Ex Parte Kosaka

Patent Trial and Appeal Board

Sep 22, 2016

10523865 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/523,865 0210712005
29880 7590 09/26/2016
FOX ROTHSCHILD LLP
PRINCETON PIKE CORPORATE CENTER
997 LENOX DRIVE
BLDG. #3
LAWRENCEVILLE, NJ 08648
FIRST NAMED INVENTOR
Hideko Kosaka
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.
105321.00009 1872
EXAMINER
GERIDO, DWAN A
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
09/26/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
ipdocket@foxrothschild.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HIDEKO KOSAKA
Appeal2014-008150
Application 10/523,865
Technology Center 1700
Before CATHERINE Q. TIMM, MARK NAGUMO, and
JEFFREY R. SNAY, Administrative Patent Judges.
SNAY, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellant, Hideko Kosaka,2 appeals under 35 U.S.C. § 134(a) from
the Examiner's decision rejecting claims 1, 13, and 19-22. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 We cite to the Specification ("Spec.") filed Feb. 7, 2005; Final Office
Action ("Final Act.") mailed Nov. 6, 2013; Examiner's Answer ("Ans.");
and Appellant's Appeal Brief ("Br.").
2 Appellant identifies Arkray, Inc. as the real party in interest. Br. 4.
Appeal2014-008150
Application 10/523,865
BACKGROUND
The subject matter involved in this appeal relates to a protein assay
and test device. Spec. 3. Claim 1 illustrates the subject matter on appeal
and is reproduced from the Claims Appendix of the Appeal Brief as follows:
1. A method for detecting albumin in an amount between 10
and 20 mg/dL in a urine sample comprising:
a.) impregnating a test piece with urine, said test piece
comprising a protein assay indicator and a sensitizer, wherein
said protein assay indicator is a compound having the
chemical structure of one of the following Chemical Formulas
(1 )-1 and ( 1 )-2:
wherein the albumin in the urine sample is assayed in a solution
having a pH equal to or below the pKa of the protein indicator,
wherein the sensitizer is a compound that increases the
coloration sensitivity of the protein assay indicator with respect
to albumin present in the solution as compared to the
coloration sensitivity of the protein assay indicator with respect
to albumin present in the solution in the absence of the
sensitizer; and
b.) observing the color of the protein assay indicator, wherein
the protein assay indicator in the solution is from colorless to
light orange in color when the albumin is not present in the
solution, and wherein the protein assay indicator in the solution
is from red to purple in color when the albumin is present in the
solution.
2
Appeal2014-008150
Application 10/523,865
Independent claim 13 generally is directed to a test piece comprising
the indicator and sensitizer identified in claim 1.
REJECTIONS
The Examiner maintained the following grounds of rejection: 3
I. Claims 1, 13, and 19-22 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Bickar,4 Hara,5 and Corey. 6
II. Claims 19-22 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Bickar, Hara, Corey, and Cahill.7
DISCUSSION
I
Claims 1 and 13 are the sole independent claims on appeal. With
regard to Rejection I, Appellants argue the claims as a group. Br. 6-12. In
accordance with 37 C.F.R. § 41.37(c)(l)(iv), we select claim 1 as
representative, and decide the propriety of Rejection I based on the
representative claim alone.
Appellant does not dispute the Examiner's findings that Bickar
discloses a colorimetric assay for protein in blood or urine, using an
indicator composition comprising a protein-reactive dye and a sensitizer.
3 Final Act. 2-5. Ans. 2-6.
4 US 6,338,967 Bl, issued Jan. 15, 2002 ("Bickar").
5 Hara, T., On-line chemiluminescence detection of proteins separated by
capillary zone electrophoresis, 652 J. Chromatography (1993) 361-7.
6 US 5,187,104, issued Feb. 16, 1993 ("Corey").
7 US 5,593,895, issued Jan. 14, 1997 ("Cahill").
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Appeal2014-008150
Application 10/523,865
Compare Final Act. 2-3 with Br. 6-12. Neither does Appellant dispute the
Examiner's further conclusion that one of ordinary skill would have found it
obvious, in light of Corey, to incorporate Bickar' s indicator composition into
a test strip. Compare Final Act. 4 with Br. 6-12. In concluding that such
incorporation would have been obvious, the Examiner acknowledged that
Bickar teaches Eosin Y as the reactive dye, but does not teach Phloxine B or
Rose Bengal as suitable reactive dyes. 8 Final Act. 3. The Examiner found a
suggestion for making the modification based on Hara' s teaching that "Rose
Bengal is more sensitive than Eosin Y for detecting proteins." Id.
Appellant's arguments focus on the Examiner's finding of a
suggestion, in light of Hara, to use Rose Bengal or Phloxine B as the
protein-reactive dye in Bickar's colorimetric protein assay. Br. 6-12. First,
Appellant contends that Bickar's identification of Eosin Y as a suitable
protein-reactive dye is prophetic and non-enabled, and argues on that basis
that the Examiner erred in finding that one of ordinary skill in the art would
have been led by Hara to substitute Rose Bengal for Eosin Y as a protein
indicator. Br. 8. Bickar includes Eosin Y in a list of "Preferred Protein
Dyes." Bickar col. 8, Table 1. That identification in Bickar is persuasive
evidence that one of ordinary skill would have expected to be able to use
Eosin Y in Bickar' s method. Appellant does not point us to countervailing
evidence or technical reasoning to show that use of Eosin Y or any other dye
disclosed in Bickar would have necessitated more than routine
experimentation.
8 Formulas ( 1 )-1 and ( 1 )-2 correspond to Phloxine B and Rose Bengal,
respectively. Spec. 8-9.
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Appeal2014-008150
Application 10/523,865
Moreover, Bickar states that "[a]ny dye which upon binding or
reacting with a protein can undergo a change in spectroscopic properties can
be used for protein determination." Bickar col. 7, 11. 61---63. The Examiner
found that Hara teaches that Rose Bengal and Phloxine B exhibit a
detectable change in spectroscopic property upon interaction with protein.
Final Act. 3--4. Particularly, the Examiner referred to Hara's Figure 2 as
evidence that, for each of Rose Bengal and Phloxine B, "the absorption
spectra is shifted and more intense in the presence of BSA than in the
absence of BSA." Id. at 3. Hara's Figures 2(b) and 2(c) are reproduced
below. , .... "'. . ..... ,, .. I
I
Figure 2(b) is a comparative graphical depiction of the measured
absorption spectra from 400 to 600 nm for Phloxine B with and without the
presence of bovine serum albumin. Figure 2(c) shows the corresponding
absorption spectra for Rose Bengal.
Appellant argues that the spectral shifts shown in Hara "are
insufficient to be properly recognized by a human eye." Br. 10. However,
Appellant's claims, which recite "observing the color ... ", do not require
detection by a human eye. To the contrary, the Specification discloses both
visual detection and detection by measurement using a colorimeter. Spec.
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Application 10/523,865
10-11. Both are forms of "observation," and we find no disclosure in the
Specification limiting the term "observation" to human visual observation.
Additionally, the Examiner responded that "one of ordinary skill in the art
would not only consider separation of the absorption spectra, but would also
consider the absorption peaks, which as displayed by Hara et al., exhibits
[sic] a considerable and distinguishable change in the presence and absence
of albumin." Ans. 7. Appellant did not file a Reply Brief and therefore did
not dispute the Examiner's reasoning regarding Hara's demonstration of
distinguishable changes in absorption peaks. Ultimately, we are persuaded
that Hara's reported absorption spectra data shown in Hara's Figures 2(b)
and 2( c) present ample evidence that the spectroscopic response exhibited by
each of Rose Bengal and Phloxine Bis observable. 9
For the foregoing reasons, we are persuaded that the Examiner's
obviousness determination concerning representative claim 1 is supported by
a preponderance of the evidence before us. We sustain Rejection I.
II
Appellant does not separately contest the Examiner's findings in
connection with Rejection II, other than an implicit reliance on the
arguments discussed above in connection with Rejection I. Br. 12. As such,
9 Appellant's contention that Hara' s reported spectral shift for Rose Bengal
(1 lnm) and Phloxine B (13nm) cannot be distinguished based on color
alone, Br. 9, is inconsistent with the Hara report of a similar spectral shift
(12nm) for Eosin Y, id., which Appellant characterizes in the Specification
as a "[t]ypical example[] of the protein assay indicator of the present
invention," Spec. 3, that visually exhibited "good coloration" upon contact
with protein, id. at 8. Appellant has not addressed this inconsistency.
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Application 10/523,865
we sustain Rejection II for the reasons set forth above in connection with
Rejection I.
DECISION
The Examiner's decision rejecting claims 1, 13, and 19-22 is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
7