Ex Parte Soni et al

Patent Trials and Appeals Board

Mar 21, 2019

12818894 - (D) (P.T.A.B. Mar. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/818,894 06/18/2010 Abhishek S. Soni
67491 7590 03/25/2019
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.
ROP 0044 I2/26679US 8799
EXAMINER
MORGAN, ROBERT W
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
03/25/2019 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 ABHISHEK S. SONI, PAUL J. GALLEY, ALAN GREENBURG,
STEVEN BOUSAMRA, STEFAN WEINERT, and
ERIC DIEBOLD
Appeal 2017-011193
Application 12/818,894 1
Technology Center 3600
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 1-10, 14--28, 30, 32, 33, and 36-38, 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.
Appeal 2017-011193
Application 12/818,894
STATEMENT OF THE CASE
Introduction
The present invention "relate generally to devices collecting
physiological information, and particularly to a system and method
managing the implementation, execution, data collection, and data analysis
of a structured collection procedure running on a portable, hand-held
collection device as well as status reporting of the structured collection
procedure." Spec. ,r 2. Claim 1 is exemplary:
1. A portable, hand-held collection device which addresses a medical
question and improves compliancy with a structured collection procedure,
said device comprising:
a glucose meter configured to perform a blood glucose measurement
on a test strip read by a measurement engine comprising:
the measurement engine for reading the test strip;
a display;
a memory;
a processor connected to the memory and the display;
wherein the glucose meter comprises a housing containing therein the
measurement engine, the display is exhibited on one face of the housing, and
the housing has at one end a port for receiving the test strip; and
program instructions which when executed by the processor cause the
processor to:
initiate a schedule of events of the structured collection procedure
upon one or more entry criteria being met,
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Application 12/818,894
collect patient data for the structured collection procedure by
monitoring blood glucose levels and when entered in response to a request in
accordance with an event provided in the schedule of events after initiation,
store automatically in the memory the collected patient data,
assess automatically whether the collected patient data in response to
the request meets one or more adherence and/or acceptance criteria,
wherein the one or more adherence and/ or acceptance criteria is a
different criteria from the entry criteria, wherein the one or more adherence
and/ or acceptance criteria comprises a defined range of values, and if the
patient data does not fall within the range, the processor is configured to
prompt for additional patient data and automatically extend the events in the
schedule of events if an assessment provided by the processor is that steps
leading up to taking of the patient data were not accomplished;
associate automatically with the stored collected patient data a unique
identifier in the memory if satisfying the one or more adherence and/ or
acceptance criteria,
provide automatically a status report when the one or more adherence
and/or acceptance criteria are not met during the structured collection
procedure, and
end automatically the structured collection procedure upon one or
more exit criteria being met, wherein the exit criteria establishes
requirements which need to be met for exiting or completing the structured
collection procedure such that adequate contextual data is collected to
answer the medical question addressed by the structured collection
procedure and wherein the schedule of events of the structured collection
procedure continues onto a next event by which to collect further patient
data until the requirements for the exit criteria are met;
wherein when executed by the processor, the program instructions
further cause the processor to: check whether the patient data collected in
response to the request which do not meet the one or more adherence criteria
causes an adherence violation, to count the number of adherence violations,
and end automatically the structured collection procedure when the number
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Application 12/818,894
of adherence violations exceeds an acceptable number of adherence
violations for a particular type of violation, wherein the type of violation is
indicated by the processor, which is configured to provide type codes for
what caused the violation, and the processor is configured to provide the
type codes of: a measurement taken before a window, the measurement
taken after the window, the measurement skipped, incorrect amount of a
medication taken, the medication is not taken, and the medication is taken at
an incorrect time; and wherein the processor sets, for each type code, the
number of adherence violations for the automatic ending of the procedure to
address the medical question and improve the compliancy with the
structured collection procedure; and
wherein the glucose meter comprises a microprocessor, a power
source, and an indicator,
the indicator connected to the processor and which operates under the
control of the processor to emit audible, tactile, and/or visual alerts to the
individual of daily times for the blood glucose measurement; and the glucose
meter sends a message to a physician when the individual fails to complete
one of the one or more adherence criteria, wherein a communication link
between a computer of the physician and the blood glucose meter is
established upon connection via a web server.
Rejection2
Claims 1-10, 14--28, 30, 32, 33, and 36-38 stand rejected under
35 U.S.C. § 101 because the claims are directed to patent-ineligible subject
matter. Final Act. 2---6.
2 Throughout this Opinion, we refer to the (1) Final Rejection dated Sept. 9,
2016 ("Final Act."); (2) Appeal Brief dated Feb. 14, 2017 ("App. Br."); (3)
Examiner's Answer dated Apr. 28, 2017 ("Ans."); and (4) Reply Brief dated
June 28, 2017 ("Reply Br.").
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Application 12/818,894
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. v. CLS
Bankint'l, 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,
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.").
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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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
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 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's 2019 REVISED PATENT SUBJECT MATTER ELIGIBILITY
GUIDANCE, 84 Fed. Reg. 50 (Jan. 7, 2019) ("Memorandum"). Under the
guidance set forth in the Memorandum, 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:
(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
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(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 Memorandum at 54--56.
Turning to Memorandum 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. 12-15. 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").
Considering the claims as a whole, we determine each of the claims is
directed to a blood glucose meter configured to measure and monitor
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glucose levels according to adherence criteria and notify a physician when
the adherence criteria are not met ("invented blood glucose meter"). See
claims 1-10, 14--28, 30, 32, 33, and 36-38. Our determination is supported
by the Specification, which describes the shortcomings of prior art and the
resulting need for the invented device. See Spec. ,r,r 5-8.
In light of the Memorandum, because the invented blood glucose
meter 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 Memorandum 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.); see also Thales Visionix Inc. v. United States, 850 F.3d
1343, 1349 (2017) (holding the claims are not directed to an abstract idea
under Alice step one because the "claims specify a particular
configuration of inertial sensors and a particular method of using the
raw data from the sensors in order to more accurately calculate the
position and orientation of an object on a moving platform").
In particular, the invented blood glucose meter is not a mathematical
concept, because it is not a mathematical relationship, mathematical formula
or equation, or mathematical calculation. See Memorandum 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 relations), or (iii) managing personal
behavior or relationships or interactions between people (including social
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activities, teaching, and following rules or instructions). See Memorandum
at 52. In addition, the invented blood glucose meter is not a mental process,
as it is not a concept performed in the human mind (including an
observation, evaluation, judgment, opinion). See Memorandum at 52.
Because the claims are not directed to an abstract idea, we do not
sustain the Examiner's rejection of claims 1-10, 14--28, 30, 32, 33, and 36-
38 under 35 U.S.C. § 101.
DECISION
We reverse the Examiner's decision rejecting claims 1-10, 14--28, 30,
32, 33, and 36-38.
REVERSED
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