Ex Parte Danek et al

Patent Trial and Appeal Board

Nov 28, 2016

11617512 (P.T.A.B. Nov. 28, 2016)

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.
11/617,512 12/28/2006 Christopher J. Danek 11710.0004-01000 4252
11/30/2016109610 7590
Bookoff McAndrews, PLLC
2401 Pennsylvania Avenue, NW, Suite 450
Washington, DC 20037
EXAMINER
HUPCZEY, JR, RONALD JAMES
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
11/30/2016 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):
usptomail @bookoffmcandrews.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER J. DANEK, GARY S. KAPLAN,
WILLIAM J. WIZEMAN, and MICHAEL D. LAUFER
Appeal 2013-0064611
Application 11/617,5122
Technology Center 3700
Before MICHAEL C. ASTORINO, BRUCE T. WIEDER, and
MATTHEW S. MEYERS, Administrative Patent Judges.
MEYERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 11, 12, and 29-38. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 Our decision references Appellants’ Appeal Brief (“Appeal Br.,” filed
October 26, 2012) and Reply Brief (“Reply Br.,” filed April 12, 2013), and
the Examiner’s Answer (“Ans.,” mailed February 13, 2013) and Final Office
Action (“Final Act.,” mailed November 10, 2011).
2 Appellants identify Asthmatx, Inc., as the real party in interest
(Appeal Br. 3).
Appeal 2013-006461
Application 11/617,512
CLAIMED INVENTION
Appellants’ invention relates “a new treatment for asthma” which
“comprises the application of energy to the airway smooth muscle tissue”
(Spec. 14).
Claim 11, reproduced below with added bracketed notations, is
illustrative of the subject matter on appeal:
11. A method, comprising:
[a] delivering a therapeutic energy to tissue at a first
treatment site of an airway of a lung via an energy delivery
device so as to treat asthma;
[b] filtering tissue images of a portion of the airway of the
lung proximate the first treatment site from a broncho scopic
visualization system, wherein the tissue images show both tissue
at the first treatment site that has received the therapeutic energy
from the energy delivery device and tissue apart from the first
treatment site that has not received the therapeutic energy from
the energy delivery device;
[c] determining a second treatment site along the portion
of the airway of the lung based on the filtered tissue images; and
[d] delivering the therapeutic energy to the second
treatment site via the energy delivery device.
Appeal Br. (Claims. App.).
REJECTIONS
Claim 33 is rejected under 35U.S.C. § 112, first paragraph, as failing
to comply with the written description requirement.
Claims 11, 12, and 29-38 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
Claims 11, 12, 29, and 32—38 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Laufer (US 5,972,026, iss. Oct. 26, 1999) and McGee
(US 5,722,403, iss. Mar. 3, 1998).
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Claims 30 and 31 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Laufer, McGee, and Changes in Birefringence as Markers
of Thermal Damage in Tissues to Thomsen et al. (hereinafter “Thomsen”)
and “Birefringence characterization of biological tissue by use of optical
coherence tomography” to Everett et al. (hereinafter “Everett”) (see Final
Act. 7).
ANALYSIS
Written description
In rejecting dependent claim 33 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement, the
Examiner finds that there is no written description support in the
Specification to support “the delivery of the therapeutic and non-therapeutic
energy to be occurring at the same time,” as required by claim 33 (Final
Act. 2). The Examiner maintains the rejection is proper because “at no time
has the Examiner found the placement of the source 242 on or in close
proximity to the energy transfer element 108 to necessarily or inherently
require that the therapeutic and non-therapeutic energies be delivered
simultaneously” (Ans. 10).
Appellants argue that the rejection “is improper because the Examiner
has not met his burden of showing that a person skilled in the art would not
recognize disclosure of claim 33 in Appellant’s disclosure” (Appeal Br. 9).
More particularly, Appellants argue that “[paragraphs 100 through 108 in
Appellant’s specification include disclosure of an illumination source” (id.)
which “may be configured to provide additional light when the device is
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used without a scope or to supplement the illumination of the scope” {id. at
10 (citing Spec. 1100).
Whether a specification complies with the written description
requirement of 35 U.S.C. § 112, first paragraph, is a question of fact and is
assessed on a case-by-case basis. See, e.g., Purdue Pharma L.P. v.
Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (citing Vas-Cath, Inc.
v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)). The disclosure, as
originally filed, need not literally describe the claimed subject matter (i.e.,
using the same terms or in haec verba) in order to satisfy the written
description requirement. But the Specification must convey with reasonable
clarity to those skilled in the art that, as of the filing date, Appellants were in
possession of the claimed invention (see id.).
Here, we agree with Appellants that one of ordinary skill in the art
would understand from the Specification, including at least paragraphs 100
through 108, that Appellants were in possession of the claimed subject
matter in question at the time the patent application was filed. See Vas-Cath,
Inc., 935 F.2d at 1562-63. In this regard, we agree with Appellants
it follows that since illumination source 242 is configured to
provide light when the device is being used, one of ordinary skill
in the art would understand that the disclosure adequately
supports simultaneous delivery of nontherapeutic energy (e.g.,
light) and therapeutic energy (e.g.[,j heat) to tissue at a treatment
site of the airway of a lung.
(Reply Br. 5).
In view of the above, we do not sustain the Examiner’s rejection of
claim 33 under 35 U.S.C. § 112, first paragraph, as failing to comply with
the written description requirement.
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Indefiniteness
We are persuaded by Appellants’ argument that the Examiner erred in
in rejecting independent claim 11 and dependent claims claim 12 and 29—38
under 35 U.S.C. § 112, second paragraph (see Appeal Br. 10-12).
In rejecting independent claim 11 as indefinite, the Examiner finds
it is unclear to the Examiner how if the tissue images are of the
portion of the airway of the lung proximate (defined as [1]
immediately preceding or following or [2] very near, close) the
first treatment site then the tissue images can then display both
tissue at the first treatment site and tissue apart from the first
treatment site as is currently claimed.
(Final Act. 3 (brackets in original)). The Examiner further notes that
because
the Examiner does not believe that the “tissue images of a portion
of the airway of the lung proximate the first treatment site”
encompass the tissue of the first treatment site, it is unclear to the
Examiner how the tissue images would then show both the tissue
of the first treatment site and the tissue apart from the first
treatment site.
(Ans. 12-13.).
In response, Appellants take the position that the Examiner’s rejection
is improper because “one skilled in the art would understand what is claimed
when the claim terms are given their ordinary and customary meaning”
(Appeal Br. 10-11). In this regard, Appellants assert that “an image of
tissue ‘proximate’ to a first treatment site should be interpreted as an image
of tissue that is ‘very near’ to the first treatment site,” and as such, “[t]he
language of claim 11 requires that ‘the tissue images [of a portion of the
lung airway proximate the first treatment site] show both tissue at the first
treatment site . . . and tissue apart from the first treatment site’” (id. at 12
(alterations original)).
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The test for indefiniteness under 35 U.S.C. § 112, second paragraph,
is whether those skilled in the art would understand what is claimed when
the claim is read in light of the specification. See Orthokinetics, Inc. v.
Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986). Here, we
agree with Appellants that a person of ordinary skill in the art would
understand that “the claim requires images of tissue near a first treatment
site to be filtered so as to include images showing both treated and untreated
tissue, which is clear in light of the disclosure in Appellant’s specification
differentiating treated tissue from untreated tissue using filtered images”
(Appeal Br. 12 (citing Spec. 25, 108—109)). We also agree with
Appellants that “the claim phrase requiring filtering of images of tissue
‘proximate the first treatment site,’ does not necessarily exclude the first
treatment site from the filtered images” (id.).
In view of the foregoing, we do not sustain the Examiner’s rejection
of claims 11, 12, and 29—38 under 35 U.S.C. § 112, second paragraph.
Obviousness
Independent claim 11 and dependent claims 12, 29, and 32—38
We are not persuaded by Appellants’ argument that the Examiner
erred in rejecting independent claim 11 under 35 U.S.C. § 103(a) because
the combination of Laufer and McGee fails to disclose or suggest limitations
[b] and [c] of independent claim 11 which recite
filtering tissue images of a portion of the airway of the
lung . . . wherein the tissue images show both tissue at the first
treatment site that has received the therapeutic energy. . . and
tissue apart from the first treatment site that has not received the
therapeutic energy; and determining a second treatment site
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along the portion of the airway of the lung based on the filtered
tissue images.
(See Appeal Br. 13—17; see also Reply Br. 6—12). Instead, we agree with the
Examiner that the combination of Laufer and McGee discloses the argued
limitations (see Final Act. 4—6 (citing Laufer, col. 9,11. 39-47; McGee,
col. 8,1. 25 — col. 9,1. 49); see also Ans. 13—17).
Laufer is directed “to a device and method for treatment of the airway
obstruction found in chronic obstructive pulmonary diseases (COPD), such
as cystic fibrosis, chronic bronchitis, emphysema, and asthma” (Laufer,
col. 1,11. 11—15). Laufer discloses
a bronchoscope 430 having a heat treatment apparatus 470
slidably positioned within a lumen. The device also includes an
image-transmitting fiber 450 and illuminating fiber 452. Any
conventional bronchoscope with an appropriately sized and
directed working lumen may be employed. The image
transmitting fiber collects light from the distal end of the treating
apparatus and directs the light to a viewing apparatus (not shown)
for displaying an image of the obstructed air passage. The
bronchoscope may have a panning system which enables the tips
to be moved in different directions.
(Id. at col. 9,11. 39-49). Laufer further discloses
[depending on the size of the treatment device, the treatment
device can be moved to another position for further heat
treatment of the air passage. This process can be repeated as
many times as necessary to form a series of patency bands
supporting an air passage. This procedure is applied to a
sufficient number of air passages until the physician determines
that he is finished.
(Id. at col. 9,11. 55—62).
McGee “is directed to systems and methods for visualizing interior
regions of the human body” (McGee, col. 1,11. 6—7). McGee discloses an
image acquisition element (IAE) which “can comprise an apparatus for
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obtaining an image through optical coherence tomography (OCT)” {id. at
col. 8,11. 26—29). More particularly, McGee discloses “[a] type of OCT
imaging device called an optical coherence domain reflectometer (OCDR)”
which “is capable of electronically performing two- and three-dimensional
image scans over an extended longitudinal or depth range with sharp focus
and high resolution and sensitivity over the range” {id. at col. 8,11. 34—38).
In this regard, McGee discloses
[t]he optical energy supplied to the distal optic path end 220 is
transmitted by the lens 228 for reflection by the surface 230
toward tissue T. The scanned tissue T (including anatomic
structures, other internal tissue topographic features, and
deposits or lesions on the tissue) reflects the optic energy, as will
the surrounding support structure 20. The reflected optic energy
returns via the optic path 222 to the optical coupler 240.
{Id. at col. 9,11. 1—8). McGee further discloses
[reflections received from the optical path 222 (from the lens
228) and the optical path 244 (from the end mirror 250) are
received by the optical coupler 240. The optical coupler 240
combines the reflected optical signals. Due to movement of the
comer-cube retro-reflector 246, the combined signals have
interference fringes for reflections in which the difference in the
reflected path lengths is less than the source coherence length.
Due to movement of the comer-cube retro-reflector 246, the
combined signals also have an instantaneous modulating
frequency.
{Id. at col. 9,11. 30-39). Following, McGee discloses that “[t]he combined
output is coupled via fiber optic path 252 to a signal processor 254. The
signal processor 254 converts the optical output of the coupler 240 to
voltage-varying electrical signals, which are demodulated and analyzed by a
microprocessor to provide an image output to a display device 256” {id. at
col. 9,11. 40-46).
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Appellants also argue that Laufer fails to disclose or suggest “filtering
images of tissue that include both treated and untreated tissue, much less
determining a second treatment site based on filtered images of treated and
untreated tissue” (Appeal Br. 13—14; see also Reply Br. 6—9). However,
Appellants’ argument is not persuasive at least because independent claim
11 is rejected as unpatentable over the combination of Laufer and McGee,
and not over Laufer alone. See In re Merck & Co., 800 F.2d 1091, 1097
(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking the
references individually where the rejection is based upon the teachings of a
combination of references.”). Here, the Examiner relies on Laufer to the
extent Laufer discloses
displaying tissue images of a portion of the airway of the
lung . . . wherein the tissue images show both tissue at the first
treatment site that has received the therapeutic energy. . . and
tissue apart from the first treatment site that has not received the
therapeutic energy... so as to differentiate treated tissue from
untreated tissue.
(Final Act. 5 (citing Laufer, col. 9,11. 39-47)). In this regard, the Examiner
takes the position that Laufer’s “bronchoscope functions via an image
transmitting fiber to provide the displaying of images of the airway to be
viewed by a user” (Ans. 14). The Examiner also relies on Laufer as
disclosing “determining a second treatment site along the portion of the
airway of the lung based on the tissue images” (Final Act. 5 (citing Laufer,
col. 9,11. 39-47), but acknowledges that “Laufer fails to specifically recite
that the tissue images are filtered with the determining being based on the
filtering and that such filtering is electronic” (Final Act. 5). And, to address
these deficiencies, the Examiner turns to McGee (id.). More particularly, the
Examiner relies on McGee as disclosing
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a similar expandable device as that of Laufer which includes a
visualization system for assessing areas which need treatment as
well as areas which have been treated. McGee further discloses
with respect to the embodiment in figure 25, the use of optical
coherence tomography (OCT) utilizing a fiber path to provide for
a[n] image with sharp focus and high resolution (see col. 8; 25—
61). McGee further discloses the function of such an OCT
system wherein the tissue images are processed/analyzed/filtered
by the system including an electronic signal processor (254) to
produce an image output for the user to view (see col. 8, 25 — col.
9; 49).
{Id. at 5—6). Thus, Appellants’ argument regarding Laufer alone is not
persuasive to show error in the Examiner’s rejection.
Appellants further argue that “McGee fails to teach the filtering of
images, much less determining a second treatment site based on filtered
images of treated and untreated tissue” (Appeal Br. 16; see also Reply Br.
10-12). Again, however, Appellants’ argument is not persuasive at least
because independent claim 11 is rejected as unpatentable over the
combination of Laufer and McGee, and not over McGee alone. See Merck,
800 F.2d at 1097. Here, the Examiner takes the position, and we agree
that McGee does indeed require the filtering of images acquired
by the OCT system when the image output is demodulated. It
then follows that, in order to obtain the tissue images of the of
the [sic] airway as discussed in Laufer utilizing that OCT system
of McGee, the displaying of the tissue images for observation by
the user would include the step of filtering the tissue images via
the demodulation of the tissue images. Given that the tissue
images in the combined system of Laufer and McGee are filtered
for the observation by the user, the subsequent determination of
a second treatment site (the repeating of the treatment at other
sites by the energy delivery device in col. 9; 58—60 of McGee)
would then be determined or “based” off these “filtered tissue
images”.
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(Ans. 16). Thus, Appellants’ argument regarding McGee alone is not
persuasive to show error in the Examiner’s rejection.
We also are not persuaded by Appellants’ argument that the Examiner
erred in rejecting independent claim 11 under 35 U.S.C. § 103(a) because
McGee, on which the Examiner relies, fails to disclose or suggest “a filtering
step,” as required by limitation [b], because McGee merely “teaches OCT
image processing that includes sharp focus, high resolution images, as well
as the teaching of demodulated and analyzed image output” (Appeal Br. 16—
17; see also Reply Br. 9-12). Instead, we agree with the Examiner that
McGee’s disclosure regarding demodulation (see McGee, col. 8,11. 26—38;
col. 9,11. 30-45) corresponds to the claimed “filtering” of images, as
required by independent claim 11. We note this interpretation is reasonable
in light of Appellants’ Specification which does not provide any explicit
definition of “filtering” but discloses generally that
digital (electronic) filtering of the image from CCD chip
mounted at the end of the bronchoscope may permit filtering for
desirable wavelengths and/or the image could be amplified to
enable discernment. In addition, so long as long [sic] the system
delivers light containing a broad spectrum of wavelengths,
electronic or manual filtering may allow for filtering out any
undesirable components.
(Spec. 1110).
In view of the foregoing, we sustain the Examiner’s rejection of
independent claim 11 under 35 U.S.C. § 103(a). For the same reasons, we
also sustain the Examiner’s rejection of claims 12, 29, and 32—38, which
were not separately argued.
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Dependent claims 30 and 31
Appellants do not present any additional arguments in support of the
patentability of claims 30 and 31 (see Appeal Br. 17; see also Reply Br. 12).
We are not persuaded, for the reasons outlined above, that the
Examiner erred in rejecting independent claim 11 under 35 U.S.C. § 103(a).
Therefore, we sustain the Examiner’s rejection of claims 30 and 31 under
35 U.S.C. § 103(a) for the same reasons.
DECISION
The Examiner’s rejection of claim 33 under 35 U.S.C. § 112, first
paragraph, is reversed.
The Examiner’s rejection of claims 11, 12, and 29—38 under 35 U.S.C.
§112, second paragraph, is reversed.
The Examiner’s rejections of claims 11, 12, and 29—38 under
35 U.S.C. § 103(a) are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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