Ex Parte Hess

Patent Trial and Appeal Board

Jan 25, 2017

13886697 (P.T.A.B. Jan. 25, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/886,697 05/03/2013 Michael F. Hess P0022823.USV2 1059
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
HENSON, DEVIN B
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
01/27/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MEDTRONIC, INC. and
MICHAEL F. HESS1
Appeal 2015-003377
Application 13/886,697
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims relating to
measuring impedance in a patient, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Transthoracic impedance measurements give a good indication of the
fluid status of patients. . . . Fluid accumulation can occur, for example,
when the body’s mechanisms for preventing fluid accumulation are affected
1 Appellants identify the Real Party in Interest as Medtronic, Inc. (Br. 2.)
Appeal 2015-003377
Application 13/886,697
by disease, such as heart failure.” (Spec. 1:15—26.) The Specification states
that “devices which track impedance changes in a patient over time . . . use[]
data collected between 12pm and 5pm each day. This standardization is
intended to eliminate postural variability that could confound the trending
algorithm.” (Id. at 2:9-13.)
Claims 1—16 are on appeal. Claims 1 and 9 are the independent
claims and read as follows (emphasis added):
1. A non-transitory computer-readable medium programmed with
instructions for performing a method in an implantable medical device, the
medium comprising instructions for causing a programmable processor to:
measure impedances of a patient in a supine position;
measure impedances of the patient in an upright position; and
generate a diurnal delta corresponding to impedance differences
between the supine and upright positions.
9. A non-transitory computer-readable medium programmed with
instructions for performing a method in an implantable medical device, the
medium comprising instructions for causing a programmable processor to:
measure impedances of a patient in a supine position;
measure impedances of the patient in an upright position; and
generate a diurnal delta impedance value corresponding to impedance
differences between the supine and upright positions.
DISCUSSION
The Examiner has rejected claims 1,2, 5—10, and 13—16 under 35
U.S.C. § 102(b) as anticipated by Hatlestsad.2 (Ans. 2.) The Examiner has
rejected claims 3,4, 11, and 12 under 35 U.S.C. § 103(a) as obvious based
2 U.S. 7,226,422 B2, patented June 5, 2007.
2
Appeal 2015-003377
Application 13/886,697
on Hatlestsad and Siejko.3 (Ans. 5.) The same issue is dispositive for both
rejections.
The Examiner finds that Hatlestsad discloses an implantable medical
device that includes a processor programmed to carry out the functions
recited in claims 1 and 9, including “generat[ing] a diurnal delta (see col. 5,
lines 38-51 and col. 6, line 62-col. 7, line 2) corresponding to impedance
differences between the supine and upright positions (see Figures 3, 4, and 6
and col. 1, lines 54-62, and col. 5, line 38-col. 6, line 28).” (Ans. 3.)
Appellant argues that
[t]he diurnal deltas of Hatlestad [sic] are not differences (deltas)
in impedance as required by the claims. They are differences
(changes) in respiration patterns. Yes, the respiration patterns
are derived from the measured impedances, but there is never any
comparison of measured impedances or any calculation of a
difference between measured impedances.
(Br. 4.)
We agree with Appellant that Hatlestsad does not disclose generating
the “diurnal delta” values recited in the claims, as that term would be read in
light of the Specification. The Specification states that impedance
measurements can be used as an indicator of heart failure (Spec. 1:13—26),
but the presently available devices only use impedance data collected
between noon and 5:00 pm “to eliminate postural variability that could
confound the trending algorithm.” {Id. at 2:9—13.)
The Specification states that the
invention include [s] an algorithm for processing [impedance]
measurements to determine a diurnal delta, e.g., a parallel
3 US 2006/0161070 Al, published July 20, 2006.
3
Appeal 2015-003377
Application 13/886,697
comparison or cross checking of the measurements taken during
the night against the measurements taken during the daytime.
The diurnal delta may then provide a leading indicator of edema
that may be evident only when a patient is in the supine position,
which results in superior predictive value for detecting heart
failure decompensation.
(Id. at 11:23-29.)
The Specification also refers to Figure 6 as showing a “delta 706 or
difference over time between daytime 702 and nighttime 704
measurements.” (Id. at 12:10—16.4) Figure 6 shows a graph of impedance
values over time, where a solid line (702) indicates daytime values, a darker
solid line (704) indicates lower nighttime values, and a series of double­
headed arrows (706) indicates the degree of difference between the two sets
of values.
Based on these descriptions, we conclude that the broadest reasonable
interpretation of “diurnal delta” in light of the Specification is the difference
in impedance values measured during the day (when the patient is upright)
and those measured during the night (when the patient is lying down).
Hatlestsad discloses “detection of congestion by assessing the
patient’s respiratory distress . . . based on a comparison of respiration pattern
before and after the patient becomes recumbent.” (Hatlestsad 1:45—49.)
“[Congestion is indicative of heart failure.” (Id. at 1:19.) “One manner of
detecting the respiratory patterns is through monitoring trans-thoracic
impedance variation . . . during each individual inhale and exhale cycle.”
4 The Specification actually cites Figure 7, but Figure 7 is a flow chart that
does not include the graph discussed on page 12 of the Specification. From
the context, it is clear that Figure 6 is intended.
4
Appeal 2015-003377
Application 13/886,697
(Id. at 3:17—20.) Hatlestsad states that its Figure 4 “shows two illustrative
hypothetical respiration pattem[s]. . . . The rapid and shallow breathing of
the recumbent respiration pattern indicates a patient suffering from
orthopnea, or paroxysmal nocturnal dyspnea (‘PND’) that eventually occurs
upon lying down. The presence of orthopnea or PND such as shown in FIG.
4 is known to be a sign of congestion.” (Id. at 5:40-53.)
Thus, Hatlestsad discloses that impedance measurements can be used
to track respiration patterns, and a change in respiration pattern when a
patient is lying down can be a sign of heart failure. However, Hatlestsad
does not describe tracking impedance itself and determining the difference
in impedance measurements taken during the day versus those taken at
night; i.e., a “diurnal delta,” as that term would be interpreted based on the
Specification. Hatlestsad therefore does not anticipate claims 1 and 9, or
dependent claims 2, 5—8, 10, and 13—16.
The rejection of claims 3,4, 11, and 12 as obvious based on
Hatlestsad and Siejko relies on the Examiner’s finding that Hatlestsad
anticipates the independent claims. We therefore reverse the rejection under
35U.S.C. § 103(a) as well.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
5