Ex Parte Warnking

Patent Trials and Appeals Board

May 22, 2019

12227508 - (D) (P.T.A.B. May. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/227,508 02/03/2010 Reinhard Warnking
30542 7590 05/24/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
109317-2201 9204
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
05/24/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REINHARD WARNKING 1
Appeal2017-009245
Application 12/227,508
Technology Center 3700
Before JOHN C. KERINS, MICHAEL L. HOELTER, and
SEAN P. O'HANLON, Administrative Patent Judges.
KERINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from a final rejection of
claims 46-49, 51, and 52. We have jurisdiction over this appeal under 35
U.S.C. § 6(b). An oral hearing was conducted on May 7, 2019, with Nicola
A. Pisano, Esq., appearing on behalf of Appellant.
We REVERSE.
THE INVENTION
Appellant's invention relates to a method of ablating a volume of
target tissue while reducing the risk of ablating untargeted tissue distal to the
1 ReCor Medical, Inc., is identified as the real party-in-interest in this appeal.
Appeal Br. 3.
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Application 12/227,508
target tissue. Independent claim 46 is illustrative of the claimed invention
and reads as follows:
46. A method of ablating a volume of target tissue while
reducing the risk of ablating untargeted tissue distal to the target
tissue, the method comprising:
inserting into a body lumen an ablation catheter comprising at a
distal region having an ultrasound transducer configured to emit
and deliver energy to target tissue;
providing power at a first level to the ultrasound transducer for a
first time duration sufficient to ablate at least a portion of the
target tissue so as to create an initial lesion that forms a protective
barrier to obstruct subsequently emitted energy traveling toward
collateral anatomical structures distal to the initial lesion, and
thereby reduces damage to untargeted tissue distal to the target
tissue; and
upon completion of the first time duration, modulating power to
the ultrasound transducer by cycling between the first power
level and a second power level to deliver energy to the target
tissue disposed proximal to the protective barrier for a second
time duration to completely ablate the volume of target tissue,
wherein modulating power is predetermined empirically.
THE REJECTION
The Examiner rejects claims 46-49, 51, and 52 under 35 U.S.C.
§ I03(a) as being unpatentable over Fjield (US 2002/0065512 Al, published
May 30, 2002) in view of Shields (US 2007 /0249046 Al, published Oct. 25,
2007), Mandrusov (US 6,740,040 Bl, issued May 25, 2004), and McClurken
(US 2002/0062123 Al, May 23, 2002).
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Application 12/227,508
ANALYSIS
The Examiner finds that Fjield discloses the subject matter of claim
46, with the exception of modulating power, upon completion of a first time
duration in which power is not modulated and delivered at a first power
level, to an ultrasound transducer by cycling the power between that first
power level, and a second power level for a second time duration to
completely ablate the volume of target tissue. Final Act. 2-3. The
Examiner relies on Shields as disclosing the cycling of ultrasound power to
control temperature, to thereby prevent thermal damage to normal tissue. Id.
at 3, citing Shields, para. 8. The Examiner additionally relies on Mandrusov
as disclosing a process that creates lesions and controls a duty cycle of a
power source to prevent a temperature from exceeding a desired level, so as
to prevent damage to healthy tissue. Id., citing Mandrusov, col. 5, 11. 25-
45.2
The Examiner concludes that, in light of the teachings of Shields and
Mandrusov, it would have been obvious to modify the Fjield ultrasound
transducer device to include a power supply that cycles between on and off
conditions, in order to maintain the tissue acted on by the ultrasonic energy
at a certain temperature, to prevent overheating of the transducer and injury
to a patient undergoing treatment. Final Act. 4. The Examiner explains, in
response to certain arguments advanced by Appellant, that both Fjield and
2 The Examiner additionally relies on McClurken as being germane to the
claim recitation requiring power modulation to be empirically
predetermined, in the proffered obviousness rejection. Final Act. 3--4.
Because we decide the issues in this appeal based on a proposed
combination of the teachings of the other cited references, we do not address
the Examiner's findings and conclusions involving McClurken.
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Application 12/227,508
Shields involve attempts to minimize collateral damage to neighboring tissue
due to excessive tissue temperatures, and that the proposed modification to
Fjield would do so by cycling the power generated by the ultrasound device
ofFjield. Ans. 7. The Examiner's further elaboration as to the reliance on
Mandrusov is in the same vein. Id. at 8-9.
Fjield recognizes a desire to avoid or minimize collateral damage to
neighboring tissue in its method for ablating target tissue, using ultrasound
energy, in order to create an electrical conduction block in cardiac tissue.
See, e.g., Fjield, paras. 8, 16. Fjield additionally expresses that it is desirable
to provide a complete conduction block by ablating the tissue through the
entire thickness of the wall, so at to form a transmural lesion. Id., para. 59.
Fjield professes to achieve these goals by providing a device that directs
ultrasound energy into a focused, annular treatment region that produces
rapid heating and scarring of the tissue at a focal point within the tissue, as
well as in neighboring tissue. Id., paras. 14--17, 59.
Appellant maintains that it would not have been obvious to modify the
Fjield teaching in view of Shields, in that Shields does not involve tissue
ablation, and instead discloses power modulation to accomplish objectives
other than thermal ablation, notably in order to provide non-thermal effects
without causing tissue damage. 3 Appeal Br. 8. Appellant characterizes the
proposed modification of Fjield in view of Shields as being the product of
3 We do not agree with Appellant's contention that Shields teaches away
from using ultrasound energy for tissue ablation in general; rather, Shields
recognizes that the use of ultrasound energy may cause tissue ablation, and
the particular application to which Shields is directed is one in which
ablation is undesirable. Appeal Br. 8.
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Application 12/227,508
impermissible hindsight reconstruction in view of Appellant's disclosure.
Id.
We agree with Appellant that the proposed combination would not
have been obvious absent considerations found, on this record, only in
Appellant's disclosure. Neither reference involves a control scheme in
which a first power level is used in a first time duration, and then a different,
modulated power is used in a second time duration. Fjield recognizes that a
relationship exists between applied power levels and times required to obtain
the desired ablation, and expresses a preference for selecting a higher power
so as to reduce the scar or lesion formation time, apparently in the belief that
a shorter treatment time would have the effect of reducing damage to
neighboring tissue. Fjield, paras. 8, 59. The proposed modification, which
would result in a lower power, and presumably an extended period of time in
which the ultrasound energy is applied, during a second period, would be at
cross-purposes to Fjield's preferred control scheme. In effect, a person of
ordinary skill in the art would have had no reasonable expectation that the
modification would yield the result that there would be less damage to
neighboring tissue, unless the power modulation were to decrease the
effective power to a level at which no further tissue is ablated, including
further tissue desired to be ablated.
The proposed modification of Fjield in view of Mandrusov is
similarly flawed. The Examiner takes the position that Mandrusov is relied
on as disclosing creation of lesions, while controlling a duty cycle of the
power source in order to prevent a temperature form exceeding a desired
level that would cause damage to healthy tissue. Ans. 9, citing Mandrusov,
col. 5, 11. 25-45 and cl. 6. Mandrusov, like Shields, discloses the general
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Application 12/227,508
notion that ultrasound power may be modulated or controlled so as to
maintain a temperature that does not engender tissue damage. Mandrusov,
col. 5, 11. 25--45. This portion of Mandrusov relied on by the Examiner is
not actually directed to maintaining a particular temperature of the tissue
being treated, but rather is directed to maintaining the temperature of the
ultrasound transducer itself so that it does not damage blood or tissue with
which it may come into contact. Such a control scheme bears little to no
relation to a control scheme for applying power to tissue to ablate or scar the
tissue in a desired region while minimizing damage to neighboring tissue.
The combined teachings of Fjield and Mandrusov would have provided no
reasonable expectation that the proposed modification would yield the result
that there would be less damage to neighboring tissue, unless, however, the
power modulation decreases the effective power to a level at which no
further tissue is ablated, including tissue desired to be ablated.
The Examiner's articulated reasons to combine the teachings of Fjield
and Mandrusov are therefore seen to be lacking in rational underpinnings.
Accordingly, we do not sustain the rejection of claim 46, and of claims 4 7-
49, 51, and 52 depending therefrom, as being unpatentable over Fjield in
view of Shields, Mandrusov, and McClurken.
DECISION
The rejection of claims 46--49, 51, and 52 is reversed.
REVERSED
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