Ex Parte Naley et al

Patent Trial and Appeal Board

Jan 8, 2018

14176955 (P.T.A.B. Jan. 8, 2018)

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.
14/176,955 02/10/2014 Martin NALEY 43963-701.201 6860
21971 7590 01/10/2018
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
PAULSON, SHEETAL R.
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
01/10/2018 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):
patentdocket @ wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN NALEY, ANDREW BIANKIN, and
CHRISTOPHER RICHARD MOLLOY
Appeal 2016-0043681
Application 14/176,9552
Technology Center 3600
Before JOSEPH A. FISCHETTI, MICHAEL C. ASTORINO, and
TARA L. HUTCHINGS, Administrative Patent Judges.
HUTCHINGS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1—16, 21—23, and 30—32. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Our Decision references Appellants’ Appeal Brief (“App. Br.,” filed
Sept. 23, 2015) and Reply Brief (“Reply Br.,” filed Mar. 24, 2016), and the
Examiner’s Subsequent Answer (“Ans.,” mailed Feb. 17, 2016), and Non-
Final Office Action (“Non-Final Act.,” mailed Aug. 19, 2015).
2 Appellants identify Cure Forward Corp., as the real party in interest. App.
Br. 3.
Appeal 2016-004368
Application 14/176,955
CLAIMED INVENTION
Claims 1,13, and 15 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A computer-implemented suite of electronic interfaces
for use by patients and clinical trial administrators on an
electronic molecular-phenotype driven, clinical trial recruitment
platform comprising: a digital processing device comprising an
operating system configured to perform executable instructions
and a memory device; and a computer program including
instructions executable by the digital processing device to create
an application comprising:
a) a software module configured to present an interface for
allowing an individual to post a profile to a secure online
marketplace for a defined duration, for the purpose of being
recruited to clinical trials;
b) a database of profiles, each profile comprising:
i. personal information, the personal information
configured by the individual; and
ii. ii. [sic] a molecular phenotype for the individual,
the molecular phenotype determined by medical
diagnostic testing performed at a qualified facility;
c) a software module configured to execute automated
direct transfer, on demand by the individual or their authorized
healthcare representative, of molecular profiling diagnostic test
results from a first storage at the qualified facility to a second
storage accessible by the application;
d) a software module configured to present an interface for
allowing a clinical trial administrator to establish a search for the
purpose of identifying individuals eligible for enrollment by
entering clinical trial patient inclusion and exclusion criteria
comprising a molecular phenotype;
e) a software module configured to present an interface for
allowing the clinical trial administrator to identify individuals
eligible for the clinical trial, from among active posted profiles,
based on comparison of the individual-posted profiles and the
criteria;
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f) a software module configured to present an interface for
allowing the clinical trial administrator to receive notifications
when new individuals post a profile to the online marketplace
and review profile information for identified individuals;
g) a software module configured to present an interface for
allowing a clinical trial administrator to make clinical trial
enrollment offers to identified individuals, the enrollment offers
comprising an invitation or presentation of opportunity to enroll
in the clinical trial;
h) a software module configured to present offers made to
an individual or their authorized healthcare representative, the
individual the subject of the offers;
i) a software module configured to present an interface for
allowing the individual or the authorized healthcare
representative to select an offer from among the presented offers;
and
j) a software module configured to present an interface for
allowing the clinical trial administrator to monitor clinical trial
enrollment information, the clinical trial enrollment information
comprising: status of open offers of enrollment and individuals
available for enrollment in the clinical trial.
REJECTION3
Claims 1—16, 21—23, and 30-32 are rejected under 35 U.S.C. § 101 as
directed to ineligible subject matter in the form of an abstract idea.
3 The Examiner has withdrawn the rejection of claims 13, 14, and 31 under
35 U.S.C. § 103(a). Ans. 5.
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ANALYSIS
Independent Claims 1, 13, and 15, and Dependent Claims 2, 4—12, 22, 23,
and 30—32
Appellants argue claims 1, 2, 4—13, 15, 22, 23, and 30-32 as a group.
App. Br. 10. We select independent claim 1 as representative. The
remaining claims stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a
“new and useful process, machine, manufacture, or composition of matter.”
35 U.S.C. § 101. The Supreme Court, however, has long interpreted § 101
to include an implicit exception: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. See, e.g., Alice Corp. Pty. Ltd. v. CLS
BankInt7, 134 S. Ct. 2347, 2354 (2014).
The Supreme Court, in Alice, reiterated the two-step framework
previously set forth 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 Corp., 134 S. Ct. at
2355. The first step in that analysis is to “determine whether the claims at
issue are directed to one of those patent-ineligible concepts.” Id. If the
claims are not directed to a patent-ineligible concept, e.g., an abstract idea,
the inquiry ends. Otherwise, the inquiry proceeds to the second step where
the elements of the claims are considered “individually and ‘as an ordered
combination’” to determine whether there are additional elements that
“‘transform the nature of the claim’ into a patent-eligible application.” Id.
(quoting Mayo, 566 U.S. at 78).
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The Court acknowledged in Mayo, that “all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural phenomena,
or abstract ideas.” Mayo, 132 S. Ct. at 1293. We, therefore, look to whether
the claims focus on a specific means or method that improves the relevant
technology or are instead directed to a result or effect that itself is the
abstract idea and merely invoke generic processes and machinery.
See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336 (Fed. Cir. 2016).
Here, in rejecting the pending claims under § 101, the Examiner finds
that “[t]he claims are directed to the abstract idea of clinical trial
recruitment.” Non-Final Act. 2; see also Ans. 4. In the Answer, the
Examiner finds that the abstract idea can be described more specifically as
posting a profile containing personal information and molecular
phenotype for the individual, transferring molecular profiling
diagnostic test results, establishing a search for eligible patients,
presenting eligible patients for a clinical trial, presenting an offer
for enrollment to a clinical trial, allowing administrator to
monitor clinical trial enrollment^]
Ans. 8—9 (emphasis omitted). The Examiner explains that
[cjomparing patient profile information with inclusion/exclusion
criteria for a clinical trial and presenting the offer to enroll in the
clinical trial is similar to the abstract idea identified by the courts
as comparing new and stored information and using rules to
identify options. The abstract idea here is not meaningfully
different from the ideas found to be abstract in other cases before
the Supreme Court.
Id. at 9. The Examiner further finds that the additional elements or
combination of elements amount to no more than mere instructions to
implement the idea on a computer and, thus, do not amount to significantly
more than the abstract idea itself. Non-Final Act. 2; see also Ans. 4.
In other words, the Examiner finds that the claims are similar to
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Supreme Court decisions indicating that section 101 covers
neither “mental processes”—associated with or as part of a
category of “abstract ideas”—nor processes that merely invoke a
computer and its basic functionality for implementing such
mental processes, without even specifying arguably new
physical components or specifying processes defined other than
by the mentally performable steps.
SmartGene, Inc. v. Advanced Biological Labs., SA, 555 Fed. App’x. 950,
954 (Fed. Cir. 2014); see also Gottschalkv. Benson, 409 U.S. 63, 67 (1972)
(converting binary-coded decimal numbers into pure binary “can be
performed mentally” and also “can be carried out in existing computers long
in use”); Parker v. Flook, 437 U.S. 584 (1978) (alarm limit values could be
made using pencil and paper).
Numerous Federal Circuit cases also indicate information gathering
and processing claims are directed to abstract ideas. See, e.g., SmartGene,
555 Fed. App’x at 955 (“[wjhatever the bounderies of the ‘abstract ideas’
category, the claim at issue here involves a mental process excluded from
section 101: the mental steps of comparing new and stored information and
using rules to identify medical options”); Electric Power Grp., LLC v.
Alstom S.A., 830 F.3d 1350, 1353—54 (Fed. Cir. 2016) (“collecting
information, analyzing it, and displaying certain results of the collection and
analysis”); FairWarningIP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1093—
94 (Fed. Cir. 2016) (collecting and analyzing information to detect misuse
and notifying a user when misuse is detected); Accenture Glob. Servs.,
GmbHv. Guidewire Software, Inc., 728 F.3d 1336, 1344 (Fed. Cir. 2013)
(“generating tasks based on rules ... to be completed upon the occurrence of
an event”). Similar to these cases involving patent-ineligible claims,
Appellants’ claims recite, in pertinent part, interfaces for use on a clinical
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trial recruitment platform comprising a plurality of modules configured to
enable the collection, processing, and display of information. As such, we
are not persuaded that the Examiner erred in determining that the claims are
directed to an abstract idea under step one of the Alice!Mayo framework.
Appellants argue that “the claims do not preempt all applications of
recruiting for clinical trials across all fields,” and that “the Interim Eligibility
Guidance requires a Streamlined Eligibility Analysis for ‘a claim that. . .
does not seek to tie up any judicial exception such that others cannot practice
it.’” App. Br. 11 (quoting 2014 Interim Guidance on Patent Subject Matter
Eligibility, 79 Fed. Reg. 74618, 74625 (Dec. 16, 2014) (hereinafter “Interim
Guidance”); see also id. at 11—14 (discussing preemption); Reply Br. 6
(“that the Answer cannot explain how the claimed subject matter preempts
any abstraction across all fields is further evidence that the test was
misapplied”).
Yet, the streamlined analysis set in the 2014 Interim Guidance is an
optional tool for Examiners. See 2014 Interim Guidance on Patent Subject
Matter Eligibility, 79 Fed. Reg. 74618, 74625 (Dec. 16, 2014) (“a
streamlined eligibility analysis can be used” (emphasis added)). Further,
pre-emption is not the test for eligibility under § 101. Ariosa Diagnostics,
Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377 (Fed. Cir. 2015) (“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.”). Here, the Examiner’s decision to
perform a full § 101 analysis is not an error. Likewise, the absence of
complete preemption does not demonstrate patent eligibility. Id. at 1379
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(although “preemption may signal patent ineligible subject matter, the
absence of complete preemption does not demonstrate patent eligibility”).
Appellants assert that the rejection “appears to be based on an
oversimplified and conclusory determination that does not take into account
that the claims are directed to a specific suite of ‘computer-implemented
electronic interfaces for use by patients and clinical trial administrators on an
electronic molecular phenotype-driven, clinical trial recruitment platform.’”
App. Br. 12 (citing DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245,
1257 (Fed. Cir. 2014) (method of presenting a third-party web page)).
Although this statement was made in the context of preemption, to the extent
Appellants additionally argue or suggest that the claims are analogous to
those in DDR Holdings because they present a “third party web page” or
“offer a new paradigm” for the business practice of administering clinical
trials, Appellants misapprehend DDR Holdings. In DDR Holdings the
claims “specified] how interactions with the Internet are manipulated” to
“override[] the routine and conventional sequence of events ordinarily
triggered by the click of a hyperlink.” DDR Holdings, 773 F.3d. at 1258.
No analogous override to conventional Internet or computer technology is
apparent in Appellants’ claims.
Moreover, the Federal Circuit “caution[ed] . . . that not all claims
purporting to address Internet-centric challenges” are patent eligible. Id.
The court distinguished Ultramercial where “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.’” Id. (quoting Ultramercial, Inc. v. Hulu, LLC, 772 F.3d
709, 714 (Fed. Cir. 2014)). In Ultramercial, the Federal Circuit determined
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that the claims were patent-ineligible because they “broadly and generically
claim ‘use of the Internet’ to perform an abstract business practice (with
insignificant added activity).” Likewise, here, the claims broadly and
generically claim the use of software modules to perform the abstract
concept of providing a clinical trial recruitment platform.4
Appellants assert that “in the context of patent eligibility, the opposite
of ‘abstract’ is ‘applied,’ that is, an idea applied to solve a particular problem
in a specific instance.” App. Br. 12 (citing Alice, 134 S. Ct. at 2358 (“These
additional steps, we recently explained [in Mayo, 566 U.S. at 81],
transformed the processes into an inventive application of the formula”)). In
this regard, Appellants describe the problem on the patient side as a lack of
visibility to relevant trials and, similarly, on the clinical trial administrator
side as a lack of visibility to suitable patients. See id. at 13. The claimed
solution
disrupts the exising paradigm by providing a platform
specifically adapted to allow clinical trial administrators to view
pre-qualified patients in a marketplace forum and extend
enrollment offers (i.e., invitations) to individuals, identified as
suitable for their trial by molecular profile, and then allowing
those invited patients to receive, review, and select an enrollment
offer.
Id. at 16.
The portion of Alice cited by Appellants explains that the claims in
Diamond v. Diehr, 101 S. Ct. 1048 (1981), involving a computer-
implemented process for curing ruber, “were patent eligible because they
4 “An abstract idea can generally be described at different levels of
abstraction.” Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed.
Cir. 2016).
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improved an existing technological process, not because they were
implemented on a computer.” Alice, 134 S. Ct. at 2358 (emphasis added).
Here, in contrast, the problem and solution that Appellants describe relates
to a needed improvement to the conventional business practice for
establishing clinical trial enrollment, not an improvement to a technological
process or any technical problem rooted in computer technology. See
Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335—36 (Fed. Cir. 2016)
(“the first step in the Alice inquiry . . . asks whether the focus of the claims is
on the specific asserted improvement in computer capabilities ... or,
instead, on a process that qualifies as an ‘abstract idea’ for which computers
are invoked merely as a tool.”); see also id. at 1335 (“conventional business
practices are often found to be abstract ideas, even if performed on a
computer”) (citing OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359
(Fed. Cir. 2015)).
Appellants contend that their claims “cannot reasonably be
characterized as fundamental or long prevalent,” because they “recite novel
and non-obvious subject matter.” App. Br. 13. Yet, there is no requirement
in Alice or elsewhere for a claimed practice to be fundamental, long-
prevalent, non-novel, and non-obvious for a patent-ineligibility
determination. See Mayo, 566 U.S. at 89-90 (explaining that a novel and
nonobvious claim directed to a purely abstract idea is, nonetheless, patent-
ineligible); see also Diamond v. Diehr, 450 U.S. 175, 188—89 (1981) (“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 categories of possibly patentable subject matter.”).
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Turning to step two, Appellants argue that the claims recite
unconventional steps that confine the claim to a particular useful application.
App. Br. 17 (citing Interim Guidance at 74624). In this regard, Appellants
assert that claim 1 confines the invention “to a particular application wherein
an individual has used a qualified testing facility to generate diagnostic
testing results that include a molecular phoneotype and initiate direct
transfer of the results from the testing facility to the system,” and uses
“specialized interfaces to review and potentially accept an offer,” thereby
“offering] a particular new paradigm for administering clinical trials that
dramatically improves the efficiencies] of traditional methodologies.”
Although the second step in the Mayo/Alice framework is termed a
search for an “inventive concept,” the analysis is not an evaluation of
novelty or non-obviousness, but rather, a search for “an element or
combination of elements that is ‘sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the [patent-
ineligible concept] itself.’” Alice Corp., 134 S. Ct. at 2355. Moreover,
limiting the use of the abstract idea to a particular technological environment
does not make the claims any less abstract. Id. at 2358. Here, the
improvement Appellants promote relates to “traditional methodologies” for
“administering clinical trials.” But this improvement merely further
describes the abstract idea itself and, as such, does not amount to an
inventive concept sufficient to transform the abstract idea into a patent-
eligiblem application.
In the remarks section of the Non-Final Action, the Examiner finds
that
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[limitations that may quality as “significantly more”
include improvements to another technology or technical field,
improvements to the functioning of the computer itself, applying
the judicial exception with, or by use of, a particular machine,
effecting a transformation or reduction of a particular article to a
different state or thing, adding a specific limitation other than
what is well-understood, routine and conventional in the field, or
adding unconventional steps that confine the claim to a particular
useful application, other meaningful limitations beyond
generally linking the use of the judicial exception to a particular
technological environment. The current claims as recited do not
fall under any of the limitations listed above. The claims are
using general computer to carry out general computer functions.
Furthermore, the claims are simply appending well-understood,
routine, and conventional activities previously known to the
industry, specified at a high level of generality.
Non-Final Act. 8. Referring to this portion of the Non-Final Office Action,
Appellants charge that the Examiner “misinterprets and misapplies [step
two] of the Supreme Court’s framework.” App. Br. 18. Particularly,
Appellants first charge that the Examiner’s reference to “another technology
or technical field” implies that the improvement must be to a field other than
that addressed by the claimed subject matter. See id. (quoting Non-Final
Act. 8). Appellants next charge that the Examiner finds that Appellants do
not show how the claims, which include software, improves the computer
itself, but that “the [E]xaminer’s test is not the sole test.'” Id. Appellants
assert that the claimed solution adds “significantly more” than “any abstract
idea of computer-based learning,” because it “generates improvements to the
efficiency of clinical trials, the experience for the people involved, and the
associated outcomes.” Id. Appellants’ arguments are not persuasive of
Examiner error.
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As an initial matter, the Examiner did not find the claims directed to
the abstract idea of “computer-based learning,” but rather “clinical trial
recruitment,” which we slightly revised as providing a clinical trial
recruitment platform and which describes an abstract process of information
gathering and analysis. See Non-Final Act. 2. Further, Appellants do not
persuasively explain what additional elements or combinations of elements
ensure that the patent in practice amounts to significantly more than a patent
upon the abstract idea. Instead, Appellants list alleged improvements
resulting from implementation of the abstract idea itself (e.g., efficiency of
clinical trials, experience for people involved). This is not enough under
step two.
For the first time in the Reply Brief, Appellants assert that the
Examiner does not “identity any actual evidence, such as facts[,] to support
its determination that the claimed subject matter is northing more than an
abstract idea.” Reply Br. 6. Appellants charge that paragraphs 3—6 and 51—
54, and Figures 1 and 8—10 show that the claims “provid[e] a technological
improvement to the implementation of specific tools that improve the
efficiency of clinical tools.” Id. And Appellants assert that the Examiner
has not made a prima facie case for ineligibility under the first step of the
Alice framework. Id. at 7. Putting aside whether Appellants have shown
“good cause” under 37 C.F.R. § 41.41(b)(2) to present this new argument,
we respond as follows.
The USPTO carries its procedural burden when its rejection satisfies
the requirements of 35 U.S.C. § 132 by notifying the applicant of the reasons
for rejection, “together with such information and references as may be
useful in judging of the propriety of continuing the prosecution of [the]
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application.” In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (alterations
in original, quoting 35 U.S.C. § 132). Here, in rejecting the pending claims
under § 101, the Examiner analyzed the claims using the Mayo/Alice two-
step framework. The Examiner, thus, notified Appellants of the reasons for
the rejection “together with such information and references as may be
useful in judging of the propriety of continuing the prosecution of [the]
application.” 35 U.S.C. § 132. In doing so, the Examiner set forth a proper
rejection under § 101.
We have considered in substance each of Appellants’ arguments.
However, we are not persuaded that the Examiner erred in rejecting claim 1
under 35 U.S.C. § 101. Therefore, we sustain the Examiner’s rejection of
claim 1. We also sustain the Examiner’s rejection under § 101 of claims 2,
4—13, 15, 22, 23, and 30-32, which fall with claim 1.
Dependent Claims 3, 14, 16, and 21
Claim 3 depends from independent claim 1, and recites that the
molecular phenotype comprises DNA sequence information, the DNA
sequence information comprising two or more genes and two or more
variants or mutations. Claims 14 and 16 depend from claims 13 and 15,
respectively, and recite similar subject matter. Claim 21 depends from claim
3.
Appellants assert that these claims were determined by the PCT
international searching authority to be “industrially applicable under PCT
Article 33(4).” App. Br. 19. Appellants further argue that the additional
recitation required by claims 3, 14, 16, and 21 is “computer-generated” and
“shared digitally.” Id. Appellants further assert that this additional claim
element “contemplates the facts that. . . molecular phenotype . . . must be
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determined by a specialized molecular profiling diagnostic testing facility
using sophisticated computerized equipment”; “is too voluminous and
complex to be interpreted or understood by the individual directly”; and
“could be corrupted by introduction of even a single error if not shared
digitally and directly.” Id. at 19—20. Yet, claims 3, 14, 16, and 21 merely
further specify the type of information associated with each profile in the
database of profiles, which does not transform the abstract process of
information collection and analysis. See Electric Power Grp., LLC v. Alstom
S.A., 830 F.3d 1350, 1355 (“merely selecting information, by content or
source, for collection, analysis, and display does nothing significant to
differentiate a process from ordinary mental processes, whose implicit
exclusion from§ lOlundergirds the information-based category of abstract
ideas”); see also id. at 1353 (“collecting information, including when limited
to particular content (which does not change its character as information),
[has been treated] as within the realm of abstract ideas”).
In view of the foregoing, we sustain the Examiner’s rejection of
claims 3, 14, 16, and 21 under 35 U.S.C. § 101.
DECISION
The Examiner’s rejection of claims 1—16, 21—23, and 30—32 under
35 U.S.C. § 101 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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