Ex Parte Vidovich

Patent Trials and Appeals Board

Jun 27, 2019

13722511 - (D) (P.T.A.B. Jun. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/722,511 12/20/2012
69821 7590 07/01/2019
MERIT MEDICAL SYSTEMS, INC.
C/0 STOEL RIVES, LLP
ONE UTAH CENTER
201 SOUTH MAIN STREET -- SUITE 1100
SALT LAKE CITY, UT 84111
FIRST NAMED INVENTOR
Mladen I. Vidovich
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.
37621/73903 6051
EXAMINER
PENG, BO JOSEPH
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
07/01/2019 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):
msbethards@STOEL. COM
patlaw@stoel.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MLADEN I. VIDOVICH
Appeal2019-001677
Application 13/722,511
Technology Center 3700
Before FREDERICK C. LANEY, PAUL J. KORNICZKY, and
BRENT M. DOUGAL, Administrative Patent Judges.
KORNICZKY, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2019-001677
Application 13/722,511
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner's decision, as set forth in the Final Office Action dated October
27, 2017 ("Final Act."), rejecting claims 1-8 and 33-38. 2 We have
jurisdiction under 35 U.S.C. § 6(b). An oral hearing was held on May 28,
2019.
We AFFIRM-IN-PART.
THE CLAIMED SUBJECT MATTER
The claims are directed to coronary catheters and, more particularly,
to a preshaped catheter for use in cardiac ventriculography. Spec. ,r 2.
Claims 1, the only independent claim, is reproduced below with disputed
limitations italicized for emphasis:
1. A multi-angulated catheter comprising, in order:
(a) a coiled end;
(b) a first straight portion having a first straight portion
length, wherein said first straight portion length is 15 mm to 40
mm;
( c) a first shaft connected to said first straight portion at a
first obtuse angle, wherein said first obtuse angle is 105° to 140°,
wherein said first shaft has a first shaft length, and wherein said
first shaft length is 20 mm to 40 mm, said first shaft including a
The US Government Represented by the Department of Veterans
Affairs and the Board of Trustees of the University of Illinois are the
applicants ("Appellant") pursuant to 37 C.F.R. § 1.46. Filing Receipt, dated
9/18/2003. The Board of Trustees of the University of Illinois is identified
as a real party in interest. Appeal Brief, dated April 26, 2018 ("Appeal
Br."), at 3. Merit Medical Systems, Inc. is also identified as a real party in
interest. Id.
2 Claims 9-22 are cancelled, and claims 23-32 are withdrawn from
consideration. Appeal Br. 27-28 (Claims App.).
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Application 13/722,511
distal end connected to said first straight portion and a proximal
end opposite said distal end, and
( d) a second shaft connected to said first shaft on said
proximal end, said first shaft extending from said second shaft at
a second obtuse angle, wherein said second obtuse angle is 135°
to 150°, one of said first and second obtuse angles being a
positive angle and the other being a negative angle,
wherein said coiled end, said first straight portion, said
first shaft, and said second shaft define a plane, and the multi-
angulated catheter is flexible so as to afford being straightened
when it is advanced over a guide wire, said multi-angulated
catheter returning to a multi-angulated configuration after said
guide wire is withdrawn, and wherein said first straight portion
length, said first shaft length, and said first and second obtuse
angles are configured such that said coiled end is disposed at a
central left ventricular position when said catheter is inserted
from an arm of a patient and said catheter is in said multi-
angulated configuration.
REFERENCES
In rejecting the claims on appeal, the Examiner relied upon the
following prior art:
Ju
Voda
Lange
Mick
Vidyarthi
Zotz
us 5,403,292
us 5,445,625
us 6,036,682
US 6,355,026 Bl
US 2009/0082756 Al
US 2010/0069820 Al
REJECTIONS
The Examiner made the following rejections:
Apr. 4, 1995
Aug. 29, 1995
Mar. 14, 2000
Mar. 12, 2002
Mar. 26, 2009
Mar. 18, 2010
1. Claims 1-8 and 33-38 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
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2. Claims 33-38 stand rejected under 35 U.S.C. § 112, fourth
paragraph, as being of improper dependent form for failing to further limit
the subject matter of the claim upon which it depends, or for failing to
include all the limitations of the claim upon which it depends.
3. Claims 1-8 and 33-38 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Voda, Lange, and Zotz.
4. Claims 1-8 and 33-38 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Vidyarthi, Mick, Ju, and Lange.
Appellant seeks our review of these rejections.
DISCUSSION
Rejection 1: Claims 1---8 and 33-38
Claim 1 recites, "said coiled end, said first straight portion, said first
shaft and said second shaft define a plane." The Examiner finds that this
limitation is not described in the Specification. Final Act. 2-3. The
Examiner disagrees with Appellant that "[F]ig. 2 and 3 would be sufficient
to show something define[s] a plane." Id. at 3. According to the Examiner,
"Applicant has never positively written 'planar' or 'non-planar' in any
description in the disclosure. Figs. 2, 3, 4 could all be non-planar." Id. The
Examiner explains that a "mere 2D figure of a drawing does not mean each
of the element[s] (in this case, portions of the catheter) are aligned in the
same plane," and a "2D figure is merely a projection of a 3D object, it is
possible that a 3D object with 3 different portions [are] connected in
different planes from one another." Id.
In response to the Examiner's rejection, Appellant asserts that "FIGS.
2 and 3 are drawn in a single plane, not a perspective view, or a view
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Application 13/722,511
showing projections into other planes," and "[b ]ased on the written
description of these embodiments, particularly in view of the figures, one of
skill in the art would understand that the coiled end 1, the first straight
portion 2, the first shaft 14, and the second shaft 26 define a plane." Appeal
Br. 9.
Figures 2 and 4 of the Specification are presented below:
Figures 2 and 4 are schematic illustrations of a multi-angulated catheter
according to alternate embodiments of the invention. Spec. ,r,r 12, 14.
According to the Specification, Figure 4 is an "alternate" embodiment of the
embodiment illustrated in Figure 2. A comparison of the embodiments in
Figures 2 and 4 demonstrates that the only difference is Figure 4's "straight
portion 104 extends out of plane with respect to the plane defined by the first
and second shafts 14, 26,"3 as shown by the projection on the left side of
Figure 4. Spec. ,r 26. Thus, we agree with Appellant that a person of
ordinary skill in the art would have understood that the coiled end, the first
3 Figures 2 and 4 illustrate that length L14 is 20mm and 40mm,
respectively, but the Specification broadly discloses that the length L14 of
first shaft 14 may be "about 20 mm to about 40 mm." Spec. ,r 22.
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straight portion, the first shaft and the second shaft in the embodiment
illustrated in Figure 2 defines a "plane" as recited in claim 1.
For these reasons, the Examiner's rejection is not sustained.
Rejection 2: Claims 33-38
The Examiner rejects claims 33-38 under 35 U.S.C. § 112, fourth
paragraph, as being of improper dependent form for failing to further limit
the subject matter of the claim upon which it depends, or for failing to
include all the limitations of the claim upon which it depends. The
Examiner explains that dependent claims 33-38 are improper because they
claim intended use without further limiting any structures of claim 1. Final
Act. 5.
Appellant does not address the Examiner's rejection in the Appeal
Brief. In the Reply Brief, Appellant argues that the dependent claims are
directed to "various ways claim the that multi-angulated catheter is disposed
at the central left ventricular position," and the "claim language adds
structural features because the claimed catheter is configured with specific
dimensions in order to be disposed at the central left ventricular position."
Reply Br. 5.
Appellant's arguments are not persuasive because they do not identify
the purported new structural features that are limited or any specific
dimensions in the dependent claims. Thus, the Examiner's rejection is
sustained.
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Rejection 3: Claims 1---8 and 33-38
as Unpatentable Over Vada, Lange, and Zotz
The Examiner finds that Voda discloses all of the limitations of claim
1 except for (1) a "coiled end," which the Examiner finds is disclosed by
Lange, and (2) a catheter wherein "said first straight portion length, said first
shaft length, and said first and second obtuse angles are configured such that
said coiled end is disposed at a central left ventricular position when said
catheter is inserted from an arm of a patient," which the Examiner finds is
disclosed by Zotz. Final Act. 5-9. More specifically the Examiner finds
that Zotz "teaches catheters dimensioned as to facilitate accessing a left
ventricle from an arm of a patient (0197, fig. 1 A)." Id. at 7.
The Examiner reasons that it would have been obvious to one of
ordinary skill in the art "to modify the method/device of ... [Voda] to
include the coiled features of Lange ... in order to provide [an] intra vascular
guide, and to include the dimen[s]ions [and] features of Zotz ... in order to
provide easier insertion." Id. at 7-8.
Appellant argues that the Examiner's rejection is erroneous because a
person of ordinary skill in the art would not have been motivated to combine
Voda, Lange, and Zotz. Appeal Br. 11-21. According to Appellant, the
"claimed dimensions allow the multi-angulated catheter to perform
differently in a radial ventriculography operation than the catheter of Voda."
Id. at 17. Appellant explains that "the dimensions of the [ claimed] 'first
straight portion, the first shaft length, and the first and second obtuse angles
are so dimensioned as to facilitate accessing a left ventricle from an arm of a
patient"' (id. (citing Spec. ,r 7)), and that "in a radial ventriculography
operation, a physician may insert a guide wire into an arm of a patient and
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then insert the claimed multi-angulated catheter over the guide wire through
an artery into the patient's heart" (id. (citing Spec. ,r 28)).
We agree with Appellant that V oda, Lange, and Zotz are configured
to traverse different anatomy. Id. at 18. As Appellant correctly explains, (1)
"V oda discloses a catheter that is configured for accessing the left main
coronary artery from the ascending aorta;" (2) the "catheter of Lange is
configured for accessing the coronary arteries;" and (3) the "catheter of Zotz
is configured to facilitate a percutaneous minimally intensive surgical bypass
procedure, and the catheter of Zotz is configured to provide epicardial access
of the left anterior descending coronary artery from the left internal
mammary artery." Id. at 19. We also agree with Appellant that the "angles
and lengths of the catheters of V oda, Lange, and Zotz teach catheter
configurations intended for positioning of the end of the catheter outside of
the left ventricle within a coronary artery." Id. The catheters in Voda,
Lange, and Zotz are configured for different specialized applications. The
Examiner does not provide a persuasive rationale to combine these three
references that are directed to accessing different anatomies in a different
way using different dimensions.
For these reasons, the Examiner's rejection of claims 1-8 and 33-38
is not sustained.
Rejection 4: Claims 1---8 and 33-38
as Unpatentable Over Vidyarthi, Mick, Ju and Lange
The Examiner finds that the combined teachings of Vidyarthi, Mick,
Ju, and Lange disclose all of the limitations of claim 1. Final Act. 10-13.
The Examiner reasons that it would have been obvious to one of ordinary
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skill in the art to modify the method/ device of Vidyarthi because "it would
been an obvious design choice to provide a different angle of access point in
order to fit into different areas of the body" (id. at 12), and, as evidenced by
Mick and Ju, "to include the coiled features of Lange ... in order to provide
conventional coil tail and conventional design choices for the tip and portion
of the catheter" (id. at 13).
Appellant argues that the Examiner's rejection is erroneous because a
person of ordinary skill in the art would not have been motivated to combine
Vidyarthi, Mick, Ju, and Lange. Appeal Br. 21-23. According to Appellant,
because the "catheters [ of Vidyarthi, Mick, and Ju] are designed to traverse
different anatomical structures than the claimed device, modification of the
catheters as suggested by the Office would be inconsistent with their
principle of operation and thus improper. Id. at 21.
We agree with Appellant that Vidyarthi, Mick, Ju, and Lange are
configured for specialized uses and to traverse different anatomy. Id. at 21,
22. As Appellant correctly explains, (1) "Vidyarthi discloses a catheter that
is 'suitable for catheterization of a right coronary artery using a right
transradial approach"' (id. at 22 (citing Vidyarthi, Abstract)), (2) "Mick
discloses 'right and left coronary catheters that are designed to be used in a
transradial coronary catheterization"' (id. (citing Mick, Abstract)), (3) "Ju is
directed to a diagnostic coronary artery catheter formed from improved
materials" (id. (citing Ju, Field of the Invention), and (4) the "catheter of
Lange is configured for accessing the coronary arteries" (id. at 19). We also
agree with Appellant that the "angles and lengths of the catheters of
Vidyarthi, Mick, and Ju teach catheter configurations intended for
positioning of the end of the catheter outside of the left ventricle and within
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a coronary artery." Id. at 22. As Appellant also notes, "the catheters of
Vidyarthi, Mick, and Ju are configured specifically for accessing a coronary
artery and being disposed at a central ventricular position," and
"[ d]imensional changes to any of the disclosed catheters would result in a
significant change in performance." Id. The Examiner does not provide a
persuasive rationale to combine disparate references such as Vidyarthi,
Mick, Ju, and Lange, that are directed to accessing different anatomies in a
different way using different dimensions, as recited in claim 1.
For these reasons, the Examiner's rejection of claims 1-8 and 33-38
is not sustained.
DECISION
For the above reasons, the Examiner's rejection of claims 1-8 and 33-
38 under 35 U.S.C. § 112, first paragraph, is REVERSED.
The Examiner's rejection of claims 33-38 under 35 U.S.C. § 112,
fourth paragraph, is AFFIRMED.
The Examiner's two rejections of claims 1-8 and 33-38 under
35 U.S.C. § 103(a) are REVERSED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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