Cardiac Pacemakers, Inc.

Patent Trials and Appeals Board

Jul 1, 2020

15879139 - (D) (P.T.A.B. Jul. 1, 2020)

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.
15/879,139 01/24/2018 Imad Libbus 279.A44US7 7234
45458 7590 07/01/2020
SCHWEGMAN LUNDBERG & WOESSNER/BSC
PO BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
07/01/2020 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):
SLW@blackhillsip.com
uspto@slwip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte IMAD LIBBUS, KRZYSZTOF Z. SIEJKO,
MARINA V. BROCKWAY, and ROBERT J. SWEENEY

Appeal 2019-006321
Application 15/879,139
Technology Center 3700
____________

Before DANIEL S. SONG, STEFAN STAICOVICI, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant, Cardiac Pacemakers, Inc.,1 appeals under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 2–21. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies itself as the sole real party in interest. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification
The Specification “relates generally to medical devices and, more
particularly, to systems, devices and methods for managing heart failure
using neural stimulation.” Spec. 1:21–23
The Claims
Claims 2–21 are rejected. Final Act. 1. No other claims are pending.
Id. Claims 2, 18, and 20 are independent. Appeal Br. 27–30. Claim 2 is
illustrative and reproduced below.
2. A method, comprising:
delivering a heart failure (HF) therapy including
electrical stimulation;
receiving parameter values from at least one HF-related
parameter source, wherein the received parameter values
include parameter values for at least two of a respiration
parameter, a heart sound parameter or an activity parameter;
and
changing the electrical stimulation based on the received
parameter values.
Id. at 27.
The Examiner’s Rejections
The rejections before us are:
1. claims 2–21 under 35 U.S.C. § 112(a)/¶1 because the
Specification does not enable the claimed invention (Final Act. 6);
2. claims 2–17 under 35 U.S.C. § 112(b)/¶2 as being indefinite
(id. at 7);
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3. claims 2–9, 11–14, 16, and 17 under 35 U.S.C. § 102(e) as
anticipated by Pastore2 (id. at 8); and
4. claim 10 under 35 U.S.C. § 103 as unpatentable over Pastore
and Burnes3 (id. at 9);
5. claim 15 under 35 U.S.C. § 103 as unpatentable over Pastore
and Kroll4 (id. at 10); and
6. claims 18–21 for nonstatutory (obviousness-type) double
patenting over claims 14–21 of US 9,924,877 B2, issued March 27, 2018
(id. at 11).
DISCUSSION
Rejection 1—Enablement
Aside from claims 7 and 8, Appellant argues the enablement rejection
of claims 2–21 together. Appeal Br. 12–20. We choose claim 2 as
representative of claims 2–6 and 9–21 in deciding the enablement rejection.
See 37 C.F.R. § 41.37(c)(1)(iv).
Claims 2–6 and 9–21
The Examiner determined that the Specification, although “enabling
for neural stimulation, does not reasonably provide enablement for all
possible permutations of electrical stimulation,” encompassed by the claims.
Final Act. 6. The Examiner explained the problem as follows:
Claim 2 recites delivering a heart failure therapy including
electrical stimulation. The breadth of the claim would include
all types of electrical stimulation such as external stimulation,
internal stimulation, stimulation of various tissues etc. The
specification is specific to neural stimulation specifically to the

2 US 2007/0260284 Al, published Nov. 8, 2007 (“Pastore”).
3 US 2004/0186525 A1, published Sept. 23, 2004 (“Burnes”).
4 US 2003/0149453 Al, published Aug. 7, 2003 (“Kroll”).
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heart failure targets including peroneal nerve, sympathetic
column in the spinal cord and cardiac post-ganglionic neurons.
The specification does not provide support for the breadth of the
claims as presented.
Id.; see also Ans. 4–6 (explaining that certain claim scope—for example,
stimulation of one of the 12 cranial nerves or transcutaneous electrical neural
stimulation (“TENS”)—would require undue experimentation).
Appellant argues that “[t]he Examiner is improperly equating
‘enablement’ with a stringent requirement that every possible species is
included in the disclosure. This is improper because the enablement
requirement is separate and distinct from the written description
requirement.” Appeal Br. 13. Appellant’s implicit characterization of the
law of enablement is erroneous, as the Federal Circuit has held that the
enablement requirement applies to the “full scope” of the claims.
Section 112 requires that the patent specification enable those
skilled in the art to make and use the full scope of the claimed
invention without undue experimentation in order to extract
meaningful disclosure of the invention and, by this disclosure,
advance the technical arts. Because such a disclosure
simultaneously puts those skilled in the art on notice of the
enforceable boundary of the commercial patent right, the law
further makes the enabling disclosure operational as a limitation
on claim validity.
Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1070–71 (Fed. Cir.
2005) (citation, quotation marks, and footnote omitted); see also In re
Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) (“[T]he specification must
teach those of skill in the art how to make and how to use the invention as
broadly as it is claimed.” (quotation marks omitted)).
Appellant also argues that the Examiner has not set forth a prima facie
enablement rejection because the Final Action does not explicitly address all
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of the Wands factors. Appeal Br. 13 (“[T]he Examiner fails to properly
interpret the claim language, fails to address who is the person of ordinary
skill in the art, and fails to address what is considered undue
experimentation.”). Appellant, however, has not cited any legal authority to
support its implication that an enablement rejection must explicitly discuss
all eight Wands factors.
The Wands factors, consideration of which elucidates “whether a
disclosure would require undue experimentation” are: “(1) the quantity of
experimentation necessary, (2) the amount of direction or guidance
presented, (3) the presence or absence of working examples, (4) the nature
of the invention, (5) the state of the prior art, (6) the relative skill of those in
the art, (7) the predictability or unpredictability of the art, and (8) the breadth
of the claims.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
With respect to the breadth of the claims and level of skill in the art
factors, Appellant argues:
The claims are not reciting that all electrical stimulation provide
heart failure therapy, but are reciting delivering a heart failure
therapy including electrical stimulation. Additionally, if TENS
prior art indicates that TENS provide heart failure therapy, then
those ordinary skill in the art would know how to deliver TENS
as a heart failure therapy. There is absolutely no requirement that
the specification includes all that is known in the art.
Appeal Br. 16–17 (emphasis added). We agree that the Specification need
not repeat what was already known in the art. But Appellant does not even
assert, let alone substantiate, that “TENS prior art indicates that TENS
provide heart failure therapy.” Id. at 17. Nor does Appellant assert, let
alone substantiate, that “those ordinary skill in the art would know how to
deliver TENS as a heart failure therapy.” Id.
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Ultimately, Appellant’s argument is that the full scope of claim 2 is
enabled because the phrase “heart failure therapy” limits that scope to
whatever happens to be enabled. See, e.g., Reply Br. 3 (“The claim recites
‘delivering a heart failure therapy . . .’, which would not include TENS if it
does not function as a heart failure therapy.”). We disagree. If anything,
Appellant’s argument suggests the full scope of claim 2, in addition to being
not enabled, is indefinite, as it may or may not include TENS, for example.
Appellant does not apprise us of error in the enablement rejection of
claim 2. Accordingly, we affirm the enablement rejection of claim 2, as well
as that of claims 3–6 and 9–21, which fall therewith. See 37 C.F.R.
§ 41.37(c)(1)(iv).
Claim 7
Claim 7 depends from claim 2 and recites “wherein delivering the HF
therapy includes delivering electrical stimulation to heart muscle.” Appeal
Br. 27. Appellant argues that the Examiner effectively concedes enablement
in her statement that “one of ordinary skill in the art could make and use the
invention to deliver hea[r]t failure therapy including . . . cardiac muscle
stimulation.” Appeal Br. 19 (quoting Final Act. 3). We are not persuaded
that the Examiner has erred in rejecting claim 7 as not enabled. The “cardiac
muscle stimulation” to which the Examiner was referring was via an internal
electrode or the like. The Examiner explained:
The claim recites that the stimulation is delivered to the heart
muscle. Again, this is broad and certain embodiments are not
disclosed or discussed. For example this would include TENS
stimulation, external to the patient, to be delivered to the heart
muscle. It is unclear if this could or would work, no examples
are given as to what the stimulation parameters would be or how
this could be done.
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Ans. 7–8. Appellant acknowledges the Examiner’s explanation but does not
dispute it. See Reply Br. 3. Instead, Appellant merely reiterates that TENS
is not within the scope of the claim “if it does not function as a heart failure
therapy.” Id. (emphasis added).
Accordingly, we affirm the enablement rejection of claim 7.
Claim 8
Claim 8 depends from claim 2 and recites “wherein delivering the HF
therapy includes delivering electrical stimulation to a neural target.” Appeal
Br. 27. Appellant argues that the Examiner effectively concedes enablement
in her statement that “one of ordinary skill in the art could make and use the
invention to deliver hea[r]t failure therapy including . . . vagus nerve . . .
stimulation.” Appeal Br. 19 (quoting Final Act. 3). We are not persuaded
that the Examiner has erred in rejecting claim 8 as not enabled. As with
claim 7, the argument is not persuasive of error because the stimulation to
which the Examiner was referring was via an internal electrode or the like.
Further, as pointed out by the Examiner, “neural target” is much broader
than merely the vagus nerve. See Ans. 8 (“The claim recites that the
stimulation is delivered to neural targets. This would necessary include any
and all neural targets including cranial nerves, brain tissue etc.”).
Accordingly, we affirm the enablement rejection of claim 8.
Rejection 2—Indefiniteness
The Examiner determined that claims 2–17 are indefinite “as being
incomplete for omitting essential steps, such omission amounting to a gap
between the steps.” Final Act. 7. The purportedly essential step is creating a
heart failure index. Id. The Specification repeatedly describes using at least
two sensed parameters to create a heart failure index and changing the
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electrical stimulation based on the index. Spec. 2:26–28, 2:31–3:3, 5:16–19.
In contrast, claim 2 for example, recites “changing the electrical stimulation
based on the received parameter values” without an intervening heart failure
index.
Appellant argues that “[t]here is no basis for the Examiner to assert
that determining ‘indices’ is critical. It is not described that way in the
specification.” Appeal Br. 22. To which the Examiner responds: “On page
5 within the Detailed Description the heart failure index is explicitly taught
as critical and essential to the practice of the invention, see the first 3
paragraphs of the Detailed Description.” Ans. 9 (emphasis added). The
Examiner is mistaken. The cited portion of the Specification describes the
heart failure index as neither “critical” nor “essential.”
Accordingly, we reverse the indefiniteness rejection of claims 2–17.
Rejection 3—Anticipation by Pastore
Appellant argues the anticipation rejection of claims 2–9, 11–14, 16,
and 17 together. Appeal Br. 23–24. We choose claim 2 as representative in
deciding the anticipation rejection of all such claims. See 37 C.F.R.
§ 41.37(c)(1)(iv).
Appellant argues that Pastore does not teach “changing the electrical
stimulation based on the received parameter values,” as recited in claim 2.
Appeal Br. 23–24. Appellant directs our attention to paragraph 49 of
Pastore which states that “[v]arious embodiments use sensor input (e.g.
activity or respiration sensor) to determine a desired time to initiate the
sequence.” Pastore ¶49. Appellant argues that Pastore might describe
initiating an electrical stimulation sequence based on sensor input but it does
not teach “changing” it. Appeal Br. 23. For the limitation at issue, however,
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Examiner cited to paragraph 54, not paragraph 49. See Final Act. 8
(“Pastore discloses . . . changing the electrical stimulation based on the
received parameter values (paragraph 0054).”). See also Ans. 11–12
(additionally citing Pastore ¶56 and explaining in detail where and how the
limitation is taught by Pastore).
Of particular significance to an additional argument by Appellant,
Pastore describes “sens[ing] parameters associated with nerve activity or
surrogates of nerve activity such as blood pressure and respiration” and that
“[s]ense circuits 733 are used to detect and process signals from a sensor,
such as a sensor of nerve activity, blood pressure, respiration, and the like.”
Pastore ¶54. The Examiner construes claim 2’s “activity parameter” as
encompassing Pastore’s sensing of “nerve activity.” See Ans. 11
(“Paragraph 0054 indicates that the sensors 733 are for nerve activity
(broadly interpreted to be activity).”). Appellant disputes this construction,
arguing:
Activity is distinguishable from nerve activity and cardiac
activity as “activity” refers to the activity of the patient (page 18
line 1). Appellant respectfully submits that an activity sensor is
a term of art (known by those of ordinary skill in the art) that
refers to patient activity.
Reply Br. 6; see also Spec. 18:1 (“Activity sensors can be used to assess the
activity of the patient.”).
Appellant’s argument about the scope of “activity” is not persuasive.
The very next sentence of the Specification demonstrates that neural activity
is within the scope of “activity.” Referring to the sympathetic nervous
system, it states: “Sympathetic activity naturally increases in an active
patient, and decreases in an inactive patient.” Spec. 18:2–3.

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Appellant does not apprise us of error in the anticipation rejection of
claim 2. Accordingly, we affirm the anticipation rejection of claim 2, as
well as that of claims 3–9, 11–14, 16, and 17, which fall therewith. See 37
C.F.R. § 41.37(c)(1)(iv).
Rejections 4 and 5—Obviousness in view of Pastore and Burnes or Kroll
The Examiner has applied Pastore as prior art under (pre-AIA) 35
U.S.C. § 102(e) and rejected the claims as obvious under (pre-AIA) 35
U.S.C. § 103. Final Act. 8–10. Appellant argues that these rejections should
be reversed pursuant to § 103(c)(1),5 because Pastore has been identified as
prior art only under § 102(e) and it was “owned by the same person or
subject to an obligation of assignment to the same person (Cardiac
Pacemakers, Inc.).” Appeal Br. 24–25.
The Examiner does not dispute Appellant’s ownership assertion or
assert that Pastore is also prior art under any subsections 102(a)–(d).
Instead, the Examiner states that the rejected claims are not enabled by the
earliest filed application in Appellant’s claim of priority. Ans. 12. Such a
determination is not relevant to the legal issue raised by Appellant.
On the record before us, Pastore is not available as prior art under 35
U.S.C. § 103. Accordingly, the obviousness rejections of claims 10 and 15
are reversed.

5 Section 103(c)(1) states:
Subject matter developed by another person, which qualifies as
prior art only under one or more of subsections (e), (f), and (g)
of section 102, shall not preclude patentability under this section
where the subject matter and the claimed invention were, at the
time the claimed invention was made, owned by the same person
or subject to an obligation of assignment to the same person.
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Rejection 6––Nonstatutory (Obviousness-Type) Double Patenting
Appellant does not argue against, or otherwise establish error in, this
rejection. Appeal Br. 25. Accordingly, we summarily affirm it.

SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
2–21 112(a)/¶1 Enablement 2–21
2–17 112(b)/¶2 Indefiniteness 2–17
2–9, 11–
14, 16, 17
102(e) Pastore 2–9, 11–14,
16, 17

10 103 Pastore, Burns 10
15 103 Pastore, Kroll 15
18–21 Nonstatutory
Double Patenting
18–21
Overall
Outcome
2–21

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).
AFFIRMED