Ex Parte Bock et al

Patent Trials and Appeals Board

May 1, 2019

13737268 - (D) (P.T.A.B. May. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/737,268 01/09/2013 Alain Bock
67491 7590 05/03/2019
DINSMORE & SHOHL, LLP
FIFTH THIRD CENTER
ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402
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.
26932 US 1/dc 2020
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
05/03/2019 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):
daytonipdocket@dinsmore.com
pair_roche@firsttofile.com
j ackie.pike@roche.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALAIN BOCK, DAVID L. DUKE, and ABHISHEK S. SONI
Appeal2018-004561
Application 13/737,268 1
Technology Center 1600
Before ELENI MANTIS MERCADER, CATHERINE SHIANG, and
LINZY T. McCARTNEY, Administrative Patent Judges.
SHIANG, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
rejection of claims 1, 3-16, and 19-25, which are all the claims pending and
rejected in the application. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify Roche Diabetes Care, Inc. as the real party in interest.
App. Br. 2.
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Application 13/737 ,268
STATEMENT OF THE CASE
Introduction
The present invention relates to regulating blood glucose in diabetic
patients, and in particular relates to delivering insulin to reduce a risk of a
hypoglycemic episode in diabetic patients. See Spec. 1-2. Claim 5 is
exemplary:
5. A method of considering the effect of aerobic exercise on blood
glucose levels for an individual to deliver insulin based on an optimized
insulin injection profile to reduce a risk of a hypoglycemic episode at least
partially due to aerobic exercise, comprising:
generating with a computing device a prediction of future blood
glucose levels for the individual at least partly based on an exercise model,
wherein the exercise model is based on parameters that are independent of
intensity of the aerobic exercise to reduce a complexity of parameters
processed by the computing device to generate the prediction while
including at least one exercise parameter to reduce the risk of the
hypoglycemic episode; and
taking an action with the computing device at least based on the
prediction from the exercise model, wherein said taking the action with the
computing device includes utilizing an automated pancreas for collecting
one or more blood glucose readings of the individual as a parameter of the
exercise model and optimizing an insulin injection profile to prevent the
hypoglycemic episode, performing a corresponding bolus calculation, and
adjusting a bolus delivery to the individual that is based on the optimized
insulin injection profile, wherein the optimized insulin injection profile is
varying over a period of time and is based on the prediction.
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Application 13/737 ,268
Rejection2
Claims 1, 3-16, and 19-25 stand rejected under 35 U.S.C. § 101
because they are directed to patent-ineligible subject matter. Final Act. 2-6.
ANALYSIS 3
35 us.c. § 101
We have reviewed the Examiner's rejection in light of Appellants'
contentions and the evidence of record. We concur with Appellants'
contention that the Examiner erred in this case.
Section 101 of the Patent Act provides "[ w ]hoever 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. 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. Pty.
Ltd. v. CLS Bank Int'!, 573 U.S. 208,216 (2014) (internal quotation marks
and citation omitted).
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,
2 Throughout this opinion, we refer to the ( 1) Final Office Action dated
March 10, 2017 ("Final Act."); (2) Appeal Brief dated September 21, 2017
("App. Br."); (3) Examiner's Answer dated February 23, 2018 ("Ans."); and
(4) Reply Brief dated March 26, 2018 ("Reply Br.").
3 Appellants raise additional arguments. Because the identified issue is
dispositive of the appeal, we do not need to reach the additional arguments.
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Application 13/737 ,268
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. Kappas, 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 (Gottschalkv. 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
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Application 13/737 ,268
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.").
If the claim is "directed to" an abstract idea, we tum 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 ( citation 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 (Jan. 7, 2019) ("Guidance"). Under the
guidance set forth in 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) (Step 2A, Prong 1 ); 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)) (9th Ed., Rev.
08.2017, 2018) (Step 2A, Prong 2).
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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Application 13/737 ,268
(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. (Step 2B.)
See Guidance, 84 Fed. Reg. at 54--56.
Turning to Guidance Step 2A, Prong 1 (Alice step one), we agree with
Appellants that the Examiner has failed to identify a patent-ineligible
abstract idea. See App. Br. 10-13. The Federal Circuit explains the
"directed to" inquiry looks at the claims' "character as a whole," and is not
simply asking whether the claims involve a patent-ineligible concept:
The "directed to" inquiry [ ] cannot simply ask whether the
claims involve a patent-ineligible concept, because essentially
every routinely patent-eligible claim involving physical
products and actions involves a law of nature and/or natural
phenomenon-after all, they take place in the physical world.
See Mayo, 132 S.Ct. at 1293 ("For all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural
phenomena, or abstract ideas."). Rather, the "directed to"
inquiry applies a stage-one filter to claims, considered in light
of the specification, based on whether "their character as a
whole is directed to excluded subject matter."
Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016); see
also Diehr, 450 U.S. at 188 ("In determining the eligibility of respondents'
claimed process for patent protection under § 101, their claims must be
considered as a whole."); McRO, Inc. v. Bandai Namco Games Am. Inc., 837
F.3d 1299, 1314 (Fed. Cir. 2016) (the question is whether the claims as a
whole "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").
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Considering the claims as a whole, we determine each of claims 5-16
and 19-25 is directed to a method of predicting glucose levels and based on
the prediction, using insulin injection to reduce the risk of a hypoglycemic
episode ("invented treatment method"); and each of claims 1, 3, 4 is directed
to a system of predicting glucose levels and based on the prediction, using
insulin injection to reduce the risk of a hypoglycemic episode ("invented
treatment system"). Our determination is supported by the Specification,
which describes the shortcomings of prior art treatment models and the
resulting need for the invented treatment model. See Spec. 1--4.
In light of the Guidance, because the invented treatment method ( or
system) is not a mathematical concept, an identified method of organizing
human activity, or a mental process, we conclude the claims are not directed
to an abstract idea. See Guidance, 84 Fed. Reg. at 52; id. at 53 ("Claims that
do not recite matter that falls within these enumerated groupings of abstract
ideas should not be treated as reciting abstract ideas, except" in rare
circumstances.); Vanda Pharmaceuticals Inc. v. West-Ward
Pharmaceuticals, 887 F.3d 1117, 1135 (Fed. Cir. 2018) (holding "claims ...
directed to a method of using iloperidone to treat schizophrenia" are patent
eligible).
In particular, the invented treatment method ( or system) is not a
mathematical concept, because it is not a mathematical relationship,
mathematical formula or equation, or mathematical calculation. See
Guidance, 84 Fed. Reg. at 52. Further, it is not an identified method of
organizing human activity, as it is not (i) a fundamental economic principle
or practice (including hedging, insurance, mitigating risk), (ii) a commercial
or legal interaction (including agreements in the form of contracts; legal
obligations; advertising, marketing or sales activities or behaviors; business
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Application 13/737 ,268
relations), or (iii) managing personal behavior or relationships or
interactions between people (including social activities, teaching, and
following rules or instructions). See Guidance, 84 Fed. Reg. at 52. In
addition, the invented treatment method ( or system) is not a mental process,
as it is not a concept performed in the human mind (including an
observation, evaluation, judgment, opinion). See Guidance, 84 Fed. Reg. at
52.
Because claims 1, 3-16 and 19-25 are not directed to an abstract idea,
we do not sustain the Examiner's rejection of claims 1, 3-16 and 19-25
under 35 U.S.C. § 101.
DECISION
We reverse the Examiner's decision rejecting claims 1, 3-16, and 19-
25.
REVERSED
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