Jeffrey E. Hull et al.

Patent Trials and Appeals Board

Sep 30, 2019

13956221 - (D) (P.T.A.B. Sep. 30, 2019)

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.
13/956,221 07/31/2013 Jeffrey E. Hull A-2659 1738
33197 7590 09/30/2019
STOUT, UXA & BUYAN, LLP
23461 South Pointe Drive
Suite 120
Laguna Hills, CA 92653
EXAMINER
OUYANG, BO
ART UNIT PAPER NUMBER
3794
MAIL DATE DELIVERY MODE
09/30/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JEFFREY E. HULL and MARK A. RITCHART
____________________

Appeal 2019-0005551
Application 13/956,221
Technology Center 3700
____________________

Before PHILLIP J. KAUFFMAN, JEREMY M. PLENZLER, and
ALYSSA A. FINAMORE, Administrative Patent Judges.

FINAMORE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–4, 6–9, 13, 14, and 21. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 We reference herein the Specification filed July 31, 2013 (“Spec.”), Final
Office Action mailed April 19, 2017 (“Final Act.”), Appeal Brief filed
December 18, 2017 (“Br.”), and Examiner’s Answer mailed May 29, 2018
(“Ans.”).
2 Appellant is the Applicant, Avenu Medical, Inc., which, according to the
Appeal Brief, is the real party in interest. Br. 1.
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SUBJECT MATTER ON APPEAL
The invention is directed to “a device to allow extension, elongation
or repair of a previously created arteriovenous fistula between a first blood
vessel and an adjacent second blood vessel.” Spec. 3:20–22. Claim 1, the
sole independent claim, is representative of the claimed subject matter and
reproduced below.
1. A device for elongating, extending, or repairing a tissue
aperture, comprising:
a handle;
a body connected to and extending distally from the
handle, comprised of a flexible material and having a primary
lumen;
a rigid jaw member connected to and extending distally
from the flexible body; a tissue cutting element disposed on the
jaw member, wherein the jaw member comprises two elements,
each having distal ends, wherein one of the elements is pivotable
relative to the other element to create a spacing of varying sizes
between the two elements at their respective distal ends;
a lever on the handle which moves at least one of the jaw
member elements relative to the other one to increase or decrease
the spacing between the distal ends of the elements, thereby
opening or closing the jaws of the jaw member to a plurality of
incremental positions between fully opened and fully closed to
thereby achieve an optimal size extension of an aperture in tissue;
a wire connecting the lever to the jaw member which
opens or closes the jaw member;
a ratcheting mechanism on said lever which applies
variable incremental pressure within a range of
100 mN/mm2 – 500 mN/mm2 to the jaw member;
a secondary lumen disposed in one of the jaw elements
which receives a guidewire therein; and
a temperature sensor disposed on the rigid jaw member.
Br. 18, Claims App.

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REJECTIONS
The Examiner rejects the claims on appeal as follows:
I. claims 1, 4, 7, 8, and 14 under 35 U.S.C. § 103(a) as unpatentable
over Lau3, Arp4, Cuny5, Edwards6, and Weaver7;
II. claims 2 and 3 under 35 U.S.C. § 103(a) as unpatentable over Lau,
Arp, Cuny, Edwards, Weaver, and Appling8;
III. claim 6 under 35 U.S.C. § 103(a) as unpatentable over Lau, Arp,
Cuny, Edwards, Weaver, and Anderson9;
IV. claims 9 and 13 under 35 U.S.C. § 103(a) as unpatentable over Lau,
Arp, Cuny, Edwards, Weaver, and Hausen10; and
V. claim 21 under 35 U.S.C. § 103(a) as unpatentable over Lau, Arp,
Cuny, Edwards, Weaver, Pendleton11, and Gauderer12.

ANALYSIS
Rejection I
Appellant argues claims 1, 4, 7, 8, and 14 as a group. Br. 10–14. We
select independent claim 1 as representative, and the remaining claims stand
or fall with independent claim 1. 37 C.F.R. § 41.37(c)(1)(iv).

3 US 2006/0217706 A1, published Sept. 28, 2006.
4 US 2005/0277952 A1, published Dec. 15, 2005.
5 US 5,626,608, issued May 6, 1997.
6 US 2009/0234355 A1, published Sept. 17, 2009.
7 US 5,571,136, issued Nov. 5, 1996.
8 US 2004/0116901 A1, published June 17, 2004.
9 US 2012/0059371 A1, published Mar. 8, 2012.
10 US 7,875,029 B1, issued Jan. 25, 2011.
11 US 2010/0324446 A1, published Dec. 23, 2010.
12 US 6,361,540 B1, issued Mar. 26, 2002.
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The Examiner relies on Lau for disclosing most of the limitations of
independent claim 1. Final Act. 3. Lau describes a welding and separating
device “that is used to close off and separate side branches from a primary
[blood] vessel being harvested, and also possibly to sever the primary
vessel.” Lau ¶ 64. Device 30 includes modular handle unit 20 and hollow,
flexible, elongated shaft or body 36, depicted in Figure 1C as extending
distally from the handle. Id. ¶¶ 67, 68, 94, Figs. 1A–1C. Body 36
terminates at its distal end in a rigid jaw member having two
distally-extending jaw elements 40, 42. Id. ¶ 69, Fig. 1C. Control rod 112,
connected at one end to actuator or lever 44 and, at the other end, indirectly
to jaw elements 40, 42, enables the lever to open or close the jaw member.
Id. ¶¶ 69, 94, 100, Figs. 1C, 4. Second heating element 48 mounted along an
inner surface of jaw element 40 acts as a tissue cutting element. Id. ¶¶ 71,
85, Fig. 1C.
The Examiner acknowledges Lau fails to disclose “a wire connecting
the lever to the jaw member which opens or closes the jaw member” as
recited in independent claim 1, and finds Arp teaches this limitation.
Final Act. 3–4. Arp describes flexible endoscope clip applier 10 including
manual actuator 18 and pair of jaws 20. Arp ¶ 89, Fig. 1. Manual
actuator 18 includes lever 22 and control member 36 connected to lever 22
and spring 38. Id. ¶ 93, Figs. 1, 3. Paragraph 98 of Arp, in particular, uses
the terms “control member” and “control wire” interchangeably to describe
the element labeled with reference numeral 36, thereby implying that the
control member is a wire. See also id. ¶ 19. When lever 22 is pivoted
toward the distal end of device 30, it pulls control element 36 proximally,
resulting in the closing of jaw elements 20. Id. ¶ 95. When lever 22 is
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released, spring 38 forces control member 36 distally, allowing jaw
elements 20 to open. Id. ¶ 99. The Examiner reasons it would have been
obvious to replace Lau’s control rod 112 with a wire of the sort taught by
Arp “as an alternative mechanism that would [have] work[ed] equally well
to grasp tissue.” Final Act. 4. The Examiner also reasons Lau’s lever 44
and control rod 112, and Arp’s lever 22, control wire 36, and spring 38, were
known mechanisms for opening and closing jaw elements in medical
devices. Ans. 3–4.
Appellant asserts the Examiner has failed to provide an adequate
reason for combining the teachings of Lau and Arp. Br. 10–11. In
particular, Appellant contends “[t]he rejection provides no guidance at all as
to how or why the teachings of Arp would have been applied to this very
different structure of Lau, absent reference to Appellant[’s] teachings.” Id.
Appellant further argues “as is apparent from even a cursory review of the
respective references, the respective jaw elements of each are for very
different purposes.” Id. at 11. According to Appellant, Lau’s device must
fit within the constraints of a small diameter design that is less than 5 mm
and apply opening and closing forces of around 1–3 lb., whereas Arp’s
device is for the much larger-scale procedure of applying clips
endoscopically with approximately 17 lb. of pressure and no heating or
cutting. Id. (citations omitted).
“The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference . . . . Rather, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981) (citations omitted). Furthermore,
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“when a patent claims a structure already known in the prior art that is
altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Even if Arp’s
mechanism for opening and closing the jaw elements could not be physically
incorporated into Lau’s device, Appellant does not address the Examiner’s
determination that Lau’s lever 44 and control rod 112, on one hand, and
Arp’s lever 22, control wire 36, and spring 38, on the other, were known
mechanisms for opening and closing jaw elements in medical devices.
Ans. 3–4. Appellant, therefore, does not apprise us of error in the
Examiner’s determination that it would have been obvious to substitute
Lau’s mechanism for opening and closing jaw elements for the
corresponding mechanism in Arp. Id.
The Examiner also acknowledges Lau fails to describe “a ratcheting
mechanism on said lever,” as recited in independent claim 1, and finds Cuny
teaches this limitation. Final Act. 3–4. Cuny teaches endoscopic grasping
apparatus 10. Cuny 4:55–58. Apparatus 10 includes fixed handle 16,
pivotal control handle 18, and jaw elements 46, 48. Id. at 4:58–60, 5:41–43.
Elongated rod 42 connects pivotal control handle 18, at one end, to
elements 46, 48, at the other. Id. 5:65–6:6, Fig. 3. When pivotal control
handle 18 is pressed toward fixed handle 16, proximal movement of
elongated rod 42 causes jaw elements 46, 48 to close. Id. 4:55–67, 5:41–6:6,
Fig. 2. In addition, apparatus 10 has pivotally mounted trigger 20 which, in
turn, includes mating lock member 32. When pivotal control handle 18 is
pressed toward fixed handle 16, teeth 36 projecting from member 32 engage
mating teeth 30 projecting from arcuate section 26 of pivotal control
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handle 18. If the pressure on the pivotal control handle 16 is released,
engagement between teeth 30, 36 locks handles 16, 18 in position until
trigger 20 is pressed. Id. at 4:61–63, 5:5–24, 6:7–26, Fig. 2.
The Examiner reasons it would have been obvious to provide Lau’s
device with a ratcheting mechanism as taught by Cuny “to position the
forceps jaws at incremental locations to better position the jaws on tissue.”
Final Act. 4 (citing Cuny 1:20–36). The Examiner further reasons having a
ratchet for incremental jaw positions “would help to better position the jaws
on tissue, by applying consistent pressure on the tissue without having to
have the user manually apply the same pressure and fatiguing the hand.”
Ans. 4; see also Cuny 1:29–36.
Appellant argues one of ordinary skill in the art would not have had
reason to add a ratcheting mechanism to Lau’s device because Lau’s device
is designed to weld and separate a vessel grasped between its jaw elements.
Br. 12. According to Appellant, a surgeon using the device would have no
need to lock the device and free his or her hands for other tasks, as described
in Cuny. Id.; see also Cuny 1:29–44, 3:45–52.
“[I]f a technique has been used to improve one device, and a person of
ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.” KSR, 550 U.S. at 417. Locking
mechanisms, such as a ratchet, are known to provide the benefit of holding
jaw members in place. Cuny 1:37–41. Given Lau’s device requires a user
to outstretch his or her thumb and apply pressure to lever 44 through
frictional engagement between the thumb and thumb pad 144 to manipulate
the jaw members (Lau ¶ 100, Fig. 1C), Lau’s device would have been
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improved by the addition of a ratcheting mechanism to hold the jaw
members in place. Ans. 4.
Appellant also argues Cuny’s device is “bulky and unwieldy in the
context of constructing the kind of compact instrument necessary for the
application intended by Lau.” Br. 12. As set forth above, however, bodily
incorporation is not the standard for obviousness. In re Keller, 642 F.2d at
425. Moreover, the Examiner correctly finds that Cuny’s ratcheting
mechanism is designed to be positioned on the handle, and, as such, is not
subject to the size constraints applicable to those structures that must enter
the patient to weld and separate vessels. Ans. 4. For these reasons,
Appellant does not apprise us of error in the Examiner’s reason for the
combining the teachings Lau and Cuny.
The Examiner further acknowledges Lau fails to describe “a
ratcheting mechanism on said lever which applies variable incremental
pressure within a range of 100 mN/mm2 – 500 mN/mm2 to the jaw
member,” as recited in independent claim 1, and turns to Edwards.
Final Act. 3–4. Edwards describes a bipolar forceps device including jaw
elements 13, 14 for grasping and holding tissue 32 during cutting and sealing
operations. Edwards ¶¶ 24, 25. Edwards teaches that jaw elements 13, 14
should maintain a gripping force between 0.5 MPa and 1.0 MPa during a
sealing operation. Id. ¶¶ 12, 30. The Examiner finds the range 0.5 MPa to
1.0 MPa corresponds to the range 500 mN/mm2 to 1.0 N/mm2, which
touches the recited range of 100 mN/mm2 to 500 mN/mm2. Final Act. 4.
The Examiner reasons it would have been obvious to modify the ratcheting
mechanism added to Lau’s device to “appl[y] variable incremental pressure
within a range of 100 mN/mm2 – 500 mN/mm2 to the jaw member,” as
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recited in independent claim 1, because discovering optimal or workable
ranges would have involved only routine skill in the art. Id. (citing In re
Aller, 220 F.2d 454, 456 (CCPA 1955)).
Appellant argues:
substituting the spring-biased jaw members of Edwards into the
heavily and arbitrarily modified Lau system would have led one
skilled in the art to adopt the anvil and spring-biased support
member 24 of Edwards, rather than the ratcheting system of
Cuny, absent reference to Appellant’s disclosure, since Cuny’s
ratcheting mechanism is concerned with locking the jaws in
position to free up the surgeon’s hands, rather than to apply a
specified pressure to the tissue during a heating and cutting
operation.
Br. 13. The Examiner, however, is not proposing to add Edwards’s
spring-biased jaw members to Lau. Rather, the Examiner relies on
Edwards’s teachings regarding the gripping force to be applied to tissue
during welding or sealing operations as evidence that the range of gripping
pressures recited in independent claim 1 would have been obvious.
Ans. 5–6. Furthermore, “our case law does not require that a particular
combination must be the preferred, or the most desirable, combination
described in the prior art in order to provide motivation for the current
invention.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
Finally, the Examiner acknowledges Lau fails to describe “a
secondary lumen disposed in one of the jaw elements which receives a
guidewire therein,” as recited in independent claim 1, and finds Weaver
discloses this limitation. Final Act. 3–4. Weaver describes forceps
assembly 10 including forceps 14 mounted on thin, flexible guide wire 12
for easy and rapid movement through a patient’s vasculature.
Weaver 3:25–31, 5:37–44, Fig. 1. Forceps 14 includes jaw elements 20, 22.
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Id. at 3:32–45, Figs. 1–2. Jaw element 20 defines longitudinally-extending
lumen 28 for mounting jaw element 20 on guidewire 12. Id. at 3:46–51,
Fig. 2. The Examiner reasons it would have been obvious to modify one of
Lau’s jaw elements 40, 42 so as to have a secondary lumen to “help the
forceps to access a target area within tissue with the help of [the]
guidewire.” Final Act. 4–5.
Appellant argues that the reason articulated by the Examiner would
not have motivated one of ordinary skill in the art to modify a welding and
separating device such as Lau’s because Weaver applies the teaching to a
forceps assembly. Br. 13. The argument is not persuasive of error. As the
Examiner correctly explains, Weaver’s forceps assembly, like Lau’s welding
and separating device, clamps tissue between relatively pivotable jaw
elements. Ans. 5. The reason the Examiner articulates as to why the
addition of a secondary lumen would have been obvious applies equally to a
forceps assembly, such as that taught by Weaver, and a welding and
separating device, such as Lau’s.
In view of the foregoing, Appellant does not apprise us of error in the
Examiner’s rejection of independent claim 1. We, therefore, sustain the
rejection of independent claim 1, with claims 4, 7, 8, and 14 falling
therewith.
Rejections II–V
For claims 2, 3, 6, 9, 13, and 21, Appellant relies on the arguments for
independent claim 1. Br. 14–16. For the reasons discussed above, these
arguments are do not apprise us of error, and we similarly sustain the
rejections of claims 2, 3, 6, 9, 13, and 21.

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DECISION
The Examiner’s decision to reject claims 1–4, 6–9, 13, 14, and 21 is
affirmed.
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