Ex Parte Andersson et al

Patent Trial and Appeal Board

Oct 25, 2018

13994152 (P.T.A.B. Oct. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/994, 152 10/01/2013
108197 7590 10/29/2018
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
Borje S. Andersson
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.
BRJA.P0002US 1272
EXAMINER
YU,HONG
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
10/29/2018 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 BORJE S. ANDERSSON, JEFFREY TARRAND,
and BENIGNO C. VALDEZ 1
Appeal2017-005288
Application 13/994, 152
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Platform Brightworks Two, LTD as the real party in
interest. App. Br. 3.
Appeal2017-005288
Application 13/994,152
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1 and 3-28 as unpatentable under 35
U.S.C. § I03(a) as being obvious over the combination of Wong et al. (US
2003/0072807 Al, April 17, 2003) ("Wong"), Rabinow et al. (US
2005/0048126 Al, March 3, 2005 ("Rabinow"), and Tamarkin et al. (WO
2008/152444 A2, December 18, 2008) ("Tamarkin"), as evidenced by
"Biotin-PEG4-NHS", available at: http://www.chempep.com/ChemPep_
Products_PEGylation_Reagents.php?id=271611.htm, and "Polyethylene
glycol", available at: https://en.wikipedia.org/wiki/Polyethylene_glycol).2
We have jurisdiction under 35 U.S.C. § 6(b).
Abstr.
We AFFIRM IN-PART.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a parenteral azole composition.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A pharmaceutical composition suitable for parenteral
administration comprising an azole antifungal pharmaceutical
agent and a first solvent, said first solvent comprising a) an
alcohol component selected from benzyl alcohol and/or acidified
ethanol, and b) a polyethylene glycol solvent (PEG), wherein the
2 The Examiner also rejected claims 22-25 under 35 U.S.C. 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
Final Act. 3. The Examiner has withdrawn this rejection. Ans. 2.
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azole agent is dissolved in said first solvent, wherein the
composition is essentially free of non-ionic surfactants and
particulates and comprises less than 5% water (v/v).
App. Br. 11.
ISSUES AND ANALYSES
We adopt the Examiner's findings, reasoning, and conclusion that
claims 1, 3-21, and 26-28 are prima facie obvious over the prior cited art.
However, we decline to adopt the Examiner's conclusion that claims 22-25
are similarly prima facie obvious. We address the arguments raised by
Appellants below.
Issue 1
Appellants argue the Examiner erred in finding that the combined
cited prior art teaches a pharmaceutical composition suitable for parenteral
administration in which the drug is dissolved in the PEG solvent, and that
the composition is "essentially free of non-ionic surfactants and particulates
and comprises less than 5% water (v/v)." App. Br. 6.
Analysis
A. Claims 1, 3-21, and 26-28
The Examiner finds Wong teaches a stable parenteral suspension of
antifungal agents formed from a drug solution comprising a triazole such as
itraconazole or posaconazole dissolved in a first solvent including ethanol,
PEG, including PEG-4, PEG-8, PEG-9, PEG-12, PEG-14, PEG-16, PEG-
120, PEG-75, and PEG-150, N-methyl-pyrrolidone, etc., with a suitable
surfactant, including poloxamer, glutamic acid, etc. Final Act. 6. The
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Examiner finds that Wong also teaches that the drug solution is diluted with
a second solvent of water and an osmotic agent, such as dextrose, with the
concentrations of triazole and surfactant in the final suspension being from
about 0.1 to 20% w/v (1 to 200 mg/ml) and from about 0.01 to 5% w/v (0.1
to 50 mg/ml), respectively. Id. at 6-7 (citing Wong Abstr., ,r,r 24, 26, 41, 50,
53, 57, 59, 60, 66, 67, and 74--86 and Figs. 3, 4, Example 1 and claims 1, 6-
8, 15, 24, 27-29, 36, 37, and 64).
Appellants argue that the Examiner incorrectly relies upon Wong's
teaching of an intermediate formulation, referred to as a "concentrated drug
solution," as teaching the claimed pharmaceutical composition. App. Br. 4.
Specifically, Appellants argue that Wong neither teaches nor suggests that
this concentrated drug solution could be used as a pharmaceutical
composition directly. Id. Instead, assert Appellants, Wong teaches the use
of this concentrated drug solution to produce a solid particulate antifungal
composition of "submicron-to micron-sized particles of antifungal agents,"
as well as aqueous suspensions of such particles. Id. (quoting Wong Abstr.).
Appellants point to paragraph [0073] of Wong, which, Appellants
argue, teaches three different processes for making these drug products:
Method A and Method B, depicted in Figures 3 and 4 respectively, and
Method C. App. Br. 4--5. Appellants argue that Figure 3 of Wong, and the
accompanying text, teach first making the concentrated drug solution, then
mixing that concentrated drug solution with water, surfactants and optional
buffers to form a suspension of amorphous particles, semi-crystalline
particles, and/or super-cooled liquid to form a stable crystalline product
through the addition of energy. Id. at 5 (citing Wong ,r,r 79-81). Appellants
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further contend that Wong teaches optionally using the crystalline product to
form a stabilized suspension. Id. (citing Wong Fig. 3).
Appellants argue that Method B of Wong is essentially the same as
Method A, with the exception that the surfactant is added to the drug before
forming the drug concentrate. App. Br. 6. Appellants note that Wong
teaches that, at the end of the Method B, either a dry crystalline drug
formulation is obtained ("stable crystalline product") or that the crystalline
product is then used to form a stabilized suspension. 3 Id.
Appellants argue that, in contrast, the invention of claim 1 is directed
to "a pharmaceutical composition suitable for parenteral administration" and
requires that the drug be dissolved in the PEG solvent, rather than
suspended, and that the composition is "essentially free of non-ionic
surfactants and particulates and comprises less than 5% water (v/v)." App.
Br. 6. Appellants contend that the formation of the crystalline drug or
particulate suspension does not meet the limitation of claim 1, which
requires that the drug be dissolved and free of particulates and nonionic
surfactants. Id.
Appellants argue further that claim 1, directed to a "pharmaceutical
composition suitable for parenteral administration," does not read on the
"concentrated drug product" of Wong. App. Br. 7. Appellants assert that
Wong's concentrated drug product is an intermediate, and not the final, drug
product, and that Wong teaches the use of that intermediate product in the
synthesis of the intended product, which is outside of the scope of the
claims. Id. According to Appellants, the drug concentrate of Wong is not
3 Appellants make no argument with respect to Method C.
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intended to be a "pharmaceutical composition suitable for parenteral
administration" in that many of the items listed as solvents at paragraph
[0074] could never be administered to a human being, e.g., 1,4 dioxane (a
carcinogen), acetone (toxic), dimethylformamide (teratogenic), N-methyl-
2-pyrrolidone (teratogenic), and methanol (toxic). Id. Appellants contend
that Wong teaches that these solvents may be used because they are
subsequently removed from Wong's final drug product. Id.
Appellants dispute the Examiner's finding that Wong teaches that
non-ionic surfactants, which are excluded by the claims, are not required.
App. Br. 7 ( citing Final Act. 6). Appellants assert that, if the Examiner is
arguing that Wong does not require the use of surfactants, then the Examiner
is incorrect: Appellants point out that Wong requires the use of a surfactant.
Id. (citing Wong ,r 23). Alternatively, Appellants argue the Examiner finds
that Wong teaches other types of surfactants that are ionic. Id. Appellants
contend that, whereas this may be technically correct, Wong teaches that
non-ionic surfactants, such as poloxamers, are preferred (Appellants note
that poloxamers or other non-ionic surfactants are used in most of the
examples). Id. More importantly, assert Appellants, there is there is nothing
in Wong that teaches or suggests not using non-ionic surfactants. Id.
Finally, Appellants argue that the Rabinow and Tamarkin references
are irrelevant to their arguments presented supra. App. Br. 9.
We are not persuaded by Appellants' arguments. As an initial matter,
we note that Appellants' claims are directed to a composition of matter, and
that the language of the preamble to claim 1 reciting: "A pharmaceutical
composition suitable for parenteral administration" speaks to an intended use
of the composition, and not its structure, which is defined completely in the
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body of the claim. We acknowledge that the language reciting: "suitable for
parenteral administration" may impose some structural limitations upon the
claim insofar as it excludes the use of constituents that would be unsuitable
for such a purpose, e.g., toxins. However, we conclude that the language of
the preamble is not otherwise limiting on claim 1 with respect to its being a
pharmaceutical composition. See Catalina Marketing Int 'l, Inc. v.
Coo/savings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) ("[A] preamble is
not limiting 'where a patentee defines a structurally complete invention in
the claim body and uses the preamble only to state a purpose or intended use
for the invention"') (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir.
1997)).
Furthermore, Wong teaches, and Appellants do not dispute this, all of
the limitations of claim 1. Appellants argue that the concentrated drug
solution of Wong does not read on Appellants' claims because it is an
intermediate composition used in the preparation of a crystalline solid
formulation ( which may be optionally reformulated as a stabilized
suspension. See Wong Figs. 3 and 4 ). We do not find this argument
persuasive. Appellants' claims are directed to a composition of matter, and
regardless of the intended use ( or other properties) of the compositions of
Wong or claim 1, the compositions are structurally indistinguishable from
each other. Consequently, Appellants' claimed composition is obvious over
the teachings of Wong.
Appellants point out that claim 1 requires that the drug be dissolved in
the PEG solvent, rather than suspended, and that the composition be
"essentially free of non-ionic surfactants and particulates and comprises less
than 5% water (v/v)." See App. Br. 6. Appellants imply that Wong's
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suspension that is the end product of combining the concentrated drug
solution with the water/surfactant/optional buffer solution (Wong, Fig. 3)
therefore does not read upon the limitation of claim 1 requiring that the:
"azole agent is dissolved in [the] first solvent." However, with respect to its
concentrated drug solution, Wong expressly teaches that: "The first solvent
according to the present invention is a solvent or mixture of solvents [e.g.,
ethanol and PEG] in which the antifungal agent of interest is relatively
soluble." Wong ,r 7 4 ( emphasis added). We interpret "relatively soluble" to
mean that the antifungal azole-based compounds taught by Wong are
capable of being dissolved in the first solvent for the concentrated drug
solution that reads on the composition of claim 1.
Appellants also argue that Wong teaches that there is nothing in Wong
that teaches or suggests not using non-ionic surfactants, or that non-ionic
surfactants, which are barred by claim 1, are preferred by Wong. We
disagree. The Examiner identifies the concentrated drug solution of Figures
3 and 4, and their associated text, of Wong as corresponding to the
composition of claim 1. Claim 1 requires that: "the composition is
essentially free of non-ionic surfactants and particulates and comprises less
than 5% water (v/v)." However, the concentrated drug solution, prior to its
mixture with the second solvent, at least in Method A of Wong, is free of
surfactants of any kind and is also free of water, i.e., contains less than 5%
water (v/v). See Wong, Fig. 3 and ,r,r 74--75. And although the concentrated
drug solution of Wong's method B contains surfactant, Wong expressly
teaches that: "Suitable surfactants for coating the particles in the present
invention can be selected from ionic surfactants, nonionic surfactants,
biologically derived surfactants, or amino acids and their derivatives."
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Wong ,r 26. Wong thus teaches that an ionic surfactant, or other surfactants
that are not non-ionic, may be employed in its Method B, thus keeping the
concentrated drug solution "essentially free of non-ionic surfactants," as
required by claim 1.
Because we do not find Appellants' arguments persuasive that the
Examiner has failed to establish a prima facie case of obviousness, we
affirm the Examiner's rejection of claims 1, 3-21, and 26-28.
B. Dependent claims 22-25 4
Appellants argue claims 22-25 separately. App. Br. 7. Appellants
note that with respect to these claims, which are directed to infusion
solutions comprising the pharmaceutical composition of claim 1, the
Examiner finds that Wong teaches diluting the drug composition with water
and dextrose. App. Br. 7-8 ( citing Final Act. 6, 8). Appellants observe that
Wong uses the term "dextrose" in only two places, paragraphs [0028] and
[0060], and that, in each, Wong teaches suspending the drug particles in
aqueous solution that can contain dextrose. Id. at 8. Appellants assert that
Wong neither teaches nor suggests diluting the concentrated drug
composition with an aqueous dextrose solution. Id. Appellants also note
4 Appellants argue claims 22-26 together on this ground, however, we
observe that claim 26 depends directly from claim 1 and does not recite the
limitation recited and argued by Appellants with respect to claims 22-25.
App. Br. 13. We consequently attribute this to a typographical error, and
entertain Appellants' arguments upon this issue with respect to claims 22-
25.
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that claim 22 requires diluting the composition of claim 1, which is a
dissolved solution, free of particles. Id.
Appellants also dispute the Examiner's finding that, since the
surfactant is free of particles, the limitations of claim 22 are met. App. Br. 9
(citing Final Act. 14). Appellants argue that claim 22 requires the presence
of the dissolved drug as well, which in the case of Wong, is a solid
particulate. Id. Appellants point to paragraph [0026] of Wong, which is
relied upon by the Examiner, and which teaches that the surfactant is for
"coating" (and not dissolving) the particles. Id. Appellants suggest that it is
likely the case that the presence of the surfactant forms the particles in the
first place and maintains them in particle form. Id. (citing Wong ,r 71
("Alternatively, this stabilization may occur by a reordering of the surfactant
molecules at the solid-liquid interface")).
We are persuaded by Appellants' reasoning. The Examiner has
pointed to no teaching or suggestion in the prior art that suggests diluting the
composition of claim 1 (i.e., the concentrated drug solution of Wong's
Methods A and B) with "an infusion fluid selected from the group consisting
of normal saline, dextrose in water, and a lipid-based infusion emulsion
fluid," as recited in claim 22 and its dependent claims. As common as such
a dilution may be in the preparation of an infusion of a pharmaceutical
compound, the Examiner has not directed us to any reference teaching or
suggesting this limitation with respect to the concentrated drug solution of
Wong. Rather, the dilutions taught by Wong are, as Appellants correctly
argue, used to stabilize the suspended drug particles in the optional final
steps of Wong's Methods A and B. See Wong ,r,r 28, 60.
Consequently we reverse the Examiner's rejection of claims 22-25.
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DECISION
The Examiner's rejection of claims 1, 3-21, and 26-28 under 35
U.S.C. § 103(a) is affirmed.
The Examiner's rejection of claims 22-25 under 35 U.S.C. § 103(a) is
reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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