Ex Parte Roby et al

Board of Patent Appeals and Interferences

Nov 17, 2008

10103187 (B.P.A.I. Nov. 17, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARK S. ROBY,
JOHN J. KENNEDY, and RICHARD STEVENSON
__________

Appeal 2008-3143
Application 10/103,187
Technology Center 3700
__________

Decided: November 17, 2008
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-12, 16, 17, and 19-23. We have
jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-3143
Application 10/103,187

STATEMENT OF THE CASE
The claims are directed to polyolefin sutures and methods of making
such sutures, wherein the sutures contain a fray reducing amount of a fatty
acid diester of polyethylene glycol. Claims 1, 16, 20, and 21 are
representative of the claims on appeal, and read as follows:
1. A method for fabricating a polyolefin suture comprising:
a) providing a melt of at least one polyolefin, the melt containing a
fatty acid diester of polyethylene glycol; and
b) extruding the melt to form a filament.

16. A suture comprising a filament comprising a mixture of polyolefin
and fray reducing amount of a fatty acid diester of polyethylene glycol,
wherein the fatty acid diester comprises from 0.01% to 5.0% by weight of
the filament.

20. A device comprising:
a needle; and
a sterilized monofilament attached to the needle, the monofilament
comprising a mixture of polypropylene and 0.1% to 0.5% by weight
polyethylene glycol distearate.

21. A suture comprising: a filament comprising a polyolefin and a fray
reducing amount of a fatty acid diester of polyethylene glycol, wherein the
fatty acid diester comprises from 0.01% to 5.0% by weight of the filament.

The Examiner relies on the following references:
Singerman US 3,311,110 Jul. 15, 1964
Yokohama US 3,625,931 Dec. 7, 1971
Ruter US 3,821,184 Jun. 28, 1974
Mattei US 4,201,216 May 6, 1980
Chesterfield US 5,059,213 Oct. 22, 1991
Everhart US 5,439,734 Aug. 8, 1995
Kojima US 5,902,679 May 11, 1999
Birnbrich US 2002/0019184 A1 Feb. 14, 2002

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We affirm.

ISSUE (Anticipation)
The Examiner finds that Birnbrich anticipates the claimed sutures and
methods of producing the sutures of claims 1, 9, 12, 16, 17, 19, and 21; that
Everhart anticipates the claimed sutures and methods of producing the
sutures of claims 1, 9, 12, 16, 17, and 21; and Kojima anticipates the suture
of claims 21-23.
Appellants contend that Birnbrich, Everhart, and Kojima do not
anticipate the claimed suture and methods of producing the sutures.
Appellants’ primary contention is that none of the references are drawn to
sutures or to methods of producing sutures. As to Everhart, Appellants
contend further that Everhart does not disclose adding a fray reducing
amount of the fatty acid diester of polyethylene glycol. Finally, as to
Kojima, Appellants argue that Kojima does not incorporate the fatty acid
diester of polyethylene glycol into the fiber itself.
Thus, we frame the issues as to the anticipation rejections as follows:
1) Have Appellants demonstrated that the Examiner erred in rejecting the
claims over references that do not specifically teach sutures and methods of
making the sutures; 2) Have Appellants demonstrated that the Examiner
erred in rejecting certain of the claims over Everhart because Everhart does
not disclose adding a fray reducing amount of the fatty acid diester of
polyethylene glycol; and 3) Have Appellants demonstrated that the
Examiner erred in rejecting certain of the claims over Kojima as Kojima
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does not incorporate the fatty acid diester of polyethylene glycol into the
fiber itself?

FINDINGS OF FACT
FF1 The Specification teaches that “[p]olyolefin sutures are known in the
art.” (Spec. 1.)
FF2 According to the Specification:
It has now been found that the processing and handling
characteristics of polyolefin sutures can be improved by
incorporating a fatty acid diester of polyethylene glycol into the
polyolefin resin prior to spinning of the filament(s). A method
for fabricating a polyolefin suture is also provided herein. In
the novel method described herein, a polyolefin is combined
with an effective fray reducing amount of a fatty acid diester of
polyethylene glycol, preferably polyethylene glycol distearate.
The mixture of polyolefin and diester is heated to form a melt.
The melt is then extruded to form a filament. The polyolefin is
preferably polypropylene.

(Id. at 2.)
FF3 The Examiner rejects claims 1, 9, 12, 16, 17, 19, and 21 under 35
U.S.C. § 102(b) as being anticipated by Birnbrich (Ans. 4).
FF4 The Examiner cites Birnbrich for disclosing “a fiber of polypropylene
and a fatty acid diester of PEG,” and also for teaching that “the materials are
mixed, heated and spun into fibers.” (Id.)
FF5 Specifically, one aspect of Birnbrich “relates to a process for making a
synthetic fiber having increased hydrophilicity comprising the steps of: (1)
adding an effective amount of a di-C10-12 fatty acid ester of polyethylene
glycol to a polymer to form a mixture; (2) heating the mixture to form a
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melt; and (3) spinning the melt into a fiber.” (Birnbrich ¶ 9.) The polymer
is preferably a polyolefin, such as polypropylene (id. at ¶ 13.) “Typically,
the amount of the additive required to increase the hydrophilicity of a
polymer will be from about 0.5% to about 10% by weight of the polymer,
preferably the amount will be from about 0.5% to about 5% by weight and
most preferably from about 1.0% to about 2.5%.” (Id. at ¶16.)
FF6 Thus, Birnbrich teaches the steps of “providing a melt of at least one
polyolefin, the melt containing a fatty acid of diester of polyethylene
glycol,” and “extruding the melt to form a filament” (claim 1), as well as the
filament formed by the process (claim 12). Birnbrich also teaches a filament
comprising a mixture of polyolefin and a fatty acid diester of polyethylene
glycol, wherein the fatty acid diester comprises from 0.01% to 5.0% by
weight of the filament (claims 16 and 21).
FF7 The Examiner rejects claims 1, 9, 12, 16, 17, and 21 under 35 U.S.C.
§ 102(b) as being anticipated by Everhart (Ans. 4).
FF8 According to the Examiner, Everhart teaches “a fiber made out of
polypropylene and a fatty acid diester of PEG.” (Id.)
FF9 Everhart discloses a fiber formed from a polyolefin with a fatty acid
diester (col. 1, ll. 53-68). Everhart teaches that any polyolefin that can be
fiberized may be used, including polypropylene (col. 2, ll. 54-60). Everhart
also discloses an example wherein 1% of a dioleate ester of polyethylene
oxide is added to a polypropylene fiber (col. 4, Example 1).
FF10 Thus, Everhart teaches the steps of “providing a melt of at least one
polyolefin, the melt containing a fatty acid diester of polyethylene glycol,”
and “extruding the melt to form a filament” (claim 1), as well as the filament
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formed by the process (claim 12). Everhart also teaches a filament
comprising a mixture of polyolefin and a fatty acid diester of polyethylene
glycol, wherein the fatty acid diester comprises from 0.01% to 5.0% by
weight of the filament (claims 16 and 21).
FF11 The Examiner rejects claims 21-23 under 35 U.S.C. § 102(b) as being
anticipated by Kojima (Ans. 3).
FF12 According to the Examiner, Kojima teaches “a fiber (which could be
used as a suture) including a polypropylene fiber and PEG distearate.” (Id.)
FF13 Specifically, Kojima teaches:
A low-temperature adhesive fiber, characterized in that a
textile oil in an amount of 0.1-2.0% by weight per fiber, which
comprises the following surfactant composition of 5-15% by
weight of the following component (A), 5-45% by weight of the
following component (B) and 40-90% by weight of the
following component (C), is applied to a conjugate fiber of
polyolefins having a core component of polypropylene and a
sheath component of a bipolymer or terpolymer of olefins
mainly containing propylene.
(A) at least one alkali metal alkyl sulfonate,
(B) at least one compound selected from polyol esters and fatty
acid alkanol amides,
(C) at least one compound selected from dibasic acid esters and
polyethylene glycol esters.

(col. 2, ll. 24-37.)
FF14 Kojima specifically exemplifies the use of PEG distearate as
component C (col. 8, Table 1).
FF15 The textile oil is in an amount of 0.1 to 2.0% weight per fiber, and the
textile oil may be from 40% to 90% of the textile oil. Thus, component C,
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such as PEG distearate, may comprise .04% (40% of 0.1%) to 1.8% (90% of
2.0%) of the fiber.
FF16 Thus, Kojima teaches a filament comprising a polyolefin and a fatty
acid diester of polyethylene glycol, wherein the fatty acid diester of
polyethylene glycol comprises from 0.01% to 5.0% by weight of the
filament (claim 21).

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “When
the claimed compositions are not novel they are not rendered patentable by
recitation of properties, whether or not these properties are shown or
suggested in the prior art.” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990).
Moreover, anticipation has been found even when a prior art range
“does not exactly correspond to [the] claimed range,” but the prior art “range
entirely encompasses, and does not significantly deviate from, [the] claimed
ranges.” See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed.
Cir. 2005) (court found that a claimed range of 0.025 to 5% did not
significantly deviate from a prior art range of 0.01 to 20%).
As to claim construction, our mandate is to give claims their broadest
reasonable interpretation. In re American Academy Of Science Tech Center,
367 F.3d 1359, 1364 (Fed. Cir. 2004). “An essential purpose of patent
examination is to fashion claims that are precise, clear, correct, and
unambiguous. Only in this way can uncertainties of claim scope be
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removed, as much as possible, during the administrative process.” In re
Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
With regard to a claim preamble,
[i]f the claim preamble, when read in the context of the entire
claim, recites limitations of the claim, or, if the claim preamble
is “necessary to give life, meaning, and vitality” to the claim,
then the claim preamble should be construed as if in the balance
of the claim. . . . If, however, the body of the claim fully and
intrinsically sets forth the complete invention, including all of
its limitations, and the preamble offers no distinct definition of
any of the claimed invention’s limitations, but rather merely
states, for example, the purpose or intended use of the
invention, then the preamble is of no significance to claim
construction because it cannot be said to constitute or explain a
claim limitation.

Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999).

ANALYSIS
Claim 1 is drawn to “[a] method for fabricating a polyolefin suture
comprising: a) providing a melt of at least one polyolefin, the melt
containing a fatty acid diester of polyethylene glycol; and b) extruding the
melt to form a filament.” The recitation of “[a] method for fabricating a
polyolefin suture” in the preamble is merely a recitation of the intended use
of the fiber fabricated by the method, as it does not impart additional process
steps to the method, nor does it impart any additional structure to the fiber
formed. Similarly, the recitation of “suture” in claims 16, 21, 22, and 23, is
also a statement of the intended use of the claimed filament, as no structure
is imparted to the filament by the recitation of “suture” in the preamble.
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(See also Ans. 9) As noted by the Examiner, “[i]f someone took a fishing
line and used it to sew up a wound in an emergency, it would in essence be a
suture at that point. The structure has not changed.” (Id.)
Appellants argue that Birnbrich does not discuss sutures, nor does the
reference discuss methods for fabricating sutures (App. Br. 11). As to
claims 16, 17, 19, and 21, Appellants argue that Birnbrich does not disclose
a filament “wherein the fatty acid diester comprises from 0.01% to 5.0% by
weight of the filament.” (Id.)
As noted above, the fact that Birnbrich does not discuss sutures or
methods for their fabrication is not relevant to the anticipation analysis, as
the recitation of suture by independent claims 1, 16, and 21 is merely a
statement of intended use, and not a patentable limitation. As Appellants do
not argue claims 9 and 12 separately from claim 1, those claims stand or fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). Thus, the rejection is affirmed as
to claims 1, 9, and 12. Note that this same analysis is applicable to the
anticipation rejections over Everhart and Kojima.
As to claims 16, 17, 19, and 21, Birnbrich teaches that the amount of
the additive required to increase the hydrophilicity of a polymer will be from
about 0.5% to about 10% by weight of the polymer, preferably the amount
will be from about 0.5% to about 5% by weight, and most preferably from
about 1.0% to about 2.5%. Thus, Birnbrich teaches the required amount of
the fatty acid diester, and the rejection is also affirmed as to claims 16, 17,
19, and 21.
As to the rejection over Everhart Appellants assert, Everhart does not
discuss adding “a fray reducing amount of a fatty acid diester of
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polyethylene glycol.” (App. Br. 9.) As to claim 9, Appellants argue that
Everhart does not disclose using polypropylene as the polyolefin (id.). As to
claims 16, 17, and 21, Appellants argue further that Everhart does not
disclose a filament “wherein the fatty acid diester includes from 0.01% to
5.0% by weight of the filament.” (Id.)
Everhart discloses an example wherein 1% of a dioleate ester of
polyethylene oxide is added to a polypropylene fiber (FF9). That amount of
a fatty acid diester of polyethylene glycol falls within the range of a fatty
acid diester of polyethylene glycol encompassed by the claims of 0.01% to
5.0% by weight (see claims 3, 16, and 21). Thus, the amount added by
Everhart would inherently be a fray reducing amount, and the rejection is
affirmed as to claims 1, 9, and 12. In addition, as 1.0% falls within the
claimed range of 0.01% to 5.0%, the rejection is also affirmed as to claims
16, 17, and 21.
As to Kojima, Appellants argue that in the fiber of Kojima there is no
mention of incorporating the textile oil in the fiber itself. (App. Br. 8.)
Appellants argue further that Kojima does not mention adding the fatty acid
diesters of polyethylene glycol in a fray reducing amount, nor does the
reference mention the amounts added (id.).
Claims 21-23 are drawn to “[a] suture comprising: a filament
comprising a polyolefin and a fray reducing amount of a fatty acid diester of
polyethylene glycol, wherein the fatty acid diester comprises from 0.01% to
5.0% by weight of the filament,” with claims 22 and 23 specifying that the
fatty acid diester comprises “0.2% to 0.4%” of the filament. There is
nothing in the claim specifying that the polyolefin and the fatty acid diester
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of polyethylene glycol are mixed, as is required by claim 16. Thus, claims
21-23 encompass filaments where the fatty acid diester of polyethylene
glycol is used as a coating of the polyolefin filament. Moreover, Kojima
teaches that the fatty acid diester of polyethylene glycol, such as PEG
distearate, may comprise .04% to 1.8% of the fiber (FF15), and thus Kojima
anticipates the claimed ranges of fatty acid diester of polyethylene glycol of
claims 21-23. The rejection of claims 21-23 as being anticipated by Kojima
is affirmed.

CONCLUSIONS OF LAW
Thus: 1) Appellants have not demonstrated that the Examiner erred
in rejecting the claims over references that do not specifically teach sutures
and methods of making the sutures; 2) Appellants have not demonstrated
that the Examiner erred in rejecting the claims over Everhart because
Everhart does not disclose adding a fray reducing amount of the fatty acid
diester of polyethylene glycol; and 3) Appellants have not demonstrated that
the Examiner erred in rejecting the claims over Kojima even though Kojima
does not incorporate the fatty acid diester of polyethylene glycol into the
fiber itself.

ISSUE (Obviousness)
The Examiner concludes that the claims are obvious within the
meaning of section 103.
Appellants contend that the Examiner has engaged in impermissible
hindsight in arriving at the obviousness rejections on appeal.
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Thus, the issue on Appeal is: Have Appellants shown that the
Examiner engaged in impermissible hindsight in combining the references in
the obviousness rejections on appeal?

FINDINGS OF FACT
FF17 The Examiner rejects claims 1-8, 12, 16, 17, and 21-23 under 35
U.S.C. § 103(a) as being obvious over the combination of Mattei and Ruter
(Ans. 5).
FF18 Mattei is cited by the Examiner for teaching “a suture of polyolefin
and a coating of PEG distearate.” (Ans. 5.)
FF19 Specifically, Mattei discloses that the “tie-down properties of
multifilament surgical sutures are improved by coating the suture with an
absorbable composition.” (Mattei, abstract.) The coating is added to the
suture to provide a final add-on of 2 to 10% by weight of the suture, and it is
“useful for improving the dry and wet tie-down smoothness of braided
sutures.” (Id. at col. 2, ll. 57-68.)
FF20 Mattei teaches the use of the coating on absorbable multifilament
braided sutures; but the reference also teaches that non-absorbable sutures,
such as those made from polyolefins, may be used (col. 8, ll. 35-50). In
addition, Mattei specifically exemplifies the use of polyethylene glycol
distearate as the coating material (col. 8, Sample 8 of the Table).
FF21 The Examiner notes that Mattei does not disclose forming the suture
by providing a melt of the polyolefin and the diester (Ans. 5).
FF22 Ruter is cited by the Examiner for teaching “that it was known that
providing a coating on a fiber tended to wear off and that adding the coating
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material to the melt before the fiber is produced provides a fiber having the
coating material throughout the fiber thus preventing the undesirable
wearing off of the coating material.” (Id.)
FF23 Specifically, Ruter teaches that “polyolefin products have a strong
tendency to attract dust,” but that the surface may be “coated with a
composition which reduces electrostatic charging.” (Ruter, col. 1, ll. 11-18.)
Ruter teaches that a “more prolonged effect is attained by incorporating the
antistatic additive into the polymeric material.” (Id. at col. 1, ll. 21-24.)
FF24 Thus, Ruter provides evidence that it was known in the art that a
coating could be incorporated into a polyolefin fiber while still retaining the
same properties it had a coating, as well as providing a more prolonged
effect.
FF25 The Examiner concludes that it “would have been obvious for Mattei
to have added the PEG distearate to the melt before forming the fiber as it
would allow for the PEG distearate to be incorporated throughout the suture
thus assuring it would not wear off.” (Ans. 5.)
FF26 The Examiner concludes further that it would have been obvious to
use the materials in the claimed ratios and weights as “‘it is not inventive to
discover the optimum or workable ranges by routine experimentation.’”
(Ans. 5 (quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955).)
FF27 The Examiner rejects claims 9-11 and 19 under 35 U.S.C. § 103(a)
over the combination of Mattei and Ruter as further combined with
Chesterfield (Ans. 6).
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FF28 The combination of Mattei and Ruter is relied upon as above. The
Examiner notes that the combination does not specifically teach using
polypropylene as the polyolefin (id.).
FF29 Chesterfield is relied upon for teaching that “it was known to make
sutures out of polypropylene.” (Id.)
FF30 The Examiner concludes that it “would have been obvious to have
used polypropylene as the generic ‘polyolefin’ of Mattei, as it provides the
necessary requisite characteristics that sutures need as evidenced by
Chesterfield.” (Id.)
FF31 The Examiner rejects claim 20 under 35 U.S.C. § 103(a) as being
obvious over the combination of Mattei and Ruter as further combined with
Singerman (Ans. 7).
FF32 The combination of Mattei and Ruter is relied upon as above. The
Examiner notes that the combination does not specifically teach the suture in
combination with a needle, as well as sterilizing the suture (id.).
FF33 Singerman is cited for teaching “that it was known to attach a suture
to a needle and to sterilize the suture.” (Id.)
FF34 The Examiner concludes that it “would have been obvious to have
sterilized the suture of Mattei and Ruter, and attach[ ] it to a needle, as this
would ensure the use of a clean suture thus preventing contamination while
threading the suture through tissue with the needle.” (Id.)
FF35 The Examiner rejects claims 2-5, 19, 22, and 23 under 35 U.S.C.
§ 103(a) over the combination of Birnbrich and Kojima (Ans. 7).
FF36 Birnbrich is relied upon as above.
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FF37 The Examiner notes that Birnbrich does not teach the use of PEG
distearate as the diester (id.).
FF38 The Examiner relies of Kojima for disclosing the use of PEG
distearate on a polypropylene fiber (id.).
FF39 Specifically, Kojima teaches a conjugate fiber having high strength
and soft feel (Kojima, col. 2, ll. 15-19).
FF40 The Examiner concludes that it “would have been obvious to have
added PEG distearate to the fiber of Birnbrich, as this material provides the
fiber with a soft feel yet high strength.” (Ans. 7.)
FF41 The Examiner rejects claims 6-8 and 10 under 35 U.S.C. § 103(a)
over the combination of Birnbrich and Ruter (id.).
FF42 Birnbrich is relied upon as above.
FF43 The Examiner notes that Birnbrich fails to disclose the mixing method
(id.).
FF44 Ruter is cited for disclosing “the claimed manner of mixing the
components of the melt.” (Id. at 8.)
FF45 The Examiner concludes that it “would have been obvious to have
formed the melt for the fibers in a manner taught by Ruter, as this would
merely be a known alternative for forming a homogenous mixture.” (Id.)
FF46 The Examiner rejects claim 11 over the combination of Birnbrich and
Yokohama (id.).
FF47 Birnbrich is relied upon as above.
FF48 The Examiner notes that Birnbrich fails to disclose the claimed melt
flow index (id.).
FF49 Yokohama is cited for disclosing “the claimed melt flow index.” (Id.)
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FF50 The Examiner concludes that it “would have been obvious to have
used a melt flow index such as that taught by Yokohama, as this would
facilitate the manufacturing of the fiber.” (Id.)
FF51 Claims 2-5, 19, 22, and 23 stand rejected under 35 U.S.C. § 103(a) as
being obvious over the combination of Everhart and Kojima (id.).
FF52 Everhart is relied upon as above.
FF53 The Examiner notes that Everhart fails to disclose the use of PEG
distearate as the diester (id.).
FF54 The Examiner relies of Kojima for disclosing the use of PEG
distearate on a polypropylene fiber (id.).
FF55 Specifically, Kojima teaches a conjugate fiber having high strength
and soft feel (Kojima, col. 2, ll. 15-19).
FF56 The Examiner concludes that it “would have been obvious to have
added PEG distearate to the fiber of Everhart, as this material provides the
fiber with a soft feel yet high strength.” (Ans. 8.)
FF57 The Examiner rejects claims 6-8 and 10 under 35 U.S.C. § 103(a)
over the combination of Everhart and Ruter (id.).
FF58 Everhart is relied upon as above.
FF59 The Examiner notes that Everhart fails to disclose the mixing method
(id.).
FF60 Ruter is cited for disclosing “the claimed manner of mixing the
components of the melt.” (Id. at 9.)
FF61 The Examiner concludes that it “would have been obvious to have
formed the melt for the fibers in a manner taught by Ruter, as this would
merely be a known alternative for forming a homogenous mixture.” (Id.)
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FF62 The Examiner rejects claim 11 over the combination of Everhart and
Yokohama (id.).
FF63 Everhart is relied upon as above.
FF64 The Examiner notes that Everhart fails to disclose the claimed melt
flow index (id.).
FF65 Yokohama is cited for disclosing “the claimed melt flow index.” (Id.)
FF66 The Examiner concludes that it “would have been obvious to have
used a melt flow index such as that taught by Yokohama, as this would
facilitate the manufacturing of the fiber.” (Id.)

PRINCIPLES OF LAW
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). “The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” Id. at 1739. An “[e]xpress
suggestion to substitute one equivalent for another need not be present to
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render such substitution obvious.” In re Fout, 675 F.2d 297, 301 (CCPA
1982).
Moreover, determining the optimum values of result effective
variables is ordinarily within the skill of the art. In re Boesch, 617 F.2d 272,
276 (CCPA 1980); see also In re Aller, 220 F.2d 454, 456 (CCPA 1955)
(“[W]here the general conditions of a claim are disclosed in the prior art, it is
not inventive to discover the optimum or workable ranges by routine
experimentation.”).

ANALYSIS
As to the rejection of claim 1, the suture of claim 12, and the claims
dependent thereon over the combination of Mattei and Ruter, Appellants
argue that Mattei does not “disclose or suggest a suture formed from a melt
of polyolefin and diester . . . with a fray reducing amount of a fatty acid
diester of polyethylene glycol,” and thus “Mattei fails to render any of the
pending claims obvious.” (App. Br. 12.) Ruter, Appellants argue, is drawn
to “antistatic compositions and the use thereof with polyolefinic articles to
reduce electrostatic charging and the attraction of dust to the polyolefinic
article,” and thus fails to remedy the deficiencies of Mattei. (Id. at 13.)
Appellants thus assert that the Examiner engaged in impermissible hindsight
to arrive at the claimed invention. (Id. at 13.)
We acknowledge that neither Mattei nor Ruter disclose a suture
formed from a melt of a polyolefin and a diester—if either reference had it
would have been more properly applied under § 102 rather than § 103. As
noted by the Examiner, however, Mattei suggests a suture comprising a
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polyolefin and polyethylene glycol distearate, a fatty acid diester of
polyethylene glycol (FF20), and Ruter supports the proposition that the
ordinary artisan was aware that a coating material could be incorporated into
a fiber and still retain the useful properties it had as a coating, and also have
a more prolonged effect (FF24). Thus, we agree with the Examiner that in
view of the teachings of Ruter it would have been obvious to one of ordinary
skill at the time of the invention to incorporate the polyethylene glycol
distearate coating into the polyolefin of suture to provide a more prolonged
effect.
In addition, we disagree that the Examiner engaged in
impermissible hindsight. As noted by the United States Supreme
Court:
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

KSR, 127 S. Ct. at 1740. Ruter provides evidence that it was known in the
art that coatings of polyolefins could be incorporated into the polyolefin
itself, and still retains its desirable property, while having a more prolonged
effect (FF24), and Appellants have not provided any evidence that it would
have beyond the skill of the ordinary artisan.1

1 In that regard we reference both Everhart and Birnbrich, both of which
demonstrate that polyolefinic filaments formed from a melt of a polyolefin
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Thus, we conclude that Appellants have not rebutted the prima facie
case of obviousness, and we affirm the rejection as to claims 1 and 12. As
Appellants do not argue claims 2-8 separately, the rejection is affirmed as to
those claims as well. 37 C.F.R. § 41.37(c)(1)(vii).
As to claims 16, 17, and 21-23, Appellants argue that the combination
of Mattei and Ruter do not teach the amount of the fatty acid diester of
polyethylene glycol as required by these claims. (App. Br. 14.)
We disagree. Mattei teaches that the coating, such as polyethylene
glycol distearate, is present as a final add-on of 2 to 10% by weight of the
suture (FF19). In addition, Mattei teaches that the coating is used to
improve the tie-down properties of the suture (id.). Thus, we agree with the
Examiner that it would have been obvious to optimize the amounts of
polyethylene glycol distearate when added to the polyolefin melt as taught
by the combination of Mattei and Ruter to obtain the best tie-down
properties. Appellants have not provided any evidence demonstrating that
the amounts would be different for that property than for the purpose of
fraying (note that fraying would also affect the tie-down properties of the
suture). Thus, we also affirm the rejection as to claims 16, 17, and 21-23.
Therefore, the rejection of claims 1-8, 12, 16, 17, and 21-23 over the
combination of Mattei and Ruter is affirmed.
Appellants argue that neither Chesterfield nor Singerman remedy the
deficiencies of the combination of Mattei and Ruter (App. Br. 15-18). We
point Appellants’ attention to the response to the analysis of the rejection of
and a fatty acid diester of polyethylene glycol were known in the art (FF6
and FF10).
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Mattei and Ruter, and thus affirm the rejection of claims 9-11 and 19 over
the combination of Mattei and Ruter as further combined with Chesterfield;
as well as the rejection of claim 20 over the combination of Mattei and Ruter
as further combined with Singerman.
As to claims 2-5, 19, 22, and 23 over the combination or Birnbrich in
view of Kojima, Appellants argue that Birnbrich does not disclose or suggest
methods of making the claimed polyolefin suture, and that Kojima fails to
remedy the deficiencies of Birnbrich (App. Br. 19). Thus, Appellants again
assert that the Examiner has engaged in impermissible hindsight in
combining the references to arrive at the claimed invention (id. at 20). As to
the rejection of claims 19, 22, and 23, Appellants argue that “Birnbrich does
not disclose polyethylene glycol distearate.” (Id.).
As to the combination of Everhart and Kojima, Appellants argue that
Kojima fails to remedy the deficiencies of Everhart, and that the Examiner
engaged in impermissible hindsight in combining the references (App. Br.
23-24). As to the rejection of claims 19, 22, and 23, Appellants argue that
the combination does not teach or suggest the claimed amounts of fatty acid
diester of polyethylene glycol (id. at 24).
Appellants’ arguments are not convincing. As discussed above with
respect to the anticipation rejection, the fact that Birnbrich and Everhart fail
to disclose a suture is not relevant, as the recitation of a suture is merely
intended use, and not a patentable limitation. Moreover, we conclude that
the ordinary artisan would have been motivated to combine Birnbrich or
Everhart with Kojima for the reasons set forth by the Examiner (see the
analysis as to the combination of Mattei and Ruter).
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As to Appellants’ argument that Birnbrich does not disclose
polyethylene glycol distearate, Kojima was relied upon to supply that
limitation. As to Appellants’ argument that the combination does not teach
or suggest the claimed amounts of fatty acid diester of polyethylene glycol;
as noted above, Birnbrich teaches a filament comprising a mixture of
polyolefin and a fatty acid diester of polyethylene glycol, wherein the fatty
acid diester comprises from 0.01% to 5.0% by weight of the filament, and
thus does teach the claimed amounts of fatty acid diester of polyethylene
glycol.
Thus, the rejection of claims 2-5, 19, 22, and 23 under 35 U.S.C.
§ 103(a) over the combination of Birnbrich and Kojima, and the rejection of
claims 2-5, 19, 22, and 23 over the combination of Everhart and Kojima, are
affirmed.
As to the combination of Birnbrich and Ruter or Yokohama,
Appellants argue that both Ruter and Yokohama fail to remedy the
deficiencies of Birnbrich, and that the Examiner engaged in impermissible
hindsight in combining the references (App. Br. 21-23). As to the
combination of Everhart and Ruter and the combination of Everhart and
Yokohama, Appellants argue that both Ruter and Yokohama fail to remedy
the deficiencies of Everhart, and that the Examiner engaged in impermissible
hindsight in combining the references (App. Br. 25-27).
These arguments are not found to be convincing for the reasons set
forth above. Thus, we affirm the rejection of claims 6-8 and 10 under 35
U.S.C. § 103(a) over the combination of Birnbrich and Ruter; the rejection
of claim 11 over the combination of Birnbrich and Yokohama; the rejection
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of claims 6-8 and 10 under 35 U.S.C. § 103(a) over the combination of
Everhart and Ruter; and the rejection of claim 11 over the combination of
Everhart and Yokohama.

CONCLUSIONS OF LAW
We conclude that Appellants have not shown that the Examiner
engaged in impermissible hindsight in combining the references in the
obviousness rejections on appeal, and we affirm all of the obviousness
rejections on appeal.

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

CONCLUSION
All of the rejections on appeal are affirmed.

AFFIRMED

cdc
Mark Farber
c/o Tyco Healthcare Group LP
150 Glover Avenue
Norwalk CT 06856
23