1 at issue in the
present appeal. According to Example 38, the claim is described as follows:
A method for providing a digital computer simulation of an
analog audio mixer comprising:
[1] initializing a model of an analog circuit in the digital
computer, said model including a location, initial value, and a
manufacturing tolerance range for each of the circuit elements
within the analog circuit;
[2] generating a normally distributed first random value for
each circuit element, using a pseudo random number generator,
based on a respective initial value and manufacturing tolerance
range; and
[3] simulating a first digital representation of the analog circuit
based on the first random value and the location of each circuit
element within the analog circuit.
Id. at 6 (bracketing added). Appellant argues that the claimed invention’s
generation of hash numbers is similar to Example 38’s generation of random
numbers, and, because the claim in Example 38 was found not to recite any
abstract idea, pending claim 1 does not recite one either. Request 5–6; Supp.
Br. 7.
We are not persuaded by Appellant’s argument. Example 38 describes
an improved digital computer simulation of an analog audio mixer to address
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poor sound quality replication of previously known prior art digital
simulation techniques. See Subject Matter Eligibility Examples: Abstract
Ideas, Examples 37 to 42, 6–7 (Jan. 7, 2019). As in KPN, from the plain
language of the claim in Example 38, no recited element can be construed
reasonably as a party or a commercial entity. In contrast, as explained above,
Appellant’s claim 1 recites, and is directed to, a commercial interaction,
which is a certain method of organizing human activity, and an abstract idea.
For these reasons, we deny Appellant’s request and make no change
to our Decision with regard to whether representative claim 1 is directed to a
judicial exception, without significantly more.

DECISION
We have reconsidered our Decision in light of Appellant’s arguments
in the Request. In view of the foregoing, Appellant’s Request for Rehearing
is denied.
Outcome of Decision on Rehearing:
Final Outcome of Appeal after Rehearing:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–4, 7, 9,
11–14,
20–23
101 Eligibility 1–4, 7, 9,
11–14,
20–23

DENIED
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Granted Denied
1–4, 7, 9,
11–14,
20–23
101 Eligibility 1–4, 7, 9,
11–14,
20–23