Ex Parte Doyle et al

Patent Trial and Appeal Board

Sep 19, 2018

13166806 (P.T.A.B. Sep. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/166,806 06/22/2011 Francis J. Doyle III
23379 7590 09/21/2018
RICHARD ARON OSMAN
530 Lawrence Expy # 332
Sunnyvale, CA 94085
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.
UCll-802 6686
EXAMINER
ALKAFAWI,EMAN A
ART UNIT PAPER NUMBER
2865
NOTIFICATION DATE DELIVERY MODE
09/21/2018 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):
richard@sci-tech.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANCIS J. DOYLE III, EY AL DAS SAU,
HOWARD ZISSER, and REBECCA A. HARVEY
Appeal2018-001483
Application 13/166,806
Technology Center 2800
Before JEFFREY T. SMITH, N. WHITNEY WILSON, and LILAN REN,
Administrative Patent Judges.
REN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 appeal under 35 U.S.C. § 134(a) from a rejection2 of
claims 36-38 and 56-67. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 The real party in interest is identified as the Regents of the University of
California. Appeal Brief of August 23, 2017 ("App. Br."), 1.
2 Final Office Action of April 6, 2017 ("Final Act."). In this opinion, we
also refer to the Examiner's Answer of October 30, 2017 ("Ans.") and the
Reply Brief of October 31, 2017 ("Reply Br.").
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Application 13/166,806
CLAIMED SUBJECT MATTER
"The invention provides computer-implemented algorithms,
computers programmed with a subject algorithm, and methods and machines
for processing continuous glucose monitoring (COM) data and issuing an
alert or negative feedback signal if hypoglycemia is imminent." Spec. ,r 16.
Claim 36, reproduced below, is illustrative of the claimed subject matter:
36. A low glucose prediction signal generator for processing
continuous glucose monitoring (CGM) data and issuing an alert
if hypoglycemia is imminent, the generator comprising:
(a) a pre-processing module that receives and modulates
the CGM data by reducing noise and adjusting for missed data
points and shifts due to calibration;
(b) a core algorithm module that receives data from the
pre-processing module and calculates a rate of change to make a
hypoglycemia prediction, and determine if hypoglycemia is
imminent; and
( c) an alarm mode module that receives data from the core
algorithm and if hypoglycemia is imminent, issues an audio or
visual alert or warning message, further comprising and
operably-linked to a CGM device and an insulin delivery pump,
the CGM device and insulin delivery pump connected by a
control algorithm using data from the GCM device to determine
the appropriate insulin delivery by the insulin delivery pump,
whereas the signal generator analyzes CGM data and CGM
trends in anticipation of impending hypoglycemia, wherein the
signal generator is controlled in a different way than the insulin
delivery, thereby providing an independent safety layer.
App. Br. 26 (Claims Appendix).
REFERENCES
The prior art references relied upon by the Examiner in rejecting the
claims on appeal are:
Malecha3 US 2009/0105573 Al Apr. 23, 2009
3 The Examiner identifies US 2009/0105573 Al as "Malachi." Final Act. 5.
2
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Application 13/166,806
Kanderian4
Budiman
US 2013/0158503 Al June 20, 2013
US 2014/0180203 Al June 26, 2014
Eyal Dassau et al. ("Dassau"), Detection of a Meal Using Continuous
Glucose Monitoring, Diabetes Care, vol. 31, no. 2, February 2008.
REJECTI0NS 5
Claims 36 and 65 are rejected under pre-AIA 35 U.S.C. I03(a) as
being unpatentable over Malecha in view of Budiman. Final Act. 5.
Claims 37 is rejected under pre-AIA 35 U.S.C. I03(a) as being
unpatentable over Malecha, in view of Budiman, Kanderian, and Dassau.
Final Act. 11.
Claims 38, 56, and 57 are rejected under pre-AIA 35 U.S.C. I03(a) as
being unpatentable over Malecha, in view of Budiman, and Dassau. Final
Act. 15.
Claim 59 is rejected under pre-AIA 35 U.S.C. I03(a) as being
unpatentable over Budiman in view of Malecha. Final Act. 28.
Claim 60 is rejected under pre-AIA 35 U.S.C. I03(a) as being
unpatentable over Budiman, in view of Malecha, Kanderian, and Dassau.
Final Act. 31.
Claim 61 is rejected under pre-AIA 35 U.S.C. I03(a) as being
unpatentable over Budiman and Dassau. Final Act. 36.
The Examiner rejects claims 56-64, 66, and 67 "under 35 U.S.C.
112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for
4 The Examiner and Appellants refer to US 2013/0158503 Al as
"Mandurian." Final Act. 11, App. Br. 4 ..
5 Claims 58, 62---64, 66, and 67 have been canceled. App. Br. 28, 30.
Rejections of these canceled claims are therefore not before us.
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Application 13/166,806
failing to particularly point out and distinctly claim the subject matter which
the inventor or a joint inventor, or for pre-AIA the applicant regards as the
invention." Final Act. 3.
Appellants have not addressed the merits addressing this rejection.
App. Br. generally. Accordingly, because the rejection has not been
withdrawn and the Appellants offer no substantive argument on the merits,
we summarily affirm the rejection. Cf Hyatt v. Dudas, 551 F.3d 1307, 1314
(Fed. Cir. 2008); Ex parte Frye, Appeal No. 2009-006013, 2010 WL
889747, *4 (BPAI 2010) (precedential) ("If an appellant fails to present
arguments on a particular issue - or, more broadly, on a particular rejection
- the Board will not, as a general matter, unilaterally review those
uncontested aspects of the rejection.") ( cited with approval in In re Jung,
637 F.3d 1356, 1365 (Fed. Cir. 2011)).
OPINION
Claim 36
In rejecting independent claim 36, the Examiner finds that Malecha
teaches or suggests a "low glucose prediction signal generator for processing
continuous glucose monitoring (CGM) data and issuing an alert if
hypoglycemia is imminent" which includes "(a) a pre-processing module
that receives and modulates the CGM data by reducing noise and adjusting
for missed data points and shifts due to calibration," "(b) a core algorithm
module that receives data from the pre-processing module and calculates a
rate of change to make a hypoglycemia prediction, and determine if
hypoglycemia is imminent" and "( c) an alarm mode module that receives
data from the core algorithm and if hypoglycemia is imminent, issues an
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audio or visual alert or warning message" as recited in claim 36. See Final
Act. 5-7 (citing various portions of Malecha).
The Examiner finds that other limitations such as "further comprising
and operably-linked to a CGM device and an insulin delivery pump, the
CGM device and insulin delivery pump connected by a control algorithm
using data from the GCM device to determine the appropriate insulin
delivery by the insulin delivery pump" and "wherein the signal generator is
controlled in a different way than the insulin delivery, thereby providing an
independent safety layer" are taught or suggested by Budiman. Id. at 8-9
( citing various portions of Budiman).
Appellants' argument does not specify which limitation that
Appellants contend is missing from the prior art teachings. Ans. 11; see, e.g.
App. Br. 5-12 (describing the prior art system of Malecha and stating,
without identifying the particular limitation at issue or providing a sufficient
explanation as to nonobviousness, that "Malecha's module predicts the users
future glycemic state based on the set of glucose concentration probabilities
(step 180). The probabilities are calculated by inputting a plurality of
glucose concentrations as a function of time, an average predicted glucose
concentration and a merit index into a trained model that outputs a set of
glucose concentration probabilities (step 170). Other than being related to
diabetes care and monitoring, this suggests nothing particularly relevant to
our invention" and that "[t]he cited art is related to our claims only in the
most general sense that it proposes methods for predicting hypoglycemia;
however, the approaches and methods used are conceptually and practically
different from one another. The cited art does not support a prima facie
rejection of our claims"); see, e.g., Reply Br. 1-2 (stating the same).
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Appellants' arguments on appeal are solely directed to Malecha. See,
e.g., App. Br. 5-12. "Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). In this
case, Appellants do not address the Examiner's findings with regard to
Budiman. Compare Final Act. 8-9, with App. Br. 5-12; compare Ans. 5-11
(explaining that the rejection of claim 37 is based on the combined teaching
of Malecha and Budiman), with Reply Br 1-2.
"It is not the function of this court [ or this Board] to examine the
claims in greater detail than argued by an appellant, looking for [patentable]
distinctions over the prior art." In re Baxter Travenol Labs., 952 F.2d 388,
391 (Fed. Cir. 1991). Because Appellants' argument is not based on the
prior art teaching as a whole and because the argument does not identify
reversible error in the Examiner's findings with regard to any particular
limitation recited in claim 36, we sustain the rejection of claim 36.
Claim 65
With regard to the obviousness rejection of claim 65 based on
Malecha and Budiman, Appellants again argue, without addressing the
teaching of Budiman, that "[t]he cited art is related to our claims only in the
most general sense that it proposes methods for predicting hypoglycemia;
however, the approaches and methods used are conceptually and practically
different from one another. The cited art does not support a prima facie
rejection of our claims." App. Br. 13. Appellants' argument does not
specify the claim limitation that Appellants contend are not taught or
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suggested by the combined prior art teaching. Id. The rejection of claim 65
is sustained for the same reason as those set forth for claim 3 6.
Claims 37, 60, & 61
The Examiner rejects claim 37 over Malecha, in view of Budiman,
Kanderian, and Dassau. Final Act. 11. Appellants' argument for claim 3 7 is
again solely directed to Malecha and does not specify the particular
limitation that Appellants contend are not taught or suggested by the
combined prior art teaching. App. Br. 13-15. The rejection of claim 37 is
sustained for the same reason as those set forth for claim 36.
The Examiner rejects claim 60 over Budiman, in view of Malecha,
Kanderian, and Dassau. Final Act. 31. Appellants' argument for claim 60
does not discuss the teachings of Budiman, Malecha, Kanderian, or Dassau.
App. Br. 24. The Examiner rejects claim 61 over Budiman and Dassau.
Final Act. 36. Appellants' argument for claim 61 does not discuss the
teaching of Budiman or Dassau. App. Br. 25. For both claims 60 and 61,
Appellants state, without factual support, that the Examiner's respective
rejection of claims 60 and 61 "mischaracterizes that template as Budiman,
and decorates that template with out-of-context words from Malecha,
Mandurian [Kanderian], and Dassau." App. Br. 24, 25. The rejections of
claims 60 and 61 are sustained for the same reason as those set forth for
claim 36.
Claim 38, 56, & 57
The Examiner rejects claims 38, 56, 57 over Malecha, in view of
Budiman, and Dassau. Final Act. 15. Appellants' argument is again solely
directed to Malecha and does not specify the particular limitation that
Appellants contend are not taught or suggested by the combined prior art
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teaching. App. Br. 15-18. The rejection of claims 38, 56, and 57 is
sustained for the same reason as those set forth for claim 36.
Claim 59
For the rejection of claim 59 over Budiman and Malecha, Appellants
acknowledge that "Budiman describes an integrated insulin delivery system
having safety features to prevent hypoglycemia" as well as "an internal
comparison function, wherein nominal and measured sensor sensitivities are
compared to ensure the sensor is correctly calibrated. Where a calibration
anomaly is detected, the system implements a safety protocol, such as
autocorrect, recalibration or termination." App. Br. 21, 22. Appellants
argue for the nonobviousness of claim 59 without addressing Malecha. Id.
at 19-22. Appellants' argument "[t]he cited art proposes methods for CGM
and insulin delivery with built-in calibration monitoring. We claim nothing
of the kind. The cited art does not support a prima facie rejection of our
claims" does not specify the particular claim limitation that Appellants
contend are not taught or suggested by the combined prior art teaching. Id.
The rejection of claim 59 is sustained for the same reason as those set forth
for claim 36.
DECISION
The Examiner's decision is affirmed.
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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