Ex Parte Okamoto et al

Board of Patent Appeals and Interferences

Sep 22, 2010

10522045 (B.P.A.I. Sep. 22, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/522,045 01/19/2005 Masashi Okamoto 10873.1576USWO 4002
52835 7590 09/23/2010
HAMRE, SCHUMANN, MUELLER & LARSON, P.C.
P.O. BOX 2902
MINNEAPOLIS, MN 55402-0902
EXAMINER
SHAW, AMANDA MARIE
ART UNIT PAPER NUMBER
1634
MAIL DATE DELIVERY MODE
09/23/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MASASHI OKAMOTO, TATSUO KAMATA,
YUJI IZUMIZAWA, and ATSUSHI MURAKAMI
____________

Appeal 2010-002788
Application 10/522,045
Technology Center 1600
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1, 4-12, and 14-26,
the only claims pending in this application. We have jurisdiction under 35
U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
The claims are directed to a method of collecting a microorganism or
a cell from a liquid sample. Claim 1 is representative and is reproduced in
“APPENDIX A” of Appellants’ Brief (App. Br. 10).
The rejections presented by the Examiner follow:
1. Claims 1, 4-8, 10-12, 14, 25, and 26 stand rejected under 35 U.S.C
§ 103(a) as unpatentable over the combination of Wardlaw2, Lyman3, and
Tsuchiya4.
2. Claims 9 and 16-24 stand rejected under 35 U.S.C § 103(a) as
unpatentable over the combination of Wardlaw, Lyman, Tsuchiya, and
Britschgi5.
3. Claim 15 stands rejected under 35 U.S.C § 103(a) as unpatentable over
the combination of Wardlaw, Lyman, Tsuchiya, and Krupey6.
We affirm. However, because our rationale differs from the
Examiner’s, we designate the affirmance a new ground of rejection.
ISSUE

Does the preponderance of evidence on this record support a
conclusion of obviousness?
FINDINGS OF FACT
FF 1. “Sato teaches a method of collecting a virus from a liquid sample
using particles[, such as hydrogel particles] capable of being bound by
virus[ ]” (Ans. 3).

2 Wardlaw, US 2001/0033808 A1, published October 25, 2001.
3 Lyman et al., US 4,683,058, issued July 28, 1987.
4 Tsuchiya, US 5,747,277, issued May 5, 1998.
5 Britschgi et al., US 5,726,021, issued March 10, 1998.
6 Krupey et al., US 5,658,779, issued August 19, 1997.
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FF 2. Sato teaches “particles capable of being bound by viruses . . . having
either a cationic group or an anionic group or both at their surfaces” (Sato 1:
¶ [0009]).
FF 3. “The anionic group in . . . [Sato’s particles] may include a carboxyl
group . . . . These anionic groups may be present in the state they have
formed salts” (Sato 4: ¶ [0065] (emphasis added)).
FF 4. Sato’s “carboxyl-containing particles may include polymer or
copolymer particles of a carboxyl group-containing monomer”, such as
“acrylic acid [and] methacrylic acid” (Sato 4: ¶ [0069] (emphasis added)).
FF 5. “Wardlaw teaches a method that uses hydrogels for collecting
microorganisms that are present in a liquid sample” (Ans. 5).
FF 6. Wardlaw teaches that suitable hydrogels include “poly(acrylic acid)
[in Na+form]” and “poly(methacrylic acid) [in Na+form]” (Wardlaw 3:
¶ [0025] (emphasis added, alteration original))
FF 7. Appellants disclose that their “water-absorbing resin is not
particularly limited” and that “[s]pecific examples of the water-absorbing
resin include . . . crosslinking substances of polyacrylate polymer,
crosslinking substance of polymethacrylate polymer . . . [wherein] [s]pecific
examples of polyacrylate include sodium polyacrylate” (Spec. 4: 33 - 5: 13
(emphasis added)).
FF 8. Sato’s “virus-binding particles . . . [are] desirably added to a sample
in the form of a virus-separating reagent prepared by the virus-binding
particles in a medium such as saline” (Sato 7: ¶ [0097] (emphasis added)).
FF 9. “Sato does not teach that the water absorbing resin particles (i.e.
hydrogels) absorb substantially all of the liquid in the liquid phase of the
sample” (Ans. 4-5).
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FF 10. Wardlaw teaches that “it is typically desired to use enough hydrogel
so that essentially all of the water in the sample will be absorbed” (Ans. 5;
see also Wardlaw 4: ¶ [0032] (Wardlaw suggests the use of a hydrogel that
is not in its aqueous equilibrium state so that the hydrogel will absorb the
aqueous phase of a sample placed into contact with the hydrogel).
FF 11. The Examiner finds that “in instances where there is enough
hydrogel to absorb essentially all of the water in the sample, one would not
have to separate the water absorbing particles from the liquid phase prior to
the collecting step” (Ans. 5).
FF 12. “Sato does not teach a method wherein the collecting solution is
contacted with the water absorbing particles without separating the water
absorbing particles from the liquid phase” (Ans. 4-5).
FF 13. Wardlaw teaches that “[i]solation and concentration of formed
constituents[, e.g., microbes, cells, etc.7,] on the hydrogel surface . . . allows
harvesting of specific formed constituents from the hydrogel surface for
further analysis of the harvested constituents” (Wardlaw 2: ¶ [0012]).
FF 14. Sato teaches the use of a collecting solution, e.g., a salt solution, to
disassociate virus from the particles (Ans. 4 (emphasis added)).
FF 15. Appellants disclose that their “collecting solution is not particularly
limited, and may be, for example, water, distilled water, ion exchanged
water, ultrapure water, a buffer, or the like” (Spec. 4: 13-15 (emphasis
added)).
FF 16. Wardlaw teaches that:
It will be appreciated that the examination of various types of
cells or particulates using the centrifugation technique is time-

7 Wardlaw 1: ¶ [0007].
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consuming and requires considerable skill on the part of the
technician. This technique is also not precise due to the loss or
destruction of sample components during centrifugation, and in
the case of urinalysis, the imprecision of the decantation and re-
suspension steps.

(Wardlaw 1: ¶ [0006]).
FF 17. Wardlaw teaches that:
Formed constituents can also be separated from a
biologic fluid sample by filtering. . . . Problems encountered
with this technique include the cost of the various filters; the
need to know the size of the target formed constituents; the
plumbing required to force the sample to flow through the
filter; and the potential of filter clogging.

(Wardlaw 1: ¶ [0007]).
FF 18. Sato teaches that ultracentrifugation is an example of a conventional
method for separating viruses (Sato 1: ¶ [0006]).
FF 19. The Examiner relies on Lyman to teach a “filter tube . . . adapted to
fit within the upper portion of a standard plastic centrifugation tube”,
wherein upon centrifugation of a sample in the centrifugation tube
“permeable materials [are allowed to] pass through the filter and accumulate
at the bottom of the centrifugation tube” (Ans. 6-7).
FF 20. The Examiner relies on Tsuchiya to teach that a person of ordinary
skill in the art would know how to select “a filter with an appropriate pore
size for detecting a particular microorganism” (Ans. 7).
FF 21. The Examiner finds that while Sato teaches that the collected virus
can be used for PCR analysis, Sato is not limited to using the isolated virus
in PCR analysis because Sato teaches that “‘the viruses having been
separated by the particles are used to make nucleic acid extraction,
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examination, and diagnosis, in particular, examination and diagnosis
involving nucleic acid amplification’ (para 0019)” (id. at 15; see also Sato
12: claim 9 (“A method of detecting viruses comprising the steps of . . .
subjecting the viruses bound to the particles, to an immunological assay”))
FF 22. Appellants do “not contest[ ] the relevance of Britschgi to claims 9
and 16-24 nor its suitability for combination with Sato, Lyman and
Tsuchiya” (App. Br. 9).
FF 23. Appellants do “not contest[ ] the relevance of Krupey to claim 15 nor
its suitability for combination with Sato, Lyman and Tsuchiya” (id.).
ANALYSIS
The claims have not been argued separately and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative.
In summary, the forgoing findings of fact establish that Sato teaches a
method of collecting virus from a liquid sample wherein the virus is bound
to hydrogel particles (FF 1). Sato’s hydrogel particles may be polymers of
acrylic acid or a salt form thereof (FF 2-4). “Wardlaw teaches a method that
uses hydrogels for collecting microorganisms that are present in a liquid
sample” (FF 5). Poly(acrylic acid) in sodium form is a suitable hydrogel for
use in Wardlaw’s method (FF 6). Appellants disclose that their water-
absorbing resin is “not particularly limited” and includes resins, such as
“sodium polyacrylate” (FF 7). Accordingly, the combination of Sato and
Wardlaw suggests a resin with in the scope of Appellants’ claim 1.
Sato differs from Wardlaw and Appellants’ claim 1 by suggesting a
desire to use a hydrogel resin that is already in or near its aqueous
equilibrium state, i.e., a hydrogel in a medium such as saline, prior to the
addition of sample (FF 8). Accordingly, Sato does not teach that the water
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absorbing resin particles absorb substantially all of the liquid in the liquid
phase of the sample (FF 9). Wardlaw, however, provides an alternative to
Sato’s method. In particular, Wardlaw suggests the desire to use a hydrogel
that is not in its aqueous equilibrium state (FF 10). Accordingly, Wardlaw
teaches that “it is typically desired to use enough hydrogel so that essentially
all of the water in the sample will be absorbed” (id.).
As the Examiner explains, using a hydrogel in the form suggested by
Wardlaw “one would not have to separate the water absorbing particles from
the liquid phase prior to the collecting step” because essentially all of the
aqueous phase will be absorbed by the hydrogel (FF 11). Therefore, while
Sato does not teach a method wherein a “collecting solution is contacted
with the water absorbing particles without [first] separating the water
absorbing particles from the liquid phase” (FF 12), by modifying Sato with
Wardlaw, Sato’s preliminary separation step that separates the hydrogel
from the aqueous supernatant becomes unnecessary.
Sato and Wardlaw both suggest the removal of a component adhered
to a hydrogel surface (FF 13-14). In particular, Sato teaches the use of a
collecting solution such as a salt solution (FF 14). Appellants disclose that
their collecting solution is “not particularly limited” and includes solutions
such as water, buffer, or the like (FF 15). Accordingly, Sato teaches a
collecting solution within the scope of Appellants’ claim 1. There is no
persuasive evidence and/or argument that Sato’s collecting solution could
not be used to collect a component, e.g., a virus, adhered to a hydrogel as
taught by Wardlaw.
While Wardlaw teaches that constituents, such as cells or particulates,
can be separated from a fluid by centrifugation and/or filtration, Wardlaw
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suggests that these techniques can be problematic for various reasons (FF
16-17). Nevertheless, Sato teaches that ultracentrifugation is a conventional
method for separating virus (FF 18). In this regard, the Examiner relies on
Lyman and Tsuchiya as evidence that a centrifugation tube and filter that
falls with in the scope of Appellants’ claim 1 was known in the art prior to
the date of Appellants’ claimed invention (see FF 19-20).
In view of the foregoing analysis, we agree with the Examiner that
one of ordinary skill in the art would have found it prima facie obvious to
modify Sato to include hydrogels capable of absorbing essentially all of the
water in a sample (see, e.g., Ans. 13-14).
We also agree with the Examiner’s finding that Sato is not limited to
the isolation of virus for PCR analysis (FF 21). Therefore, we are not
persuaded by Appellants’ contentions regarding the use of Sato’s method in
the preparation of a sample for nucleic acid amplification, e.g., PCR. (App.
Br. 5-7).
Appellants contend that “Sato teaches that their particles . . . bind[ , or
specifically bind] and thereby separate[ ] only the viruses for the purposes of
examining and diagnosing the viruses . . . (paragraph [007])” (App. Br. 6;
see also id. at 8 (“Sato specifically teaches that their particles capture only
the viruses, and leads away from using the particles in a manner that would
capture components other than viruses as taught by Wardlaw)). Appellants
have not identified, and we do not find, a requirement in the cited paragraph
of Sato that suggests that Sato’s particles only bind and/or separate virus.
The same is true of Appellants’ citation of Sato’s “paragraph [0020], [0023],
and [0065]” (id.). Accordingly, we are not persuaded by Appellants’
unsupported contentions.
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For the foregoing reasons we are not persuaded by Appellants’
unsupported contention that “[t]he use of hydrogel particles in amounts that
would absorb essentially all of the liquid in the sample as taught by Wardlaw
would in fact frustrate the purposes of Sato”, because “the hydrogel particles
would capture unwanted components that may adversely affect the
amplification reaction of the viral gene, which is often very sensitive to the
presence of other components as indicated by Sato” (App. Br. 7).
We agree with Appellants’ contention that in Sato’s method “the
amount of the [hydrogel] particles is dependent upon the amount of viruses
present in the sample” (App. Br. 8). However, the rejection presented for
our review is the combination of, inter alia, Sato and Wardlaw. As
discussed above, when Sato’s method is modified with Wardlaw’s
alternative hydrogel form the focus is no longer on the relationship between
the virus and hydrogel, as taught by Sato, but instead shifts to the
relationship between the aqueous volume of the sample and the hydrogel as
taught by Wardlaw. Accordingly, we are not persuaded by Appellants’
contention regarding Sato’s teaching of a relationship between virus and the
hydrogel (App. Br. 7-8).
We are not persuaded by Appellants’ contention that “Wardlaw leads
away from the use of centrifugation and filters as taught by Lyman and
Tsuchiya” (App. Br. 8). Appellants have failed to provide persuasive
argument and/or evidence that the problems associated with centrifugation
and filtration discussed in Wardlaw (FF 16-17) are applicable to the isolation
of virus, which as Sato discloses, are conventionally isolated by
ultracentrifugation (FF 18).
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For the foregoing reasons we find no error in the combination of Sato,
Wardlaw, Lyman, and Tsuchiya. Because Appellants do not contest the
relevance of Britschgi or Krupey in combination of Sato, Wardlaw, Lyman,
and Tsuchiya (FF 23-24) we affirm the rejections over Sato, Wardlaw,
Lyman, and Tsuchiya in combination with either Britschgi or Krupey.
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness.
The rejection of claim 1 under 35 U.S.C § 103(a) as unpatentable over
the combination of Sato, Wardlaw, Lyman, and Tsuchiya is affirmed.
Claims 4-8, 10-12, 14, 25, and 26 fall together with claim 1.
The rejection of claims 9 and 16-24 under 35 U.S.C § 103(a) as
unpatentable over the combination of Sato, Wardlaw, Lyman, Tsuchiya, and
Britschgi is affirmed.
The rejection of claim 15 under 35 U.S.C § 103(a) as unpatentable
over the combination of Sato, Wardlaw, Lyman, Tsuchiya, and Krupey is
affirmed.
TIME PERIOD FOR RESPONSE
Because our rationale differs from that of the Examiner, we designate
the affirmance as a new ground of rejection pursuant to 37 C.F.R. § 41.50(b)
(effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286
Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 C.F.R. § 41.50(b)
provides “[a] new ground of rejection pursuant to this paragraph shall not be
considered final for judicial review.”
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37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the Examiner, in which
event the proceeding will be remanded to the Examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record. . . .

AFFIRMED; 37 C.F.R. § 41.50(b)

dm

HAMRE, SCHUMANN, MUELLER & LARSON, P.C.
P.O. BOX 2902
MINNEAPOLIS MN 55402-0902