Rosenman, Daniel C. et al.

Patent Trials and Appeals Board

Nov 20, 2019

14257895 - (D) (P.T.A.B. Nov. 20, 2019)

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.
14/257,895 04/21/2014 Daniel C. Rosenman 212/888C2 1132
23371 7590 11/20/2019
CROCKETT & CROCKETT, PC
6B Liberty
Suite 145
Aliso Viejo, CA 92656
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3783
MAIL DATE DELIVERY MODE
11/20/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte DANIEL C. ROSENMAN, PETER A. ALTMAN,
BRIAN K. HAKIM, DANIEL J. KAYSER, ROBERT E. MASTON, and
DOUGLAS McETCHIN
____________________

Appeal 2018-0000791
Application 14/257,895
Technology Center 3700
____________________

Before LISA M. GUIJT, BRADLEY B. BAYAT, and
PAUL J. KORNICZKY, Administrative Patent Judges.

BAYAT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the decision
rejecting claims 1–28, which are the only claims pending in the application.
An oral hearing was held on October 22, 2019. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as “BioCardia, Inc.” Appeal Br. 1.
Appeal 2018-000079
Application 14/257,895

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Claimed Invention
Appellant’s invention relates “to site-specific delivery of therapeutic
agents, structures and catheter systems to achieve site-specific delivery of
therapeutic agents, and means for implanting and using these systems to
enable delivery of therapeutic agents to the body.” Spec. 1:11–15.
Independent claim 1, reproduced below, is illustrative of the subject
matter on appeal.
1. A system for delivering a drug to a target site within a
patient's body comprising:
a steerable guide catheter comprising:

a guide catheter having a distal end, a proximal end and a
longitudinal axis; and

a steering pullwire for deflecting the guide catheter;

a first handle, disposed at the proximal end of the guide
catheter, said first handle having a control means operably
connected to the steering pullwire; and

a drug delivery catheter operably connected to the guide
catheter, the delivery catheter comprising:

a second handle secured to the proximal end of the drug
delivery catheter, said second handle disposed proximal to the
first handle and having a longitudinal axis, a distal end, and a
proximal end;

a delivery catheter having a lumen, said delivery catheter
protruding out of the distal end of the second handle and
aligned substantially along the longitudinal axis of the second
handle and extensible beyond the distal end of the guide
catheter;

a helical drug delivery needle operably connected to the distal
end of the delivery catheter; and
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Application 14/257,895

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said second handle being operable to rotate and advance the
drug delivery catheter within the guide catheter.

Appeal Br. (Claims App.).

Rejections
Claims 1–3, 13–17, 27, and 28 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Lesh et al. (US 2001/0007933 A1, pub. July 12,
2001) (“Lesh”) and Badger et al. (US 5,030,204, iss. July 9, 1991)
(“Badger”).
Claims 4 and 18 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Lesh, Badger, and Weaver et al. (US 5,843,028, iss. Dec.
1, 1998) (“Weaver”).
Claims 5–12 and 19–26 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Lesh, Badger, and Berg et al. (US 5,911,715, iss.
June 15, 1999) (“Berg”).

ANALYSIS
Claims 1–3, 13–17, 27, and 28
In rejecting independent claim 1 as unpatentable over Lesh and
Badger, the Examiner finds Lesh discloses all of the limitations of claim 1
except that “it does not disclose a steerable guide catheter having a first
handle with control means operably connected to a steering pullwire and
which is disposed distal of the second handle.” Final Act. 3. To cure this
deficiency, the Examiner finds:
Badger discloses a guide catheter for cardiovascular
procedures (abstract). The guide catheter has a distal end, a
proximal end and a longitudinal axis; a steering pullwire 16 for
deflecting the guide catheter; and a first handle 20 (not just luer
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but entire section), disposed at the proximal end of the guide
catheter, said first handle having a control means 24 operably
connected to the steering pullwire. The guide catheter is
designed to have a second catheter inserted into it where the
second catheter extends beyond the distal end of the guide
catheter (fig 2). An inserted catheter is capable of rotating and
advancing through the guide catheter via twisting and pushing
of the inserted catheter. Also, the second handle of an inserted
device would be disposed proximal the first handle of the guide
catheter as the inserted device is inserted via the proximal end
of the device of Badger. It would have been obvious to one of
ordinary skill in the art at the time the invention was made to
provide a guide catheter with pullwire for the device of Lesh as
taught by Badger to assist in placing the catheter of Lesh
(Badger discloses its particular guide catheter provides stiffness
and strength in addition to a deformable tip - Col.2 ll. 48–54).

Id.
Alleging error in the rejection, Appellant argues that “[t]his is not a
motivation to make a combination: This is merely a conclusory statement
that the combination would be obvious. It is inadequate to support a
rejection.” Appeal Br. 10 (“The proposed combination would result in a
system with duplicative steering systems, for no reason apparent in the
art.”). In particular, Appellant contends:
Mere incantation of a characteristic appearing in a prior art
device does nothing to establish a motivation for altering that
device. It does not demonstrate why an artisan would be
motivated to make any particular modification, or whether an
artisan would seek to increase strength at the expense of
stiffness, increase stiffness at the expense of strength, increase
both, or decrease both. So, the mere incantation of strength and
stiffness does not constitute identification of a motivation to
make the Examiner’s proposed combination, and no prima facie
case of obviousness is established by merely mentioning
strength and stiffness.
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Reply Br. 2. Appellant’s arguments are persuasive.
A claim is unpatentable under § 103(a) if the differences between the
claimed subject matter and the prior art are such that the subject matter, as a
whole, would have been obvious at the time the invention was made to a
person having ordinary skill in the art to which said subject matter pertains.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). An invention
“composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
prior art.” Id. at 418. Instead, a determination of unpatentability on a
ground of obviousness must include “‘articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness.’” Id.
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The obviousness
evaluation “should be made explicit” and it “can be important to identify a
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.”
Id.
We find the Examiner’s rationale to combine the teachings of the
references is predicated upon a conclusory statement that lacks articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness. In response to Appellant’s arguments as to a lack of
motivation to combine Lash and Badger, the Examiner asserts that “Badger
provides stiffness and strength in addition to steering, as stated in the
original rejection, stiffness and strength being a motivation by themselves.”
Answer 8. Lesh is directed to an infusion catheter for delivery of ablation
liquids to cardiac tissue using a novel hollow infusion needle for controlling
the location and extent of the ablation, designed such that it can be imbedded
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in and secured to the tissue to be treated. Lesh ¶¶ 9, 11. Badger is directed
to an improved guiding catheter with a deflectable distal segment with
sufficient stiffness and strength to support dilation catheters for their
placement within a patient’s coronary vasculature. Badger 2:48–54.
According to Badger, the segment’s shape and stiffness “aid in providing
support to a dilation catheter when the balloon thereof is being advanced
across a tight lesion.” Id. 2:39–44. The Examiner does not support
adequately why one of ordinary skill would have been concerned with
“stiffness” and “strength” to modify the apparatus of Lesh, which is
concerned with “direct endocardial infusion of sclerosing agents at the
precise location of tachycardia.” Lesh ¶ 10. The Examiner’s reasoning is
inadequate because it fails to explain why one of ordinary skill in the art
would have been motivated to modify Lesh’s catheter with Badger to reach
the claimed invention. It is well settled that obviousness cannot be sustained
by mere conclusory statements. Kahn, 441 F.3d at 988; accord KSR, 550
U.S. at 418. As such, a prima facie case of obviousness has not established
as to independent claim 1.
Accordingly, we do not sustain the rejection of independent claim 1
under 35 U.S.C. § 103(a), as well as dependent claims 2 and 3. Cf. In re
Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) (“dependent claims are
nonobvious if the independent claims from which they depend are
nonobvious.”). We also do not sustain the rejection of independent claims
13, 15, and 27, and dependent claims 14, 16, and 28, because the Examiner
relies on the same deficient reasoning as claim 1. See Final Act. 4–6.

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Application 14/257,895

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Claims 4–12 and 18–26
The rejections of dependent claims 4–12 and 18–26, which depend
from either independent claim 1 or 15, are not sustained for the same reasons
discussed above with respect to claims 1 and 15.

Summary:
Claims
Rejected
35 U.S.C.
§
Basis Affirmed Reversed
1–3, 13–17,
27, 28
103 Lesh, Badger 1–3, 13–17,
27, 28
4, 18 103 Lesh, Badger, Weaver 4, 18
5–12, 19–26 103 Lesh, Badger, Berg 5–12, 19–26
Overall Outcome 1–28

CONCLUSION
The decision to reject claims 1–28 under 35 U.S.C. § 103(a) is
reversed.
REVERSED