Ex Parte Furst et al

Patent Trial and Appeal Board

May 13, 2016

11368298 (P.T.A.B. May. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/368,298 0310312006
27885 7590
FAY SHARPE LLP
1228 Euclid Avenue, 5th Floor
The Halle Building
Cleveland, OH 44115
05/16/2016
FIRST NAMED INVENTOR
Joseph G. Furst
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.
ICON 200034US01 6336
EXAMINER
ZISKA, SUZANNE E
ART UNIT PAPER NUMBER
1619
MAILDATE DELIVERY MODE
05/16/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH G. FURST and RAYMOND W. BUCKMAN JR. 1
Appeal2013-003180
Application 11/368,298
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
uECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device comprising a bioabsorbable metal alloy. The Examiner rejects the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is ICON Medical Corp.
(App. Br. 1.)
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Application 11/368,298
STATEMENT OF THE CASE
The Specification explains that bioabsorbable medical devices, such
as stents, have the following advantage.
By at least partially removing the stent from the body
passageway, potential problems with thrombosis, in-stent
restenosis, vascular narrowing and/or restenosis in the body
passageway in and/or around at the treatment location of the
stent is reduced or eliminated. Such removal or partial removal
of the stent from the body passageway also can result in the
complete or partial removal of a potential obstruction in the
body passageway for potentially future procedures in the body
passageway.
(Spec. 3.)
Claims 45-51 and 53-94 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 45 is representative of the
claims on appeal, and reads as follows:
45. A medical device that is at least partially formed of a
bioabsorbable metal alloy which is formulated to at least
degrade, at least partially dissolve or be at least partially
absorbed in the body of a patient, at least 99 weight percent of
said metal alloy formed of magnesium[,]2 rare earth metal and
one or more metals selected from the group consisting of
calcium, yttrium, zinc and zirconium, said metal alloy including
only one of zinc or calcium, said magnesium constitutes at least
90 weight percent of said metal alloy, said zinc content when
included in said metal alloy is 0.1--4 weight percent of said
metal alloy, said calcium content when included in said metal
alloy is 0.1-1 weight percent of said metal alloy, said rare earth
content is up to 2.5 weight percent of said metal alloy.
2 We note that in order to be consistent with the dependent claims there
should be a comma between magnesium and rare earth metals in claim 45,
as the dependent claims make clear that the rare earth metal component is
separate from the magnesium component.
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Application 11/368,298
The following grounds of rejection are before us for review:
I. claims 45-51, 53, 54, 63-81, and 87-94 under 35 U.S.C.
§ 103(a) as unpatentable over Heublein,3 in view of Bronfin,4 Harder,5
and Lyon6; and
II. claims 55---62 and 82-86 under 35 U.S.C. § 103(a) as
unpatentable over Heublein, in view ofBronfin, Harder, Lyon, Allen,7
and Regar. 8
I. Obviousness over Heublein, Bronfzn, Harder, and Lyon
The issue is: Does the preponderance of the evidence of record
support the Examiner's conclusion that the combination of references
teaches the claimed medical device having the claimed metal composition?
Findings of Fact
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (see Final Act. 7-11; Ans. 3-7, 9-17). For
emphasis only we highlight the following:
FPL Heublein teaches that "[a]dvantageous decomposition times have
furthermore been afforded by materials with magnesium as main
constituent and either 0-40% lithium, 0-5% iron and less than 5%
other metals or rare earths." (Heublein i-fi-f 15-16; Ans. 3 ("in one
3 Heublein et al., US 2002/0004060 Al, issued Jan. 10, 2002 ("Heublein").
4 Bronfin et al., US 6,767,506 B2, issued July 27, 2004 ("Bronfin").
5 Harder et al., US 2006/0246107 Al, published Nov. 2, 2006 ("Harder").
6 Lyon et al., US 2006/0228249 Al, published Oct. 12, 2006 ("Lyon").
7 Allen et al., US 6,334,856 Bl, issued Jan. 1, 2002 ("Allen").
8 Regar et al., Stent development and local drug delivery, 59 British Medical
Bulletin 227--48 (2001) ("Regar").
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Application 11/368,298
embodiment Heublein discloses the magnesium alloy without lithium
without iron and containing 5% other metals or rare earths").)
FF2. Heublein teaches a "[ m ]edical implant made of a metallic material,
characterized in that the material is degradable in vivo through
corrosion" and that the "material contains as subsidiary constituents
one or more elements from the group comprising the following: Mn,
... Zr, ... Ca, ... Zn." (Heublein claims 1 and 6; see also Ans. 3.)
FF3. Heublein teaches that "[t]he biological, mechanical and chemical
properties of the materials can be beneficially affected if a subsidiary
constituent is provided in the form of manganese, ... zirconium, ...
calcium, ... zinc." (Heublein i-f 14.)
FF4. Bronfin teaches
It has now been found that certain combinations of elements in
magnesium-based alloys, comprising neodymium, yttrium,
zirconium, zinc, and calcium confer on the alloys superior
properties. These properties include good castability, excellent
creep and corrosion resistance combined with high tensile and
compressive yield strength at ambient and elevated
temperatures 200° C. and 250° C.
(Bronfin col. 3, 11. 54---60; see Ans. 4.)
FF5. Harder teaches the production of implants that at least in some region
contain elements yttrium, neodymium or zirconium. (Harder i-f 1.)
Specifically, "the use of one or more of the elements from the group
yttrium (Y), neodymium (Nd) or zirconium (Zr) for the production of
a pharmaceutical formulation for inhibiting the proliferation of human
smooth muscle cells." (Harder i-f 21; see Ans. 4.) "The elements
yttrium, neodymium and/or zirconium are thus suitable in particular
for restenosis prophylaxis after stent implantation." (Harder i-f 22.)
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FF6. Lyon teaches that
commercial magnesium zirconium alloy RZ5 (equivalent to
ZE41) which contains 4% by weight zinc, 1 % by weight RE
[rare earth] and 0.6% by weight zirconium, it was found that the
preferred alloys of the present invention showed a much lower
tendency to suffer from oxide-related defects. Such reduced
oxidation is normally associated in magnesium alloys with the
presence of beryllium or calcium.
(Lyon i-f 46; see Ans. 4.) Lyon teaches that "[t]he presence of zinc in the
present alloys contributes to their good age hardening behaviour, and a
particularly preferred amount of zinc is 0.2 to 0.6% by weight, more
preferably about 0.4% by weight." (Lyon i-f 31; see Ans. 4.)
Principle of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 7-11; FF 1-FF6) and agree that
the claims are rendered obvious by Heublein, Bronfin, Harder, and Lyon
(see Final Act. 7-11; Ans. 3-7, 9-1 7). We address Appellants' arguments
below.
"Appellant acknowledged that Heublein discloses several metal alloys
that can be biodegradable." (App. Br. 15.) However, Appellants contend
that "[t]he alloys disclosed in Heublein have a different composition from
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Application 11/368,298
the alloys defined in the claims on Appeal. ... [and] Heublein does not
disclose, teach or suggest the calcium and zinc limitations." (App. Br. 15.)
We are not persuaded. Heublein teaches that up to 5% of the
composition can be "other metals or rare earth metals" (FF 1) and teaches
that not only chemical but also mechanical properties are affected by the
addition of other subsidiary constituents (see FF2 and FF3). As noted by the
Examiner "the rejection is an obviousness rejection, not anticipation and
therefore the cited prior art (ie [sic] Heublein) is not required to teach all
possible biodegradable metal alloys." (Ans. 10.) Additionally, as pointed
out by the Examiner "Heublein not only discloses that magnesium is a
preferred ... main constituent but also discloses that other metals can
beneficially affect the biological[,] mechanical and chemical properties of
the medical implant materials." (Ans. 10, see also 11; FF1-FF3.)
"Heublein[,therefore,] explicitly discloses the advantages to the presence of
zinc, zirconium and calcium and thus teaches addition of zinc, zirconium
and calcium [to the magnesium containing composition] will be successful."
(Ans. 10.)
Appellants contend that "[a] corrosion resistant metal alloy [as taught
in Bronfin] is contrary to a biodegradable alloy." (App. Br. 16; see Reply
Br. 2.) "Lyon [similarly] teaches that the inclusion of zinc in magnesium
alloys reduces oxidation." (App. Br. 17; see Reply Br. 2 and 4.)
Additionally, Appellants contend that the Examiner has not "explained why
one skilled in the art would use any teachings regarding a non-biodegradable
alloy when attempting to create a biodegradable alloy." (Reply Br. 2.)
We are not persuaded. The Examiner relies on the combined
teachings to arrive at the conclusion that the combination discloses not only
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the major magnesium component but that the references recognize that the
manipulation of the subsidiary components, are shown to affect properties
that are known to be important for stent production (see FFl, FF3, FF4,
FF6). Specifically, the Examiner finds that
combinations of elements in magnesium based alloys
comprising neodymium, yttrium, zirconium, zinc and calcium
confer superior properties on alloys which include good
castability, excellent creep and corrosion resistance combine
with high tensile strength . . . . Castability (good flow of melted
alloy into thin mold sections, low sticking of the melted alloy to
the mold, resistance to oxidation during the casting process,
lack of cracking during cooling and solidifying stages of
casting; ... ) and tensile strength are properties germane to
stents and other medical device, lacking evidence to the
contrary.
(Ans. 4, see also 5-7, 11-14 (each citing to the importance of good
castability and tensile strength). Here, the Examiner has identified
properties such as castability and tensile strength of the metal as a reason to
modify the taught compositions.
The law does not require that the teachings of the reference be
combined for the reason or advantage contemplated by the inventor, as long
as some suggestion to combine the elements is provided by the prior art as a
whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976). Furthermore, the Examiner explains
that "[t]he allegedly 'adverse teachings' as evidenced by the 'corrosion
resistance' and other properties are not adverse at all but in fact controllable
by the choice of [the] combination of elements as disclosed by Heublein and
Bronfin." (Ans. 14.)
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Appellants contend that the Examiner's rejection is based on
hindsight. (Reply Br. 1.)
We are not persuaded. While we are fully aware that hindsight bias
often plagues determinations of obviousness, Graham v. John Deere Co.,
383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has
clearly stated that the "combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR, 550 U.S. at 416.
The Examiner explains that
Heublein discloses many combinations of alloys can be
"successful" as noted by the beneficial affects achieved by the
addition of one or more elements such as zinc, calcium and
zirconium . . . . Heublein again provides a reasonable
expectation of success . . . . [that, t ]he alloy material can
therefore be selected depending on the case for which it is used.
(Ans. 11; see also FF3.) One of the Examiner's identified reason for
combining references is that when making stents and other medical devices
that metal properties such as "[c]astability ... and tensile strength are
properties germane to stents and other medical device." (Ans. 4, see also 5,
6, 7, 11, 12, 13, 14.) Here, the Examiner has identified properties such as
castability and tensile strength of the metal as a reason to modify the
composition of the references. See In re Beattie, 974 F.2d at 1312.
Accordingly, we are not persuaded by Appellants contention that the
Examiner used hindsight in making the rejection. Appellants have not
identified what critical information could only be gleaned from the
Specification that was necessary for the Examiner to reach the conclusion of
obviousness.
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On the record before us, we conclude the Examiner did not err in
rejecting claim 45 under 35 U.S.C. § 103(a) as being unpatentable over the
combination of Heublein, Bronfin, Harder, and Lyon. As claims 46-51, 53,
54, 63-81, and 87-94 have not been argued separately, they fall with claim
45. 37 C.F.R. § 41.37(c)(l)(iv).
II. Obviousness over Heublein, Bronfin, Harder, Lyon, Allen, and Regar
The Examiner has rejected claims 55---62 and 82-86 as obvious based
on the combination of Heublein, Bronfin, Harder, Lyon, Allen, and Regar
(Ans. 2-7). Appellants' only argument with respect to this rejection is that
dependent claims 55---62 and 82-86 directly or ultimately depend from
independent claims 45 and 66. For the same reasons discussed for
independent claims 45 and 66 Appellants contend that these dependent
claims are also allowable (App. Br. 19). This argument is not persuasive
because, as discussed above (J. ), we conclude that the combination of
Heublein, Bronfin, Harder, and Lyon would have made obvious the claimed
medical device containing the recited bioabsorbable alloy. We affirm the
rejection of claims 55---62 and 82-86 for the reasons given by the Examiner.
(See Ans. 7-9, and Response to Argument Ans. 9-17.)
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SUMMARY
We affirm the rejection of the claims under 35 U.S.C. § 103(a) over
Heublein, Bronfin, Harder, and Lyon. Claims 45-51, 53, 54, 63-81, and
87-94 we not separately argued and fall with claim 45.
We affirm the rejection of claims 55---62 and 82-86 under 35 U.S.C.
§ 103(a) over Heublein, Bronfin, Harder, Lyon, Allen, and Regar.
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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