Ex Parte Stopek et al

Patent Trial and Appeal Board

Aug 9, 2016

12721937 (P.T.A.B. Aug. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121721,937 03/11/2010
50855 7590 08/11/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Joshua Stopek
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-02029 (203-6825) 2106
EXAMINER
HARVEY, TIJLIANNA NANCY
ART UNIT PAPER NUMBER
3733
NOTIFICATION DATE DELIVERY MODE
08/11/2016 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 JOSHUA STOPEK and JONATHAN D. THOMAS 1
Appeal 2014-004883
Application 12/721,937
Technology Center 3700
Before EDWARD A. BROWN, AMANDA F. WIEKER, and
SEAN P. O'HANLON, Administrative Patent Judges.
WIEKER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Joshua Stopek and Jonathan D. Thomas ("Appellants") appeal under
35 U.S.C. § 134(a) from the Examiner's final rejection of claims 1, 4-8, and
11-19. 2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the Real Party in Interest is Covidien LP. Appeal
Br. 2.
2 Claims 2, 3, 9, and 10 have been cancelled. Id.
Appeal2014-004883
Application 12/721,93 7
CLAIMED SUBJECT MATTER
The invention concerns "degradable implants, and more specifically,
[] medical devices having more than one degradation zone." Spec. 1.
Claims 1 and 19 are illustrative of the subject matter on appeal, and recite:
1. A fixation device comprising
at least two homogeneous degradation zones fabricated
from polymeric materials that are not reinforced with ceramic or
particulate fillers, the at least two homogeneous degradation
zones including
a first degradation zone having a first degradation
rate and
a second degradation zone having a second
degradation rate that is different from the first degradation
rate, and
an interphase providing a gradient or gradual transition
between the first degradation zone and the second degradation
zone,
wherein a region of the interphase closer to the first
homogeneous degradation zone comprises more of the
polymeric material of the first degradation zone than a
region of the interphase closer to the second homogeneous
degradation zone.
19. A fixation device comprising
at least two homogeneous degradation zones fabricated
from polymeric materials that are not reinforced with ceramic or
particulate fillers, the at least two homogeneous zones including
a first degradation zone comprising a copolymer
having a first ratio of monomers and
a second degradation zone comprising the
copolymer at a second ratio of monomers that is different
from the first ratio of the first degradation zone, and
an interphase providing a transition between the first
degradation zone and the second degradation zone,
wherein a region of the interphase proximal to the
first homogeneous degradation zone comprises a ratio of
2
Appeal2014-004883
Application 12/721,93 7
monomers of the copolymer closer to the first ratio of the
copolymer of the first degradation zone and a region of the
interphase proximal to the second homogeneous
degradation zone comprises a ratio of monomers of the
copolymer closer to the second ratio of the second
degradation zone.
Appeal Br. 16, 18 (Claims App.) (emphases and paragraph structure added).
REJECTIONS
The claims stand rejected as follows:
I. Claims 1, 4---6, 11, 12, and 14--18 under 35 U.S.C. § 103(a) as
unpatentable over Athanasiou (US 6,013,853, iss. Jan. 11,
2000), Brown (US 6,626,950 B2, iss. Sept. 30, 2003), Jarrett
(US 5,342,395, iss. Aug. 30, 1994), and Leitao (US 6,069,295,
iss. May 30, 2000). 3
II. Claims 7, 8, and 13 under 35 U.S.C. § 103(a) as unpatentable
over Athanasiou, Brown, Jarrett, Leitao, and uave (US
2005/0267565 Al, pub. Dec. 1, 2005).
III. Claim 19 under 35 U.S.C. § 103(a) as unpatentable over
Athanasiou, Brown, Leitao, Walter (US 2001/0051833 Al, pub.
Dec. 13, 2001), and Alford (US 2005/0090828 Al, pub. Apr.
28, 2005).
3 Although the Examiner lists claim 13 as part of Rejection I, the subject
matter of claim 13 is addressed in the rejection over Athanasiou, Brown,
Jarrett, Leitao, and Dave (Rejection II). See Final Act. 5-7.
3
Appeal2014-004883
Application 12/721,93 7
ANALYSIS
Re} ections I-II
Independent claim 1 requires, inter alia, "an interphase providing a
gradient or gradual transition" between the claimed first and second
degradation zones, wherein the portion of the interphase that is closer to the
first zone comprises more of the first zone's polymeric material than the
portion of the interphase that is closer to the second zone. Appeal Br. 16
(Claims App.).
The Examiner finds Athanasiou discloses, inter alia, first and second
degradation zones (12, 14) formed from polymeric materials that lack
ceramic or particulate filler reinforcement, as claimed. Final Act. 2 (citing
Athanasiou, 10:61-11 :4). The Examiner finds Athanasiou fails to disclose,
inter alia, the claimed interphase, but finds Leitao teaches an interphase that
"provides a gradient or gradual transition between [its] first and second
zones, wherein a region of the interphase closer to the first zone comprises
more of the material of the first zone than a region of the interphase closer to
the second zone." Id. at 3--4 (citing Leitao, 6:59-7:19). The Examiner also
finds Brown teaches an interphase (26) that "creates a strong mechanical
junction while simultaneously providing a gradual change in material
properties for the purpose of regenerating different tissues in intimate
contact with one another." Id. at 4 (citing Brown, 3:49-55, Fig. 1).
The Examiner concludes it would have been obvious to a person of
ordinary skill in the art to modify Athanasiou to include an interphase that
provides "a gradient or gradual transition between [Athanasiou's first and
second zones] wherein a region of the interphase closer to the first
4
Appeal2014-004883
Application 12/721,93 7
homogeneous degradation zone comprises more of the polymeric material of
the first degradation zone than a region of the interphase closer to the second
homogeneous degradation zone," as taught by Leitao, in order to "create a
strong mechanical junction while simultaneously providing a gradual change
in material properties for the purpose of regenerating different tissues in
intimate contact with one another, as taught by [Brown]." Id. at 5.
Appellants contend that the asserted prior art fails to teach the claimed
interphase. Appeal Br. 6. Specifically, Appellants argue Leitao discloses a
calcium phosphate coating on a titanium substrate, which is formed by "the
reaction chemistry between the calcium phosphate (i.e., a ceramic) and the
titanium (i.e., a non-degradable, non-polymeric material)." Id. at 7-8.
According to Appellants, "a person of ordinary skill in the art would not
have understood Leitao to have taught a gradual transition between any two
different materials, but rather, a gradual transition of calcium and
phosphorous from a calcium phosphate coating to a substrate." Reply Br. 2.
Furthermore, Appellants argue that if the references were combined as
proposed by the Examiner, the combination "would produce an implant
including the implant materials of Athanasiou having the surface roughness
of Leitao so that the implant can 'very efficiently be coated with a layer of
calcium phosphate, either in vitro, or in vivo."' Id. at 3 (citing Leitao, 2: 16-
17).
The Examiner responds that Appellants' claim 1 does not limit the
process used to create the interphase 's gradual transition, and that a person
skilled in the art "would know how to combine the materials in the zones of
[Athanasiou] to create the gradual transition." Ans. 10. Further, the
5
Appeal2014-004883
Application 12/721,93 7
Examiner responds that "Leitao was not relied upon for the teaching of
specific materials but was instead relied upon to teach providing a gradual
transition between two different materials." Id.
We agree with Appellants. Leitao discloses a solid implant having a
particular surface roughness such that, when placed in solutions of bone-
forming components, a coating of calcium phosphate forms on the implant's
surface. Leitao, 1:37--42, 2:15-17. 4 Leitao discloses that, in one example,
the depth profile of this surface coating presents "a gradual transition of
calcium and phosphorous from the coating to the substrate, indicating the
incorporation of these elements in the surface (oxide layer), and thus a
chemical bonding between coating and substrate." Id. at 6:59---67; see also
id. at 7 :21-23. The portions of Leitao cited by the Examiner do not disclose
a "gradual transition between two different materials," as the Examiner
asserts (Ans. 10). Instead, Leitao teaches a surface coating on a substrate
(i.e., on a solid implant), but does not teach a "gradual transition" between
different zones in that underlying substrate. Therefore, we agree with
Appellants that if the references were combined as proposed by the
Examiner, the result would be to modify Athanasiou's implant to include a
coating, as taught by Leitao, bonded to Athanasiou's implant. This
combination does not satisfy claim 1 's requirement that the device include
"an interphase providing a gradient or gradual transition" between the
claimed first and second degradation zones. Accordingly, we cannot sustain
the Examiner's rejection of independent claim 1, or the rejections of
4 Contrary to Appellants' suggestion, (Appeal Br. 8), Leitao's implant may
be formed from "biodegradable polymers." Leitao, 1:66-2:9.
6
Appeal2014-004883
Application 12/721,93 7
dependent claims 4--8 and 11-18, which depend directly or indirectly from
claim 1.
Re} ection III
Independent claim 19 requires, inter alia, "an interphase providing a
transition" between the claimed first and second degradation zones, wherein
the portion of the interphase proximal the first zone comprises a ratio of
monomers closer to the first zone's ratio and the portion of the interphase
proximal the second zone comprises a ratio of monomers closer to the
second zone's ratio. Appeal Br. 18 (Claims App.).
The Examiner finds Athanasiou discloses, inter alia, first and second
degradation zones formed from polymeric materials that lack ceramic or
particulate filler reinforcement, as claimed. Final Act. 7. The Examiner
relies on Leitao and Brown, as in claim 1, as teaching an interphase. The
Examiner also relies on Alford as teaching "a device made from a
copolymer comprising PGA and PLA has a PLA to PGA ratio of 82: 18 as
such a ratio is advantageous when the surrounding tissue is bone," and relies
on Walter as teaching "a device made from a copolymer comprising PGA
and PLA has a PLA to PGA ratio of 7 5 :25 as such a ratio is advantageous
when the surrounding tissue is cartilage." Id. at 8 (citing Alford i-f 29; Walter
,-r 72).
The Examiner concludes it would have been obvious to a person of
ordinary skill in the art to modify Athanasiou to include an interphase that
provides "a transition between [Athanasiou's first and second zones]
wherein a region of the interphase proximal to the first homogeneous
degradation zone comprises more of the polymeric material of the first
7
Appeal2014-004883
Application 12/721,93 7
degradation zone than a region of the interphase closer to the second
homogeneous degradation zone," and vice versa with respect to the second
homogenous degradation zone, as taught by Leitao, in order to "create a
strong mechanical junction while simultaneously providing a gradual change
in material properties for the purpose of regenerating different tissues in
intimate contact with one another, as taught by [Brown]." Id. at 8-9. The
Examiner also concludes it would have been obvious to a person of ordinary
skill in the art to modify Athanasiou, in light of Alford and Walter, "such
that the second ratio of monomers is different from the first ratio of
monomers ... as the different ratios are advantageous for different types of
tissue, such as bone and cartilage," which would lead to the distribution of
monomer ratios as claimed. Id. at 9.
Appellants rely on the arguments presented, and found persuasive,
with respect to claim 1, and contend that Alford and Walter fail to cure the
deficiencies of Athanasiou, Brown, and Leitao. Appeal Br. 13-14. We
agree with Appellants for the reasons discussed with respect to claim 1,
namely, that Athanasiou, Brown, and Leitao fail to render obvious "an
interphase providing a transition" between the claimed first and second
degradation zones. The Examiner's application of Alford and Walter does
not cure these deficiencies. Accordingly, we cannot sustain the Examiner's
rejection of claim 19.
DECISION
The rejections of claims 1, 4--8, and 11-19 are REVERSED.
REVERSED
8