Peter Kotanko et al.

Patent Trials and Appeals Board

May 27, 2021

2021000471 (P.T.A.B. May. 27, 2021)

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.
13/642,364 10/19/2012 Peter Kotanko 8142.0087 1270
121159 7590 05/27/2021
Kacvinsky Daisak Bluni PLLC (BOS)
2601 Weston Parkway, Suite 103
Cary, NC 27513
EXAMINER
WINSTON III, EDWARD B
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
05/27/2021 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):
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER KOTANKO, STEPHAN THIJSSEN,
LEN USVYAT, and NATHAN W. LEVIN
Appeal 2021-000471
Application 13/642,364
Technology Center 3600
Before MURRIEL E. CRAWFORD, HUBERT C. LORIN, and
MICHAEL L. WOODS, Administrative Patent Judges.
CRAWFORD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision to reject claims 6 and 8–10. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Fresenius Medical
Care Holdings, Inc. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The claims are directed to identifying when a patient undergoing
hemodialysis is at increased risk of death by a logistic regression model.
Spec. 2:7–9. Claim 6, reproduced below, is illustrative of the claimed
subject matter:
6. A method of identifying and treating a patient undergoing
periodic hemodialysis treatments at increased risk of death,
comprising:
selecting one or more clinical or biochemical parameters
associated with a probability of death of the patient while the
patient is undergoing periodic hemodialysis treatments, the one
or more clinical or biochemical parameters selected from the
group consisting of serum sodium level, equilibrated normalized
protein catabolic rate (enPCR), eKdrt/V, transferrin saturation
index (TSAT), serum creatinine level, serum bicarbonate level,
sodium gradient during dialysis, erythropoietin (EPO) resistance
index (ERI), and percent change in ferritin level in the previous
six months;
obtaining patient data for the one or more clinical or
biochemical parameters associated with a probability of death of
the patient while the patient is undergoing periodic hemodialysis
treatments;
estimating the probability of death of the patient over a
future time interval based on the patient data by a logistic
regression model including model coefficients, the model
coefficients determined by analyzing data from deceased patients
that were previously undergoing periodic hemodialysis
treatments, the analysis including a longitudinal analysis
backwards in time on the one or more clinical or biochemical
parameters of the deceased patients;
identifying the patient as having an increased risk of death
when the probability of death of the patient is greater than a
predetermined alert threshold probability of death; and
administering a therapeutic intervention to decrease the
patient's risk of death.
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REJECTIONS
The Examiner rejected claims 6 and 8–10 under 35 U.S.C. § 101 as
directed to ineligible subject matter.
The Examiner rejected claims 6 and 8–10 under 35 U.S.C. § 103(a) as
unpatentable over Kotanko (US 2010/0099958 A1, published Apr. 22,
2010), Casscells (US 6,454,707 B1, issued Sept. 24, 2002), and Schreiber
(US 2003/0225162 A1, published Dec. 4, 2003).
OPINION
Rejection under § 101
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.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208,
216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
and Alice. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
we first determine what concept the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
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Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (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 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that “a claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). Having
said that, the Supreme Court also indicated that a claim “seeking patent
protection for that formula in the abstract . . . is not accorded the protection
of our patent laws, . . . and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment.” Id. (citing Benson and Flook); see, e.g., id. at 187 (“It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.”).
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If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). “A
claim that recites an abstract idea must include ‘additional features’ to
ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (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. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (Jan. 7, 2019) (“Guidance”). Under the Guidance, we first look to
whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes); and
(2) additional elements that integrate the judicial exception into
a practical application (see Manual of Patent Examining
Procedure (“MPEP”) § 2106.05(a)–(c), (e)–(h)).
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:
(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.
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See Guidance.
Appellant’s Arguments
The Appellant argues claim 6 is not directed to an abstract mental
process, because the “administration of a therapeutic intervention upon
determination of a patient’s increased risk of death is not a process that can
be performed ‘in the mind,’ as alleged by the Office.” Appeal Br. 5; see
also Reply Br. 2.
In response, the Examiner finds the limitation is broad, and would
encompass a verbal message to a patient. Answer 4 (“[I]f a patient[’]s
probability of dying is decreased based on the patient stopping the use of
drugs, drinking alcohol and/or smoking tobacco, a verbal therapeutic
intervention is/can be the doctor telling the patient he/she needs to stop
doing one of the mentioned acts.”).
The Appellant counters that “communication between a provider and
a patient, [] necessarily involves activity performed outside of the human
mind for one or both actors.” Reply Br. 3.
We are unpersuaded by the Appellant’s arguments.
In support of the “administering” limitation, the Appellant directs us
to page 3, lines 4–7 of the Specification (Appeal Br. 4), which states,
“[i]dentifying the patient as having an increased risk of death is preferably
accomplished within a sufficient lead time to allow for therapeutic
intervention to decrease the patient’s risk of death.” Spec. 3:4–7. This
sentence is repeated at page 6, lines 3–6. The Specification also describes
that “[t]he ability to alert clinic staff and physicians of patients at higher risk
of death is crucial for timely diagnostic and therapeutic interventions.”
Spec. 11:15–16. We find no further discussion of the meaning of
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“administering a therapeutic intervention” in the Specification.2 Therefore,
we agree with the Examiner that this phrase should be construed broadly,
and that could include verbal instructions to a patient. In the context of
§ 101 analysis, this limitation, broadly construed, encompasses a simple
output step, based on the result of “identifying the patient as having an
increased risk of death.” An output step of results are considered an
insignificant extra-solution activity, given no weight. See Bilski, 561 U.S. at
610–11 (“Flook stands for the proposition that the prohibition against
patenting abstract ideas ‘cannot be circumvented by attempting to limit the
use of the formula to a particular technological environment’ or adding
‘insignificant postsolution activity.”’) (Quoting Diehr, 450 U.S. at 191–92).
The Appellant also argues:
the claimed method integrates the selection of clinical or
biochemical parameters, obtainment of patient data, estimation
of a probability of death by a logistic regression model, and
administration of a therapeutic intervention into a specific,
practical application, namely, the identification and treatment of
a patient at increased risk of death, and thus, the claimed method
is not “directed to” an abstract idea.
Appeal Br. 6. Citing Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd.,
887 F.3d 1117, 1134 (Fed. Cir. 2018), and Classen Immunotherapies, Inc. v.
Biogen IDEC, 659 F.3d 1057, 1067–68 (Fed. Cir. 2011), the Appellant
argues the “specific application” of the determined relationships was the key
to the Court finding the claims in Vanda to recite eligible subject matter. Id.

2 The limitation was entered by amendment, filed August 12, 2015. Should
prosecution continue in the case, we suggest the Examiner should determine
if sufficient written description support is present for this limitation in the
original disclosure.
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This is unpersuasive, because in this set of claims, there is no specific
application of the identified risk of death. This is because the Specification
is silent on what one does once this identification is made, other than the
broadly construed “administering” clause, which could be no more than a
verbal or written instruction, unlike the situation in Vanda and Classen. For
example, as noted by the Appellant, in Vanda, the claims call for the
administration of iloperidone. Vanda, 887 F.3d at 1135. In Classen, the
claims included an immunization step. Classen, 659 F.3d at 1067–68.
We are also unpersuaded by the Appellant’s citation to McRO, Inc. v.
Bandai Namco Games Am. Inc., 837 F.3d 1299, 1312–13 (Fed. Cir. 2016),
and argument that, like in McRO, claim 6 recites rules and “provides for a
specific application of the clinical or biochemical parameters and model
recited in the claim.” Appeal Br. 7; see also id. at 8.
In McRO, the court found that, rather than invoking the computer
merely as a tool, “[c]laim 1 of the [asserted] patent is focused on a specific
asserted improvement in computer animation.” McRO, 837 F.3d at 1314.
The court found that the plain focus of the claim was on an improvement to
computer functionality itself, not on economic or other tasks for which a
computer is used in its ordinary capacity. Unlike McRO, which focused on a
specific means or method that improved the relevant technology, as
discussed, claim 6 here is directed to a method of analysis, with an
“administering step” that broadly represents only insignificant extra-solution
activity.
Step 2B Arguments about Inventive Concept
We are unpersuaded by the Appellant’s argument that, under
Berkheimer v. HP, Inc., 881 F.3d 1360, 136 (Fed. Cir. 2018), the Examiner
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has failed to show that the claimed parameters and “estimating” are well-
understood, routine, and conventional, because, according to the Appellant,
the claims are “an unconventional method of identifying and treating a
patient undergoing periodic hemodialysis treatments that is neither well-
understood nor routine in the field.” Appeal Br. 9. The argument fails,
because it is arguing that the entire method, which the Examiner finds is an
abstract mental process, is not well-understood, routine, and conventional.
But the analysis here is whether the “additional elements” transform the
abstract mental process into eligible subject matter. See Guidance at 56.
The Examiner found claim 6, in its entirety, recites an abstract mental
process, and recites no “additional elements” for the Step 2B analysis.3
Therefore, there is no possibility for an “additional element” that “amounts
to significantly more” than the abstract mental process claimed. A novel and
nonobvious claim directed to a purely abstract idea is, nonetheless, patent-
ineligible. See Mayo, 566 U.S. at 90.
For these reasons, we sustain the rejection of claims under § 101.
The Rejection under § 103(a)
In rejecting claim 6, the Examiner finds Kotanko fails to disclose the
step of “the probability of death of the patient over a future time interval
based on the patient data by a logistic regression model.” Final Act. 6. The
Examiner finds Casscells “teaches the multivariate logistic regression
analysis of variables of systolic blood pressure (SBP), creatinine (CR),

3 Actually, the Examiner identified “using a ‘CPU’” as an additional element
in claim 6. Final Act. 2. But, as correctly noted by the Appellant (Appeal
Br. 5), there is no CPU, or any computer, processor, or machine recited in
claim 6.
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leukocyte count (WBC), lymphocyte count (lymph), last temperature (temp,
indicating the last recorded temperature divided categorically into
.gtoreq.97.degree. F. and <97.degree. F.) and diastolic blood pressure
(DBP).” Final Act. 6 (citing Casscells, 5:35–57). The Examiner
additionally finds that this combination does not disclose the “selecting”
limitation, which the Examiner finds in Schreiber. Id. at 7.
We are persuaded by the Appellant’s argument that Casscells, which
is directed to monitoring a patient with congestive heart failure, “does not
supply a teaching to modify the method of Kotanko to include the step of
‘estimating the probability of death of the patient over a future time
interval.’” Appeal Br. 12.
In response, the Examiner repeats the statement from page 6 of the
Final Action. Answer 5.
We thus find no definitive statement by the Examiner about the entire
limitation
estimating the probability of death of the patient over a future
time interval based on the patient data by a logistic regression
model including model coefficients, the model coefficients
determined by analyzing data from deceased patients that were
previously undergoing periodic hemodialysis treatments, the
analysis including a longitudinal analysis backwards in time on
the one or more clinical or biochemical parameters of the
deceased patients.
Specifically, the “logistic regression analysis” is purported to be
shown in Casscells, but we are unclear on where the “estimating the
probability of death of the [dialysis] patient over a future time interval” is
disclosed. Casscells indicates the “strongest predictor of death during the
patient’s hospital stay was the last recorded oral temperature, followed by
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the lymphocyte count,” (Casscells, 5:52–55), but this, along with the
surrounding cited text, does not discuss estimating the probability of death
for a future time interval, because it does not appear to make any prediction.
All words in a claim must be considered in judging the obviousness of
the claimed subject matter. See In re Wilson, 424 F.2d 1382, 1385 (CCPA
1970). Because we do not see how the Examiner has addressed the
“estimating” language in claim 6, we do not sustain the rejection of claims
as obvious.
CONCLUSION
The rejection under § 101 is affirmed, and the rejection under § 103(a)
is reversed.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
6, 8–10 101 6, 8–10
6, 8–10 103(a) Kotanko,
Casscells,
Schreiber
6, 8–10
Overall
Outcome
6, 8–10
RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED