Ex Parte Schwartz

Patent Trial and Appeal Board

Oct 31, 2017

11154367 (P.T.A.B. Oct. 31, 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.
11/154,367 06/16/2005 Yitzhack Schwartz BIO5078USNP 2323
27777 7590 11/02/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
RAM, JOCELYN D
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
11/02/2017 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):
j nju spatent @ corn s .j nj. com
lhowd@its.jnj.com
pair_jnj @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YITZHACK SCHWARTZ1
Appeal 2016-007743
Application 11/154,367
Technology Center 3700
Before TONI R. SCHEINER, ERIC B. GRIMES, and RYAN H. FLAX,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of ablating epicardial tissue, which have been rejected on the basis that they
recite new matter and would have been obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Innervation of the heart by the parasympathetic nervous system has a
marked influence ... on atrial fibrillation. Recent research has
1 Appellant identifies the Real Party in Interest as Biosense Webster, Inc.
(Br. 1.)
Appeal 2016-007743
Application 11/154,367
demonstrated that parasympathetic ganglia are located in discrete epicardial
fat pads,” known as the RPV fat pad, the IVC-ILA fat pad, and the SVC-AO
fat pad. (Spec. 2—5.) “It is known that individuals having a high level of
vagal tone are predisposed to supraventricular arrhythmias, particularly atrial
fibrillation. Ablation of epicardial fat pads has been found to affect vagally
mediated atrial fibrillation.” (Id. 16.)
Claims 1, 3—7, 10, and 22—29 are on appeal. Claim 1 is illustrative
and reads as follows (emphasis added):
Claim 1. A method for ablating epicardial tissue within a
body of a subject, comprising the steps of:
percutaneously inserting a catheter comprising a position
sensor at a distal tip into a pericardial cavity of said body;
locating epicardial target tissue in said pericardial cavity
for ablation thereof, wherein said epicardial target tissue is
only one epicardial fat pad;
determining position coordinates of said catheter relative
to an epicardial surface of a heart using a control unit and the
position sensor, said position coordinates comprising location
and orientation information of the distal tip of the catheter;
displaying said location and orientation information of
the distal tip of the catheter relative to the epicardial surface of
the heart on a display;
disposing said catheter in proximity to said only one
epicardial fat pad;
orienting said distal tip of said catheter with respect to
said only one epicardial fat pad using a deflection wire coupled
to a distal end of said catheter and manipulating a specified
surface of an electrode of said distal tip of said catheter against
said only one epicardial fat pad using said deflection wire so as
to maximize energy transfer from said catheter to said only one
epicardial fat pad; and
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Application 11/154,367
directing sufficient energy from said distal tip of said
catheter preferentially toward said only one epicardial fat pad
to ablate neural structures therein.
Claim 23, the only other independent claim, is directed to a similar
method and also recites that “said epicardial target tissue is only one
epicardial fat pad” and that the catheter “direct[s] sufficient energy from said
distal tip of said catheter preferentially toward said only one epicardial fat
pad to ablate neural structures therein.” (Appeal Br. 22—23 (Claims App’x).)
The claims stand rejected as follows:
Claims 1, 3—7, 10, and 22—29 under 35 U.S.C. § 112, first paragraph,
as lacking adequate written description (Final Action2 2—3);
Claims 1, 3, 4, 6, 7, and 22—29 under 35 U.S.C. § 103(a) as obvious
based on Vaska,3 Cosman,4 Phan,5 and Chiou6 (Final Action 4);
Claim 5 under 35 U.S.C. § 103(a) as obvious based on Vaska,
Cosman, Phan, Chiou, and Coleman7 (Final Action 8); and
Claim 10 under 35 U.S.C. § 103(a) as obvious based on Vaska,
Cosman, Phan, Chiou, and Walsh8 (Final Action 8—9).
2 Office Action mailed Aug. 20, 2015.
3 US 2003/0079753 A1 (pub. May 1, 2003).
4 US 2002/0111615 A1 (pub. Aug. 15,2002).
5 US 2003/0078644 A1 (pub. Apr. 24, 2003).
6 Chiou et al., Efferent Vagal Innervation of the Canine Atria and Sinus and
Atrioventricular Nodes: The Third Fat Pad, 95 Circulation 2573 (1997).
Our citations are to the copy of record, which has pages numbered 1—22.
7 US 2004/0015106 Al (pub. Jan. 22, 2004).
8 US 6,802,857 B1 (issued Oct. 12, 2004).
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Application 11/154,367
I
The Examiner has rejected all of the claims on appeal on the basis that
“there is no support in the original disclosure for the limitation of ‘only one
epicardial fat pad’ in independent claims 1 and 23.” (Final Action 3.) The
Examiner finds:
Paragraphs [0047]-[0048] in combination with Figure 4 recite
that “it is determined whether more epicardial fat pads remain to
be ablated”. Thus, it is possible that one fat pad is ablated, but it
is possible that more than one fat pad is ablated, and there is no
disclosure as to how this decision is determined. . . . Although
the Specification does not disclose only ablating multiple fat
pads, this does not provide a basis for only ablating one fat pad.
(Id.)
As Appellant points out (Br. 8), however, the disputed limitation is
supported by at least original claim 8, which stated “[t]he method according
to claim 1, wherein said target tissue comprises an epicardial fat pad.”
(Spec. 10.) This language is also found in the Specification itself. (Id. 118).
And the Specification describes determining the locations of fat pads “one-
by-one, following ablation of each fat pad.” (Id. 144.) In our view, the
Specification provides a description that demonstrates that Appellant was in
possession of a method of ablating only one fat pad at the time the
application was filed. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (“[T]he test for sufficiency is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.”). We therefore reverse the rejection under 35 U.S.C. § 112,
first paragraph.
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Application 11/154,367
II
The Examiner has rejected all of the claims on appeal as obvious
based on Vaska, Cosman, Phan, and Chiou, by themselves or further
combined with either Coleman or Walsh. The same issue is dispositive for
all of these rejections.
The Examiner finds that Vaska discloses most of the limitations of
claim 1 (Final Action 4); that Cosman would have made it obvious to
modify Vaska’s method to include determining position coordinates of the
catheter relative to the treatment area and display the catheter’s position on a
display {id. at 5); and that Phan would have made it obvious to use a
deflection wire to accurately deflect the distal end of Vaska’s catheter to a
desired location {id. at 6).
The Examiner also finds that Vaska “is silent as to targeting only one
epicardial fat pad,” but that “Chiou discloses an epicardial target tissue of
only one epicardial fat pad (Group 1, SVC-Ao fat pad . . .).” (Id.) The
Examiner concludes that it would have been obvious to modify Vaska’s
method “to target only one epicardial fat pad, as taught by Chiou, because it
was determined that the SVC-Ao fat pad played a crucial role in vagal
innervation of the atria, and was determined to be the ‘head station’ of vagal
fibers traveling to both atria and to the sinus and AV nodes (Chiou, page 6,
13).” {Id.)
Appellant argues, among other things, that Chiou “fails to disclose,
suggest or even infer that only one epicardial fat pad is specifically targeted,
isolated with precision, for example, using a position sensor on its device
and control unit and ablated.” (Br. 14.) Appellant argues that Chiou’s
teachings, which
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Application 11/154,367
are focused on open chest procedures and conducting surgery on
3 fat pads at a time in a non-specific and non-targeted manner,
actually teach away from Applicant’s claimed invention which is
a minimally invasive apparatus and method using a catheter with
position sensor and control unit for determining position
coordinate information for isolating, identifying and ablating
only one epicardial fat pad in a very precise and minimally
invasive way.
(Id. at 15.)
We agree with Appellant that the cited references would not have
made obvious the claimed method of ablating “only one epicardial fat pad.”
Vaska discloses “epicardial ablation devices and methods useful for creating
transmural lesions that electrically isolate the pulmonary veins for the
treatment of atrial fibrillation.” (Vaska | 8.) Vaska’s method thus is
focused on clinical treatment, specifically for atrial fibrillation.
Chiou discloses a study “to investigate the functional pathways of
efferent vagal innervation to the atrial myocardium and sinus and
atrioventricular (AV) nodes.” (Chiou 1, Background.) Chiou “determined
the actions of phenol and epicardial radiofrequency catheter ablation
(RFCA) applied to different sites at or near the atrial myocardium.” (Id.,
Methods and Results.)
“In group 1 dogs (n=5), RFCA was applied to the fat tissue located
between the medial SVC and aortic root (superior to the right pulmonary
artery) (SVC-Ao fat pad . . .).” (Id. at 5.) In other groups of dogs (Groups
2—8) phenol or RFCA were used to ablate other fat pads, combinations of fat
pads, or other areas of the heart. (Id. at 5—6.)
Chiou concluded that “most efferent vagal fibers to the atria appear to
travel through the newly described SVC-Ao fat pad . . . and then project onto
the IVC-LA and RPV fat pads and to both atria. A few vagal fibers may
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Application 11/154,367
bypass the SVC-Ao fat pad and go directly to the IVC-LA or RPV fat pads
to innervate atrial myocardium.” (Id. at 13.) “Thus, the SVC-Ao fat pad
appears to be the ‘head station’ of vagal fibers traveling to both atria and to
the sinus and AV nodes in the dog. Total efferent vagal denervation of these
structures is accomplished easily by RFCA of all three fat pads.” (Id.)
When describing the “Clinical Implications” of its findings, however, Chiou
states:
An atrium that is more homogeneous electrically would have a
reduced propensity to fibrillate. Therefore, total efferent vagal
denervation of the atria might reduce the possibility of regional
parasympathetic supersensitivity and might be an antifibrillatory
maneuver. This could easily be accomplished by RFCA of the
RPV, IVC-LA, and SVC-Ao fat pads.
(Id. at 14.)
Thus, when describing the implications of its study for clinical
treatments, Chiou states that its findings suggest that ablation of all three of
the RPV, IVC-LA, and SVC-Ao fat pads might provide a treatment for atrial
fibrillation. Chiou does not state that its results suggest that ablating only
the SVC-Ao fat pad would provide an effective treatment for atrial
fibrillation. As noted above, Vaska is directed to clinical treatment of atrial
fibrillation. We therefore agree with Appellant that the cited references
would not have led a skilled worker to modify Vaska’s method by ablating
“only one epicardial fat pad,” as required by claims 1 and 23. For that
reason, we reverse the rejection of claims 1, 3, 4, 6, 7, and 22—29 under 35
U.S.C. § 103(a) based on Vaska, Cosman, Phan, and Chiou.
Claims 5 and 10 stand rejected as obvious based on Vaska, Cosman,
Phan, and Chiou, further combined with Coleman or Walsh. (Final Action
8—9.) These rejections, however, rely on the Examiner’s conclusion that
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Application 11/154,367
Vaska, Cosman, Phan, and Chiou would have suggested all of the limitations
of claim 1. As discussed above, that conclusion is not supported by the
combination of Vaska, Cosman, Phan, and Chiou. Therefore, we reverse the
rejections of claim 5 and claim 10 for the same reason discussed above with
respect to claim 1.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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