PRISMA HEALTH - UPSTATE

Patent Trials and Appeals Board

Sep 28, 2021

2021001686 (P.T.A.B. Sep. 28, 2021)

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.
15/296,680 10/18/2016 David L. Cull GHS-87 (PHU-00003) 4815
22827 7590 09/28/2021
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
BALDORI, JOSEPH B
ART UNIT PAPER NUMBER
3711
NOTIFICATION DATE DELIVERY MODE
09/28/2021 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):
USDOCKETING@DORITY-MANNING.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID L. CULL and THOMAS B. O'HANLAN
Appeal 2021-001686
Application 15/296,680
Technology Center 3700
Before JENNIFER D. BAHR, BENJAMIN D. M. WOOD, and
MICHELLE R. OSINSKI, Administrative Patent Judges.
WOOD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–8, and 19–23. Claims 2 and 9–18
have been canceled. Appeal Br. 30–31 (Claims App.). We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42(a).
Appellant identifies the real party in interest as Prisma Health-Upstate.
Appeal Br. 3.
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CLAIMED SUBJECT MATTER
The claims are directed to an arteriovenous (AV) fistula cannulation
simulator. Spec. ¶¶ 2, 7. In the context of this case, an AV fistula is a
surgical connection made between an artery and a vein, allowing blood to
flow directly from the artery to the vein at increased pressure and flow rate.
See https://www.azuravascularcare.com/medical-services/dialysis-access-
management/av-fistula-creation/ (last visited Sept. 9, 2021). Surgically
created AV fistulas provide vascular access for hemodialysis. Id. To
cannulate an AV fistula for hemodialysis, “it is necessary to insert two large
gauge (usually 15 g to 17 g) needles through a patient’s skin and into a
vessel having high blood flow rate.” Spec. ¶ 2. “AV fistula cannulation is
an almost entirely tactile skill that requires locating the AV fistula in the
subcutaneous tissue and proper assessment of the fistula orientation and
depth followed by accurate placement of the needle end within the lumen of
the vessel.” Id. Patients who opt for home hemodialysis must learn how to
perform this cannulation, and a cannulation simulator can help with this
training. Spec. ¶¶ 2, 5–6.
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A cannulation simulation device comprising:
a support;
a plurality of artificial fistulas held in conjunction with the
support, each artificial fistula including an upper barrier having
a radial curvature and an axial length and further including a
lower barrier, each artificial fistula defining a fistula opening
between the upper barrier and the lower barrier;
a plurality of vibration motors, each of the plurality of
vibration motors being in mechanical communication with one
of the plurality of artificial fistulas;
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a control system configured to selectively activate each
vibration motor and thereby vibrate the associated artificial
fistula and simulate mixed venous and arterial blood flow
vibration of an arteriovenous fistula; and
a pad having a thickness of from 0.25 inches to 1 inch
configured to be removably located on an upper surface of the
support such that the pad overlays the upper barriers of the
artificial fistulas.

REFERENCES
Name Reference(s)/Basis Date
Bloom US 5,839,904 Nov. 24, 1998
Izzat US 5,947,744 Sep. 7, 1999
Nelson US 9,033,713 B2 May 19, 2015
Toly US 2004/0126746 A1 Jul. 1, 2004
Hoskins US 2013/0052626 A1 Feb. 28, 2013
Rios US 2014/0212864 A1 Jul. 31, 2014

REJECTIONS
Claims Rejected 35 U.S.C. § Reference(s)/Basis
1, 3–8, 19–23 112(a) Written Description
1, 3–8, 19–23 112(b) Indefiniteness
1, 5–8 103 Hoskins, Nelson, Izzat
3 103 Hoskins, Nelson, Izzat, Rios
4 103 Hoskins, Nelson, Izzat, Toly
19, 22, 23 103 Hoskins, Nelson, Izzat, Bloom
20 103 Hoskins, Nelson, Izzat, Bloom, Rios
21 103 Hoskins, Nelson, Izzat, Bloom, Toly

OPINION
Claims 1, 3–8, 19–23—§ 112(b)—Indefiniteness
We first address the Examiner’s rejection of the pending claims under
35 U.S.C. § 112(b) as indefinite. The Examiner determines that the
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recitation in claims 1 and 19 that “a control system selectively activates
vibration ‘and simulate[s] mixed venous and arterial blood flow vibration of
an arteriovenous fistula’” is unclear. Final Act. 3–4. The Examiner finds
that the disclosure “only describe[s] the use of ‘any suitable vibration motor’
to vibrate each fistula to provide a ‘tactile cue of location, width, and
direction,’ and thus “it is exceedingly unclear what is attempting to be
claimed, since there is no description of what this particular blood flow
mixing vibration is, or what characteristics these specific types of vibrations
produced have.” Id. at 4. Thus, according to the Examiner, “it is unclear
what, if any, particular types of vibrations are attempting to be claimed.”
Final Act. 4 (citing Spec. ¶¶ 2, 45–46).
Appellant responds that “the type of vibration being claimed is a
vibration that simulates the mixed venous and arterial blood flow of an AV
fistula.” Appeal Br. 15. Appellant disputes that this term encompasses “any
basic pulsation,” asserting that “[t]he suggestion that the plain language of
the claims could mean something other than what the words say, i.e., that the
plain language of the claim regarding the vibration of an arteriovenous
fistula could instead refer to any basic pulsation, is not supported by any
reasonable interpretation of the claims, particularly when read in light of the
specification.” Id. at 17. Appellant submits that “a person having ordinary
skill in the art (who is well aware of the vibrational characteristics of
arteriovenous fistulas and that these characteristics are clearly different from
the characteristics of a basic pulsatile flow) would understand the vibration
characteristics required of the vibration motors of the claims and would
understand the metes and bounds of the claimed subject matter.” Id. at 18.
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Claim 1 recites “a control system configured to selectively activate
each vibration motor and thereby vibrate the associated artificial fistula and
simulate mixed venous and arterial blood flow vibration of an arteriovenous
fistula.” Appeal Br. 30 (Claims App.) (emphasis added). Claim 19 contains
a similar limitation. Id. at 31. That claim 1 recites both vibrating the
artificial fistula and simulating mixed venous and arterial blood flow
vibration of an arteriovenous fistula indicates that the control system must
do more than simply vibrate the artificial fistula in any manner; instead the
claim requires vibrating the artificial fistula in a certain way that
accomplishes the claimed simulation.
This interpretation is supported by the relevant prosecution history.
The claims as originally filed either did not recite any vibration motor or
vibration, or simply required that the artificial fistula be vibrated without
specifying how it was to be vibrated. For example, the originally filed claim
15, which depended from originally filed claim 11, recited a method for
cannulation training comprising “engaging a vibration motor in
communication with the artificial fistula such that the upper barrier of the
artificial fistula vibrates.” Amendment (Oct. 18, 2016), 16.2 The
interpretation is also consistent with Appellant’s position that the claims do
not encompass “any basic pulsation,” i.e., any vibration.

2 Independent claim 1 was subsequently amended to recite a control system
to activate each vibration motor and vibrate the associated artificial fistula
“to simulate mixed venous and arterial blood flow vibration of an
arteriovenous fistula.” Amend. (Sept. 30, 2019), 2 (emphasis added). A
later amendment changed “to simulate” to “and simulate,” as the claim
appears in its current version.
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Having determined that the limitation at issue is limited to certain
vibrations that “simulate mixed venous and arterial blood flow vibration of
an arteriovenous fistula,” it is still necessary to determine what sort of
vibration that would be. The Specification does not address this issue;
indeed, it does not use the term “mixed venous and arterial blood flow.”
The Specification generally states that one or more vibration motors can be
in “mechanical communication” with each artificial fistula “so as to vibrate
the upper barrier” of the fistula and “provide a tactile cue . . . to a trainee of
the location, width, and direction of the underlying fistula.” Spec. ¶ 46.
According to the Specification, “[a]ny suitable vibration motor . . . is
encompassed, such as those commonly found in cell phones that can be used
to mimic the vibrations of fistula.” Id. ¶ 47. Neither of these provisions
discusses the specific parameters of “the vibrations of fistula,” however.
Appellant further alleges that one of ordinary skill in the art “is well
aware of the vibrational characteristics of arteriovenous fistulas,” that “these
characteristics are clearly different from the characteristics of a basic
pulsatile flow,” and that one of ordinary skill in the art “would understand
the vibration characteristics required of the vibration motors of the claims
and would understand the metes and bounds of the claimed subject matter.”
Appeal Br. 18. Appellant does not, however, provide evidentiary support for
these allegations. In the absence of such support they constitute attorney
argument, to which we accord no weight. In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997).
Appellant also denies that the claimed vibrations that simulate mixed
venous and arterial blood flow vibrations of an AV fistula read on the
specific vibrations generated by Izzat, the reference on which the Examiner
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relies to teach this limitation. Izzat teaches “a model for practicing coronary
artery grafting on a beating heart.” Izzat, 2:5–6. Izzat’s training device
comprises a motor that simulates the motion of a beating heart; the speed of
the motor can be adjusted to reproduce heart rates between 40 to 150 cycles
per minute. Id. at 3:47–50. Irregular heartbeats can also be simulated. Id. at
3:50–53. Appellant asserts that “the vibration motor of Izzat simulates the
motion of a beating heart rather than the characteristic vibration of an
arteriovenous fistula.” Appeal Br. 23. Appellant thus acknowledges that an
AV fistula exhibits “characteristic vibration[s],” but it is not clear from the
Specification or any other evidence of record how to recognize such
characteristic vibrations.3
During prosecution, a claim may be rejected as indefinite “when it
contains words or phrases whose meaning is unclear.” MPEP § 2173.05(e).
Based on the foregoing, we agree with the Examiner that the term “a control
system configured to selectively activate each vibration motor and thereby
vibrate the associated artificial fistula and simulate mixed venous and
arterial blood flow vibration of an artieriovenous fistula” is unclear. Thus,
Appellant has not shown error in the Examiner’s determination that claims 1
and 19, and their dependent claims 3–8 and 20–23, are indefinite.
The Remaining Rejections
The Examiner also rejected claims 1, 3–8, and 19–23 under 35 U.S.C.
§ 103 as unpatentable over various prior-art references, and under 35 U.S.C.
§ 112(a) as failing the written-description requirement. Final Act. 2–14. In

3 Appellant asserts that an AV fistula “causes the blood flow of the two
vessels to impact in a chaotic, non-pulsatile, but recognizably vibratory
fashion,” Appeal Br. 22–23, but provides no support for this assertion.
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view of the indefiniteness of these claims, however, it is not possible to
ascertain their scope. Accordingly, we find that the Examiner’s rejections of
claims 1, 3–8, and 19–23 under 35 U.S.C. § 103 are necessarily based on
speculation and assumptions. See In re Steele, 305 F.2d 859, 862 (CCPA
1962) (“We do not think a rejection under 35 U.S.C. § 103 should be based
on . . . speculations and assumptions . . . [I]t is essential to know what the
claims do in fact cover.”). Therefore, we summarily decline to sustain the
rejections of these claims under 35 U.S.C. § 103. We find the reasoning in
Steele to be applicable to the written description rejection as well, because
reaching a decision as to whether the claims have adequate written
description support requires that we first understand the metes and bounds of
the claims. Cf. In re Moore, 439 F.2d 1232, 1235 (CCPA 1971) (One is not
in a position to determine whether a claim is enabled under the first
paragraph of 35 U.S.C. § 112 until the metes and bounds of that claim are
determined under the second paragraph of this section of the statute.).
It should be understood, however, that our decision in this regard is
based solely on the indefiniteness of the claimed subject matter and does not
reflect the adequacy of the prior art evidence applied in support of the
rejection before us. Once definite claims are presented, the Examiner is free
to apply the same, different, or additional prior art as the Examiner so
chooses.

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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–8, 19–
23
112(a) Written
Description
1, 3–8, 19–
23
1, 3–8, 19–
23
112(b) Indefiniteness 1, 3–8, 19–
23

1, 5–8 103 Hoskins, Nelson,
Izzat
1, 5–8
3 103 Hoskins, Nelson,
Izzat, Rios
3
4 103 Hoskins, Nelson,
Izzat, Toly
4
19, 22, 23 103 Hoskins, Nelson,
Izzat, Bloom
19, 22, 23
20 103 Hoskins, Nelson,
Izzat, Bloom, Rios
20
21 103 Hoskins, Nelson,
Izzat, Bloom, Toly
21
Overall
Outcome
1, 3–8, 19–
23

TIME PERIOD FOR RESPONSE
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)(1)(iv).
AFFIRMED