Ex Parte UM et al

Patent Trial and Appeal Board

Nov 15, 2018

14513970 (P.T.A.B. Nov. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/513,970 10/14/2014
89980 7590 11/19/2018
NSIPLAW
P.O. Box 65745
Washington, DC 20035
FIRST NAMED INVENTOR
Soong Ho UM
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.
042154.0007 1030
EXAMINER
KRASS, FREDERICK F
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/19/2018 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):
pto@nsiplaw.com
pto.nsip@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SOONG HO UM AND SEUNG WON SHIN
Appeal2017-003300
Application 14/513,970 1
Technology Center 1600
Before DONALD E. ADAMS, DEBORAH KATZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of producing a DNA-lipid particle, which have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
"Liposomes are spherical vesicles in which a phospholipid bilayer
surrounds an aqueous phase filling an inner space of the vesicle." (Spec. 1.)
"[L ]iposomes are receiving attention as a particle structure prepared through
1 Appellant, is the Applicant, RESEARCH & BUSINESS FOUNDATION
SUNGKYUNKW AN UNIVERSITY, which Appellant identifies as the real
party in interest. (See BIB DATA SHEET; Appeal Br. 3.)
Appeal2017-003300
Application 14/513,970
assembly with polymers, drugs, and antigens." (Id. at 2.) The claimed
invention is directed at making particles using water-soluble polymers,
lipids, and an organic solvent.
Claims 12, 14--16, and 23-26 are on appeal. 2 Claim 12 is
representative and reads as follows:
12. A method of producing a particle, comprising:
a) mixing a water-soluble polymer, a lipid, and an
organic solvent to form a mixed solution;
b) preparing an emulsion by stirring the mixed solution
or treating the mixed solution with ultrasonic waves; and
c) removing the organic solvent from an upper layer of
the emulsion by centrifugation of the emulsion,
wherein the water-soluble polymer is a
polydeoxyribonucleic acid crosslinked by covalent bond.
(Appeal Br. 17 .)
The following grounds of rejection by the Examiner are before us on
review:
Claims 12, 14--16, and 23-25 under 35 U.S.C. § 103 as unpatentable
over Irvine, 3 Schneider4 and Tiwari. 5
Claim 26 under 35 U.S.C. § 103 over Irvine, Schneider, Tiwari, and
Payne. 6
2 Claims 17-22 stand withdrawn from consideration. (Appeal Br. 17 .)
3 Irvine et al., US 2010/0323018 Al, published Dec. 23, 2010.
4 Schneider, US 4,224,179, issued Sep. 23, 1980.
5 Tiwari et al., Development and characterization of novel carrier gel core
liposomes based transmission blocking malaria vaccine, 140 J. Controlled
Release, 157---65 (2009).
6 Payne et al., US 4,744,989, issued May 17, 1988.
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Application 14/513,970
DISCUSSION
Obviousness of claims 12, 14-16, and 23-25
The Examiner finds that Irvine teaches making lipid-coated DNA-
hydrogel nanoparticles. (Final Action 3.) The Examiner explains that the
process Irvine teaches does not require the use of organic solvents and
involves mixing dried phospholipid film with an aqueous solution of X-
DNA and a crosslinking agent and then sonicating the mixture. (Id.) The
Examiner explains that Irvine teaches that a solvent-less process allows for
the resultant nanoparticles to be suitable for in vivo use. (Id.) The Examiner
notes, that while a solvent is not required by Irvine, Irvine does not teach
away from the use of a solvent in the process of making a lipid-coated DNA-
hydrogel nanoparticle. (Id.; see also Ans. 5---6.)
The Examiner notes that Schneider teaches a method of preparing
liposomes that uses an organic solvent. (Final Action 3) In the Schneider
method, explains the Examiner, a solution of a phospholipid in an organic
solvent is sonicated with a solution to be encapsulated and then the liposome
precursor formed is centrifuged, which results in the precursor moving from
the organic solvent phase to the aqueous phase crossing the organic-water
interphase that includes a lipid barrier. (Id.) The liposome encapsulating the
desired solution forms during passage through the lipid barrier. (Id.) The
Examiner notes that Schneider "teaches that this method has improved
yields and avoids the need for recovery and replenishment of the
concentration in active ingredients of the initial aqueous liquid." (Id. at 4.)
The Examiner relies on Tiwari for teaching that the method of preparing
liposomes described in Schneider is suitable for preparing gel core
liposomes. (Id.)
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Application 14/513,970
The Examiner contends that it would have been obvious to one of
ordinary skill in the art to have used an organic solvent as taught in
Schneider with the amphiphilic phospholipid and X-DNA of Irvine and then
to have removed the solvent with centrifugation as taught by Schneider
because such a process would have been expected to result in improved
yields and to avoid the "need for recovery and replenishment of the
concentration in active ingredients of the initial aqueous liquid." (Id.)
Appellant argues that the Examiner's rejection is in error for two
reasons. First, Appellant argues that Irvine teaches away from using an
organic solvent. (Appeal Br. 11-13; Reply Br. 2-3.) Second, Appellant
argues that Schneider is a very different process from that described by
claim 12 and thus "[a] person skilled in the art would not have been
motivated to combine Irvine, Schneider, and Tiwari to arrive at claim 12."
(Appeal Br. 14).7
7 In its Reply Brief, Appellant newly argues that the method taught by
Schneider "is not applicable to Irvine and/or Tiwari" because "Schneider's
methods are for preparing a second aqueous liquid containing liposomes that
encapsulate a first aqueous liquid" whereas "Irvine or Tiwari does not
involve encapsulating a first aqueous liquid into a second aqueous liquid."
(Reply Br. 4) "[T]he reply brief [is not] an opportunity to make arguments
that could have been made in the principal brief on appeal to rebut the
Examiner's rejections, but were not." Ex parte Borden, 93 USPQ2d 1473,
1474 (BPAI 2010) (informative). As stated in Ex parte Borden,
consideration by the Board of new arguments presented for the first time in
the Reply Brief that could have been presented earlier would "vitiate the
force of the requirement in Board Rule 37(c)(l)(vii) that '[a]ny arguments or
authorities not included in the brief ... will be refused consideration by the
Board, unless good cause is shown."' Id. Appellant has not demonstrated
any specific Examiner findings presented for the first time in the Answer
necessitating this new argument in rebuttal in the Reply Brief. Nor do we
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Application 14/513,970
We do not find Appellant's arguments persuasive.
We agree with the Examiner that Irvine does not teach away from
using an organic solvent. It is true, as Appellant asserts, that a reference
teaches away from a claimed invention if it "criticize[ s ], discredit[ s ], or
otherwise discourage[ s ]" modifying the reference to arrive at the claimed
invention. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). That is not
what Irvine does, however. Irvine merely explains that an organic solvent is
not needed in some embodiments of its disclosure. (Irvine ,r 26 ("In some
embodiments, the method does not comprise the use of organic solvents."), ,r
96 ("the particles may be synthesized in aqueous conditions without the use
of organic solvents"), and ,r 104 ("The method does not require the use of
organic solvents.").) "A reference does not teach away, [] if it merely
expresses a general preference for an alternative invention but does not
criticize, discredit, or otherwise discourage investigation into the invention
claimed." Galderma Labs., L.P. v. Tolmar, Inc., 731 F.3d 731, 738 (Fed.
Cir. 2013).
Under 35 U.S.C. § 103, a reference must be considered not only for
what it expressly teaches, but also for what it fairly suggests. In re
Lamberti, 545 F.2d 747 (CCPA 1976); In re Simon, 461 F.2d 1387 (CCPA
1972). That Irvine discloses that an organic solvent is not needed in some
embodiments, fairly suggests that an organic solvent can be used. That is
true even though Irvine teaches that when an organic solvent is not used,
there are advantages to the particle so produced, i.e., they are suitable for in
find any substantial differences in the Examiner's initial findings and the
Examiner's findings stated in the Answer that would warrant the new
arguments presented in the Reply Brief for the first time.
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Application 14/513,970
vivo use. (Reply Br. 4 ( quoting Irvine ,r 104).) As Irvine teaches, the
particles are contemplated for in vitro use as well. (Irvine ,r 175.)
Regardless of whether the particles are to be used in vivo, or in vitro,
Schneider teaches that when lipid particles encapsulating another ingredient
are made in the presence of an organic solvent, the solvent is separated from
the particles by classical methods, such as centrifugation. (Schneider 5:37-
43 3:32---60.) In light of the teachings of Irvine and Schneider, it would have
been obvious to have used an organic solvent in the method of Irvine, as
Irvine itself suggests, and it would have been obvious to have removed the
organic solvent from the particles using centrifugation, a classical separation
technique, as taught by Schneider. "It is well-established that the Board is
free to affirm an examiner's rejection so long as 'appellants have had a fair
opportunity to react to the thrust of the rejection."' In re Jung, 637 F.3d
1356, 1365 (Fed. Cir. 2011) (citing In re Kronig, 539 F.2d 1300, 1302---03
( CCP A 197 6)). While the Examiner gave a different reason for relying on
Schneider, we note that the Examiner, nevertheless, pointed Appellant to
disclosure in Schneider that teaches separation of lipid particles from
organic solvent by centrifugation and indicated that such a procedure would
have been obvious to one of ordinary skill in the art to separate the lipid
particles in the aqueous medium from the separate organic solvent phase.
(Final Action 3--4). Thus, we determine that Appellant has had an
opportunity to respond to the thrust of the obviousness of claim 12 as we
articulated it above. 8
8 We further note that while the Examiner relies on Tawari to establish that
the method of Schneider can be used to make gel core liposomes, which is
the particle made in Irvine, we do not find it necessary to rely on the
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Appellant's second argument appears to suggest that Schneider is
non-analogous art because it is "significantly different" than the claimed
invention. (Appeal Br. 13.) We disagree. "Two criteria have evolved for
determining whether prior art is analogous: (1) whether the art is from the
same field of endeavor, regardless of the problem addressed, and (2) if the
reference is not within the field of the inventor's endeavor, whether the
reference still is reasonably pertinent to the particular problem with which
the inventor is involved." In re Clay, 966 F.2d 656, 658-59 (Fed. Cir.
1992). As Appellant acknowledges, Schneider teaches sonicating a mixture
to create particles. (Appeal Br. 13.) We further note that the particles that
are created are lipid based particles obtained from a mixture of water-soluble
polymer, lipid, and an organic solvent. These are the compositional
elements required of claim 12 to form the claimed particles. Thus, we find
that Schneider is in the same field of endeavor as the claimed invention,
even if there are differences between Schneider and claim 12.
For the reasons set forth above, we are not persuaded that the
Examiner erred in rejecting claim 12 as being obvious over Irvine,
Schneider, and Tawari.
Claims 14--16 and 23-25 have not been argued separately and
therefore fall with claim 12. 37 C.F.R. § 4I.37(c)(l)(iv).
teachings of Tawari to affirm the Examiner's obviousness rejection. See In
re Bush, 296 F.2d 491,496 (CCPA 1961) (holding that the Board may rely
on fewer references than relied upon by the Examiner without designating it
as a new ground of rejection).
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Application 14/513,970
Obviousness of Claim 2 6
The Examiner relies on Payne for teaching that the use of ethyl acetate
as the organic solvent for forming liposomes would have been obvious to
one of ordinary skill in the art. (Final Action 5.) Appellant does not contest
the Examiner's findings in this regard. Rather, Appellant argues only that
"Payne does not cure the deficiency that the combination of Irvine,
Schneider and Tiwari lacks to make claim 12 obvious to a person skilled in
the art." (Appeal Br. 14.) For the reasons discussed previously, however,
we do not find Appellant's arguments concerning the alleged infirmity of the
Examiner's rejection of claim 12 over the combination of Irvine, Schneider,
and Tawari persuasive. Thus, we are not persuaded that the Examiner erred
in rejecting claim 26 as being obvious over Irvine, Schneider, Tawari, and
Payne.
SUMMARY
We affirm the rejection of claims 12, 14--16, and 23-25 under 35
U.S.C. § 103(a) as unpatentable over Irvine, Schneider and Tiwari.
We affirm the rejection of claim 26 under 35 U.S.C. § 103(a) over
Irvine, Schneider, Tiwari, and Payne.
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
8