Mark Deem et al.

Patent Trials and Appeals Board

Oct 29, 2020

2020002382 (P.T.A.B. Oct. 29, 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.
13/081,406 04/06/2011 Mark Deem 4680.06US02 3875
24113 7590 10/29/2020
PATTERSON THUENTE PEDERSEN, P.A.
80 SOUTH 8TH STREET
4800 IDS CENTER
MINNEAPOLIS, MN 55402-2100
EXAMINER
CLARK, RYAN T
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/29/2020 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):
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johnson@ptslaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARK DEEM, VIVEK SHENOY, and
MARTIN L. MAYSE

Appeal 2020-002382
Application 13/081,406
Technology Center 3700
____________

Before MICHAEL J. FITZPATRICK, MICHELLE R. OSINSKI, and
CARL M. DEFRANCO, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
final decision rejecting claims 1–5, 7–16, 18, 112–114, and 116–121. 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 Nuvaira, Inc. as the sole real party in interest. Appeal
Br. 2.
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STATEMENT OF THE CASE
The Specification
The Specification “generally relates to the field of pulmonary
treatments.” Spec. 1:8.
The Claims
Claims 1–5, 7–16, 18, 112–114, and 116–121 are rejected. Final Act.
1. Claims 6, 17, 19–111, and 115 are cancelled. Id. at 2. No other claims
are pending. Id.; see also Appeal Br. 18–24. Claim 1 is illustrative and
reproduced below.
1. A system for pulmonary treatment, comprising:
a pulmonary treatment device having a first elongate
member and an energy delivery element, the energy delivery
element being positionable through at least a portion of a trachea
and within a first airway via a pharynx, the energy delivery
element being monopolar and configured to deliver energy
radially outward from within the first airway to a wall of the first
airway to alter nerve tissue of a nerve trunk located along an
outer wall of the first airway, wherein the pulmonary treatment
device comprises an expandable member configured to move
between a contracted configuration and an expanded
configuration, and an energy emitter assembly, the energy
emitter assembly including the energy delivery element disposed
on a conduit configured for receiving media therethrough to cool
the energy delivery element, the energy emitter assembly being
configured to extend circumferentially about the expandable
member when in the expanded configuration; and
a protection device having a second elongate member and
a protection member, the protection portion being positionable in
an esophagus via the pharynx while the pulmonary treatment
device is positioned in the first airway, the protection device
being free of energy delivery elements, and being configured to
absorb heat from a wall of the esophagus to inhibit damage to
non-target tissue,
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wherein the first and second elongate members are
configured to simultaneously extend through the pharynx when
the energy delivery element is positioned within the first airway
and the protection device is positioned within the esophagus.
Appeal Br. 18.
The Examiner’s Rejections
The rejections before us, all under 35 U.S.C. § 103(a), are as follows:
1. claims 1–5, 7, 8, 10, 11, 14–16, 18, 112–114, and 116–121 as
unpatentable over Mayse2 and Lafontaine3 (Final Act. 2);
2. claim 9 as unpatentable over Mayse, Lafontaine, and Fishel4
(id. at 6); and
3. claims 12 and 13 as unpatentable over Mayse, Lafontaine, and
Ingle5 (id. at 7).
DISCUSSION
Rejection 1
Appellant argues the rejection of all claims together. Appeal Br. 12–
15. We choose claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv).
Mayse is directed to pulmonary treatments systems. Mayse, Abstract
(“Systems, assemblies, and methods to treat pulmonary diseases”). The
Examiner found that Mayse teaches most of the subject matter of claim 1 but
“fails to disclose a protection device having a second elongate member and a
protection member, the protection portion being positionable in an
esophagus via the pharynx while the pulmonary treatment device is

2 US 2009/0306644 A1, published Dec. 10, 2009 (“Mayse”).
3 US 2008/0161890 A1, published July 3, 2008 (“Lafontaine”).
4 US 2009/0069875 A1, published Mar. 12, 2009 (“Fishel”).
5 US 6,216,704 B1, issued Apr. 17, 2001 (“Ingle”).
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positioned in the first airway, the protection device being free of energy
delivery elements, and being configured to absorb heat from a wall of the
esophagus to inhibit damage to non-target tissue.” Final Act. 2–3 (citing
Mayse ¶¶141, 142, and 152 and Figs. 2A, 15A, 15B, and 17).
Lafontaine “is directed towards methods, systems, and apparatus for
protecting esophageal tissue during ablation.” Lafontaine, Abstract. The
Examiner found that Lafontaine teaches “a protection device (Fig. 4
esophageal catheter 400) having an elongate member (Fig. 4 elongate
member 404) with a protective member (Fig. 4 balloon 402) positionable in
the esophagus to absorb heat (acts as a heat sink, paragraph [0065]) from a
wall of the esophagus and inhibit damage to non-target-tissue during
ablation.” Final Act. 3.
The Examiner concluded:
It would have been obvious to one of ordinary skill in the
art at the time of the invention to have included the device of
Lafontaine together with the device of Mayse in order to protect
non-target tissue from ablation energy so that tissue not meant to
be treated can be kept at normal body temperatures (Lafontaine
par. [0065]); further, Mayse recognizes the need to cool adjacent
tissues to prevent injury thereto (par. [0144]). The combination
of Mayse with Lafontaine teaches wherein the first and second
elongate members are configured to simultaneously extend
through the pharynx when the energy delivery element is
positioned within the first airway and the protection device is
positioned within the esophagus since this is a functional
limitation that the device of Mayse and Lafontaine would be
capable of preforming.
Id. at 3–4.
Appellant first argues that Mayse “teaches cooling of non-target tissue
between the energy emitter and the target nerve tissue, and not beyond the
nerve tissue[.] . . . Mayse does not disclose or suggest specifically
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protecting the esophagus and tissue proximate the esophagus, and is silent
with respect to positioning a protection member in the esophagus to protect
the esophagus and surrounding tissue.” Appeal Br. 13–14 (citing Mayse
¶144). This argument is not persuasive of error because the Examiner does
not rely on Mayse for teaching the protection of esophageal tissue
specifically. Rather, the Examiner cites Mayse for generally teaching “the
need to cool adjacent tissue to prevent injury thereto.” Final Act. 4 (citing
Mayse ¶144). The Examiner relies on a different reference, Lafontaine, for
teaching the protection of esophageal tissue specifically. Id. at 3; see also In
re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“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.”).
Appellant argues that “Lafontaine is directed to methods of treating
cardiac arrhythmias with catheter ablation therapy via ablation of cardiac
tissues, in which the ablation catheter is inserted into the heart,” and “the
skilled person would have no reason to believe that Lafontaine teaches
anything relevant to lung treatment, which is the focus of Mayse.” Appeal
Br. 14. As the Examiner notes (see Ans. 5), this appears to be an argument
that Lafontaine is non-analogous art.
A prior art reference is analogous art if it meets either of the following
criteria: “(1) whether the art is from the same field of endeavor, regardless
of the problem addressed, and (2) if the reference is not within the field of
the inventor’s endeavor, whether the reference still is reasonably pertinent to
the particular problem with which the inventor is involved.” In re Clay, 966
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F.2d 656, 658–59 (Fed. Cir. 1992). The Examiner finds that Lafontaine
meets both criteria. Ans. 5 (“Lafontaine is in the same field of endeavor
because Lafontaine pertains to an in vivo ablation device. Lafontaine is also
reasonably pertinent to the particular problem because it is using a balloon to
cool the esophagus to prevent damage to the esophagus.”). We see no error
in the Examiner’s finding that Lafontaine is analogous art.
Appellant replies, however, that it was not challenging Lafontaine’s
status as analogous art and was “instead highlighting that Mayse and
Lafontaine are directed at solving two very different problems.” Reply
Br. 3. However, there is no legal requirement for references to be directed to
solving the same or similar problems in order for their teachings to be
combined.
Appellant argues that Lafontaine teaches an “ablation catheter is
inserted into the heart, and not into the airway.” Appeal Br. 14. Thus,
according to Appellant, “one of skill in the art, having a device already
positioned in the airway via the pharynx [i.e., Mayse’s first elongate member
carrying electrode 2004], would not be motivated, absent the present
disclosure, to introduce yet another device into the esophagus [i.e.,
Lafontaine’s protective device] also via the already substantially occluded
pharynx.” Id.
The Examiner answers this argument, in part, by pointing out that
there are no limitations in the claim directed to the size of the pulmonary
treatment device and protection device or their corresponding elongate
members. Ans. 4. The Examiner adds that Appellant “has not presented any
supporting reasons that the structures of Mayse and Lafontaine would not be
capable of fitting in the pharynx at the same time.” Id. Finally, the
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Examiner cites evidence showing that it is possible, and was known prior to
Appellant’s claimed invention, to have “multi-balloon configurations
inserted in the pharynx at the same time.” Id. (citing US 4,231,365, issued
Nov. 4, 1980 to Scarberry, Fig. 1; US 6,374,827, issued Apr. 23, 2002 to
Bowden et al., Fig. 3).6
In reply, Appellant “maintain[s] that one of skill in the art would not
be motivated to introduce two devices, i.e. the cooled ablation catheter of
Mayse and the esophageal cooling device of Lafontaine, through the same
lumen, i.e. the pharynx, absent the present disclosure.” Reply Br. 2.
Appellant relies on the fact that neither Mayse nor Lafontaine teaches two
devices “configured to be simultaneously introduced via the pharynx and
into the trachea and esophagus.” Id. However, as explained in the rejection
and above, each of those references provide a reason for introducing a
unique device through the pharynx—Mayse introducing an ablation device
through the pharynx for use in the trachea/bronchi and Lafontaine
introducing a protection device through the pharynx for use in the
esophagus.
The prior art provides a reason to combine these teachings. See Final
Act. 3–4. Appellant does not rebut adequately that reason. Nor does
Appellant substantiate its own argument that a person of ordinary skill in the
art would not, or could not, introduce both devices through the pharynx
simultaneously. Lastly, Appellant does not dispute the Examiner’s finding
that it is possible, and was known, to insert multiple medical devices into the

6 These references were listed in a May 19, 2015, Notice of References
Cited.
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pharynx at the same time. See Ans. 4 (citing US 4,231,365, Fig. 1; US
6,374,827, Fig. 3); see generally Reply Br.
None of Appellant’s arguments apprises us of error in the Examiner’s
rejection of claim 1. Accordingly, we affirm the rejection of claim 1, as well
as that of claims 2–5, 7, 8, 10, 11, 14–16, 18, 112–114, and 116–121, which
fall therewith. 37 C.F.R. § 41.37(c)(1)(iv).
Rejections 2 and 3
Appellant argues the patentability of claims 9, 12, and 13 solely on the
basis that the additional cited teachings from Fishel and Ingle do not remedy
the alleged deficiency in the rejection of claim 1 from which they ultimately
depend. Appeal Br. 16. Thus, for similar reasons, we affirm the rejection of
claims 9 as unpatentable over Mayse, Lafontaine, and Fishel, and the
rejection of claims 12 and 13 as unpatentable over Mayse, Lafontaine, and
Ingle.
SUMMARY
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–5, 7, 8, 10,
11, 14–16,
18, 112–114,
116–121
103(a) Mayse, Lafontaine 1–5, 7, 8,
10, 11,
14–16, 18,
112–114,
116–121

9 103(a) Mayse, Lafontaine,
Fishel
9
12, 13 103(a) Mayse, Lafontaine,
Ingle
12, 13
Overall
Outcome
1–5, 7–16,
18, 112–
114, 116–
121

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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