Ex Parte Clifford et al

Patent Trial and Appeal Board

Feb 27, 2014

11749725 (P.T.A.B. Feb. 27, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ANTON CLIFFORD,
JOSHUA MAKOWER, and WILLIAM FACTEAU
__________

Appeal 2012-006434
Application 11/749,725
Technology Center 3700
__________

Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
system for bilateral treatment of target tissue associated with each ear. The
Patent Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm-in-part.

1 Appellants identify the Real Party in Interest as Acclarent, Inc. (App. Br.
2.)
Appeal 2012-006434
Application 11/749,725

2
STATEMENT OF THE CASE
Claims 17-35 are on appeal. Claims 17, 24-27, and 30 are
representative and read as follows:
17. A system for bilateral treatment of target tissue associated with each
ear, which includes the tympanic membrane of a patient, the system
comprising:
a first device having at least one treatment delivery surface, wherein
the first device is adapted to be aligned with the target tissue of one ear of
the patient;
a second device having at least one treatment delivery surface,
wherein the second device is adapted to be aligned with the target tissue of
the other ear of the patient;
a first range finder configured to verify that one of the at least one
treatment delivery surface is within range of the target tissue; and
the first and second devices being actuatable to effect therapeutic
remodeling of the target tissues of each ear of the patient.

24. The system of claim 17, wherein the at least one treatment delivery
surface of the first device and the second device each comprise tympanic
membrane penetrators configured for a myringotomy.

25. The system of claim 24, wherein the first and second devices
comprise electromechanical actuators effecting movement of the penetrators
in response to electrical signals, the electromechanical actuators comprising
springs biased to extend and/or retract the penetrators.

26. The system of claim 25, wherein the first and second devices further
comprise tympanostomy tubes carried with the movement of the penetrators,
the electromechanical actuators inhibiting retraction of the tubes when the
penetrators are retracted.

27. The system of claim 17, further comprising a local pain inhibitor
including a local anesthetic or local anesthesia for application to the ears to
effect the synchronized therapeutic remodeling, and further comprising first
and second iontophoresis electrodes supported by a support structure and a
return iontophoresis electrode configured to be operatively coupled with the
Appeal 2012-006434
Application 11/749,725

3
first and second iontophoresis electrodes such that the first iontophoresis
electrode is adapted to be supported in one ear of the patient and the second
iontophoresis electrode is adapted to be supported in the other ear of the
patient.

30. The system of claim 29, wherein one or more of the first and second
range finders includes a member adapted to contact the target tissue of the
patient that is mechanically integrated with either the first or second device.

The Examiner rejected the claims as follows:
• claims 17-24 and 28-35 under 35 U.S.C. § 103(a) as unpatentable
over Epley2 and Kaplan;3
• claims 25 and 26 under 35 U.S.C. § 103(a) as unpatentable over
Epley, Kaplan, and Reisinger;4 and
• claim 27 under 35 U.S.C. § 103(a) as unpatentable over Epley,
Kaplan, and Vernon.5

OBVIOUSNESS
I. The Rejection of claims 17-24 and 28-35
A. Independent Claim 17
The Examiner found that Epley disclosed a system (20) for bilateral
treatment of a patient, the system including a first device (36) adapted to be
aligned with a first ear having at least one treatment delivery surface (36a).
(Ans. 4.) The Examiner found that Epley taught that device (36) could be

2Patent Application Publication No. US 2005/0182385 A1 by John M. Epley
et al., published Aug. 18, 2005.
3 Patent No. US 6,770,080 B2 issued to Aaron V. Kaplan et al., Aug. 3,
2004.
4 US Patent No. 5,496,329 issued to John R. Reisinger, Mar. 5, 1996.
5 US Patent No. 3,991,755 issued to Jack A. Vernon et al., Nov. 16, 1976.
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Application 11/749,725

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used in combination with a second device on the opposite side of the
apparatus, also having at least one treatment delivery surface and adapted to
be aligned with the other ear of the patient. (Id. at 4-5.) The Examiner
found that Epley’s first and second devices are actuable to effect therapeutic
remodeling of target tissues. (Id. at 5 (citing Epley [0078]).) However, the
Examiner found that Epley did not expressly disclose a first range finder.
(Id.)
The Examiner found that Kaplan taught a system for treating the
tympanic membrane comprising a range finder, i.e., an imaging system
having an illumination light transmitter (58), an imaging lens end (60), and
an aiming light transmitter (62) configured to verify that a treatment delivery
surface, i.e., probe (24), is within range of the target tissue. (Id.) According
to the Examiner, it would have been obvious to a person of ordinary skill in
the art at the time the invention was made to have combined the range finder
taught by Kaplan into the system of Epley to determine the position and/or
location for insertion of a tympanostomy tube.
Appellants contend:
As can best be understood, Epley discloses frame structure 22
to which device 36 is snap-attached. Since the frame 22 and
snap attachment appear to define a guide for device 36, it is
submitted that one of ordinary skill in the art would not have
incorporated the alleged range finder of Kaplan, which as
stated, identifies a distance between Kaplan’s guide structure
and a tympanic member, into the Epley frame 22. Such a
modification of Epley would not lead to verifying that the
Epley device 36 is within range of a tympanic membrane, as is
required by the claims.

(App. Br. 6.)
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Appellants assert that even if the teachings of Epley and Kaplan were
combined, the combination would not yield the claimed invention. (Id.)
According to Appellants, “it is actually with respect to the guide structure
and not the treatment delivery device of probe 24 disclosed in Kaplan from
which a distance is determined.” (Id.) Therefore, Appellants assert that
Kaplan does not disclose a range finder configured to verify that a treatment
delivery surface is within range of target tissue. (Id. at 6-7.)
After considering all the evidence and arguments, we conclude that
the record supports a conclusion of prima facie obviousness for independent
claim 17. In particular, we find that Appellants have not considered
properly the full disclosure of Kaplan. Specifically, Kaplan’s imaging
system is not limited to determining the distance between Kaplan’s guide
structure and the tympanic membrane. Kaplan also discloses, “[a]n aiming
light beam may be transmitted from aiming light transmitter 62, with the
aiming beam acting as a light pointer to indicate the alignment of the probe.”
(Kaplan col. 9, ll. 28-31.) Additionally, Kaplan expressly states that “the
aiming beam and probe may be aligned by inserting an aiming beam
transmitter into the probe lumen to verify orientation of the probe lumen . . .
.” (Id. at ll. 42-44.) Thus, Kaplan’s disclosure supports the Examiner’s
finding that its aiming light transmitter, i.e., range finder, is configured to
verify that the treatment delivery surface, i.e., probe, is properly aligned and
oriented with, i.e., within range of, the target tympanic membrane tissue.
In the Reply Brief, Appellants further assert that the Examiner has
mischaracterized Epley as disclosing a device “being actuable to effect
therapeutic remodeling of target tissues,” as required by claim 17. (Reply
Br. 6.) According to Appellants, “Epley patent does not teach such
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remodeling, but in fact is directed towards a device for ‘selectively
controlled and metered introduction of a medical fluid, such as a drug
through the tympanic membrane and into the middle ear.’” (Id. (quoting
Epley [0002]).)
We have considered Appellants’ argument, but remain unpersuaded of
nonobviousness. At issue is the meaning of the claim term “therapeutic
remodeling.” More specifically, the issue is whether the broadest reasonable
interpretation of this claim term includes providing a port structure in the
tympanic membrane for introduction of a therapeutic fluid. We find that it
does. Appellants have not identified an evidentiary basis on this record to
support a contrary interpretation. (See Reply Br. 6.) Nor has our review of
the Specification revealed a definition for this term. Therefore, we look to
the ordinary and customary meaning of the term “remodel,” which is defined
as “to change the structure, shape, or appearance of (something): to alter the
structure of.”6 See In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Therefore, considering the ordinary and customary meaning of the term
“remodel,” we find that one of ordinary skill in the art would have
interpreted “therapeutic remodeling” broadly and reasonably as including
any change to the structure of the target tissue, i.e., the tympanic membrane.
We find that the disclosed use of Epley’s device “to pierce the tympanic
membrane” to create a “port structure” (see Epley [0078] and ABSTRACT)
amounts to such a structural change, and is, therefore, “actuable to effect
therapeutic remodeling of the target tissues,” as recited by claim 17.

6 Merriam Webster Online Dictionary, M-W.COM, http://www.merriam-
webster.com/dictionary/remodel (last visited Feb. 27, 2014).
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Accordingly, we affirm the rejection of claim 17. Claims 18-24, 28,
29, and 31-35 have not been argued separately and therefore fall with claim
17.
B. Dependent Claim 30
The Examiner found that Kaplan’s range finder, i.e., aiming light
transmitter (62), is adapted to contact the target tissue of the patient and is
mechanically integrated with its first device. (Ans. 9.)
Appellants assert that the Examiner’s statement in the Final Rejection
that Kaplan disclosed “‘a range finder that includes a member (24, FIG. 2)
adapted to contact the target tissue’” describes a structure that does not exist
in Kaplan because member (24) is a probe and not a range finder. (App. Br.
7.)
The Examiner clarified in the Answer that it is Kaplan’s member (62),
the aiming light transmitter, and not the probe (24) that is interpreted as the
range finder. (See Ans. 9.) However, we do not find that the Examiner has
established that Kaplan’s aiming light transmitter is adapted to “contact” the
target tissue, as required by claim 30. The instant Specification refers to
optical targeting methods as involving the use of a “non-contact technique.”
(Spec. [0140].) Consistent with this description, dependent claim 32
distinguishes a “member adapted to contact the target tissue of the patient”
and a “laser configured to emit on the target tissue . . . .” (App. Br. 13,
Claims App’x.) Thus, given the broadest reasonable interpretation
consistent with the Specification, see In re Am. Acad. of Sci. Tech. Ctr., 367
F.3d 1359, 1364 (Fed. Cir. 2004), we find that a person of ordinary skill in
the art would have interpreted the claim phrase “contact the target tissue” as
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requiring the transmitter device to physically touch the target tissue and not
merely having the transmitter to emit light upon the tissue.
Accordingly, we reverse the rejection of claim 30.
II. The Rejection of claims 25 and 26
The Examiner relied on the combination of Epley and Kaplan as
discussed regarding the rejection of independent claim 17, and further found
that Kaplan taught a system for treating tissues of the ear, the system having
electromechanical actuators effecting movement of the penetrators in
response to electrical signals. (Ans. 10 (citing Kaplan col. 12, ll. 15-30).)
The Examiner found that Reisinger taught an electromechanical actuator
comprising springs biased to extend and/or retract the penetrators along an
axis oriented along the ear canal. (Id. at 11.) According to the Examiner, it
would have been obvious to a person of ordinary skill in the art at the time
the invention was made to have modified the system of Epley with the
electromechanical actuators of Kaplan to actuate the cutting implement to
simultaneously make an incision in the tympanic membrane of each ear, and
to include the springs taught by Reisinger to provide an alternate means of
deployment for tubes such as by actuation of a compression spring. (Id.)
Appellants contend that the cited art does not provide a teaching or
suggestion of an electromechanical actuator including a spring, as required
by claims 25 and 26.
We agree with Appellants. In particular, we do not find that the
record evidence supports the Examiner’s finding that Kaplan discloses a
system comprising “electromechanical actuators effecting movement of the
penetrators in response to electrical signals.” (Ans. 10.) The Examiner
relies on Kaplan column 12, lines 15-30 in support of this finding. (Id.)
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Although Kaplan teaches that treatment is effected by its actuating probe
actuator (44), we do not see any disclosure that the actuator is
electromechanical or that it effects movement of the probe in response to
electrical signals. A conclusion that the claimed subject matter is prima
facie obvious must be supported by evidence, as shown by some objective
teaching in the prior art or by knowledge generally available to one of
ordinary skill in the art that would have led that individual to combine the
relevant teachings of the references to arrive at the claimed invention. See
In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). Because this evidence is
missing, we reverse the rejection of claims 25 and 26.
III. The Rejection of claim 27
The Examiner relied on the combination of Epley and Kaplan as
discussed regarding independent claim 17. (See Ans. 12.) Additionally, the
Examiner found that Vernon disclosed a local pain inhibitor comprising a
local anesthetic or local anesthesia and iontophoresis electrodes (24a)
supported by a support structure and adapted to be supported in an ear of the
patient, and a return iontophoresis electrode (64) configured to be
operatively coupled to the iontophoresis electrodes. (Id.) According to the
Examiner, it would have been obvious to a person of ordinary skill in the art
at the time the invention was made to have modified the Epley system to
include the iontophoresis system and local pain inhibitor taught by Vernon
to deliver anesthetic to the treatment site in a minimally invasive manner.
(Id.) Additionally, the Examiner reasoned that it would have been obvious
for the person having ordinary skill in the art to have included a second
electrode with the same operation as the first electrode (64) because it would
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have amounted to mere duplication of the essential working part of a device
involving only routine skill in the art. (Id. at 13.)
Appellants contend:
Vernon, however, in fact describes a companion electrode 64
that is subsequently taught to be placed on “the surface of the
body remote from the section to be anesthetized.” As such, any
structure of Vernon which might be characterized as a return
iontophoresis electrode, could not be operatively coupled with
first and second iontophoresis electrodes because these do not
exist in Vernon.

(App. Br. 9.)
Appellants’ argument has been carefully considered, but we do not
find it convincing. Vernon disclosed that its anesthetic-driving electrode 24,
exemplified as electrode form 24a in Figure 7, “may assume different
configurations where it is to be applied to the anesthesia of different body
parts.” (Vernon col. 4, ll. 44-49.) The Examiner reasoned that it would have
been obvious for a person of ordinary skill in the art at the time the invention
was made merely to have duplicated this electrode to provide for a different
configuration, as taught by Vernon. Vernon’s disclosure and the Examiner’s
reasoning properly support the Examiner’s finding that Vernon taught or
suggested first and second iontophoresis electrodes. Further, Vernon
disclosed a “companion ground electrode, indicated schematically at 26,
comprises an electrode 64 of electrically conducting material.” (Vernon col.
5, ll. 4-6.) We agree with the Examiner that this companion ground
electrode 64 is the return electrode this disclosure supports the Examiner’s
finding that Vernon taught a return electrode. Appellants have not
established persuasively otherwise by asserting that the companion electrode
is taught to be placed on the surface of the body remote from the section to
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11
be anesthetized. Being positioned remotely from the section to be
anesthetized does not establish or even suggest that the companion ground
electrode is not operably coupled to the anesthetic-driving electrode(s).
Indeed, Vernon explains that the companion ground electrode is connected
into the electric circuit (id. at col. 5, l. 17), which reasonably provides a
configuration for the electrode to be operatively coupled with first and
second electrodes, as required by claim 27.
Accordingly, we affirm the rejection of claim 27.

SUMMARY
We affirm the rejection of claims 17-24, 28, 29, and 31-35 as
unpatentable over Epley and Kaplan;
we reverse the rejection of claim 30 as unpatentable over Epley and
Kaplan;
we reverse the rejections of claims 25 and 26 as unpatentable over
Epley, Kaplan, and Reisinger; and
we affirm the rejection of claim 27 as unpatentable over Epley,
Kaplan, and Vernon.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

cdc

Notice of References Cited

Application/Control No.

11/749,725
Applicant(s)/Patent Under
Reexamination
Anton Clifford et al.
Examiner

Katrina Stransky
Art Unit

3700

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Merriam Webster Online Dictionary, M-W.COM, http://www.merriam-
webster.com/dictionary/remodel (last visited Feb. 27, 2014).

V

W

X

*A copy of this reference is not being furnished with this Office action. (See Manual of Patent Examining Procedure, Section 707.05(a).)
**APS encompasses any electronic search i.e. text, image, and Commercial Databases.
U.S. Patent and Trademark Office
Remodel - Definition and More from the Free Merriam-Webster Dictionary
file:///S|/...rica/2%20Ready%20for%20Mailing/Remodel%20-%20Definition%20and%20More%20from%20the%20Free%20Merriam-Webster%20Dictionary.htm[2/27/2014 10:05:19 AM]
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re·mod·el transitive verb \(ˌ)rē-ˈmä-dəl\
: to change the structure, shape, or appearance of
(something)
Full Definition of REMODEL
: to alter the structure of : REMAKE
Examples of REMODEL
We remodeled the kitchen last year.

First Known Use of REMODEL
1789
Related to REMODEL
Synonyms
alter, make over, modify, recast, redo, refashion, remake,
change, revamp, revise, rework, vary
Antonyms
fix, freeze, set, stabilize
Related Words
deform, metamorphose, mutate; regenerate,
revolutionize, transfigure, transform, transmute;
commute, convert, exchange; rejigger, retool
more
Rhymes with REMODEL
role model, spokesmodel
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