Ex Parte Yoon et al

Board of Patent Appeals and Interferences

Jan 7, 2011

10307139 (B.P.A.I. Jan. 7, 2011)

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.
10/307,139 11/27/2002 Hye-sung Yoon 21046 9518
7590 01/07/2011
M. Wayne Western
THORPE, NORTH & WESTERN, L.L.P.
P. O. Box 1219
Sandy, UT 84091-1219
EXAMINER
HARTLEY, MICHAEL G
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
01/07/2011 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte HYE-SUNG YOON, TAE-HUN KIM, MYOUNG-SEOK KOH,
CHONG-TAEK HONG, CHAUL-MIN PAI, JUNG-NAM IM
and JANG-IL SEO
____________

Appeal 2010-011117
Application 10/307,139
Technology Center 1600
____________

Before RICHARD E. SCHAFER, RICHARD TORCZON, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52 begins to run from the “MAIL DATE” (paper
delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode)
shown on the PTOL-90A cover letter attached to this decision.
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This is a decision on the appeal, under 35 U.S.C. § 134, by the Patent
Applicant from the Patent Examiner’s rejections of claims 1, 4-6, 8, 9, 11-
20, 22-24, 26, 27, and 29-44. The Board’s jurisdiction for this appeal is
under 35 U.S.C. §§ 6(b). We affirm.

STATEMENT OF THE CASE
The pending claims involve block copolymers useful for
manufacturing surgical articles, such as sutures (Spec. 2:5-16). Claims 1, 4-
6, 8, 9, 11-20, 22-24, 26, 27, and 29-44 are pending and stand rejected by the
Examiner as follows:
Claims 1, 4-6, 8, 9, 11-20, 22-24, 26, 27, and 29-44 under 35 U.S.C.
§ 103(a) as obvious in view of D’Aversa,2 Jarrett,3 and Bezwada4 (Ans. 3);
and
Claims 1, 4-6, 8, 9, 11-20, 22-24, 26, 27, and 29-44 under 35 U.S.C.
§ 103(a) as obvious in view of D’Aversa, Jarrett, Bezwada, and Denesuk5
(Ans. 6).
Claims 1, 8, 9, 40, and 43 are representative and read as follows:
1. An AB type di-block copolymer comprising a p-dioxanone A
block, and a segmented copolymer B block comprising ε-
caprolactone and trimethylene carbonate, wherein the inherent
viscosity of said AB type di-block copolymer is within the
range of 0.8 to 4.0 dL/g as measured in a 0.1 g/dL solution of
hexafluoroisopropanol at 25 °C, and wherein the content of said
p-dioxanone blocks are within the range of 60 to 90 mole%.

2 U.S. Pat. App. Pub. 2001/0018599 A1, published Aug. 30, 2001.
3 U.S. Pat. No. 5,080,665, issued Jan. 14, 1992.
4 U.S. Pat. No. 5,951,997, issued Sept. 14, 1999.
5 U.S. Pat. No. 6,576,246 B1, issued June 10, 2003.
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8. The diblock copolymer of claim 1 has an inherent viscosity
within the range of 1.0 to 3.5 dL/g as measured in a 0.1 g/dL
solution of hexafluoroisopropanol at 25°C.

9. The diblock copolymer of claim 1 has a Young's modulus of
180,000 psi or less.

40. A block copolymer comprising an A block of p-dioxanone
units represented by formula (1) and a B block comprising a
segmented copolymer of ε-caprolactone and trimethylene
carbonate, said B block is represented by formula (2),

wherein x, y, and z respectively represents an integer between
10 to 104 and
wherein the inherent viscosity of said block copolymer is within
the range of 0.8 to 4.0 dL/g as measured in a 0.1 g/dL solution
of hexafluoroisopropanol at 25 °C, and wherein the content of
said p-dioxanone blocks are within the range of 60 to 90
mole%.

43. The surgical article of claim 18, wherein the surgical article
is a monofilament suture.

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ISSUES
The main issue in this appeal is whether the copolymer structure
recited in claims 1 and 20 would have been reasonably suggested to a person
of ordinary skill in the art by the teachings of D’Aversa, Jarrett, and
Bezwada.
Appellants also argue the patentability of certain dependent claims.
We address the issues raised by those arguments in the separately listed
sections below.
LEGAL PRINCIPLES
“A known or obvious composition does not become patentable simply
because it has been described as somewhat inferior to some other product for
the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “[A]
reference may teach away from a use when that use would render the result
inoperable.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1381 (Fed.
Cir. 2007).
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
See In re Ludtke, supra. Whether the rejection is based on
“inherency” under 35 U.S.C. § 102, on “prima facie
obviousness” under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced by
the PTO's inability to manufacture products or to obtain and
compare prior art products. See In re Brown, 459 F.2d 531, 59
CCPA 1036, 173 USPQ 685 (1972).
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).

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FINDINGS OF FACT (“FF”)
D’Aversa
1. D’Aversa describes a braided suture coated with a biocompatible
polymer, which is melted at a temperature sufficient “to allow the polymer
to be redistributed into the interstices of the braided suture” in order to
provide improved strength (D’Aversa, ¶ [0005]).
2. D’Aversa lists numerous biocompatible polymers that can be
utilized with the braided suture (id. at ¶¶ [0010] – [0013]).
3. Among these, D’Aversa discloses solid homopolymers of poly(p-
dioxanone) and copolymers of ε-caprolactone and trimethylene carbonate
(id. at ¶ [0012]).
4. According to D’Aversa, the “preferred aliphatic polyesters for use
as coatings are low molecular weight copolymers selected from the group
consisting of” (id. at ¶ [0013]):
· poly (ε-caprolactone-coglycolide);
· poly(ε-caprolactone-co-trimethylene carbonate);
· poly(ε-caprolactone-co-lactide); and
· poly(ε-caprolactone-co-p-dioxanone).
5. D’Aversa teaches that the polymeric coating can be a random,
block, or segmented polymer (id. at ¶ [0014].)
6. The “inherent viscosity of the “preferred random copolymers” is
described by D’Aversa as between about 0.05 to about 0.8 dL/g (id. at ¶
[0017]).
7. D’Aversa discloses that “it is possible to use polymers with an
inherent viscosity greater than about 0.8 dL/G” but “it maybe exceedingly
difficult to do so.” (Id. at ¶ [0018].)
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Bezwada
8. Bezwada discloses that its invention relates to biocompatible,
segmented polymers of aliphatic polyesters of ε-caprolactone, p-dioxanone,
and glycolide with a Young’s modulus of less than 200,000 psi (Bezwada,
col. 1, ll. 5-10 & 53-63).
9. Bezwada describes prior art polymers used in surgical clips or
staples with a Young’s modulus over 200,000 and having a hard phase of
repeating units and a soft phase of repeating units (id. at col. 1, ll. 24-36).
10. The hard phase “consist[s] of glycolic acid ester, lactic acid ester
linkages and mixtures thereof.” (Id. at col. 1, ll. 30-32.)
11. The “soft phase repeating units compris[es]” trimethylene
carbonate, p-dioxanone, or ε-caprolactone linkages (id. at col. 1, ll. 32-34).
12. Bezwada states that the prior art patents described in its
Background section did not “recognize that especially flexible sutures could
be manufactured from a copolymer of glycolic repeating units
copolymerized with a random polymer predominantly of para-dioxanone
and ε-caprolactone repeating units.” (Id. at col. 1, ll. 41-45).
13. Figure 1 of Bezwada shows the process of making the segmented
polymers having the following step:
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Figure 1, reproduced above, shows a process step of preparing a
segmented polymer of repeating units of glycolide, p-dioxanone, and ε-
caprolactone (id. at col. 2, ll. 27-30).
14. Bezwada discloses that polymerization is carried out until the
desired molecular weight and viscosity are achieved (id. at col. 3, ll. 50-54).
15. Bezwada teaches that the inherent viscosity is between about 0.7
to about 4 dL/g (id. at col. 4, ll. 24-25).
16. Bezwada teaches that its polymers can be used to “prepare a vast
array of useful devices . . . [including] implantable and medical and surgical
devices, . . . [with] preferred devices being suture anchor devices, adhesion
prevention films and hemostatic foam barriers (id. at col. 4, ll. 58-64).
17. The polymers can also be extruded to prepare fibers to be
fabricated into sutures or ligatures (id. at col. 4, ll. 65-67).
18. “In another embodiment of the present invention, the inventive
polymers may also be used as coatings for sutures and the like to improve
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knot strengths and tiedown properties . . . [and] is suited to applying to
braided sutures (id. at col. 5, ll. 22-25 & 35-40).

Jarrett
19. Jarrett describes surgical repair devices made from block
copolymers (Jarrett, col. 2, ll. 27-28).
20. Jarrett discloses that its polymeric material can comprise hard and
soft phases, with the soft phase comprising copolymers of poly(trimethylene
carbonate), poly(p-dioxanone), or poly(ε-caprolactone) and mixtures of them
(id. at col. 6, ll. 14-20, ll. 40-45, & ll. 60-65).
21. Jarrett discloses polymers with various inherent viscosities,
including 1.44 dL/g (col. 8, l. 52); 1.56 dL/g (col. 9, l. 52), and 1.65 dL/g
(col. 10, l. 30).

Level of ordinary skill in the art
22. The ordinary skilled worker routinely configured biocompatible
polymers comprising trimethylene carbonate, p-dioxanone, and ε-
caprolactone into medical devices (FF2-FF4, FF10, FF11, F13, F16, &
FF20), including polymers having block and di-block structures (FF5 &
FF13).
ANALYSIS
Claims 1 & 20
The claims are directed to AB and ABA type di-block and tri-block
copolymers comprising a “p-dioxanone block A” and a “B block comprising
ε-caprolactone and trimethylene carbonate,” where the copolymer has an
inherent viscosity within the range of 0.8 to 4 dL/g. The Examiner
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acknowledged that the claimed structure was not expressly described in a
single publication, but found the structure obvious in view of the disclosures
of D’Aversa, Jarrett, and Bezwada (Ans. 4-6). Based on the description in
the cited publications of each of the three recited monomers of claims 1 and
20, the Examiner concluded:
Obviousness stems from the notion that the copolymer of
instant claims is no more than a combination of known
subcomponents (trimethylene carbonate, eta-capralactone [sic],
and p-dioxanone) to achieve a predictable result. The prior art
clearly recognizes that each of the subcomponents is part of a
small group of related biodegradable, biocompatible ester
monomers that, when polymerized, degrade in the body over
time. The resulting polymers are also known to be useful in
making surgical devices, such as sutures.
(Ans. 5).
Appellants contend that to “arrive” at the claimed structure, “the three
monomeric units presently claimed would need to be selected from
numerous monomeric units described in D’Aversa . . . and arranged in the
particular order as claimed.” (App. Br. 19.)
Appellants also contend that it would not have been obvious to
combine D’Aversa and Bezwada because D’Aversa described a coating
applied to a braided suture and Bezwada described a monofilament suture,
and therefore the “respectively polymers are used for entirely disparate
purposes.” (Id.)
Furthermore, Appellants contend that Bezwada discloses that its
improved properties result from glycolic repeating units, which “stand in
sharp contrast with the present AB and ABA block polymers” (id. at 20).
Appellant also maintains that Bezwada teaches away because it disparages
polymers that use trimethylene carbonate monomer (Reply Br. 10-11).
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Selection Argument
The prior art publications cited by the Examiner provide sufficient
evidence to establish that each of three recited monomers had been
incorporated into copolymers. D’Aversa specifically described a preferred
di-block copolymer with ε-caprolactone and trimethylene carbonate (FF3 &
FF4), corresponding to block B of claims 1 and 20. Both Jarrett and
Bezwada described polymeric phases comprising ε-caprolactone,
trimethylene carbonate, and p-dioxanone (FF11 & FF20) – all three of the
monomers required by claims 1 and 20. Although the publications did not
specifically describe D’Aversa’s ε-caprolactone and trimethylene carbonate
block plus p-dioxanone – as claimed – the fact that all three monomers had
been used together reasonably suggests configurations that would include
the claimed block structures.
Appellants argue that the number of different polymers disclosed in
D’Aversa would have made the choice of the three claimed monomers
unreasonable (Reply Br. 7-8). This argument is not persuasive. D’Aversa
describes a polymer of ε-caprolactone and trimethylene carbonate as
preferred (FF3 & FF4) and Jarrett and Bezwada describe all three monomers
as conventional constituents of biocompatible medical devices (FF11 &
FF20). The evidence of record shows that the recited trimethylene
carbonate, p-dioxanone, and ε-caprolactone were obvious choices for
making biocompatible medical devices (FF16 & FF19), such as sutures
(FF1). Persons of ordinary skill in the art would have recognized these
monomers as typical components of a biocompatible medical device,
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components that would have routinely been incorporated into a polymer
structure to achieve the desired properties (FF14 & FF22).
The prior art also taught random, block, and segmented polymers
(FF5), including a di-block polymer containing two of the three monomers
recited in claims 1 and 20 (FF13). The cited prior art publications did not
restrict their disclosures to the specifically recited embodiments, but rather
generally characterized useful biocompatible polymers as comprising
various different monomers, without limiting the components to a particular
structure or configuration (FF2-FF4, FF10, FF11, & FF20). Persons of
ordinary skill in the art were therefore familiar with biocompatible polymers
comprising trimethylene carbonate, p-dioxanone, and ε-caprolactone, A and
B block structures, as well as other structural configurations. These broad
teachings provide evidence that the skilled worker routinely configured
biocompatible polymers comprising trimethylene carbonate, p-dioxanone,
and ε-caprolactone into medical devices (FF22) and would have had reason
to make a block structure as claimed.

Combination
The D’Aversa and Bezwada publications are not aimed at disparate
purposes, as urged by Appellants. Bezwada expressly taught that its
polymers can be used in “a vast array of useful devices,” and specifically
mentioned their use as coating polymers to strengthen braided sutures
(FF18), a similar use to the one described in D’Aversa (FF1). Appellants
have defined the field of endeavor too narrowly by focusing on Bezwada’s
disclosure of monofilaments, when Bezwada expressly described other uses
for its polymers (FF16). All three cited publications describe the same
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monomers in medical type devices (FF3, FF4, FF8, FF11, & FF20), making
them reasonably pertinent to the same problem addressed by Appellants in
designing block copolymers for surgical articles (Spec. 1). Claims 1 and 20
are directed to a copolymer, not a specific device – and therefore D’Aversa,
Jarrett, and Bezwada were properly combined because all three described
polymers of trimethylene carbonate, p-dioxanone, or ε-caprolactone for the
same general purpose.

Teaching Away
Appellants contend that Bezwada teaches away from the claimed
invention because its polymers comprise glycolic repeating units and
disparage polymers with trimethylene carbonate.
Firstly, the claims do not exclude glycolide. Copolymer block B of
claims 1 and 20 recites that the copolymer is “comprising” ε-caprolactone
and trimethylene carbonate. The claim term “comprising” is open-ended,
permitting the inclusion of additional components, including the monomer
glycolide taught by Bezwada.
Secondly, Appellants contend that Bezwada “specifically” disparages
the use of trimethylene carbonate in its Background section (Reply Br. 9),
but did not cite to a particular column or line number where this
disparagement is allegedly found. Bezwada described prior art
biocompatible polymers with trimethylene carbonate (FF11). Bezwada
stated that the prior art had not recognized that “especially flexible sutures
could be manufactured from a copolymer of glycolic repeating units
copolymerized with a random polymer predominantly of para-dioxanone
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and ε-caprolactone repeating units.” (FF12). Appellants did not explain
how these statements constituted words of disparagement.
Moreover, even if the prior art copolymers were characterized as
inferior, this would not defeat the obviousness rejection. “A known or
obvious composition does not become patentable simply because it has been
described as somewhat inferior to some other product for the same use.”
Gurley, 27 F.3d at 553.

Inherent Viscosity
Appellants contend that D’Aversa “teaches away” from the claimed
inherent viscosities of “0.8 to 4.0 dL/g” because D’Aversa stated “it is
possible to use polymers with an inherent viscosity greater than about 0.8
dL/g” but “it may be exceedingly difficult to do so.” (FF7)
D’Aversa made this statement with respect to redistributing a melted
coating polymer into the interstices of a braided suture (FF1). The claims
are not drawn to a braided suture with a coating polymer, but rather are
directed more generically to a copolymer. The Examiner provided sufficient
evidence that the claimed copolymer with an inherent viscosity in excess of
the range disclosed in D’Aversa would have been obvious to the ordinary
skilled worker. Jarrett and Bezwada described copolymers with viscosities
greater than 0.8 dL/g (FF15 and FF21). Barrett expressly stated that the
reaction conditions could be adjusted to achieve a desired viscosity (FF14),
establishing that it was within the level of ordinary skill in the art to have
chosen a desired viscosity. Moreover, a finding that a product would have
been inferior is not a teaching away unless the evidence shows, for example,
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that the direction taken would have led to an inoperable product. ICON, 496
F.3d at 1381.

Claims 8 and 26
Representative claim 8 is directed to a copolymer of claim 1 having an
inherent viscosity within the range of 1.0 to 3.5 dL/g. Appellants contend
that this range is not obvious in view of D’Aversa’s disparaging viscosities
above 0.8 dL/g. This is the same argument made for the range recited in
claim 1 which we found deficient for the reasons discussed above.

Claims 9, 16, 19, 27, 34, and 37
Representative claim 9 is directed to a copolymer of claim 1 having a
Young’s modulus of 180,000 psi or less. Appellants argue that Bezwada
characterizes these values as low (App. Br. 23).
This argument has little merit. Bezwada specifically describes
polymers with a Young modulus as being less than 200,000 psi, a range
overlapping with the claimed range (FF8). Whether this range is “low” or
not is not pertinent because overlapping ranges are sufficient to establish an
obviousness presumption. In re Harris, 409 F.3d 1339, 1341 (Fed. Cir.
2005).

Claim 40
Independent claim 40 is drawn to a block copolymer with the same
blocks A and B recited in claim 1, but further requiring that the components
are in a quantity of between 10 to 104. Appellants contend that the claimed
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structure is not suggested by Bezwada alone or in combination with the
other cited publications (App. Br. 25).
Bezwada generically refers to repeating units and shows such
structures (FF9, FF12, & FF13). While Bezwada does not specifically
disclose the actual number of monomers in each block, Bezwada refers to
repeating units, reasonably suggesting a plurality of monomers within the
broadly claimed range of 10 to 10,000 (104). Similarly, D’Aversa and Jarrett
would have been understood to describe polymers comprising a plurality of
repeating units (FF3-FF5 & FF20).
In sum, for the following reasons, we conclude that the Examiner
provided sufficient evidence to shift the burden to Appellants to show that
polymers comprising monomers within the claimed range would not have
been obvious to a person of ordinary skill in the art: (1) the absence of actual
recited monomer numbers in the prior art when weighed against the broadly
claimed range; (2) the fact that multiple repeating units are clearly taught in
the cited prior art publications; and (3) the inability of the Examiner to
determine how many units were present in the prior art copolymers (Best,
562 F.2d at 1255). Appellants did not provide adequate evidence to rebut
the Examiner’s reasonable presumption.

Claims 43 and 44
Appellants contend that claims 43 and 44, which are drawn to
monofilament sutures, would not have been obvious to the person of
ordinary skill in the art (App. Br. 25).
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Bezwada teaches that its biocompatible polymers can be used to
fabricate fibers to be made into sutures (FF17), reasonably suggesting the
use of the claimed copolymer to manufacture such a medical device.

D’Aversa, Jarrett, Bezwada, and Denesuk
Because we determined that the claims were obvious over D’Aversa,
Jarrett, and Bezwada, it is unnecessary for us to consider the additionally
cited Denesuk publication. We therefore affirm the rejection of claims 1, 4-
6, 8, 9, 11-20, 22-24, 26, 27, and 29-44 for the same reasons as set forth
above.
SUMMARY
The obviousness rejection under 35 U.S.C. § 103(a) of claims 1, 8, 9,
20, 40, and 43 is affirmed. Claims 4-6, 11-19, 22-24, 26, 27, 29-42, and 44
fall with them because separate reasons for their patentability were not
addressed. See 37 C.F.R. § 41.37(c)(1)(vii).

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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bim

M. WAYNE WESTERN
THORPE, NORTH & WESTERN, L.L.P.
P. O. BOX 1219
SANDY, UT 84091-1219