Medidata Solutions, Inc.

Patent Trials and Appeals Board

Mar 25, 2020

14140734 - (D) (P.T.A.B. Mar. 25, 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 03/25/2020
Steptoe & Johnson LLP
1330 Connecticut Avenue NW
Washington, DC 20036
EXAMINER
NILFOROUSH, MOHAMMAD A
ART UNIT PAPER NUMBER
3685
NOTIFICATION DATE DELIVERY MODE
03/25/2020 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 APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–4, 7, 9, 11–14, and 20–23. See Final
Act. 1, Advisory Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
An oral hearing was held on March 10, 2020.
We affirm.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Medidata Solutions,
Inc. Appeal Br. 4.
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CLAIMED SUBJECT MATTER
The claims are directed to a method and system for ensuring clinical
data integrity. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A computer-implemented method for ensuring integrity of
data, comprising:
receiving, by a computer processor, audits from an
eClinical system, wherein the audits are generated as a result of
transactions occurring at the eClinical system;
generating, using the computer processor, a data stream
and a first audit stream;
generating, using the computer processor, a first hash
number by applying a hashing algorithm to the first audit stream;
transmitting, using the computer processor, the data
stream and first audit stream to a data provider; and
transmitting, using the computer processor, the first hash
number to a data checker, the data provider using a second
computer processor to provide to the data checker a second audit
stream based on the first audit stream; and
the data checker using a third computer processor to
generate a second hash number based on the second audit stream
and comparing the first hash number to the second hash number
to detect discrepancies in the data.
REJECTION2
Claims 1–4, 7, 9, 11–14, and 20–23 stand rejected under 35 U.S.C.
§ 101 because the claimed invention is directed to a judicial exception
without significantly more. Final Act. 15.

2 After the Final Action, Appellant cancelled claims 17–19. See Advisory
Act, dated Nov. 16. 2017. In the Answer, the Examiner withdrew the
rejections of canceled claims 17–19 and pending claims 22 and 23 under
35 U.S.C. § 112, second paragraph. The Examiner also withdrew the
rejections of claims under 35 U.S.C. § 103. Ans. 3.
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ANALYSIS
Appellant argues that the Examiner’s rejection of claim 1 under
35 U.S.C. § 101 as directed to patent-ineligible subject matter is in error.
Appeal Br. 9. To the extent Appellant has not advanced separate, substantive
arguments for particular claims, or other issues, such arguments are waived.
37 C.F.R. § 41.37(c)(1)(iv). Appellant argues claims 1–4, 7, 9, 11–14, and
20–23 as a group. Appeal Br. 9. Given our discretion under 37 C.F.R.
§ 41.37(c)(1)(iv), we decide the § 101 rejection of claims 1–4, 7, 9, 11–14,
and 20–23 based on representative claim 1.
Principles of Law
“Whether a claim is drawn to patent-eligible subject matter is an issue
of law that we review de novo.” SiRF Tech., Inc. v. Int’l Trade Comm’n, 601
F.3d 1319, 1331 (Fed. Cir. 2010).
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l,
573 U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first
determine what concept the claim is “directed to.” See Alice, 573 U.S.
at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
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risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making waterproof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Court held that “a claim drawn to subject matter otherwise statutory does not
become nonstatutory simply because it uses a mathematical formula.”
Diehr, 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as
nothing more than a process for molding rubber products and not as an
attempt to patent a mathematical formula.”). Having said that, the Court also
indicated that a claim “seeking patent protection for that formula in the
abstract . . . is not accorded the protection of our patent laws, and this
principle cannot be circumvented by attempting to limit the use of the
formula to a particular technological environment.” Id. (citation omitted)
(citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that
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an application of a law of nature or mathematical formula to a known
structure or process may well be deserving of patent protection.”).
If the claim is “directed to” an abstract idea, we turn to the second part
of the Alice and Mayo framework, where “we must examine the elements of
the claim to determine whether it contains an ‘inventive concept’ sufficient
to ‘transform’ the claimed abstract idea into a patent-eligible application.”
Alice, 573 U.S. at 221 (quotation marks omitted). “A claim that recites an
abstract idea must include ‘additional features’ to ensure ‘that the [claim] is
more than a drafting effort designed to monopolize the [abstract idea].’” Id.
(alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely
requir[ing] generic computer implementation[] fail[s] to transform that
abstract idea into a patent-eligible invention.” Id.
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. See 2019 Revised
Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“2019 Revised Guidance”).3 “All USPTO personnel are, as a matter of
internal agency management, expected to follow the guidance.” Id. at 51;
see also October 2019 Update at 1.
Under the 2019 Revised Guidance and the October 2019 Update, we
first look to whether the claim recites:

3 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p
df).
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(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or mental
processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h) (9th ed.
Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).4
2019 Revised Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional” in the field (see MPEP
§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
2019 Revised Guidance, 84 Fed. Reg. at 52–56.

4 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application. See 2019 Revised Guidance - Section III(A)(2), 84
Fed. Reg. 54–55.
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Step 1
Claim 1, as a method claim, falls within the process category of § 101.
See 2019 Revised Guidance, 84 Fed. Reg. at 53–54 (citing MPEP
§§ 2106.03, 2106.06).
Step 2A(i): Does the Claim Recite a Judicial Exception?
The Examiner determined that claim 1 is directed to “organizing
information and performing a calculation on the information before
providing the information to a sponsor of a clinical study, and then providing
the result of the calculation to a regulatory agency, in order to allow the
regulatory agency to detect tampering with the information when the
sponsor forwards the information to the regulatory agency.” Final Act. 16.
The Examiner determined this is a certain method of organizing human
activity, and thus an abstract idea. Id. at 17. In addition, the Examiner
determined that the recited generation and comparison of hash numbers is a
mathematical relationship/formula. Ans. 5. The Examiner identified the
following steps as part of the recited abstract idea(s):
“receiving ... audits from a clinical source,” “assembling ... the
audits indo a data stream and a first audit,” “generating ... a first
hash number by applying a hashing algorithm to the first audit
stream,” “transmitting ... the data stream and the first audit
stream to a data provider [or sponsor of a clinical study],”
“transmitting ... the first hash number to a data checker [or a
regulatory agency],” “the data provider [or sponsor] ...
provid[ing] to the data checker [or regulatory agency] a second
audit stream based on the first audit stream,” and “the data
checker [or regulatory agency] .... generat[ing] a second hash
number based on the second audit stream and comparing the
first hash number to the second hash number.”
Final Act. 16.
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Consistent with Appellant’s description of the claims, we find that the
limitations we summarize above describe commercial or legal interactions,
which fall into the certain methods of organizing human activity category of
abstract ideas. See Revised Guidance, 84 Fed. Reg. at 52; Ans. 5.
For the first time in the Reply Brief, Appellant argues that the
Examiner erred in determining that the claimed invention is “method of
organizing human activity” because the Examiner “did not satisfy his burden
to cite ‘to an appropriate court decision that supports the identification of the
subject matter recited in the claim language as an abstract idea.’” Reply
Br. 9. Appellant also argues for the first time in the Reply Brief that the
Examiner erred by not citing specific cases to support the determination that
claim1 recites a mathematical relationship/formula or an idea of itself. Reply
Br. 10–15.
We note that the 2019 Revised Guidance “extracts and synthesizes
key concepts identified by the courts as abstract ideas” (84 Fed. Reg. at 52)
and does not require comparing claims to those already found to recite or be
directed to an abstract idea.
Because we agree with the Examiner that the claim recites an abstract
idea, we proceed to Prong Two of Step 2A to determine if the idea is
integrated into a practical application, in which case the claim as a whole
would not be “directed to” merely an abstract idea.
Step 2A(ii): Judicial Exception Integrated into a Practical Application?
Because we determined that claim 1 recites a patent-ineligible
concept, we next determine whether the recited judicial exception is
integrated into a practical application of that exception by: (a) identifying
whether there are any additional elements recited in the claim beyond the
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judicial exception(s); and (b) evaluating those additional elements
individually and in combination to determine whether they integrate the
exception into a practical application.
We use the term “additional elements” for claim features, limitations,
or steps that the claim recites beyond the identified judicial exception. See
2019 Revised Guidance, 84 Fed. Reg. at 55 n.24. In claim 1, the additional
elements include the limitations “computer processor,” “second computer
processor,” “third computer processor,” and “eClinical system.”
The Examiner determined that none of the additional limitations is
sufficient to amount to significantly more than the judicial exception
because the additional computer elements “only involve[] the use of generic
computers performing generic computing functions to implement the
abstract idea.” Final Act. 17.
Appellant argues that the claims are similar to claim 2 of Example 21
of the PTO’s July 2015 Update to the 2014 Interim Guidance on Subject
Matter Eligibility, Appendix 1: Examples (“July 2015 Update”). Appeal
Br. 9. Hypothetical claim 2 was found patent-eligible in Example 21
because, when looking at the additional elements as an ordered combination,
the invention as a whole amounts to significantly more than simply
organizing and comparing data. The example explains that the invention
claimed in claim 2 addresses the Internet‐centric challenge of alerting a
subscriber with time sensitive information when the subscriber’s computer is
offline. This is addressed by transmitting the alert over a wireless
communication channel to activate a stock viewer application, which causes
the alert to display and enables the connection of the remote subscriber
computer to the data source over the Internet when the remote subscriber
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computer comes online. The example explains that these are meaningful
limitations that add more than generally linking the use of the abstract idea
(the general concept of organizing and comparing data) to the Internet,
because they solve an Internet‐centric problem with a claimed solution that
is necessarily rooted in computer technology, similar to the additional
elements in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed.
Cir. 2014). See Ans. 6–8.
In DDR, instead of a computer network operating in its normal,
expected manner by sending a website visitor to a third-party website via a
clicked advertisement, the claimed invention generated and directed the
visitor to a hybrid page that presented: (1) product information from the
third party, and (2) the visual “look and feel” elements from the host
website, thus retaining the visitor at the original website. DDR, 773 F.3d at
1258–59. Given this particular Internet-based solution, the court held that
the claimed invention did not merely use the Internet to perform a business
practice known from the pre-Internet world, but rather was necessarily
rooted in computer technology to overcome a problem specifically arising in
computer networks. Id. at 1257.
That is not the case here. Unlike in DDR or claim 2 of Example 21,
Appellant’s “method for ensuring integrity of data” is not claimed as solving
or otherwise addressing a problem specifically arising in computer networks.
Claim 1. For example, Appellant’s claimed invention recites no language
that pertains to “alerting a subscriber with time sensitive information when
the subscriber’s computer is offline” by a transmission of an alert to an
application that “cause[d] the alert to display and enable[d] the connection of
the remote subscriber computer to the data source over the Internet when the
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remote subscriber computer comes online,” as in claim 2 of Example 21.
Nor does claim 1 recite improving the three recited computer processors, as
recited in claim 1, or any (unclaimed) computer or network.
We note that, although the Federal Circuit in DDR held claims
“necessarily rooted in computer technology” to be patent eligible, the court
issued a relevant warning:
[W]e caution, however, that not all claims purporting to address
Internet-centric challenges are eligible for patent. For example,
in our recently-decided Ultramercial opinion, the patentee
argued that its claims were “directed to a specific method of
advertising and content distribution that was previously
unknown and never employed on the Internet before.” But this
alone could not render its claims patent-eligible. In particular,
we found the claims to merely recite the abstract idea of
“offering media content in exchange for viewing an
advertisement,” along with “routine additional steps such as
updating an activity log, requiring a request from the consumer
to view the ad, restrictions on public access, and use of the
Internet.”
DDR Holdings, 773 F.3d at 1258 (citations omitted).
Considering claim 1 as a whole, then, Appellant’s invention lacks a
technical solution to a technical problem like the claims in DDR and claim 2
of Example 21. Claim 1 as a whole merely uses instructions to implement
the abstract idea on a computer or, alternatively, merely uses a computer as a
tool to perform the abstract idea. Here, the additional limitation(s) do not
integrate the judicial exception into a practical application. More
particularly, the claims do not recite (i) an improvement to the functionality
of a computer or other technology or technical field (see MPEP
§ 2106.05(a)); (ii) a “particular machine” to apply or use the judicial
exception (see MPEP § 2106.05(b)); (iii) a particular transformation of an
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article to a different thing or state (see MPEP § 2106.05(c)); or (iv) any other
meaningful limitation (see MPEP § 2106.05(e)). See 2019 Revised
Guidance, 84 Fed. Reg. at 55. Rather, claim 1 recites an abstract idea as
identified in Step 2A(i), supra, and none of the limitations integrates the
judicial exception into a practical application.
Therefore, because the abstract idea is not integrated into a practical
application, we conclude that the claim is directed to the judicial exception.
Step 2B — “Inventive Concept” or “Significantly More”
If the claims are directed to a patent-ineligible concept, as we
conclude above, we proceed to the “inventive concept” step. For Step 2B we
must “look with more specificity at what the claim elements add, in order to
determine ‘whether they identify an “inventive concept” in the application of
the ineligible subject matter’ to which the claim is directed.” Affinity Labs of
Texas, LLC v. DIRECTV, LLC, 838 F.3d 1253, 1258 (Fed. Cir. 2016)
(quoting Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed.
Cir. 2016)). We look to see whether there are any “additional features” in the
claims that constitute an “inventive concept,” thereby rendering the claims
eligible for patenting even if they are directed to an abstract idea. Alice, 573
U.S. at 221. Those “additional features” must be more than “well-
understood, routine, conventional activity.” Mayo, 566 U.S. at 79.
The Examiner determined that the additional elements in claim 1
merely involve a processor performing the conventional computer functions
of providing data to the data provider and a hash number to the data checker,
and the data provider forwarding the data to the data checker. The data
checker then performs a calculation on the received data and compares the
result to the received hash. Ans. 7–8.
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We agree with the Examiner that claim 1 does not recite any
additional elements that are not well-understood, routine, and conventional.
Appellant argues for the first time in the Reply Brief that the
Examiner proffered no factual evidence to support that the additional
elements are well-understood, routine, and conventional. See Reply Br. 7
(citing Berkheimer v. HP, Inc., 881 F .3d 1360 (Fed. Cir. Feb. 8, 2018)).
We are not persuaded by Appellant’s argument that the Examiner
erred. The Specification describes that “[t]he present invention is not
intended to be limited to any particular operating system, software
application, or market,” and “any examples of particular software
applications or markets used herein are included for illustration purposes and
are not intended to be limiting.” Spec. ¶ 9. In addition, the Specification
describes that “[t]he blocks shown in FIGS. 1–3 are examples of modules
that may comprise systems 100, 200, and 300, and do not limit the blocks or
modules that may be part of or connected to or associated with these
systems.” Spec. ¶ 24. Moreover, the Specification describes that “[a]spects
of the present invention may be embodied in the form of a system, a
computer program product, or a method. Similarly, aspects of the present
invention may be embodied as hardware, software or a combination of
both.” Spec. ¶ 35.
Because the Specification describes the additional elements in general
terms, without describing the particulars, we conclude the claim limitations
may be broadly but reasonably construed as reciting conventional computer
components and techniques, particularly in light of Appellant’s
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Specification, as cited above. See Berkheimer Memo5 § III.A.1; Spec. ¶¶ 9,
24, 35. Moreover, courts have recognized that receiving or transmitting data
over a network, in a manner similar to that recited in the claims, is well-
understood, routine, and conventional. OIP Techs., Inc. v. Amazon.com, Inc.,
788 F.3d 1359, 1363 (Fed. Cir. 2015) (sending messages over a network);
buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014)
(computer receives and sends information over a network).
We conclude claim 1 does not have an inventive concept because the
claim, in essence, merely recites various computer-based elements along
with no more than mere instructions to implement the identified abstract idea
using the computer-based elements.
Appellant does not direct our attention to anything in the Specification
that indicates the computer components perform anything other than well-
understood, routine, and conventional functions. See buySAFE, 765 F.3d at
1355 (“That a computer receives and sends the information over a
network—with no further specification—is not even arguably inventive”); In
re TLI Commc’ns LLC Patent Litig., 823 F.3d 607, 614 (Fed. Cir. 2016)
(server that receives data, extracts classification information from the
received data, and stores the digital images insufficient to add an inventive

5 “Changes in Examination Procedure Pertaining to Subject Matter
Eligibility, Recent Subject Matter Eligibility Decision (Berkheimer v. HP,
Inc.)” at 3 (Apr. 19, 2018) (explaining that a specification that describes
additional elements “in a manner that indicates that the additional elements
are sufficiently well-known that the specification does not need to describe
the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)” can
show that the elements are well understood, routine, and conventional).
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concept); Alice, 573 U.S. at 225–26 (receiving, storing, sending information
over networks insufficient to add an inventive concept).
Instead, Appellant argues that, because the Examiner has withdrawn
the rejection under 35 U.S.C. § 103, the Examiner has determined that the
claims include allowable subject matter over the prior art and, by definition,
the claims are not “well-understood, routine, and conventional in the field.”
Reply Br. 6.
Appellant’s argument is unavailing. The novelty of any element or
steps in a process, or even of the process itself, is of no relevance in
determining whether the subject matter of a claim falls within the § 101
categories of possibly patentable subject matter. Diamond v. Diehr, 450 U.S.
175, 188–89 (1981). Our reviewing court further guides that “[e]ligibility
and novelty are separate inquiries.” Two-Way Media Ltd. v. Comcast Cable
Commc’ns, LLC, 874 F.3d 1329, 1340 (Fed. Cir. 2017); see also Affinity
Labs of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253, 1263 (Fed. Cir. 2016)
(holding that “[e]ven assuming” that a particular claimed feature was novel
does not “avoid the problem of abstractness”).
Appellant also argues that the Examiner erred by not providing a
written analysis of the dependent claims. Reply Br. 8. We disagree with
Appellant that the Examiner did not provide written analysis of the
dependent claims. In the Final Action, the Examiner determined that all
claims recite an abstract idea (Final Act. 16), determined that “method
claims 1–4, 7, 9, 20, and 21 recite that the method steps are performed using
computer processors and claims 22 and 23 recite that functions are
performed using a processor and a memory” (id. at 17), and also addressed
the additional elements of the dependent claims (id. at 18).
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Because the claims are directed to an abstract idea and lack an
inventive concept, we sustain the Examiner's § 101 rejection of independent
claim 1 and grouped claims 2–4, 7, 9, 11–14, and 20–23, not argued
separately with particularity.
DECISION
We affirm the Examiner’s decision rejecting claims 1–4, 7, 9, 11–14,
and 20–23.
DECISION SUMMARY
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

TIME PERIOD FOR RESPONSE
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)(iv).
AFFIRMED