Ex Parte Lovett et al

Board of Patent Appeals and Interferences

Feb 23, 2010

10920549 (B.P.A.I. Feb. 23, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte ERIC G. LOVETT, JEFFREY E. STAHMANN, KENT LEE,
QUAN NI, and JESSE W. HARTLEY
____________________

Appeal 2009-003343
Application 10/920,549
Technology Center 3700
____________________

Decided: February 23, 2010
____________________

Before: WILLIAM F. PATE III, JOHN C. KERINS, and STEFAN
STAICOVICI, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
20. App. Br. 3. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2009-003343
Application 10/920,549

2
The claims are directed to a system and method for detecting cardiac
activity and disordered breathing. Claim 1, reproduced below, is illustrative
of the claimed subject matter:
1. A system, comprising:

a lead system configured for subcutaneous, non-
intrathoracic placement relative to a heart of a patient; and

an implantable device, the implantable device comprising
cardiac activity detection circuitry and disordered breathing
detection circuitry, the cardiac activity detection circuitry
coupled to the lead system and configured to detect cardiac
rhythms, and the disordered breathing detection circuitry
coupled to the lead system and configured to detect disordered
breathing.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Cohen US 5,330,505 Jul. 19, 1994
Rissmann
Park
Burnes
Cho
Tehrani
US 2002/0035380 A1
US 2003/0153953 A1
US 2003/0195571 A1
US 2004/0138719 A1
US 2005/0085865 A1
Mar. 21, 2002
Aug. 14, 2003
Oct. 16, 2003
Jul. 15, 2004
Apr. 21, 2005

REJECTIONS
Claims 1, 2, 13-15, and 19 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Rissmann. Ans. 3.
Appeal 2009-003343
Application 10/920,549

3
Claims 1-4, 13-17, 19 and 20 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Burnes and Rissmann. Ans. 4.
Claims 1, 2, 6-9, 11, 14-16, 19 and 20 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Cho and Rissmann. Ans. 8.
Claims 5 and 18 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Burnes, Rissmann, and Park. Ans. 11.
Claim 10 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Rissmann and Cohen. Ans. 12.
Claim 12 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Burnes, Rissmann, and Tehrani. Ans. 12.
The Examiner contends that claims 1-20 are not entitled to the benefit
of the filing date of provisional application 60/504,229 for lack of
descriptive support therein.

ISSUES
Appellants argue the rejection of claims 1, 2, 13-15, and 19 as being
anticipated by Rissmann as a group. App. Br. 9-11. We select claim 1 as
the representative claim, and claims 2, 13-15, and 19 will stand or fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The sole issue raised by Appellants
regarding this rejection is whether the Examiner erred by interpreting
Rissmann’s circuitry for sensing a “lack of respiration” as the claimed
“disordered breathing detection circuitry.” Appellants contend “disordered
breathing” requires breathing, not a lack thereof. App. Br. 9-11; Reply Br 9-
11.
Appellants argue the rejection of claims 1-4, 13-17, 19 and 20 as
being unpatentable over Burnes and Rissmann as a group. App. Br. 12-18;
Appeal 2009-003343
Application 10/920,549

4
Reply Br 11-16. We select claim 1 as the representative claim, and claims
2-4, 13-17, 19 and 20 will stand or fall with claim 1. Appellants contend that
the Examiner erred in rejecting claim 1 as being unpatentable over Burnes
and Rissmann because the Examiner’s proposed combination would render
Burnes inoperable for its intended purpose. App. Br. 12-14. Appellants also
contend that Burnes teaches away from using Rissmann’s non-intrathoracic
electrodes and Rissmann teaches away from using Barnes’ intracardiac
leads. App. Br. 15-16. Appellant additionally contends that neither reference
discloses determining the presence of disordered breathing using
information sensed from a location not proximate the heart, as claimed. App.
Br. 16-17. In light of these contentions, the next issue for our consideration
is whether the Examiner erred in concluding that the subject matter of claim
1 would have been obvious to one having ordinary skill in the art over the
combination of Burnes and Rissmann.
Appellant argues the rejection of claims 1, 2, 6-9, 11, 14-16, 19 and
20 as being unpatentable over Cho and Rissmann as a group. App. Br. 18-
22; Reply Br 16-17. We select claim 1 as the representative claim, and
claims 2, 6-9, 11, 14-16, 19 and 20 will stand or fall with claim 1. Cho
discloses a system and method similar to Burnes’ method. In addressing the
Examiner’s proposed combination of Cho and Rissmann, Appellants repeat
the arguments noted above regarding the Examiner’s proposed combination
of Burnes and Rissmann. We must determine whether the Examiner erred in
concluding the subject matter of claim 1 would have been obvious to one
having ordinary skill in the art over the combination of Cho and Rissmann.
Appeal 2009-003343
Application 10/920,549

5
Regarding the prior-art rejections of claims 5, 10, 12 and 18,
Appellants’ arguments are based solely upon dependency. App. Br. 23-24;
Reply Br 17-18.
Since Appellants do not contend that any rejection would be
overcome if the present application were entitled to the benefit of the filing
date of provisional application 60/504,229, Appellants’ arguments are moot
and are not addressed herein.

FINDINGS OF FACT
1. The Specification identifies apnea as a type of disordered breathing
wherein the patient ceases to breathe. Cessation of breathing related to
apnea may last for a minute or longer. Spec. 3: 24 - 4: 8.
2. The Specification provides that “[d]etection of disordered breathing may
involve comparing one condition or multiple conditions to one or more
thresholds or other indices indicative of disordered breathing.” Spec. 18:
24-26. For Example, “[t]he onset of disordered breathing may be
determined using the impedance signal 530 [sic 500].” Spec. 48: 7-9.
“Detection of sleep apnea and severe sleep apnea is illustrated in figure
5C” wherein “[a] condition of severe sleep apnea is detected when the
non-breathing period 760 exceeds a second predetermined interval . . .
[f]or example . . . about 20 seconds.” Spec. 50: 5-15; Fig. 5C.
3. Rissmann discloses a system for sensing cardiac activity which can
additionally “check for the presence or absence of respiration.” “[T]his
lack of respiration can be used to confirm the QRS findings of cardiac
arrest.” Rissmann further discloses that “[t]he same technique can be
used to provide information about the respiratory rate.” P. 3, para. [0048].
Appeal 2009-003343
Application 10/920,549

6
4. Burnes discloses an implantable medical device (IMD) 100 including
leads 106, 122, 138 extending from a control unit 102 to electrodes 116,
120, 128, 130, 140, 142, which may be routed intracardially. P. 2, para.
[0028] – p. 3, para. [0030]; Fig. 1. Electrical pulses are outputted from
the control unit 102 via the leads 106, 122, 138 to one or more of the
electrodes 116, 120, 128, 130, 140, 142 so that a portion of body tissue,
such as the heart 114, may be stimulated in order to provide cardiac
pacing 616, sleep apnea interruption pulses 612 or both 616. P. 3, para.
[0031]; p. 4, para. [0044] – p. 5, para. [0046]; Fig. 6.
5. Burnes additionally discloses that the control unit may include a sleep
apnea detection device 142 which may be incorporated into the IMD or
can, in the alternative, be incorporated in a wireless unit 144. P. 3, para.
[0034]; Fig. 1.
6. Burnes notes that the specific means 610 by which sleep apnea is
detected and the specific means 604 by which the desirability of cardiac
pacing is determined are not material to the practice of the invention, and
any known means may be employed for detecting these conditions. P. 5,
para [0047]; Fig. 6. Some examples of detecting sleep apnea are by
sensing airflow at the nose or mouth or sensing a heart rate. An example
of determining the desirability of cardiac pacing is by electrocardiogram.
P. 5, para [0047].
7. Cho discloses an IMD 10 capable of delivering a therapy to prevent or
terminate sleep-related disordered breathing (SRDB). IMD 10 is capable
of delivering electrical stimulation therapy to excitable body tissue, via
electrodes 22 and lead 15, to prevent, terminate or reduce the duration or
Appeal 2009-003343
Application 10/920,549

7
occurrence of SRDB. The IMD may also provide cardiac pacing therapy.
P. 3, paras. [0025]-[0026].
8. Cho additionally discloses that IMD 10 is coupled to the heart 11 via a
cardiac lead capable of both sensing the need for, and delivering cardiac
pacing. P. 3, para. [0030]; Fig. 2. Cho recognizes that alternative lead and
electrode systems may be employed. P. 3, para. [0030].
9. Cho teaches that an external system 2A may be employed to collect
respiration data for diagnosis of SRDB. P. 3, para. [0028]. Cho
recognizes that the disordered breathing detection system may also be
incorporated into the IMD. P. 7, para. [0065].

PRINCIPLES OF LAW
A determination of anticipation, as well as obviousness, involves two
steps. First is construing the claim, a question of law, followed by, in the
case of anticipation or obviousness, a comparison of the construed claim to
the prior art. This comparison process involves fact-finding. Key
Pharmaceuticals v. Hercon Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998)
(citations omitted).
The PTO applies to verbiage of the proposed claims the broadest
reasonable meaning of the words in their ordinary usage as they would be
understood by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
the written description contained in applicant’s specification. In re Morris,
127 F.3d 1048, 1054-55 (Fed. Cir. 1997). Reading a claim in light of the
specification, to thereby interpret limitations explicitly recited in the claim,
is a quite different thing from reading limitations of the specification into a
Appeal 2009-003343
Application 10/920,549

8
claim, to thereby narrow the scope of the claim by implicitly adding
disclosed limitations which have no express basis in the claim. In re Prater,
415 F.2d 1393, 1404-05, (CCPA 1969). Although the claims are interpreted
in light of the specification, limitations from the specification are not read
into the claims. In re Van Geuns, 988 F.2d 1181 (Fed. Cir. 1993).
In construing claim terms, the general meanings gleaned from
reference sources, such as dictionaries, must always be
compared against the use of the terms in context, and the
intrinsic record must always be consulted to identify which of
the different possible dictionary meanings is most consistent
with the use of the words by the inventor. “Where there are
several common meanings for a claim term, the patent
disclosure serves to point away from the improper meanings
and toward the proper meanings.”
Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1300 (Fed.
Cir. 2003) (quoting Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d
1243, 1250 (Fed. Cir. 1998)); Ferguson Beauregard/Logic Controls, Div. of
Dover Resources, Inc. v. Mega Systems, LLC, 350 F.3d 1327, 1338-39 (Fed.
Cir. 2003).
While features of an apparatus may be recited either structurally or
functionally, claims directed to an apparatus must be distinguished from the
prior art in terms of structure rather than function. See e.g., In re Schreiber,
128 F.3d at 1477-78.
A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference. Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628,
631 (Fed. Cir. 1987). These elements must be arranged as in the claim under
review but this is not an ipsissimis verbis test. In re Bond 910 F.2d 831, 832
(Fed. Cir. 1990).
Appeal 2009-003343
Application 10/920,549

9
The Examiner bears the initial burden of factually supporting any
prima facie conclusion of obviousness. The key to supporting any prima
facie conclusion of obviousness under 35 U.S.C. § 103 is the clear
articulation of the reason(s) why the claimed invention would have been
obvious. The Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007) noted that the analysis supporting a rejection under 35 U.S.C.
§ 103 should be made explicit. The Federal Circuit has stated that
“rejections on obviousness grounds cannot be sustained by mere conclusory
statements; instead, there must be some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness.” In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR, 550
U.S. at 418.
The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.
KSR, 550 U.S. at 416. A prima facie conclusion of obviousness may be
supported by a showing that the claims are directed to a process, machine,
manufacture, or composition of matter already known in the prior art that is
altered by the mere substitution of one element for another known in the
field, and such modification yields a predictable result. See id. (citing United
States v. Adams, 383 U.S. 39, 40 (1966)). “[I}f a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” KSR, 550
U.S. at 417. When considering obviousness of a combination of known
elements, the operative question is thus “whether the improvement is more
Appeal 2009-003343
Application 10/920,549

10
than the predictable use of prior-art elements according to their established
functions.” Id.
A prior art reference must be considered in its entirety, i.e., as a
whole, including portions that would lead away from the claimed invention.
W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed.
Cir. 1983). If proposed modification would render the prior art invention
being modified unsatisfactory for its intended purpose, then there is no
suggestion or motivation to make the proposed modification. In re Gordon,
733 F.2d 900 (Fed. Cir.1984).

ANALYSIS
The Examiner has reasonably construed the claim term “disordered
breathing detection circuitry” to include the circuitry described by
Rissmann. See Fact 3. The meaning attributed to the term is consistent with
Appellants’ usage of the term in the Specification. As used by Appellants,
“disordered breathing” includes “cessation of breathing” for an
indeterminate period of time. See Fact 1. An inspiration need not be detected
after a period of non-breathing in order to determine that “disordered
breathing” has occurred. See Fact 2. Additionally, even if Appellants’
proposed construction that “disordered breathing” requires breathing, were
adopted, Rissmann’s circuitry, being able to provide information about the
“rate” of respiration, would be capable of detecting “disordered breathing”
wherein breathing has not ceased. See Fact 3. Thus, Appellants have not
established that the Examiner erred by interpreting Rissmann’s circuitry as
the claimed “disordered breathing detection circuitry.”
Appeal 2009-003343
Application 10/920,549

11
Regarding the combination of Burnes and Rissmann, reading Burnes
as a whole, it would have been more appropriate to regard Burnes as
suggesting “adding” detection circuitry such as Rissmann’s, rather than
“substituting” Rissmann’s detection circuitry for the stimulation circuitry of
Burnes, as suggested by the Examiner. Ans. 5; See Facts 5 and 6. Since the
suggestion to use any means for detecting sleep apnea or the desirability of
cardiac pacing is readily apparent from reading Burns, the thrust of the
rejection remains the same; it would have been obvious to one having
ordinary skill in the art to include Rissmann’s detection circuitry in the
Burnes device. Such a modification involves no more than the arrangement
of familiar elements according to their known use in order to predictably
detect cardiac and breathing conditions. This modification would not render
Burnes inoperable for its intended purpose as Appellants suggest. App. Br.
13-15; Reply Br 11-16. To the contrary, Burnes requires some type of
detection circuitry in order to operate properly. Burnes does not regard a
discussion of all possible embodiments of such circuitry as necessary to
practicing Burnes’ invention. See Fact 6.
Essential to a “teaching away” argument is that that the prior art teach
away from the claimed invention. Appellants’ arguments that Burnes teaches
away from placement of stimulating electrodes non-intrathoracicly, as is
done by Rissmann, and that Rissmann teaches away from intracardiac
stimulating electrodes (App. Br. 15-16), do not establish that either
Rissmann or Burnes teaches away from the subject matter of claim 1, which
makes no restrictions on the placement of stimulating electrodes. Contrary to
Appellants’ assertion, Burnes specifically suggests determining the presence
of disordered breathing using information sensed from a location not
Appeal 2009-003343
Application 10/920,549

12
proximate the heart and clearly suggests the capability of using signals
received by electrodes different from those disclosed, which are used solely
for stimulation. Contra App. Br. 16-17; fact 4-6.
Turning to the Examiner’s rejection of claim 1 as being unpatentable
over the combination of Cho and Rissmann, as noted above, Cho possesses
many structural and procedural similarities to Burnes. Cf. Fact 4-6 and 7-9.
Like Burnes, Cho suggests various structures, including non-intrathoracic
ones, that may be employed for detecting the presence of disordered
breathing. Fact 9. Unlike Burnes, Cho provides a specific example wherein
the intracardiac stimulation circuitry is also employed for detecting cardiac
activity. Fact 8. However, again like Burnes, Cho specifically suggests that
alternative lead and electrode systems may be employed. Fact 8. Including
Rissmann’s detection circuitry in Cho involves the predictable use of
familiar elements in order to determine breathing and cardiac conditions. If
Cho’s detection circuitry were omitted, the proposed combination amounts
to substitution of known elements which perform the same function.
Including a non-intrathoracic lead system, such as Rissmann’s, or replacing
Cho’s detection circuitry, in order to detect the need for breathing or cardiac
support would not require removing Cho’s stimulating electrodes and related
circuitry as Appellants suggest. Thus this modification would not render Cho
inoperable for its intended purpose. Contra App. Br. 18-19.
Appellants’ “teaching away” argument regarding the combination of
Cho and Rissmann (App. Br. 20-21) is again directed to features of Cho, the
stimulation circuitry, not appearing in claim 1. Appellants’ argument is
therefore again unpersuasive.
Appeal 2009-003343
Application 10/920,549

13
Appellants’ arguments regarding the rejection of claim 1, as being
anticipated by Rissmann, that are repeated to address the rejections over
Burnes and Rissmann or Cho and Rissmann (App. Br. 16-17, 21-22) remain
unpersuasive for the reasons indicated above. Furthermore, nonobviousness
cannot be established by attacking the references individually when the
rejection is predicated upon a combination of prior art disclosures. See In re
Merck & Co. Inc., 800 F.2d 1091, 1097, (Fed. Cir. 1986). The relevant
inquiry is whether the claimed subject matter would have been obvious to
those of ordinary skill in the art in light of the combined teachings of those
references. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). Combining
the teachings of references does not mandate combination of their specific
structures. In re Nievelt, 482 F.2d 965, 968 (CCPA 1973).

CONCLUSIONS OF LAW
The Examiner did not err by interpreting Rissmann’s circuitry as the
claimed “disordered breathing detection circuitry.” The Examiner did not err
in concluding that the subject matter of claim 1 would have been obvious to
one having ordinary skill in the art over the combination of Burnes and
Rissmann. The Examiner did not err in concluding that the subject matter of
claim 1 would have been obvious to one having ordinary skill in the art over
the combination of Cho and Rissmann.

DECISION
For the above reasons, the Examiner’s rejections of claims 1-20 are
affirmed.
Appeal 2009-003343
Application 10/920,549

14
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)(1)(iv) (2009).

AFFIRMED

Vsh

HOLLINGSWORTH & FUNK
8500 NORMANDALE LAKE BLVD
SUITE 320
MINNEAPOLIS MN 55437