Ex Parte Sliwa

Patent Trial and Appeal Board

Jun 7, 2017

12346042 (P.T.A.B. Jun. 7, 2017)

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.
12/346,042 12/30/2008 JohnW. Sliwa 0E-043600US/065513-000088 8800
67337 7590 06/09/2017
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
EXAMINER
GUPTA, VANI
ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
06/09/2017 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):
MN_IPMail @ dykema. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN W. SLIWA1
Appeal 2016-001511
Application 12/346,042
Technology Center 3700
Before RICHARD J. SMITH, TAWEN CHANG, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for both providing therapy to a tissue and detecting a characteristic of said
tissue. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellant, the real party in interest is St. Jude Medical, Atrial
Fibrillation Division, Inc. (Appeal Br. 3.)
Appeal 2016-001511
Application 12/346,042
STATEMENT OF THE CASE
Background
“It is common to diagnose or assess the state of tissue in a body
contemporaneously with treatment of the tissue by either imaging the
affected tissue or sensing one or more characteristics of the tissue. Cardiac
tissue undergoing ablation to create tissue necrosis, for example, is often
imaged using a separate internal or external imaging device (e.g., an
intravascular ultrasound (IVUS) catheter).” (Spec. 12.)
Claims on Appeal
Claims 4—26 and 29—32 are on appeal. (Claims Appendix, Appeal Br.
22—26.) Claim 5 is illustrative and reads as follows:
5. A device for both providing therapy to a tissue and detecting a
characteristic of said tissue, comprising:
a deformable, tubular body including a connector configured to
connect to an irrigation fluid source;
an electrode supported by said body and configured to deliver
therapeutic energy to said tissue along a first path, said electrode
including an aperture extending through a wall of said electrode and
in fluid communication with said irrigation fluid source, said aperture
configured to deliver irrigation fluid to the tissue;
an acoustic transducer supported by said body and configured
to receive acoustic energy along a second path wherein said first path
and said second path are aligned; and,
an electronic control unit configured to receive a signal
generated by said acoustic transducer responsive to said acoustic
energy and to determine said characteristic of said tissue responsive to
said signal
wherein said electronic control unit controls delivery of said
therapeutic energy responsive to said characteristic of said tissue.
(Appeal Br. 22 (Claims App’x).)
2
Appeal 2016-001511
Application 12/346,042
Examiner’s Rejection’s
1. Claims 4—14, 18—26, and 29—32 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Govari2 and Coen.3 (Ans. 2—10.)
2. Claims 15 and 16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Govari, Coen, and Johnson.4 (Ans. 10-11.)
3. Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Govari, Coen, and Azure.5 (Ans. 11.)
ISSUE
Whether a preponderance of evidence of record supports the
Examiner’s rejections under 35 U.S.C. § 103(a).
ANALYSIS
This issue in this appeal turns on the following limitations that appear
in each of the independent claims (5, 10, and 29):
an electrode supported by said body and configured to deliver
therapeutic energy to said tissue along a first path, said electrode
including an aperture extending through a wall of said electrode and
in fluid communication with said irrigation fluid source, said aperture
configured to deliver irrigation fluid to the tissue.
(Appeal Br. 22, 23, and 25—26.)
The Examiner’s rejections are based on the teachings of alternate
embodiments of Govari, as illustrated in FIG. 2 and FIG. 4B below, and
Coen. (Ans. 2—11.)
2 Govari et al., US 2009/0149753 Al, pub. June 11, 2009 (“Govari”).
3 Coen et al., US 2005/0177151 Al, pub. Aug. 11, 2005 (“Coen”).
4 Johnson et al., US 2003/0109871 Al, pub. June 12, 2003 (“Johnson”).
5 Azure, US 2008/0071264 Al, pub. March 20, 2008 (“Azure”).
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Appeal 2016-001511
Application 12/346,042
Fig. 2 above is an illustration of a tissue probe from Govari.
Figure 4B above is an illustration of a tissue probe from Govari.
The Examiner finds that Govari teaches an electrode 62 supported by
a body and configured to deliver therapeutic energy to tissue along a first
path. (Ans. 3; see FIG. 2 above.) The Examiner notes that electrode 62
“does not include an aperture extending through a wall of said electrode and
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Appeal 2016-001511
Application 12/346,042
in fluid communication with said irrigation fluid source, said aperture
configured to deliver fluid to the tissue.” (Ans. 3.) However, the Examiner
relies on FIG. 4B of Govari to suggest “an electrode (82)6 that behaves in the
same way as electrode (62). ft has a central aperture (86) in the electrode [],
which is in fluid communication with said fluid source via the tube 92 [],
said aperture configured to deliver fluid to the tissue.” (Id.) The Examiner
refers to paragraph 79 of Govari as support for the limitations of “fluid
communication” and delivery of fluid to the tissue. (Id.) Paragraph 79 of
Govari reads as follows:
[0079] In contrast to probes 70 and 80, probe 91 performs
ablation cryogenically, so that the ablation element of probe
91 comprises a cooling element 93. Element 93 is typically
formed in the shape of a generally hollow toroid, the region at
the center of the toroid, aperture 86, being filled by material
88. Element 93 receives cold gas, via a supply tube 92, from
ablation module 32, and also exhausts the gas, via a tube not
shown in FIG. 4B. The outer walls of element 93 thus cool and
ablate tissue 66. However, it will be appreciated that probe 91
may comprise any other convenient cryogenic system for
ablating tissue 66. For operating probe 91, module 32, in
addition to being configured as a transceiver, also supplies
cold gas, typically by evaporating liquid nitrogen, to tube 92.
(Govari 179.)
The Examiner refers to Coen as teaching “irrigation fluid that ‘flows
through fluid lumen and exists out of annular aperture and over ablation
electrode.”’ (Ans. 4, citing Coen 135.) FIG. 2B of Coen is illustrated
below.
6 Electrode 82 is actually illustrated in FIG. 4A of Govari, and FIG. 4B
illustrates a cooling element 93. (Govari 179.)
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Appeal 2016-001511
Application 12/346,042
Figure 2B above is an illustration of an ablation electrode device of
Coen.
Based on the foregoing, the Examiner concludes that it would have
been obvious to one skilled in the art to modify the tubular structure of FIG.
2 of Govari to include the connector connected to a fluid source of FIG. 4B
of Govari, “to provide one[] with additional means of treating the tissue of
interest, as described in paragraph [0079]” and to “modify the electrode of
[FIG. 2 of Govari] to include the electrode with an aperture of [FIG. 4B of
Govari] also for the same reasons indicated in paragraph [0079].” (Ans. 4.)
The Examiner also concludes that it would have been obvious to one
skilled in the art
to modify the cryogenic therapy teachings of Govari to include
the fluid irrigation flow path through electrode aperture teachings
of Coen to include additional means [for] cooling effects of the
exiting irrigation fluid, supplementing Govari’s means of
cooling and ablating tissue [], thereby maximizing the size and
depth of the ablation lesion and reducing the duration of the
ablation process.7
(Id. at 5.)
7 Coen states that cooling of the electrode “[maximizes] the size and depth of
the ablation lesion and [reduces] the duration of the ablation process.”
(Coen Abstract.)
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Appeal 2016-001511
Application 12/346,042
Appellant contests the Examiner’s incorporation of certain features of
the cryogenic ablation catheter illustrated in FIG. 4B of Govari with the
radio-frequency ablation catheter of FIG. 2 of Govari. (Appeal Br. 5—9.) In
particular, Appellant argues that “the aperture 86 is clearly not ‘in fluid
communication with said fluid source’” and that “no fluid ever reaches or
flows through aperture 86 and therefore is not ‘deliver[ed] ... to said
tissue.’” {Id. at 6.) Moreover, according to Appellant, the embodiments in
Figures 2 and 4B of Govari “are mutually exclusive due to their reliance on
different forms of ablation energy.” {Id. at 8.) As to Coen, Appellant
argues that “[t]he aperture (100) of Coen clearly exists outside of the
electrode (90) and irrigation flowing through the aperture (100) flows
around an outer wall of the electrode (90) as illustrated in Figure 2B.” {Id. at
7-8.)
We find that Appellant has the better position. The Examiner bears
the initial burden of establishing a prima facie case of obviousness, and has
not done so. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In
this case, the Examiner does not provide a clearly articulated “reason that
would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does.” KSR
Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
As an initial matter, we agree with Appellant that the radio-frequency
ablation electrode 62 of Govari’s FIG. 2 is distinguishable from the
cryogenic ablation cooling element 93 of FIG. 4B. Moreover, the aperture
86 in cooling element 93 is filled with a material 88, such as silicone, and
the cold gas enters and exists element 93, whereby “[t]he outer walls of
element 93 thus cool and ablate tissue 66.” (Govari || 75 and 79.) Thus,
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Application 12/346,042
contrary to the Examiner, we find that the Govari aperture 86 is not in fluid
communication with the fluid source (cooling gas) or configured to deliver
fluid to the tissue.
We are likewise unpersuaded by the Examiner’s bases for a
conclusion of obviousness. As to providing an “additional means of treating
the tissue of interest” (Ans. 4), the Examiner does not explain how or why
one of skill in the art would combine radio-frequency electrode ablation with
cryogenic ablation. As to including “additional means [for] cooling effects”
(Ans. 5), the Examiner does not explain how or why one of skill in the art
would further cool a cryogenic cooling element that is already cooled by a
cold gas.
CONCLUSION OF LAW
A preponderance of evidence of record fails to support the
Examiner’s rejections under 35 U.S.C. § 103(a).
SUMMARY
We reverse the rejections of all claims on appeal.
REVERSED
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