Ex Parte Galley et al

Patent Trial and Appeal Board

Mar 23, 2018

13593557 (P.T.A.B. Mar. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/593,557 08/24/2012
98067 7590 03/27/2018
Harness Dickey & Pierce (Roche)
5445 Corporate Drive, Suite 200
Troy, MI 48098-2683
FIRST NAMED INVENTOR
Paul J. Galley
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.
31016 US (15878A-82) 3262
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/27/2018 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):
rmills@hdp.com
pair_roche@firsttofile.com
troymailroom@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL J. GALLEY, ALAN M. GREENBURG,
MARSHALL M. PARKER, JOHN F. PRICE, ROBINS. WAGNER, and
RICHARD W. WILSON
Appeal2017-006310 1
Application 13/593,5572
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
JAMES A. WORTH, Administrative Patent Judges.
WORTH, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
Final Rejection of claims 1-9 and 13-22. Claims 10-12 have been
withdrawn. We have jurisdiction under 35 U.S.C. §§ 134 and 6(b ).
We affirm.
1 Our Decision refers to Appellants' Appeal Brief ("Appeal Br.," filed Aug.
29, 2016) and Reply Brief ("Reply Br.," filed Mar. 9, 2017), and the
Examiner's Final Office Action ("Final Act.," mailed May 4, 2016) and
Answer ("Ans.," mailed Jan. 10, 2017).
2 According to Appellants, the real party in interest is Roche Diabetes Care,
Inc. (Appeal Br. 3).
Appeal2017-006310
Application 13/593,557
Statement of the Case
Background
Appellants' application relates to "diabetes care medical devices used
for diagnostics and therapy, and more particularly to a diabetes management
device incorporating a bolus calculator that determines a maximum allowed
blood glucose level of a patient to compare to a current blood glucose
measurement." Spec. i-f 1.
According to the Specification, "when the current bG [blood glucose]
measurement is less than the target bG value, the allowable amount of bG
value is set equal to the sum of the target bG value and the correction delta
bG value." Id. i-f 11, Fig. 8. "If the bolus calculator 22a determines that the
current bG measurement value is greater than the target bG value, the bolus
calculator sets the currently allowed bG value equal to the maximum
allowed bG value." Id. i-f 86, Fig. 8. The Specification then refers to various
ways of calculating the correction delta bG value depending, inter alia, on
the time elapsed. See, e.g., id. i-fi-115, 27, 78, 92, Fig. 9.
The Claims
Claims 1 and 13 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal:
1. A computer-implemented method for determining an
allowable amount of blood glucose (bG) of a patient, the
allowable amount of blood glucose being used to calculate a
bolus recommendation for a patient, the method comprising:
maintaining a plurality of active advice history records,
each of the plurality of active advice history records having been
generated during a predetermined time period relative to a
current time, and each of the plurality of active advice history
records identifying data relating to one or more bG influencing
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Application 13/593,557
events and including a time corresponding to the one or more bG
influencing events;
receiving, at the one or more processors, a current bG
measurement corresponding to the patient, the current bG
measurement indicating a current bG level of the patient;
determining, at the one or more processors, a target bG
value for the patient, the target bG value corresponding to a
desired bG level for the patient;
determining, at the one or more processors, a correction
delta bG value based on one or more records of the plurality of
active advice history records, the correction delta bG value being
indicative of an aggregated bG lowering effect of the events
defined in the one or more active advice history records on a bG
value of the patient;
determining, at the one or more processors, a correction
meal rise value based on a specific active advice history record
of the plurality of active advice history records, the correction
meal rise value being indicative of an amount the bG level of the
patient can increase with respect to the target bG value without
requiring a correction bolus;
determining, at the one or more processors, a maximum
allowed bG value based on the target bG value, the correction
delta bG value, and the correction meal rise value;
comparing, at the one or more processors, the current bG
measurement to the target bG value;
setting, at the one or more processors, the allowable
amount of bG value equal to the maximum allowed bG value
when the current bG measurement is greater than the target bG
value; and
setting, at the one or more processors, the allowable
amount of bG value using the target bG value and the correction
delta bG value and excluding the correction meal rise value when
the current bG measurement is less than the target bG value.
(Appeal Br. 17-18, Claims App.)
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Application 13/593,557
The Issue
The Examiner rejected claims 1-9 and 13-22 under 35 U.S.C.
§ 101 as lacking patentable subject matter.
The Examiner determines that the claims are directed to an abstract
idea of mathematical relationships, where the mathematical relationships are
determining a target blood glucose value, determining a correction delta
blood glucose value, determining a correction meal rise value, determining a
maximum allowed blood glucose value, and comparing the current blood
glucose measurement to the target blood glucose value. Final Act. 2--4. The
Examiner further determines that the method steps themselves do not
purport to improve the functioning of the computer itself nor do they effect
an improvement in any other technology or technical field. Id. at 4. The
Examiner determines that the claims here maintain history records
(information), receive a measurement (information), determine values based
on the information, and set allowable values. Ans. 3 (citing Electric Power
Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016); FairWarning
IP, LLC v. Iatric Systems, Inc., 839 F.3d 1089 (Fed. Cir. 2016)).
Appellants assert that claim 1 addresses the problem of accurately
recommending an amount of insulin or an amount of carbohydrates to be
ingested by a person with diabetes. Appeal Br. 12. Appellants argue that
the Examiner characterized the invention too broadly and that the claimed
steps are not abstract because they involve more than the mathematical
relationships indicated by the Examiner. See Appeal Br. 12-13; Reply Br.
3--4 (citing Enfzsh, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016));
Reply Br. 4 (citing McRO, Inc. v. Bandai Namco Games America Inc., 837
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F.3d 1299 (Fed. Cir. 2016)). Appellants argue that the Examiner
inappropriately required Appellants to submit evidence to support the
assertion that the claims provide a technological solution. See Appeal Br.
14.
To determine whether a claim is invalid under § 101, we employ the
two-step Alice framework. In step one, we ask whether the claims are
directed to a patent ineligible concept, such as an abstract idea or law of
nature. Alice Corp. Pty. Ltd. v CLS Bank Intl, 134 S. Ct. 2347, 2355 (2014);
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012);
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir.
2015). While method claims are generally eligible subject matter, method
claims that are directed only to abstract ideas and/or natural phenomena are
directed to a patent ineligible concept. Ariosa, 788 F.3d at 1376.
Alice Step One
We have reviewed the Examiner's determinations, and we agree that
claim 1 is directed to the abstract idea of data processing according to
mathematical relationships. The Examiner's determinations are adequately
supported by the intrinsic evidence. Neither the claims nor the Specification
provide any technological improvements to the mechanics of insulin
delivery or blood glucose monitoring. Rather, the claims are directed to the
information-processing steps of "maintaining ... records," "receiving ... [a]
measurement," "determining ... value[s]," and "setting ... [a] value." See
claim 1. We agree with the Examiner that this type of data processing is
abstract, both as a matter of mathematical relationships and data processing.
SmartGene, Inc. v. Advanced Biological Laboratories, SA, 555 Fed. Appx.
950, 955 (Fed. Cir. 2014)(claim directed "the mental steps of comparing
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new and stored information and using rules to identify medical options" was
held to be unpatentable subject matter); Electric Power Group, 830 F.3d at
1353-54 (presenting the results of the collection and analysis without more
are patent ineligible abstract concepts). Comparing blood glucose values
and calculating correction values are the types of comparisons that were held
abstract in SmartGene, and the receiving and processing of data is the type
of routine data processing held abstract in Electric Power Group. See also
Parker v. Flook, 437 U.S. 584, 594 (1978) (method of updating alarm based
on algorithmic calculation held patent ineligible subject matter). Further, the
recited calculations are used to determine a dosage of insulin or
carbohydrates, based in part on natural phenomena, in a similar fashion to
the claims at issue in Mayo, which were directed to optimizing the dosage of
6-thioguanine. See 566 U.S. at 71.
Appellants state that the claims do not recite a basic concept that is
similar to any abstract idea previously identified by the courts and that the
Examiner failed to point to any controlling case law with analogous claims
which were held to be ineligible. Appeal Br. 12. However, the Examiner's
Answer provided citations to case law. See Ans. 3.
Appellants argue that claimed method improves the accuracy of the
bolus recommendation. See Appeal Br. 13; Reply Br. 4. However, this is an
argument that goes to utility rather than abstractness and does not make the
claimed invention less abstract as in Mayo, where, as referred to above,
information for optimizing therapeutic efficiency of 6-thioguanine was also
designed to improve patient care, but was found unpatentable. Mayo, 566
U.S. at 71.
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Alice Step Two
In Alice step two, we examine the elements of the claims to determine
whether they contain an inventive concept sufficient to transform the
claimed naturally occurring phenomena into a patent-eligible application of
the phenomena. Mayo, 566 U.S. at 71-72 (quoting Alice, 134 S. Ct. at
2355). We must consider the elements of the claims both individually and
as an ordered combination to determine whether additional elements
transform the nature of the claims into a patent-eligible concept. Ariosa, 788
F.3d at 1375.
Appellants argue that, as in Diamond v. Diehr, 450 U.S. 175 (1981),
the claims improve a technological area. Appeal Br. 13-14. Appellants
assert by effecting an improvement in the area of diabetes treatment in the
particular way according to the steps recited in the pending claims, the
claims provide a solution to an identified problem and as such are
transformed into patent eligible subject matter. Appeal Br. 13. We are
unpersuaded. In Diehr, the claim at issue was directed to significantly more
than a mathematical formula because it was "drawn to an industrial process
for the molding of rubber products." 450 U.S. at 192. The Examiner
correctly finds that using an analyzer to receive a test strip and determining a
measurement from blood are well-known, routine and conventional in the
diabetes management technology (see, e.g., Spec. i-f 6), and that the claims
do not purport to improve computer technology or other technology areas,
beyond referring to the patent-ineligible subject matter of maintaining
records, receiving measurements, and setting an allowable amount or
displaying a recommended amount, which are extra-solution activities. See
Final Act. 4. We agree that this is patent-ineligible subject matter. Electric
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Power Group, LLC v. Alstom S.A., 830 F.3d at 1353-54 (Fed. Cir. 2016);
see also Mayo, 566 U.S. at 79 ("Purely 'conventional or obvious' '[pre]-
solution activity' is normally not sufficient to transform an unpatentable law
of nature into a patent-eligible application of such a law. Flook, 437 U.S. at
590, 98 S. Ct. 2522; see also Bilski, 561 U.S. at--, 130 S. Ct. at 3230
'[T]he prohibition against patenting abstract ideas "'cannot be circumvented
by" ... adding "insignificant post-solution activity"' (quoting Diehr, supra. at
191-192, 101 S. Ct. 1048))."). Indeed, the Specification provides only
generic and routine computer structures, such as a display (i-f 51 ); a database
(i-f 52); a processing subsystem (id.); memory such as RAM (id. at 52-53);
and a calculator software module (see id. at i154). Nor is there an
improvement in the composition or the handling of insulin itself.
Appellants argue that the Examiner's rejection appears to only
consider the steps individually rather than as an ordered combination.
Appeal Br. 14. To the extent that Appellants contend that the claimed
invention is patentable based on an ordered combination of limitations, this
type of ordered combination has been found to be patent ineligible by
SmartGene, where the comparison of received data according to a rule was
held to be abstract.
As such, we sustain the Examiner's rejection under§ 101 of claim 1.
Claims 2-9 fall with claim 1 because they were not argued separately. 37
C.F.R. § 41.37(c)(l)(iv).
Although Appellants argue the patentability of claims 13 and 21 under
separate headings, Appellants present similar arguments as for the
patentability of independent claim 1. Claims 13 and 21 are directed to a
device with similar requirements as claim 1. We determine that the claimed
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invention is similarly directed to rules-based data processing and does not
purport to provide an improvement in the mechanics of insulin delivery nor
in computer technology.
With respect to claim 21, Appellants argue that "the claims" are
analogous to that for transformation of cardiac signals in Arrhythmia
Research Technology v. Corazonix Corp., 958 F.2d 1053 (Fed. Cir. 1992).
Appeal Br. 15. Claim 21 recites "The device of claim 13 further comprises a
bG analyzer configured to receive a test strip and operates to determine the
current bG measurement from a sample of blood on the the [sic] test strip."
Appeal Br. 26, Claims App. However, a review of the intrinsic evidence,
including the Specification, indicates that claim 21 is not directed to an
improvement in the sensing of blood glucose, but rather is directed to data
processing, as is claim 13, from which it depends. See Electric Power
Group, LLC v. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed. Cir. 2016) (no
particular assertedly inventive technology for performing functions).
Claim 21 is directed to a device, based on its dependency from independent
claim 13, which performs analysis of allowable blood glucose values based
on data gathered from a source. This is analogous to the claims at issue in
Electric Power, which performed an analysis on power grid events based on
data gathered from a source. Id. at 1352. As such, we sustain the
Examiner's rejection under§ 101 of claims 13-22 for similar reasons as
independent claim 1.
DECISION
The Examiner's decision to reject claims 1-9 and 13-22 under 35
U.S.C. § 101 is affirmed.
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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)(l )(iv).
AFFIRMED
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