Ex Parte Bayon et al

Patent Trial and Appeal Board

May 24, 2017

11881837 (P.T.A.B. May. 24, 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.
11/881,837 07/30/2007 Yves Bayon H-SP-00047 (1600-73) 2605
50855 7590
Covidien LP
60 Middletown Avenue
c/o Legal - Mailstop MS 54
North Haven, CT 06473
05/26/2017 EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
05/26/2017 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 YVES BAYON, PHILIPPE GRAVAGNA,
MICHEL THERIN, ALFREDO MENEGHIN, and
SUZELEI MONTANARI
Appeal 2015-001452
Application 11/881,837
Technology Center 3700
Before: CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
Appeal 2015-001452
Application 11/881,837
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a final rejection of
claims 1—6, 8—35, and 39-42. App. Br. 1. Claims 7 and 36—38 have been
canceled. App. Br. 27, 31. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
THE CLAIMED SUBJECT MATTER
The claims are directed to a bioresorbable knit. Claim 1 is
independent, and claims 2—6, 8—35, and 39-42 depend directly or indirectly
from claim 1. Claim 1, reproduced below (and reformatted for clarity), is
illustrative of the claimed subject matter:
1. A bioresorbable three-dimensional prosthetic knit comprising
a first face,
a second face, and
a spacer,
said first face and said second face being opposite and
separated from one another by a thickness of said knit and
being connected to one another by said spacer,
said first face and said second face being porous,
said first face and said second face comprising yams
made of material which undergoes slow bioresorption,
said spacer comprising yams made of material which
undergoes slow bioresorption and yams made of regenerated
and oxidized cellulose which undergoes rapid bioresorption,
wherein the spacer exhibits at least two-speed
bioresorption kinetics to allow gradual cellular integration to
occur inside the knit, and
wherein said yams used for the spacer and said yams used
for said first and second faces are intertwined.
REFERENCES
Vyakamam
Tayot
Ory
US 6,365,149 B2
US 6,391,939 B2
US 6,443,964 B1
Apr. 2, 2002
May 21, 2002
Sept. 3, 2002
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Application 11/881,837
Nelson US 2003/0203003 A1 Oct. 30, 2003
Fricke US 2005/0228408 A1 Oct. 13, 2005
Bar US 2006/0093655 A1 May 4, 2006
Mathisen US 2006/0142786 A1 June 29, 2006
Kondonis US 2006/0264698 A1 Nov. 23, 2006
Therin US 2007/0032805 A1 Feb. 8, 2007
Buevich US 2009/0018559 A1 Jan. 15,2009
Fronio US 2009/0204129 A1 Aug. 13, 2009
REJECTIONS
Claims 1, 3—6, 8—10, 12, 16, 22—26, and 40-42 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Therin, Bar, and Mathisen. Final
Act. 2.
Claims 27 and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Therin, Bar, Mathisen, and Buevich. Id. at 5.
Claims 27—29 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Therin, Bar, Mathisen, and Tayot. Id. at 6.
Claims 30-35 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Therin, Bar, Mathisen, and Nelson. Id. at 6.
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Therin, Bar, Mathisen, and Kondonis. Id. at 7.
Claims 18—21 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Therin, Bar, Mathisen, and Fronio. Id. at 7.
Claims 14 and 15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Therin, Bar, Mathisen, and Vyakamam. Id. at 8.
Claims 11 and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Therin, Bar, Mathisen, and Fricke. Id. at 9.
Claims 1,2, and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Ory, Bar, and Mathisen. Id. at 9.
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Claims 27—29 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Ory, Bar, Mathisen, and Tayot. Id. at 11.
ANALYSIS
Claims 1, 3—6, 8—10, 12, 16, 22—26, 40—42—Obviousness—
Therin, Bar, and Mathisen
Claims 1, 3—6, 8—10, 12, 16, 22—26, 40 and 41
Appellants argue claims 1, 3—6, 8—10, 12, 16, 22—26, 40 and 41 as a
group. App. Br. 9—18. We select claim 1 as representative of this group. 37
C.F.R. § 41.37(c)(l)(iv). We address claim 42 separately.
The Examiner finds that Therin teaches a bioresorbable 3D knit
comprising a first face and a second face (labeled ‘A’ and ‘B’ in Figure 4)
being opposite and separated from one another by a spacer (labeled ‘C’ in
Figure 4), the first and second faces being porous and made of material that
undergoes slow bioresorption (polylactic acid, or “PLA”); the spacer
comprised of yams made of a material that undergoes slow bioresorption
(PLA) and yams made of a material that undergoes rapid bioresorption
(poly-glycolic acid, or “PGA”), with the yams used for the spacer and the
first and second faces being intertwined. Final Act. 2—3 (citing Therin H 21,
30, 33, 35, 57, 60, 61,61; Fig. 4). The Examiner acknowledges, however,
that Therin does not expressly teach that the spacer yams that undergo rapid
bioresorption are made of regenerated and oxidized cellulose, or that the
spacer exhibits two-speed bioresorption. Id. at 3.
For the first of these limitations lacking in Therin, the Examiner relies
on Bar. According to the Examiner, Bar teaches a reinforced bioresorbable
wound dressing comprising a spacer (i.e., the “second absorbable woven or
knitted fabric/reinforcement fabric”) made of fibers of regenerated oxidized
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cellulose and PLA attached to and surrounded by a first absorbable
nonwoven fabric. Id. at 3^4 (citing Bar || 14, 19, 22, 24). Bar also teaches
that this spacer or second “reinforcement fabric provides strength to the
dressing.” Id. at 4 (citing Bar 112). Finally, the Examiner determines that it
would have been obvious to a person of ordinary skill at the time of the
invention “to modify the yams of the spacer of Therin with yams of
regenerated oxidized cellulose and with yams of PLA, as taught by Bar, for
the purpose of providing strength to the knit.” Id. at 4 (citing Bar 112).
For the limitation in claim 1 requiring the spacer to exhibit two-speed
reabsorption kinetics, the Examiner finds that Mathisen teaches “a mesh that
exhibits at least two-speed bioresorption kinetics to allow gradual cellular
integration to occur inside the mesh ... for the purpose of having a
substantially constant modulus of elasticity and for the regenerating tissue to
gradually take over the load applied to the tissue defect area and thus build
up the strength and compliance needed to take over the full load once the
support from the mesh is lost.” Id. (citing Mathisen || 1, 13, 14, 21, 28, 33,
34). The Examiner determines that it would have been obvious to modify
the Therin/Bar device to include two-speed bioresorption kinetics within the
spacer, as taught by Mathisen, to obtain this benefit as expressly taught by
Mathisen. Id. (citing Mathisen || 1, 13, 14).
Appellants dispute that claim 1 would have been obvious over Therin,
Bar, and Mathisen. App. Br. 3—8. With respect to the combination of
Therin and Bar, Appellants argue that Bar does not teach the claimed spacer.
For example, Appellants assert that Bar’s second knit reinforcement fabric,
which the Examiner finds as corresponding to the claimed spacer, (1) does
not connect a first face of a three-dimensional knit to a second face of the
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three-dimensional knit; (2) does not represent the thickness of Bar’s
hemostatic wound dressing; and (3) is required to remain a separate layer
rather than act as a “spacer.” App. Br. 5—6; see also Reply Br. 4—6.
Appellants also argue that a person of ordinary skill in the art would not
have been motivated “by Bar” to “substitute” Therin’s yams with Bar’s knit
reinforcement fabric, because the claims do not require the spacer to provide
strength and Therin does not teach that its knits require strengthening “at the
alleged spacer.” App. Br. 6; Reply Br. 7.
The Examiner responds that Bar’s second absorbable reinforcement
fabric is a spacer, in that Bar’s first absorbable non woven fabric “covers” the
entire second absorbable fabric. Ans. 3 (citing Bar 124). The Examiner
further responds that because Bar’s second reinforcement fabric is a spacer
and because Bar teaches using a combination of PLA and regenerated
oxidized cellulose for strength purposes (Bar || 12, 14, 19, 22), a person of
ordinary skill in the art would have been motivated to employ such material
as Therin’s spacer.1 Final Act. 4, Ans. 3.
In view of the above, we are not persuaded that Appellants have
shown error in the Examiner’s rejection of claim 1. Regarding whether Bar
teaches a spacer, we note that the Examiner relies on Therin, not Bar, to
1 It is further noted that while Bar teaches the second fabric as
interconnecting the various “staple[s] of the first” fabric (Bar 124), the
Examiner did not rely on Bar for disclosing first and second faces opposite
each other and connected to one another by the spacer or for disclosing “a
thickness of the knit.” See Final Act. 2. Further, despite Appellants’
assertion that Bar’s “spacer” must remain a separate layer, paragraph 24 of
Bar teaches that the first and second fabrics are “imbedded” in each other
and hence no indication that Bar’s “spacer” must remain a separate layer as
asserted.
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teach this limitation. See Final Act. 3. Nonetheless, we agree with the
Examiner that Bar’s reinforcement layer can be a spacer to the extent that it
is enclosed within Bar’s porous layer. See Bar 124 (teaching that
“substantially none” of the second absorbable fabric (i.e., “spacer”) is visibly
devoid of coverage by the first absorbable fabric). Therefore, because Bar
specifically teaches using oxidized regenerated cellulose to increase the
strength of its reinforcement layer (Bar H 12, 19), a person of ordinary skill
in the art would have been motivated to use oxidized regenerated cellulose
in Therin’s spacer to improve its strength.
As for combining Mathisen with Therin and Bar, Appellants argue
that Mathisen fails to remedy the deficiencies of Therein and Bar because
Mathisen does not teach the claimed spacer. App. Br. 7. Appellants also
dispute that a person of ordinary skill in the art would have been motivated
to modify Therin to incorporate the two-speed bioresorption kinetics taught
by Mathisen because Mathisen does not disclose using two-speed
bioresorption “specifically at the location of the spacer of a three-
dimensional knit.” App. Br. 8.
As above, Appellants’ argument that Mathisen does not teach the
claimed spacer is not persuasive of error because the Examiner relies on
Therin, not Mathisen, for this teaching. We also agree with the Examiner
(Ans. 3, citing Mathisen || 1, 13, 14, 21, 25, 28, 33, 34) that because any
one or more of Mathisen’s layers A—E, or a combination thereof, can be
made from materials that exhibit the claimed two-speed bioresorption
kinetics, any part of Therin’s knitted mesh, including Therin’s spacer, can be
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modified to exhibit two-speed bioresorption kinetics.2 In other words,
Appellants do not explain how the benefit of Mathisen’s two-speed
bioresorption would not have been obvious to employ at other locations as
well (such as “at the location of the spacer of a three-dimensional knit”).
For the foregoing reasons, we sustain the Examiner’s rejection of
claims 1, 3—6, 8—10, 12, 16, 22—26, 40 and 41 as obvious over Therin, Bar,
and Mathisen.
Claim 42
Claim 42 depends indirectly from claim 1 via claims 40 and 41.
Claim 40 depends from claim 1 and additionally recites, “wherein the yams
made of material which undergoes slow bioresorption of the spacer are
monofilament yams, and the yams made of regenerated and oxidized
cellulose which undergoes rapid bioresorption of the spacer are
multifilament yams.” Claim 41 depends from claim 40 and additionally
recites, “wherein the yams made of material which undergoes slow
bioresorption of the first and second face of the knit are multifilament
yams.” Claim 42 depends from claim 41 and additionally recites, “wherein
the yams made of material which undergoes slow bioresorption of the first
face, the second face, and the knit comprise poly(lactic acid).” The
Examiner finds that Therin teaches these additional limitations. Final Act. 3
(citing Therein || 34, 35, 57, 59-61, 63). Appellants respond that none of
the references teaches the claimed combination of (1) “first and second faces
2 As the Examiner notes (Final Act. 3), Therein already discloses an
embodiment in which the spacer comprises a combination of slow-
bioresorbing PLA and fast-bioresorbing PGA, which would inherently
exhibit two-speed bioresorbing kinetics.
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including multifilament yams of PLA,” and (2) “a spacer including a
monofilament yam of PLA and a multifilament yam of regenerated and
oxidized cellulose.” App. Br. 9. We agree with the Examiner, however, that
Therin teaches first and second faces and a spacer comprised of yams made
from PLA. Final Act. 2—3 (citing Therin H 35, 60, 64). We also agree with
the Examiner (Ans. 6) that Therin teaches using monofilaments and/or
multifilaments in both the spacer and first and second faces. Therefore, we
are not persuaded that the Examiner erred in rejecting claim 42 as obvious
over Therin, Bar, and Mathisen.
Claims 11, 13—15, 17—21, 27—29, and 30—35—Obviousness—
Therin, Bar, Mathisen, and Additional References
The Examiner rejects dependent claims 11, 13—15, 17—21, 27—29, and
30-35 as obvious over Therin, Bar, Mathisen, and one of Buevich, Tayot,
Nelson, Kondonis, Fronio, Vyakamam, and Fricke. Final Act. 6—9.
Appellants raise the same arguments against these rejections as they do with
respect to claim 1. App. Br. 9-18. As we found those arguments
unpersuasive above, we likewise find them unpersuasive as they pertain to
these rejections. Accordingly, we sustain these rejections.
Claims 1, 2, and 39—Obviousness—Ory, Bar, and Mathisen.
The Examiner finds that Ory teaches all of the limitations of claims 1,
2, and 39, except that it does not expressly teach first and second faces
comprising yams that undergo slow bioresorption, the spacer being made of
regenerated and oxidized cellulose and yams made of material that
undergoes slow bioresorption, or two-speed bioresorption kinetics. Final
Act. 10. For these limitations, the Examiner relies on Bar and Mathisen for
reasons similar/identical to those discussed supra. Id. at 10-11. Appellants
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respond with the same arguments presented above concerning the rejections
based on Therin, Bar, and Mathisen. App. Br. 18—23. We find these
arguments unpersuasive for the same reasons. Accordingly, we sustain the
Examiner’s rejection of claims 1, 2, and 39 as obvious over Ory, Bar, and
Mathisen.
Claims 27—29—Obviousness—Ory, Bar, Mathisen, and Tayot
The Examiner rejects dependent claims 27—29 as obvious over Ory,
Bar, Mathisen, and Tayot. Final Act. 11—12. Appellants raise the same
arguments against this rejection as they do with respect to the previous
rejection. App. Br. 23—24. As we found those arguments unpersuasive
above, we likewise find them unpersuasive here. Accordingly, we sustain
this rejection.
DECISION
For the above reasons, the Examiner’s rejections of claims 1—6, 8—35,
and 39-42 are 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)(l)(iv).
AFFIRMED
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