Medidata Solutions, Inc.

Patent Trials and Appeals Board

Aug 19, 2020

14565607 - (D) (P.T.A.B. Aug. 19, 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.
14/565,607 12/10/2014 Stephen Young 20622.0055 (IDF-55) 5294
127350 7590 08/19/2020
Steptoe & Johnson LLP
1330 Connecticut Avenue NW
Washington, DC 20036
EXAMINER
DURANT, JONATHAN W
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
08/19/2020 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 STEPHEN YOUNG, MLADEN LAUDANOVIC,
and ANSON KRING
________________

Appeal 2019-004556
Application 14/565,607
Technology Center 3600
____________

Before ERIC S. FRAHM, BETH Z. SHAW, and MATTHEW J. McNEILL,
Administrative Patent Judges.

McNEILL, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1‒17, which are all the claims pending in this application.
An oral hearing was held July 29, 2020. A transcript will be entered into the
record in due course. We have jurisdiction under 35 U.S.C. § 6(b).
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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STATEMENT OF THE CASE
Introduction
Appellant’s application relates to monitoring adverse event rates for a
clinical trial to detect sites that are under- or over-reporting events relative to
expectation. Spec. ¶ 16. Claims 1 and 8 are illustrative of the appealed
subject matter and read as follows:
1. A system for assessing a clinical trial site’s adverse event
reporting rate, comprising:
an adverse event and visit count processor for receiving
adverse event and subject visit data from a plurality of clinical
trial sites, and calculating for each clinical trial site a total visit
count and a total adverse event count; and
a site adverse event rate processor for:
receiving the total visit count and total adverse
event count for each clinical trial site;
calculating a trial-level adverse event rate for the
clinical trial;
calculating for each clinical trial site an expected
total adverse event count based on the clinical trial site's
total visit count and the trial-level adverse event rate; and
comparing for each clinical trial site the expected
total adverse event count to the total adverse event count
to assess the probability that the clinical trial site is
under-reporting or over-reporting adverse events.

8. A system for assessing a clinical trial site’s adverse event
reporting rate, comprising:
an adverse event and visit count processor for:
receiving adverse event and subject visit data from
a plurality of clinical trial sites;
receiving an expected visit calendar identifying
distinct visits for the clinical trial; and
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calculating for each clinical trial site:
a subject count and an adverse event count
associated with each distinct visit; and
a total adverse event count for all subjects
and all distinct visits; and
a site adverse event rate processor for:
receiving the subject count and adverse event
count associated with each distinct visit;
receiving the total adverse event count;
calculating for each distinct visit a trial-level
adverse event rate;
calculating for each clinical trial site:
an expected adverse event count for each
distinct visit, using the trial-level adverse event
rate for the same distinct visit; and
an expected total adverse event count as the
sum of the expected adverse event counts for each
distinct visit; and
comparing for each clinical trial site the expected
total adverse event count to the total adverse event count
for the clinical trial site to assess the probability that the
clinical trial site is under-reporting or over-reporting
adverse events.
The Examiner’s Rejections
Claims 1‒17 stand rejected under 35 U.S.C. § 101 as being directed to
patent-ineligible subject matter. See Final Act. 2‒5.
Claims 1‒3 stand rejected under 35 U.S.C. § 103 as unpatentable over
Grundstrom (US 2014/0375650 A1; Dec. 25, 2014) and Nelson et al.,
Evaluation of Signal Detection Methods for Use in Prospective Post-
licensure Medical Product Safety Surveillance, FDA-2009-N-0192 (2009)
(“Nelson”). See Final Act. 6‒10.
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To the base combination, the Examiner adds Totten (US
2008/0313017 A1; Dec. 18, 2008) to reject claims 4 and 5 (see Final Act.
10‒12); Smith (US 2008/0300902 A1; Dec. 4, 2008) to reject claims 6 and 7
(see Final Act. 12‒14); Schultz (US 2009/0292554 A1; Nov. 26, 2009) to
reject claim 8, 9, and 15 (see Final Act. 14‒25); Schultz and Totten to reject
claims 10 and 11 (see Final Act. 25‒27); Schultz and Richman (US
6,631,384 B1; Oct. 7, 2003) to reject claim 12 (see Final Act. 27‒30); and
Schultz and Smith to reject claims 13, 14, 16, and 17 (see Final Act. 30‒32).
ANALYSIS
Patent-Ineligible Subject Matter
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 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 Supreme Court’s two-step framework, described in Mayo
and Alice. Alice, 573 U. S. 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 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.”).
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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, 69 (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 water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 183 n.7 (quoting Corning v. Burden, 56 U.S.
(15 How.) 252, 267–68 (1854))); 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
Supreme 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 176; 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 Supreme 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 an application of a law of nature or
mathematical formula to a known structure or process may well be deserving
of patent protection.”).
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If the claim is “directed to” an abstract idea, we turn to the second
step 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 PTO published revised guidance on the
application of § 101. USPTO’s January 7, 2019 Memorandum, 2019
Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50
(“Revised Guidance”). Under that guidance, we first look to whether the
claim recites:
(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); and
(2) additional elements that integrate the judicial
exception into a practical application (see Manual of Patent
Examining Procedure (“MPEP”) §§ 2106.05(a)–(c), (e)–(h)
(9th Ed. Rev. 08.2017, Jan. 2018)).
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim:
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(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.
See Revised Guidance.
Revised Guidance Step 1
Step 1 of the Revised Guidance asks whether the claimed subject
matter falls within the four statutory categories of patentable subject matter
identified by 35 U.S.C. § 101: process, machine, manufacture, or
composition of matter. See Revised Guidance. Claim 1 recites an “[a] system
for accessing a clinical trial site’s adverse event reporting rate.” Appellant
does not argue the Examiner erred in concluding claim 1 falls within the four
statutory categories of patentable subject matter. We agree with the
Examiner’s conclusion because claim 1 falls within the machine or
manufacture categories.
Revised Guidance Step 2A, Prong 1
Under Step 2A, Prong 1 of the Revised Guidance, we determine
whether the claims recite 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). See Revised Guidance.
The Examiner determines claim 1 is directed to a system for assessing
a clinical trial site’s adverse event reporting rate. Final Act. 2. The Examiner
determines the claims are similar to collecting information, analyzing it, and
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displaying certain results. Id. The Examiner determines the claims, therefore,
recite a mental process (see Ans. 8‒9), an “idea of itself” (see Final Act. 3),
and mathematical relationships and formulas (see Final Act. 3).
Claim 1 recites “a system for assessing a clinical site’s adverse event
reporting rate, comprising an adverse event and visit count processor” and “a
site adverse event rate processor.” The “adverse event and visit count
processor” performs the steps of “receiving adverse event and subject visit
data from a plurality of clinical trial sites” and “calculating for each clinical
trial site a total visit count and a total adverse event count.” The “site
adverse event rate processor” performs the steps of “receiving the total visit
count and total adverse event count for each clinical trial site;” “calculating a
trial-level adverse event rate for the clinical trial;” “calculating for each
clinical trial site an expected total adverse event count based on the clinical
trial site’s total visit count and the trial-level adverse event rate;” and
“comparing for each clinical trial site the expected total adverse event count
to the total adverse event count to assess the probability that the clinical trial
site is under-reporting or over-reporting adverse events.”
We agree with the Examiner that these limitations, under their
broadest reasonable interpretation, recite “assessing a clinical site’s adverse
event reporting rate.” In particular, the “receiving adverse event and subject
visit data” and “receiving the total visit count” steps characterize gathering
data to be used in calculations. These data gathering steps are insignificant
pre-solution activity. See MPEP § 2106.05(g). The three “calculating” steps
and the “comparing” step are each evaluations performed on the recited data
that has either been received or calculated in previous steps. We agree that
this is an abstract idea under the Revised Guidance because each of these
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calculations and comparisons are evaluations that may be performed in the
human mind or by a human using pen and paper. Thus, claim 1 recites
concepts performed in the human mind, which fall within the mental
processes category of abstract ideas identified in the Revised Guidance.
Appellant argues that the claims cannot be performed in the human
mind. See Reply Br. 5‒7. In particular, Appellant argues that the amount of
data involved in these calculations is “not trivial” and therefore these
calculations cannot be performed in the human mind. Reply Br. 6. In
support, Appellant cite examples from the Specification of clinical trials that
involve hundreds, thousands, or tens of thousands of patients. Id. (citing
Spec. ¶¶ 1, 21). Appellant argues the amount of data precludes these
calculations from being performed in the human mind. Id.
We disagree. First, the claims do not require any particular number of
adverse events, subject visits, total visits, or any other information used in
the claimed calculations. Thus, under the broadest reasonable interpretation,
the numbers involved in these calculations may be small and easily
manageable in the human mind, as found by the Examiner. See Ans. 9.
Appellant’s argument is, therefore, not commensurate with the scope of the
claims. Second, even if the examples provided in Appellant’s Specification
were commensurate with the scope of the claims, Appellant fails to persuade
us that an ordinarily skilled artisan could not perform these calculations in
their mind or with pen or paper. Our reviewing court has made it clear that
mental processes remain unpatentable even when automated to reduce the
burden on the user of what once could have been done with pen and paper.
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir.
2011) (“That purely mental processes can be unpatentable, even when
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performed by a computer, was precisely the holding of the Supreme Court in
Gottschalk v. Benson[, 409 U.S. 63, 67 (1972)].”). While the claimed system
certainly purports to accelerate the process of assessing adverse event
reporting rates, the speed increase comes from the capabilities of a general-
purpose computer, rather than the patented method itself. See Bancorp
Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278
(Fed. Cir. 2012) (“[T]he fact that the required calculations could be
performed more efficiently via a computer does not materially alter the
patent eligibility of the claimed subject matter.”).
For these reasons, Appellant does not persuade us of Examiner error
with respect to Step 2A, Prong 1 of the Revised Guidance. We, therefore,
conclude claim 1 recites an abstract idea under the Revised Guidance.
Revised Guidance Step 2A, Prong 2
Under Step 2A, Prong 2 of the Revised Guidance, we next determine
whether the claims recite additional elements that integrate the judicial
exception into a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)).
The “additional elements” recited in claim 1 include “an adverse event and
visit count processor” and “a site adverse event rate processor.” These
additional elements do not constitute “additional elements that integrate the
judicial exception into a practical application.”
Appellant argues claim 1 is directed to an improvement to another
technology or technical field because the claimed system improves upon the
prior art adverse event assessment technology that had calculated adverse
event rate as merely the total count of adverse events divided by the total
count of subjects in the clinical site or clinical trial. Appeal Br. 25. Appellant
also argues claim 1 integrates any mental process into a practical application
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because the claimed invention uses these calculations to determine whether a
clinical site is under-reporting or over-reporting adverse events. See Reply
Br. 8‒9.
Appellant does not persuade us of Examiner error. Appellant argues
the claim improves “adverse event assessment technology” by changing the
manner in which the adverse event reporting rate is assessed. Id. However,
this is an improvement to the abstract idea itself, not an improvement to any
technology or technical field. The identified improvements do not “enable[]
a computer . . . to do things it could not do before.” Finjan, Inc. v. Blue Coat
Sys., Inc., 879 F.3d 1299, 1305 (Fed. Cir. 2018). Claims whose focus is “not
a physical-realm improvement but an improvement in wholly abstract
ideas,” are not eligible for patenting. SAP Am., Inc. v. InvestPic, LLC, 898
F.3d 1161, 1168 (Fed. Cir. 2018); see also Interval Licensing LLC v. AOL,
Inc., 896 F.3d 1335, 1346 (Fed. Cir. 2018) (“It is well-settled that placing an
abstract idea in the context of a computer does not ‘improve’ the computer
or convert the idea into a patent-eligible application of that idea.”).
As stated by our reviewing court, “[w]e often analyze software-related
claims by asking whether the claims focus on a ‘specific asserted
improvement in computer capabilities’ instead of on ‘a process that qualifies
as an “abstract idea” for which computers are invoked merely as a tool.’”
Ubisoft Entm’t, S.A. v. Yousician Oy, No. 2019-2399, 2020 WL 3096369, at
*2 (Fed. Cir. June 11, 2020) (nonprecedential) (quoting Finjan, 879 F.3d at
1303).
“This is not a situation where the claims ‘are directed to a specific
improvement to the way computers operate’ and therefore not directed to an
abstract idea, as in cases such as Enfish, LLC v. Microsoft Corp., 822 F.3d
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1327, 1336 (Fed. Cir. 2016). . . . To the contrary, the claims are written at a
distinctly high level of generality.” Solutran, Inc. v. Elavon, Inc., 931 F.3d
1161, 1167 (Fed. Cir. 2019). The focus of the claims is on the practice of
assessing adverse event rates, “and the recited generic computer elements
‘are invoked merely as a tool.’” Credit Acceptance Corp. v. Westlake Svcs.,
859 F.3d 1044, 1055 (Fed. Cir. 2017) (citing Enfish, LLC v. Microsoft Corp.,
822 F.3d 1327, 1335–36 (Fed. Cir. 2016)); see also Versata Dev. Grp., Inc.
v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) (collecting cases).
Appellant’s argument that the claims integrate the mental process into
a practical application because the claimed invention is used to determine
whether a clinical site is under-reporting or over-reporting adverse events is
also unpersuasive. To integrate the exception into a practical application, the
additional claim elements must, for example, improve the functioning of a
computer or any other technology or technical field (see MPEP
§ 2106.05(a)), apply the judicial exception with a particular machine (see
MPEP § 2106.05(b)), affect a transformation or reduction of a particular
article to a different state or thing (see MPEP § 2106.05(c)), or apply or use
the judicial exception in some other meaningful way beyond generally
linking the use of the judicial exception to a particular technological
environment (see MPEP § 2106.05(e)). See Revised Guidance.
Appellant does not persuade us that the claims integrate the abstract
idea into a practical application for any of these reasons. To the extent
Appellant contends that the recited limitations, including those detailed
above in connection with Prong 1, integrate the abstract idea into a practical
application (see Reply Br. 8‒9), these limitations are not additional elements
beyond the abstract idea, but rather are directed to the abstract idea as noted
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previously. See 2019 Revised Guidance, 84 Fed. Reg. at 54 (instructing that
additional recited elements should be evaluated to determine whether the
claim integrates the exception into a practical application of the exception;
see also 2019 Revised Guidance, 84 Fed. Reg. at 55 n.24 (“USPTO
guidance uses the term ‘additional elements’ to refer to claim features,
limitations, and/or steps that are recited in the claim beyond the identified
judicial exception.” (Emphasis added)).
Thus, Appellant does not persuade us of Examiner error with respect
to Step 2A, Prong 2 of the Revised Guidance. We, therefore, conclude the
judicial exception is not integrated into a practical application under the
Revised Guidance.
Revised Guidance Step 2B
Under Step 2B of the Revised Guidance, we next determine whether
the claims recite an “inventive concept” that “must be significantly more
than the abstract idea itself, and cannot simply be an instruction to
implement or apply the abstract idea on a computer.” BASCOM Glob.
Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir.
2016). There must be more than “computer functions [that] are ‘well-
understood, routine, conventional activit[ies]’ previously known to the
industry.” Alice, 573 U.S. at 225 (second alteration in original) (quoting
Mayo, 566 U.S. at 73).
As discussed above, Appellant argues claim 1 is directed to a
technological improvement. As explained above, Appellant’s argument that
the claims recite an improvement to computer technology is unpersuasive
because claim 1 recites an improvement to a mental process, not an
improvement to computer technology. Appellant does not persuasively
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identify any “inventive concept” sufficient to transform the claims from an
abstract idea to a patent-eligible application. For these reasons, we agree
with the Examiner (see Ans. 11‒12) that the claims do not recite an
“inventive concept” sufficient to transform the claims from an abstract idea
to a patent-eligible application. We, therefore, sustain the patent-ineligible
subject matter rejection of claim 1. We also sustain the rejection of
independent claims 8 and 15, which Appellant argues are patent eligible for
the same reasons. See Appeal Br. 9‒27; Reply Br. 4‒11.
Dependent Claims
Appellant argues the Examiner erred in concluding dependent claims
2‒7, 9‒14, 16, and 17 are directed to patent-ineligible subject matter because
the Examiner’s findings are conclusory and ignore claim limitations. See
Appeal Br. 27‒28.
Appellant does not persuade us of Examiner error. The dependent
claims recite further detail regarding system for assessing a clinical site’s
adverse event reporting rate, but do not recite limitations that change the
nature of the recited abstract idea or that change the claims into something
significantly more than the abstract idea. For example, claim 2 recites
“wherein the calculating a trial-level adverse event rate for the clinical trial
comprises dividing the sum of the total adverse event counts for all sites by
the sum of the total visit counts for all sites.” In other words, claim 2 recites
further detail regarding the method of performing a “calculating” step
recited in claim 1. This additional detail does not materially affect the
abstract idea analysis and does not add additional elements to the claim.
Similarly, claim 4 recites:
wherein the total visit count for each clinical trial site is
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calculated as a weighted count by:
receiving subject visit data from a plurality of clinical
trial sites; and
calculating for each clinical trial site and for each
reported visit a weighted visit count, wherein the weighted
count contribution represents an estimated proportion of all
required visit data that have been already reported for the
subject for the given reported visit.
Appellant argues the “weighted count” and “weighted visit count”
limitations integrate the abstract idea into a practical application. We
disagree for the same reasons discussed above with respect to claim 1. That
is, the identified limitations are not “additional elements,” nor does
Appellant persuasively explain how these limitations improve the
functioning of a computer or any other technology or technical field (see
MPEP § 2106.05(a)), apply the judicial exception with a particular machine
(see MPEP § 2106.05(b)), affect a transformation or reduction of a particular
article to a different state or thing (see MPEP § 2106.05(c)), or apply or use
the judicial exception in some other meaningful way beyond generally
linking the use of the judicial exception to a particular technological
environment (see MPEP § 2106.05(e)). See Revised Guidance.
Appellant’s arguments regarding the remaining dependent claims are
unpersuasive for the same reasons. We, therefore, sustain the patent-
ineligible subject matter rejection of claims 2‒7, 9‒14, 16, and 17.
Obviousness
Independent claim 1
We have reviewed the Examiner’s obviousness rejection of claim 1 in
light of Appellant’s contentions that the Examiner has erred. We disagree
with Appellant’s contentions. Except as noted below, we adopt as our own:
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(1) the findings and reasons set forth by the Examiner with respect to the
obviousness rejection of claim 1 in the action from which this appeal is
taken and (2) the reasons set forth by the Examiner in the Examiner’s
Answer with respect to the obviousness rejection of claim 1 in response to
Appellant’s Appeal Brief. We concur with the conclusions reached by the
Examiner. We highlight the following additional points.
Appellant argues the Examiner erred in rejecting claim 1 as
unpatentable over Grundstrom and Nelson. See Appeal Br. 30‒34; Reply
Br. 11‒16. In particular, Appellant argues the Examiner erred in finding the
combination of references teaches or suggests a “system for assessing a
clinical trial site’s adverse event reporting rate,” “calculating for each
clinical trial site an expected total adverse event count based on the clinical
trial site’s total visit count and the trial-level adverse event rate,” and
“comparing for each clinical trial site the expected total adverse event count
to the total adverse event count to assess the probability that the clinical trial
site is under-reporting or over-reporting adverse events.” See Appeal Br. 30‒
34; Reply Br. 11‒16.
Appellant argues the Examiner erred because the claims focus on
calculating an adverse event reporting rate and Grundstrom’s teachings
focus on identifying adverse event rates that differ from trial averages. See
Appeal Br. 30‒31. Appellant argues the Examiner acknowledges that
Grundstrom does not disclose adverse event counts based on subject visits,
but states without support that it would be a simple substitution to use such a
count. See id. at 31. According to Appellant, this substitution is not “simple”
and is based on unfounded inferences. See Reply Br. 14‒15.
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The Examiner finds Grundstrom teaches comparing a rate of study
indicators for each site with a mean rate across an entire trial. Ans. 14; see
also Grundstrom ¶ 38. The Examiner finds Grundstrom teaches evaluating
this adverse event data for each patient at each site. Ans. 14 (citing
Grundstrom ¶¶ 39‒42). The Examiner finds Grundstrom does not expressly
disclose that the adverse event rate calculation uses the number of patient
visits, but Grundstrom teaches evaluating protocol deviations compared to
the total number of patient visits. Id. (citing Grundstrom ¶ 108). The
Examiner finds calculating adverse event rates compared to the number of
patient visits would have been an obvious, simple substitution of one known
element for another to obtain predictable results. Ans. 14‒15.
Appellant does not persuade us of Examiner error. As found by the
Examiner, Grundstrom teaches calculating a mean number of adverse events
for each patient at each clinical trial site. Grundstrom ¶ 38. Grundstrom
teaches that after these values are calculated, “the mean for each site is
compared against the study mean.” Id. If the mean varies from the study
mean by more than a threshold amount, “indicators” are generated to
identify the site to the clinical trial managers. Id. ¶¶ 37‒38. We agree with
the Examiner that Grundstrom does not explicitly teach performing the
claimed “calculating” and “comparing” steps because Grundstrom’s
calculations and comparisons are based on average adverse event rates at
clinical sites, rather than total adverse event counts. See Ans. 14‒15.
However, Grundstrom’s teachings would have at least suggested to an
ordinarily skilled artisan that total counts are compared at least because
average adverse event rates are merely total adverse event counts divided by
the number of patients at a clinical site. Grundstrom ¶ 38. This is further
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supported by the visualization tools taught by Grundstrom to display this
information, including Figure 6 which depicts adverse event rate per site and
further depicts total adverse events and total subjects screened in the same
visualization tool. See Grundstrom Fig. 6, ¶¶ 38‒42. We agree with the
Examiner that this finding is further supported by Grundstrom’s teachings
that total patient visit counts are used in calculations such as protocol
deviation calculations. See Ans. 14 (citing Grundstrom ¶ 108). Appellant’s
arguments to the contrary do not persuasively identify error in the
Examiner’s findings.
Accordingly, we sustain the obviousness rejection of claim 1. We also
sustain the obviousness rejection of dependent claims 2‒7, for which
Appellant relies on the same arguments. See Appeal Br. 37.
Independent Claims 8 and 15
The Examiner finds the combination of Grundstrom, Nelson, and
Schultz teaches or suggests “receiving an expected visit calendar identifying
distinct visits for the clinical trial,” as recited in claim 8. See Final Act. 18
(citing Schultz ¶ 117); Ans. 16‒17. In particular, the Examiner finds
Grundstrom teaches aspects pertaining to patient visits, but is deficient with
respect to “distinct” patient visits. See Ans. 16‒17 (citing Grundstrom
¶¶ 108, 15‒17, 32, 33, 38, 39‒42). The Examiner finds Schultz teaches
“distinct visits.” See id. at 17 (citing Schultz ¶ 117).
Appellant argues the Examiner erred in rejecting claims 8 and 15
because the cited combination does not teach or suggest the “receiving” step.
See Appeal Br. 34‒37; Reply Br. 17‒18. In particular, Appellant argues
neither Grundstrom nor Schultz teaches “distinct visits” in reference to
patient visits and, even if that were taught, neither reference nor the
Appeal 2019-004556
Application 14/565,607

19

combination teaches “receiving an expected visit calendar” as claimed. See
id.
Appellant persuades us of Examiner error with respect to these claims.
Schultz teaches an “expected CRA monitoring visit schedule for each site.”
Schultz ¶ 117. CRAs are clinical research assistants (id. ¶ 38) that monitor
sites for various reasons (id. ¶ 98). Schultz’s teaching of a “schedule” for
expected CRA monitoring visits does not relate to patient visits to clinical
sites, and the Examiner fails to explain or sufficiently establish how this
teaching, in combination with Grundstrom and Nelson, teaches or suggests
“receiving an expected visit calendar” as claimed. We, therefore, do not
sustain the obviousness rejection of claim 8. We also do not sustain the
obviousness rejection of independent claim 15, which recites commensurate
limitations. We also do not sustain the obviousness rejection of claims 9‒14,
16, and 17, which depend from independent claims 8 and 15.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1‒17 101 Eligibility 1‒17
1‒3 103 Grundstrom,
Nelson
1‒3
4, 5 103 Grundstrom,
Nelson, Totten
4, 5
6, 7 103 Grundstrom,
Nelson, Smith
6, 7
8, 9, 15 103 Grundstrom,
Nelson, Schultz
8, 9, 15
10, 11 103 Grundstrom,
Nelson, Schultz,
Totten
10, 11
Appeal 2019-004556
Application 14/565,607

20

12 103 Grundstrom,
Nelson, Schultz,
Richman
12
13, 14, 16,
17
103 Grundstrom,
Nelson, Schultz,
Smith
13, 14,
16, 17
Overall
Outcome
1‒17

CONCLUSION
Because we sustain at least one ground of rejection with respect to
each claim on appeal, we affirm the decision of the Examiner rejecting
claims 1‒17. See 37 C.F.R. § 41.50(a)(1) (2018).
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.
§ 41.50(f).

AFFIRMED