Ex Parte Larson et al

Patent Trial and Appeal Board

Apr 13, 2016

12925611 (P.T.A.B. Apr. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/925,611 10/26/2010
48519 7590 04/15/2016
ROBERT L McDOWELL
1170 JACKSON HEIGHTS DR
WEBSTER, NY 14580-9367
FIRST NAMED INVENTOR
Marian L. Larson
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
ML-03-US 5724
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
04/15/2016 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):
rmcdowel@rochester.rr.com
rlmemcd@aol.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIAN L. LARSON and EUGENE A. LARSON
Appeal2014-002589
Application 12/925,611
Technology Center 3700
Before JENNIFER D. BAHR, WILLIAM A. CAPP, and
GEORGE R. HOSKINS, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the final
rejection of claims 1---6, 9, 11-15, 17-19, and 21 as unpatentable under 35
U.S.C. § 103(a) over Messerly (US 2009/0156926 Al, pub. June 18, 2009),
Neuberger (US 2004/0199151 Al, pub. Oct. 7, 2004), Souney (US
2002/0040186 Al, pub. Apr. 4, 2002), and Diederich (US 2007/0255267
Al, pub. Nov. 1, 2007). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal2014-002589
Application 12/925,611
THE INVENTION
Appellants' invention relates to a device for treating vascular disease.
Spec. i-f 2. Claim 1, reproduced below, is illustrative of the subject matter on
appeal.
1. An imaging and therapeutic medical device for the
treatment of vascular disease, said device comprising:
a transcutaneous imaging and/or Doppler flow modality to
visualize the site of treatment,
a therapeutic modality comprising a therapy catheter, said
catheter being movable through a vascular region during
treatment,
wherein said imaging modality and said therapeutic
modality are combined into a single device with said device
having a common user interface and display,
said imaging and/or Doppler flow modality providing
treatment site information including catheter position and blood
flow to the interface and display;
wherein said treatment site information is integrated with
the therapeutic modality to effect automatic real time
adjustment and optimization of therapy parameters including
control of therapy thermal dose and speed of movement of the
catheter.
OPINION
Appellants argue claims 1---6, 9, 11-15, 17-19, and 21 as a group.
Appeal Br. 10-16. We select claim 1 as representative. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015).
The Examiner finds that Messerly discloses an imaging and
therapeutic medical device for the treatment of vascular disease with a
transcutaneous imaging modality to visualize the site of treatment and a
moveable catheter that are combined in a single device with a common user
interface and display. Final Action 2. The Examiner relies on Souney as
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Application 12/925,611
disclosing Doppler ultrasound imaging for blood flow and velocity. Id. at 3.
The Examiner relies on Neuberger as disclosing treatment site information
that is integrated with a therapeutic modality/catheter to effect automatic real
time adjustment of therapy parameters including control of therapy radiation
dose and speed of movement of the catheter. Id. The Examiner relies on
Diederich to disclose controlling radiation/thermal dose based on real-time
feedback monitoring. Id. The Examiner concludes that it would have been
obvious to a person of ordinary skill in the art at the time the invention was
made to modify Messerly to use Doppler ultrasound imaging and automatic
real time adjustment of therapy parameters as taught by Souney, Neuberger,
and Diederich to achieve the claimed invention. Id. According to the
Examiner, a person of ordinary skill in the art would have done this for
effective therapy treatment that minimizes injury to healthy tissue. Id.
Appellants argue that modifying Messerly with the teaching of each of
Souney, Neuberger, and Diederich would render Messerly inoperable for its
intended purpose. Appeal Br. 11, 13. In response, the Examiner states that
each of Appellants' inoperability arguments is conclusory and lacks
evidentiary support. Ans. 8, 10-11. The Examiner explains that Messerly
already teaches the insertion of a catheter into a vascular lumen and explains
that Souney is relied on merely as incorporating well-known Doppler
principles in an ultrasound system. Id. at 8-9. The Examiner further
responds that using a catheter to provide therapy would not be considered
inoperative. Id. at 10. Appellants' inoperability arguments are not
persuasive as they amount to nothing more than unsubstantiated attorney
argument. See Invitrogen Corp. v. Clontech Labs, Inc., 429 F.3d 1052, 1068
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Application 12/925,611
(Fed. Cir. 2005) (unsubstantiated attorney argument is no substitute for
competent evidence).
Appellants attempt to distinguish their invention from Neuberger by
arguing that Neuberger is limited to monitoring and changing output based
on withdrawal speed. Appeal Br. 12. Appellants attack Neuberger as
measuring vein diameter prior to treatment and not by imaging during
treatment. Appeal Br. 12. In response, the Examiner states that the rejection
relies on the embodiment in paragraphs 33 and 34 of Neuberger and that
Appellants' factual allegations are based on a different embodiment. Ans. 9.
Neuberger discloses an embodiment with an optical speed and
position device through which a catheter can be advanced or withdrawn.
Neuberger i-f 33. This embodiment includes an illumination source (LED),
an imaging device, an image processing means, and means to relay speed or
position information to the control device. Id. Position and speed
information is continually relayed to the control unit which can then alter the
radiation dose. Id. In a further embodiment disclosed in paragraph 34, the
control unit controls both the speed of the withdrawal and the emitted power.
Id. i-f 34. The Examiner's finding that Neuberger discloses automatic, real
time adjustment and optimization of therapy parameters including control of
thermal dose and speed of movement of the catheter is supported by a
preponderance of the evidence.
Appellants' argument that Neuberger measures vein diameter prior to
treatment, even if true, does not apprise us of Examiner error. Neuberger
discloses that speed of movement of the catheter may vary based on changes
in vein diameter. Id. For purposes of the claim, as it is currently drafted, it
is immaterial whether vein diameter is measured before or during therapy.
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Application 12/925,611
The claim merely requires that treatment site information is integrated with
the therapy modality; it does not require that each and every item of
treatment site information that is provided to the interface and display is
provided in real time.
Appellants argue that Messerly does not disclose an energy output to
conduct therapy. Appeal Br. 11. Appellants argue that Messerly does not
move through a vasculature path while delivering a therapeutic treatment.
Id. This argument is unpersuasive as the Examiner relies on Neuberger as
disclosing therapy. Ans. 8 (citing Neuberger i-f 33). Similarly, with respect
to the claim limitation directed to providing treatment site blood flow
information to the interface and display, the Examiner relies on Souney as
disclosing Doppler ultrasound imaging of blood flow. Final Action 3 (citing
Souney i-fi-16, 60). Appellants do not dispute that Souney discloses Doppler
imaging. Appeal Br. 11. Appellants merely argue that Souney's disclosure
is "unrelated" to Messerly. Id. Also, Appellants attack Diederich as a
stationary system that does not obtain thermal information transcutaneously.
Appeal Br. 13. In response, the Examiner states that Messerly is relied on as
disclosing placing catheters at target sites and that Diederich is relied on as
disclosing using catheters to treat tissue at a target site. Ans. 11 (citing
Diedrich i-fi-1 79, 110).
Appellants' arguments amount to individual attacks on references that
are proposed in combination. However, non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references. In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 425 (CCPA
1981 ). Appellants essentially argue that attacking references individually is
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Application 12/925,611
an appropriate means to challenge an obviousness rejection. Appeal Br. 15-
16. 1 In view of case authorities such as Merck and Keller, we disagree with
Appellants' position. The Examiner's finding that the proposed combination
discloses an imaging/Doppler flow modality that provides treatment site
information including catheter position and blood flow to an interface and
display is supported by a preponderance of the evidence. Appellants have
advanced neither evidence nor persuasive technical reasoning that tends to
show that a person of ordinary skill in the art would not have been able to
combine the references in the manner proposed through the exercise of only
ordinary skill.
Finally, Appellants argue that the claimed invention uses outcome
from the treatment (changes in blood flow and catheter position) on a real
time basis to automatically control the speed of withdrawal of the catheter
and other parameters of the catheter therapeutic energy. Appeal Br. 15.
Appellants attempt to distinguish their invention by focusing attention on the
objectives purportedly achieved by their invention which relate to
Appellants' interpretation of the meaning of "proper" as used in the phrase
"proper thermal dose" in Appellants' Specification. Appeal Br. 14; see also
Spec. i-fi-1 34, 41. Appellants contend that the invention uses real time
imaging information based on morphology (blood flow) and that a "proper"
1 "Each reference has its deficiencies that render the combination inadequate
to suggest the claimed invention. To say Applicants cannot address the
weakness of each reference and explain how such weakness renders the
overall combination lacking in leading the skilled artisan to the claimed
invention is unreasonable. Applicants have commented on each reference
but such comments have ultimately been directed to how the suggested
combination is lacking and still does not direct one to the claimed
invention." Appeal Br. 15-16.
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Application 12/925,611
dose relates to changing morphology of the venous tissue. Appeal Br. 14. 2
Appellants summarize their position by arguing:
The claimed invention links real-time therapy outcome (as
imaged and quantified by Doppler blood flow change resulting
from the vein response to therapeutic heat) to the control of
catheter withdrawal and other parameters linked to therapeutic
power output, such that the continuation of treatment benefits
real-time from the outcome of the immediate past treatment.
Appeal Br. 16.
The Examiner responds by stating that Neuberger adjusts the energy
level based on morphology of the venous tissue. Ans. 11 (citing Neuberger
i-fi-1 3 7, 46, 51 ). In addition, the Examiner states, in essence, that Appellants'
argument is not commensurate with the scope of the claims. Ans. 12.
The term "proper thermal dose" does not appear in claim 1. 3 During
examination of a patent application, pending claims are given their broadest
reasonable construction consistent with the specification. In re Am. Acad. of
Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Essentially,
Appellants urge us to narrow the scope of the language in claim 1 directed to
effecting "automatic real time adjustment and optimization of therapy
2 "There is a differentiating definition of proper (which Applicants use in
reference to 'changing morphology of the venous tissue) and "constant
energy levels["] as disclosed by Neuberger. Appeal Br. 14.
3 The phrase "proper thermal dose" does appear in claim 12, which depends
indirectly from claim 1, and it also appears in claim 18, which depends
indirectly from claim 13. Claims App. However, Appellants' Appeal Brief
does not identify the claims in which the phrase "proper thermal dose"
appears. Appeal Br. 14. Under the circumstances, we do not consider
Appellants to have properly set forth separate arguments for the patentability
of claims 12 and 18. See 37 C.F.R. § 41.37(c)(iv) ("any claims argued
separately ... shall be argued under a separate subheading that identifies the
claim( s) by number.").
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Application 12/925,611
parameters" by importing Appellants' construction of "proper thermal dose"
as it is purportedly used in the Specification. However, it is improper to
read a limitation from the specification into the claims. See Arlington
Indus., Inc. v. Bridgeport Fittings, Inc., 345 F.3d 1318, 1327 (Fed. Cir.
2003). Appellants' "proper thermal dose" argument is not commensurate
with the scope of claim 1. The Examiner's finding that the proposed
combination discloses automatic real time adjustment and optimization of
therapy parameters is supported by a preponderance of the evidence.
We have considered Appellants' other arguments and find them to be
without merit. We sustain the rejection of claim 1---6, 9, 11-15, 17-19,
and 21.
DECISION
The decision of the Examiner to reject claims 1---6, 9, 11-15, 17-19,
and 21 is 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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