Ex Parte Bhavaraju et al

Patent Trial and Appeal Board

May 31, 2018

13836260 (P.T.A.B. May. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/836,260 03/15/2013
68851 7590 06/04/2018
KNOBBE, MARTENS, OLSON & BEAR, LLP
DEXCOM, INC.
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Naresh C. Bhavaraju
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.
DEXCOM.214A 8398
EXAMINER
MESSERSMITH, ERIC J
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
06/04/2018 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NARESH C. BHA V ARAJU, SEBASTIAN BOHM,
ROBERT J. BOOCK, DAITING RONG, and PETER C. SIMPSON1
Appeal2017-006221
Application 13/836,260
Technology Center 3700
Before DEMETRA J. MILLS, ERIC B. GRIMES, and RY ANH. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method for processing data from a continuous glucose sensor. 2
The Examiner's rejections of claims 1-10, 12-16, and 20-23 under 35
U.S.C. § 102(b) and§ 103(a) are appealed. We have jurisdiction under 35
U.S.C. § 6(b ).
We affirm.
1 The Real Party in Interest is identified as "DexCom, Inc." Appeal Br. 3.
2 We have considered, and herein refer to, the Specification of Mar. 15, 2013
("Spec."); Final Office Action of Dec. 4, 2015 ("Final Action"); Appeal
Brief of Aug. 3, 2016 ("Appeal Br."); Examiner's Answer of Dec. 22, 2016
("Answer"); and Reply Brief of Feb. 21, 2017 ("Reply Br.").
Appeal2017-006221
Application 13/836,260
STATEMENT OF THE CASE
The Specification states:
Electrochemical sensors are useful in chemistry and
medicine to determine the presence or concentration of a
biological analyte. Such sensors are useful, for example, to
monitor glucose in diabetic patients and lactate during critical
care events. A variety of intravascular, transcutaneous and
implantable sensors have been developed for continuously
detecting and quantifying blood glucose values. Many
conventional implantable glucose sensors suffer from
complications within the body and provide only short-term or
less-than-accurate sensing of blood glucose.
Spec. ,r 4.
Independent claim 1, reproduced below, is representative:
1. A method for processing data from a continuous glucose
sensor, the method comprising:
receiving sensor data generated by a continuous glucose
sensor, wherein the sensor data is indicative of a concentration
of glucose in a user;
identifying, using a processor module, a post-implantation
loss of sensitivity of the continuous glucose sensor, wherein
identifying the post-implantation loss of sensitivity comprises
determining a severity of the loss of sensitivity;
processing the sensor data, using the processor module,
responsive to the identification of the loss of sensitivity; and
deactivating continuous glucose sensor system responsive
to the determination of the occurrence of the post-implantation
loss of sensitivity event.
Appeal Br. 14 (Claims App'x).
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Appeal2017-006221
Application 13/836,260
The following rejections are appealed: 3
Claims 1--4, 8, 10, 12-16, 20-21, and 23 stand rejected under 35
U.S.C. § I02(b) as anticipated by Keimel. 4 Final Action 3.
Claim 5 stands rejected under 35 U.S.C. § I03(a) over Keimel and
Willis. 5 Id. at 7.
Claims 6, 7, and 22 stand rejected under 35 U.S.C. § I03(a) over
Keimel and Bohm. 6 Id.
Claim 9 stands rejected under 35 U.S.C. § I03(a) over Keimel and
Brauker. 7 Id. at 8.
DISCUSSION
Only those arguments made by Appellants in the Appeal Brief and
properly presented in the Reply Brief have been considered in this Decision.
Arguments not so presented in the Briefs are waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474
(BP AI 2010) (informative) ("Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived."). Statements
in a brief that "merely mention [a] claim ... and lack any type of separate,
substantive argument concerning the claim" are not sufficient to constitute
3 Claim 3 also stands rejected under 35 U.S.C. § 112, 4th paragraph, as being
of improper dependent form for failing to further limit the subject matter of
the claim ( claim 1) upon which it depends. Appellants indicate that they do
not appeal this rejection; thus, we affirm it. See Appeal Br. 5.
4 US 6,666,821 B2 (issued Dec. 23, 2003) ("Keimel").
5 US 2007/0299617 Al (published Dec. 27, 2007) ("Willis").
6 US 2012/0265035 Al (published Oct. 18, 2012) ("Bohm").
7 US 2007 /0208246 Al (published Sept. 6, 2007) ("Brauker").
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Appeal2017-006221
Application 13/836,260
separate argument regarding that claim under 37 C.F.R. § 4I.37(c)(l)(iv). In
re Kao, 639 F.3d 1057, 1065 (Fed. Cir. 2011).
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prim a f acie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). Regarding obviousness, "[t]he
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results." KSR Int 'l Co.
v. Teleflex Inc., 550 U.S. 398,416 (2007). "[T]he analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ." Id. at 418. "In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
What matters is the objective reach of the claim. If the claim extends to
what is obvious, it is invalid under§ 103." Id. at 419.
The Examiner determined that the appealed claims are anticipated by
Keimel and, regarding claims 5-7, 9, and 22, would have been obvious over
Keimel in combination with one of Willis, Bohm, or Brauker, as
respectively indicated in the Final Action and Answer. Final Action 2-9;
Answer 2-12.
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Appeal2017-006221
Application 13/836,260
Appellants present a single substantive argument for patentability and
argue all claims as a group based on the patentability of claim 1. Appellants
argue Keimel fails to teach the "identifying, using a processor module, a
post-implantation loss of sensitivity of the continuous glucose sensor" claim
1 element ( emphasis added) because Keimel does not discuss "sensitivity,"
and, regarding the obviousness rejections, the combined prior art references
fail to remedy this alleged shortcoming of Keimel. See Appeal Br. 9--12;
Reply Br. 5-11.
The determinative issue here is the interpretation of the claim 1 term
"sensitivity." The Specification illuminates the meaning of this term in the
context of the claims as follows:
The terms "sensitivity" or "sensor sensitivity," as used herein,
are broad terms, and are to be given their ordinary and
customary meaning to a person of ordinary skill in the art ( and
is not to be limited to a special or customized meaning), and
refer without limitation to an amount of signal produced by a
certain concentration of a measured analyte, or a measured
species (such as, for example, H202) associated with the
measured analyte (such as, for example, glucose). For example,
in one embodiment, a sensor has a sensitivity of from about 1 to
about 300 picoAmps of current for every 1 mg/dL of glucose
analyte.
Spec. ,r 122 (emphasis added). We, therefore, in accordance with the
Specification and the ordinary and customary meaning of the claim term,
interpret "sensitivity" broadly so as to refer to an amount of signal produced
by a certain concentration of a measured analyte. Thus, if a given
concentration of glucose or 02 or H202, for example, at a sensor produces a
specific amount of signal, e.g., X picoAmps, at the sensor, if the amount of
signal increases ( e.g., X + 1 picoAmps) or decreases ( e.g., X - 1 picoAmps)
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Appeal2017-006221
Application 13/836,260
while the concentration of glucose or 02 or H202 is constant, that represents
a loss in sensitivity; the sensor can no longer accurately indicate the analyte
concentration by its signal - sensitivity is lost.
Keimel discloses using a processor to determine if a sensor's
performance is degrading/deteriorating/becoming inaccurate. Keimel 1 :37-
39, 4:24---63, 5:38-50, 7:20-27, Figure 7, claims 8, 26. Keimel explains that
one reason for such loss of sensor performance relates to the deterioration of
the catalyst of the sensor needed for the electrochemical reaction at the
sensor that creates an electrical signal in response to the presence of an
analyte. Keimel 4:52-60. Once (or as) this catalyst is lost, sensor sensitivity
to the analyte is lost. Id. Keimel's system detects this loss in sensitivity.
See, e.g., id. at 5:38-50.
Because we are not persuaded by Appellants' arguments that
Keimel' s system does not measure sensitivity loss, as discussed above, we
affirm each of the rejections on appeal. All claims were argued together and
fall with claim 1.
SUMMARY
The rejection under 35 U.S.C. § 112, paragraph four, is affirmed.
The anticipation rejection is affirmed.
The obviousness rejections are each 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)(l )(iv).
AFFIRMED
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