Ex Parte Ladet

Patent Trial and Appeal Board

Oct 27, 2017

13192007 (P.T.A.B. Oct. 27, 2017)

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.
13/192,007 07/27/2011 Sebastien Ladet 1600-148 (H-SP-00190) 5193
50855 7590
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
EXAMINER
FALKOWITZ, ANNA R
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
10/31/2017 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):
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
mail @ cdfslaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SEBASTIEN LADET
Appeal 2016-0053941
Application 13/192,007
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a method for bonding a
polymeric fiber to a biological tissue. The Examiner rejected the claims
under 35 U.S.C. § 103 as obvious. We have jurisdiction under 35 U.S.C. §
6(b). The rejection is reversed.
1 The Appeal Brief (“Appeal Br.”) identifies Sofradim Production as the
real-parties-in-interest. Appeal Br. 1.
Appeal 2016-005394
Application 13/192,007
STATEMENT OF THE CASE
Claims 1—6, 11, 14, 15, and 17 stand rejected by the Examiner under
pre-AIA 35 U.S.C. §103 as obvious in view of U.S. Pat. App. No.
2009/0247651 Al, publ. Oct. 1, 2009 (“Kapiamba”), U.S. Pat. App. No.
2009/0266467 Al, publ. Oct. 29, 2009 (“Stopek”), and EP 1 897 500 Bl,
publ. Jul. 29, 2009 (“Stopek EP”). Examiner’s Answer (“Ans.”) 6.
Claim 1, the only independent claim on appeal, is reproduced below:
1. A method for bonding a polymeric fiber to biological tissue
comprising:
providing a polymeric fiber having a plurality of surface
reactive members of a specific binding pair attached on a
surface of the fiber;
attaching a plurality of linking members to the surface of
the polymeric fiber, each linking member having at least one
complimentary surface reactive member of the specific binding
pair and at least one tissue reactive member, wherein the
complimentary surface reactive member covalently attaches the
linking member to the surface reactive member of the
polymeric fiber via click chemistry and the tissue reactive
member remains capable of covalently bonding to biological
tissue; and
contacting the polymeric fiber with the tissue, wherein
upon contact of the tissue reactive members on the surface of
the polymeric fiber with biological tissue, covalent bonds are
formed between the tissue reactive members and the biological
tissue, thus adhering the polymeric fiber to the biological tissue.
The Examiner indicated that Appellant has elected a species for
examination where “said polymeric fiber comprises a multifilament suture of
the instantly elected species of copolymers of poly(lactic acid) and
poly(glycolic acid), and wherein the surface reactive species comprises
azides and alkynes binding to one another by a Huisgen cycloaddition
reaction.” Ans. 7.
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Appeal 2016-005394
Application 13/192,007
CLAIM 1
Clam 1 has the following key elements:
(1) a polymeric fiber;
(2) a surface reactive member;
3) a linking member having:
3a) a complimentary surface reactive member; and
3b) a tissue reactive member.
Fig.l of the Specification, reproduced below and annotated herein,
illustrates a configuration of the recited elements of claim 1:
Fig. 1 shows the polymeric fiber “having a plurality of surface
reactive members [12]” and “linking member [20]” having “at least one
complimentary surface reactive member [14]” and “at least one tissue
reactive member [16].”
In claims 3 and 4, the surface reactive member 12 is an azide (shown
above as N3) and the complimentary surface reactive member 14 is an
alkyne.
The claims require the complimentary surface reactive member [14]
and the surface reactive member [12] to covalently bind “by click
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Appeal 2016-005394
Application 13/192,007
chemistry” and form a “specific binding pair.” This configuration is
illustrated in Fig. 2 of the Specification reproduced below:
Fig. 2, reproduced above, shows complimentary surface reactive
member 14 covalently bound to surface reactive member 12. The tissue
The Examiner found that Kapiamba describes adhering a medical
device to tissue “comprising contacting a first component possessing at least
two alkylene [alkyne] groups with a second component possessing at least
two azide groups,” which correspond to the complimentary surface reactive
member 14 and the surface reactive member 12. Final Act. 4 (citing
Kapiamba 1 8). The components can be attached to cores. Kapiamba 113.
The cores can be polymeric. Id., H 14—17. Kapiamba teaches that the
functional alkyne and azide groups are contacted with a catalyst to
tissue reactive member lib 120
/
reactive member 116 (or 16 in Fig. 1) is required by the claim to “remain[ ]
capable of covalently bonding to biological tissue.”
OBVIOUSNESS REJECTION
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Application 13/192,007
polymerize together which the Examiner found meets the claimed limitation
that the reactive members are covalently attached “via click chemistry.”
Final Act. 4; Kapiamba ^fl[ 8, 12.
The Examiner also found that while Kapiamba discloses that the
polymerized components can be attached to a tissue, Kapiamba “does not
specifically disclose . . . wherein the bond between the tissue surface and the
composition is covalent.” Final Act. 5. However, the Examiner found
“found that “Stopek discloses compositions comprising polymers including
the combination of polyglycolide and polylactide ([0021] and [0032]) that
can be selectively functionalized to form covalent bonds with tissues and/or
medical devices, meeting the limitation wherein the reactive member is able
to form a bond with biological tissue.” Id. at 5—6.
The Examiner determined it would have been obvious to have
modified Kapiamba with Topek’s teachings. The Examiner concluded that
the modification was
as a matter of design choice, as instantly claimed, with a
reasonable expectation of success, at the time of the instant
invention. Said design choice amounting to comb[in]ing prior
art elements according to known methods to yield predictable
results of polymeric bioadhesive formed from click chemistry
that covalently bonds to at least one tissue surface.
Id., at 6. The Examiner also cites paragraphs 14 and 33 of Stopek. Id. at 7.
Appellant contends that Kapiamba “fail to disclose, teach, or suggest a
linking member which includes both a complimentary surface reactive
member and a tissue reactive member.” Appeal Br. 7. Appellants contend
that Stopek does not make up for this deficiency because it doesn’t disclose
a linking member. Stopek, Appellants contend, “discloses a bioabsorbable
adhesive composition which include a lipid segment (Ri), a bioabsorbable
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Application 13/192,007
group (A), and a polymer segment (R2) wherein the lipid or polymer
segments (Ri or R2) may include addition functional groups for bonding the
composition to tissue” and thus does not teach two type of reactive members
as claimed. Id. at 8.
Appellants’ argument is not persuasive.
Paragraph 33 of Stopek is reproduced below:
[0033] In addition, terminal lipid or polymer segments may be
functionalized with bioreactive groups targeted for binding
and/or bonding to tissue to function as adhesives, either by
covalent, ionic, hydrogen, electrostatic, combinations thereof,
and the like. For example, in embodiments, a terminal lipid
segment or a terminal polymer segment may be functionalized
with a group capable of reacting with amines native to tissue,
thereby bonding the composition of the present disclosure to the
tissue to which it is applied. Suitable groups for such bonding
include, but are not limited to, isocyanates, ketones, aldehydes,
succinimides, epoxides, carboxylic acids, combinations thereof,
and the like.
Stopek, 133.
Thus, Stopek teaches functionalizing the groups on the polymeric
adhesive so it can be attached to a tissue. Id. As found by the Examiner,
Stopek teaches that the polymer can be formed from glycolide and lactide
(Stopek || 21, 33) which are the same constituents described by Kapiamba
for its polymeric core (Kapiamba 116). Consequently, one of ordinary skill
in the art would have had reason to apply Stopek’s teaching to the polymeric
core of Kapiamba in order to attach the adhesive to tissue covalently as
taught by both Stopek and Kapiamba. The resulting core would have a
complimentary reactive group on one part and the functional tissue binding
group of Stopek on the other part, producing a “linking member having at
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Application 13/192,007
least one complimentary surface reactive member of the specific binding
pair and at least one tissue reactive member” as recited in claim 1.
While Appellant contends that none of the cited prior art describes
linking members as claimed (Appeal Br. 9), the rejection is based on § 103
and the obviousness of modifying the core of Kapiamba with a functional
group to achieve tissue binding as expressly described in Kapiamba
(Kapiamba 177). Because Kapiamba does not teach how tissue binding
would be achieved, it is reasonable that one of ordinary skill in the art would
have looked to conventional ways of accomplishing it, such as using the
functional groups describe in Stopek for linking a polymer to a tissue
(Stopek 133). Since both Stopek and Kapiamba teach the same types of
polymers (glycolide and lactide), it would have been further reasonable and
obvious to modify Kapiamba’s polymer core as taught by Stopek.
Appellant also contends that the cited prior art does not “disclose,
teach, or suggest a method for bonding a polymeric fiber to biological tissue
which includes providing a polymeric fiber having a plurality of surface
reactive members of a specific binding pair attached on a surface of the
fiber” as recited in claim 1. Appeal Br. 4, 5—6. Appellant contends that
Stopek only describes sutures and that Stopek teaches its adhesive
composition can be used in place of a suture. Reply Br. 5 (citing paragraph
55 and 66 of Stopek). Appellant makes the same argument for Kapiamba:
Rather, cited paragraphs [0072] and [0077] of Kapiamba
disclose that the composition is a two-part adhesive which
“may be used to bind tissue together either as a replacement
of, or as a supplement to. sutures” and that the composition
can be used “to adhere a medical device to tissue ... [the]
composition ... can be applied to the device, to the tissue
surface, or to both,” respectively.
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Application 13/192,007
Id. at 6 (Emphasis in original.)
We agree with Appellant that the cited disclosures in Kapiamba and
Stopek teach the adhesives as replacements for a suture, i.e., the elected
species of a polymeric fiber. The Examiner did not provide an adequate
explanation as to why one of ordinary skill in the art would have had reason
to provide a suture (the elected polymeric fiber) with the adhesive of
Kapiamba or Stopek. The Examiner stated it was “design choice,” but failed
to provide a reason for doing so. Ans. 9. The Examiner correctly states that
Kapiamba teaches that its adhesive can be used to attach medical devices to
a tissue, but fails to explain why a suture, which has the same purpose as the
adhesive, would be substituted for a medical device. Id., 12. (It “can be
important to identify a reason that would have prompted [PHOSITA] to
combine the elements in the way the claimed new invention does.” KSR
Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).)
In response to Appellant’s arguments, the Examiner stated:
One of ordinary skill in the art would be motivated to do so in
order to create a composition that can react with functional
groups found in tissue in order to adhere tissue edges, seal
air/fluid leaks in tissue, adhere medical devices of fill voids in
tissue (Stopek [0033] and [0014]), and it is known the time of
the invention that the multifilament barbed polymer suture
decreases slippage of the suture at the size of the wound and
allows for bioactive agents to be placed in a precisely defined
location for controlled and sustained release within a tissue
wound closure by depositing said agent on the barb (Stopek EP
[0003] and [0015]).
Id. at 13.
The Examiner’s reasoning explains why the skilled worker would use
the adhesive and the sutures independently, but not together as required by
the claim where the suture is adhered to the tissue by the covalent bonds as
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Application 13/192,007
required by claim 1. Because the Examiner did not establish a reason for
modifying a suture with the surface reactive member and linking member of
the claim, we reverse the obviousness rejection of claim 1, and dependent
claims 2—6, 11, 14, 15, and 17.
REVERSED
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