Ex Parte Farr et al

Patent Trial and Appeal Board

Oct 29, 2012

11263725 (P.T.A.B. Oct. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ISAAC FARR and JULIO CARTAGENA
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Appeal 2011-005650
Application 11/263,725
Technology Center 1600
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Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
preparing organic nanoparticles. The Examiner entered rejections for lack of
written description and anticipation.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part.
STATEMENT OF THE CASE
The Specification discloses that providing pharmaceutical
compositions in the form of millimeter or micron sized particles can
significantly improve the bioavailability of a drug having poor aqueous
solubility (see Spec. 1). Appellants’ invention is directed to the use of an
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emulsification technique to prepare nanometer sized particles that contain
pharmaceutical compounds (see id. at 3).
Claims 1, 5-8, 10-14, 16, 17 and 19-25 stand rejected and appealed
(App. Br. 5).1 Claim 1, the only independent claim, illustrates the appealed
subject matter and reads as follows (some paragraphing added):
1. A method of preparing organic nanoparticles, comprising:
generating a mixture of a therapeutically active agent having a
molecular weight ranging from about 151.16 g/mol to about 1500
g/mol, a first liquid, and a second liquid, the therapeutically active
agent being more soluble in the second liquid than in the first liquid,
the first liquid and the second liquid being selected from the group
consisting of alcohols, chlorinated solvents, ketones, and
combinations thereof; and
adding a third liquid selected from the group consisting of
water, linear alkanes (C5 to C30), cycloalkanes (C5 to C8) and
combinations thereof to the mixture of the therapeutically active
agent, the first liquid, and the second liquid,
whereby the adding of the third liquid causes the mixture to
form an emulsion, the emulsion being formed in the absence of a
stabilizing agent and being a continuous phase including the first
liquid and a discontinuous phase including the therapeutically active
agent and the second liquid,
whereby the forming of the emulsion causes the therapeutically
active agent to precipitate to form organic nanoparticles of the
therapeutically active agent, and
wherein at least a portion of the second liquid diffuses from the
discontinuous phase to the continuous phase.

1 Appeal Brief entered September 27, 2010.
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The following rejections are before us for review:
(1) Claims 1, 5-8, 10-14, 16, 17, and 19-25, under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description requirement
(Ans. 3-4); and
(2) Claims 1, 5-8, 10-14, 16, 17, and 19-25, under 35 U.S.C. § 102(b)
as anticipated by Desai2 as evidenced by Fermentek3 (Ans. 8-10).
WRITTEN DESCRIPTION
The Examiner found that two recitations in claim 1 lacked adequate
descriptive support: (1) the lower limit of the range of molecular weights for
the therapeutically active agent, “about 151.16 g/mol,” and (2) the recitation
of “’the emulsion being formed in the absence of a stabilizing agent’” (Ans.
3-4). While we agree with Appellants that feature (1) is adequately
supported by the Specification, we agree with the Examiner that feature (2)
is not.
As to feature (1), as the Examiner contends, the Specification provides
two explicit ranges of molecular weights for the material included in the
nanoparticles, (a) from about 200 to about 3,000, and (b) from about 300 to
about 1,500 (Spec. 5-6). However, as Appellants point out, the Specification
discloses that any organic materials, including pharmaceutical compounds,
can be formed into nanoparticles (Spec. 3).
Moreover, as Appellants further point out, the Specification also
provides an extensive list of compounds amenable to the claimed processing

2 U.S. Patent No. 5,916,596 (issued June 29, 1999).
3 Material Safety Data Sheet for Taxol,
http://www.fermentek.co.il/MSDS/taxol-MSDS.htm (page access dated
October 2, 2008).
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techniques, including acetaminophen, which undisputedly has a molecular
weight corresponding to the lower limit of the range recited in claim l (see
Spec. 7; see also App. Br. 11). As Appellants further argue, the list in the
Specification includes a number of other compounds (propofol, trans-
stilbene, anthracene) with molecular weights intervening the lower limit
recited in claim 1 and the lower limit of the broader range disclosed at pages
5-6 of the Specification (see id.).
Given these facts, we are not persuaded that Appellants’ disclosure
would have failed to convey to an ordinary artisan that Appellants invented,
and were in possession of, nanoparticles of therapeutically active agents
having the range of molecular weights recited in claim 1.
Appellants’ arguments do not persuade us, however, that a
preponderance of the evidence supports the position that the Specification
would have conveyed to an ordinary artisan that Appellants invented a
process of making nanoparticles by emulsion formation, “the emulsion being
formed in the absence of a stabilizing agent,” as claim 1 requires.
Specifically, Appellants contend that the Board has previously held
that a negative limitation excluding a catalyst from a claimed process was
adequately described, despite the absence of word-for-word support, where
the supporting specification’s disclosure of the process cried out for a
catalyst if one were used (App. Br. 11 (citing Ex parte Parks, 30 USPQ2d
1234 (BPAI 1993))).
Thus, Appellants argue, the Specification not only “specifically list[s]
examples of stabilizing agents (e.g., surfactants and detergents) that are not
used during formation of the emulsion; but the emulsion formation examples
provided throughout the application as filed do not include stabilizing
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agents” (App. Br. 12 (citing Spec. 6-7, and 11)). Appellants argue,
therefore, that their “originally-filed disclosure would have conveyed to one
having ordinary skill in the art that the Appellants had possession of the
concept of forming the emulsion in the absence of not only surfactants and
detergents, but all stabilizing agents” (id.; see also Reply Br. 6-7).
We agree with Appellants that, “[i]n order to satisfy the written
description requirement, the disclosure as originally filed does not have to
provide in haec verba support for the claimed subject matter at issue.”
Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir.
2000).
Nonetheless, the disclosure must convey with reasonable clarity to
those skilled in the art that the inventor was in possession of the invention.
See id. “Put another way, one skilled in the art, reading the original
disclosure, must immediately discern the limitation at issue in the claims.”
Id.
Here, as Appellants argue, the Specification explicitly states that, “[i]n
one aspect, such an emulsion can be formed without surfactants or
detergents” (Spec. 3). As Appellants point out, the Specification lists a
number of liquids that can be used to form the emulsion that ultimately
yields the nanoparticles (Spec. 6-7). As Appellants also point out, the single
working example uses only a first liquid (ethanol), second liquid
(chloroform), and third liquid (water), to obtain an emulsion that contains
glyburide nanoparticles (Spec. 11).
Appellants do not, however, point to a single occurrence of the claim
term “stabilizing agent” in the Specification as originally filed. Nor do
Appellants point to a clear definition in the Specification for “stabilizing
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agent” such that an ordinary artisan would immediately discern that
Appellants invented a process that excluded such an agent.
Moreover, Appellants have advanced no clear or specific evidence of
record suggesting that an ordinary artisan would have known or recognized
that surfactants and detergents were examples of stabilizing agents in the
context of this invention. Thus, we are not persuaded that a skilled artisan,
advised that “an emulsion can be formed without surfactants or detergents”
(Spec. 3 (emphasis added)), would have immediately discerned that
surfactants and detergents were stabilizing agents, or that the disclosure of
excluding those two types of compounds from the process of forming the
disclosed emulsions would have equated to a limitation excluding formation
of the emulsion of claim 1, “in the absence of a stabilizing agent.”
Given these facts, we are not persuaded that a preponderance of the
evidence fails to support the Examiner’s finding that the Specification does
not adequately describe, within the meaning of 35 U.S.C. § 112, first
paragraph, a process of forming an emulsion “in the absence of a stabilizing
agent.” We therefore affirm the Examiner’s rejection of claim 1 for lack of
written description. As they were not argued separately, claims 5-8, 10-14,
16, 17, and 19-25 fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
ANTICIPATION
Appellants argue that, because claim 1 requires the emulsion to be
formed in the absence of a stabilizing agent, and because Desai forms its
emulsions using a serum albumin stabilizing agent, Desai does not anticipate
claim 1 (see App. Br. 12-13). The Examiner responds that, as an alternative
to using serum albumin in its formulations, Desai also describes
embodiments that use certain polymers which would not be considered
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stabilizing agents, and that Desai’s processes would therefore be
encompassed by claim 1 (see Ans. 11).
As to claim 1, we find that Appellants have the better position on this
issue.
As the Examiner found, Desai describes a process of administering
the anticancer drug taxol4 (Desai, col. 1, ll. 20-23), in the form of
nanoparticles that are prepared from an oil in water emulsion (id. at col. 5, ll.
43-50). As Appellants point out, however, Desai explicitly states that
“proteins, (e.g., human serum albumin) are employed as a stabilizing agent”
(id. at col. 5, ll. 51-52; see also col. 10, ll. 1-54 (process uses emulsion-
forming step including first, second, and third liquids encompassed by
Appellants’ claim 1, but uses human serum albumin “stabilizing agent”)).
Thus, we agree that claim 1, by its terms, does not encompass Desai’s
processes.
We note Desai’s disclosure that certain synthetic polymers, such as
polylactides, can be used as alternatives to the albumin stabilizing agent (see
id. at col. 15, l. 58). However, given that this disclosure immediately
follows a description of using the proteins “as stabilizing agents” (id. at col.
15, l. 17), and further given that the synthetic polymers are described as
being used “[s]imilarly” to the protein stabilizing agents (id. at col. 15, l.
36), we agree with Appellants that an ordinary artisan would have viewed
Desai as using the synthetic polymers as stabilizing agents.

4 The Examiner cited Fermentek as evidence that taxol, also known as
paclitaxel, inherently has a molecular weight within the range of claim 1 (see
Ans. 8).
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We therefore also agree with Appellants that claim 1 does not
encompass Desai’s processes. Accordingly, we reverse the Examiner’s
anticipation rejection of claim 1, and its dependent claims 5-8, 10-14, 16, 17,
and 19-23, over Desai.
Appellants’ arguments do not persuade us, however, that a
preponderance of the evidence fails to support the Examiner’s finding of
anticipation as to claims 24 and 25.
Claim 24 recites, “[a] plurality of organic nanoparticles prepared
according to the method of claim [1, wherein the method further comprises
drying the organic nanoparticles to at least substantially remove the first
liquid, the second liquid, and the third liquid]” (App. Br. 21).
Claim 25 recites “[a] plurality of organic nanoparticles prepared
according to the method of claim 1” (id. at 22).
As to product-by-process claims, as stated in In re Thorpe, 777 F.2d
695, 697 (Fed. Cir. 1985) (citations omitted):
[E]ven though product-by-process claims are limited by and
defined by the process, determination of patentability is based
on the product itself.
The patentability of a product does not depend on its
method of production. If the product in a product-by-process
claim is the same as or obvious from a product of the prior art,
the claim is unpatentable even though the prior product was
made by a different process.

Also, once the Examiner establishes that a product recited in terms of
its process of making is prima facie unpatentable due to anticipation,
Appellants bear the burden of proving “that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product.”
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Id. at 698 (quoting In re Fitzgerald, 619 F.2d 67, 70 (CCPA 1980); In re
Best, 562 F.2d 1252, 1255 (CCPA 1977)).
Here, Appellants urge only that, in contrast to the claimed particles,
Desai’s particles “contain a polymer shell thereon” (App. Br. 15).
However, the processes by which the particles of claims 24 and 25 are
produced are recited in open comprising language, which does not exclude
steps beyond those recited in the claims. See Invitrogen Corp. v. Biocrest
Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003) (“The transition
‘comprising’ in a method claim indicates that the claim is open-ended and
allows for additional steps.”).
Thus, while the process of claim 1 may exclude Desai’s use of a
polymeric stabilizing agent in the emulsion-forming step, claim 1
nonetheless encompasses subsequent steps by which a polymeric coating,
such as that described by Desai, would be added. Indeed, Appellants’ claims
19 and 20 explicitly recite adding supplementary ingredients, including
polymers, to the nanoparticles after their precipitation (see App. Br. 19-20).
Contrary to Appellants’ arguments, therefore, claims 24 and 25 encompass
particles having a polymeric coating.
Accordingly, we acknowledge that Desai’s particles are prepared by
an emulsion-forming process that includes a serum albumin stabilizer in
addition to the first, second, and third liquids recited in Appellants’ claim 1
(see Desai, col. 10, ll. 1-54). However, because claims 24 and 25 encompass
particles formed by a process that includes subsequent steps, such as
addition of an outer polymer coating, the fact that Desai’s process yields
particles with a polymer coating does not demonstrate that claims 24 and 25
fail to encompass the particles produced by Desai’s process.
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Therefore, as Appellants’ arguments do not persuade us that the
Examiner erred in finding that claims 24 and 25 encompass the particles
described by Desai, we affirm the Examiner’s anticipation rejection as to
those claims.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1, 5-8, 10-14, 16, 17, and 19-25, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
We also affirm the Examiner’s anticipation rejection of claims 24 and
25 over Desai as evidenced by Fermentek, but reverse that rejection as to
claims 1, 5-8, 10-14, 16, 17, and 19-23.

TIME PERIOD
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-IN-PART

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