Ex Parte Anderson et al

Board of Patent Appeals and Interferences

Oct 1, 2009

11070967 (B.P.A.I. Oct. 1, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte STEVEN M. ANDERSON and JANEL LANPHERE
____________________

Appeal 2009-012096
Application 11/070,967
U.S. Patent Publication 2006/0199009
Technology Center 1700
____________________

Decided: October 1, 2009
____________________

Before: FRED E. McKELVEY, Senior Administrative Patent Judge,
and RICHARD E. SCHAFER and SALLY GARDNER LANE,
Administrative Patent Judges.

McKELVEY, Senior Administrative Patent Judge.

DECISION ON APPEAL
A. Statement of the case 1
Boston Scientific Scimed, Inc. ("Boston"), the real party in interest, 2
seeks review under 35 U.S.C. § 134(a) of a final rejection (mailed 16 June 3
2006). 4
The application was filed on 02 March 2005. 5
Claims 1-12, 14-20 and 28-34 are on appeal. 6

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The Examiner relies on the following prior art: 1
Cochran U.S. Patent 4,671,994 09 Jun. 1987
Kubota U.S. Patent 6,586,364 01 Jul. 2003
2
The reader should know that "et al" is not used in this opinion. 3
Cochran and Kubota are prior art under 35 U.S.C. § 102(b). 4
We have jurisdiction under 35 U.S.C. § 134(a). 5
B. Findings of fact 6
References to the specification are to U.S. Patent Publication 7
2006/0199009. 8
Additional findings as necessary may appear in the Discussion portion 9
of the opinion. 10
The invention 11
The Boston invention relates to particles. Specification, ¶ 0001. 12
In one aspect, the invention features a particle with a diameter of at 13
most about 3,000 microns and an internal pressure of at least about 1.1 14
atmospheres at a temperature of less than about 25ºC. Specification, ¶ 0003. 15
The particle can encapsulate one or more gases, such as carbon 16
dioxide, nitrogen, oxygen, or water vapor. Specification, ¶ 0015. 17
The particle can burst at a temperature of at least about 35ºC. and/or at 18
an internal pressure of at least about 1.2 atmospheres. Specification, ¶ 0018. 19
The particle can include a gas generator, and when the gas generator 20
is heated to a temperature of at least about 25ºC., the internal pressure of the 21
particle can increase. Specification, ¶ 0018. 22
The gas generator can include, for example, dry ice, ice, water, and/or 23

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saline. The gas generator can be disposed in an interior region of the 1
particle or within one or more pores of the particle. When exposed to a 2
temperature of at least about 25ºC., the gas generator can generate gas, e.g., 3
carbon dioxide or water vapor. Specification, ¶ 0019. 4
Fig. 1A is reproduced below. 5
6
Fig. 1A depicts a cross-sectional view of an embodiment of a particle 7
Fig. 1B is reproduced below. 8
9
Fig. 1B depicts a cross-sectional view of the particle bursting 10
Fig. 1A shows a particle 10-A at a temperature of less than about 11
25ºC. Particle 10-A has a coating 12 that encloses an interior region 12

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14 formed of a matrix 18 and ferromagnetic particles 16. Pockets 20 of 1
carbon dioxide gas are dispersed throughout matrix 18. At a temperature of 2
less than about 25ºC., particle 10-A has an internal pressure of at least about 3
1.1 atmospheres. Specification, ¶ 0061. 4
Fig. 1B shows a burst particle 10-B, which is the result of the 5
exposure of particle 10-A to a temperature of at least about 35ºC. The 6
increase in temperature results in increase pressure of the carbon dioxide gas 7
within pockets 20, and thus in the internal pressure of particle 10-A. This 8
increase in internal pressure eventually causes particle 10-A to burst, 9
forming burst particle 10-B. When particle 10-A bursts, it releases 10
ferromagnetic particles 16. Specification, ¶ 0062. 11
A particle such as particle 10-A can be used, for example, to enhance 12
tissue heating and/or an ablation procedure. For example, Figs. 2A-2E [not 13
reproduced] illustrate the use of multiple particles 10-A in an ablation 14
procedure that involves the exposure of unhealthy tissue to RF energy to 15
damage or destroy the unhealthy tissue. Specification, ¶ 0090. 16
Fig. 2A [not reproduced] shows a portion 100 of a subject including a 17
liver 110 and skin 120. Liver 110 includes healthy tissue 130 and unhealthy 18
tissue 140 (e.g., cancerous tissue, such as a cancerous tumor). Fig. 2B [not 19
reproduced] illustrates the delivery of particles 10-A into unhealthy tissue 20
140 of liver 110 using a needle 160. Needle 160 is in fluid communication 21
with a syringe 170, which contains a composition including particles 10-A 22
suspended in a carrier fluid 180. An end 190 of needle 160 is inserted into 23
unhealthy tissue 140, and particles 10-A and carrier fluid 180 are then 24
injected from syringe 170 into unhealthy tissue 140. Specification, ¶ 0091. 25

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While particles 10-A generally are intact when first delivered into 1
unhealthy tissue 140 (as shown in Fig. 2B), as particles 10-A are heated to 2
body temperature (about 37ºC.), particles 10-A burst, forming burst 3
particles 10-B. As shown in Fig. 2C [not reproduced], when particles 10-A 4
burst, they release ferromagnetic particles 16 into unhealthy tissue 140. In 5
certain embodiments in which coating 12 and matrix 18 are formed of a 6
bioerodible or bioabsorbable material, coating 12 and matrix 18 can be 7
eroded and/or absorbed by the body, leaving ferromagnetic particles 16 8
distributed throughout unhealthy tissue 140 (as shown in Fig. 2D [not 9
reproduced]). Specification, ¶ 0095. 10
Particle 10-A can be designed to burst once particle 10-A has reached 11
a predetermined temperature—at most about 200ºC. For example, particle 12
10-A can burst at about 37ºC. Specification, ¶ 0066. 13
Typically, the thickness of coating 12 of particle 110-A can be 14
selected to accommodate an increase in the internal pressure of particle 10-A 15
to a predetermined level, at which point particle 110-A may burst. In some 16
embodiments, coating 12 can have a thickness of at most 0.02 inch (e.g., at 17
most 0.01 inch, at most 0.005 inch, at most 0.004 inch), and/or at least 18
0.00004 inch (e.g., at least 0.004 inch, at least 0.005 inch, at least 0.01 19
inch). For example, coating 12 may have a thickness of from 0.00004 inch 20
to 0.02 inch (e.g., from 0.001 inch to 0.02 inch). Specification, ¶ 0068. A 21
thickness of 0.00004 inches is 1.016 microns; a thickness of 0.02 inches is 22
508 micros. 23
Coating 12 and matrix 18 of particle 10-A can be formed of the same 24

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materials or different materials. For example, coating 12 and/or matrix 18 1
can be formed of at least one polymer and/or at least one non-polymer. In 2
certain embodiments, coating 12 and/or matrix 18 can be formed of at least 3
gelling precursor. In general, coating 12 and/or matrix 18 can be formed of 4
one or more materials that are biocompatible, bioerodible, and/or 5
bioabsorbable. Specification, ¶ 0069. 6
Examples of polymers include carboxymethyl celluloses, 7
hydroxyethyl celluloses, substituted celluloses, polyesters, polystyrenes, 8
polysaccharides (e.g., alginate, agarose) and polyethylenes. Specification, 9
¶ 0070. 10
Claims on appeal 11
Claim 1, reproduced from the claim appendix of the Appeal Brief, 12
reads [bracketed matter and indentation added]: 13
A particle[:] 14
[1] having an internal pressure of at least about 1.1 15
atmospheres and at most about 5.0 atmospheres at a 16
temperature of less than about 25ºC, 17
[2] wherein the particle has a diameter of at most about 18
3,000 microns and 19
[3] the particle bursts at a temperature of at most about 20
200ºC. 21

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Claim 12, reproduced from the claim appendix of the Appeal Brief, 1
reads: 2
The particle of claim 1, 3
[4] wherein the particle comprises a gas generator, and 4
[5] when the gas generator is heated to a temperature of 5
at least about 25ºC, the internal pressure of the particle 6
increases to at least about 1.2 atmospheres. 7
Examiner's rejections 8
Claims 1-11, 19-20 and 28-34 were rejected under 35 U.S.C. § 102(b) 9
as anticipated by Cochran. Examiner's Answer, page 3. 10
Boston agrees that claims 1-11, 19-20 and 28-34 stand or fall together. 11
Appeal Brief, page 3. 12
Claims 12 and 14-18 stand rejected as being unpatentable over 13
Cochran and Kubota, although some mention is made of U.S. Patent 14
6,410,508 (Isales) with respect to claim 18. Examiner's Answer, pages 5-6. 15
Isales is not discussed by Boston. 16
Boston does not argue the separate patentability of claims 14-18 apart 17
from claim 12. Accordingly, claims 12 and 14-18 stand or fall together. 18
Since claim 18 stands or falls with claim 12, there is no occasion to 19
discuss Isales. 20
Prior art 21
(1) Cochran 22
Fig. 6 of Cochran is reproduced below. 23

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1
Fig. 6 depicts a cross-section of an enlarged microsphere 2
Cochran's invention relates to fiber reinforced hollow film forming 3
material microspheres 17 made from (1) a fiber and (2) film forming 4
material composition. The fiber reinforced hollow microspheres 17 are used 5
to make shaped and molded articles and to make insulation materials. 6
Col. 1:5-10. 7
More specifically, Fig. 6 shows a detailed cross-section of an enlarged 8
microsphere 17 with reinforcing fibers 31 uniformly dispersed 9
throughout the wall of the microspheres. The fibers 31 are disposed 10
generally parallel to the inner and outer wall surfaces of the microsphere and 11
are adhered or bonded to each other and to the hardened molten film forming 12
material forming the wall of the microsphere. The contained volume of the 13
microsphere contains a blowing gas 10. Col. 9:18-27. 14
The microspheres can be made of glass (col. 11), metal materials 15
(col. 12) and organic film forming materials and plastics (col. 13). Of 16
interest in this case are the microspheres formed of plastics. 17

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The organic film forming material and compositions and particularly 1
the plastic compositions from which the hollow plastic microspheres of the 2
present invention are made can be widely varied to obtain the desired 3
characteristics. Col. 13:55-59. 4
The plastic compositions that can be used to form microspheres of the 5
present invention include thermosetting and thermoplastic materials such as 6
polyethylene, polystyrene and polyesters. The plastic compositions also 7
include organic materials such as cellulose acetate, cellulose acetate-8
butyrate, and cellulose acetate-propionate. Col. 14:7-19. 9
The plastic compositions are formulated such that they have a high 10
rate of viscosity increase with the hardening temperature or the 11
thermosetting temperature such that the microsphere walls will solidify, 12
harden and strengthen before the blowing gas within the sphere decreases in 13
volume and pressure a sufficient amount to cause the microsphere to 14
collapse. Col. 14:40-46. 15
The fiber reinforced hollow microspheres, particularly the glass, metal 16
and plastic microspheres can be blown with a gas, e.g. an inert gas. 17
Col. 14:60-62. 18
The inert gases used to blow the fiber reinforced microspheres for use 19
as insulation materials are selected to have a low heat conductivity and 20
generally involve heavy gas molecules which do no transfer heat readily. 21
Suitable blowing gases include carbon dioxide and nitrogen. For certain 22
uses, oxygen or air can be used as or added to the blowing gas. Col. 14:63 23
through col. 15:2. 24

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The Examiner found that Cochran describes particles that have an 1
outer diameter of 200 to 5000 microns. Examiner's Answer, page 3; 2
col. 21:52. The outer diameter is preferably 500 to 3000 microns and more 3
preferably 750 to 2000 microns. Col. 21:53-54. 4
The Examiner further found that the Cochran particles have a gas 5
pressure (or internal pressure) of 5 to 100 psia (which the Examiner found 6
converts to 0.34 to 6.80 atm). Col. 21:60-61. Preferably the pressure is 5 to 7
75 psia and more preferably 5 to 12 psia. Col. 21:60-62. 8
The Examiner still further found that the particles—after being 9
made—are inherently kept a room temperature. Examiner's Answer, page 3. 10
The Examiner found that room temperature is about 20ºC., which is 68ºF. 11
Id. Boston does not challenge the Examiner's room temperature finding. 12
Based on these findings, the Examiner found that Cochran describes a 13
particle with an outer diameter of at most 3000 microns (preferred and more 14
preferred embodiments) and an internal pressure of at least about 1.1 15
atmospheres at a temperature of less than about 25ºC (which is apparently 16
Boston's room temperature). 17
Cochran's preferred wall thickness is 10 to 100 microns (0.00039 to 18
0.0039 inches). Col. 21, Table II. 19
The Examiner called attention to col. 17:52-63 of Cochran: 20
The quench or heating fluid used to harden the plastic 21
microspheres is at a temperature such that it rapidly cools 22
or heats the microspheres to solidify, harden and 23
strengthen the liquid plastic before the inner gas pressure 24
decreases to a value at which the plastic microsphere 25

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would collapse or burst the microsphere. The quench 1
cooling fluid can be at a temperature of 0ºF to 200ºF. . . . 2
The heating fluid used to harden the microspheres can be 3
at a temperature of 100º to 800ºF . . . . depending on the 4
plastic composition. 5
Example 6 describes a microsphere made from a thermoplastic 6
polyethylene. Col. 25. 7
According to Example 6, there is added to a thermoplastic 8
polyethylene polymer about twenty-two volume percent of glass fibers, one 9
micron in diameter and twenty microns in length. The glass fiber and plastic 10
composition is heated to form a fluid have a viscosity of about 10 to 20 11
poises at the blowing nozzle. After processing in the apparatus shown in 12
Cochran Fig. 1 [not reproduced] entrained falling elongated cylinders 13
assume a spherical shape, are cooled to about ambient temperature by a cool 14
quench fluid consisting of a fine water spray which quickly cools, solidifies 15
and hardens the plastic microspheres. Col. 25:13-42. 16
Uniform sized, smooth, fiber reinforced hollow plastic microspheres 17
having uniform 2000 to 3000 micron diameter, uniform 20 to 40 micron wall 18
thickness and filled with nitrogen gas are obtained. Col. 25:43-46. 19
(2) Kubota 20
Kubota's invention relates to heat-sensitive microcapsules that are 21
broken by heating to a predetermined temperature, and recording mediums 22
using the heat-sensitive microcapsules. Col. 1:6-9. 23

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An object, referred to as a second object, of Kubota's invention is to 1
provide a heat-sensitive microcapsule that is sensitively broken even by 2
heating in a short time. Col. 2:19-21. 3
Supposedly as a result of intense research, Kubota is said to have 4
found that a heat-sensitive microcapsule containing at least a gas-developing 5
agent and a coloring composition is sensitively broken even by heating in a 6
short time. Thus, a second heat-sensitive microcapsule comprises a shell 7
wall, and a coloring composition and a heat decomposition-type gas-8
developing agent enclosed in the shell wall, and has such a temperature-9
breaking characteristic that the shell wall is broken by heating to a 10
temperature equal to or higher than a decomposition temperature of 11
the heat decomposition-type gas-developing agent to release the coloring 12
composition. In the second heat-sensitive microcapsule, the gas-developing 13
agent is decomposed at a temperature equal to or higher than its 14
decomposition temperature to provide N2 gas, etc., thereby increasing the 15
inner pressure of the microcapsule. Therefore, the shell wall of the 16
microcapsule is sensitively broken by the increased inner pressure to fix the 17
coloring composition to the substrate. Col. 2:46-64. 18
The Kubota second heat-sensitive microcapsule comprises 19
a shell wall, and a coloring composition and a heat decomposition-type 20
gas-developing agent (blowing agent or foaming agent) enclosed in the shell 21
wall, and has such a temperature-breaking characteristic that the shell wall is 22
broken by heating to a temperature equal to or higher than a decomposition 23
temperature of the heat decomposition-type gas-developing agent to release 24
the coloring composition. The second heat-sensitive microcapsule is broken 25

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to release its enclosures not by melt of the shell wall, but by inner pressure 1
that is increased by the heat decomposition-type gas-developing agent. 2
Although the second heat-sensitive microcapsule is not broken by applying 3
pressure or by heating during storage or transport to stably maintain its 4
enclosures, the second heat-sensitive microcapsule is entirely or partially 5
broken by increased inner pressure to release its enclosures when the heat 6
decomposition-type gas-developing agent contained therein is heated to a 7
predetermined temperature to develop N2 gas. Col. 7:38-57. 8
The heat decomposition-type gas-developing agent is preferably 9
decomposed at 70 to 300º to provide a gas. Col. 7:59-64. 10
C. Discussion 11
Examiner’s § 102 rejection based on Cochran 12
The Examiner found that the microspheres described by Cochran 13
inherently anticipate the subject matter of claim 1. 14
Anticipation requires that each and every element as set forth in the 15
claim is found, either expressly or inherently described, in a single prior art 16
reference. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). If a prior art 17
reference does not expressly set forth a particular element of the claim, that 18
reference still may anticipate if that element is "inherent" in the disclosure of 19
the reference. Id. Inherency, however, may not be established by 20
probabilities. Id., citing In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). 21
Boston cites inter partes infringement decisions to make the same points. 22
We, on the other hand, have gone out of our way to limit the citations to ex 23
parte decisions. There is a reason. Ex parte practice differs from inter 24
partes infringement practice. For example, it is possible for the Examiner to 25

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make out a prima facie case of inherency by establishing that an applicant's 1
claimed composition prima facie appears to be the same as a composition 2
described in a reference. In re Spada, 911 F.2d 705 (Fed. Cir. 1990). 3
Unlike accused infringers in inter partes infringement cases (or for that 4
matter parties in interference cases), the USPTO has no means for making 5
and comparing properties or characteristics of compositions. Charles Pfizer 6
& Co., Inc. v. F.T.C., 401 F.2d 574, 579 (6th Cir. 1968); In re Brown, 459 7
F.2d 531, 535 (CCPA 1972). Accordingly, if the Examiner has a reasonable 8
basis for believing that a reference describes a claimed product, the burden 9
of going forward with the evidence shifts to the applicant. In re Spada, 10
supra. See also In re Fitzgerald, 619 F.2d 67, 70 (CCPA 1980); In re Best, 11
562 F.2d 1252, 1254 (CCPA 1977). The burden of going forward with the 12
evidence applicable in ex parte practice does not apply in inter partes cases. 13
In this case, the "missing" limitation of claim 1 not explicitly 14
described by Cochran is "the particle bursts at a temperature of at most about 15
200ºC." The Examiner found that Cochran describes hardening of 16
microspheres at a temperature as low as 100ºF (ca. 38ºC). Based on the 17
finding, the Examiner reasoned that heating a microsphere hardened at 18
100ºF to a temperature of 200º C (ca. 392ºF) would burst that specific 19
microsphere. 20
The record supports findings that: 21
1. The microspheres can made from the same material, 22
e.g., polyethylenes, polyesters, polystyrenes and various 23
cellulose materials. 24

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2. The Cochran thermoplastic polyethylene polymer 1
Example 6 microsphere has a diameter of 2000 to 3000 microns 2
which is the same as Boston's diameter of at most about 3000 3
microns. 4
3. While not a claimed feature, Cochran's wall thickness 5
of 20 to 40 microns falls squarely within Boston's described 6
wall thickness of from 0.00004 inches (1.016 microns) to 0.02 7
inches (508 micros). 8
4. The Examiner found that Cochran's "preferably" 5 to 9
75 psia internal gas pressure considerably overlaps Boston's 10
claimed internal pressure of at least about 1.1 atmospheres to at 11
most about 5.0 atmospheres at room temperature. 12
5. The internal gases can be the same: e.g., nitrogen 13
(described in Cochran Example 6), carbon dioxide, oxygen. 14
Because of the numerous common features of the Boston microsphere 15
and the Cochran microspheres, the Examiner had a reasonable basis for a 16
prima facie case of anticipation. In re Best, supra. 17
It is true, as Boston argues, that Cochran seeks a very strong 18
microsphere. The fact remains that Cochran's polyethylene based 19
microsphere seems to have all the explicitly described characteristics of 20
Boston's claimed subject matter. If Boston's microspheres burst at a 21
temperature of at most about 200ºC, there is a plausible basis for expecting 22
that Cochran's polyethylene microspheres would burst at the same 23
temperature. 24

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But, Boston maintains that a reasonable expectation is not enough. 1
Boston would have the Examiner prove (sans an ability to test products) that 2
the burst temperature is the same. While the accused infringer may have to 3
prove the point, in ex parte practice the burden of going forward with the 4
evidence shifts to the applicant—even where the utility of the reference 5
produce differs from that of the claimed product. In re Spada, supra. 6
We decide appeals on the basis of the record and arguments presented. 7
In the event of further prosecution (e.g., RCE or continuation), Boston may 8
wish to consider whether the fibers in the Cochran microsphere constitute a 9
relevant difference between the Cochran and Boston microspheres. A 10
comparative test between the Cochran Example 6 polyethylene shell with 11
fibers and a similar shell without fibers may prove Boston's point. However, 12
no such proof has been presented in this application. 13
The decision of the Examiner rejecting claims 1-11, 19-20 and 28-34 14
is affirmed. 15
Examiner’s § 103 rejection based on Cochran and Kubota 16
The Examiner found that Cochran differs from claim 12 in that the 17
claim calls for a gas generator, whereas Cochran does not describe the use of 18
a gas generator. 19
To make up for the difference, the Examiner cites Kubota. 20
Kubota describes the use of microspheres having a gas generator. 21
Kubota's purpose in having a gas generator is to generate heat to cause the 22
microsphere to burst so that material within the microsphere can be used in 23
connection with recording mediums. 24

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The Examiner reasoned that it would have been obvious to use a gas 1
generator in the Cochran microspheres in order to release liquid material 2
contained in the Cochran microspheres or to break open the microspheres in 3
a short period of time. 4
Cochran does not describe any desire to cause its microspheres to 5
burst. While those microspheres prima facie anticipate Boston's claim 1 6
microspheres, we perceive of no apparent reason which would have 7
prompted a person of ordinary skill to substitute the Kubota gas generator 8
for the gas in the Cochran microsphere given that Cochran has no interest in 9
bursting microspheres. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418 10
(2007). The § 103 rejection, in this instance, appears to have been based on 11
hindsight after a peek at Boston's specification. 12
The decision of the Examiner rejecting claims 12 and 14-18 is 13
reversed. 14

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D. Decision 1
Boston has not sustained its burden on appeal of showing that the 2
Examiner erred in rejecting the claims 1-11, 19-20 and 28-34 as being 3
unpatentable under 35 U.S.C. § 102(b) over Cochran. 4
Boston has sustained its burden on appeal of showing that the 5
Examiner erred in rejecting the claims 12 and 14-18 as being unpatentable 6
under 35 U.S.C. § 103 over Cochran and Kubota. 7
Upon consideration of the appeal, and for the reasons given herein, 8
it is 9
ORDERED that the decision of the Examiner rejecting 10
claims 1-11, 19-20 and 28-34 as anticipated by Cochran is affirmed. 11
FURTHER ORDERED that decision of the Examiner rejecting 12
claims 12 and 14-18 as unpatentable under § 103 over Cochran and Kubota 13
is reversed. 14
FURTHER ORDERED that no time period for taking any 15
subsequent action in connection with this appeal may be extended under 16
37 C.F.R. § 1.136(a)(1)(iv) (2008). 17

AFFIRMED-IN-PART and REVERSED-IN-PART

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