Ex Parte Viola et al

Patent Trial and Appeal Board

Aug 30, 2016

12634308 (P.T.A.B. Aug. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/634,308 12/09/2009
50855 7590 09/01/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Frank Viola
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.
H-US-01401 (203-6101) 7290
EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/01/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANK VIOLA and NADY A BELCHEV A
Appeal2014-008381
Application 12/634,308
Technology Center 3700
Before JENNIFER D. BAHR, LINDA E. HORNER, and
BRANDON J. WARNER, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Frank Viola and Nadya Belcheva (Appellants) appeal under 35 U.S.C.
§ 134 from the Examiner's decision rejecting claims 1, 2, 6, 19, and 23-25
under 35 U.S.C. § 103(a) as unpatentable over Demarais (US 2007 /0208360
Al, pub. Sept. 6, 2007) and Quill1(WO2005/112787 A2, pub. Dec. 1,
2005) and rejecting claim 20 under 35 U.S.C. § 103(a) as unpatentable over
Demarais, Quill, and Granger (US 5,569,301, iss. Oct. 29, 1996). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Both the Examiner and Appellants refer to this reference as "Quill." For
consistency and convenience, we do likewise herein.
Appeal2014-008381
Application 12/634,308
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A method of gastric reduction comprising the steps of:
inserting through the esophagus at least one bi-directional
barbed suture such that the at least one bi-directional barbed
suture is positioned in proximity to the muscularis of the stomach
of a subject, the at least one bi-directional barbed suture having
a first end, the first end having a pointed configuration, and a
second end, the second end having a pointed configuration,
wherein the muscularis comprise at least first, second, third and
fourth surfaces, the first, second, third and fourth surfaces in at
least partially interfacing relationship to one another with respect
to the interior volume of the stomach;
inserting the first end of the at least one bi-directional
barbed suture through the muscularis and serosa to form at least
first and second exterior pull regions external to the stomach by
inserting the first end of the at least one bi-directional barbed
suture through the first surface, wherein the first end of the at
least one bi-directional barbed suture enters the first surface of
the muscularis through the serosa to a position external to the
stomach and returns through the serosa and exits the first surface
of the muscularis and penetrates into the interior volume of the
stomach and inserting the first end of the at least one bi-
directional barbed suture that has penetrated the interior volume
of the stomach into the second surface of the muscularis, wherein
the first end of the at least one bi-directional barbed suture enters
the second surface of the muscularis and serosa to a position
external to the stomach and returns through the serosa and exits
the second surface of the muscularis and penetrates into the
interior volume of the stomach resulting in a series sequential
uncrossed purse string configuration before reducing the interior
volume of the stomach;
inserting the second end of the at least one bi-directional
barbed suture through the muscularis and serosa to form at least
third and fourth exterior pull regions by inserting the second end
of the at least one bi-directional barbed suture through a third
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Application 12/634,308
surface wherein the second end of the at least one bi-directional
barbed suture enters the third surface of the muscularis through
the serosa to a position external to the stomach and returns
through the serosa and exits the third surface of the muscularis
and penetrates into the interior volume of the stomach and
inserting the second end of the at least one barbed suture that has
penetrated the interior volume of the stomach into a fourth
surface of the muscularis, wherein the second end of the at least
one bi-directional barbed suture enters the fourth surface of the
muscularis and serosa to a position external to the esophagus and
returns through the serosa and exits the fourth surface of the
muscularis and penetrates into the interior volume of the stomach
resulting in a series sequential uncrossed purse string
configuration before reducing the interior volume of the
stomach;
pulling the first end of the at least one bi-directional
barbed suture to cause the first exterior pull region to move the
first surface towards the interior volume and to cause the second
exterior pull region to move the second surface towards the
interior volume, to reduce the interior volume of the stomach;
and
pulling the second end of the at least one bi-directional
barbed suture to cause the third exterior pull region to move the
third surface towards the interior volume and to cause the fourth
exterior pull region to move the fourth surface towards the
interior volume, to reduce the interior volume of the stomach.
DISCUSSION
Rejection I
Claims 1, 2, 6, 19, 23, and 24
Appellants do not assert any separate arguments for patentability of
dependent claims 2, 6, 19, 23, or 24 apart from their dependence, directly or
indirectly, from independent claim 1. See Appeal Br. 11. We select claim 1
as representative, with claims 2, 6, 19, 23, and 24 standing or falling
therewith. See 37 C.F.R. § 41.37(c)(l)(iv).
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Application 12/634,308
The Examiner finds that Demarais discloses a method of reducing
stomach volume, substantially as claimed, including, inter alia,
inserting the first suture end through the muscularis and serosa
and then penetrating back into the interior of the stomach (Fig.
76; [0154]; suture end passed through adjacent plications 800) to
form at least first and second exterior pull regions external to the
stomach ([0154]; Fig. 76; two adjacent plications 800) in a series
sequential uncrossed configuration (Fig. 76 and para. [0154]
depict and disclose a series sequential uncrossed purse string
suturing configuration of suture).
Final Act. 5-6. The Examiner finds that "Demarais fails to teach the suture
comprising a bi-directional barbed suture having a removable needle at
[each end] wherein the first suture end is pulled to move the first and second
surfaces inward and the second suture end is separately pulled to move the
third and fourth surfaces inward." Id. at 6. The Examiner relies on Quill for
teaching a bi-directional barbed suture, and determines:
[I]t would have been obvious to ... modify the method of
Demarais to include the use of a bi-directional barbed suture with
a needle removably attached to the first and second ends wherein
the first suture end is pulled to move the first and second surfaces
inward and the second suture end is separately pulled to move
the third and fourth surfaces inward in order to facilitate delivery
and placement of the bi-directional suture while also preventing
movement of the suture relative to the tissue in either direction
and positioning and supporting the sutured tissue with higher
mechanical performance than conventional suturing methods
allow, as taught by Quill.
Id. at 6-7.
Appellants argue that Demarais does not disclose inserting the bi-
directional barbed suture through the muscularis and serosa before reducing
the interior volume of the stomach. Appeal Br. 6-8; Reply Br. 3. In
particular, Appellants assert that "Demarais discloses that 'a single gathering
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Appeal2014-008381
Application 12/634,308
element [812], or suture, can be passed through each plication [800], and
then the free ends of the gathering element would be tensioned."' Appeal
Br. 7 (citing Demarais, para. 154). According to Appellants, "[b ]y forming
the plication 800 prior to passing the gathering element [812] therethrough,
Demarais clearly discloses that the stomach volume is reduced (by the
formation of the plication) prior to the passage of the gathering
element." Id. at 7-8; see Reply Br. 3 (asserting "that the suture ends are
passed through the stomach tissue after the interior volume of the stomach is
reduced").
Appellants' argument does not identify error in the Examiner's
rejection because it is not commensurate with the scope of claim 1. See In
re Self, 671F.2d1344, 1348 (CCPA 1982) (limitations not appearing in the
claims cannot be relied upon for patentability). Notably, claim 1 does not
require inserting the bi-directional barbed suture before any reduction in
stomach volume. Rather, the claim requires inserting each end of the suture
"before reducing the interior volume of the stomach." Appeal Br. 22-23,
Claims App. Referring to paragraph 154 of Demarais, the Examiner
explains that Demarais discloses
an initial stomach volume having plications already placed
therein[,] with the plications then having a suture passed
therethrough before the suture is subsequently tensioned or
cinched to further gather the plications to a reduced stomach
volume (as shown in Fig. 7 6) that is less than the initial, plicated-
only stomach volume.
Ans. 2 (emphasis added). Appellants do not specifically address the
explanation for the Examiner's finding, much less point to any defect
therein.
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Application 12/634,308
Appellants further argue that Demarais does not disclose "exterior
pull regions external [to] the stomach," as recited in claim 1. Appeal Br. 7;
Reply Br. 3--4. Pointing to an annotated reproduction of Demarais's Figure
7 6 on page 7 of the Appeal Brief, Appellants assert that "gathering element
[812] pass[ es] only through plication 800 ... without forming exterior pull
regions external the stomach." Appeal Br. 7. Appellants also assert that
paragraphs 151 and 154 of "Demarais clearly recite[] that the gathering
element(s) are 'pass[ed] through each plication' and that the 'plications [are
formed] within the stomach cavity."' Reply Br. 3. According to Appellants,
"[s]ince the gathering element(s) and plication(s) of Demarais are
specifically described within the stomach cavity, and are further illustrated in
Fig. 76 within the stomach cavity, ... the gathering element(s) and
plication(s) of Demarais do not form 'exterior pull regions external the
stomach."' Id. at 4.
We do not find Appellants' argument persuasive. The Examiner
characterizes figure 7 6 of Demarais as depicting that, at each plication 800,
gathering element 812 "pass [es] entirely through the stomach wall to a
central point within a plication that is external to the folded stomach volume
(i.e. first 'half of the folded plication), and then the suture further continues
to pass back through the entirety of the stomach wall." Ans. 3. Although
Demarais does refer to plications within the stomach (see Demarais, para.
151 ), Figure 7 6 shows that each plication comprises the exterior stomach
wall folded onto itself. As the gathering element passes through each
plication, it exits and reenters the exterior stomach wall, forming a pull
region with part of the gathering element outside of the stomach interior. As
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Application 12/634,308
such, Appellants do not persuade us of error in the Examiner's finding that
Demarais discloses exterior pull regions external to the stomach.
Appellants still further argue that Demarais does not disclose the steps
of "pulling the first end of the at least one bi-directional barbed suture ... to
reduce the interior volume of the stomach" and "pulling the second end of
the at least one bidirectional barbed suture ... to reduce the interior volume
of the stomach." Appeal Br. 9--10; Reply Br. 5---6. In particular, Appellants
assert that "Demarais discloses pulling/tensioning both free ends of the
gathering element or suture simultaneously," and "fails to disclose pulling
on only one end of the gathering element, i.e., the first end or the second
end, to reduce the volume of the stomach." Appeal Br. 9 (emphasis added)
(citing Demarais, paras. 106, 154 ); see Reply Br. 5. The Examiner responds
to this argument by correctly pointing out that claim 1 does not specify
pulling only one end at a time. Ans. 4. As such, we are not persuaded of
error because Appellants' argument is not commensurate with the scope of
claim 1. See In re Self, 671 F.2d at 1348.
Appellants also argue that "by requiring both free ends to be clipped
together prior to being pulled at the same time ... , Demarais effectively
teaches away from the present method wherein ... pulling on only one of the
first or second ends of the suture reduces the interior volume of the
stomach" and that "pulling/tensioning ... only one end of the gathering
element of Demarais would render Demarais inoperable for its intended
purpose." Appeal Br. 9--10 (emphasis added). This line of argument is not
convincing because, as discussed above, claim 1 does not require pulling
only one end of the suture at a time.
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Application 12/634,308
For the above reasons, Appellants do not apprise us of error in the
Examiner's determination that the subject matter of claim 1 would have been
obvious. Accordingly, we sustain the rejection of claim 1, and of claims 2,
6, 19, 23, and 24 falling therewith, under 35 U.S.C. § 103(a) as unpatentable
over Demarais and Quill.
Claim 25
Independent claim 25 recites a method of gastric reduction including
the steps of "pulling only the first end of the bi-directional barbed suture to
cause the first exterior pull region to move the first surface towards the
interior volume to reduce a first portion of the interior volume of the
stomach" and "pulling only the second end of the bi-directional barbed
suture to cause the second exterior pull region to move the second surface
towards the interior volume to reduce a second portion of the interior
volume of the stomach." Id. (emphasis added). See Appeal Br. 25-26,
Claims App. The Examiner's rejection of this claim relies on the same
findings and reasoning applied in the rejection of claim 1. See Final Act. 4--
7.
Appellants initially reassert the argument presented against the
rejection of claim 1 that Demarais does not disclose forming "exterior pull
region[ s] external to the stomach" because the gathering element 812 passes
through plication 800, which is within the stomach. Appeal Br. 13-14; see
Reply Br. 6-8. For the reasons discussed above, this argument does not
apprise us of error vis-a-vis claim 1 and is likewise not persuasive with
respect to claim 25.
Appellants also argue that "Demarais fails to disclose pulling on only
a first end of the suture to reduce a first portion of the interior volume of the
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Application 12/634,308
stomach and/or pulling on only a second end of the suture to reduce a second
portion of the interior volume of the stomach." Appeal Br. 16 (emphasis
added). In particular, Appellants assert that "Demarais discloses
pulling/tensioning both free ends of the gathering element or suture
simultaneously to further reduce the volume of the entire stomach." Id.
Appellants' argument is not persuasive because it essentially
addresses Demarais in isolation, rather than considering the combined
teachings of the cited references. See In re Merck & Co., 800 F .2d 1091,
1097 (Fed. Cir. 1986) (nonobviousness cannot be established by attacking
the references individually when the rejection is predicated upon a
combination of prior art disclosures). Here, the Examiner acknowledges that
Demarais does not disclose "a bi-directional barbed suture having a
removable needle at the first and second ends wherein the first suture end is
pulled to move the first and second surfaces inward and the second suture
end is separately pulled to move the third and fourth surfaces inward." Final
Act. 6. However, the Examiner finds that Quill discloses
suturing methods and devices comprising the use of a
bidirectional barbed suture (Abstract; page 1, lines 13-18) with
a needle removably attached to the first and second ends (page 7,
lines 37-39; page 8, lines 3-10) in place of standard sutures in a
wide variety of procedures including purse-string type suturing
techniques (page 9, lines 2---6; page 16, lines 10-20) wherein
suturing begins at the intermediate point/transition section of the
bi-directional suture and proceeds as each respective suture end
is sutured and pulled away from the intermediate point for
approximating tissue (page 9, lines 17-22; see exemplary Figs.
32, 34 and 36) in order to facilitate delivery and placement of the
bi-directional suture (page 7, lines 37-39; page 8, lines 3-10),
for preventing movement of the suture relative to the tissue in
either direction, and for positioning and supporting the sutured
tissue with higher mechanical performance than conventional
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Application 12/634,308
suturing methods allow (Abstract; page 3, lines 1---6; page 15, line
8-page 16, line 9).
Id. (emphasis added). The Examiner determines:
[I]t would have been obvious . . . to modify the method of
Demarais to include the use of a bi-directional barbed suture with
a needle removably attached to the first and second ends wherein
the first suture end is pulled to move the first and second swfaces
inward and the second suture end is separately pulled to move
the third and fourth surfaces inward in order to facilitate delivery
and placement of the bi-directional suture while also preventing
movement of the suture relative to the tissue in either direction
and positioning and supporting the sutured tissue with higher
mechanical performance than conventional suturing methods
allow, as taught by Quill.
Id. at 6-7 (emphasis added). Appellants' argument does not address or point
out error in the Examiner's findings with respect to Quill or the reasoning
articulated for the proposed combination of Demarais and Quill.
Appellants argue that "Demarais effectively teaches away from the
present method wherein" pulling only one of the first and second ends of the
suture reduces the interior volume of the stomach because Demarais requires
clipping together both ends of the gathering element prior to tensioning and
reducing stomach volume. Appeal Br. 16 (citing Demarais, para. 106).
Appellants' argument is not convincing. The fact that Demarais discloses a
particular embodiment in which the ends of a suture are clipped together
prior to tensioning and reducing stomach volume does not constitute a
teaching away. Prior art does not teach away from claimed subject matter
merely by disclosing a different solution to a similar problem unless the
prior art also criticizes, discredits, or otherwise discourages the solution
claimed. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Moreover,
Appellants do not point to, nor do we find, any disclosure in Demarais
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Application 12/634,308
criticizing, discrediting, or otherwise discouraging pulling only a first or
second end of the bi-directional barbed suture to reduce the interior volume
of the stomach.
Appellants also argue that "pulling ... only one end of the cited
gathering element of Demarais would render Demarais inoperable for its
intended purpose" because it "would result in the withdrawal of the
gathering element from the stomach wall, with the second end of the
gathering element simply following the path of the first end of the gathering
element through the tissue." Appeal Br. 16-17. This line of argument is
unavailing because it is not responsive to the Examiner's rejection as
presented. Here, the Examiner articulates reasoning supported by rational
underpinnings for modifying the gastric volume reduction method of
Demarais to use Quill's bi-directional barbed suture and separately pull each
end of the bi-directional barbed suture such that the stomach surfaces move
inward, thereby reducing stomach volume. Final Act. 6-7 (reasoning that
such modification would "facilitate delivery and placement of the bi-
directional suture while also preventing movement of the suture relative to
the tissue in either direction and positioning and supporting the sutured
tissue with higher mechanical performance than conventional suturing
methods allow"). Appellants do not specifically address the Examiner's
articulated reasoning for the proposed combination of Demarais and Quill or
explain why the reasoning is in error.
Additionally, the substitution of Demarais's gathering element (i.e.,
suture) with the known bi-directional barbed suture of Quill, as the
Examiner proposes, amounts to nothing more than the simple substitution of
one known element for another. See KSR Int'! Co. v. Teleflex Inc., 550 U.S.
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398, 417 (2007). As to pulling only the first end or second end of the bi-
directional barbed suture to reduce the interior volume of the stomach, it is
apparent that there are only two alternatives for pulling the bi-directional
barbed suture in Demarais's method as modified by Quill: namely, (1)
separately pulling each end, or (2) simultaneously pulling both ends. In
cases such as this, "[ w ]hen there is a design need or market pressure to solve
a problem and there are a finite number of identified, predictable solutions, a
person of ordinary skill has good reason to pursue the known options within
his or her technical grasp." KSR, 550 U.S. at 421. The result of the
selection of any of those knovn1 options "is likely the product not of
innovation but of ordinary skill and common sense." Id.
For the above reasons, Appellants' arguments do not apprise us of
error in the Examiner's determination that the subject matter of claim 25
would have been obvious. Accordingly, we sustain the rejection of claim 25
under 35 U.S.C. § 103(a) as unpatentable over Demarais and Quill.
Rejection II
In contesting the rejection of claim 20, Appellants rely on the
arguments presented for patentability of claim 1, from which this claim
depends, and assert that Granger does not cure the purported deficiencies of
Demarais and Quill. Appeal Br. 18-20. For the reasons discussed above,
Appellants' arguments fail to apprise us of deficiencies in the combination
of Demarais and Quill. Accordingly, we sustain the rejection of claim 20 as
unpatentable over Demarais, Quill, and Granger.
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DECISION
The Examiner's decision rejecting claims 1, 2, 6, 19, 20, and 23-25 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)(l )(iv).
AFFIRMED
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