Ex Parte Wilke et al

Patent Trial and Appeal Board

Jul 31, 2018

12839156 (P.T.A.B. Jul. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/839, 156 07/19/2010
29200 7590
K&L Gates LLP-Chicago
Baxter
P.O. Box 1135
Chicago, IL 60690-1135
08/02/2018
FIRST NAMED INVENTOR
Robert C. Wilke
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.
P6920USOO
BX2017TO 1700
CONFIRMATION NO.
7668
EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/02/2018 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT C. WILKE, PAUL J. ANDERSON, and
DOUGLAS DUCHON
Appeal2016-004644 1
Application 12/839,1562
Technology Center 3700
Before MICHELLE R. OSINSKI, TARA L. HUTCHINGS, and
MATTHEWS. MEYERS, Administrative Patent Judges.
HUTCHINGS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 1, 5-14, and 18-23, which constitute all the claims
1 Our decision references Appellants' Appeal Brief ("App. Br.," filed
Oct. 8, 2015), Reply Brief ("Reply Br.," filed Mar. 30, 2016), and
Specification ("Spec.," filed July 19, 2010), and the Examiner's Answer
("Ans.," mailed Feb. 1, 2016), and Final Office Action ("Final Act.," mailed
Apr. 8, 2015).
2 Appellants identify Wound Care Technologies, Inc. as the real party in
interest. App. Br. 3.
Appeal 2016-004644
Application 12/839,156
pending in this application. Claims 2--4 and 15-17 have been cancelled.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
CLAIMED INVENTION
Appellants' claimed invention "relate[s] generally to wound closure
by facilitating stretching of body tissue. More specifically, the disclosure
relates to a system and method of facilitating stretching the body tissue
adjacent a wound by use of continuous or dynamic force." Spec. 1 :6-9.
Claims 1, 10, and 23 are the independent claims on appeal. Claim 1,
reproduced below with added paragraph formatting and bracketed
annotations, is illustrative of the claimed subject matter:
1. A wounds closure system comprising:
[(a)] a suture line
[ (i)] adapted to be sutured through body tissue
adjacent an open wound,
[(ii)] the suture line adapted to be sutured so as to
pass into the body tissue at an entry point and exit at an
exit point,
[(iii)] the suture line including a plurality of barbs
extending outwardly at an acute angle with respect to a
surface of the suture line; and
[ (b)] a housing
[ (i)] that houses a spring that is adapted to apply a
continuous pulling force on the suture line for stretching
the body tissue toward the open wound,
[(ii)] wherein the spring is configured to take up
any slack of the suture line during stretching of the body
tissue and keep the suture line taut,
[(iii)] the housing including a spool rotatably
coupled to the housing, the spool coupled to the spring
and adapted for winding the spring for the application of
the continuous pulling force on the suture line,
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[(iv)] wherein the suture line is adapted to directly
pass into and out of the body tissue at the entry and exit
points so that the continuous pulling force on the suture
line for stretching the body tissue is taken by the
immediate body tissue surrounding the entry and exit
points,
[(v)] wherein the suture line with the plurality of
barbs is the only structure passed into and out of the body
tissue at the entry and exit points.
REJECTIONS
Claims 1, 5, 6, 9--14, and 18-23 are rejected under 35 U.S.C. § I03(a)
as unpatentable overRavikumar (US 2005/0131430 Al, pub. June 16,
2005), Kaplan (US 2007/0208377 Al, pub. Sept. 6, 2007), and Wilke (US
2006/0058842 Al, pub. Mar. 16, 2006).
Claims 7 and 8 are rejected under 35 U.S.C. § I03(a) as unpatentable
over Ravikumar, Kaplan, Wilke, and Schaller (US 2001/0018592 Al, pub.
Aug. 30, 2001 ).
ANALYSIS
Independent Claims 1, 10, and 23, and Dependent Claims 5, 6, 9, 11-14,
and 18-22
We are persuaded by Appellants' argument that the Examiner's
rejection of independent claims 1, 10, and 23 under 35 U.S.C. § I03(a)
cannot be sustained because the rejection is based on improper hindsight
reconstruction (App. Br. 11-16; see also Reply Br. 2-8), i.e., that it would
not have been obvious to a person of ordinary skill in the art at the time of
Appellants' invention to combine Ravikumar, Kaplan, and Wilke in the
manner the Examiner proposes, absent impermissible hindsight.
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Application 12/839,156
By way of background, Ravikmnar relates to suturing devices that
clamp and anchor suture material to tissue. Ravikumar ,r 2. Conventional
suturing techniques suffer time inefficiencies due to surgeons tying double
knots to anchor tissue with suture material, and conventional clamping
devices are susceptible to inadvertent slippage of the suture material and loss
of tension. Id. ,r,r 4--5. Addressing these shortcomings, Ravikumar teaches a
suturing device for surgical applications that includes first and second
elements that are rotatable with respect to one another about a central axis.
Id. at Abstract. Each element has a cut out, which is sized to accept suture
thread material. Id. ,r,r 26-27, Abstract, Fig. 2. Specifically, the first and
second elements are initially positioned to align the first and second cutouts,
and suture thread material is placed within the first and second cutouts
subject to the desired amount of tension. Id. ,r 31. While maintaining this
tension, the second element is crimped, collapsing the second cutout and
grasping the suture material thread disposed therein, affixing the second
element to the suture material thread at a position near the sewn tissue. Id.
,r 32. The operator then inserts a mandrel into the central cylinder to rotate
the first element with respect to the second element. Id. ,r 33. By rotating
the first element with respect to the second element, the suture material in
the first cutout wraps around a central cylinder, binding the suture material
thereto. Id. In this way, the suture material is held by the two elements with
the desired amount of tension. Id. Suture thread material is passed from
tissue on one side of the wound to tissue on the other side of the wound to
draw the wound edges together. See id. at Fig. 2.
In rejecting independent claims 1, 10, and 23 under§ 103(a), the
Examiner cites Ravikumar as disclosing limitations (a)(i), (a)(ii), and (b)(iv),
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Application 12/839,156
as recited in claim 1, and similarly recited in claims 10 and 23. Final Act. 7-
8 ( citing Ravikumar ,r,r 30-31, Fig. 2). The Examiner acknowledges that
Ravikumar does not disclose limitation (a)(iii). Id. at 8. However, the
Examiner finds that Kaplan teaches this limitation. Id. at 8-9 (citing Kaplan,
,r,r 50, 69-75, 94, 97, Figs. 12-18, 38, and 39); see also Ans. 3 ("Kaplan is
cited for teaching the beneficial use of incorporated barbed sutures for
providing tension on wound tissue upon suture retraction and allowing for
suture travel in only one direction"). And the Examiner concludes that it
would have been obvious to a person of ordinary skill in the art at the time
of Appellants' invention to modify Ravikumar with Kaplan's plurality of
barbs to 'join and hold closed an open wound." Final Act. 9.
Kaplan describes a suture method using a suture having a plurality of
barbs. Kaplan, Abstract. The barbs permit movement of the suture through
tissue in a direction of movement of the first end, and prevent movement of
the suture in the opposite direction. Id.; see also id. ,r 50. Like the suturing
described in Ravikumar, Kaplan describes closing a wound by passing
suture material through tissue on opposite sides of the wound and drawing
the sides of the tissue together. See, e.g., id. ,r 56.
The Examiner acknowledges that Ravikumar and Kaplan do not
disclose limitations (b )(i}-(b )(iii), as recited in claim 1, and similarly recited
in claims 10 and 23. Final Act. 10. The Examiner cites to Wilke for
disclosing these limitations. Id. at 10-11 (citing Wilke ,r,r 1, 7, 8, 57, 61,
69-72, 89, 91, Figs. 1-7B); see also Ans. 3 ("Wilke is cited for its teaching
of a self-regulating and self adjusting suture tensioning system that
eliminates and does away with any need for onerous manual suture tension
readjustments such as required by Ravikumar").
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Wilke describes closing a large wound by facilitating stretching of
skin tissue. See Wilke ,r,r 1-8. One technique for closing a large wound
involves gradual or progressive closure by suturing vessel loops to the
wound edge and drawing the edges together with large sutures. Id. ,r,r 3--4.
However, current methods for gradual closure require repeatedly readjusting
the sutures to draw the wound edges together, and a substantial amount of
tension is put on wound edges during the period adjustment to obtain the
necessary closure force, risking skin tears or necrosis. Id. ,r 5. Wilke
describes a need for a gradual wound closing technique that self-adjusts and
uses continuous or dynamic tension to draw the wound edges together
without obstructing the wound. Id. ,r 7. To address this need or problem,
Wilke describes a wound closure system that includes a plurality of anchors
20 positioned around the periphery of a wound 12. Id. ,r 55, Fig. 1.
The anchors are attached to the skin and are connected to one another
by tension line 30. Id. Tension apparatus 40 applies tension to tension line
30, drawing the anchors inwardly toward each other, thus closing the wound.
Id. ,r 56. Specifically, biasing member 50, mounted within tension apparatus
40, provides tension to take up the slack on tension line 30. See id. ,r 57
Figs. 2, 5. Each anchor 20 is mechanically fastened to the skin (e.g., staples,
sutures, barbs). Id. ,r,r 77-78. If barbs are used to attach anchor 20 they
preferably have a bearing surface with a large enough width perpendicular to
the direction of the tension to prevent cutting through the skin when pulled
toward the wound in tension. Id. ,r 78. Stated differently, Wilke addresses
problems with skin tearing experienced when using prior art direct suturing
methods, and instead of sutures, applies tension to anchors, which
redistribute the force over a wider surface area, to gradually close a wound.
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The Examiner cites to portions of Wilke describing known problems
with direct suturing, and then determines that it would have been obvious to
modify Ravikumar and Kaplan
to have the biasing member comprising a spring that is separate
from the suture line with no portion of the biasing member
located within the periphery of the wound with the spring-based
biasing member further comprising the specific housing and
spring elements of [ the claims] in order to facilitate the stretching
and expansion of skin tissue by providing a biasing member that
is self-regulating and self-adjusting and uses continuous or
dynamic tension to draw a wound closed[,] thereby eliminating
the need for constant readjustment involved with static systems,
as taught by Wilke.
Final Act. 11. In the Answer, the Examiner additionally finds
Ravikumar discloses a suturing system and method (see Fig. 2)
... wherein suture tension is manually provided as suture
slack is taken up and spooled within the device (10') ([0033].
The secondary reference to Wilke is only cited for its teachings
of a self-regulating and self-adjusting tension member via
continuous spring tension in a suture tensioning system and
method in order to eliminate and do away with any need for
onerous manual tension readjustments in systems and
methods such as Ravikumar.
Ans. 3 (emphasis added).
Yet, we find no disclosure at paragraph 33 of Ravikumar of a gradual
or progressive wound closure technique (i.e., repeatedly readjusting the
sutures to draw the wound edges together and take up slack). Instead, as set
forth above, paragraphs 32-33 of Ravikumar describe affixing suture
material in the the second cutout to the second element by crimping the
second element at a desired tension, and then binding the suture material in
the first cutout to the central cylinder by twisting the first element relative to
the second element. The Examiner does not adequately explain, and we do
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not see how, paragraph 33 of Ravikmnar describes onerous manual tension
readjustments involving taking up suture slack and spooling suture material
into the device. To the contrary, because Ravikumar's operator deforms and
affixes the second element of the suturing device to the suturing material, it
is unclear how one of ordinary skill could manually readjust the suture
tension once the suture device is deformed at the initial desired tension,
much less how or why one of ordinary skill in the art would modify
Ravikumar's suturing device to include a housing that is adapted to apply a
continuous pulling force on the suture line to take up slack, as called for in
limitations (b )(i}-(b )(iii) of claim 1, and similarly recited in claims 10 and
23.
Wilke also provides no such motivation for such a combination.
Instead, Wilke describes shortcomings with known progressive wound
closure techniques involving sutures (e.g., tissue tearing and necrosis), and
therefore avoids sutures in favor of anchors connected by a tension line. We
agree with Appellants that it is unclear, and the Examiner does not
adequately explain, how or why one of ordinary skill in the art would have
been motivated to modify Ravikumar and Kaplan with Wilke to result in the
claimed invention.
The Examiner has failed to articulate any reasoning with rational
underpinning for combining the cited references to arrive at the claimed
invention, as recited in independent claims 1, 10, and 23, without
impermissible hindsight. As such, the Examiner has failed to establish a
prima facie case of obviousness. KSR Int'! Co. v. Teleflex, Inc., 550 U.S.
398,418 (2007) ("[R]ejections on obviousness grounds cannot be sustained
by mere conclusory statements. Instead, there must be some articulated
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reasoning with some rational underpinning to support the legal conclusion of
obviousness.") ( citation omitted).
In view of the foregoing, we do not sustain the Examiner's rejection
of independent claims 1, 10, and 23, and dependent claims 5, 6, 9, 11-14,
and 18-22 under 35 U.S.C. § 103(a).
Dependent Claims 7 and 8
The Examiner's rejection of dependent claims 7 and 8 based on
Schaller, in combination with Ravikumar, Kaplan, and Wilke, does not cure
the deficiency in the Examiner's rejection of independent claim 1.
Therefore, we do not sustain the rejection of dependent claims 7 and 8 under
35 U.S.C. § 103(a) for the same reasons set forth above with respect to
independent claim 1.
DECISION
The Examiner's rejections of claims 1, 5-14, and 18-23 under 35
U.S.C. § 103(a) are reversed.
REVERSED
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