Ex Parte Donner et al

Patent Trials and Appeals Board

Apr 12, 2019

13182691 - (D) (P.T.A.B. Apr. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/182,691 07/14/2011 Horst Donner
67491 7590 04/16/2019
DINSMORE & SHOHL, LLP
FIFTH THIRD CENTER
ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402
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.
RMD0011
NA/24052-US- l
CONFIRMATION NO.
6900
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
04/16/2019 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):
daytonipdocket@dinsmore.com
pair_roche@firsttofile.com
j ackie.pike@roche.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HORST DONNER, FRANK BERGMANN,
NINA LASSONCZYK, MANFRED WATZELE, and
MARCUS SCHMID 1
Appeal2018-005767
Application 13/182,691
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
DAVID COTTA, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims that comprise a solvent for absorbing
nucleic acids on to a solid phase. The Examiner rejected the claims under 35
U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant appeals
the Examiner's determination that the claims are unpatentable. We have
jurisdiction for the appeal under 35 U.S.C. § 6(b). The Examiner's decision
is affirmed.
1 The Appeal Brief ("Appeal Br." entered Sept. 22, 2017) lists ROCHE
MOLECULAR SYSTEMS, INC as the real-parties-in-interest. Appeal Br.
1.
Appeal2018-005767
Application 13/182,691
STATEMENT OF THE CASE
The claims in this appeal are directed to methods for absorbing
nucleic acids on to a solid phase (independent claims 35, 45, 66),
compositions to utilize in the method (independent claims 25, 67), and kits
to use in the method (independent claim 50). All of the claims comprise
tetraethylene glycol dimethyl ether ("TDE") which is a solvent that enables
the adsorption of a nucleic acid to a solid phase. Spec. 4:8-9; 16: 1-3.
The claims stand rejected by the Examiner as follows:
1. Claims 25, 30-34, 45--46, 52-53, and 60-62 under 35 U.S.C.
§ I03(a) as obvious in view of Kojima et al. (US. 2002/0192667 Al,
published Dec 19, 2002) ("Kojima"), Yamashita et al. (US 2005/0123965
Al, June 9, 2005) ("Yamashita"), Berkelman (US 2006/00166368 Al,
published July 27, 2006) ("Berkelman"), Sprinzl et al. Compilation of tRNA
sequences and sequences of RNA genes, Nucleic Acid Research, 26( 1) 148-
153 (1998) ("Sprinzl"), and Liu et al. Proceedings National Academy of
Science, 101(26) 9740-9744 (2004) ("Liu"). Ans. 2.
2. Claim 54 under 35 U.S.C. § I03(a) as obvious in view of Kojima,
Yamashita, Berkelman, Sprinzl, and Liu, as applied for claims 25 above, and
further in view of Smith et al. (US 2002/0086326 Al, published July 4,
2002) ("Smith"). Ans. 9.
Appellants' arguments only addressed independent claim 25, but list
Smith (which was only cited in connection with the rejection of dependent
claim 54) among the art applied by the Examiner. (Appeal Br. 14).
Consequently, we have considered both rejections together. Appellants also
did not argue the claims separately. The claims therefore stand or fall
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Application 13/182,691
together. 37 C.F.R. § 4I.37(c)(l)(iv). We have selected claim 25 as
representative to decide both rejections. Claim 25 is reproduced below:
25. A composition for isolating nucleic acids from a biological
sample, the composition comprising between about 20% and
26% tetraethylene glycol dimethyl ether ("TDE") by volume,
an aqueous buffer, a chaotropic agent, lysed biological sample
comprising nucleic acids and other sample components, and a
solid phase having the nucleic acids adsorbed thereon.
DISCUSSION
The Examiner found that Yamashita describes methods and
compositions for isolating nucleic acids which include utilizing an organic
solvent "having two to ten carbon atoms that are selected from aliphatic
ethers, aliphatic esters, and aliphatic ketones." Ans. 5. The claimed species
of tetraethylene glycol dimethyl ether ("TDE") is included in this group, but
it is not specifically named. Id. The Examiner found that one of the
preferred examples is diethylene glycol dimethyl ether, which is also known
as "diglyme." Id. The Examiner found that Kojima also describes utilizing
diglyme to isolate nucleic acid. Ans. 6.
The Examiner acknowledged that neither of Yamashita and Kojima
specifically disclose the claimed species of tetraethylene glycol dimethyl
ether ("TDE"). However, the Examiner found that Yamashita and Kojima
each "suggest the use of aliphatic ethers [of two to ten carbon atoms],
including glyme [ ethylene glycol dimethyl ether] and diglyme [ diethylene
glycol dimethyl ether], in the isolation of nucleic acids, thus suggesting to
one of skill in the art other members of the glyme family in solvents for
isolation of nucleic acids," including the claimed species which is a
tetraglyme. Ans. 7. As evidence that tetraglymes were known and part of
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the series of glymes described in Yamashita and Kojima, the Examiner
identified Berkelman as disclosing diglyme, triglyme, or tetraglyme [the
claimed TDE] as a solvent in coupling a dye to a protein. Id.
The Examiner cited the Manual of Patent Examination and Practice
("MPEP") as disclosing that a prima case of obviousness can be made based
on structural similarities between compounds, leading to the expectation that
the compounds with similar structures would have similar properties. Ans.
8. The Examiner concluded it would have been obvious to one of ordinary
skill in the art to have used a tetraglyme in the nucleic acid isolation method
of Yamashita and Kojima with a reasonable expectation of success because
the two publications teach that structurally related compounds ( e.g., glyme,
diglyme) are useful in nucleic acid isolation. An. 8-9. The Examiner found
one of ordinary skill in the art would have reasonably expected that the
claimed tetraethylene glycol dimethyl ether ("TDE"), which is tetraglyme,
would have similar properties. Id.
The Examiner also cited Sprinzl and Liu for teaching isolation of
RNAs (Ans. 8), but these teachings are not in dispute and were not
challenged by Appellants in their briefs.
Appellants argue that "although TDE falls within the broad disclosure
of aliphatic ethers having 1-10 carbons of Yamashita, Kojima provides very
specific guidance for the selection of Diglyme, and unequivocally teaches
away from both the supposed general equivalence of the glyme family as
organic solvents for extraction of nucleic acid, and the specific modification
of substitution the Diglyme of Yamashita and Kojima with the Tetraglyme
of Berkelman." Appeal Br. 15. Appellants state that Kojima teaches that "a
relatively low viscosity (relative to that of ethanol) is important/significant
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Application 13/182,691
to achieving the yield and duration of the adsorption process as achieved by
Kojima with Diglyme." Id. at 16. Appellants argue that "this relatively low
viscosity is a feature shared by all the aliphatic ethers set forth by Yamashita
as preferred for nucleic acid extraction methods." Id. Furthermore,
Appellants state that "[n]either Triglyme nor Tetraglyme, both longer linear
aliphatic ethers, are specifically disclosed as suitable by either reference."
Id. Appellants contend that "long linear organic compounds would be
expected by a person of ordinary skill in the art to possess high viscosity
coefficients, and the viscosity coefficient of ... Tetraglyme (TDE) is
reported as between 3.3 and 4.0, nearly 400% higher than the viscosity of
the ethanol standard taught by Kojima." Id. at 16-17. For this reason,
Appellants argue that Kojima teaches away from replacing the diglyme with
the claimed tetraglyme. Id. at 17.
We begin addressing this argument by reproducing the passage in
Kojima relied upon by Appellants in their "teaching away" argument.
Kojima teaches:
As compared with ethanol, namely a compound
representative of the alcohols described in Tokuhyo No.
501321/1996, the additive solution Diglyme applied in the
present invention is lower in viscosity and, therefore, the
viscosity of the mixed solution in the adsorption process
becomes lower, hence the resistance against passage thereof
through the column 14 becomes lower, as evidenced by the
result that the time required for adsorption process is shortened
by 10 seconds. Foaming is also prevented, hence the degree of
contamination decreased, and the adsorption operability
improved.
Kojima ,r 118.
Kojima discloses in this paragraph that the passage of a solution
through a column is shortened by ten seconds when "the additive solution
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Diglyme" is applied to a column as compared to using ethanol. Id. Kojima
teaches that this result is because "the additive solution Diglyme applied in
the present invention is lower in viscosity and, therefore, the viscosity of the
mixed solution in the adsorption process becomes lower, hence the
resistance against passage thereof through the column 14 becomes lower."
Id.
The rejected claims, however, are not limited to using a column with
the solid phase support on which nucleic acid adsorption is accomplished.
Ans. 11, 16. Neither Kojima nor Yamashita are limited to utilizing a column
containing the nucleic acid adsorption support (Kojima ,r 9; Yamashita ,r 9).
Appellants did not provide persuasive evidence that one of ordinary skill in
the art would have understood that the benefit of using a low viscosity
solution when using a column comprising the adsorption support applied to
other procedures where the support was used without a column, for instance,
in a test tube. Appellants' argument is not commensurate with the full scope
of claim 25.
In addition, as noted by the Examiner, Appellants disclosed the
viscosity of diglyme, triglyme, and tetraglyme in the Appeal Brief, but did
not provide objective evidence of these values (Ans. 14--15), such as in a
declaration by an expert and/or the source of the viscosity values cited in the
Appeal Brief. The Appeal Brief did not even list the units of the viscosity
values. Appellants also state that the "relatively low viscosity is a feature
shared by all the aliphatic ethers set forth by Yamashita as preferred for
nucleic acid extraction methods," but provide no objective evidence to
support this assertion. Appeal Br. 16. An argument made by counsel in a
brief does not substitute for evidence lacking in the record. Estee Lauder,
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Application 13/182,691
Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). Even if diglyme
was considered to have advantages over other compounds disclosed in
Yamashita and Kojima, each of these publications disclose a genus of
compounds which include the claimed tetraglyme/TBE and which are
described as useful in their nucleic acid isolation methods. Kojima ,r,r 11-
12; Yamashita ,r,r 20-21. Ethanol, which was disclosed to have a higher
viscosity than the diglyme, was disclosed by Kojima to work in the isolation
procedure. Kojima 117. There is no evidence that increasing the viscosity
of the solvent- e.g., by suing a solvent other than diglyme -would make the
isolation procedure inoperable. In re ICON Health and Fitness, Inc., 496
F.3d 1374, 1381 (Fed. Cir. 2007) ("[A] reference may teach away from a use
when that use would render the result inoperable.").
Appellants have not identified persuasive evidence that other
compounds within the broad genus disclosed in Yamashita and Kojima were
disparaged in any way when used in a nucleic acid isolation procedure. As
found by the Examiner, "a reference that does 'not criticize, discredit, or
otherwise discourage investigation into the invention claimed,' does not
teach away."' Ans. 6 (citing Depuy Spine, Inc. v. Medtronic Sofamor
Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009), 16. A "finding that prior art as
a whole suggests the desirability of a particular combination need not be
supported by a finding that the prior art suggests that the combination
claimed by the patent applicant is the preferred, or most desirable,
combination." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
In the Reply Brief, Appellants argued that there is "a fundamental
fallacy that just because molecules share a repeating unit [as in the glyme,
diglyme, triglyme, and claimed tetraglyme], they are therefore 'similar' in
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structure and share a predictable composition behavior)." Reply Br. 2-3.
This a new argument made in Reply Brief. The Examiner had previously
rejected the claims based on the finding that similar structures would be
expected to have similar properties. Final Act. 14--15. Appellants did not
address this finding in the Appeal Brief, but waited until the Reply Brief to
reply. The argument is therefore waived because it was first raised in the
Reply Brief. 37 C.F.R. § 41.41(a)(2). Even ifwe were to consider
Appellants' improperly raised argument, we would not be persuaded that the
Examiner erred. Appellants did not provide persuasive evidence that would
undermine the Examiner's finding that TBE would be expected to have
similar properties to diglyme and the other related compounds disclosed in
the Yamashita and Kojima publications.
Appellants contend that "[t]hroughout examination of the rejected
claims Appellant cited to data set forth in the instant application as well as in
Yamashita and Kojima showing that among the polyether family referenced
by Yamashita, TDE yielded surprisingly superior results, in particular for
differential extraction processes." Reply Br. 2.
In the Appeal Brief, Appellants state:
The present inventor surprisingly discovered that tetraethylene
glycol dimethyl ether ("TDE" or "tetraglyme"), a compound
that is environmentally non-toxic and safe to work with under
laboratory conditions, provides excellent yield in the recited
nucleic acid isolation/purification methods. In addition, the
present inventors further surprisingly discovered that adding
glycerol formal to the TDE compositions enhances yield across
a wide range of TDE concentrations.
Appeal Br. 3.
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Appellants did not identify objective data to support these assertions
of surprising and excellent results. The claims also do not require the
addition of glycerol.
An applicant cannot prove unexpected results with
attorney argument and bare statements without objective
evidentiary support. See In re Lindner, 59 C.C.P.A. 920,457
F.2d 506,508 (CCPA 1972); In re Geisler, 116 F.3d 1465 (Fed.
Cir. 1997) ("attorney argument [is] not the kind of factual
evidence that is required to rebut a prima facie case of
obviousness"); In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995)
("It is well settled that unexpected results must be established
by factual evidence. Mere argument or conclusory statements
... [do] not suffice.") (quoting In re De Blauwe, 736 F.2d 699,
705 (Fed. Cir. 1984)).
CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003).
Thus, while we have considered this argument, we find it
unpersuasive.
For the foregoing reasons, the obviousness rejection of claim 25 is
affirmed. Claims 30-34, 45--46, 52-54, and 60-62 fall with claim 25
because separate reasons for their patentability were not provided.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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