Ex Parte Lindstrom

Patent Trial and Appeal Board

Feb 19, 2019

14320431 (P.T.A.B. Feb. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/320,431 06/30/2014
22878 7590
Agilent Technologies, Inc.
Global IP Operations
5301 Stevens Creek Blvd
Santa Clara, CA 95051
02/21/2019
FIRST NAMED INVENTOR
Derek Lee Lindstrom
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.
20130226-02 6113
EXAMINER
SISSON, BRADLEY L
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
02/21/2019 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 DEREK LEE LINDSTROM
Appeal2018-000914
Application 14/320,431
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to
methods of combining nucleic acid fragments. The Examiner rejected the
claims as failing to comply with the written description requirement, as
lacking utility, and as failing to comply with the enablement requirement.
We have jurisdiction under 35 U.S.C. § 6(b ). We reverse.
1 Appellant identifies the Real Party in Interest as Agilent Technologies, Inc.
(see App. Br. 2).
2 We have considered and herein refer to the Specification of June 30, 2014
("Spec."); Final Office Action ofNov. 21, 2016 ("Final Act."); Appeal Brief
of Apr. 6, 2017 ("App. Br."); Examiner's Answer of Sept. 6, 2017 ("Ans.");
and Reply Brief of Nov. 6, 2017 ("Reply Br.").
Appeal2018-000914
Application 14/320,431
Statement of the Case
Background
"Many methods have been developed to ligate double stranded DNA
fragments into larger molecules. Assembly methods that allow the user to
dictate the order and orientation of the assembled fragments ... rely on the
specific hybridization of short single-stranded overhangs" (Spec. 1 ).
The Claims
Claims 1 and 3-20 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A method of combining nucleic acid fragments,
compnsmg:
(a) providing two double-stranded DNA molecules
having a common sequence, wherein the common sequence is
at the end of each molecule;
(b) nicking one strand in the common sequence of both
molecules at a respective nicked site with one or more Cas9
nicking enzymes;
( c) moderately denaturing both molecules to remove a
single-stranded fragment from the nicked site to said end of
each molecule, wherein the single-stranded fragment includes
4-30 bases of the common sequence, resulting in an
overhanging sequence in each molecule, and the overhanging
sequences in both molecules are complementary to each other;
and
(d) allowing the overhanging sequences of both
molecules to anneal to each other, and ligating the molecules.
The Issues
A. The Examiner rejected claims 1 and 3-20 under 35 U.S.C. § 112(a),
written description (Final Act. 3-8).
B. The Examiner rejected claims 1 and 3-20 under 35 U.S.C. § 101 and
112(a) enablement as lacking utility (Final Act. 12-16).
2
Appeal2018-000914
Application 14/320,431
A. 35 US.C. § l 12(a), written description
The Examiner rejected the claims as lacking a written description of
the claimed genus of double-stranded DNAs. The Examiner finds:
While an applicant is not required to teach each and every
possible embodiment encompassed by the claims, the
specification still must provide a full, clear, and concise
description of the genus encompassed by the claims so that one
would be readily able to determine if a species fell within the
claims' scope, and to also reasonably suggest that applicant had
possession of the invention at the time of filing.
(Final Act. 6).
We find that the Examiner erred. As Appellants correctly point out,
the claims are drawn to "a platform technology for combining nucleic acids,
which technology is not dependent on particular sequence requirement"
(App. Br. 4). See Palko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed.
Cir. 2006). "[T]he determination of what is needed to support generic
claims to biological subject matter depends on a variety of factors, such as
the existing knowledge in the particular field, the extent and content of the
prior art, the maturity of the science or technology, the predictability of the
aspect at issue." Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
There can be no reasonable dispute that the method would function
with any DNA sequence containing a protospacer adjacent motif (PAM),
whether one of the millions described in the publicly available literature or
one newly sequenced today (see Spec. 9). Appellants are not claiming that
the genus of DNA molecules are new, but rather the application of the
method to ordinary double-stranded DNA. The genus of DNA molecules
are thus fully described since it is the double-stranded structure which is
necessary for the method to work. Thus, we can discern no reason why a
3
Appeal2018-000914
Application 14/320,431
description of the DNA molecules is lacking. Similarly, the Specification
teaches that any Cas9 nickase enzyme among those described and well-
known would function (see Spec. 10).
B. 35 US.C. § 101 and l 12(a), enablement
The Examiner finds:
the claimed method can result in the production of a nucleic
acid having "any sequence." The fact that the end product can
be virtually any nucleic acid is not considered to satisfy the
specific utility requirement of MPEP 2107.01 II A. The case at
hand is deemed to be analogous to scenario set forth in MPEP
2107.01 II B (D) in that method of making a material that itself
has no specific, substantial, and credible utility is not
considered to satisfy the substantial utility requirement.
(Final Act. 15-16).
We find the Examiner erred. As Appellants correctly point out the
"present methods are, inter alia, useful research tools as well - as would be
apparent to one skilled in the art, the present methods represent a step
forward in genetic engineering, as they provide new techniques for
combining two DNA molecules that have a common sequence" (App. Br. 7).
"[T]o satisfy the 'substantial' utility requirement, an asserted use must
show that that claimed invention has a significant and presently available
benefit to the public." In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005).
There can be no reasonable dispute that a general method that joins
two nucleic acids, whether by restriction enzyme cleavage followed by
ligation with DNA ligase, fusion polymerase chain reaction, or the instantly
claimed Cas9 process, has specific, substantial, and credible utilities
4
Appeal2018-000914
Application 14/320,431
immediately recognizable by the ordinary molecular biologist for use in
cloning and other procedures.
Therefore, because there is substantial, specific, and credible utility in
performing the generic method of ligation using a Cas9 nicking enzyme, we
reverse the Examiner's erroneous utility and enablement rejections.
SUMMARY
In summary, we reverse the rejection of claims 1 and 3-20 under
35 U.S.C. § 112(a), written description.
We reverse the rejection claims 1 and 3-20 under 35 U.S.C. § 101 and
112(a) enablement as lacking utility.
REVERSED
5