Ex Parte Delaney

Patent Trial and Appeal Board

Feb 9, 2016

11533512 (P.T.A.B. Feb. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111533,512 0912012006
96845 7590 02/11/2016
Advent, LLP
3930 South 147th Street
Suite 101
Omaha, NE 68144
FIRST NAMED INVENTOR
Jeffrey W. Delaney
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.
50325.0005US01 4502
EXAMINER
DEAK, LESLIE R
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
02/11/2016 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):
sloma@adventip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY W. DELANEY
Appeal2013-010863
Application 11/533,512
Technology Center 3700
Before JILL D. HILL, THOMAS F. SMEGAL, and LISA M. GUIJT,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jeffrey W. Delaney (Appellant1) appeals under 35 U.S.C. § 134(a)
from the Examiner's decision to reject claims 1 and 25-50. Br. 6. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 According to Appellant, the real party in interest is Board of Regents of
the University of Nebraska. Br. 4.
Appeal2013-010863
Application 11/533,512
CLAIMED SUBJECT MATTER
Claims 1, 33, 44, and 50 are independent. Claim 1, reproduced below,
is illustrative of the subject matter on appeal.
1. An implant for implanting in a body, comprising:
a vascular graft having a generally elongated
tubular shape and a wall defining an interior; and
a valve disposed in the wall, the valve including an
elastomeric membrane barrier that is impermeable to
fluids to prevent the communication of fluids th[r]ough the
valve,
wherein the valve is configured to permit
penetration of the elastomeric membrane barrier by a
surgical instrument inserted through the valve from the
interior of the vascular graft to enable access by the
surgical instrument to an area external to the vascular
graft.
THE REJECTION
Claims 1, 25, 26, 32-37, 43, and 50 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Carter (US 6,090,067; iss. July 18, 2000).
Claims 27-31, 38--42, and 44--49 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Carter and Nelson (US 5,824,071; iss. Oct.20,
1998).
OPINION
Claims 1, 25, 26, 32-37, 43, and 50-Anticipated by Carter
Independent claim 1 and dependent claims 25, 26, and 32
Regarding independent claim 1, the Examiner finds that "Carter
discloses a vascular graft 140 having a generally elongated tubular shape, a
. . . hemostatic [valve] 142 disposed in the wall of the graft that prevents
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Application 11/533,512
fluid flow therethrough ... , wherein the valve is configured to permit
penetration of the elastomeric membrane by a surgical instrument." Final
Act. 2 (citing Carter, e.g., col. 5, 11. 50-59). The Examiner further finds that
"Carter does not specifically disclose that the valve may permit penetration
from the interior of the graft to the exterior of the graft," however, the
Examiner determines that the claims do not include "any structural
limitations that provide such a configuration," and notes that Appellant's
Specification discloses that a hemostatic valve is suitable. Id. (citing Spec. i-f
24). The Examiner finds that "the hemostatic valve disclosed by Carter is
capable of permitting access across either side of the valve, specifically
since [Appellant] discloses that a hemostatic valve, without structural
modification, would be suitable for the claimed invention." Id.
First, Appellant argues that "the Examiner has distilled Appellant's
invention down to a 'gist' or 'thrust of the invention (i.e., 'a graft with a
valve'), and has, as a result, failed to consider the claimed invention 'as a
whole,' as required by M.P.E.P. § 2141.02." Br. 18. However, this section
of the MPEP relates to the examination guidelines for determining
obviousness under 35 U.S.C. § 103, and is, therefore, not relevant to the
Examiner's rejection of independent claim 1under35 U.S.C. § 102.2
2 "A patent may not be obtained though the invention is not identically
disclosed ... as set forth in section 102 of this title, if the differences
between the subject rnatter sought to be patented 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 peii.ains." 35 U.S.C. § 103(a).
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Application 11/533,512
Second, Appellant argues that Carter is non-analogous art, and
therefore, improperly relied on by the Examiner. Br. 18-20. However,
analogous art arguments are irrelevant to anticipation rejections. See Twin
Disc, Inc. v. United States, 231USPQ417, 424 (Cl. Ct. 1986); see also In re
Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) ("A reference may be from
an entirely different field of endeavor than that of the claimed invention or
may be directed to an entirely different problem from the one addressed by
the inventor, yet the reference \vill still anticipate if it explicitly or inherently
discloses every limitation recited in the clahns.").
Third, Appellant argues that
Carter nowhere discloses or suggests a valve that "is configured
to permit penetration of the elastomeric membrane barrier by a
surgical instrument inserted through the valve from the interior
of the vascular graft to enable access by the surgical instrument
to an area external to the vascular graft" as recited in claim 1.
Br. 20. The Examiner responds that the claims, as written, do limit the
valve's structure to permit penetration in only one direction, and that
Carter's hemostatic valve, as disclosed, meets the claim limitation of
"be[ing] 'configured' to be penetrated from the interior of the graft." Ans. 9.
Language in an apparatus cfaim directed to the function, operation,
intent-of-usei and materials upon which these apparatus components work,
that does not structurally limit the apparatus components or patentably
differentiate the claimed apparatus from an otherwise identical prior art
apparatus, will not support patentability. See, e.g., Jn re Yanush, 477 F.2d
958, 959 (CCPA 1973); In re Ludtke, 441 F.2d 660, 663-64 (CCPA 1971);
In re Rishoi, 197 F.2d 344-45 (CCPA 1952). A prior art apparatus having
the same or obvious structure as a claimed apparatus renders a claimed
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Application 11/533,512
apparatus unpatentable under 35 U.S.C. § 102 as kmg as it is capable of
performing the claimed process or function. Jn re Yanush, 477 F.2d at 959
("[A] use lirnitation [which J does not irnpart a stn1ctural feature different
from those of the prior art'~ is satisfied by a stn1cture that "inherently
possesses [the same] capability.~') (citations omitted).
We are not persuaded by Appellant's argument. The Examiner does
not find that Carter's valve requires any modification to meet the limitations
of claim 1, but rather finds that Carter's valve as disclosed is configured so
as to perform as claimed. As noted by the Examiner, Appellant's
Specification discloses that a hemostatic valve is an example of a valve
formed within the vascular graft, which is penetrable by a surgical
instrument. See Spec. 24. Appellant does not dispute that Carter depicts a
hemostatic valve that has the same structure as Appellant's claimed
hemostatic valve, or that Carter describes the valve as receiving medical
instruments in at least one direction. See Carter, Figs. 6-8. Appellant does
not present persuasive argument or evidence to contradict the Examiner's
finding that Carter's hemostatic valves are, therefore, also configured to
permit penetration from the interior of the graft to an area external to the
graft. Thus, we are not apprised of error in the Examiner's finding that
Carter's hemostatic valve is "configured to permit penetration ... from the
interior of the graft ... to an area external to the vascular graft," as required
by claim 1.
Accordingly, we sustain the Examiner's rejection of independent
claim 1. Appellant chose not to present separate arguments for the
patentability of claims 25, 26, and 32, which depend from claim 1. Br. 20.
Thus, we also sustain the Examiner's rejection of claims 25, 26, and 32.
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Application 11/533,512
Independent claim 33 and dependent claims 34-37 and 43
Appellant repeats the arguments presented supra with respect to
independent claim 1, contending that i) the Examiner failed to consider the
invention "as a whole;" ii) Carter is non-analogous art; and iii) Carter fails to
disclose a valve configured to permit penetration of the elastomeric
membrane barrier, as claimed. See Br. 21-23, 24. For the reasons stated
supra, we are not persuaded by Appellant's arguments.
Appellant further argues that
Carter nowhere discloses or suggests a "vascular graft
configured to separate cyanotic blood flow from the heart and
route this blood flow directly to the lungs, the vascular graft
including a first end for attachment to the inferior vena cava, a
second end for attachment to a pulmonary artery and a wall
defining an interior," as recited in claim 33.
Br. 23. Appellant submits that instead, "Carter discloses a surface access
hemostatic valve for a hemodialysis graft," and that "Carter nowhere
discloses or otherwise suggests that the graft and surface access hemostatic
valve are suitable for use in a Fontan procedure." Id. Appellant contends
that "[ o ]ne of ordinary skill in the art, such as a vascular surgeon, would
understand that a 'vascular graft' is a specific type of device used to patch
injured or diseased areas of arteries, or for replacement of whole segments of
larger arteries," and that claim 33 recites a "vascular graft" configured as
claimed. Id. Appellant further contends that "[ o ]ne of ordinary skill in the
art would recognize that none of the components disclosed by Carter can be
used as a vascular graft to patch an injured or diseased area of an artery, or
replace a whole segment of a larger artery." Id. at 23-24. Appellant
concludes that "none of the components of the Carter graft would be suitable
for use as a 'vascular graft' as presently recited." Id. at 24.
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The Examiner responds that "there is no structural limitation of the
claimed apparatus that performs such a separation," and finds that Carter
"can perform the separation," as recited in claim 33. Ans. 10. The
Examiner finds that Carter "discloses a graft that is attached to a patient's
vasculature, thereby disclosing a 'vascular graft."' Id. at 10-11. The
Examiner further finds that because Carter discloses that the "graft is sutured
to vascular structures," Carter supports the Examiner's finding that Carter is
suitable as a vascular graft as claimed. Id. at 11.
We agree with the Examiner that Carter discloses a "vascular graft,"
as claimed, in that Carter discloses a graft attached to a patient's
vasculature. 3 See, e.g., Carter, col. 5, 11. 12-15 ("After the graft 102 and the
valve 100 have been installed ... access to the blood of the patient flowing
through the interior of the graft 102 is provided ... . ");see also Carter, col.
5, 11. 52-59 ("graft 140 comprising an arteriovenous (A-V) fistula is
connected between an artery and a vein of a patient P ... utilizing
conventional surgical techniques.").
As discussed supra, apparatus claims must distinguish over prior art
apparatus by the structure defined by the claims, and not by a process or
function performed by the apparatus. Here, Appellant does not identify any
structural differences between Carter's graft and the claimed graft, or
explain why Carter's graft, and components thereof, would not be suitable
"to separate cyanotic blood flow from the heart and route this blood flow
3 An ordinary definition of the claim term "vascular," when used as an
adjective, for example, to modify "graft," is "of, relating to, or affecting, a
tube for the conveyance of a body fluid .... " WEBSTER'S THIRD INT'L
DICTIONARY, 2535 (1993). This ordinary definition is consistent with
Appellant's Specification.
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Application 11/533,512
directly to the lungs, the vascular graft including a first end for attachment to
the inferior vena cava [and] a second end for attachment to a pulmonary
artery." Without more, Appellant's argument appears to represent mere
attorney argument without supporting evidence. See In re Schulze, 346 F .2d
600, 602 (CCPA 1965) ("Argument in the brief does not take the place of
evidence of record.") (citations omitted). Thus, we are not apprised of error
in the Examiner's finding that Carter discloses a "vascular graft" that is
"configured to separate cyanotic blood flow from the heart and route this
blood flow directly to the lungs, the vascular graft including a first end for
attachment to the inferior vena cava [and] a second end for attachment to a
pulmonary artery," as required by claim 33.
Accordingly, we sustain the Examiner's rejection of independent
claim 33. Appellant chose not to present separate arguments for the
patentability of claims 34--37 and 43, which depend from claim 33. Br. 24.
Thus, we also sustain the Examiner's rejection of claims 34--37 and 43.
Independent claim 5 0
Appellant repeats the arguments presented supra with respect to claim
1, contending that i) the Examiner failed to consider the invention "as a
whole;" ii) Carter is non-analogous art; and iii) Carter fails to disclose a
valve configured to permit penetration of the elastomeric membrane barrier,
as claimed. See Br. 25-28.
Appellant further argues that
Carter nowhere discloses or suggests a "vascular graft
configured to separate cyanotic blood flow from the heart and
route this blood flow directly to the lungs, the vascular graft
including a first end for surgical suturing to the inferior vena
cava, a second end for surgical suturing to a pulmonary artery
and a wall defining an interior," as recited in claim 50.
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Application 11/533,512
Br. 27 (emphasis, in bold font, added). Regarding this claim limitation,
Appellant repeats the arguments presented supra with respect to claim 33.
Notably, the only difference between the claim language of claim 33 and the
claim language of claim 50, with respect to this claim limitation, is that
claim 33 recites "attachment" where claim 50 recites "surgical suturing."
Br. 41, 44 (Claims App.). The Examiner correctly finds that Carter's "graft
is sutured to vascular structures," in that a conventional surgical technique is
suturing. Ans. 11; see e.g., Carter, col. 5, 11. 57-59.
Accordingly, for the reasons discussed supra, with respect to claim
33, we also sustain the Examiner's rejection of independent claim 50.
Claims 27-31, 38--42, and 44-49- Obviousness over Carter and Nelson
Analogous Art
As an initial matter, Appellant argues that the Examiner erred by
relying on Carter and Nelson, because Carter and Nelson are not analogous
art. Br. 28. In particular, Appellant contends that Carter and Nelson "are
directed to other fields of endeavor" and "are not 'reasonably pertinent' to
the problem involved." Id. Appellant identifies the problem, which is
addressed by Appellant, as "rerouting blood flow as a treatment for
congenital heart disease, and more specifically ... connecting the pulmonary
artery to the inferior vena cava when performing a Fontan procedure." Id. at
28-29. Appellant submits that "Carter is directed to a surface access
hemostatic valve for a hemodialysis graft that includes a tube and a
hemostatic valve mounted at the distal end of the tube so that the hemostatic
valve is positioned at the surface of the skin (outside the body) of the
patient," whereby "[d]uring hemodialysis, the valve permits access to the
patient's blood flow via insertion of an instrument through the hemostatic
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Application 11/533,512
valve (from outside the patient's body), through the tube, and into the graft."
Id. at 29. Appellant further submits that "Nelson is directed to supplying
retrograde perfusion of the myocardium via a conduit disposed between the
left ventricle and the coronary sinus," whereby "the conduit includes a
pressure-limiting valve that functions to prevent pressure in the coronary
sinus from exceeding a predetermined value." Id. Appellant explains that
Nelson's valve "does not permit penetration by a surgical instrument."
Appellant concludes that "these references would not logically have
commended themselves to Appellant's attention in considering the problem
addressed by the present disclosure," and are therefore, not analogous art.
Id.
The Examiner finds that Carter, Nelson, and Appellant's Specification
"are all concerned with creating an implantable blood flow pathway within a
patient's vascular circulation," and "[a]s such, the references are pertinent to
one another as well as Appellant's invention." Ans. 17.
The Federa1 Circuit has explained that "[t]he analogous art inquiry is a
factual one, requiring inquiry into the similarities of the problems and the
closeness of the subject matter as viewed by a person of ordinary skm."
Scient~flc Plastic Prods., inc. 1'. Biotage AB, 766 F.3d 1355, 1360 (Fed. Cir.
2014 ).
Criteria for determining whether prior art is analogous may be
summarized as ''( 1) whether the art is from the same field of
endeavor, regardless of the prob1em addressed, and (2) if the
reference is not vvithin the field of the inventor's endeavor,
whether the reference still is reasonably pertinent to the
particular problem with \vhich the inventor is involved."
Td ' l') -q ( ... I ' (-'! 966- F' '/d 6"6- ··,;;;o -q (F ~ c· 1CJ91"l') _u. at _1)_. c1tmg n re .ay, ) .... ,,_, , (Lo----)_. eci. .ir. _. LJ.
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Application 11/533,512
Here, a particular problem involving Appellant is to provide an
implantable vascular tube graft that allows easy, reliable, and repeated
access to an area within the patient. See Spec. i-f 8. Carter is reasonably
pertinent to this particular problem, in that Carter discloses a surface access
hemostatic valve, whereby a graft is implanted in a patient, and more
specifically, connected between an artery and vein of the patient using
conventional surgical techniques, such that an instrument may easily,
reliably, and repeatedly access the interior of the graft. See Carter, Abstract,
col. 1, 54, col. 2, 11. 15-16, 22-23. Carter further explains that a sheath, for
example, may be inserted through a valve on the graft to allow access to the
interior of the graft for accessing blood flowing through the graft, or a
catheter, for example, may be inserted through a valve on the graft to permit
access to a clot within the patient. See id., col. 5, 11. 11-17, col. 6, 11. 36-57,
Figs. 21, 22.
Appellant's invention also addresses the problem of precisely locating
the valve on a graft after implantation in the patient. See Spec. i-f 9. Because
Nelson discloses using radiopaque marker rings embedded in a plug
implanted in a patient for finding the location and orientation of the plug
when disposed within a coronary ostium of a patient, we determine that
Nelson is likewise reasonably pertinent to a particular problem addressed by
Appellant. See Nelson, col. 6, 11. 30-47.
Thus, Carter and Nelson are analogous art properly relied on by the
Examiner.
Radiopaque Marker
Claims 27-31, 38--42, and 44--49 all require "a marker configured to
allow location of the valve." Br. 40-44 (Claims App.). Appellant argues,
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Application 11/533,512
inter alia, that Carter's surface access hemostatic valve "would have no need
[for] a radiopaque marker since the portal could be located visually." Id. at
30; see also id. at 40 (Claims App.). Appellant maintains that even in the
context of Carter's embodiment depicted in Figure 9, which shows two
valves 82, 88, wherein valve 88 is located at the skin's surface and valve 82
is remote from skin surface, a radiopaque marker on valve 82 would not be
needed because the valve 88 provides access to valve 82 and is located
visually. Id. The Examiner responds, with respect to Carter, that "Li]ust
because one may visually locate one valve, it does not necessarily follow
that one may visually locate a subcutaneously located valve," which may
"become disconnected or otherwise fail to function." Ans. 16.
We find Appellant's argument persuasive. Carter discloses a surface
access hemostatic valve positioned at the surface of the skin of the patient.
See Carter, Abstract. Thus, we agree with Appellant that the Examiner's
reasoning lacks rational underpinning, in that a marker would not be
required to determine the access point or surface access valve to operate the
device. With respect to Carter's embodiment depicting two valves, we are
persuaded by Appellant that locating the first surface access valve would
provide sufficient indication of the location of the second subcutaneous
valve, due to the connection of the valves by a chamber, and especially in
view of Carter's teaching that the medical instrument enters the vascular
graft via the surface access valve, such that there is no need to locate the
second valve to operate the device.
Accordingly, we do not sustain the Examiner's rejection of claims 27-
31, 38--42, and 44--49 as unpatentable over Carter and Nelson.
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DECISION
The Examiner's decision to reject claims 1, 25, 26, 32-37, 43, and 50
under 35 U.S.C. § 102(b) is AFFIRMED.
The Examiner's decision to reject claims 27-31, 38--42, and 44--49
under 35 U.S.C. § 103(a) is 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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