Ex Parte Steinke et al

Board of Patent Appeals and Interferences

Jul 18, 2012

11122263 (B.P.A.I. Jul. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte TOM A. STEINKE, CORBETT W. STONE, and
RAPHAEL M. MICHEL
____________

Appeal 2009-014766
Application 11/122,263
Technology Center 3700
____________

Before LINDA E. HORNER, MICHAEL C. ASTORINO, and
JOHN W. MORRISON, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Tom A. Steinke et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s decision rejecting claims 2, 4-16, 18-31, and 33-38
under 35 U.S.C. § 103(a) as unpatentable over Kittrell ‘431 (US 5,199,431;
iss. Apr. 6, 1993), MacKinnon (US 6,546,272 B1; iss. Apr. 8, 2003), Kittrell
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‘100 (US 5,562,100; iss. Oct. 8, 1996), and Casscells (US 2004/0111016
A1; pub. Jun. 10, 2004).1 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
THE INVENTION
Appellants’ claimed invention relates to “devices, systems, and
methods which facilitate the controlled detection, characterization, and
selective eccentric removal of atherosclerotic plaques in arteries via a laser
catheter system.” Spec. 1, para. [0006]. Claim 2, reproduced below, is
representative of the subject matter on appeal.
2. A catheter system for remodeling of
atherosclerotic material within a blood vessel of a patient,
the system comprising:
an elongate catheter having a proximal end and a
distal end with an axis therebetween, the catheter having at
least one window for transmission of laser energy near the
distal end;
at least one optical conduit extending between the
proximal end of the catheter and the at least one window;

1 Appellants submitted an after-final Amendment in which they sought to
cancel claims 3 and 39-44 and amend claims 2, 18, and 33. Amendment
under 37 CFR 1.116, dated Jul. 28, 2008. The Examiner entered the after-
final Amendment, which rendered moot the following rejections made in the
final Office Action: claims 18, 20-31, 33, and 35-38 under 35 U.S.C.
§ 102(b) as anticipated by Kittrell ‘431; claims 41 and 43 under 35 U.S.C.
§ 102(b) as anticipated by Kittrell ‘100; claim 39 under 35 U.S.C. § 103(a)
as unpatentable over Kittrell ‘100 and MacKinnon; claim 40 under
35 U.S.C. § 103(a) as unpatentable over Kittrell ‘100, MacKinnon, and
Casscells; and claims 42 and 44 under 35 U.S.C. § 103(a) as unpatentable
over Kittrell ‘431, MacKinnon, and Casscells. Advisory Action, dated Aug.
11, 2008; Ans. 2-4. The Examiner stated in the Advisory Action that “[t]he
rejections applied to [cancelled claims 40, 42, and 44]; the combination of
MacKinnon et al, Kittrell et al (‘100 and ‘431), and Casscells, III et al still
apply to the amended claims.” Advisory Action at p. 2.
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an optical coherence tomographer coupled to the at
least one optical conduit, the tomographer generating
image signals from imaging light from a plaque so as to
characterize the plaque, the imaging light transmitted
through the at least one window; and
a remodeling laser coupled to the tomographer, the
laser transmitting plaque-remodeling laser energy based
on the characterized plaque to the at least one optical
conduit in response to the imaging signals, wherein the
remodeling laser energy is less than plaque ablation
energy such that the plaque is remodeled by mildly heating
the plaque without ablating.
ISSUES
Appellants argue that the rejection of independent claims 2, 18, and
332 should not be sustained because “[t]he scope and contents of the [prior
art] fail to teach the remodeling of plaque with laser energy that is based on
the characterized plaque and that is less than plaque ablation energy such
that the plaque is remodeled by mildly heating the plaque without ablating.”
Reply Br. 10 (claim 2), 16 (claim 18), and 20 (claim 33).3

2 Appellants do not present separate arguments for dependent claims 4, 14-
16, 19-31, and 34-38. These dependent claims stand or fall with their
respective independent claims. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
3 Appellants argue in the Supplemental Appeal Brief that methods disclosed
for determining a tissue type in Casscells, MacKinnon, Kittrell ‘100, and
Kittrell ‘431 are “completely different” and “appear to be non-compatible
with each other” and that the rejections based on these three references are
“conclusory and the Examiner did not articulate adequate rationale to
modify and/or combine [the references] so as to provide the presently
claimed invention.” See, e.g., Supp. App. Br. 11-12. For the reasons
discussed infra and provided in the Response to Arguments section of the
Examiner’s Answer, we find the prior art is properly combinable and that the
Examiner articulated adequate reasoning based on rational underpinnings for
combining the prior art in the manner claimed. See Ans. 6, 10-14.
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Appellants further argue the rejection of independent claim 2 is
improper because “[t]he scope and contents of the prior art fail to teach the
use of optical coherence tomography to characterize plaque.” Reply Br. 8.
Appellants also argue that the rejection of dependent claim 54 is
improper because “[t]he scope and contents of the prior art fails to teach a
remodeling laser used in the treatment of plaque eccentrically offset from the
catheter relative to the axis (of the elongate catheter).” Reply Br. 13.
The issues presented by this appeal are:
Would the prior art, when combined, have resulted in a system and
method that includes characterizing plaque and remodeling the plaque with
laser energy that is based on the characterized plaque and that is less than
plaque ablation energy such that the plaque is remodeled by mildly heating
the plaque without ablating?
Would the prior art, when combined, have resulted in a system that
uses optical coherence tomography to characterize plaque?
Would the prior art, when combined, have resulted in a system that
uses a remodeling laser in the treatment of plaque eccentrically offset from
the catheter relative to the axis of the elongate catheter?
ANALYSIS
Remodeling of plaque
With regard to the argument that the prior art does not teach
remodeling of plaque, Appellants argue each of the references individually
and fail to address the Examiner’s rejection, which is based on a
determination of what would have been obvious to one of ordinary skill in

4 Appellants argue claims 5-13 as a group. Reply Br. 14. We select claim 5
as representative. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
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the art in view of the combined teachings of the prior art. One cannot show
nonobviousness by attacking references individually where the rejections are
based on combinations of references. See In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986) (citation omitted); In re Keller, 642 F.2d 413,
426 (CCPA 1981) (citation omitted).
In particular, Appellants argue that Kittrell ‘431 discloses a laser
catheter for ablating tissue and does not remodel the tissue by mild heating
without ablating. Reply Br. 11. This argument is not persuasive because the
Examiner did not rely on Kittrell ‘431 to teach remodeling of plaque without
ablating. See Ans. 8-9 (Examiner relies on Casscells to “teach the
desirability of treating certain types of plaques, known as vulnerable
plaques[,] using gentle heating”). For the same reason, Appellants’
arguments that MacKinnon and Kittrell ‘100 fail to teach remodeling of
plaque by mild heating without ablation is not persuasive. Reply Br. 11.
With regard to Casscells, Appellants argue that while Casscells
mentions “gentle heat treatment” of atherosclerotic plaque, it “only casually
mentions ‘a catheter equipped with a laser’” and that “[t]he remodeling of
plaque by ‘mildly heating the plaque’ with laser energy and ‘without
ablation,’ particularly based on the OCT image and/or associated
characterization of the plaque, is not disclosed.” Id.
Casscells discloses that “appropriate gentle heating of the vulnerable
plaques can be accomplished with any suitable heating catheter that is able
to regulate the temperature applied to the plaque at 39º - 44º C. for 5 to 60
minutes, and which includes means for perfusing the downstream portion of
the vessel.” Casscells, para. [0171]. Casscells also teaches the use of a
“multi-parameter catheter system [that] includes means for visible
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wavelength monitoring of the color and physical appearance of plaque and
the vessel wall surface as the catheter is moved within the vessel” as a
means to detect the vulnerable plaque. Casscells, para. [0107]. Thus,
Casscells discloses the need to image and characterize the plaque as
vulnerable plaque based on the chemical composition and an image of the
plaque and then mildly heating the plaque without ablation. While Casscells
does not disclose using an image obtained by optical coherence tomography,
the Examiner relied on MacKinnon for this disclosure, which is discussed
infra. Further, the Examiner’s rejection is based on using the laser catheter
of Kittrell ‘431 to administer the technique of using mild heat to treat
vulnerable plaques. Ans. 6, 9-10. As such, Appellants’ argument that
Casscells “only casually mentions ‘a catheter equipped with a laser’” is not
persuasive of error.
Use of optical coherence tomography to characterize plaque
Appellants argue that Kittrell ‘431, Kittrell ‘100, and Casscells do not
disclose “the use of optical coherence tomography (OCT) or characterizing
tissue using OCT.” Reply Br. 9-10. This argument is not persuasive
because the Examiner did not rely on Kittrell ‘431, Kittrell ‘100, or
Casscells to teach the use of OCT. See Ans. 6, 8-9 (Examiner relies on
MacKinnon to teach using OCT to provide images of extremely fine
resolution in real time, Kittrell ‘100 to teach a plaque discrimination device
that uses laser induced fluorescence, and Casscells to teach treatment of
vulnerable plaques by remodeling and detection of such vulnerable plaques
based on their chemical composition).
With regard to MacKinnon, Appellants argue that “OCT is only
mentioned in the context of image acquisition, not in the context of
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characterizing any body structures.” Reply Br. 9. This argument is not
persuasive of error because it is not commensurate with the scope of claim 2
and it does not address the Examiner’s proposed combination of the
teachings of the prior art. The argument is not commensurate with the scope
of claim 2 because the claim recites “an optical coherence tomographer . . .
generating image signals from imaging light from a plaque so as to
characterize the plaque.” App. Br. 21, Claims Appx., emphasis added. The
claim does not call for the optical coherence tomography or any analyzer
device to characterize the plaque. Rather, the claim broadly recites that the
image signals from the OCT are used to characterize the plaque. As such,
the claim encompasses a physician viewing the image provided by the OCT
in order to characterize the plaque. The claim also encompasses an analyzer
that uses the image signals from the OCT along with other data to
characterize the plaque.
Appellants’ argument also fails to address the Examiner’s proposed
combination of the teachings of the references. The Examiner determined
that Casscells “teaches detecting such [vulnerable] plaques based on their
chemical composition, which is determined by spectroscopy” and Kittrell
‘431 “teach[es] a laser catheter with a plurality of optical fibers that
transport diagnostic light to the distal end of the fiber which allows spectral
diagnostics to determine whether or not the tissue is to be removed.”
Ans. 9-10. We agree with the Examiner that it would have been obvious to
use the laser catheter of Kittrell ‘431 to identify vulnerable plaques, as
determined by spectroscopy, as taught by Casscells, accompanied by
supplemental visual monitoring of the plaque, as taught by Casscells (para.
[0107-0108]) to characterize a vulnerable plaque, and that it would have also
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been obvious to one of ordinary skill to use optical coherence tomography to
acquire an image of the plaque for visual monitoring because of its high
resolution, as taught by MacKinnon. MacKinnon, col. 1, ll. 30-44. As such,
Appellants’ argument that MacKinnon fails to explicitly teach using OCT to
characterize body structures is not persuasive of error.
Appellants assert that MacKinnon teaches away from using OCT for
characterizing tissue in vivo by suggesting that “it is still desirable to be able
to conduct a biopsy of the site to obtain a sample that can be analyzed using
conventional diagnostic tests and techniques.” Reply Br. 9 (citing
MacKinnon, col. 9, ll. 1-23). The fact that MacKinnon provides its catheter
with a removable scanning unit so that the catheter passage can
accommodate a conventional biopsy tool does not teach away from using
OCT to characterize tissue in vivo. Rather, MacKinnon teaches that the
OCT catheter apparatus “is able to provide detailed in viva images of the site
of interest for diagnostic purposes.” MacKinnon, col. 9, ll. 1-3. Diagnosing
the condition of the tissue/matter at the site of interest would encompass
characterizing the tissue/matter based on the in vivo images provided by the
OCT catheter. As such, this teaching supports a finding that MacKinnon
teaches using image signals generated from OCT to characterize plaque.
The fact that MacKinnon’s catheter can also accommodate a biopsy tool for
further analysis of the tissue does not detract from this teaching. Ans. 8.
Treatment of eccentrically offset plaque
Claim 5 depends from independent claim 2 and recites “wherein the at
least one window is radially oriented for imaging and remodeling of plaque
eccentrically offset from the catheter relative to the axis.” App. Br. 21,
Claims Appx. Appellants argue that “neither Kittrell et al (‘431),
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MacKinnon et al, Kittrell (‘100), nor Casscells, III et al teach a remodeling
laser used in the treatment of plaque eccentrically offset from the catheter
relative to the axis (of the elongate catheter) as required by claim 5.” Reply
Br. 14. The Examiner found that Kittrell ‘431 teaches a laser catheter for
removing plaque eccentrically offset from the catheter relative to the axis
and that it would have been obvious to modify the catheter of Kittrell ‘431 to
use it to characterize and remodel vulnerable plaques based on the teachings
of MacKinnon, Kittrell ‘100, and Casscells. Ans. 14-15. We agree with the
Examiner that Kittrell ‘431 teaches treatment of plaque eccentrically offset
from the catheter relative to the axis. Kittrell ‘431, figs. 17A-D, col. 16, ll.
14-33. The fact that Kittrell ‘431 does not arguably teach a “remodeling
laser” is not persuasive of error because the Examiner has proposed to
modify Kittrell’s laser so that it remodels vulnerable plaque without
ablating.
CONCLUSIONS
The prior art, when combined, would have resulted in a system and
method that includes characterizing plaque and remodeling the plaque with
laser energy that is based on the characterized plaque and that is less than
plaque ablation energy such that the plaque is remodeled by mildly heating
the plaque without ablating.
The prior art, when combined, would have resulted in system that uses
optical coherence tomography to characterize plaque.
The prior art, when combined, would have resulted in system that uses
a remodeling laser in the treatment of plaque eccentrically offset from the
catheter relative to the axis of the elongate catheter.
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DECISION
We AFFIRM the decision of the Examiner to reject claims 2, 4-16,
18-31, and 33-38.
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

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