Ex Parte Rontal

Patent Trial and Appeal Board

Nov 19, 2014

12427257 (P.T.A.B. Nov. 19, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte MICHAEL RONTAL1
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Appeal 2012-010035
Application 12/427,257
Technology Center 3700
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Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s
rejections of claims 1, 4–7, 9–10 and 14 as unpatentable. We have
jurisdiction under 35 U.S.C. § 6(b). Oral argument was heard on November
13, 2014.
We affirm-in-part.
STATEMENT OF THE CASE
Appellant’s invention is intended for removing biofilm from nasal
sinuses or other body tissues using ultrasound. (Spec. Abstract.)

1 According to Appellant, the Real Party in Interest is the named inventor,
Michael Rontal. (Appeal Br. 1.)
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Representative claim 1, the only independent claim on appeal, reads as
follows (formatted):
1. Medical treatment apparatus, comprising:
an elongated tube having a proximal end and a distal
end adapted to be inserted into a cavity within a living body
having a biofilm coating so that the distal end of the tube is
disposed within the cavity and its proximal end is exterior of
the body, the tube containing
a first lumen for introducing fluid into the cavity and
a second lumen for suctioning fluid from the cavity;
a first port for introducing fluid containing biofilm
treatment reducing agents into the proximal end of the first
lumen;
a second port at the proximal end of the tube for
applying a suction force to the second lumen to suction fluid
from the cavity; and
an ultrasonic generator disposed externally of the body
and operative to introduce ultrasonic energy through an
external wall of the body and into the biofilm at a power
level below the level which will destroy the tissue underlying
the biofilm.

The following grounds of rejection are before us for review:
Claim 14 stands rejected as drawn to unpatentable subject matter
under 35 U.S.C. § 101.
Claims 1 and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Khudiev2 and Stoddard.3

2 A.M. KHUDIEV, "Low-frequency Ultrasound Therapy in Systemic Curing
of Chronic Purulent Maxillary Sinusitis" 5 VESIN OTORINOLARINGOL; 44-46
(2003) (Citations herein are to the English translation of record).
3 Stoddard, US 5,484,398, issued January 16, 1996.
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Claims 4, 9, and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Khudiev, Stoddard, and Meyer.4
Claims 5 and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Khudiev, Stoddard, and Kagawa.5
Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Khudiev, Stoddard, Kagawa, and Satou.6
FINDINGS OF FACT
Specification
FF1. Under some conditions, bacteria exude a hydrated matrix of
exopolymers, typically polysaccharides, which form a protective
biofilm on the surface of living tissue and foreign bodies such as heart
valves. (Spec. ¶¶ 2–5.) Biofilms insulate embedded bacteria from
externally-applied biocides such as antibiotics. (Id. ¶ 6.)
Consequently, “[a]ntibiotic concentrations of 1000 to 2000 times
higher than possible with systemic applied antibiotics would be
required to destroy the bacteria of a biofilm.” (Id.) “When the
biofilm is formed on living tissue, the biochemical products and toxic
wastes it secretes may affect the tissue surface to produce an
inflammatory state and areas of chronic infection, such as chronic ear
disease, osteomyelitis, chronic tonsillitis, prostatitis, vaginitis, and
calculi, as in the kidney.” (Id. at 2.)

4 Meyer, US 4,998,527, issued March 12, 1991.
5 Kagawa et al., US 5,163,433, issued November 17, 1992.
6 Satou et al., US 2003/0125620 Al, published July 3, 2003.
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FF2. Appellant’s Abstract discloses ultrasonic methods and devices
for treating body surfaces such as nasal sinuses coated with biofilms
the surface is irrigated and suctioned with a fluid
which may contain a biocide or other chemical agent
for disrupting the biofilm while ultrasonic energy is
applied to either the fluid barrier formed over the
biofilm or a body surface proximal to the biofilm.
Action of the fluid enhanced by the ultrasonic energy
tends to remove sections of biofilm which are
suctioned out of the site. . . . .
FF3. In some embodiments, irrigation fluid and ultrasound are
provided by a unitary device 10 inserted into the sinus area or other
body lumen. (See e.g., Figures 1–6.) “Alternatively, in the
embodiment of the invention illustrated in Figure 9 [reproduced
below], the ultrasound may be applied separately from the instrument
10 through the patient's body.” (Spec. ¶ 35.)

FF4. “Figure 9 illustrates a method of treatment of a sinus to remove
a biofilm in the mucosal blanket, wherein ultrasonic energy is
introduced through the head from a facial probe while the sinus cavity
is subjected to irrigation and suction via a probe inserted into the
cavity.” (Id. ¶ 26.)
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Khudiev
FF5. Khudiev is directed to “Low-Frequency Ultrasound Therapy
System [for] Curing Chronic Purulent Maxillary Sinusitis.” (Khudiev
Title.) Khudiev Figures 1 and 2 are reproduced below.

Khudiev Figure 1 shows ultrasound apparatus Y3P-M.
Its mode of operation is based on biological properties
of the low-frequency ultrasound (bactericidal,
antiseptic, etc.), as well as on capability of ultrasound
waves of low and medium intensity (up to 3W/cm2) to
stimulate regenerative functions of various organs and
tissues. The working frequency of the apparatus is 26.5
KHz, amplitude of the output ultrasonic vibrations up
to 80 μm.
(Khudiev translation at 1.) Khudiev Figure 2 shows a hand piece for the
apparatus useful “for intra-cavity treatment of inflammatory diseases of
upper jaw cavities.” (Id. at 3.) The hand piece comprises ultrasound
transmitter 1; valve 2 for providing a medication solution; adaptor 3;
cap/spacer 4; flexible tubing 5; and punction needle 6. (Id.)
FF6. Khudiev teaches that using the ultrasound apparatus with the
handpiece, patients with chronic purulent maxillary sinusitis were
treated via a puncture in the upper jaw cavity. (Id. at 1.)
The flexible tube of the transmitter/transducer of
ultrasound vibrations was attached to the base of the
punction needle. Simultaneously, the medicinal
solution was directly supplied through the valve 2.
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The [ultrasound] medication solution was delivered
into upper jaw cavity through the cavity inside the
transmitter and the punction needle. Atomized
particles of the medication solution were evolving into
minutest energy carriers of the longitudinal ultrasound
waves, they were deposited onto all wall of the cavity
and acted on bacteria embedded into thickness of the
slimy shell [ie., the biofilm].
(Id. at 2.) Khudiev further states that “low intensity ultrasound
effectively suppresses the pathogenic flora in the purulent-inflammatory
area. A wide spectrum of antibiotics, bactericidic and bacteriostatic
medications, ferments, etc. can be used as medicinal solutions.” (Id. at
1.)
ANALYSIS
35 U.S.C. § 101
Appellant makes no argument regarding the patentability of dependent
claim 14 under 35 U.S.C. § 101. We summarily sustain the Examiner’s
rejection without comment on its underlying merits. 37 C.F.R.
§ 41.37(c)(1)(vii). See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir.
2008) (“When the appellant fails to contest a ground of rejection to the
Board, . . . the Board may treat any argument with respect to that ground of
rejection as waived. In the event of such a waiver, the PTO may affirm the
rejection of the group of claims that the examiner rejected on that ground
without considering the merits of those rejections.”).
35 U.S.C. § 103(a)
The Examiner rejects all claims on appeal as obvious based on
Khudiev, as modified by Stoddard (claims 1 and 14), Stoddard and Meyer
(claims 4, 9, and 10), Stoddard and Kagawa (claims 5 and 7), or Stoddard,
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Kagawa, and Satou (claim 6). In each case, the correctness of the
Examiner’s rejections turn on the meaning of introducing of ultrasonic
energy “through an external wall of the body,” as set forth in claim 1, the
only independent claim on appeal.
The Examiner finds that Khudiev discloses an “ultrasonic generator
(i.e. ultrasonic transmitter 1) disposed externally of the body and operative
to introduce low-frequency ultrasonic energy through an external wall of the
body and into the biofilm” (Ans. 6); i.e., via a portion of the handpiece
inserted into the patient’s body. (See Khudiev Figure 2.)
Appellant contends that claim 1 embodies the invention illustrated in
Figure 9 of the drawings, wherein, “ultrasonic energy is introduced through
the head from a facial probe while the sinus cavity is subjected to irrigation
and suction via a probe inserted into the cavity.” (See App. Br. 2 (quoting
Spec. ¶ 26) (emphasis added).) Appellant argues that Khudiev fails to
disclose “an ultrasonic generator disposed externally of the body and
operative to introduce ultrasonic energy through an external wall of the body
and into the biofilm,” as set forth in claim 1, but rather, “conducts ultrasonic
energy into the biofilm coated cavity by transmitting ultrasonic waves
through the irrigating fluid.” (Id. at 4–5.)
“Only when a claim is properly understood can a determination be
made . . . whether the prior art anticipates and/or renders obvious the
claimed invention.” Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239
F.3d 1343, 1351 (Fed. Cir. 2001). The PTO gives a disputed claim term its
“broadest reasonable interpretation consistent with the specification, and . . .
claim language should be read in light of the specification as it would be
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interpreted by one of ordinary skill in the art.” In re Bond, 910 F.2d 831,
833 (Fed. Cir. 1990).
Applying the broadest reasonable interpretation in light of the
Specification, we agree with Appellant that Khudiev fails to disclose the
introduction of ultrasonic energy “through an external wall of the body,” as
required by claim 1. As we interpret this language, the ultrasonic energy
must be provided separately from the portion of the instrument inserted into
a patient’s lumen and traverse an external body wall, such as bones and
tissues of the head illustrated in Figure 9. In contrast, the ultrasonic energy
applied by Khudiev is directed into a body cavity via a handpiece or probe
within that body cavity, and does not traverse an external body wall before
interacting with the target biofilm.
Because the Examiner provides no evidence showing that Khudiev
teaches or suggests all limitations of claim 1, or that the failings of Khudiev
are remedied by Stoddard, Kagawa, Meyer, and Satou, we reverse.
SUMMARY
We summarily affirm the rejection of claim 14 under 35 U.S.C. § 101
as drawn to unpatentable subject matter. 37 C.F.R. § 41.37(c)(1)(vii).
We reverse the rejection of claims 1 and 14 under 35 U.S.C. § 103(a)
as unpatentable over Khudiev and Stoddard.
We reverse the rejection of claims 4, 9, and 10 under 35 U.S.C.
§ 103(a) as unpatentable over Khudiev, Stoddard, and Meyer.
We reverse the rejection of claims 5 and 7 under 35 U.S.C. § 103(a)
as unpatentable over Khudiev, Stoddard, and Kagawa.
We reverse the rejection of claim 6 under 35 U.S.C. § 103(a) as
unpatentable over Stoddard, Kagawa, and Satou.
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TIME PERIOD FOR RESPONSE
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

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