Brian D. Scherzer et al.

Patent Trials and Appeals Board

Jul 23, 2019

14861046 - (D) (P.T.A.B. Jul. 23, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/861,046 09/22/2015 Brian D. SCHERZER UTSB.P1060US.D1 3541
108197 7590 07/23/2019
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
SOROUSH, ALI
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
07/23/2019 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BRIAN D. SCHERZER, JONATHAN C. EVANS, and
JAMES E. HITT
____________

Appeal 2019-001013
Application 14/861,046
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

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Introduction
Appellants1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 5, 6, 11–13, 15, 18, 20, and 21.
(Appeal Brief filed September 4, 2018 (“App. Br.”) 4.)
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
Appellants’ Specification is directed to particles of poorly water
soluble drugs prepared by freezing a solution of the drug in an organic
solvent onto cold solid surfaces. (Specification dated September 22, 2015
(“Spec.”) ¶ 10.) The Specification discloses that decreasing particle size is
known to increase the rate of dissolution of a particulate drug. (Spec. ¶ 5.)
However, Appellants assert that milling drug particles may cause the drug to
change forms (e.g., from crystalline to amorphous) or otherwise lose activity
after being exposed to excessive mechanical shear. (Id.) By rapidly
freezing a solution of drug and organic solvent and then removing the
organic solvent, Appellants assert that the process results in drug particles
with a high surface area and enhanced dissolution rates as compared to
unprocessed drug particles. (See Spec. ¶¶ 10, 39, 41.)
Appellants’ claim 15 recites:
Drug particles produced by a method which comprises:

(a) cooling a cold solid surface to less than 5°C;

(b) selecting a freezable organic solvent with a freezing
point not higher than the temperature of the cold surface and
into which a poorly water soluble drug substance dissolves;

1 Appellants report that the real party in interest is Board of Regents, The
University of Texas System.
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(c) dissolving the poorly water soluble drug substance in
the freezable organic solvent into a solution;

(d) contacting the solution with the cold solid surface so
as to freeze the solution, wherein the rate of freezing of the
solution is determined by the difference between the freezing
point of the freezable organic solvent and the temperature to
which the cold solid surface is cooled in step (a); and

(e) removing the organic solvent, wherein the resulting
particles have a mean volume average particle size from less
than 0.05 microns to 24 microns, a surface area of at least 2
m2/g and exhibit an in vitro dissolution rate of at least 2 times
better than that of the unprocessed drug when measured at a 2
minute time point.

(App. Br. 11–12.) Our analysis focuses on claim 15, as Appellants do not
argue the claims separately. See 37 C.F.R. § 41.37(c)(iv).
The Examiner rejects the claims under 35 U.S.C. § 102(b) as
anticipated by Mosharraf.2
Analysis
The Examiner finds the claims recite a product-by-process. (Final
Act. 3.) Therefore, the Examiner determines that the patentability of the
product does not depend on the process by which it is made. (Id.) The
Examiner finds Mosharraf teaches milling a poorly water soluble drug (e.g.,
oxazepam), resulting in particles having an average particle mean volume
size of 3.99 μm and a surface area of 4.05 m2/g. (Id., citing Mosharraf p. 39,
Table 1; p. 41.) Because Mosharraf teaches a poorly water soluble drug

2 Mosharraf, M. and Nyström, C., The effect of particle size and shape on the
surface specific dissolution rate of microsized practically insoluble drugs,
122 Int’l J. Pharmaceutics 35–47 (1995).
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having the same particle size and surface area as the claimed product
resulting from the recited process, the Examiner finds Mosharraf anticipates
the claims. (Id.)
Appellants contend that the process of the pending product-by-process
claims results in a different product than the prior art Mosharraf particles.
(Reply Brief filed November 15, 2018 (“Reply Br.”) 2.) Appellants support
their contention with the Declaration of Dr. Williams.3 Dr. Williams refers
to the claimed technique as “thin-film freezing” or “ultra-rapid freezing”
(“TFF/URF”). (Williams Decl. ¶ 2.) Dr. Williams declares that Mosharraf’s
mechanical milling produces discrete particles as opposed to TFF/URF
which produces aggregates of high porosity. (Reply Br. 2, citing Williams
Decl. ¶ 4.) Dr. Williams also declares that sublimation of the frozen solvent
results in “interconnected/matrix particle morphology/geometries” which is
distinct from breaking a single particle in multiple subdivided particles by
mechanical shearing. (Reply Br. 2–3, citing Williams Decl. ¶ 5.) Dr.
Williams declares “[a]s a result of the completely different techniques,
immunosuppressive drugs and excipient(s) produced by TFF/URF are
always amorphous.” (Id.)
Appellants contend that process limitations in the claims connote
structure, and therefore may be used to distinguish the invention from the
prior art. (Reply Br. 4.) In particular, Appellants support their arguments by
citing In re Nordt Devel. Co., 881 F.3d 1371, 1374 (Fed. Cir. 2018), as

3 Declaration of Robert O. Williams III, PhD., filed October 25, 2017
(“Williams Decl.”).
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applied by the Board in Ex Parte Williams, No. 2017-003283 (PTAB
October 26, 2018). (Reply Br. 4–6.)
In re Nordt states that when considering the patentability of product
claims that contain process limitations, claim scope is generally based on the
product itself, not the process. 881 F.3d at 1374. However, if the process
limitation connotes specific structure and may be considered a structural
limitation, that structure should be considered. (Id.) In In re Nordt, the
Court of Appeals for the Federal Circuit found that the process claim terms
“injection molded” connoted structure that was distinguishable from the
prior art. See 881 F.3d at 1375. Applying In re Nordt in Ex Parte Williams,
the Board found that “ultra-freezing connotes a structural limitation,” and
thus considered that structure as a limitation of the product itself. See Ex
Parte Williams, slip op. 6.
Unlike In re Nordt and Ex Parte Williams, Appellants do not direct us
to any process limitation that connotes specific structure. (See Reply Br. 4–
6.) For example, Appellants refer to particles prepared by “ultra-freezing”
or “thin-film freezing” as having a different structure than the prior art
particles. (See Reply Br. 4.) Unlike the claims in Ex Parte Williams, the
claims here do not recite “ultra-freezing,” or any similar limitation. (See Ex
Parte Williams, slip op. 2.) Moreover, Appellants’ claims do not include
any of the type of process limitations that have been previously found to
connote structure, e.g., “injection molded,” “chemically engraved,”
“integral,” or “superimposed.” See 881 F.3d at 1376. Because, Appellants
do not direct us to any process limitation that connotes specific structure, we
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conclude that the claim scope is based on the product itself and not the
process. 881 F.3d at 1374.
Appellants contend that Mosharraf’s mechanically milled particles
will necessarily have totally different morphology and physical properties as
compared to drug particles prepared by thin-film freezing. (App. Br. 6.)
Appellants cite to Dr. Williams’s declaration, arguing that thin-film freezing
results in an aggregate matrix of high porosity, containing drugs and
excipients that are always amorphous. (See App. Br. 8–9.) However, this
description contradicts the specification, which states that “[s]urprisingly,
the resulting drug particles are substantially crystalline in nature, despite the
fact that the present invention involves rapid freezing.” (Spec. ¶ 42.)
We are not persuaded by Appellants’ arguments, because, as noted by
the Examiner, none of these argued features are recited by the claims. (See
Final Act. 4.) Rather the claims recite particles defined in terms of mean
volume average particle size and surface area. (Id.) Because the Examiner
has identified particles with the same morphology in the prior art, we are not
persuaded that the Examiner erred.
Appellants contend that the claimed improvement of in vitro
dissolution rate distinguishes the claimed particles from Mosharraf’s
micronized drug. (App. Br. 5.) Appellants cite to Table B of the
Specification for showing a “dramatic improvement” in dissolution that was
not related to size reduction as the particle size of the processed drug did not
decrease. (App. Br. 6.) Appellants contend the bulk drugs listed in Table B
are similar to the Mosharraf’s micronized product and thus Mosharraf is
distinguishable by comparison. (See App. Br. 6.)
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The Examiner finds that improved dissolution is an inherent property
of the product. (Final Act. 4.) The Examiner finds that Table B does not list
oxazepam, and Appellants do not compare the structure of oxazepam to the
drugs listed in Table B. (Examiner’s Answer dated October 19, 2018
(“Ans.”) 3.) The Examiner thus finds that Appellants have not established
that Mosharraf’s particles would not have the same claimed dissolution
profile. (Ans. 4.)
We are not persuaded by Appellants’ arguments. Where the claimed
and prior art products are identical, the PTO can require an applicant to
prove that the prior art products do not inherently possess the characteristics
of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The
fairness of the burden-shifting is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art products. (Id.)
Here, the Examiner has established a prima facie case of anticipation.
Appellants have not met their burden to “prove that the subject matter shown
to be in the prior art does not possess the characteristic relied on.” In re
King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Because Appellants have not
provided persuasive evidence that the prior art does not inherently possess
the characteristics of the claimed particles, we are not persuaded that the
Examiner erred.
After consideration of Appellants’ evidence and arguments, we are
not persuaded that the Examiner erred in finding the prior art anticipates
Appellants’ pending claims 5, 6, 11–13, 15, 18, 20, and 21.
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Conclusion
Upon consideration of the record and the reasons given, the rejection
of claims 5, 6, 11–13, 15, 18, 20, and 21 is sustained.
Therefore, we affirm the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED