Ex Parte WILLIAMS et al

Patent Trial and Appeal Board

Oct 24, 2018

14621337 (P.T.A.B. Oct. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/621,337 02/12/2015
108197 7590 10/26/2018
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Robert 0. WILLIAMS III
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.
UTSB.Pl039US.Cl 9199
EXAMINER
VANHORN, ABIGAIL LOUISE
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
10/26/2018 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT 0. WILLIAMS III, KEITH P. JOHNSTON,
PRAPASRI SINSWAT, JASON T. MCCONVILLE,
ROBERT TALBERT, JAY I. PETERS, ALAN B. WATTS, and
TRUE L. ROGERS 1
Appeal2017-003283
Application 14/621,337
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmacological composition which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ). 2
We REVERSE.
1 Appellants identify the Real Party in Interest as The Board of Regents of
the University of Texas System and its exclusive licensee, Lung
Therapeutics, Inc. Appeal Br. 3.
2 An oral hearing was held on Oct. 16, 2018. A transcript of the hearing will
be added to the file when it becomes available.
Appeal2017-003283
Application 14/621,337
STATEMENT OF THE CASE
"The treatment of solid organ transplants, especially lung transplants,
with the currently available immunosuppressive drugs is limited due to poor
penetration into the lung following oral or intravenous administration,
associated with significant adverse effects following long term treatment."
Spec. 1. While pulmonary formulations of immunosuppressant have been
developed, they often involve use of solvents such as ethanol or propylene
glycol which have proved to be unsatisfactory. Id. The Specification
describes "improved pharmaceutical compositions that include rapidly
dissolving nanoparticles of tacrolimus that are administered by pulmonary
delivery." Spec. 2.
Claims 45-62 are on appeal. Claim 45 is illustrative and reads as
follows:
45. A pharmaceutical composition comprising
immunosuppressive drug-containing nanoparticles, the
nanoparticles comprising an amorphous immunosuppressive
drug and a carbohydrate, said nanoparticles prepared by a
process comprising mixing the amorphous immunosuppressive
drug with the carbohydrate; and ultra-rapid freezing the drug
and carbohydrate into a high potency amorphous nanoparticle
by ultra-rapid freezing on a solid substrate.
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Appeal2017-003283
Application 14/621,337
The claims stand rejected3 as follows:
Claims 45--47 have been rejected under 35 U.S.C. § I03(a) as
unpatentable over Williams4 in view of Straub. 5
Claims 45-62 have been rejected under 35 U.S.C. § I03(a) as
unpatentable over Williams in view of Straub in further view of Iacono. 6
DISCUSSION
While Appellants have argued the rejections separately, the arguments
presented are identical for both rejections. Appeal Br. 12. Therefore, we
review the rejections together.
The Examiner finds that Williams teaches the production of
nanoparticles and micro-particles by spray freezing into a liquid. Final Act.
4. The nanoparticles may include an immunosuppressant such as
cyclosporine and an excipient. Id. The Examiner finds that the resulting
3 Claims 45-53 and 55-62 were rejected on the grounds of non-statutory
obviousness-type double patenting over US 9,044,391 B2, issued June 2,
2015. That rejection was withdrawn after Appellants filed a terminal
disclaimer. Advisory Act. Mailed Aug. 8, 2016.
4 Williams III et al., US 2003/0041602 Al, published Mar. 6, 2003
("Williams").
5 Straub et al., US 2002/0142050 Al, published Oct. 3, 2002 ("Straub").
6 Iacono, US 2002/0006901 Al, published Jan 17, 2002 ("Iacono").
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Appeal2017-003283
Application 14/621,337
particles "permit for an effective dry-powder inhalation therapy for both
short and long term release of the therapeutics." Id.
The Examiner finds that Williams does not teach the use of lactose as
an excipient, however, the Examiner finds that Straub provides this teaching.
Final Act. 5. The Examiner concludes that
It would have been obvious to one of ordinary skill in the
art at the time of the instant invention to combine the teachings
of Williams et al. and Straub et al. and utilize porous matrices of
sugars such as lactose and drugs such as cyclosporine and/or
tacrolimus to form aggregated nanoparticles. One of ordinary
skill in the art would have been motivated to formulate matrices
of these ingredients in order to develop formulations which
maintain the cyclosporine and/or tacrolimus in amorphous form
for inhalation as suggested by Straub et al. One of ordinary skill
in the art would have been motivated to utilize excipients such as
lactose in order to enhance the dissolution of the active ingredient
( cyclosporine) as taught by Straub et al. and suggested by
Williams et al.
Final Act. 6.
The Examiner further finds that the claims are recited in a product by
process format. Final Act. 6. The Examiner finds that "[a]bsent a
demonstration of structural differences between aggregated amorphous
nanoparticles made by ultra-rapid freezing [as] opposed to the spray freezing
into liquid as taught by Williams et al., the process limitations are given little
patentable weight." Id. at 7.
Appellants contend that the use of ultra-rapid freezing as recited in the
claims does in fact produce a structurally different product. In support of
this contention Appellants offer the Declaration of one of the inventors, Dr.
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Appeal2017-003283
Application 14/621,337
Williams. 7 Dr. Williams testified that the use of ultra-rapid freezing
("URF") "always results in interconnected/matrix particle
morphology/geometries since it does not utilize atomization of a feed liquid
into extremely high surface area droplets within the cryogenic liquid."
Williams Deel. ,r 4. Dr. Williams also testified that the spray freezing into
liquid ("SFL") technique used in Williams "never results in the formation of
interconnected/matrix particle morphologies/geometries because of the
extremely high turbulence of the feed liquid, turbulent boiling of liquid
nitrogen at atmospheric conditions (Leidenfrost) and extremely high
atomization pressures that must be used to prevent freezing at the tip of the
atomizing nozzle." Id. Dr. Williams supports his conclusion by citing to
Yang. 8 Id. ,r 5.
The issue before us is whether the process limitations in the claims
distinguish the present invention from the prior art, namely Williams.
Generally, process limitations in a product by process claim are given
little if any weight in determining patentability. In re Nordt Devel. Co. LLC,
881 F.3d 1371, 1374 (Fed. Cir. 2018) (citing In re Thrope, 777 F2d 695,697
(Fed. Cir. 1985)). "If the process limitation connotes specific structure and
may be considered a structural limitation, however, that structure should be
considered." Id. (citing In re Garnero, 412 F.2d 276,279 (CCPA 1969)).
7 Declaration of Robert 0. Williams III, PhD., filed July 29, 2016
("Williams Deel.").
8 Yang et al., High bioavailability from nebulized itraconazole nanoparticle
dispersions with biocompatible stabilizers, 361 Int'l J. Pharm. 177
(2008)("Yang").
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Appeal2017-003283
Application 14/621,337
The claims at issue in Nordt recited the limitation that the product be
injection molded. Id. at 1375. The Board held that the term "injection
molded" was a process limitation and did not accord the limitation any
weight in determining the patentability of the product-by-process claims. Id.
The Federal Circuit vacated the Board's decision and remanded for
reconsideration. Id. at 1376. The Federal Circuit found that while the
application described injection molding as a process of manufacture, the
Specification also taught that the process produced products that were
structurally different than those produced by other processes. Id. at 1375.
In the present case Appellants have offered persuasive evidence that
the ultra-rapid freezing process produces a structurally different nanoparticle
than those produced by spray-freezing into liquid. Dr. Williams has testified
that ultra-rapid freezing always produces interconnected/matrix particle
morphology/geometries whereas spray freezing into liquid never produces
such particles. Williams Deel. ,r 4. We therefore agree with Appellants that
the limitation calling for the product to be produced by ultra-rapid freezing
connotes a structural limitation and distinguished the claimed invention from
the prior art.
The Examiner contends that while ultra-rapid freezing may produce a
different structure, the claims fail to recite that structure. Ans. 3--4. The
Examiner argues the data presented in Yang is not persuasive in that the
compositions tested were not the same. Ans. 4 and 7-8. The Examiner also
argues that the Williams declaration is unpersuasive in that the claims do not
recite the structural differences produced by ultra-rapid freezing. Ans. 5-6.
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Appeal2017-003283
Application 14/621,337
We have considered the Examiner's arguments and are not persuaded.
As discussed above, Appellants have provided substantial evidence to show
that the limitation calling for the composition to be prepared using ultra-
rapid freezing itself imparts a structural limitation in the claims. Dr.
Williams has testified that ultra-rapid freezing always produces particles that
have interconnected/matrix particle morphology/ geometries whereas the
prior art process does not. Williams Deel. ,r 4. This is sufficient evidence to
show that the process recited in the claims imparts a structural limitation into
the claims.
With respect to the Yang article, Dr. Williams has testified that the
differences in the formulations are slight. Williams Deel. ,r 5. Dr. Williams
also testified that the different surfactants "would have had a similar effect
on the formulations in a the [sic] head-to-head comparison of SFL to URF."
Id. The Examiner has offered no persuasive evidence to show why Dr.
Williams' conclusions are incorrect. Moreover, as Appellants point out, the
testimony of Dr. Williams alone is sufficient to establish the ultra-rapid
freezing produces a different morphology than spray freezing into liquid.
Reply. 3.
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that the subject matter of the claims would have
been obvious over Williams combined with Straub or Straub and Iacono.
SUMMARY
We reverse the rejections under 35 U.S.C. § 103(a).
REVERSED
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