Ex Parte Difiore

Patent Trial and Appeal Board

Jul 27, 2017

13715952 (P.T.A.B. Jul. 27, 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.
13/715,952 12/14/2012 Attilio E. Difiore 289-PDD-99-08-DIV 3077
79990 7590
C. R. Bard, Inc.
Bard Peripheral Vascular, Inc.
1415 W. 3rd Street
P.O. Box 1740
Tempe, AZ 85280-1740
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
07/31/2017 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):
BPVIP.Docket@crbard.com
Charles .Runyan @ crbard. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ATTILIO E. DIFIORE
Appeal 2015-008019
Application 13/715,952
Technology Center 3700
Before LYNNE H. BROWNE, ANNETTE R. REIMERS, and
LISA M. GUIJT, Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134 of the Examiner’s
decision2 rejecting claims 1 and 3—6. We have jurisdiction under 35 U.S.C.
§ 6(b).
1 Appellant identifies the real party in interest as C.R. Bard, Inc. Appeal Br.
4.
2 Appeal is taken from the Final Office Action dated June 9, 2014 (“Final
Act.”), as supplemented by the Advisory Action dated August 21, 2014.
Appeal 2015-008019
Application 13/715,952
We AFFIRM-IN-PART and designate our affirmance of the
Examiner’s rejection of claims 1, 4, and 5 under 35 U.S.C. § 103(a) as NEW
GROUNDS OF REJECTION pursuant to 37 C.F.R § 41.50(b).
CLAIMED SUBJECT MATTER
Claim 1 is the sole independent claim on appeal. Claim 1, reproduced
below, is illustrative of the subject matter on appeal with disputed
limitations in italicized font.
1. A method of medical treatment, comprising:
providing a vascular access device having a length from a
distal end to proximal end and comprising:
a unitary tubular wall having a first end defining a graft
portion and a second end defining a catheter portion,
the graft portion including a wall defining a single lumen
having a substantially constant diameter,
the catheter portion including a wall defining a lumen in
fluid communication with the single lumen of the graft portion,
a distal end of the catheter portion having a diameter smaller
than the substantially constant diameter and including a
plurality of transverse holes, wherein the vascular access device
has a smooth inner surface that exhibits no change in surface
chemistry throughout the length of the vascular access device;
suturing a proximal end of the graft portion to a side
opening of an artery; and
placing the catheter portion into a vein without an
anastomosis by inserting the distal end of the catheter portion
into a side opening of a vein such that the distal end lies within
the vein at a location downstream from the side opening of the
vein.
REJECTIONS
I. Claim 1 stands rejected under 35 U.S.C. § 102(e) as anticipated
by Dossa (US 6,338,724 Bl; issued Jan. 15, 2002) and alternatively, under
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35 U.S.C. § 103(a) as unpatentable over Dossa and Hibbs (US 5,300,032;
issued Apr. 5, 1994).
II. Claim 3 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Dossa and Martin (US 5,188,593; issued Feb. 23, 1993).
III. Claims 4 and 6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Dossa, Hibbs, and Hanson (US 5,399,352; issued Mar. 21,
1995).
IV. Claim 5 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Dossa, Hibbs, Hanson, and Kowligi (US 5,152,782;
issued Oct. 6, 1992).
ANALYSIS
Rejection I
Independent Claim 1 - Anticipation by Dossa
Regarding the above italicized limitation of claim 1, which requires
the vascular access device to have a smooth inner surface that exhibits no
change in surface chemistry throughout the length of the device, the
Examiner finds that
Dossa states the vascular device minimizes turbulence through
its lumen and thus it can be said it inherently has a smooth
surface. It is also known that a roughened surface would promote
cell and potential blood clotting emboli to form and cause
turbulence. Thus it must be a smooth inner surface with no
change in chemistry along the length of the vascular device.
Final Act. 4.
Appellant acknowledges that Dossa “discloses minimizing flow
turbulence within the vein due to the connection between the catheter and
the vein.” Appeal Br. 11 (citing Dossa 3:56—61). Appellant submits,
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however, that Dossa does not disclose that such turbulence is minimized by
a smooth inner surface, and argues that minimizing turbulence “may be
achieved in a number of ways that does not involve the uniformity of
surface.” Id. at 12. Appellant also submits that to the extent the Examiner
requires Appellant to provide evidence that the inner surface of Dossa’s
device is not smooth, the Examiner is improperly shifting the burden of
presenting a prima facie case of anticipation to Appellant. Id. at 14.
Dossa discloses that
[bjecause apparatus 10 does not force high-pressure blood into
the entrance of vein[] 20, but instead allows the blood to exit
through holes 22 in catheter 18 at locations downstream from the
entrance to vein 20, apparatus 10 . . . minimizes flow turbulence
within vein 20, especially in the sensitive area at which the vein
is connected to plastic catheter 18. The connection between
catheter 18 and the wall of vein 20 will not have to experience a
high flow turbulence.
Dossa 3:52—61 (emphasis omitted). Thus, a preponderance of the evidence
supports Appellant’s argument that Dossa addresses turbulence at the
connection between the catheter and the vein—not throughout the length of
the lumen of the vascular access device as claimed, and further, attributes
the minimization of flow turbulence to holes in the catheter downstream of
the connection between the catheter and the vein—not to a smooth inner
surface within the length of the lumen of the vascular access device, as
claimed. In other words, the Examiner erred by concluding that because
Dossa addresses flow turbulence, Dossa inherently discloses that the Dossa’s
vascular access device has a smooth inner surface throughout its length.
Although the Examiner also determined that “[i]t is well known in the
art that catheter devices are provided with smooth inner surfaces for
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uninterrupted blood flow,” the Examiner fails to provide any evidence to
support this finding.3 Ans. 7.
Accordingly, we cannot sustain the Examiner’s rejection of claim 1
under 35 U.S.C. § 102(b) as anticipated by Dossa because Dossa does not
explicitly or inherently disclose that the inner surface of Dossa’s vascular
access device is smooth.
Independent Claim 1 — Obviousness over Dossa and Hibbs
As an alternative to the findings with respect to Dossa as discussed
supra, the Examiner relies on Hibbs for showing a medical device 20 that
uses two sections joined or bonded, and providing a smooth inner surface
that exhibits no change in surface chemistry throughout its length. Final
Act. 4 (citing Hibbs 5:35—39, Fig. 2). The Examiner explains that Hibbs is
relied on for teaching that “the chemistry for the region in which the bonding
occurred can result in an even mix of materials resulting in the same
chemistry throughout the section.” Ans. 8. The Examiner reasons that it
would have been obvious to modify Dossa’s device to include a smooth
inner surface that exhibits no change in surface chemistry throughout its
length in view of the teaching of Hibbs, “such that it allows for elements that
pass across it to have limited frictional inhibition.” Final Act. 4.
As an initial matter, Appellant argues that Hibbs is improperly relied
on by the Examiner, because Hibbs is non-analogous art. Appeal Br. 16. In
support, Appellant contends that “Hibbs is directed at a catheter introducer
3 Notably, Martin discloses a medical device that “provides a relatively
smooth internal surface to minimize traumatic flow created forces on the
blood as blood flow passes through the tubes and associated lumens.”
Martin 10:8—12.
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that requires a relatively rigid tubular body and a soft flexible tubular tip to
achieve specific goals associated with introducers.” Id. Appellant
concludes that “[a] catheter introducer is neither in the field of [Appellant’s]
endeavor, nor is the catheter design reasonably pertinent to any particular
problem with which the inventor was concerned.” Id.
“The analogous-art test requires that the Board show that a reference
is either in the field of the applicant’s endeavor or is reasonably pertinent to
the problem with which the inventor was concerned in order to rely on that
reference as a basis for rejection.” In re Kahn, 441 F.3d at 986—87 (citing In
re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992)). Appellant’s Specification
identifies the field of endeavor as “medical devices, and more particularly, to
a device that provides an improved method for vascular access.” Spec. 12.
Hibbs’ catheter introducer is “inserted through the skin into a blood vessel,”
and therefore, Hibbs’ catheter introducer is in the same field of endeavor as
Appellant’s invention: devices for providing vascular access. Hibbs 1:10—
12. Moreover, Hibbs’ catheter introducer addresses the problem of causing
trauma to the blood vessel. Id. at 1:10—15 (“The invention relates to catheter
introducers . . . which are inserted through the skin into a blood vessel. . .
without. . . excess trauma to the blood vessel.”). Appellant’s invention
likewise addresses “minimizing] damage to the vascular system,” and
therefore, Hibbs is reasonably pertinent to a problem with which Appellant
was concerned. See Spec. 1 8. Thus, Hibbs is properly relied on by the
Examiner as analogous art.
Appellant argues, inter alia, that “[a]lthough[] Hibbs discloses a
‘continuous smooth inner . . . wall,’ such a disclosure does not support a
finding that the inner surface has no change in its surface chemistry as
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claimed.” Appeal Br. 15. Appellant submits that “[ijnstead, Hibbs discloses
sections of different materials,” and “[t]he Examiner has made no suggestion
or showing that the different materials of Hibbs embody the same chemical
properties.” Id.', see id. 15—16 (citing Hibbs 3:53—56, 4:11—15). Appellant
further submits that Hibbs specifically discloses that “[rjegion 32 is the
region of [the] bond and generally includes a varying mixture resulting from
chemical or thermal fusion of the materials of body 24 and tip 26.” Id. at 16
(citing Hibbs 5:34—39). Appellant concludes that because “Hibbs provides a
varying mixture along the device,. . . Hibbs expressly does not disclose the
claimed ‘no change in surface chemistry through the length of the device.’”
Id.', see also Reply Br. 8.
We are persuaded by Appellant’s argument regarding Hibbs, which
relies on differences in the chemical compositions of the materials of the
inner surface of the vascular device for concluding that the surface
chemistries of such materials do not exhibit no change throughout the length
of the vascular access device, as claimed. However, with regard to this
claim limitation and the Examiner’s findings in the rejection of claim 1 as
anticipated by Dossa, the Examiner clarifies that, with respect to Dossa, the
embodiment in Dossa wherein “a graft portion and a catheter portion for a
vascular device can be made integral or interpreted to be unitary with the
material being the same,” is relied upon, and the Examiner determines that
because the material is the same, the inner surface of Dossa’s vascular
access device “would not have any chemical change throughout the length.”
Ans. 7; see also id. at 8 (“Dossa clearly used a single material which
inherently has no change in surface chemistry.”).
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Appellant submits that ‘“surface chemistry’ is the ‘chemical reactions
at interfaces.’” Reply Br. 4 (citing Wikipedia). Appellant argues that “the
smoothness of the interior wall does not relate to or require the same
chemistry along the wall” (Appeal Br. 10) and also that “[a] generic
assertion that the interior surface of Dossa is smooth does not necessitate a
finding or conclusion that there is no change ‘in surface chemistry
throughout the length of the vascular access device,’ as claimed” {id. at 14
(emphasis added); see also Reply Br. 3—5). Appellant also argues that
“Dossa is silent regarding the chemical properties of the inner surface.”
Reply Br. 5; see also id. at 6 (“Dossa still does not inherently require no
change in surface chemistry.”). Appellant submits that
because of the influences of manufacturing processes,
environmental exposures, surface variations, roughness, among
other factors, the surface chemistry of the different portions of
the Dossa device cannot be determined. As Dossa is silent with
regard to the surface chemistry as well as the factors that affect
surface chemistry, a determination of the surface chemistry
cannot be found to necessarily be present [in Dossa].
Id. at 6. Appellant further submits that “[e]ven assuming arguendo that the
Dossa graft-catheter is of the same material and is made unitary, it does not
necessitate no change in surface chemistry,” because “the catheter end and
the graft end have different diameter sections for attachment to the artery,
and insertion into the vein,” and “[tjherefore, the ends of the device must
necessarily be made differently,” and “the manufacturing process affects
surface chemistry.” Id. at 7.
The Specification makes a single reference to “surface chemistry.”
With reference to Figure 5, which depicts a fourth embodiment of the
invention, the Specification discloses that
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[t]he graft-catheter 80, similar to the graft-catheter 70, has a graft
section 82 and a catheter section 84. The graft section 82 may
be comprised of ePTFE[4] and the catheter section 84 may be
comprised of polyurethane with the graft section 82 and the
catheter section 84 joined in region 86 by an injection molded
hub process. The internal surface of the graft-catheter 80 is
molded or coated with an inner polyurethane coating 92 that is
applied to the ePTFE 88 of the graft section 82 and the
polyurethane material 90 of the catheter section 84. The inner
polyurethane coating 92 smoothes the inner surface of the graft-
catheter 80, so that superior blood contact characteristics will be
achieved, and provides the bloodstream with a surface that
exhibits no change in surface chemistry throughout the length of
the graft-catheter 80. The inner polyurethane coating 92 may be
utilized in any of the embodiments.
Spec. 139 (emphasis added). Thus, the Specification attributes the
unchanging surface chemistry of the inner surface to the inner polyurethane
coating.
Whether formed as two separate parts joined together or made as an
integral unit, Dossa discloses providing a vascular access device comprised
of graft 12 and catheter 18 made of the same materials, wherein graft 12 is
“constructed of a relatively thin wall of [PTFE]” and catheter 18 is “likewise
[] constructed of a relatively thin wall of PTFE.” Dossa 3:29-30, 35—36.
Because Dossa teaches an integral unit formed from PTFE, we determine
that Dossa provides a sound basis to establish that the inner surface of
Dossa’s vascular device inherently presents an inner surface with the same
surface chemistry throughout the length of the vascular device. We are not
persuaded by Appellant’s argument that Dossa’s catheter and graft ends
must have different diameter sections, as the diameters disclosed in Dossa
4 See Spec. 1 5 (“expanded polytetrafluoroethylene (ePTFE)”).
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are suggested only. See, e.g., Dossa 3:32—42 (“[gjraft 12 may typically have
. . . an outer diameter of about 6 millimeters;” “[cjatheter 18, which may
flare outward at its connection with graft 12, may have ... a diameter of
about 6 to 14 French at its thinner end, depending on the anatomy of the
particular patient;” “[cjatheter 18 may have a funnel configuration; for
example the outer diameter of the end that is connected to graft 12 may be
about 16 french and the diameter of the other end may be about 12 french.”)
(emphasis added). Moreover, Appellant has not provided sufficient support
for determining that Dossa’s graft and catheter sections must necessarily be
made differently, resulting in surface chemistries that exhibit change.
Appellant’s contentions appear to represent mere attorney argument without
supporting evidence. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir.
1984) (“Arguments and conclusions unsupported by factual evidence carry
no evidentiary weight”).
Absent such evidence, we determine that a preponderance of evidence
supports the Examiner’s finding that Dossa discloses providing a vascular
access device having an inner surface that exhibits no change in surface
chemistry throughout the length of the vascular access device, as recited in
claim 1. We remind Appellant that when the Examiner relies on inherency
to satisfy the feature recited in a claim, the Examiner bears the burden of
showing a “sound basis for believing that the products of the applicant and
the prior art are the same.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
If such sound basis has been established, the burden is then shifted to
Appellant to show they are not the same. Id.
Thus, we determine that the Examiner has sufficiently supported the
finding that Dossa inherently discloses an inner surface that exhibits no
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change in surface chemistry throughout the length of the vascular device.
Because Appellant does not apprise us of error in the Examiner’s finding
that Hibbs discloses a smooth inner surface, or the Examiner’s rationale for
modifying Dossa in view of Hibbs, we sustain the Examiner’s rejection of
claim 1 under 35 U.S.C. § 103(a) as unpatentable over Dossa and Hibbs.5
To the extent we have relied on findings and reasoning not relied on by the
Examiner in the rejection of claim 1 as unpatentable over Dossa and Hibbs,
we designate our affirmance of this Rejection as a new ground of rejection
under 37 C.F.R. §41.50(b) to provide Appellant with a full and fair
opportunity to respond to the Rejection, as modified.
Rejection II
Dependent Claim 3 — Obviousness over Dossa and Martin
Claim 3, which depends from claim 1, recites “wherein the providing
a vascular access device includes providing a vascular access device wherein
the graft portion wall consists of polyurethane having a first durometer
value, and wherein the catheter portion wall consists of polyurethane having
a second durometer value different from the first durometer value.” Appeal
Br. 28 (Claims App.). Because the Examiner does not rely on Martin to cure
the deficiency of Dossa discussed above in the rejection of claim 1 as
anticipated by Dossa, we cannot not sustain the Examiner’s rejection of
5 We agree with Appellant that the Examiner erred by determining that “if
[a] surface is smooth it must not have a change in surface chemistry,”
because a smooth surface may still have a difference in surface composition,
structure, or properties at an interface of the smooth surface. Ans. 7
(emphasis added).
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claim 3, which depends from claim 1, under 35 U.S.C. § 103 as unpatentable
over Dossa and Martin.
Rejection III
Dependent claim 4 — Obviousness over Dossa, Hibbs, and Hanson
Claim 4, which depends from claim 1, recites, in relevant part,
“providing a vascular access device consisting of [ePTFE] having the inner
surface entirely coated by a polyurethane material from the distal end to the
proximal end of the vascular access device.” Appeal Br. 29 (Claims App.).
The Examiner finds that Dossa does not disclose that “the device consists of
ePTFE having the inner surface coated with polyurethane,” and relies on
Hanson for teaching that “a vascular device of the same material as Dossa
([PTFE]) in which the tubular structure 4 has a catheter portion 6 coupleable
to a first vessel and a graft portion 12 coupleable to a second vessel.” Final
Act. 8. The Examiner also relies on Hanson for teaching that the device may
be “made of ePTFE.” Id. (citing Hanson 7:47—50 (“The first element 4 of
the device 10 can be comprised of any biocompatible material, including but
not limited to, conventional vascular graft materials”); see also Dossa 1:12—
13, 19) (“various types of arterio-venous (AV) conduit have been provided
to provide access to the bloodstream . . . including . . . [ePTFE].”).
The Examiner further finds that Hanson teaches “to coat the blood
contacting surface with polyurethane to improve biocompatibility.” Final
Act. 8 (citing Hanson 4:45—51, 53, 55—57). The Examiner reasons that it
would have been obvious “to incorporate a polyurethane coating on the inner
surface of the device as taught by Hanson with the vascular device of Dossa
as modified with Hibbs such that it improves the biocompatibility of the
medical apparatus.” Id.
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Appellant submits that
Hanson actually states: “The first surface of the device of the
present invention can further comprise a coating on a portion of
the surface in contact with the lumen of the conduit which
improves the biocompatibility of the first surface. For example,
a portion of the luminal surface of the first element, i.e., the
luminal surface of a vascular graft or vascular patch, can be
coated with a polymer.”
Appeal Br. 23 (citing Hanson 4:45—51). Appellant argues that “[s]ince
Hanson specifically identifies a coating only at a surface between the device
and the natural tissue conduit [(or blood vessel)6] to which it is attached, it
does not provide a coating on the entirety of the device, as claimed.” Reply
Br. 13. Appellant also argues that “the Examiner has not provided an
articulated reasoning why a person of skill in the art would extend a coating
designed for compatibility between the device and tissue to extend over the
device not in contact with tissue.” Id.
We are persuaded by Appellant’s arguments. We agree that the
Examiner does not find that Hanson discloses coating the inner surface of
Hanson’s device from the distal to the proximal end. Further, we agree that
the Examiner’s reason for coating Dossa’s vascular access device, namely,
“to improve biocompatibility,” does not explain why the coating is desirable
within the lumen of Dossa’s vascular access device rather than only at the
ends attached to or in contact with tissue (i.e., an artery or a vein). See
Dossa, Fig. 1.
Notwithstanding, Hibbs discloses that it is known to use a
polyurethane material as a coating on the inner surfaces of a device inserted
6 See Hanson 3:26, 29 (“The phrase ‘natural tissue conduit’ as used herein
means . . . blood vessels.”).
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into a blood vessel to provide anti-thrombogenic properties. See Hibbs,
1:10—12, 2:26—28, 3:63—65 (“A lubricious anti-thrombogenic hydrogel
coating 80 ... is provided on the interior surfaces of the introducer.”); 6:36—
37 (“The lubricious hydrophilic coating 80 is a biocompatible hydrogel
material such as a copolymer of polyurethane and polyvinylpyrrolidone.”);
6:45 46 (“Copolymers of polyurethane and polyvinylpyrrolidone have the
advantage of being highly anti-thrombogenic.”). Moreover, Dossa discloses
that “[t]he system may be constructed of one or more specific materials”
including “[mjaterial . . . covered with thrombus resistant coatings.” Dossa
5:4—8. Thus, we determine that it would have been obvious to one skilled in
the art at the time of the invention to coat the inner surface of Dossa’s
vascular device, as modified in view of the teachings of Dossa and/or
Hanson to be made from ePTFE, whereby the entire inner surface is coated
from distal to proximal ends by a polyurethane material to provide anti-
thrombogenic properties, as taught in Hibbs and as desired in Dossa.
Accordingly, we sustain the Examiner’s rejection of claim 4 under 35
U.S.C. § 103(a) as unpatentable over Dossa, Hibbs, and Hanson, and to the
extent we have relied on findings and reasoning not relied on by the
Examiner, we designate our affirmance of this Rejection as a new ground of
rejection under 37 C.F.R. §41.50(b) to provide Appellant with a full and fair
opportunity to respond to the Rejection, as modified.
Dependent claim 6 — Obviousness over Dossa, Hibbs, and Hanson
Claim 6, which depends from claim 1, recites, in relevant part,
“providing a vascular access device having a gradual taper between the
substantially constant diameter graft portion and the distal end of the
catheter portion, wherein the gradual taper extends for a length longer than
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half an end to end length of the graft portion.” Appeal Br. 29 (Claims
App.).
The Examiner finds that Dossa does not disclose the gradual taper, as
claimed, and relies on Hanons for teaching “a gradual taper for a catheter
portion.” Final Act. 8 (citing Hanson, Fig. 2). The Examiner reasons that
“[i]t would have been an obvious expedient to find the optimal dimensions
for the catheter portion to match the vessel dimensions and use a gradual
taper as taught by Hanson with the vascular access device of Dossa as
modified with Hibbs such that it prevents leakage by having a snug
attachment therein.” Id.
Appellant submits that “Appellant is unable to find any taper in the
device of Hanson,” and in particular, at catheter portion 6 in Figure 2.
Appeal Br. 24. Figure 2 of Hanson is reproduced below.
Figure 2 of Hanson depicts a local drug delivery device attached to a natural
tissue conduit, with numeral 6 referring to an end of the conduit. See
Hanson 2:43—46, 7:37.
The Examiner determines that Figure 2 of Hanson shows “a thickness
that differs along the length for the graft device thus establishing a gradual
taper.” Ans. 13. The Examiner also finds that “Hanson mentions that the
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conduit can have a tapered design.” Id. The Examiner further finds that
Figure 2 of Hanson “is described as having a cannula tip . . . which is known
in the art that tapers are involved with such structures to enable insertion into
[a] vessel.” Id. (citing Hanson 7:59).
Appellant replies that the Examiner fails to make a finding that the
prior art discloses the taper, as claimed, namely, “a taper that ‘extends for a
length longer than half an end to end length of the graft portion. Reply Br.
13.
We are persuaded by Appellant’s arguments. Hanson does not clearly
depict the taper as claimed and is silent regarding the dimensions of any
taper. When a reference does not disclose that the drawings are to scale and
is silent as to dimensions, the drawing features are of little value in
establishing measurements. See MPEP § 2125; Hockerson-Halberstadt, Inc.
v. Avia Group Inti Inc., 222 F.3d 951, 956 (Fed. Cir. 2000) (“[I]t is well
established that patent drawings do not define the precise proportions of the
elements and may not be relied on to show particular sizes if the
specification is completely silent on the issue.”).
Accordingly, we cannot sustain the Examiner’s rejection of claim 6
under 35 U.S.C. § 103(a) as unpatentable over Dossa, Hibbs, and Hanson.
Rejection IV
Dependent Claim 5 — Obviousness over Dossa, Hibbs, Hanson, and Kowligi
Claim 5, which depends from independent claim 1, recites, in relevant
part, “providing a vascular access device consisting of [ePTFE] having the
inner surface entirely coated by a polyurethane material from the distal end
to the proximal end of the vascular access device and an outer surface of the
catheter portion wall coated by a polyurethane material.” Appeal Br. 29
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(Claims App.). Appellant argues that “Doss[a], Hibbs, and Hanson fail to
disclose features of independent claim 1 from which claim 5 directly
depends” and that “Kowligi does not provide the missing features.” Appeal
Br. 26. Appellant also submits, for the first time in the Reply Brief, that
“Appellant relies on the arguments presented in the Appeal Brief and [supra
with respect to claim 4] with respect to the deficiencies of Hanson to teach
the coating,” as claimed. Reply Br. 13. However, we sustained the
Examiner’s rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over Dossa and Hibbs, as discussed supra, such that Kowligi need not cure
any deficiencies in the Examiner’s rejection. Further, we rely on the
findings and reasoning, as set forth supra with respect to claim 4, in this
rejection of claim 5 to the extent the claim limitations of claim 4 and claim 5
are the same.
Accordingly, we sustain the Examiner’s rejection of claim 5 under
103(a) as unpatentable over Dossa, Hibbs, Hanson, and Kowligi, and we
designate our affirmance of this Rejection as a new ground of rejection
under 37 C.F.R. §41.50(b) to provide Appellant with a full and fair
opportunity to respond to the Rejection, as modified.
DECISION
The Examiner’s rejection of claim 1 under 35 U.S.C. § 102(e) as
anticipated by Dossa is REVERSED.
The Examiner’s rejection of claim 1 under 35 U.S.C. § 103(a) as
unpatentable over Dossa and Hibbs is AFFIRMED and designated a NEW
GROUND OF REJECTION pursuant to our authority under 37 C.F.R. §
41.50(b).
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The Examiner’s rejection of claim 3 under 35 U.S.C. § 103(a) as
unpatentable over Dossa and Martin is REVERSED.
The Examiner’s rejection of claim 4 under 35 U.S.C. § 103(a) as
unpatentable over Dossa, Hibbs, and Hanson is AFFIRMED and designated
a NEW GROUND OF REJECTION pursuant to our authority under 37
C.F.R.§ 41.50(b).
The Examiner’s rejection of claim 6 under 35 U.S.C. § 103(a) as
unpatentable over Dossa, Hibbs, and Hanson is REVERSED.
The Examiner’s rejection of claim 5 under 35 U.S.C. § 103(a) as
unpatentable over Dossa, Hibbs, Hanson, and Kowligi is AFFIRMED and
designated a NEW GROUND OF REJECTION pursuant to our authority
under 37 C.F.R. § 41.50(b).
Regarding the new grounds of rejection, Appellant, WITHIN TWO
must exercise one of the following two options with respect to the
new ground[s] of rejection to avoid termination of the appeal as to the
rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new Evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the examiner, in
which event the prosecution will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same Record. ... 37 C.F.R. §
41.50(b).
18
Appeal 2015-008019
Application 13/715,952
Should Appellant elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed
rejections, the effective date of the affirmance is deferred until conclusion of
the prosecution before the examiner unless the affirmed rejections is
overcome.
If Appellant elects prosecution before the Examiner and this does not
result in allowance of the application, abandonment or a second appeal, this
case should be returned to the Patent Trial and Appeal Board for final action
on the affirmed rejection, including any timely request for rehearing thereof.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN—PART; 37 C.F.R, $ 41.50(b)
19