Ex Parte Matthiesen

Patent Trials and Appeals Board

Mar 21, 2019

14348134 - (D) (P.T.A.B. Mar. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/348,134 03/28/2014
22878 7590
Agilent Technologies, Inc.
Global IP Operations
5301 Stevens Creek Blvd
Santa Clara, CA 95051
03/25/2019
FIRST NAMED INVENTOR
Steen Hauge Matthiesen
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.
09138.0155-00000 2010
EXAMINER
CROW, ROBERT THOMAS
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
03/25/2019 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):
IPOPS.LEGAL@agilent.com
Agilentdocketing@cpaglobal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEEN HAUGE MATTHIESEN 1
Appeal2018-005964
Application 14/348, 134
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134 from the Examiner's
rejection of claims to method for hybridizing nucleic acid sequences, which
have been rejected for failure to comply with the written description
1 Appellant identifies the Real Party in Interest as Dako Denmark A/S.
Appeal Br. 2.
2 We have considered and herein refer to the Specification of Mar. 28, 2014
("Spec."); Final Office Action of July 3, 2017 ("Final Act."); Advisory
Action of Oct. 4, 2017 ("Adv. Act."); Appeal Brief of Dec. 15, 2017
("Appeal Br."); Examiner's Answer of Feb. 1, 2018 ("Ans."); and Reply
Brief of Apr. 2, 2018 ("Reply Br.").
Appeal2018-005964
Application 14/348, 134
requirement, as indefinite, and for non-statutory obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
In hybridization, known segments of nucleic acids and probes or
primers are used to bind or hybridize to a target nucleic acid. Spec. 1. The
Specification describes a hybridization technique that "provides several
potential advantages over prior art hybridization applications, such as faster
hybridization times, higher denaturation temperatures, lower hybridization
temperatures, and less toxic hybridization solvents." Spec. 4.
Claims 27, 28, 31-36, 38,-50, 52-55, and 60-68 3 are on appeal.
Claim 27 is representative and reads as follows:
27. A method of hybridizing nucleic acid sequences
compnsmg:
- providing a first nucleic add sequence,
- providing a second nucleic acid sequence,
- providing a hybridization composition comprising
formamide, and
- combining the first and the second nucleic acid
sequence and the hybridization composition for at least a time
period sufficient to hybridize the first and second nucleic acid
sequences, wherein the time period is less than 4 hours, and
wherein the hybridization is before a stringent wash,
wherein the concentration of formamide is 10% to 25%
v/v·
'
3 Claim 68 was added to the application in an Amendment After Final filed
Sept. 5, 2017. The Examiner rejected claim 68 as indefinite and for non-
statutory obviousness-type double patenting in an Advisory Action mailed
Oct. 4, 2017.
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Application 14/348, 134
wherein the hybridization composition further comprises
15% to 80% w/v of an accelerating agent and 400 mM to 1200
mM of a salt.
The claims stand rejected as follows:
Claims 27, 28, 31-36, 38-50, 52-55, and 60-67 have been rejected
under 35 U.S.C. § 112, first paragraph, for failure to comply with the written
description requirement.
Claim 68 has been rejected under 35 U.S.C. § 112, second paragraph,
as indefinite. 4
Claims 27, 28, 31-36, 38-50, 52-55, and 60-68 have been rejected
for non-statutory obviousness type double patenting over claims 1---6 and
18-54 ofMatthiesen5 as evidenced by Schubart6 and Belogi. 7
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether the Examiner
properly determined that the amended claims contain new matter not
described in the Specification as filed.
In response to a rejection for indefiniteness, Appellant amended the
then pending claims to recite that the percentage of accelerating agent
present in the recited composition is on a weight per volume (wt/v) basis.
4 Claims 27, 28, 31-36, 38-50, 52-55, and 60-67 were also rejected under
35 U.S.C. § 112, second paragraph, as indefinite. Final Act. 4. This
rejection was withdrawn by the Examiner. Ans. 8.
5 Matthiesen, US 9,303,287 B2, issued Apr. 5, 2016 ("Matthiesen").
6 Schubart, US 5,919,894, issued July 6, 1999 ("Schubart").
7 Belogi et al., US 2008/0076923 Al, published Mar. 27, 2008 ("Belogi").
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Application 14/348, 134
Amendment filed Jan. 26, 2016 ("Amend. I"). Appellant argued that the
amendment was supported by the Specification, incorporated the teachings
of Poulsen, 8 and that Poulsen taught the use of dextran sulfate on a wt/v
basis. Amend. I, 7-8. Subsequently, Appellant amended the Specification
to specifically recite the disclosure of Poulsen previously incorporated by
reference, namely, that dextran sulfate was present in a wt/v basis.
Amendment filed June 8, 2017 ("Amend. II").
The Examiner maintained the rejection for written description finding
that the Specification did not contain a teaching that the accelerating agent
was used on a wt/v basis. Final Act. 3. The Examiner maintains that the
amendment to the claims reciting the percentage of accelerating agent in
terms of wt/v represent new matter. Id.
Principles of Law
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must "clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed." In
other words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject
matter as of the filing date.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
( en bane) ( citation omitted, alteration in original).
[T]he test requires an objective inquiry into the four comers of
the specification from the perspective of a person of ordinary
skill in the art. Based on that inquiry, the specification must
8 Poulsen et al., US 2005/0266459 Al, published Dec. 1, 2005 ("Poulsen").
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Application 14/348, 134
describe an invention understandable to that skilled artisan and
show that the inventor actually invented the invention claimed.
Id.
Analysis
We agree with Appellant that the Specification provides adequate
written support of the percentage of accelerating agent being based on wt/v.
The Specification as filed incorporates by reference the teachings of Poulsen
which states that dextran sulfate is used on a wt/v basis in hybridization.
Spec. 24; Poulsen ,r 40. Incorporation by reference can be used to satisfy the
written requirement. 37 C.F.R. § 1.57(c)(l).
Appellant has also amended the Specification to specifically recite the
same disclosure found in Poulsen regarding the use of dextran sulfate.
Amend II, 2 and 8. Thus, the Specification, as amended, now includes an
express discussion of an accelerating agent being used on a wt/v basis.
Finally, Appellant has offered evidence in the form of a Declaration of
Dr. Matthiesen,9 the inventor, who states that one skilled in the art, reading
the present Specification, would understand that the accelerating agent is
used on a wt/v basis. Appeal Br. 6-7; Matthiesen Deel. ,r,r 3-5. Dr.
Matthiesen states that the Specification teaches that dextran sulfate is used as
a solid and that when solids are incorporated into a solution, one skilled in
the art would understand that the percentage recited refers to a wt/v basis.
Id.
9 Declaration of Steen H. Matthiesen Under 37 C.F.R. § 1.132, filed June 8,
2017 ("Matthiesen Deel.").
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Appeal2018-005964
Application 14/348, 134
We find that Appellant has persuasively demonstrated that when read
in context, the Specification supports the conclusion that accelerating agents
are used on a wt/v basis.
The Examiner contends that the teaching that dextran sulfate may be
used on a wt/v basis does not support a finding that any accelerating agent
can be used on a wt/v basis. Ans. 9-10. The Examiner contends that
accelerating agents can be either a solid or a liquid and that dextran sulfate
in not representative of the entire class of agents. Id. The Examiner also
finds Dr. Matthiesen's Declaration unpersuasive in that it does not present
evidence as to whether the present Specification meant to say wt/v. Id. at
10. The Examiner also points to several references where the use of dextran
sulfate is taught on a volume/volume basis. Id. at 11-13. The Examiner
contends that given the fact that the art routinely used both wt/v and v/v, one
skilled in the art would not conclude that the instant Specification refers to
wt/v. Id. at 13.
We have considered the Examiner's arguments and are not persuaded.
As discussed above, the incorporation by reference of Poulsen adds the
teachings of using dextran sulfate on a wt/v basis. Thus, the Specification
describes using an accelerating agent on a wt/v basis. In addition, we find
that Appellant has presented evidence that one skilled in the art, reading the
Specification, would understand that the accelerating agent would be used
on a wt/v basis. Dr. Matthiesen has not only expressed his opinion on this
point, but also given a factual basis for the opinion. Matthiesen Deel. ,r,r 3-
5. Other than the statement that the Examiner does not consider the
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Application 14/348, 134
Declaration to provide evidence, the Examiner has failed to adequately
explain why the Examiner doubts Dr. Matthiesen's testimony.
While we agree with the Examiner that the art appears to use both
wt/v and v/v, we do not find that this supports the conclusion that one skilled
in the art would not understand which basis was meant in the present
Specification. Again, the reference incorporated by reference clearly teaches
the use of an accelerating agent on a wt/v basis. We agree with Appellant
that one skilled in the art reading the entire disclosure in context would
understand that the accelerating agent is to be used on wt/v basis.
Conclusion of Law
We conclude that use of accelerating agents on a weight by volume
basis is adequately described in the Specification and the amendment to the
claims to add that limitation does not constitute new matter.
INDEFINITENESS
Issue
The issue with respect to this rejection is whether the Examiner has
properly concluded that the lack of a basis for the percentage of the
accelerating agent in claim 68 renders the claim indefinite
Claim 68 recites the limitation "wherein the hybridization
composition further comprises 15% to 80% of an accelerating agent."
Appeal Br. 17-18 (Claims App'x). The Examiner finds that the failure to
recite the basis for the percentage of the accelerating agent renders the claim
indefinite. Ans. 7.
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Application 14/348, 134
Appellant contends that a person of ordinary skill in the art would
understand from reading the Specification that the accelerating agent is used
on a wt/v basis and that the claim refers to that basis. Appeal Br. 9--10.
Principles of Law
"The standard of indefiniteness is somewhat high; a claim is not
indefinite merely because its scope is not ascertainable from the face of the
claims." Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342
(Fed. Cir. 2003). Rather, "[a] claim is indefinite if, when read in light of the
specification, it does not reasonably apprise those skilled in the art of the
scope of the invention." Id.
Analysis
We agree with Appellant that claim 68 is not indefinite. As discussed
above, the Specification teaches that at least one accelerating agent is used
on a wt/v basis. In addition, Appellant has presented persuasive evidence
that one skilled in the art would interpret the teachings of the Specification
as calling for the use of an accelerating agent on a wt/v basis. Based on the
foregoing, we conclude that one skilled in the art would interpret claim 68 as
calling for a percentage of an accelerating agent on a wt/v basis.
Conclusion of Law
We conclude that the Examiner has not established that claim 68 is
indefinite.
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Appeal2018-005964
Application 14/348, 134
OBVIOUSNESS-TYPE DOUBLE PA TENTING
Issue
The issue with respect to this rejection is whether the Examiner has
shown that the claims of the present application are not patentably distinct
from claims 1---6 and 18-54 of Matthiesen as evidenced by Schubart and
Belogi.
Claim 1 of Matthiesen reads:
1. A composition comprising at least one polar aprotic solvent
in an amount effective to enable hybridization of a nucleic
acid sequence to an RNA sequence within a cell in a sample
having a preserved cell morphology, and at least 10%
dextran sulfate, wherein the polar aprotic solvent is not
dimethyl sulfoxide (DMSO).
The Examiner finds that pending claims are not patentably distinct
from those of Matthiesen "because both sets of claims contain the same
limitations ( e.g., reaction times, salts, accelerating agents, concentrations
and temperatures, and formamide )." Final Act. 6. The Examiner finds that
the additional elements recited in the present claims would have been
discovered through routine experimentation and, absent evidence of
unexpected results, would have been obvious. Id. at 7.
Appellant contends that the present claims are patentably distinct in
that the claims of Matthiesen do not recite a hybridization composition that
contains formamide in the claimed concentration. Appeal Br. 10. Appellant
points to claims 7-10 of Matthiesen as teaching that either formamide is not
to be used or to be used at concentration less than the concentration recited
in the present claims. Id. Appellant also argues that the fact that the claims
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Application 14/348, 134
of Matthiesen may dominate the present claims is not sufficient to establish
double patenting.
Principles of Law
Obviousness-type double patenting entails a two-step analysis. First,
the allegedly conflicting claims are construed and, second, the difference(s)
between the claims are considered to determine whether the claims are
patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955,
968 (Fed. Cir. 2001 ). "A later patent claim is not patentably distinct from an
earlier patent claim if the later claim is obvious over, or anticipated by, the
earlier claim." Id.
"[T]he analysis in the Pfizer decision shows that obviousness-type
double patenting encompasses any use for a compound that is disclosed in
the specification of an earlier patent claiming the compound and is later
claimed as a method of using that compound." Sun Pharm. Industries Ltd. v.
Eli Lilly & Co., 611 F.3d 1381, 1386 (Fed. Cir. 2010) (citing Pfizer, Inc. v.
Teva Pharms. USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008)).
Analysis
We find that the Examiner's finding of obviousness-type double
patenting is correct. Claim 1 of Matthiesen claims a composition that
contains a polar aprotic solvent and at least 10% dextran sulfate. Matthiesen
col. 50, 11. 56-61. While Matthiesen does not list a specific amount of
solvent, the claim refers to an amount effective to enable hybridization. Id.
Matthiesen teaches that the amounts of polar aprotic solvent can range from
1 % to 95% (v/v) with concentrations of 1 % to 5%, 5% to 10%, 10%, 10% to
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Application 14/348, 134
20%, 20% to 30%, 30% to 40%, 40% to 50%, or 50 to 60 % being suitable.
Matthiesen col. 3, 1. 64- col. 4, 1. 5. Schubart and Belogi teach that
fonnamide is a polar aprotic solvent. Schubart col. 5, 11. 10-20; Belogi ,r 38.
The compounds recited in claim 1 of Matthiesen overlap with the
compounds used in the claimed method.
In addition, claim 1 specifically refers to the use of the compound to
hybridize a nucleic acid sequence to an RNA sequence. Matthiesen col. 50,
11. 5 6-57. Thus, the claim itself suggests the method recited in the present
claims. As such, the present method claims are not patentably distinct from
the product claims of Matthiesen.
Appellant's arguments with respect to formamide are not persuasive.
While we agree that claims 7-10 either teach against using formamide or
using a lower amount, as shown above, the teachings of claim 1 embrace the
claimed method including the use of formamide in the claimed amounts.
Moreover, as the Examiner has pointed out, the rejection is not based on
claims 7-10. Ans. 15.
Conclusion
We conclude that the Examiner correctly determined that claim 2 7 is
not patentably distinct from claims 1---6 and 18-54 of Matthiesen as
evidenced by Schubart and Belogi.
Claims 28, 31-36, 38-50, 52-55, and 60---68 have not been argued
separately and therefore fall with claim 27. 37 C.F.R. § 4I.37(c)(l)(iv).
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Application 14/348, 134
SUMMARY
We reverse the rejection under 35 U.S.C. § 112, first paragraph.
We reverse the rejection under 35 U.S.C. § 112, second paragraph.
We affirm the rejection for non-statutory obviousness-type double
patenting.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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