Ex Parte de Vries et al

Patent Trials and Appeals Board

Oct 29, 2018

14053405 - (D) (P.T.A.B. Oct. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/053,405 10/14/2013
127350 7590 10/31/2018
Steptoe & Johnson LLP
1330 Connecticut Avenue NW
Washington, DC 20036
FIRST NAMED INVENTOR
Glen de Vries
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
20622.0034 (IDF-34) 5348
EXAMINER
DURANT, JONATHAN W
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
10/31/2018 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
rgreenfeld@steptoe.com
ipdocketing@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, ISAAC WONG, and
MICHELLE MARLBOROUGH
Appeal2017-002714
Application 14/053,405 1
Technology Center 3600
Before BRUCE T. WIEDER, TARA L. HUTCHINGS, and
ROBERT J. SILVERMAN, Administrative Patent Judges.
WIEDER, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner's final rejection of claims 1, 3-13, and 15-21. We have
jurisdiction under 35 U.S.C. § 6(b ). Oral arguments were presented on
October 16, 2018.
We AFFIRM and enter a NEW GROUND OF REJECTION pursuant
to our authority under 37 C.F.R. § 41.50(b).
1 According to Appellants, the real party in interest is Medidata Solutions,
Inc. (Appeal Br. 3.)
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Application 14/053,405
CLAIMED SUBJECT MATTER
Appellants' invention relates to allowing "disparate ... clinical data
recording devices ... to be to be assimilated into a unified clinical system."
(Spec. ,r 12.)
Claims 1, 8, 12, and 16 are the independent claims on appeal. Claim 1
is illustrative. It recites:
1. A method for controlling workflow using audits from
disparate clinical data input functionalities, comprising:
receiving, at a first component of a clinical data system, an
audit from at least one clinical data input functionality;
calculating, by a computer processor, whether the received
audit constitutes a sufficient audit of the clinical data system,
wherein the sufficiency is a configurable attribute of the clinical
data system and wherein if the received audit constitutes said
sufficient audit, then the received audit comprises a first
sufficient audit, and if the received audit is not sufficient,
transmitting the received audit to a second component of the
clinical data system, generating a dependent audit at the second
component, and supplementing the received audit with data
contained in the dependent audit to generate the first sufficient
audit;
calculating, at the first component, workflow instructions
in accordance with which the first sufficient audit is transmitted
to a further component of the clinical data system and to an audit
service;
generating at the further component a second sufficient
audit related to the first sufficient audit; and
persisting the first sufficient audit and the second
sufficient audit in a database associated with the audit service.
REJECTIONS
Claims 1, 3-13, and 15-21 are rejected under 35 U.S.C. § 101 as
directed to a judicial exception without significantly more.
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Claims 1, 3-11, and 15-21 are rejected under 35 U.S.C. § 112(a) as
failing to comply with the enablement requirement. 2
Claims 1, 3-13, 15, 20, and 21 are rejected under 35 U.S.C. § 112(b)
as being indefinite for failing to particularly point out and distinctly claim
the subject matter which Appellants regard as the invention.
Claims 1, 3---6, 8-10, 12, 13, 15, 19, and 20 are rejected under
35 U.S.C. § 103 as obvious in view of Simske (WO 2011/136781 Al, pub.
Nov. 3, 2011), Ingrassia (US 2011/0225178 Al, pub. Sept. 15, 2011), and
Natoli (US 2009/0080408 Al, pub. Mar. 26, 2009).
Claims 7 and 11 are rejected under 35 U.S.C. § 103 as obvious in
view of Simske, Ingrassia, Natoli, and Corbett-Clark (US 2004/0177090 Al,
pub. Sept. 9, 2004).
Claims 16 and 17 are rejected under 35 U.S.C. § 103 as obvious in
view of Simske and Natoli.
Claim 18 is rejected under 35 U.S.C. § 103 as obvious in view of
Simske, Natoli, and Corbett-Clark.
Claim 21 is rejected under 35 U.S.C. § 103 as obvious in view of
Simske, Ingrassia, Natoli, and Bayliss (US 7,912,842 Bl, iss.
Mar. 22, 2011.)
2 Although the Final Action refers to the written description requirement of
§ 112(a) (see Final Action 4), as discussed infra, the Examiner concludes
that the Specification does not meet the enablement requirement of§ 112(a)
(see id. at 7-15).
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The § 101 rei ection
ANALYSIS
"Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title." 35 U.S.C. § 101. Section 101, however,
"contains an important implicit exception: Laws of nature, natural
phenomena, and abstract ideas are not patentable." Alice Corp. Pty. Ltd. v.
CLS Bankint'l, 134 S. Ct. 2347, 2354 (2014) (quotingAss'nfor Molecular
Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)).
Alice applies a two-step framework, earlier set out in Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66
(2012), "for distinguishing patents that claim laws of nature, natural
phenomena, and abstract ideas from those that claim patent-eligible
applications of those concepts." Alice, 134 S. Ct. at 2355.
Under the two-step framework, it must first be determined if "the
claims at issue are directed to a patent-ineligible concept." Id. If the claims
are determined to be directed to a patent-ineligible concept, e.g., an abstract
idea, then the second step of the framework is applied to determine if "the
elements of the claim ... contain[] an 'inventive concept' sufficient to
'transform' the claimed abstract idea into a patent-eligible application." Id.
at 2357 (citing Mayo, 566 U.S. at 72-73, 79).
With regard to step one of the Alice framework, the Examiner
determines that the claims are
directed to systems and methods . . . which merely apply the
abstract idea of auditing a clinical trial (i.e. receiving an audit,
calculating whether the received audit constitutes a sufficient
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audit, generating a dependent audit if the received audit is not
sufficient, calculating workflow instructions, generating a
second sufficient audit, and persisting the audits).
(Final Action 3.)
Appellants disagree and argue that "claim 1 is directed to a method for
controlling workflow using audits from disparate clinical data input
functionalities." (Appeal Br. 8.) Appellants further argue that "[a]n audit as
claimed in the present invention is . . . a concrete set of information related
to the specific transaction" and that "[a] 'sufficient audit' is one that includes
all of the who, what, when, where, and why of the transaction." (Id. at 10.)
Moreover, Appellants argue, "the Examiner did not identify any case that
found 'auditing a clinical trial' to be abstract and he did not adequately
articulate why 'auditing a clinical trial' was similar to other cases." (Id.
at 19.)
Under step one of the Alice framework, we "look at the 'focus of the
claimed advance over the prior art' to determine if the claim's 'character as a
whole' is directed to excluded subject matter." Affinity Labs of Texas, LLC
v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016) (quoting Elec.
Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016)).
The Specification provides evidence as to what the claimed invention
is directed. In this case, the Specification discloses that the invention relates
to allowing "disparate ... clinical data recording devices ( also called
'clinical data input functionalities' or 'data-exporting devices' in this
application) to be to be assimilated into a unified clinical system." (Spec.
,r 12.) The Specification identifies "clinical data recording devices" or
"clinical data input functionalities" as including devices such as "Fitbit
Flexâ„¢, and ECG [electrocardiogram] and glucose monitors." (Id.) The
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Specification discloses that "an audit is a record of a transaction occurring at
one or more of the clinical data input functionalities or any downstream
clinical system or component of clinical data system 160." (Id. ,r 14.) The
Specification also discloses that "an audit of the present invention may
simply be constituted by the data received from a clinical data input
functionality." (Id. ,r 15.) And, the Specification discloses that "[t]he
sufficiency of an audit, described with reference to the clinical data
embodiments herein, may be a variable, configurable attribute of a clinical
data system 160." (Id.)
The Specification also discloses:
Workflow service 162 may provide workflow instructions
by which the export data and/or audits it receives are transmitted
to the downstream components of clinical data system 160. For
example, workflow service 162 may receive audits 150, 152, 154
from clinical data input functionalities 110-118, parse the
received audits and, based on the stored workflow instructions
and the audit data, calculate specific workflow instructions
regarding where to transmit or route audits 150, 152, 154 ....
(Id. ,I 18.)
The Specification does not define the term "persisting," however, we
note that the term "persistent data" includes "[ d]ata that remain intact from
session to session such as customer and vendor records. Although they may
be updated, they are relatively permanent. Persistent data are stored in a
database on disk, SSD or magnetic tape." (https://www.pcmag.com/
encyclopedia/term/49122/persistent-data, last visited Oct. 26, 2018.) This is
in accord with the Examiner's determination that "persisting the audit
amounts to a step of storing." (See Answer 8.)
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Like the Specification, claim 1 also provides evidence as to what the
claim is directed. Claim 1 recites "receiving ... an audit from at least one
clinical data input functionality," "calculating ... whether the received audit
constitutes a sufficient audit ... and if the received audit is not sufficient,
transmitting the received audit to a second component ... generating a
dependent audit at the second component, and supplementing the received
audit," "calculating workflow instructions in accordance with which the first
sufficient audit is transmitted to a further component," "generating at the
further component a second sufficient audit," and persisting the first
sufficient audit and the second sufficient audit." In short, Appellants' claim
is directed to receiving information, analyzing the information, issuing
instructions in view of the analysis, generating additional information, and
storing the information.
"[W]e have treated collecting information, including when limited to
particular content (which does not change its character as information), as
within the realm of abstract ideas." Elec. Power Grp., 830 F.3d at 1353. "In
a similar vein, we have treated analyzing information by steps people go
through in their minds, or by mathematical algorithms, without more, as
essentially mental processes within the abstract-idea category." Id. at 1354.
"And we have recognized that merely presenting the results of abstract
processes of collecting and analyzing information, without more (such as
identifying a particular tool for presentation), is abstract as an ancillary part
of such collection and analysis." Id. "Here, the claims are clearly focused
on the combination of those abstract-idea processes." Id.; see also
Answer 8. Similarly, "creat[ing] electronic records, track[ing] multiple
transactions, and issu[ing] simultaneous instructions," have been identified
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by the courts as within the realm of abstract ideas. See Alice, 134 S. Ct.
at 2359.
Although we and the Examiner describe, at different levels of
abstraction, to what the claims are directed, it is recognized that "[a]n
abstract idea can generally be described at different levels of abstraction."
Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240 (Fed. Cir. 2016). In this
case, that does not "impact the patentability analysis." See id. at 1241.
Moreover, here, the limitations do not recite implementation details. See id.
Appellants argue that the Examiner erred because "the Examiner did
not identify any case that found 'auditing a clinical trial' to be an abstract
idea and he did not adequately articulate why 'auditing a clinical trial' was
similar to these other cases." (Appeal Br. 19.)
We do not find Appellants' argument persuasive. The law does not
require identifying a case specifically determining "auditing a clinical trial"
to be an abstract idea. By way of example, in Fair Warning IP, LLC v. Iatric
Sys., Inc., 839 F.3d 1089, 1093-94 (Fed. Cir. 2016), claim 1 of
FairWaming's patent recited "[a] method of detecting improper access of a
patient's protected health information ... comprising: generating a rule for
monitoring audit log data," "applying the rule," "storing, in a memory, a hit
if the event has occurred," "and providing notification." In Electric Power,
claim 12 of Electric Power's '710 patent recited "[a] method of detecting
events on an interconnected electric power grid ... comprising: receiving a
plurality of data streams," "receiving data from other power system data
sources," "receiving data from ... non-grid data sources," "detecting and
analyzing events in real-time," "displaying the event analysis results and
diagnoses," "displaying concurrent visualization of measurements,"
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"accumulating and updating the measurements," "and deriving a composite
indicator." In determining FairWaming's claims to be directed to an
abstract idea, the Federal Circuit analogized those claims to the claims in
Electric Power and noted that Electric Power "explained that the 'realm of
abstract ideas' includes 'collecting information, including when limited to
particular content"' as well as analyzing and presenting information. See id.
Here, the Examiner has sufficiently articulated why the steps of claim 1 may
be analogized to those in Electric Power. See Answer 8.
Appellants seek to analogize their claims to those in DDR Holdings,
LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014), arguing that
the pending claims . . . requir[ e] numerous different technical
operations, including six for claim 1 alone: calculating
sufficiency of a received audit, generating a dependent audit,
supplementing the received audit, calculating workflow
instructions, generating a second sufficient audit, and persisting
the audit. Cf DDR Holdings, 773 F.3d at 1257 (describing three
different operations or steps that the patent-eligible claim recites
in order to "address the problem of retaining website visitors"). [3J
(Appeal Br. 27 .)
In DDR Holdings, the Federal Circuit stated that the claims "specify
how interactions with the Internet are manipulated to yield a desired result -
a result that overrides the routine and conventional sequence of events
ordinarily triggered by the click of a hyperlink." DDR Holdings, 773 F.3d
at 1258 ( emphasis added). Appellants do not persuasively argue why, e.g.,
3 To the extent Appellants are arguing that the number of steps in a claim is
determinative of whether the claim is directed to an abstract idea, we
disagree. See, e.g., Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir.
2014) (determining an eleven-step method claim to be directed to an abstract
idea).
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receiving information, analyzing the information, issuing instructions in
view of the analysis, generating additional information, and storing the
information, is analogous to "overrid[ing] the routine and conventional
sequence of events ordinarily triggered by the click of a hyperlink." See id.
Appellants also seek to analogize their claims to those in Enfzsh, LLC
v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016). (Appeal Br. 27-29.)
However, in Enfish, "the focus of the claims [was] on the specific asserted
improvement in computer capabilities (i.e., the self-referential table for a
computer database)." Enfish, 822 F.3d at 1335-36. And "the claims [were]
not simply directed to any form of storing tabular data, but instead [were]
specifically directed to a self-referential table for a computer database," i.e.,
the claims recited a "means for configuring said memory according to a
logical table." Id. at 1336-37. Unlike Enfish, the claims here do "not claim
a particular way of programming or designing the software ... , but instead
merely claim the resulting systems. Essentially, the claims are directed to
certain functionality." Apple, Inc., 842 F.3d at 1241 (citation omitted). For
example, the claims do not specify how workflow instructions are calculated
or how a second sufficient audit is generated. "Indeed, the claim language
here provides only a result-oriented solution, with insufficient detail for how
a computer accomplishes it. Our law demands more." Intellectual Ventures
I LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1342 (Fed. Cir. 2017).
In view of the above, we agree with the Examiner that claim 1 is
directed to an abstract idea.
Step two of the Alice framework has been described "as a search for
an ' "inventive concept" ' -i.e., an element or combination of elements that
is 'sufficient to ensure that the patent in practice amounts to significantly
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more than a patent upon the [ineligible concept] itself."' Alice, 134 S. Ct.
at 2355 (alteration in original) (citing Mayo, 566 U.S. at 72-73).
Appellants argue that "[t]he multiple limitations of the pending claims
are plainly more specific and technical than the three limitations of the
claims recited in DDR Holdings." (Appeal Br. 31.) Specifically, Appellants
argue that "the method of claim 1 requires (1) receiving an audit, (2)
calculating sufficiency of the audit, (3) transmitting the received audit, (4)
generating a dependent audit, ( 5) supplementing the received audit,
( 6) calculating workflow instructions, (7) generating a second sufficient
audit, and (8) persisting the audit." (Id. at 30.)
Nothing in Appellants' description of claim 1 requires a computer
processor. This is in contrast to the claims in DDR Holdings where "the
claimed solution is necessarily rooted in computer technology in order to
overcome a problem specifically arising in the realm of computer networks."
DDR Holdings, 773 F.3d at 1257. To the extent Appellants' claim 1 recites
a computer processor, it is simply in the step of "calculating ... whether the
received audit constitutes a sufficient audit," i.e., it performs the routine
function of analyzing information. See Elec. Power Grp., 830 F.3d at 1355.
Nonetheless, in a Supplemental Brief, filed October 9, 2018,
Appellants argue that "the Examiner made conclusions with respect to
claim 1 that additional elements in that claim were 'well-understood,
routine, and conventional.' Final Office Action at 3, 63 ('well-understood,
routine, and conventional activities previously known to the pertinent
industry')." (Supp. Br. 3--4.) And, Appellants further argue, these
conclusions did not satisfy the Examiner's burden under Berkheimer. (Id.
at 4, citingBerkheimerv. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).)
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Berkheimer recognizes that "[t]he question of whether a claim
element or combination of elements is well-understood, routine and
conventional to a skilled artisan in the relevant field is a question of fact."
Id. at 1368. Berkheimer further recognizes that "[t]he mere fact that
something is disclosed in a piece of prior art, for example, does not mean it
was well-understood, routine, and conventional." Id. at 1369.
Here, the Examiner finds that claim 1 recites
generic computer structure that serves to perform generic
computer functions that are well-understood, routine, and
conventional activities previously known to the pertinent
industry (such as receiving information from electronic clinical
data systems, using a computer processor to perform calculations
and data processing to achieve a solution more quickly,
generating and recording event log data electronically,
transferring information between electronic systems, and storing
data in an electronic database).
(Final Act. 3; see also id. at 63.) However, as discussed above, claim 1
recites a computer processor only for performing the function of analyzing
information, and there can be no question that analyzing information is a
routine and conventional task for a computer processor. See, e.g., Elec.
Power Grp., 830 F.3d at 1355 (the steps of collecting, analyzing and
displaying information, even if limited to a specific content, are
conventional).)
Appellants argue, for the first time in the Supplemental Brief, that
"the Examiner did not refer to the other independent claims (8, 12, and 16,
which were described by Appellant separately, see App. Br. at 12-13.)"
(Supp. Br. 4; see also Appeal Br. 30-31 (also describing claims 1 and 8, but
not presenting separate arguments).) Although claims 8, 12, and 16 are
"described" in the Appeal Brief at pages 12-13, Appellants did not
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separately argue these claims in the Appeal Brief. Appellants also argue, for
the first time in the Supplemental Brief, that "the Examiner did not cite to
anything in dependent claims 3-7, 9-11, 13, 15, and 1 7-21 that is 'well-
understood, routine, and conventional."' (Id.) But these dependent claims
were also not separately argued in the Appeal Brief, e.g., Appellants did not
argue that the Examiner failed to make a determination that particular
limitations of these dependent claims were well-understood, routine and
conventional. "[T]he failure of appellant to separately argue claims which
appellant has grouped together shall constitute a waiver of any argument that
the Board must consider the patentability of any grouped claim separately."
37 C.F.R. § 4I.37(c)(l)(iv).
Appellants seek to analogize claim 1 to Example 35, claim 2, in the
December 2016 "Subject Matter Eligibility Examples: Business Methods"
("Eligibility Examples") supplement to the 2014 Interim Guidance on
Subject Matter Eligibility (2014 IEG). 4 (Reply Br. 12-13.) We disagree.
In discussing Example 35, claim 2, the Eligibility Examples explains
that "the claimed combination of additional elements presents a specific,
discrete implementation of the abstract idea." (Eligibility Examples 10.) As
discussed above, here the claims do "not claim a particular way of
programming or designing the software ... , but instead merely claim the
resulting systems. Essentially, the claims are directed to certain
functionality." Apple, Inc., 842 F.3d at 1241 (citation omitted).
Taking the claim steps separately, the function performed at each step
is purely conventional. Receiving information, analyzing the information,
4 Available at https://www.uspto.gov/sites/default/files/documents/ieg-bus-
meth-exs-dec2016.pdf.
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issuing instructions in view of the analysis, generating additional
information, and storing the information are basic computer functions. See,
e.g., Elec. Power Grp., 830 F.3d at 1355-56. Appellants argue, however,
that the claims "are still patent eligible because the combination of the steps
... 'operates in a non-conventional and non-generic way to ensure that'
disparate clinical data input functionalities may interoperate within a clinical
data system, which did not occur before." (Reply Br. 13.) We do not find
this argument persuasive because although claim 1 recites "disparate clinical
data input functionalities" in its preamble, only a single clinical data input
functionality is required by the claim ("at least one clinical data input
functionality"). Thus, Appellants' argument is not commensurate with the
scope of the claim. Moreover, "[i]t has been clear since Alice that a claimed
invention's use of the ineligible concept to which it is directed cannot supply
the inventive concept that renders the invention 'significantly more' than
that ineligible concept." BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281,
1290 (Fed. Cir. 2018); see also FairWarning, 839 F.3d at 1096-97
("FairWaming contends that its system allowed for the compilation and
combination of ... disparate information sources and that the patented
method 'made it possible to generate a full picture of a user's activity,
identity, frequency of activity, and the like in a computer environment.'
As we have explained, 'merely selecting information, by content or source,
for collection, analysis, and [announcement] does nothing significant to
differentiate a process from ordinary mental processes, whose implicit
exclusion from § 101 undergirds the information-based category of abstract
ideas.' Elec. Power, 830 F.3d at 1355." (internal citation omitted).)
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Appellants also seek to analogize the present claims to those in
Amdocs (Israel) Limited v. Openet Telecom, Inc., 841 F.3d 1288 (Fed. Cir.
2016). (Reply Br. 14--15.) Specifically, Appellants argue that "Appellant's
[sic] claims include receiving and supplementing steps that are similar to the
receiving and correlating steps in the claim in Amdocs." (Id. at 15.)
We disagree. In relevant part, claim 1 of Amdocs recites "computer
code for using the accounting information with which the first network
accounting record is correlated to enhance the first network accounting
record." Amdocs, 841 F.3d at 1299 (emphasis added). In an earlier opinion,
Amdocs (Israel) Limited v. Openet Telecom, Inc., 761 F.3d 1329 (Fed. Cir.
2014) ("Amdocs I''), the court had "construed 'enhance' as meaning 'to
apply a number of field enhancements in a distributed fashion.' [Amdocs
1] at 1340. We took care to note how the district court explained that '[i]n
this context, "distributed" means that the network usage records are
processed close to their sources before being transmitted to a centralized
manager.' [Amdocs 1] at 1338." Amdocs, 841 F.3d at 1300.
In view of the above claim interpretation of the term "enhance," we
do not find Appellants' argument persuasive. Specifically, Appellants do
not explain what limitation( s) in claim 1 correspond to the claim element "to
enhance the first network accounting record," when the term "enhance" is
properly construed.
Appellants also argue that the claims "do not tie up or preempt any
abstract idea" and that "recent Federal Circuit cases have held that claims
that do not preempt an abstract idea are patent eligible." (Reply Br. 13,
citing McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314
(Fed. Cir. 2016).) We disagree.
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"Where a patent's claims are deemed only to disclose patent ineligible
subject matter under the Mayo framework, as they are in this case,
preemption concerns are fully addressed and made moot." Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015).
In other words, "preemption may signal patent ineligible subject matter,
[but] the absence of complete preemption does not demonstrate patent
eligibility." Id.
In view of the above, we agree with the Examiner that claim 1 seeks
to claim patent-ineligible subject matter. Independent claims 8, 12, and 16,
and dependent claims 3-7, 9-11, 13, 15, and 17-21 are not separately
argued in the Appeal or Reply Briefs and fall with representative claim 1.
See 37 C.F.R. § 4I.37(c)(l)(iv).
The§ l 12(a) reiection
With regard to claim 1, the Examiner concludes that
the recited steps of "generating a dependent audit at the second
component, and supplementing the received audit with data
contained in the dependent audit to generate the first sufficient
audit," is not described in the specification that one skilled in the
art would know how to program the disclosed computer to
perform the necessary steps as claimed. The specification does
not describe the algorithm ( e.g. the necessary steps and/or
flowcharts) that perform [sic] the claimed function in sufficient
detail.
One skilled in the art would not know how to program a
computer to perform these steps without knowing how these
steps are actually performed.
(Final Action 4---6.) Applying the same reasoning, the Examiner reaches a
similar conclusion with regard to the claim 1 steps "calculating, at the first
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component, workflow instructions in accordance with which the first
sufficient audit is transmitted to a further component of the clinical data
system and to an audit service" (id. at 6), and "generating at the further
component, a second sufficient audit related to the first sufficient audit" (id.
at 7). In other words, the Examiner concludes that the Specification does not
meet the enablement requirement of§ 112(a).
The test for compliance with the enablement requirement is whether
the Specification, as filed, is sufficiently complete to enable any person
skilled in the art to make and use the claimed invention without undue
experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). When
rejecting a claim for lack of enablement, "the PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the application."
In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993).
Factors to be considered in determining whether a
disclosure would require undue experimentation . . . include (1)
the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, ( 4) the nature of the invention, ( 5) the state
of the prior art, ( 6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth of
the claims.
In re Wands, 858 F.2d at 737. The Examiner does not address the Wands
factors.
With regard to the Examiner's determination that "[t]he specification
does not describe the algorithm (e.g. the necessary steps and/or flowcharts)
that perform [sic] the claimed function" (Final Action 5), we note that
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"normally, writing code for ... software is within the skill of the art, not
requiring undue experimentation, once its functions have been disclosed."
Fonar Corp. v. General Elec. Co., 107 F.3d 1543, 1549 (Fed. Cir. 1997).
"Thus, flow charts or source code listings are not a requirement for
adequately disclosing the functions of software." Id. Here, the Examiner
does not sufficiently explain why a person skilled in the art would have to
engage in undue experimentation to practice the claimed invention.
Therefore, we will reverse the rejection of claim 1 under§ 112(a).
The Examiner relies on similar reasoning in rejecting claims 3-11 and
15-21 under§ 112(a). (See Final Action 8-15.) And for similar reasons, we
will reverse the rejection of those claims under§ 112(a).
The§ l 12(b) reiection
With regard to claim 1, the Examiner concludes that the claim is
indefinite because "[t]he term 'sufficient' is not defined by the claim, the
specification does not provide a standard for ascertaining the requisite
degree, and one of ordinary skill in the art would not be reasonably apprised
of the scope of the invention." (Final Action 16.) And, in view of the
definition of "audit" in paragraph 14 of the Specification ("an audit is a
record of a transaction occurring at one or more of the clinical data input
functionalities or any downstream clinical system or component of clinical
data system 160"), "it is particularly difficult to know what may be meant by
a 'sufficient audit."' (Id.) Independent claims 8 and 12 contain similar
language.
Appellants argue that "[a] 'sufficient audit' for a transaction is one
that includes all of the who, what, when, where, and why of that
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transaction." (Appeal Br. 39. 5) Appellants also argue that "Specification
,r 0026 describes in detail when audits are insufficient and what needs to
make them sufficient (or standardized)." (Id. at 40.)
Thus, an audit may be insufficient if it does not include
correlatable data such as "identifiers of the protocol by which the
clinical data in the audit are received, the clinical study, site(s),
subject(s), and time, dependency or causality stamps" and the
system will supply such data in order to make the audit sufficient
or standardized.
(Id. at 41, quoting Spec. ,r 26.)
Paragraph 26 of the Specification discloses, in relevant part:
In some embodiments of the present invention, the clinical
data input functionalities, such as EDC [ electronic data capture]
110 or activity tracker 112, may not transmit sufficient data to
constitute an audit for use by clinical data system 160. Instead,
the insufficient data, once received by a component of clinical
data system 160, may be viewed as programmatically
supplemented by one or more subsequent, dependent ( described
further with regard to FIGS. 4 and 5 herein) audits, which
dependent audits contain data which is required to constitute an
audit and which is correlatable to the insufficient, received data.
Correlatable data may include identifiers of the protocol by
which the clinical data in the audit are received, the clinical
study, site(s), subject(s), and time, dependency or causality
stamps.
(Spec. ,r 26.)
Paragraph 26 of the Specification refers to "[ c ]orrelatable data
[which] may include identifiers of the protocol by which the clinical data in
the audit are received, the clinical study, site(s), subject(s), and time,
dependency or causality stamps." But it does not disclose that this data, no
5 Appellants provide no citation to the record in direct support of this
proffered definition of the term "sufficient audit." (See Appeal Br. 10.)
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more and/or no less, constitutes a "sufficient audit." It does not disclose that
"[a] 'sufficient audit' ... is one that includes all of the who, what, when,
where, and why of that transaction," as argued by Appellants. (See Appeal
Br. 39.)
The Federal Circuit has stated that
when the USPTO has initially issued a well-grounded rejection
that identifies ways in which language in a claim is ambiguous,
vague, incoherent, opaque, or otherwise unclear in describing
and defining the claimed invention, and thereafter the applicant
fails to provide a satisfactory response, the USPTO can properly
reject the claim as failing to meet the statutory requirements of
§ 112(b).
In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014). In this case, the
Examiner presents a well-grounded rejection identifying why the term
"sufficient audit" is unclear in this context. Appellants' arguments do not
overcome the rejection.
New ground o(reiection: § l 12(b) reiection o(claim 19
Claim 19 depends from independent claim 16. Claim 19 recites, in
relevant part, "wherein the computer processor further calculates the
sufficiency of an audit ... and, if the received audit does not constitute a
sufficient audit, transmits the received audit to a second component .... "
For the reasons discussed above, we find, as with claim 1, that the
term "sufficient audit" is unclear in the context of the claim. Therefore, we
will enter a new ground of rejection of claim 19 under § 112(b ).
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The § 103 reiections
The Examiner finds that Simske discloses "calculating, at the first
component, workflow instructions in accordance with which the first
sufficient audit is transmitted (See page 21, first complete paragraph,
page 15, first complete paragraph, workflows updated based on updates to
database, downstream workflows affected, also see page 12, first complete
paragraph[)] .... " (Final Action 19--20.) Appellants disagree and argue
that Simske does not disclose "generat[ing] workflow instructions that direct
where the first sufficient audit is transmitted." (See Appeal Br. 47--48.)
Simske discloses an information tracking system that "may assist in
creating an accurate provenance record (i.e., history) of a product and/or
document." (Simske 2-3.) By way of example, Simske, in the first
complete paragraph on page 21, discloses that its system
may be used for validation of missing reads in an existing track-
and-trace/provenance through noncontradictory sensor
information. In this example, the information input at
subscribers A, Band Dis obtained for the provenance, but there
is a missed read at subscriber C. Non-subscriber sensor network
information may be used to provide a read at Subscriber C. For
example, data may be retrieved from a news website which
posted surveillance footage of rats in a warehouse of Subscriber
C, and product at issue is shown in the footage. This information
credibly located the product at Subscriber C at the timing
between leaving Subscriber Band arriving at Subscriber D. The
data aggregation thus creates a fully-explicit provenance (i.e., a
complete time stamp) for the product.
(Id. at 21.) Thus, this paragraph, cited by the Examiner, discloses creating a
complete provenance for a product. But even if we consider this complete
provenance to be similar to a sufficient audit, the Examiner does not
sufficiently explain how this discloses "calculating ... workflow
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instructions in accordance with which the first sufficient audit is transmitted
to a further component," as recited in claim 1.
Simske defines the term "workflow" as referring "to an automated
process during which products, documents, information, or tasks are passed
from one participant to another for action or informative purpose, according
to a set of procedural rules." (Id. at 3.) And in the first complete paragraph
on page 15, Simske discloses that when its registry database
is updated, it is to be understood that these updates may also
affect one or more workflows upstream, downstream, and or at
the point at which the database ... is updated (e.g., at the node
where the request entry was submitted, or the triggering event
occurred, or the audit was initiated).
(Id. at 15.) But, again, the Examiner does not sufficiently explain how this
discloses "calculating ... workflow instructions in accordance with which
the first sufficient audit is transmitted to a further component," as recited in
claim 1.
The first complete paragraph on page 12 of Simske discloses:
All of the collected sensor data is transmitted to the
computing device 16, which alone or in conjunction with the
anonymity/obfuscation engine 30 and/or the filter 32 is
configured to process the data and generate output that is directly
transmitted to an originator of a request and/or is used to update
the database 20. In particular, the generated output may be used
to change and/or update one or more fields in the database 20,
thereby altering a workflow currently in the system 18. The
computing device 16 is configured to generate analytics ( e.g.,
which process raw data and generate logical data representations
of the raw data) after performing one or more analyses on the raw
data. The analysis performed will depend, at least in part, upon
the query, triggering event, or external condition that initiated the
data search. The analysis performed may also depend upon the
reputation, reliability, ranking, etc. of the data producer ( e.g.,
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subscriber or nonsubscriber), especially in instances where there
is conflicting data.
(Id. at 12.) This paragraph discloses transmitting all of the collected sensor
data, i.e., an audit from the sensor(s), to the computing device 16, i.e., a
computer processor, and transmitting some output to an originator of a
request. However, the Examiner does not sufficiently explain how this
discloses "calculating ... workflow instructions in accordance with which
the first sufficient audit [i.e., the audit itself,] is transmitted to a further
component."
Independent claims 8, 12, and 16 include similar language and the
Examiner relies on the above disclosures in Simske in rejecting these claims
under§ 103(a). (See Final Action 29--30, 38, 50.) In view of the above, we
will reverse the rejection of independent claims 1, 8, 12, and 16 and
dependent claims 3-7, 9--11, 13, 15, and 17-21 under§ 103(a).
DECISION
The Examiner's rejection of claims 1, 3-13, and 15-21 under
35 U.S.C. § 101 is affirmed.
The Examiner's rejection of claims 1, 3-11, and 15-21 under
35 U.S.C. § 112(a) is reversed.
The Examiner's rejection of claims 1, 3-13, 15, 20, and 21 under
35 U.S.C. § 112(b) is affirmed.
The Examiner's rejections of claims 1, 3-13, and 15-21 under
35 U.S.C. § 103 are reversed.
We enter a new ground of rejection of claim 19 under 35 U.S.C.
§ 112(b).
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This decision contains a new ground of rejection pursuant to 37
C.F.R. § 4I.50(b). Section 4I.50(b) provides that, "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 41.50(b) further provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THIS DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the Examiner, in which event the
proceeding will be remanded to the Examiner.
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record.
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)(l )(iv).
AFFIRMED; 37 C.F.R. § 4I.50(b)
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