Ex Parte Stojadinovic et al

Patent Trial and Appeal Board

Aug 29, 2017

13083090 (P.T.A.B. Aug. 29, 2017)

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.
13/083,090 04/08/2011 Alexander Stojadinovic WRAMC 09-04A 11 CON 7407
27370 7590
Cahn & Samuels, LLP
1100 17th St., NW, Ste. 401
Washington, DC 20036
08/29/2017 EXAMINER
SKIBINSKY, ANNA
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
08/29/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEXANDER STOJADINOVIC, ERIC ELSTER,
DOUG K. TADAKI, JOHN S. EBERHARDT, III,
TREVOR BROWN, THOMAS A. DAVIS,
JONATHAN FORSBERG, and JASON HAWKS WORTH1
Appeal 2017-000369
Application 13/083,090
Technology Center 1600
Before JOHN G. NEW, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEW, Administrative Patent Judge.
1 Appellants state that the real party-in-interest is the Government of the
United States. App. Br. 3.
Appeal 2017-000369
Application 13/083,090
DECISION ON APPEAL
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of Appellants’ claims 1—6 and 8—212 as
unpatentable under 35 U.S.C. § 101 as being directed to nonstatutory subject
matter.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to a method for determining a
patient-specific probability of disease by collecting clinical parameters from
a plurality of patients to create a training database. A fully unsupervised
Bayesian Belief Network model is created using data from the training
database; and, the fully unsupervised Bayesian Belief Network is validated.
Clinical parameters are collected from an individual patient; and, such
clinical parameters are input into the fully unsupervised Bayesian Belief
Network model via a graphical user interface. The patient-specific
probability of the healing rate of an acute traumatic wound is output from
the fully unsupervised Bayesian Belief Network model and sent to the
graphical user interface for use by a clinician in pre-operative planning.
Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
2 Claim 7 is canceled. App. Br. 20.
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1. A method for determining a patient-specific probability of
impaired wound healing, said method including:
collecting biomarker levels from a plurality of patients
having known wound healing outcomes to create a training
database, the biomarker levels being collected from at least one
of serum, wound effluent and biopsy tissue, the biomarker levels
including gene expression levels for an IP-10 gene, IL-6 gene,
MCP-1 gene, IL-5 gene, and RANTES gene;
creating a fully unsupervised Bayesian Belief Network
model using data from the training database, said creating of the
fully unsupervised Bayesian Belief Network model including
identifying at least one conditional dependence relationship
between the known wound healing outcomes and the biomarker
levels;
validating the fully unsupervised Bayesian Belief Network
model;
collecting the biomarker levels for an individual patient;
receiving the biomarker levels for the individual patient
into the fully unsupervised Bayesian Belief Network model;
calculating the patient-specific probability of impaired
wound healing with the fully unsupervised Bayesian Belief
Network model by comparing the biomarker levels of the
individual patient to reference biomarker profiles of the plurality
of patients having known would healing outcomes;
outputting the patient-specific probability of impaired
wound healing from the fully unsupervised Bayesian Belief
Network model to a graphical user interface for use by a
clinician;
and updating the fully unsupervised Bayesian Belief
Network model using the biomarker levels for the individual
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patient and the patient-specific probability of impaired wound
healing.
App. Br. 14-15.
ISSUES AND ANALYSES
Except as otherwise indicated herein, we agree with and adopt the
Examiner’s findings of fact and conclusions that the appealed claims are
directed to nonstatutory subject matter. We address the arguments raised by
Appellants below.
Issue
Appellants argue that the Examiner erred because, contrary to the
Examiner’s findings, the claims are not directed towards a judicially-created
exception to 35 U.S.C. § 101 and, even if they were, the claims recite
“additional elements” that amount to significantly more than the judicial
exception and are therefore patentable. App. Br. 8.
Analysis
Appellants argue that the claims are: (1) directed to a method; and (2)
recite “additional elements” that amount to significantly more than the
judicial exception. App. Br. 8. Appellants point to the Supreme Court’s
holding in Alice Corp. Pty. Ltd. v. CLS BankInt’l, 134 S. Ct. 2347 (2014)
that the “additional elements” requirement may be satisfied by an “inventive
concept.” Id. (citing Alice Corp., 134 S. Ct. at 2355).
Appellants argue that claim 1 recites an inventive concept and,
furthermore, that art of record fails to teach such a concept. App. Br. 11. By
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way of example, Appellants assert that the art of record fails to teach
collecting and comparing gene expression levels for an IP-10 gene, IL-6
gene, MCP-1 gene, IL-5 gene, and RANTES gene (biomarker levels) of an
individual patient to reference biomarker profiles of patients having known
wound healing outcomes. Id. Appellants contend that the Examiner
incorrectly finds that the claims ‘“are routine, conventional and well
understood steps and elements.’” Id. (quoting Final Act. 4—5). Appellants
argue that such a conclusory statement is insufficient to support in effect the
taking of official notice that the prior art teaches these elements.
Appellants also argue that the Examiner erred in concluding that the
entire claim does not have to be considered when determining whether it
contains “‘significantly more,’” stating instead that the additional elements
that are to be examined must be outside of, or in addition to, the judicially-
created exception. App. Br. 11 (quoting Adv. Act. 23). Appellants point to
the USPTO’s 2014 Interim Guidance on Patent Subject Matter Eligibility,
which provides that:
[a] claim directed to a judicial exception must be analyzed to
determine whether the elements of the claim, considered both
individually and as an ordered combination, are sufficient to
ensure that the claim as a whole amounts to significantly more
than the exception itself—this has been termed a search for an
inventive concept.
App. Br. 12 (emphases omitted).
We are not persuaded by Appellants’ arguments. Rather, we find that
the facts of this case are directly analogous to those of Mayo Collaborative
Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). In Mayo, the
3 Examiner’s Advisory Action, mailed Sept. 11, 2015 (“Adv. Act.”).
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Supreme Court held that claims applying a natural law describing the
relationships between the concentration in the blood of certain thiopurine
metabolites and the likelihood that the drug dosage will be ineffective or
induce harmful side-effects were directed to nonstatutory subject matter in
violation of 35 U.S.C. § 101. 566 U.S. at 72—73. We conclude that
Appellants’ claims are unpatentable for similar reasons.
In Alice Corp. Pty. Ltd. v. CLS Banklnt’l, the Supreme reiterated the
two-step analysis set forth in Mayo to determine whether the claims at issue
are unpatentable under Section 101. 134 S.Ct. 2347, 2355 (2014). First, we
determine whether the claims are directed to a patent ineleigible concept,
i.e., laws of nature, natural phenomena, and abstract ideas. Alice Corp., 134
S.Ct. at 2355. Next, we consider the elements of each claim both
individually and “as an ordered combination” to determine whether the
additional elements “transform the nature of the claim” into a patent-eligible
application. Id.
We agree with Appellants that the claims on appeal are directed to a
process, i.e., a “method for determining a patient-specific probability of
impaired wound healing.” See claim 1. However, we find that, contrary to
Appellants’ argument, the claims are directed to one of the judicially-created
exceptions: a phenomenon of nature, viz., the relationship between
“biomarker levels including gene expression levels for an IP-10 gene, IL-6
gene, MCP-1 gene, IL-5 gene, and RANTES gene” and the “probability of
impaired wound healing.” See claim 1. We must therefore inquire as to
whether the claims do significantly more than simply describe these natural
relations. Or, as the Supreme Court inquired in Mayo, “do the patent claims
add enough to their statements of the correlations to allow the processes they
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describe to quality as patent-eligible processes that apply natural laws?”
Mayo, 566 U.S. at 77. We conclude that they do not.
Appellants’ claims require collecting data from a number of patients
concerning expression of the several biomarkers and wound healing
outcomes and assembling that information into a graphic probabilistic
inference model, i.e., a Bayesian Belief Network model, a type of model that
Appellants do not dispute was well-known in the contemporary art.4 Claim
1 then requires the person conducting the analysis to “compar[e] the
biomarker levels of the individual patient to reference biomarker profiles of
the plurality of patients having known would healing outcomes” by
“calculating the patient-specific probability of impaired wound healing with
the fully unsupervised Bayesian Belief Network model,” outputting the
determined probability to a “graphical user interface for use by a clinician,”
and subsequently adding the patient’s data to the model. We find these facts
similar to those in Mayo, wherein the Court found “[t]he upshot is that the
[...] steps simply tell doctors to gather data from which they may draw an
inference in light of the correlations.” Mayo, 566 U.S. at 79.
Appellants’ claim 1 instructs clinicians to “calculate] the patient-
specific probability of impaired wound healing with the fully unsupervised
Bayesian Belief Network model” and view the results on “a graphical user
interface.” We do not agree that these routine steps, namely, applying a
well-known probabilistic inference model to data collected regarding
existing patient conditions, comparing the data using the model to obtain
4 See, e.g., K. Murphy, A Brief Introduction to Graphical Models and
Bayesian Networks (1998) available at: https://www.cs.ubc.ca/~murphyk/
Bayes/bnintro.html (last visited August 14, 2017) (“Kelly”).
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calculated probabilities, and displaying the results on a generic graphical
user interface (“GUI,” e.g., a computer monitor), add “significantly more” to
the claims sufficient to overcome the claims’ preemptory use of a law of
nature. We find that use of the Bayesian Belief Network model does no
more than add a calculation step to the claimed process, one that could be
performed by a person of ordinary skill using an ordinary computer or paper
and pencil. See Kelly. Moreover, Appellants’ Specification discloses no
specifically-designed computer, GUI, or algorithms; consequently, we find
that these steps constitute no more than insignificant extra-solution activity.
See In re Bilski, 545 F.3d 943, 963 (Fed. Cir. 2008); see also In re TLI
Comms. LLC Patent Litig., 823 F.3d 607, 614 (Fed. Cir. 2016) (Recital of
generic computer components is insufficient to add an inventive concept to
an otherwise patent-ineligible concept).
We can distinguish the instant appeal from Diamond v. Diehr, 450
U.S. 175 (1981), in which the Supreme Court held that claiming the use of
an abstract idea (i.e., the Arrhenius equation) did not render the claimed
process of curing synthetic rubber unpatentable because, although the
process employed a well-known mathematical equation, the claims did not
seek to pre-empt the use of that equation. Diehr, 450 U.S. at 187.
Appellants’ claims, however, as did those in Mayo, seek to claim a
phenomenon of nature and add only and well-known calculation,
comparison, and display steps to characterize that phenomenon as a
probability. See Mayo, 566 U.S. at 73 (“[T]he steps in the claimed processes
(apart from the natural laws themselves) involve well-understood, routine,
conventional activity previously engaged in by researchers in the field”).
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Consequently, because Appellants’ claims do not add “significantly
more” than the claimed phenomenon of nature other than well-understood,
routine, conventional calculation and display activity, we affirm the
Examiner’s rejection of the claims.
DECISION
The Examiner’s rejection of claims 1—6 and 8—21 as unpatentable
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)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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