Ex Parte Blanchard et al

Patent Trial and Appeal Board

Aug 28, 2017

13209270 (P.T.A.B. Aug. 28, 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
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/209,270 08/12/2011 Daniel B. Blanchard 101672.0142P 9751
34284 7590
Rutan & Tucker, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
EXAMINER
BOSQUES, EDELMIRA
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/30/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL B. BLANCHARD and RYAN C. PATTERSON
Appeal 2016-006507
Application 13/209,270
Technology Center 3700
Before BRANDON J. WARNER, MICHAEL L. WOODS, and
ANTHONY KNIGHT, Administrative Patent Judges.
WOODS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Daniel B. Blanchard and Ryan C. Patterson (“Appellants”) appeal
under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 1-12,
14, 15, 30, 31, and 33—41. Appeal Br. 4. CR Bard, Inc., as stated by
Appellants, is the real party in interest. Id. We have jurisdiction over this
appeal under 35 U.S.C. § 6(b).
SUMMARY OF THE DECISION
We REVERSE
Appeal 2016-006507
Application 13/209,270
CLAIMED SUBJECT MATTER
Appellants’ invention relates to “a catheter assembly used to gain
access to a vasculature or other internal portion of a patient. . . with at least
one lumen . . . capable of power injection.” Spec. ^ 2. Claims 1 and 38 are
independent, and claim 1 is reproduced below, with emphases and
indentations added for clarity.
1. A catheter assembly, comprising:
a catheter tube defining at least one lumen, the catheter
tube formed from a tube material that defines a proximal portion
and a distal portion of the catheter tube,
wherein the arithmetic product of an elastic modulus and
an area moment of inertia for at least a portion of the distal
portion of the catheter tube defined by the catheter tube material
is greater relative the arithmetic product of an elastic modulus
and an area moment of inertia for at least a portion of the
proximal portion of the catheter tube,
wherein the distal portion is configured for insertion into
vasculature,
wherein the catheter tube is designed for power injection
and wherein the distal portion is designed to remain stable within
the vasculature during power injection of fluids into the
vasculature.
Appeal Br. 29 (App. A).
THE REJECTIONS1
I. Claims 1—4, 7, 8, 10-12, 31, 33, 35, and 36 stand rejected under
35 U.S.C. § 102(b) as anticipated by Malecki (US 2005/0080406 Al,
published Apr. 14, 2005). Final Act. 4.
1 We understand that a rejection of claim 35 as being indefinite (Final Act.
3) has been functionally withdrawn following the cancellation of the claim
(Appeal Br. 9) and the Examiner’s omission of the rejection in the Answer’s
“Grounds of Rejection” (see Ans. 2-17).
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II. Claims 1 and 14 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Labianca (US 4,769,016, issued Sep. 6, 1988). Final Act. 8.
III. Claims 1 and 14 stand rejected under 35 U.S.C. § 102(e) as
anticipated by Chevalier (US 2009/0247987 Al, published Oct. 1, 2009).
Final Act. 9.
IV. Claim 5 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Malecki. Final Act. 10.
V. Claim 6 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Malecki and Mickley (US 2009/0143748 Al, published
June 4, 2009). Final Act. 11.
VI. Claim 9 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Malecki and Williams (US 5,707,385, issued Jan. 13,
1998). Final Act. 12.
VII. Claim 30 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Malecki and Kirkman (US 5,509,900, issued Apr. 23,
1996). Final Act. 12.
VIII. Claim 34 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Malecki, Kirkman, and Humphries (US 6,651,477 B2,
issued Nov. 25, 2003). Final Act. 13.
IX. Claim 15 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Chevalier and Okada (US 2005/0038411 Al, published
Feb. 17,2005). Final Act. 14.
X. Claims 37-39 and 41 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Malecki and Muni (US 5,316,706, issued May 31,
1994). Final Act. 15.
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Application 13/209,270
XI. Claim 40 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Malecki, Muni, Kirkman, and Humphries (US 6,651,477
B2, issued Nov. 25, 2003). Final Act. 16.
XII. Claims 38 and 41 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Choi (US 6,482,211 Bl, issued Nov. 19, 2002) and Muni.
Final Act. 17.
ANALYSIS
Rejection I: Anticipated by Malecki
The Examiner rejects claims 1—4, 7, 8, 10-12, 31, 33, 35, and 36 as
anticipated by Malecki. Final Act. 4. For the reasons that follow, we
reverse the rejection.
Malecki describes patent foramen ovale (“PFO”) as a condition that
may occur in newborn babies when a flap of tissue is missing in a baby’s
heart, and a “hole remains open as an atrial septal defect.” Malecki 4.
Malecki discloses a catheter device “for treating the patent foramen ovale
[PFO] and applying energy to . . . tissues adjacent to a PFO to substantially
close the PFO acutely.” Id. ^ 14; see id. at Abstr. To illustrate Malecki’s
catheter device, we reproduce Figure 3, below:
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Application 13/209,270
Figure 3 depicts a “catheter apparatus” embodiment of Malecki’s
invention. Id. Tf 38. In particular, Figure 3 depicts PFO-treatment apparatus
200 with catheter device 210. Id. ^ 49. Energy transmission member 214
may be disposed within device 210 and coupled to tissue apposition member
212. Id. Device 210 may also include an isolation portion 228 to help
stabilize member 212 during use. Id.
In rejecting the claims as anticipated by Malecki, the Examiner finds
that Malecki discloses the claimed “catheter tube” 200 with a “proximal
portion” 210 and a “distal portion” 212, as called for in claim 1. Final Act.
4. The Examiner further finds that Malecki discloses two limitations, which
are at the heart of our Decision, and which we address separately, below.
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1) wherein the arithmetic product of an elastic modulus and an
area moment of inertia for at least a portion of the distal
portion of the catheter tube defined by the catheter tube
material is greater relative the arithmetic product of an elastic
modulus and an area moment of inertia for at least a portion of
the proximal portion of the catheter tube . . .
The Examiner interprets this limitation to “mean that the distal end
has a higher bending stiffness than the proximal end.” Ans. 20. Based on
this interpretation, and with apparent reference to Malecki’s Figure 3,
reproduced supra, the Examiner finds that Malecki’s “tube 200 is more
flexible at the area pointed by 210 than at the area pointed by 212 due to
collapsible frame on 212.” Final Act. 4 (citing Malecki ^ 53, 54) (emphasis
omitted, emphasis added). In the Answer, the Examiner also references the
equation for the area moment of inertia of a cylinder, and explains that “[i]f
the moment of inertia . . . was calculated, the moment of inertia would be
higher at the distal end that at the proximal end of the catheter, based on the
dimensions seen in Figure 3.” Ans. 20 (emphasis added).
In contesting the rejection, Appellants argue that Malecki does not
disclose this limitation, and that nothing in Malecki, including its paragraphs
53 and 54, support the Examiner’s finding. Appeal Br. 12-13.
Appellants’ argument is persuasive. The Examiner’s finding is one of
inherency, and “[t]o establish inherency, the extrinsic evidence must make
clear that the missing descriptive matter is necessarily present in the thing
described in the reference, and that it would be so recognized by persons of
ordinary skill.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)
(citations and internal quotations omitted) (emphasis added). “Inherency . . .
may not be established by probabilities or possibilities [and the] mere fact
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that a certain thing may result from a given set of circumstances is not
sufficient.” Id.
We find nothing in paragraphs 53 and 54 to support the Examiner’s
finding that Malecki’s tissue apposition member 212—the claimed “distal
portion”—has an “arithmetic product of an elastic modulus and an area
moment of inertia . . . [that] is greater [than] the arithmetic product of an
elastic modulus and an area of moment of interim” of “proximal portion”
210, as called for in the claims. Additionally, the Examiner’s finding that
the presence of collapsible frame 212 necessarily means, “200 is more
flexible at the area pointed by 210 than at the area pointed by 212,” is not
supported by a preponderance of the evidence. Final Act. 4.
Furthermore, although we appreciate the Examiner’s citation to the
equation for the area moment of inertia for a cylinder (Ans. 20), Malecki’s
Figure 3 does not provide sufficient information for us to determine the
moment of inertia of Malecki’s “distal portion” 212 and “proximal portion”
210. For example, Figure 3 does not provide the inside diameters of
portions 210 and 212, and we are not convinced that “distal portion” 212 is
even cylindrical, to thereby lend itself to the Examiner’s proffered equation.
See Malecki Fig. 3.
Accordingly, that the preponderance of the evidence does not support
a finding that the claimed limitation is necessarily present in Malecki’s
structure.
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2) wherein the catheter tube is designed for power injection . . .
With respect to the above limitation, the Examiner finds that
Malecki’s device is capable of power injection, thereby satisfying the
claimed limitation. See Final Act. 5.
In contesting the rejection, Appellants argue that the claim requires a
catheter “designed for power injection,” and that the Examiner has not cited
to anything within Malecki to support a finding that Malecki’s device could
withstand the high pressures of power injection. See Appeal Br. 10-11. In
support of its argument, Appellants submit as evidence a website from the
U.S. Food and Drug Administration (“FDA”) that explains that not all
vascular access devices are capable of being used for power injection. Id. at
10 (citing Reminders from FDA Regarding Ruptured Vascular Access
Devices from Power Injection, (August 25, 2014), http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/
ucm070193.htm).
Appellants’ argument is persuasive. Here, Appellants’ proffer
evidence to support its assertion that only some catheters are capable of
power injection. See, e.g., id. We find unavailing the Examiner’s
unsupported assertion that Malecki’s catheter is one of these catheters. Final
Act. 5. In particular, the Examiner’s finding that Malecki’s device—which
is used for closing an atrial septal defect (see Malecki 4, 14)—is capable
of power injection is conclusory and inadequately supported by the record.
For the foregoing reason, we do not sustain the rejection of claims 1-
4, 7, 8, 10-12, 31, 33, 35, and 36 as anticipated by Malecki.
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Rejections IV—VIII, X, and XI: Unpatentable Over Malecki
and Other Cited Art
In rejecting claims 5, 6, 9, 30, 34, and 37—41 under one of Rejections
IV-VIII, X, and XI, the Examiner relies on the same unsupported findings
discussed above in connection with Rejection I. See Final Act. 10-14 and
15-17. For the same reasons we do not sustain the rejection of claims 1—4,
7, 8, 10-12, 31, 33, 35, and 36 as anticipated by Malecki, we likewise do not
sustain the rejections of claims 5, 6, 9, 30, 34, and 37-41 as unpatentable
over Malecki and other cited art.
Rejection II: Anticipated by Labianca
The Examiner rejects claims 1 and 14 as anticipated by Fabianca.
Final Act. 8. For the reasons that follow, we reverse the rejection.
The Examiner finds that Fabianca discloses the claimed catheter
assembly. Id. To illustrate the Examiner’s findings, we reproduce Figure 1
of Malecki, below:
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Application 13/209,270
Figure 1 depicts Labianca’s “peritoneo-venous shunting system”
comprising tube 10 made of “flexible and resilient synthetic polymer, such
as silicone rubber” (Labianca, col. 2,11. 63-65), catheter 16, and tip 18 (see
id. at col. 3,11. 13-19). Labianca discloses that tip 18 is made of titanium
alloy. Id. at col. 3,11. 37-38. The Examiner relies on Labianca’s tube 10 as
satisfying the claimed “catheter tube” and Labianca’s catheter 16 and tip 18
as also satisfying the claimed “proximal portion” and “distal portion,”
respectively. Final Act. 8.
The Examiner further finds that “the arithmetic product of an elastic
modulus and an area moment of inertia for at least a portion of the distal
portion [18] ... is greater relative the arithmetic product of an elastic
modulus and an area moment of inertia for at least a portion of the proximal
portion [16].” Id. (emphasis omitted). In support of this finding, the
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Examiner explains that “even though the distal portions of the tubes are
about the same inner and outer diameters as the proximal portions, the
elastic modulus of the material of the distal portion is higher (therefore the
distal portion has a higher bending stiffness) than the material of the
proximal portion.” Ans. 20-21.
The Examiner’s finding is not supported by a preponderance of the
evidence.
Although Labianca’s tip is made of titanium alloy, and the “proximal
portion” may be made of silicone rubber, the Examiner’s finding that the
disclosed structure satisfies the claimed limitation is based on inherency, and
we are not persuaded that Labianca’s structure necessarily discloses the
claimed limitation “the arithmetic product of an elastic modulus and an area
moment of inertia for at least a portion of the distal portion ... is greater
relative the arithmetic product of an elastic modulus and an area moment of
inertia for at least a portion of the proximal portion.” See In re Robertson,
169 F.3d at 745. Notably, neither Labianca nor the record includes
information pertaining to the elastic modulus for silicone rubber, the elastic
modulus for titanium alloy, or the area moment of inertia for Labianca’s
“distal portion” 18 and “proximal portion” 16.
The Examiner further finds that Labianca’s catheter tube is designed
for power injection. Id. at 8-9. This finding is also unavailing. As
explained above, Appellants proffer evidence to support its assertion that
only some catheters are capable of power injection. See Appeal Br. 16-17;
see also id. at 10 (citing FDA website). As explained similarly above with
respect to Rejection I, the Examiner does not dispute this evidence but
instead concludes, without providing adequate evidentiary support, that
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Labianca’s catheter is nonetheless capable of power injection. See Ans. 17-
18.
For the foregoing reasons, we do not sustain the rejection of claims 1
and 14 as anticipated by Labianca.
Rejection III: Anticipated by Chevalier
The Examiner rejects claims 1 and 14 as anticipated by Chevalier.
Final Act. 9. For the reasons that follow, we reverse the rejection.
The Examiner finds that Chevalier discloses the claimed catheter
assembly, citing Figures 2 and 3 of Chevalier. See id. To illustrate these
findings, we reproduce Chevalier’s Figures 2 and 3, below:
FIG. 2
ORB
Figures 2 and 3 depict different embodiments of Chevalier’s catheter.
Chevalier 5, 6. Chevalier’s catheters include tip section 16, lumen 11,
catheter shaft 12, abutting structure 60 (shown in Fig. 2), and abutting
structure 70 (shown in Figure 3). Id. 18, 19. Chevalier’s catheters are
drainage catheters used for percutaneous insertion into abscesses (or other
structures) to drain fluids. Id. 2, 4.
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The Examiner finds that Chevalier’s “catheter tube” 12 defines
“proximal portion” 12 and “distal portion” (from 20 to 1E in Fig. 2) and that
“the arithmetic product of an elastic modulus and an area moment of inertia
for at least a portion of the distal portion ... is greater relative the arithmetic
product of an elastic modulus and an area moment of inertia for at least a
portion of the proximal portion,” as recited in claim 1. Final Act. 9. In
support of this finding, the Examiner explains that “even though the distal
portions of the tubes are about the same inner and outer diameters as the
proximal portions, the elastic modulus of the material of the distal portion is
higher (therefore the distal portion has a higher bending stiffness) than the
material of the proximal portion.” Ans. 20-21.
The preponderance of the evidence does not support the Examiner’s
inherency finding. Here, the Examiner’s finding that “the distal portions of
the tubes are about the same inner and outer diameters as the proximal
portions” is unsupported by the record. See Ans. 20-21. In particular, the
“distal portions” of Chevalier’s Figure 2 and Figure 3 embodiments are
tapered, and the Examiner fails to take into account how these tapered
structures affect the area moment of inertia.
The Examiner also finds that Chevalier’s catheter tube is capable of
performing power injection. Final Act. 10. This finding, however, is also
unsupported by the record, and the Examiner fails to controvert Appellants’
assertion and evidence that only some catheters are capable of power
injection, and that Chevalier’s drainage catheter is not one of those
specially-designed power injection catheters. See Appeal Br. 18-19; see id.
at 10 (citing FDA website).
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For the foregoing reasons, we do not sustain the rejection of claims 1
and 14 as anticipated by Chevalier.
Rejection IX: Unpatentable Over Chevalier and Okada
In rejecting claim 15 under Rejection IX, the Examiner relies on the
same unsupported findings discussed above in connection with Rejection III.
See Final Act. 14. For the same reasons we do not sustain the rejection of
claims 1 and 14 as anticipated by Chevalier, we likewise do not sustain the
rejection of claim 15 as unpatentable over Chevalier and Okada.
Rejection XII: Unpatentable Over Choi and Muni
The Examiner rejects claims 38 and 41 as unpatentable over Choi and
Muni. Final Act. 17. For the reasons that follow, we reverse the rejection.
In support of the rejection, the Examiner cites to Choi’s Figures 5A
and 6 for disclosing the claimed catheter. See id. at 17-18. To illustrate the
Examiner’s findings, we reproduce Choi’s Figures 5A and 6, below:
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Figures 5A and 6 depict Choi’s catheter assembly. Choi, col. 5,11. 5-
17. In particular, these figures depict Choi’s catheter assembly 70 that uses
guide wires 110, 112 for delivering angulated stent 100 into a side branch
vessel during a coronary angioplasty procedure. Id. at col. 1,11. 6-12; col. 3,
11. 25-34; col. 6,1. 42-col. 7,1. 13.
The Examiner finds that Choi’s “catheter tube” 70 includes “proximal
portion” 72 and “distal portion” 74, wherein “an area moment of inertia {the
size of the distal portion is larger than the size of the proximal portion) for
the distal portion of the catheter tube is greater than an area of moment of
inertia for the proximal portion of the catheter tube.” Final Act. 17-18
(emphasis added).
The Examiner’s inherency finding is not supported by a
preponderance of the evidence. In particular, Claim 38 requires an “area
moment of inertia” of the distal portion to be greater than an “area moment
of inertia” at a proximal portion, and the Examiner’s reliance on Figures 5A
and 6 for disclosing this feature is not supported. The Examiner’s finding
relies upon several assumptions, including the particular geometries of
Choi’s catheter assembly 70, which are missing from the record.
We also disagree with the Examiner’s finding that Choi’s stent
delivery catheter, which uses guide wires, is capable of power injection.
Final Act. 18. As explained supra, Appellants proffer evidence to support
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its assertion that not every catheter is capable of power injection (see Appeal
Br. 25-25; id. at 10 (citing FDA website)). The Examiner’s finding that
Choi’s guide-wire based stent delivery catheter is one of those catheters is
not supported by a preponderance of the evidence. Final Act. 18. We
further note that the Examiner misreads Choi for disclosing removal of its
guidewire to “allow for power injection if required by the procedure.” Ans.
28 (citing Choi, col. 4,11. 45-50). Contrary to the Examiner’s finding, the
cited portion of Choi discloses withdrawal of the catheter, while leaving the
guide wires in place, “should further intervention requiring two wires be
necessary.” Choi, col. 4,11. 45-50.
For the foregoing reasons, we do not sustain the rejection of claims 38
and 41 as unpatentable over Choi and Muni.
SUMMARY
The Examiner’s decision to reject claims 1-12, 14, 15, 30, 31, and
33-41 under Rejections I-XII is reversed.
REVERSED
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