Ex Parte Tatebe et al

Board of Patent Appeals and Interferences

Jan 23, 2012

10551279 (B.P.A.I. Jan. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BOARD OF PATENT APPEALS AND INTERFERENCES
____________________

Ex parte KEN TATEBE and KATSUYUKI OOBA
____________________

Appeal 2011-006176
Application 10/551,279
Technology Center 1700
____________________

Before: FRED E. McKELVEY, RICHARD TORCZON and
SALLY GARDNER LANE, Administrative Patent Judges.

McKELVEY, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2011-006176
Application 10/551,279

2

Statement of the case
Terumo Kabushiki Kaisha (“Appellant Terumo”), the real party in interest 1
(Brief, page 2), seeks review under 35 U.S.C. § 134(a) of a final rejection dated 2
16 June 2011. 3
The application was filed in the USPTO on 27 September 2005. 4
Previously, the application was filed on 24 March 2004 as International 5
Application PCT/JP04/004024, which entered the national stage as to the United 6
States on 27 September 2005. 35 U.S.C. § 371. 7
The application on appeal claims priority of (1) Japanese patent application 8
2003-087812, filed 27 March 2003 and (2) Japanese patent application 2003-9
379492, filed 10 November 2003. 10
The application has been published as U.S. Patent Application Publication 11
2006/0194336 A1. 12
The Examiner relies on the following evidence. 13

Tatebe

Japanese patent
application publication
2001-165930

Publication date
22 June 2001
14
Tatebe is a Japanese language document. In this opinion, references to 15
Tatebe are to an English translation of the Japanese language document. 16
Appellant Terumo does not contest the prior art status of the evidence relied 17
upon by the Examiner. 18
We have jurisdiction under 35 U.S.C. § 134(a). 19
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Appeal 2011-006176
Application 10/551,279

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Page 12: last line to page 13:11 states (italics added): 1
The aperture means a pore opened at the surface of the porous 2
membrane, and the surface of the second layer should preferably have a 3
glossiness of not higher than 11, preferably 3 to 10, more preferably 3 to 8. 4
When the surface of the second layer has a glossiness within the above-5
defined range, the surface of the second layer [is said to have] irregularities 6
and is in a gloss and luster-free state. As will be described hereinafter, for 7
measurement of a reflection absorbance, direct light reflected from the 8
surface serves as a noise, and thus, the surface of the second layer should 9
preferably have irregularities and be in a gloss and luster-free state. 10
Glossiness is measured using JIS Z8741. Specification, page 25:5-6. 11
We understand JIS Z8741 to be a Japanese Industrial Standard for measuring 12
glossiness. 13
Page 38:9 through page 39:20 reads (italics added): 14
A porous membrane to be assessed was fixed on a sample holder of a 15
spectrophotometer (UV-2400(PC)S, made by Shimadzu Corporation) so as 16
to measure a reflection absorbance, to which 5 μl of a human blood, 17
adjusted in blood glucose level to 100 μg/dl or 400 μg/dl, was added to the 18
surface of a first layer by use of a micropipette . . . to measure reflection 19
absorption spectra of reflection absorbance on the surface of the second 20
layer. Based on the results, an analytical curve was made from the relation 21
between the blood glucose level and the reflectivity ratio to obtain a gradient 22
thereof. FIG. 5 [, reproduced above,] is a graph showing the analytical 23

Appeal 2011-006176
Application 10/551,279

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curve. The reflectivity ratios at the respective blood glucose levels and the 1
gradients of the analytical curves are shown in Table 5. 2
3
Table 5
Example 8 Example 9 Example 10 Example 11
Glossiness 3.0 6.0 10.0 43
Blood Glucose
Level at 100
0.39 0.39 0.39 0.39
Blood Glucose
Level at 400
1.56 1.52 1.50 1.36
Gradient 0.0039 0.0038 0.0037 0.0032
4
From these results, [Appellant Terumo says that] it was found that when the human 5
blood having a blood glucose level of 400 μg/dl was measured, the porous 6
membrane of Example 11 which had a glossiness of 43 lowered in reflectivity ratio 7
when comparing with the porous membranes of Examples 8 to 10 having a 8
glossiness of 3 to 10, with a smaller gradient of the analytical curve. The need for 9
the measurement of blood glucose level is mainly for patients, such as diabetic 10
patients, having a high blood glucose level, particularly, an elevated blood glucose 11
level, for example, of 400 μg/dl. When a porous membrane [is used] having a 12
glossiness of 11 or below, a measuring accuracy in such a high range of blood 13
glucose level [is said to be] . . . improved. 14

Appeal 2011-006176
Application 10/551,279

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Claims on appeal 1
Claims 1 and 4-7 are on appeal. 2
Only Claims 1 and 6-7 are discussed in the argument section of Appellant 3
Terumo’s Appeal Brief. 4
Claims 1 and 6-7, which we reproduce from pages 1-2 of the Claim 5
Appendix of the Appeal Brief, reads [matter in brackets and indentation added; 6
contested limitations in issue in italics]: 7
Claim 1 8
A test paper comprising a porous membrane 9
[1] having a function of separating an object that should be filtered out 10
from a sample by filtration and 11
[2] carrying thereon a reagent capable of giving a color by reaction 12
with a specified component in the sample, 13
[a] wherein said porous membrane has 14
[i] a first layer having a surface to which a sample is supplied 15
and 16
[ii] a second layer having a surface at which the sample is 17
percolated and measured, 18
[b] said first layer being made of large-sized pore portions whose 19
section density is 40% or less, with a surface of said first layer being a 20
smooth surface having apertures thereat, 21
[c] said second layer being made of small-sized pore portions whose 22
section density exceeds 40%, with a surface of said second layer having 23
apertures thereat, 24

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[d] wherein said first layer and said second layer together constitute a 1
single [porous] membrane portion formed by a single casting operation, and 2
[e] wherein said porous membrane has a thickness of 50 to 200 μm 3
and a porosity of 60 to 95%, 4
[f] said first layer has an average pore size of 0.5 to 10 μm in the 5
surface thereof, and 6
[g] said first layer is located from the surface of said first layer within 7
a range of 1/5 to 1/2 of a thickness of said porous membrane, and 8
[h] said second layer has an average pore size of 0.1 to 3.0 μm in the 9
surface thereof, and 10
[h] said second layer has a surface glossiness according to JIS Z8741 11
not higher than 11. 12
Claim 6 13
A porous membrane which comprises 14
[1] a first layer having a surface and 15
[2] a second layer having another surface, 16
[a] wherein said first layer is made of large-sized pore portions 17
whose section density is 40% or less, 18
[b] with a surface of said first layer being a smooth surface 19
having apertures thereat, 20
[c] said second layer is made of small-sized pore portions 21
whose section density exceeds 40%, with a surface of the second layer 22
having apertures thereat, 23

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Application 10/551,279

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[d] wherein said first layer and said second layer together 1
constitute a single membrane portion formed by a single casting 2
operation, and 3
[e] wherein a membrane thickness ranges from 50 to 200 μm, 4
a porosity ranges from 60 to 95%, 5
[f] said first layer has an average pore size of from 0.5 to 10 μm 6
in the surface thereof, and 7
[g] said first layer is located from the surface of said first layer 8
within a range of 1/5 to 1/2 of a thickness of said porous membrane, 9
and 10
[h] said second layer has an average pore size of 0.1 to 3.0 μm 11
in the surface thereof, and 12
[i] said second layer has a surface glossiness according to 13
JIS Z8741 not higher than 11. 14
Claim 7 15
The porous membrane according to Claim 6, wherein a ratio between the 16
average pore size in the surface of said first layer and the average pore size in the 17
surface of said second layer is in the range of 1 to 6. 18
Examiner’s rejection 19
Claims 1 and 4-7 have been rejected as being unpatentable under 35 U.S.C. 20
§ 103(a) over the Tatebe Japanese patent application. 21
Analysis 22
In presenting its appeal, Appellant Terumo presents four basic arguments. 23
We take them up in the same order as presented in the Appeal Brief. 24

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Application 10/551,279

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Average pore size in the surface of the first and second layers 1
Appellant Terumo alleges that its claims are patentable based on average 2
pore sizes in the surfaces of the first and second layer. Appeal Brief, page 6 3
(starting with A. Anticipation) and ending at page 7:5. 4
Claims 1 and 6 call for (1) a first layer having an average pore size of 0.5 to 5
10 μm in the surface thereof and (2) a second layer having an average pore size of 6
0.1 to 3.0 μm in the surface thereof. 7
The two claims do not specify the average pore size of the rest of the first 8
and second layers, i.e., the “non-surface” portions of the first and second layers. 9
Appellant Terumo agrees that Tatebe describes a first layer having an 10
average pore size of 3 to 10 μm and a second layer having an average pore size of 11
0.1 to 2 μm. Appeal Brief, page 6; Tatebe, page 11:4-5 and 12-13. The Tatebe 12
pore size ranges fall within the scope of Appellant Terumo’s claimed pore sizes. 13
In a light most favorable to Appellant Terumo, one would suppose that the Tatebe 14
pore size is uniform throughout each layer—which, of course, would include the 15
“in the surface thereof” of the Tatebe layers. Since Appellant Terumo does not 16
explicitly call for the “non-surface thereof” pores to have a different size from that 17
of the “in the surface thereof” pores, we agree with the Examiner that the “in the 18
surface thereof” pore sizes do not distinguish the claims on appeal from the Tatebe 19
prior art. 20
Single membrane formed by a single casting system 21
Appellant Terumo maintains that its claims differ from the Tatebe prior art 22
because its first and second layers are made by a single casting operation. Appeal 23
Brief, page 7:6 (starting with B. Obviousness) to page 8:3. 24

Appeal 2011-006176
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Claim 1 and 6 call for a “first layer and … [a] second layer [that] together 1
constitute a single [porous] membrane portion formed by a single casting 2
operation.” The limitation is a product-by-process limitation. However, the claims 3
are directed to an article. 4
It is possible to define an article by the manner in which it is made and to 5
distinguish that article from one made by a different manner. In re Luck, 476 F.2d 6
650, 653 (CCPA 1973) (a product claim may include process steps to wholly or 7
partially define the claimed product). However, the USPTO has no means to make 8
products and test those products to determine whether any differences exist. 9
Accordingly, in a case like this it is up to the applicant to present data to establish a 10
difference. 11
The “evidence” of a difference is an attorney statement that “[w]hen two 12
layers are stacked together [as in Tatebe], the resultant product, unlike a product 13
formed by a single casting operation [as claimed], has a discontinuity and two 14
additional surfaces, i.e., where the two layers are in contact.” Appeal Brief, 15
page 7:30 to page 8:1. Attorney argument is not evidence. In re Walters, 168 F.2d 16
79, 80 (CCPA 1948) (statements of counsel in a brief cannot take the place of 17
evidence). 18
In response to the attorney argument, the Examiner points to ¶ 0027 of 19
Tatebe. Tatebe discloses that the two layers may be “fusion-bonded” with each 20
other. Appellant Terumo has not presented a cogent response to the Examiner’s 21
observation concerning “fusion-bonding” or how Tatebe’s “fusion-bonding” article 22
differs from the claimed “formed in a single casting operation” article. 23
24

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Application 10/551,279

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The 40% or less and 40% or more section density limitations 1
Appellant Terumo urges patentability based on limitations related to “section 2
density.” Appeal Brief, page 8:4-20. 3
Claims 1 and 6 are limited to a first layer with “large-sized” pores having a 4
section density of 40% or less. They also are limited to a second layer with “small-5
sized” pores having a section density of 40% or more. Section density is discussed 6
in the Specification at page 12 (amended paragraph) and pages 31-32 (amended 7
paragraph). 8
The Examiner found that Tatebe describes (1) thickness, (2) porosity and 9
(3) pore size for each of its first and second layers. Final Rejection, page 4:3-7; 10
Answer, page 5:1-4. The 3-10 μm pore size of the first layer and the 0.1 to 2 μm 11
pore size of the second layer, suggested to the Examiner that the second layer has 12
the higher density. The Examiner’s finding is reasonable because the larger the 13
pores, the less material in the layer and hence, the lower weight. Based on the 14
finding, the Examiner further found that the section density limitations “have been 15
implicitly disclosed.” Appellant Terumo has not shown that the Examiner is 16
wrong—particularly given the inability of the USPTO to make and compare 17
products. 18
The glossiness limitation 19
Appellant Terumo argues that a glossiness limitation renders the claimed 20
subject matter non-obvious. Appeal Brief, page 8:21 to page 9:24. 21
Claim 1 and 6 call for a second layer that has a surface glossiness according 22
to JIS Z8741 not higher than 11. 23

Appeal 2011-006176
Application 10/551,279

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The Examiner found that Tatebe describes the use of optical measuring 1
apparatus, including spectrophotometer UV-2400 (PC)S [the spectrophotometer 2
described by Appellant Terumo], to determine light reflection absorbance at the 3
surface of a membrane to thereby analyze change in reflection. Answer, page 5; 4
Tatebe, page 25, ¶ 0038. Based on the noted Tatebe disclosure, the Examiner 5
further found that “surface glossiness” or “the surface reflectivity” is a variable 6
that can be modified and therefore is a result oriented variable. The Examiner still 7
further found that one skilled in the art would modify surface and membrane 8
material to achieve an optimum result. Answer, page 5. The properties said to be 9
obvious to optimize include “noise” and “optical measurements.” Answer, page 10
10, last ¶. 11
Appellant Terumo responds by maintaining that it is well-established that a 12
parameter must first be recognized as a result-effective variable. Curiously, no 13
authority was cited in the Appeal Brief. When Appellant Terumo filed its Reply 14
Brief, it called attention to In re Antonie, 559 F.2d 618 (CCPA 1977). According 15
to Appellant Terumo, Antonie held that modifying the ratio of tank volume to 16
contractor area in a wastewater treatment device to maximize treatment capacity 17
was not an art recognized variable—even though the prior art discussed increasing 18
the contractor area to increase efficiency. Varying the contractor area while 19
maintaining the tank volume constant would, of course, also vary the “ratio.” 20
Reply Brief, page 2. See also In re Yates, 663 F.2d 1054 (CCPA 1981), which also 21
held that a property was not a result oriented variable. The underlying rationale of 22
both of these cases was based, at least in part, on the proposition that “obvious to 23
try” is not a proper obviousness standard. However, KSR Int’l Inc. v. Teleflex Inc., 24

Appeal 2011-006176
Application 10/551,279

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550 U.S. 380, 421 (2007), may have undermined the rejection of the “obvious to 1
try” rationale upon which Antonie and Yates are bottomed. 2
While both Appellant Terumo and the Examiner have a point, at the end of 3
the day we do not see where, or how, the prior art establishes that glossiness is a 4
property which one skilled in the art would have recognized as a result-effective 5
variable in the context of the claimed invention. The only credible evidence in this 6
record that there is a connection between (1) blood glucose level, (2) reflectivity 7
ratio and (3) glossiness is found in Appellant Terumo’s Fig. 5 (reproduced above) 8
and associated description in Appellant Terumo’s Specification. Neither Appellant 9
Terumo nor the Examiner has pointed to evidence related to any relationship 10
between glossiness in connection with test papers (generally or for Appellant 11
Terumo’s purpose). We decide appeals on the record before us. On this record, 12
we are unable to find that glossiness is a result-effective variable vis-à-vis blood 13
glucose level. Solely on this very narrow ground, we reverse. 14
Decision 15
Upon consideration of the appeal, and for the reasons given herein, it is 16
ORDERED that the decision on the Examiner rejecting claims 1 and 17
4-7 is reversed. 18
FURTHER ORDERED that no time period for taking any 19
subsequent action in connection with this appeal may be extended under 37 C.F.R. 20
§ 1.136(a)(1)(iv). 21
REVERSED 22

KMF