Kai Singbartl et al.

Patent Trials and Appeals Board

Aug 7, 2019

13235005 - (D) (P.T.A.B. Aug. 7, 2019)

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.
13/235,005 09/16/2011 Kai Singbartl UPITT-17205 1797
23535 7590 08/07/2019
MEDLEN & CARROLL, LLP
1440 Broadway
SUITE 1010
Oakland, CA 94612
EXAMINER
DILLAHUNT, SANDRA E
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
08/07/2019 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):
cjcollins@medlencarroll.com
docketing@medlencarroll.com
rldalton@medlencarroll.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KAI SINGBARTL and JOHN A. KELLUM JR
____________

Appeal 2019-001964
Application 13/235,0051
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
DEBORAH KATZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 2, 4, 6–10,
and 21–26 (App. Br. 3). Examiner entered a rejection under 35 U.S.C.
§ 101. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellants identify “University of Pittsburgh – Of The Commonwealth Of
Higher Education” as the real party in interest (Appellants’ June 29, 2018
Appeal Brief (App. Br.) 3).
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2
STATEMENT OF THE CASE
Appellants’ disclosure relates “to the field of the prevention and
treatment of kidney disease. The treatment of kidney disease may be
tailored depending upon the need for, or expectation of, long-term dialysis.”
(Spec.2 1: 9–11). Appellants’ only independent claim, claim 1, is
representative and reproduced below:
1. A method for predicting dialysis independence after an acute
renal injury, comprising:
a) initiating renal replacement therapy in a patient having an
acute renal injury, wherein said patient does not have an end
stage renal disease;
b) collecting at least two urine samples from said patient within
fourteen days of said initiating renal replacement therapy;
c) introducing said at least two urine samples into an assay
device that detects a hyaluronic acid value normalized to
urinary creatinine content in said urine sample, wherein said
hyaluronic acid level decreases between an earlier urine sample
hyaluronic acid value and a later urine sample hyaluronic acid
level; and
d) calculating therefrom an area under the curve receiver
operated characteristic (AUC ROC) [determination] patient
value between said earlier and later urine sample hyaluronic
acid levels;
e) correlating said AUC ROC patient value to an AUC ROC
predetermined threshold value to determine a probability of
recovery versus non-recovery for said patient;
f) predicting a recovery of said patient when said probability of
recovery [versus] non-recovery correlates said AUC ROC
patient value is at or above said AUC ROC predetermined
threshold value; and

2 Appellants’ September 16, 2011 Specification.
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g) removing said patient from said renal replacement therapy
under conditions of dialysis independence.
(App. Br. i.)3

Grounds of rejection before this Panel for review:
Claims 1, 2, 4, 6–10, and 21–26 stand rejected under 35 U.S.C. § 101.

ISSUE
Does the preponderance of evidence of record support Examiner’s
finding that Appellants’ claimed invention is directed to patent ineligible
subject matter?
PRINCIPLES OF LAW
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 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. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,

3 Appellants’ claim 1, as reproduced in Appellants’ Appeal Brief includes
edit notations. Appellants’ claim 1 is reproduced, herein, with the
understanding that the edits were entered and alters the text of the claims to
account for misspellings in the claim are reproduced in Appellants’ Appeal
Brief.
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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.”).
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 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1853))); and manufacturing flour (Gottschalk, 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
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attempting to limit the use of the formula to a particular technological
environment.” Id. (citing Gottschalk and Parker); 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.”).
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. (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.
The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50 (January 7, 2019) (“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 MPEP § 2106.05(a)–(c), (e)–(h)).
See 84 Fed. Reg. 54–55. Only if a claim (1) recites a judicial exception and
(2) does not integrate that exception into a practical application, do we then
look 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 84 Fed. Reg. 51.
ANALYSIS
Applying the Revised Guidance to the facts on this record, we find
that Appellants’ claims are directed to patent-eligible subject matter.
The Revised Guidance instructs us first to determine whether any
judicial exception to patent eligibility is recited in the claim. The Revised
Guidance identifies three judicially-excepted groupings identified by the
courts as abstract ideas: (1) mathematical concepts, (2) certain methods of
organizing human behavior such as fundamental economic practices, and (3)
mental processes.
Appellants’ claimed invention includes calculating, correlating, and
predicting steps (d)–(f), which comprise both mathematical concepts and
mental processes under the Revised Guidance. Thus, the claims recite
abstract ideas. See generally, Digitech Image Techs., LLC. v. Elecs. For
Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014) (“Without additional
limitations, a process that employs mathematical algorithms to manipulate
existing information to generate additional information is not patent
eligible”); Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed.
Cir. 2016) (“analyzing information by steps people go through in their
minds, or by mathematical algorithms, without more, [are] essentially
mental processes falling within the abstract idea category”).

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Having determined that Appellants’ claim 1 is recites an abstract idea,
a judicial exception, the Revised Guidance directs us to next consider
whether the claims integrate the judicial exception into a practical
application. On this record, we find that Appellants’ claimed method
includes additional elements sufficient to integrate the judicial exception into
a practical application.
As Appellants’ explain, their
claimed embodiments do establish a specific application of the
judicial exception that is encompassed by the “removing” step
which represents a specific application of a relationship
between hyaluronic acid and renal disease that was based upon
an analysis between AUC ROCs between a threshold value and
a patient value to remove a patient from renal replacement
therapy.
(Reply Br. 6.) Stated differently, the mental process and calculating steps of
Appellants’ claimed invention are applied to a patient undergoing renal
replacement therapy to determine the patient’s probability of renal recovery
and, based on the results of the mental process steps of e) and f) (i.e. the
patient’s probability of recovery is above a predetermined threshold value),
the patient is removed from renal replacement therapy under conditions of
dialysis independence.
As Appellants’ further explain, “one of skill in the art would
understand that [Appellants’] [c]laim 1 steps (f) & (g) operate in conjunction
with each other” and
[i]t is quite clear from the order of the Applicants’ method that
the operation of the “removing” step (g) is predicated on the
execution of the “predicting” step (f) where the correlations of
the patient and threshold “AUC ROC values” are a specific

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application of the judicial exception that results in the removal
of the renal replacement therapy.
(see Reply Br.4 3; see also id. at 6 (Appellants’ “recited reference to ‘dialysis
independence’ is not a condition of renal replacement therapy removal but ‘a
consequence of’ renal replacement therapy removal”)). Therefore, we are
not persuaded by Examiner’s assertion that “[r]emoving a patient from renal
replacement therapy is not an application of the judicial exception because
neither the AUC ROC value nor the prediction are used to make the decision
to remove the patient from renal replacement therapy” (Ans. 15).
Thus, on this record, we agree with Appellants (Reply Br. 5) that their
claims are like those in Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd.,
887 F.3d 1117, 1134-35 (Fed. Cir. 2018). In Vanda, the claims at issue were
not directed to an abstract idea, under Alice step one, because they involved
using the acquired data to direct a treatment program, in contrast to the
claims at issue in Mayo, which involved acquiring patient information, but
did not require any particular use of the acquired information. See id.; see
also Diehr, 450 U.S. at 179 n.5 (the claims in Diehr recited a method for
operating a rubber-molding press including the step of “opening the press
automatically when a said comparison [of calculated cure time vs. elapsed
time] indicates equivalence.” Thus, the recited mathematical equation in
Diehr had the practical application of automatically operating a press).
Similarly, as discussed above, on this record, Appellants’ claims involve the
use of mental process steps to direct a treatment program, which integrates
the judicial exception into a practical application (see Reply Br. 5).

4 Appellants’ January 4, 2019 Reply Brief.
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For the foregoing reasons, we find that Appellants’ claimed invention
is patent eligible.
CONCLUSION
The preponderance of evidence of record fails to support Examiner’s
finding that Appellants’ claimed invention is directed to patent ineligible
subject matter. The rejection of claims 1, 2, 4, 6–10, and 21–26 under 35
U.S.C. § 101 is reversed.

REVERSED