Ex parte Whalen II

UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte THOMAS J. WHALEN II, CHINH N. TRAN, NOAH M. ROTH,
and RICHARD J. GREFF
__________
Appeal 2007-4423
Application 10/281,142
Technology Center 1600
__________
Decided: July 23, 2008
__________
Before MICHAEL R. FLEMING, Chief Administrative Patent Judge, and
SALLY G. LANE, ERIC GRIMES, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition for embolizing an aneurysm, which the Examiner has rejected
for anticipation, obviousness, and obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.

Appeal 2007-4423
Application 10/281,142
STATEMENT OF THE CASE
The Specification states that “[e]mbolizing compositions (embolic
compositions) heretofore disclosed in the art include those comprising a
biocompatible polymer, a biocompatible solvent and a contrast agent which
allowed visualization of the in vivo delivery of the composition” (Spec. 3).
“Such compositions typically contain no more than about 8 weight percent
of biocompatible polymer based on the weight of the total composition”
(id.).
The Specification states that prior art embolic compositions had the
drawback that “upon ejection of the embolic composition in a vascular site,
the coherent mass subsequently formed was often distal and not proximate
the ejection port of the catheter. Moreover, upon solidification, the solid
mass formed was often linear in shape (i.e., having a ‘string shape’).” (Id.)
This property of the prior art compositions is said to lead to difficulty in site-
specific delivery of the embolic composition, and the danger that fragments
of the solidified composition will embolize an artery or “lodg[e] at undesired
locations in the vasculature” (id.).
The Specification discloses that “formation of a solid non-migratory
mass having a substantially contiguous or ‘ball’ shape can be achieved by
use of embolic compositions . . . [having] a viscosity of at least 150 cSt at
40° C” (id.).1 According to the Specification, “the viscosity of these
compositions is significantly higher than those containing 8 weight percent
polymer, thereby rendering it difficult to employ conventional delivery
1 Viscosity can be measured in units of centiStokes (cSt) or centipoise (App.
Br. 6).
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means (e.g., syringe). . . . However, delivery means such as the threaded
syringes described [in two provisional patent applications] now renders the
use of these highly viscous compositions practical.” (Id. at 4.)
Claims 1-17 are pending and on appeal. Claim 1 is representative and
reads as follows:
1. A composition capable of embolizing an aneurysm at a vascular site
comprising:
(a) 	a biocompatible polymer;
(b) 	a biocompatible contrast agent wherein a sufficient amount of
said contrast agent is employed in said composition to effect visualization in
vivo; and
(c) 	a biocompatible solvent which solubilizes said biocompatible
polymer
wherein a sufficient amount of said polymer are [sic] employed
in said composition such that, upon delivery to a vascular site, a polymer
precipitate forms which embolizes said vascular site; and
further wherein the biocompatible polymer has a molecular
weight sufficient to impart to the composition a viscosity of at least about
150 cSt at 40º C.
The components recited in claim 1 – biocompatible polymer,
biocompatible contrast agent, and biocompatible solvent – are the same as
those in known embolic compositions (Spec. 3). Thus, if claim 1 differs
from the prior art, it is by virtue of the limitation that “the biocompatible
polymer has a molecular weight sufficient to impart to the composition a
viscosity of at least about 150 cSt at 40° C.” Claim 2, the only other
independent claim on appeal, also includes this limitation.
As we interpret it, this limitation requires only that the claimed
composition have “a viscosity of at least about 150 cSt at 40° C.” Although
the claim also refers to the molecular weight of the polymer in the
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Application 10/281,142
composition, that reference does not limit the claim: If a composition
comprises the recited polymer and has the recited viscosity, then the
polymer necessarily “has a molecular weight sufficient to impart” the
resulting viscosity, at whatever concentration of polymer is present.
The Examiner has rejected the claims as follows:
• Claims 1-17 stand rejected for obviousness-type double patenting
based on claims 1-5 of Greff ‘568,2 claims 1-46 of Evans,3 claims 1-6 of
Greff ‘508,4 and claims 1-6 of Greff ‘767;5
• Claims 1-13 and 15-17 stand rejected under 35 U.S.C. § 103 as
obvious in view of Evans;
• Claims 1-17 stand rejected under 35 U.S.C. § 103 as obvious in
view of Greff ‘767; and
• Claims 1-6, 9, 10, and 14-17 stand rejected under 35 U.S.C.
§§ 102(b) or 103 as anticipated by or obvious in view of Taki.6
DOUBLE PATENTING
The Double Patenting Issue
Claims 1-17 stand rejected for obviousness-type double patenting
based on claims 1-5 of Greff ‘568, claims 1-46 of Evans, claims 1-6 of Greff
‘508, and claims 1-6 of Greff ‘767.7 The Examiner’s position is:
2 Greff et al., U.S. Patent 5,580,568, issued Dec. 3, 1996.
3 Evans et al., U.S. Patent 5,695,480, issued Dec. 9, 1997.
4 Greff et al., U.S. Patent 5,581,508, issued Dec. 22, 1998.
5 Greff et al., U.S. Patent 5,667,767, issued Sept. 16, 1997.
6 Taki et al., “A new liquid material for embolization of arteriovenous
malformations,” 11 AJNR, Amer. Journal of Neuroradiology 163 (1990).
7 In the Answer, the Examiner also rejected claims 1-17 based on claims 1-
15 of U.S. Patent 6,531,111 (Ans. 4). However, Appellants have filed a
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Appeal 2007-4423
Application 10/281,142
both the patented claims and the instant pending claims are
directed to compositions comprising a biocompatible polymer,
a biocompatible contrast agent and a biocompatible solvent.
Therefore, each set of the patented claim[s] anticipates the
scope of the pending claim[s]. Accordingly, it would have been
obvious to one of ordinary skill in the art at the time of
invention to practice the pending claims when in possession of
the patented claims. 	Thus, the pending claims are obvious
variants of the patented claims.
(Ans. 4.)
Appellants contend that “[t]here is no teaching of viscosity in any of
Claim 1-5 of the ‘568 patent” (App. Br. 11); “[t]here is no teaching, in either
the specification or the claims of [Evans], of viscosities of 150 centiStokes at
40°C” (id. at 12); “it is unclear why Claims 1-17 [sic] of [Greff ‘508] would
motivate one skilled in the art to make and use the high viscosity embolic
composition of the claims on Appeal” (id. at 13); and “for the same reasons
noted for the ‘508 patent, the rejection of Claims 1-17 . . . over Claims 1-6
of the ‘767 patent is in error” (id.).
In view of these conflicting positions, the double-patenting issue
presented is: Are the rejected claims directed to a composition that is an
obvious variant of the compositions claimed in Greff ‘568, Evans, Greff
‘508, or Greff ‘767?
Findings of Fact Relating to Double Patenting
FF1. Claim 1 of Greff ‘568 is directed to a composition comprising:
(a) from about 2.5 to about 8 weight percent of a cellulose
diacetate having an acetyl content of from about 31 to about
40 weight percent;
terminal disclaimer with respect to the ‘111 patent (terminal disclaimer
received July 19, 2004) so that basis of the rejection has been overcome.
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Application 10/281,142
(b) from about 10 to about 40 weight percent of a water
insoluble contrast agent selected from the group consisting of
tantalum, tantalum oxide and barium sulfate;
(c) 	from 	about 	52 	to 	about 	87.5 	weight 	percent 	of 	a
biocompatible solvent
wherein the weight percent of the cellulose diacetate, water
insoluble contrast agent and biocompatible solvent is based
on the total weight of the complete composition.
(Greff ‘568, col. 9, ll. 37-50.)
FF2. 	Claim 1 of Evans is directed to a composition comprising:
(a) 	from 	about 	2.5 	to 	about 	8.0 	weight 	percent 	of 	a
biocompatible polymer;
(b) from about 10 to about 40 weight percent of a water
insoluble, biocompatible contrast agent having an average
particle size of about 10 μm or less; and
(c) 	from 	about 	52 	to 	about 	87.5 	weight 	percent 	of 	a
biocompatible solvent
wherein the weight percent of the polymer, contrast agent and
biocompatible solvent is based on the total weight of the
complete composition.
(Evans, col. 11, ll. 47-58.)
FF3. Claim 1 of Greff ‘508 is directed to a composition comprising:
(a) from about 2.5 to about 8.0 weight percent of an ethylene
vinyl alcohol copolymer;
(b) from about 20 to about 40 weight percent of a water
insoluble contrast agent selected from the group consisting of
tantalum, tantalum oxide and barium sulfate;
(c) 	from 	about 	52 	to 	about 	87.5 	weight 	percent 	of 	a
biocompatible solvent
wherein the weight percent of each of the components is based
on the total weight of the complete composition.
(Greff ‘508, col. 10, ll. 7-16.)
FF4. Claim 1 of Greff ‘767 is directed to a composition comprising:
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Application 10/281,142
(a) from about 2.5 to about 8.0 weight percent of an ethylene
vinyl alcohol copolymer;
(b) from about 10 to about 40 weight percent of a water
insoluble contrast agent selected from the group consisting of
tantalum, tantalum oxide and barium sulfate;
(c) 	from 	about 	52 	to 	about 	87.5 	weight 	percent 	of 	a
biocompatible solvent
wherein the weight percent of each of the components is based
on the total weight of the complete composition.
(Greff ‘767, col. 9, ll. 37-50.)
FF5. Claims 1-5 of Greff ‘568, claims 1-46 of Evans, claims 1-6 of
Greff ‘508, and claims 1-6 of Greff ‘767 do not limit the claimed
compositions to those having a particular viscosity, and therefore encompass
compositions having the components recited in those claims, in the recited
concentrations, regardless of the viscosity of the resulting compositions.
FF6. The Examiner has not pointed to any evidence showing that any
composition encompassed by claims 1-5 of Greff ‘568, claims 1-46 of
Evans, claims 1-6 of Greff ‘508, or claims 1-6 of Greff ‘767 would
inherently have a viscosity of at least about 150 cSt at 40° C.
Discussion of the Double Patenting Issue
We conclude that the Examiner has not shown that the composition of
the claims on appeal is an obvious variant of the compositions of claims 1-5
of Greff ‘568, claims 1-46 of Evans, claims 1-6 of Greff ‘508, or claims 1-6
of Greff ‘767.
The analyses for obviousness under 35 U.S.C. § 103 and obviousness-
type double patenting are not identical; for one thing, “[t]he objects of
comparison are very different: Obviousness compares claimed subject
matter to the prior art; nonstatutory double patenting compares claims in an
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Application 10/281,142
earlier patent to claims in a later patent or application.” Geneva Pharms.,
Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378 n.1 (Fed. Cir. 2003).
The purpose of an obviousness-type double patenting rejection is “to prevent
an unjustified extension of the term of the right to exclude granted by a
patent by allowing a second patent claiming an obvious variant of the same
invention to issue to the same owner later.” In re Berg, 140 F.3d 1428, 1431
(Fed. Cir. 1998).
Here, all of the claims cited by the Examiner are limited to
compositions containing less than about 8 weight percent polymer (FF1 to
FF4). The instant Specification states that known embolic compositions
typically contained less than about 8 weight percent polymer (Spec. 3) and
that such compositions often formed undesirable “string shaped” masses
(id.).
The Examiner has not directed us to evidence sufficient to show that
any composition encompassed by the relied-upon patented claims – with less
than about 8 weight percent polymer – would have a viscosity of 150 cSt at
40° C. Therefore, the Examiner’s finding that the relied-upon patented
claims anticipate the claims on appeal is not supported by the evidence.
The Examiner has not provided any other reasoned, fact-based
explanation supported by the evidence of record to justify a conclusion that
the compositions defined by the claims on appeal are obvious variants of the
compositions of claims 1-5 of Greff ‘568, claims 1-46 of Evans, claims 1-6
of Greff ‘508, or claims 1-6 of Greff ‘767. We therefore reverse the
rejections for obviousness-type double patenting.
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REJECTIONS BASED ON THE PRIOR ART
The Obviousness and 102(b)/103 Issues
The Examiner finds that the compositions taught by Evans and Taki
“inherently possess the same viscosity” as the claimed composition because
they “comprise similar components[s] used in overlapping ranges of
concentrations as those claimed” (Ans. 5-6; see also id. at 7). Alternatively,
the Examiner concludes that the claimed compositions would have been
obvious in view of the compositions taught by Evans, Greff ‘767, and Taki
because “it would have been prima facie obvious to optimize the viscosity
range of [the known] compositions by routine experimentation” (id. at 6, 7).
Appellants argue that Evans, Greff ‘767, and Taki refer to viscosity
only in passing and when they do, they indicate that the disclosed
compositions should have a viscosity well under 150 cSt (Evans and Greff
‘767) or are of “low viscosity” (Taki) and it is “unclear why [the prior art
disclosures] would motivate one skilled in the art to make and use [a] high
viscosity embolic composition” (App. Br. 12, 13-14, 15-16).
In view of these conflicting positions, the issue presented with respect
to patentability over the cited prior art is: Do the disclosures of Evans, Greff
‘767, or Taki anticipate, or would they have rendered obvious, the claimed
compositions to those of ordinary skill in the art?
Findings of Fact Relating to the Prior Art Rejections
FF7. The Examiner finds that “Evans’ compositions have a viscosity
of less than 60 centipoise at 20° C (see col 5, lines 37-43). Accordingly,
Evans anticipates the limitations of the instant claims.” (Ans. 5.)
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FF8. The Examiner finds that “[a]lthough Evans does not specifically
recite the instantly claimed viscosity of 150 cSt at 40° C . . . , Examiner
takes the position that compositions disclosed by Evans inherently possess
the same viscosity . . . as the instantly claimed invention, because Evans’
compositions comprise similar component[s] used in overlapping ranges of
concentrations” (Ans. 5-6).
FF9. The Examiner finds that a person of ordinary skill in the art
“would have been motivated to optimize the viscosity of the Evans’ final
formulation, because he would have had a reasonable expectation of success
in achieving the safest clinical outcome and avoiding transvenous passage”
of the embolizing composition (Ans. 6).
FF10. The Examiner relies on the same reasoning in the rejections
based on Greff ‘767 and Taki (Ans. 6-8).
FF11. Evans teaches compositions comprising a biocompatible
polymer (2.5-8 wt %), a biocompatible contrast agent (10-40 wt %), and a
biocompatible solvent (52-87.5 wt %) (Evans, col. 3, ll. 32-43).
FF12. Evans teaches that one preferred composition “has a viscosity
equal to or less than 60 centipoise at 20° C” (Evans, col. 5, ll. 39-43).
FF13. According to Appellants, units of poise (or centipoise) are
related to units of Stokes (or centiStokes) according to the equation Poise =
Stokes x density (App. Br. 6).
FF14. The Examiner has not disputed that Poise = Stokes x density.
FF15. According to Appellants, “[f]or Newtonian fluids, it is well
understood that viscosity decreases as temperature increases” (App. Br. 7).
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FF16. The Examiner has not disputed that viscosity decreases as
temperature increases.
FF17. Evans discloses that “all other factors being equal, copolymers
having a lower molecular weight will impart a lower viscosity to the
composition as compared to higher molecular weight copolymers.
Accordingly, adjustment of the viscosity of the composition as necessary for
catheter delivery can be readily achieved by mere adjustment of the
molecular weight of the copolymer composition.” (Evans, col. 5, ll. 44-50.)
FF18. Greff ‘767 teaches compositions comprising an ethylene vinyl
alcohol copolymer (2.5-8 wt %), a contrast agent that is tantalum, tantalum
oxide or barium sulfate (10-40 wt %), and a biocompatible solvent (52-87.5
wt %) (Greff ‘767, col. 3, ll. 37-48).
FF19. Greff ‘767 teaches that a composition comprising 6.8 weight
percent of ethylene vinyl alcohol copolymer (“EVOH”) in dimethyl
sulfoxide (“DMSO”) has a viscosity of approximately 60 centipoise at 20° C
(Greff ‘767, col. 9, ll. 28-31).
FF20. Greff ‘767 teaches that addition of 38.5 weight percent
metrizamide (a contrast agent; Greff ‘767, col. 9, ll. 4-6) to the composition
of FF19 increased its viscosity to approximately 145 centipoise at 20° C (id.
at col. 9, ll. 31-34).
FF21. Greff ‘767 teaches that addition of 35 weight percent tantalum
or barium sulfate to a composition similar to that of FF19 did not materially
alter its viscosity (Greff ‘767, col. 9, ll. 35-37).
FF22. Greff ‘767 states that the purpose of the compositions referred
to in FF19 to FF21 was to “illustrate that certain embolizing agent/contrast
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agent combinations provide for physical properties which make injection of
the combination into vascular sites significantly more difficult” (Greff ‘767,
col. 9, ll. 24-27).
FF23. Taki teaches an embolizing composition containing “5 g of
solid ethylene vinyl alcohol copolymer (EVAL) and 35 g of powder
metrizamide dissolved in 60 g of dimethyl sulfoxide (DMSO) as a solvent”
(Taki 163).
FF24. Taki teaches that the “EVAL and DMSO mixture was of low
viscosity and could be easily injected through the narrow lumen of the
microballoon catheter, which was 150 cm in length” (Taki 168).
Discussion of the Obviousness and 102(b)/103 Issues
We determine that the Examiner has not made out a prima facie case
that the claimed compositions are anticipated by Taki or would have been
obvious in view of any of Evans, Greff ‘767, or Taki.
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987). None of the references relied on by the Examiner
expressly describes an embolizing composition having a viscosity of at least
150 cSt at 40° C as required by claim 1.
The Examiner has not provided an adequate basis – based on evidence
or scientific reasoning – to support the finding that the “compositions
disclosed by Evans inherently possess the same viscosity . . . as the instantly
claimed invention” (FF8, Ans. 5-6). The Examiner reasons that “Evans’
compositions comprise similar component[s] used in overlapping ranges of
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concentrations,” but even if some of the compositions encompassed by
Evans’ broad disclosure might have a viscosity of 150 cSt at 40° C, that
possibility is not adequate to support a finding of inherent anticipation.
“Inherency . . . may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” In re Oelrich, 666 F.2d 578, 581 (CCPA
1981). See also Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986)
(“[T]he examiner must provide some evidence or scientific reasoning to
establish the reasonableness of the examiner’s belief that the functional
limitation is an inherent characteristic of the prior art” before the burden is
shifted to the applicant to disprove the inherency.).
The Examiner has not provided evidence or scientific reasoning to
show that any specific composition disclosed by Evans is within the scope of
the instant claims, and therefore has not made out a case of inherent
anticipation by Evans. The Examiner’s finding that “Evans anticipates the
limitations of the instant claims” (FF7, Ans. 5) is not supported by the
evidence of record. The Examiner also has not shown that Taki discloses a
composition that expressly or inherently meets all the limitations of the
instant claims. We therefore reverse the rejection for anticipation based on
Taki.
The Examiner’s obviousness rejections are based on the reasoning
that a person of ordinary skill in the art “would have been motivated to
optimize the viscosity of the Evans’ [and Greff ‘767’s and Taki’s] final
formulation[s], because he would have had a reasonable expectation of
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success in achieving the safest clinical outcome and avoiding transvenous
passage” of the embolizing composition (FF9, FF10; Ans. 6-8).
The Examiner has not made out a prima facie case that the claimed
compositions would have been obvious based on the teachings of Evans,
Greff ‘767, or Taki. While “the discovery of an optimum value of a variable
in a known process is normally obvious,” In re Antonie, 559 F.2d 618, 620
(CCPA 1977), this is not always the case. One exception to the rule is where
the parameter optimized was not recognized in the prior art as one that
would affect the results. Id.
Here, the Examiner has not pointed to any teaching in the cited
references, or provided any explanation based on scientific reasoning, that
would support the conclusion that those skilled in the art would have
considered it obvious to “optimize” the prior art compositions by increasing
their viscosity to the level recited in the claims. No reason to have done so
is apparent to us based on the record. On the contrary, the references all
suggest that low viscosity was a desired property in embolic compositions.
Evans teaches that a preferred composition has a viscosity of 60 centipoise
or less at 20° C (FF12). Appellants calculate, and the Examiner does not
dispute, that 60 centipoise at 20° C corresponds to less than 75 cSt at 40° C
(App. Br. 12). Therefore, Evans’ preferred composition has a viscosity less
than half of that required by the instant claims.
Likewise, Greff ‘767 teaches that a composition with a viscosity of
145 cSt at 20° C had “physical properties which make[ ] injection . . . into
vascular sites significantly more difficult” (FF20, FF22) – and the only
physical property of the composition discussed is its viscosity. In agreement
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with the other references, Taki teaches that its composition had a low
viscosity (FF24) and had the desirable property of being easily injected
through a microballoon catheter (FF24).
Thus, the references teach that low viscosity is a desirable
characteristic for embolic compositions. In our view, none of the cited
references would have led a person of ordinary skill in the art to modify the
known embolic compositions by increasing their viscosity to at least 150 cSt
at 40° C. The Examiner has not adequately explained why such a
modification would have been obvious.
The U.S. Supreme Court recently held that rigid and mandatory
application of the “teaching-suggestion-motivation,” or TSM, test is
incompatible with its precedents. KSR Int’l Co. v. Teleflex Inc., 127 S.Ct.
1727, 1741 (2007). The Court did not, however, discard the TSM test
completely; it noted that its precedents show that an invention “composed of
several elements is not proved obvious merely by demonstrating that each of
its elements was, independently, known in the prior art.” Id.
The Court held that the TSM test must be applied flexibly, and take
into account a number of factors “in order to determine whether there was an
apparent reason to combine the known elements in the fashion claimed.” Id.
at 1740-41. Despite this flexibility, however, the Court stated that “it can be
important to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the [prior art] elements in the
way the claimed new invention does.” Id. “To facilitate review, this
analysis should be made explicit.” Id.
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The obviousness rationale addressed in KSR was premised on
combining elements known in the prior art. Id. at 1738-39. A parallel
analysis applies, however, to a rejection premised on the obviousness of
modifying a known composition to change its properties.
The KSR Court noted that obviousness cannot be proven merely by
showing that the elements of a claimed device were known in the prior art; it
must be shown that those of ordinary skill in the art would have had some
“apparent reason to combine the known elements in the fashion claimed.”
Id. at 1741.
In the same way, when the prior art teaches away from the claimed
solution as presented here (FF12, FF20, FF22 and FF 24), obviousness
cannot be proven merely by showing that a known composition could have
been modified by routine experimentation or solely on the expectation of
success; it must be shown that those of ordinary skill in the art would have
had some apparent reason to modify the known composition in a way that
would result in the claimed composition.
The Examiner has not persuasively explained why a person of
ordinary skill in the art would have had a reason to modify the compositions
taught by Evans, Greff ‘767, or Taki in a way that would result in the
compositions defined by the claims on appeal. Therefore, the Examiner has
not made out a prima facie case of obviousness under 35 U.S.C. § 103. We
reverse the rejections of claims 1-13 and 15-17 as obvious in view of Evans;
the rejection of claims 1-17 as obvious in view of Greff ‘767; and the
rejection of claims 1-6, 9, 10, and 14-17 as anticipated by or obvious in view
of Taki.
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SUMMARY
The rejections on appeal are not supported by a preponderance of the
evidence in the record and are therefore reversed.
REVERSED
Ssc:
FOLEY & LARDNER, LLP
975 PAGE MILL ROAD
PALO ALTO, CA 94304
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