Ex Parte Wagner et al

Patent Trials and Appeals Board

Jun 28, 2019

12710430 - (D) (P.T.A.B. Jun. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/710,430 02/23/2010 Robin Wagner
67491 7590 07/02/2019
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 0046 PA/WP 26286 8709
us
EXAMINER
MESSERSMITH, ERIC J
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
07/02/2019 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 ROBIN WAGNER, STEFAN WEINERT, REMMERT LAAN,
KURT WAECHTER, and CHRISTEN REES
Appeal 2018-000116
Application 12/710,430 1
Technology Center 3700
Before STEPHEN C. SIU, ELENI MANTIS MERCADER, and
CATHERINE SHIANG, 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 1-5, 7-12, 14--20, and 22-23, which are all the claims
pending and rejected in the application. We have jurisdiction under 35
U.S.C. § 6(b ).
We affirm.
1 Appellants identify Roche Diabetes Care, Inc. as the real party in interest.
App. Br. 2.
Appeal 2018-000116
Application 12/710,430
STATEMENT OF THE CASE
Introduction
The present invention relates to "a blood glucose meter for providing
therapeutic guidelines to a person having diabetes." Spec. ,r 7. In particular,
"the present disclosure provide methods and systems for determining
whether a person's blood glucose level falls within the desired range and, if
not, for providing therapeutic guidelines to the person, based on the
measured blood glucose levels." Spec. ,r 4. Claim 16 is exemplary:
16. A blood glucose meter which provides on a display
therapeutic guidelines automatically to a person having
diabetes, the blood glucose meter comprising a processor, a
memory, the display readable by the person, and a measuring
element, wherein:
the measuring element is configured to measure the
blood glucose (bG) level of the person according to operating
parameters determined for measuring bG levels on which to
base the therapeutic guidelines, wherein the operating
parameters include a starting date for measuring bG levels, an
end date for measuring bG levels, a number of daily bG level
measurements, and a plurality of daily events, wherein the
starting date and end date are determined so that measuring bG
levels is performed over at least two days, the number of daily
measurements is determined to be at least one, and at least one
daily event is determined;
the processor is in electrical communication with the
measuring element such that the processor is configured to read
the bG level of the person measured by the measuring element;
the processor is in electrical communication with the
memory such that the processor is configured to record the
measured bG levels in the memory;
the memory stores one or more predetermined bG ranges,
such that the processor is configured to read the one or more
predetermined bG ranges and the recorded bG levels, determine
whether the recorded bG levels are below, within, or above the
one or more predetermined bG ranges, and determine whether
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the recorded bG levels are below or above the one or more
predetermined bG ranges by at least a bG excursion amount,
wherein a bG level is defined as:
a hypoglycemia bG level if below the one or more
predetermined bG ranges but by an amount that is less
than the bG excursion amount,
a severe hypoglycemia bG level if below the one
or more predetermined bG ranges by at least the bG
excursion amount,
a hyperglycemia bG level if above the one or more
predetermined bG ranges but by an amount that is less
than the bG excursion amount, and
a severe hyperglycemia bG level if above the one
or more predetermined bG ranges by at least the bG
excursion amount,
wherein the processor determines automatically whether
a pattern of hypoglycemia or hyperglycemia before or after a
same or similar daily event exists when two or more of the
recorded bG levels are below or above, respectively, the one or
more predetermined bG ranges but by an amount that is less
than the bG excursion amount, and whether a pattern of severe
hypoglycemia or severe hyperglycemia before or after a same
or similar daily event exists when two or more of the recorded
bG levels are below or above, respectively, the one or more
predetermined bG ranges by at least the bG excursion amount;
and
upon the processor determining before the end date and
based on at least two or more recorded bG levels for the same
daily event that one of the patterns has occurred, the processor
is in electrical communication with the display such that the
processor is configured to transmit the therapeutic guidelines to
the display, wherein the therapeutic guidelines are based on
whether the recorded bG levels are below, within, or above the
one or more predetermined bG ranges and further based on
whether the recorded bG levels are below or above the one or
more predetermined bG ranges by at least the bG excursion
amount, wherein the therapeutic guidelines comprise one or
more of frequency information correlating recorded bG levels
to the one or more daily events and summary information
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Application 12/710,430
providing a synopsis of recorded bG levels, and further
comprise at least one of information relating to medication and
a proposed action relating to activity level, food consumption,
medication timing or doses, illness, change in disease status and
stress, said therapeutic guidelines for facilitating the person to
keep bG levels within the one or more predetermined bG
ranges,
automatically report whether the recorded bG levels
below the one or more predetermined bG ranges exhibit the
pattern of hypoglycemia before or after the same or similar
daily event,
automatically report whether the recorded bG levels
below the one or more predetermined bG ranges exhibit the
pattern of severe hypoglycemia before or after the same or
similar daily event,
automatically report whether the recorded bG levels
above the one or more predetermined bG ranges exhibit the
pattern of hyperglycemia before or after the same or similar
daily event, and
automatically report whether the recorded bG levels
above the one or more predetermined bG ranges exhibit the
pattern of severe hyperglycemia before or after the same or
similar daily event.
References and Rejections2
Claims 1-5, 7-12, 14--20, and 22-23 are rejected under 35 U.S.C.
§ 101 because they are directed to patent-ineligible subject matter. Final
Act. 2-6.
Claims 1-5, 7-12, 14--20, and 22-23 are rejected under pre-AIA 35
U.S.C. § 103(a) as being unpatentable over Ray (US 2009/0240127 Al;
published Sept. 24, 2009), Bortz (US 2003/0216628 Al; published Nov. 20,
2 Throughout this opinion, we refer to the (1) Final Office Action dated Sept.
8, 2016 ("Final Act."); (2) Appeal Brief dated Mar. 15, 2017("App. Br.");
(3) Examiner's Answer dated Aug. 7, 2017("Ans."); and (4) Reply Brief
dated Oct. 4, 2017 ("Reply Br.").
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Application 12/710,430
2003), Blomquist (US 2008/0300534 Al; published Dec. 4, 2008), and
Brauker (US 2005/0203360 Al; published Sept. 15, 2005). Final Act. 6-12.
ANALYSIS
35 u.s.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,
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
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Application 12/710,430
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
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
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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, 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 p ATENT 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 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. 11-21; Reply Br. 2-14. 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."
Enfish, 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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Application 12/710,430
Considering the claims as a whole, we determine claim 16 is directed
to a blood glucose meter that measures blood glucose levels according to
operating parameters, records the blood glucose levels, determines whether
the recorded blood glucose levels are below, within, or above predetermined
blood glucose ranges to identify whether a pattern of hypoglycemia, severe
hypoglycemia, hyperglycemia or severe hyperglycemia has occurred, and
automatically provides the appropriate therapeutic guidelines if one of such
patterns has occurred ("invented blood glucose meter"). See claim 16. Our
determination is supported by the Specification, which describes the need to
improve the existing blood glucose meters, and the resulting invented
device. See Spec. ,r,r 1-7.
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 claim 16 is 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,
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Application 12/710,430
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
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.
Therefore, claim 16 is not directed to an abstract idea. For similar
reasons discussed above, each of claims 1-5, 7-12, 14, 15, 17-20, and 22-
23 recites similar functions or processes, and is not directed to an abstract
idea.
Accordingly, we do not sustain the Examiner's rejection of claims 1-
5, 7-12, 14--20, and 22-23 under 35 U.S.C. § 101.
35 u.s.c. § 1033
On this record, the Examiner did not err in rejecting the claims.
We disagree with Appellants' arguments. To the extent consistent
with our analysis below, we adopt the Examiner's findings and conclusions
in (i) the action from which this appeal is taken (Final Act. 6-12) and (ii) the
Answer (Ans. 13-17).
3 To the extent Appellants advance new arguments in the Reply Brief
without showing good cause, Appellants have waived such arguments. See
37 C.F.R. § 41.41(b)(2).
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I
Appellants argue Ray alone does not teach all of the claim limitations
of the independent claims. See App. Br. 22-26, 29-30. In particular,
Appellants describe the deficiencies of Ray acknowledged by the Examiner.
See App. Br. 22-26, 29-30.
Appellants' arguments are unpersuasive. Because the Examiner relies
on the combination of Ray, Bortz, Blomquist, and Brauker to teach the
independent claims, Appellants cannot establish nonobviousness by
attacking Ray individually. See In re Merck & Co., 800 F.2d 1091, 1097
(Fed. Cir. 1986); Final Act. 6-11.
Similarly, Appellants' arguments that "Bortz does not teach automatic
pattern determinations of severe hyperglycemia and severe hypoglycemia
before or after a same or similar daily event, with a starting date and an end
date that are determined so that measuring bG levels is performed over at
least two days and before the end date to determine a pattern" (App. Br. 27;
see also Reply Br. 16-17); "Blomquist does not disclose or suggest upon a
computing device/processor determining before an end date and based on at
least two or more recorded bG levels for the same daily event that one of the
patterns has occurred, automatically providing therapeutic guidelines to a
person" (App. Br. 28); "Brauker does not disclose or suggest automatically
providing, by a computing device, therapeutic guidelines to a person based
on an automatic determination of a pattern by the computing device from
measured blood glucose of the person" (App. Br. 28); and "[n]one of the
cited references of Bortz, Blomquist, or Branker remedy the deficiencies of
Ray and do not disclose or suggest [certain limitations]" (App. Br. 30) are
unpersuasive. Because the Examiner relies on the combination of Ray,
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Bortz, Blomquist, and Brauker to teach the disputed limitations, Appellants
cannot establish nonobviousness by attacking a reference individually. See
Merck, 800 F .2d at 1097; Final Act. 6-11.
II
Appellants contend
Ray ( as well as none of the other cited references alone or in
combination) does not describe at least that measuring bG
levels is performed over at least two days and determining
automatically whether a pattern of hypoglycemia or
hyperglycemia before or after a same or similar daily event
exists when two or more of the recorded bG levels are below or
above, respectively, the one or more predetermined bG ranges
as recited in the present independent claims.
App. Br. 23; see also Reply Br. 15-16. In particular, Appellants argue
Ray does not describe at least that measuring bG levels is
performed over at least two days, and Ray is silent regarding
determining automatically whether a pattern of hypoglycemia
or hyperglycemia before or after a same or similar daily event
exists over that at least two day period as recited in the present
claims.
App. Br. 24; see also Reply Br. 15-16.
Appellants have not persuaded us of error. Appellants acknowledge
Bortz ... describes ... the steps of obtaining a plurality of
blood glucose readings taken within a predetermined time
category and time period" and ... [t]he date range in which to
take the readings, which is the data range over which the
readings to be analyzed are taken, include a Begin Date and
End Date that may be set to cover any time period ( a default
period is 30 days). Bortz, paragraph [0025].
App. Br. 26.
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Therefore, Bortz' s disclosure of "a Begin Date and End Date may be
set to cover any time period. The default time period may be 30 days"
(Bortz ,r 25) teaches the claimed "at leave two days."
Further, Ray teaches:
In particular, a hypoglycemic pattern by time slot sub-routine
120 may be used to determine if there is a high incidence of
hypoglycemia occurring at a particular recurring time interval
i. In one embodiment, the time interval may recur daily and be
equal to about one eighth of a day. The eight daily time slots
may include before breaifast, after breaifast, before lunch,
after lunch, before dinner, after dinner, bedtime, and overnight,
which can be pre-defined by default management settings or
customized by the user.
Ray ,r 69 ( emphases added).
Therefore, Ray teaches determining whether a pattern of
hypoglycemia exists before or after a same or similar daily event, such as
breakfast. As a result, Ray teaches determining whether a pattern of
hypoglycemia or hyperglycemia "before or after a same or similar daily
event exists," as required by the independent claims.
III
Appellants contend:
Brau[]ker ... does not disclose or suggest a computing device
determining before an end date that one of the patterns has
occurred and automatically providing by a computing
device/processor therapeutic guidelines to a person as recited
in the present independent claims.
App. Br. 29 ( emphasis added); see also Reply Br. 17-18. In particular,
Appellants argue "[t]he person provided with the chart/information of
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Brau[]ker is relied upon to form their own decision and guidance from the
chart/information." App. Br. 29; see also Reply Br. 17-18.
Appellants have not persuaded us of error. Brauker explains:
In some embodiments, the dynamic and intelligent estimation
of the preferred embodiments determines a possibility of the
patient avoiding clinical risk, based on the analyte
concentration, the rate of change, and other aspects of the
dynamic and intelligent estimative algorithms of the preferred
embodiments. If there is minimal or no possibility of avoiding
the clinical risk, a clinical risk alarm will be triggered.
However, if there is a possibility of avoiding the clinical risk,
the system can wait a predetermined amount of time and re-
analyze the possibility of avoiding the clinical risk. In some
embodiments, when there is a possibility of avoiding the
clinical risk, the system will further provide targets, therapy
recommendations, or other information that can aid the patient
in proactively avoiding the clinical risk.
Brauker ,r 335 (emphases added).
Therefore, Brauker teaches "automatically providing, by the
computing device, therapeutic guidelines to the person," as required by
claims 1 and 8. 4 Appellants' response that
such therapy recommendations are still not the automatically provided
therapeutic guidelines as recited in the present claims that are based
on whether the recorded bG levels are below, within, or above the one
or more predetermined bG ranges and comprise at least one of
information relating to medication and a proposed action to facilitate
the person to keep bG levels within the one or more predetermine bG
ranges.
(Reply Br. 18) is unpersuasive. Because the Examiner relies on Ray and
Brauker collectively to teach those limitations, Appellants cannot establish
4 Contrary to Appellants' assertion (App. Br. 29), claim 16 does not recite
such a limitation.
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nonobviousness by attacking Brauker individually. See Merck, 800 F .2d at
1097; Final Act. 8-9. 5
Because Appellants have not persuaded us the Examiner erred, we
sustain the Examiner's rejection of independent claims 1, 8, and 16.
We also sustain the Examiner's rejection of corresponding dependent
claims 2-5, 7, 9-12, 14, 15, 17-20, and 22-23, as Appellants do not advance
separate substantive arguments about those claims.
DECISION
We reverse the Examiner's decision rejecting claims 1-5, 7-12, 14--
20, and 22-23 35 U.S.C. § 101.
We affirm the Examiner's decision rejecting claims 1-5, 7-12, 14--20,
and 22-23 under 35 U.S.C. § 103.
Because we affirm at least one ground of rejection with respect to
each claim on appeal, we affirm the Examiner's decision rejecting claims 1-
5, 7-12, 14--20, and 22-23. See 37 C.F.R. § 4I.50(a)(l).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). See 37
C.F.R. § 41.50(±).
5 Appellants also argue "Blomquist does not describe such an automatic
determination of therapeutic guidelines as recited in the present claims but
rather presents a recommended user action from table entries" (App. Br. 27;
see also Reply Br. 17). Appellants' argument is not commensurate with the
scope of the claims, as Appellants have not shown the claims recite "an
automatic determination of therapeutic guidelines." In any event, as
discussed above, because Brauker teaches "automatically providing, by the
computing device, therapeutic guidelines to the person," Blomquist does not
need to separately teach that limitation.
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AFFIRMED
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