Ex Parte Larson

Patent Trial and Appeal Board

May 22, 2018

12403665 (P.T.A.B. May. 22, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/403,665 03/13/2009 Torbjorn LARSON
122945 7590 05/24/2018
Mylan Pharmaceuticals Inc.
5005 Greenbag Road
Morgantown, WV 26501
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.
US-PCT08/02 (M) 1102
EXAMINER
MCMILLIAN, KARA RENITA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
05/24/2018 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):
mylan_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TORBJORN LARSON 1
Appeal2017-005156
Application 12/403,665
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and ELIZABETH A. LA VIER,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant states that the real party-in-interest is MEDA PHARMA SARL.
App. Br. 1.
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Application 12/403,665
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 7-12, 14--16, 24, 27-31, and 34.
Specifically, claims 1, 7-12, 14--16, 24, and 27 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Ludwig (WO 97 /34607, September 25, 1997) ("Ludwig")
and Lekare (US 2003/0171344 A 1, September 11, 2003) ("Lekare").
Claims 28-31 and 34 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Ludwig, Lekare, Singh,
(IN 867 /DEL/2006 A, January 18, 2008) ("Singh") and Currie et al. (WO
99/12545, March 18, 1999) ("Currie").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to a topical antiviral composition
comprising acyclovir, penciclovir, or omaciclovir in a glucocorticoid-free
pharmaceutical carrier and having utility in the treatment or prophylaxis of
herpesvirus infections. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A topical antiviral composition for treating recurrent
herpesvirus infections, wherein the composition comprises about
4 to about 7 weight percent of an acyclic guanosine analogue
selected from the group consisting of: acyclovir, penciclovir and
omaciclovir in an oil-in-water or water-in-oil pharmaceutical
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carrier comprising about 18 to about 22 weight percent propylene
glycol and about 12 to about 18 weight percent isopropyl C[12r
C22 alkanoic acid ester, wherein each reference to weight percent
is relative to the entire weight of the composition, wherein either
acyclovir, penciclovir, or omaciclovir is the sole active
ingredient present in the composition, and wherein the
composition treats recurrent herpesvirus infections.
App. Br. 34.
ISSUE AND ANALYSIS
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are obvious over the prior art. We address
Appellant's arguments below.
A. Claims 1, 7-12, 14--16, 24, and 27
Issue 1
Appellant argues that the Examiner erred by improperly ignoring the
state of the art and, relatedly, that the Examiner improperly ignored the
"use" limitation present in all of the claims. App. Br. 16, 18.
Analysis
The Examiner finds that Ludwig teaches an oil-in-water topical
formulation comprising 0.075% to 10% acyclovir and preferably 1 % to 5%
w/w acyclovir. Final Act. 7 (citing Ludwig 2). The Examiner also finds
Ludwig teaches that such formulations may also comprise polyhydric
alcohols such as propylene glycol preferably in an amount from 0% to 30%.
Id. (citing Ludwig 3). The Examiner finds Ludwig further teaches that the
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oil-in water topical formulations also comprise suitable oils or fats, including
straight or branched chain, mono- or dialkyl esters such as isopropyl
myristate, an isopropyl C12-C22 alkanoic acid ester (see Appellant's claim 9).
Id. at 8 (citing Ludwig 3). The Examiner also notes that Ludwig does not
teach the inclusion of pharmaceutical agents other than acyclovir. Id.
The Examiner finds that Lekare teaches topical antiviral compositions
comprising acyclovir and a combination of a lower concentration of
propylene glycol in conjunction with an isopropyl alkanoic acid ester
allowing for good penetration and release of the antiviral component while
at the same time avoiding instability. Final Act. 9 (citing Lekare i-f 7).
Specifically, the Examiner finds Lekare teaches that the preferred isopropyl
C12-C22 alkanoic ester is isopropyl myristate in an amount of about 12 to
about 18 weight percent, and preferably 15 weight percent. Id.
The Examiner concludes that a person of ordinary skill would
therefore have found it obvious to combine the teachings of Ludwig with the
teachings of Lekare to provide a composition with good penetration and
release of the antiviral component while at the same time avoiding
instability. Final Act. 10.
Appellant argues that, at the time of the filing of Appellant's
application, it was widely acknowledged that topical compositions
containing acyclovir as the sole active ingredient were not efficacious in
treating recurrent herpesvirus infections. App. Br. 16-17. Appellant points
to a number of references published prior and subsequent to the March 13,
2009 filing of the application as evidence that, prior to the filing date, it was
believed in the art that the employment of acyclovir as a single active
ingredient in a topical formulation was ineffective in the treatment of
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recurrent herpesvirus infections and that the effectiveness of single active
ingredient compositions was not known until after the filing date. 2 Id. at 18.
Appellant argues that the Examiner has provided no reason or motivation
why a person of ordinary skill in the art would ignore the teachings of these
references and combine Ludwig and Lekare to arrive at the claimed
invention. Id.
Appellant next argues, relatedly, that the Examiner has improperly
refused to acknowledge the limitation of treating recurrent herpesvirus
infections, as recited in both the preamble and the body of claim 1. App. Br.
18-19. Appellant asserts that a "preamble may provide context for claim
construction, particularly, where ... that preamble's statement of intended
use forms the basis for distinguishing the prior art in the patent's prosecution
history." Id. at 19 (quoting Metabolite Labs., Inc. v. Lab. Corp. of Am.
Holdings, 370 F.3d 1354, 1358 (Fed. Cir. 2004)); also citing Catalina Mktg.
Int'! Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808---09 (Fed. Cir. 2002)
(holding that "clear reliance on the preamble during prosecution to
2 Appellant cites T.G. Evans et al., Double-Blind, Randomized, Placebo-
Controlled Study of Topical 5% Acyclovir-I % Hydrocortisone Cream
(ME-609) for Treatment of UV Radiation-Induced Herpes Labial is, 46( 5)
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1870, 1873 (2002)
("Evans"); R. Cortesi et al., Acyclovir Delivery Systems, 5(11) EXPERT
OPIN. DRUG DELIV., 1217, 1218 (2008) ("Cortesi"); C.M. Hull et al., Early
treatment of cold sores with topical ME-609 decreases the frequency of
ulcerative lesions: A randomized, double-blind, placebo-controlled,
patient-initiated clinical trial, 64 J. AM. ACAD. DERMATOL., 696el, 696e9
(2010) ("Hull"); and J. Harmenberg et al., Early Treatment of Cold Sores
with Topical ME-609 Decreases the Frequency of Ulcerative Lesions: A
Randomized, Double-Blind, Placebo-Controlled, Patient-Initiated Clinical
Trial, 90(2) ACTA DERM. VENEREOL. 122, 128 (2010) ("Harmenberg").
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distinguish the claimed invention from the prior art transforms the preamble
into a claim limitation because such reliance indicates use of the preamble to
define, in part, the claimed invention").
Appellant argues that the Examiner is incorrect in asserting that "it
would be obvious that the same composition would be capable of
performing the same function." App. Br. 19 (citing Final Act. 11).
Appellant contends that the Examiner has not shown that the combination of
the elements in the prior art cited by the Examiner "naturally" results in a
topical formulation containing acyclovir as the sole active ingredient that is
efficacious in treating recurrent herpesvirus infections. Id. at 20 (quoting
Par Pharm., Inc. v. TWI Pharms., 773 F.3d 1186, 1197 (Fed. Cir. 2014)).
Rather, Appellant argues, a person of ordinary skill in the art would have
been aware that topical formulations comprising acyclovir as the only active
ingredient were not efficacious in treating recurrent herpesvirus infections
and, therefore, the Examiner's conclusion that the combination of elements
"naturally" results in a composition that treats a recurrent herpesvirus
infection was error. Id.
We are not persuaded by Appellant's arguments. Appellant contends
that it was not appreciated in the art at the time of filing that the claimed
composition would have been effective at treating recurrent herpesvirus
infections and that the claim is directed to the use of the claimed
composition in the treatment of such infections. We emphasize, first, that
the claims on appeal are directed to a composition of matter, viz., a
composition comprising a single acyclic guanosine analogue and a
pharmaceutical carrier comprising propylene glycol and an isopropyl C12-C22
alkanoic acid ester. Claim 1 recites the intended use of the composition
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twice; first in the preamble to the claim and, second, in the final limitation of
the body of the claim.
With respect to the former, we agree with the Examiner that, in this
instance, the recitation in the preamble of the intended use of the claimed
composition in the treatment of recurrent herpesvirus infections is not
limiting on the claim. Generally, a preamble limits the invention if it recites
essential structure or steps, or if it is "necessary to give life, meaning, and
vitality" to the claim. See Catalina, 289 F .3d at 808 (citing Pitney Bowes,
Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)).
Moreover, a preamble may limit an invention when it is employed to
distinguish a new use of a prior art apparatus or process. Bristol-Myers
Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001).
Conversely, 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." Catalina, 289 F.3d at
808 (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). In the
appeal before us, the preamble recites no essential structure or steps: a
person of ordinary skill would still understand the complete scope of the
claimed composition if the preamble was omitted. Rather, the preamble
recites merely the purpose or intended use of the composition, viz., the
treatment of recurrent herpesvirus infection. We consequently agree with
the Examiner that the language of the preamble is not limiting on the claim.
With respect to the final limitation in the body of the claim, which
recites: "wherein the composition treats recurrent herpesvirus infections,"
we agree with the Examiner that the limitation recites an inherent property
of the claimed composition. Appellant's argument that this property was
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unknown at the time of the filing of Appellant's application is immaterial
because the claimed composition would have necessarily possessed that
property at the time of filing whether or not it was known in the
contemporary art. Generally, structures and their properties are
indistinguishable. As our reviewing court held:
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed
product .... Whether the rejection is based on 'inherency' under
35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C.
§ 103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO' s inability to
manufacture products or to obtain and compare prior art
products.
In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977). The burden thus devolves
upon Appellant to provide evidence demonstrating that the combined prior
art cited by the Examiner did not necessarily possess the property of being
able to treat recurrent herpesvirus infections (regardless of whether that
property was appreciated in the art when the present application was filed).
This Appellant has not done, and we consequently are not persuaded by
Appellant's arguments.
Issue 2
Appellant argues that the combined art does not teach all of the
limitations of claim 1 and that a person of ordinary skill would have had no
reason to combine the teachings of Ludwig and Lekare to arrive at
Appellant's claimed invention. App. Br. 20-21.
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Analysis
Appellant argues, first, that Ludwig discloses various formulations
comprising acyclovir, none of which, they argue, have the same quantities of
inactive ingredients as the claimed composition. App. Br. 21. According to
Appellant, Ludwig teaches using the formulations to treat mice infected
cutaneously with wild-type HSV-1, but provides no teaching or suggestion
that the compositions it discloses provide reason for a person of ordinary
skill in the art to believe that the compositions it discloses would be
efficacious in treating recurrent herpesvirus infections. Id.
Appellant next argues that a person of ordinary skill in the art would
have had no reason or motivation to combine Ludwig and Lekare. App. Br.
21. Appellant points to the Examiner's finding that Lekare teaches the
quantities of isopropyl myristate and propylene glycol recited in the
composition of the pending claims, but argue that Lekare teaches topical
formulations comprising both acyclovir and glucocorticoids as dual active
ingredients, 15-25% propylene glycol and 10-25% isopropyl alkanoic acid
ester. Id. at 21-22 (citing Lekare i-fi-16, 14, 18, 19). Appellant asserts,
therefore, that the combination of Ludwig and Lekare teaches a breadth of
components of topical acyclovir formulations, and, together, they disclose
broad ranges for these components. Id. at 22.
We do not find Appellant's arguments persuasive. The composition
of claim 1 comprises, in relevant part: (1) 4 to about 7 weight percent of an
acyclic guanosine analogue, as the sole active ingredient; (2) about 18 to
about 22 weight percent propylene glycol and; (3) about 12 to about 18
weight percent isopropyl C12-C22 alkanoic acid ester. Ludwig teaches
compositions comprising: (1) "In a preferred aspect ... from 0.5% to 10%
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w/w ac[y ]clovir" [an acyclic guanosine analogue] as the sole active
ingredient; (2) "from 0 to 30% by weight of propylene glycol"; and (3)
"[ s ]traight or branched chain, mono- or dialkyl esters such as ... isopropyl
myristate [an isopropyl C12-C22 alkanoic acid ester; see claim 9] .... "
Ludwig 2-3. Ludwig is silent with respect to the concentration of isopropyl
myristate to be used in its compositions.
Lekare teaches:
A topical composition compnsmg an anti[-]inflammatory
glucocorticoid and a nucleoside analogue antiviral agent [e.g.,
acyclovir3] in a pharmaceutical carrier characterized in that the
carrier comprises about 15 to about 25 weight % propylene
glycol and about 10 to about 25 weight percent isopropyl C12-C22
alkanoic ester.
Lekare Abstr.; see also i-f 6. Lekare further teaches that: "The antiviral agent
is included in the formulation in substantially conventional concentrations
for the respective nucleoside, for example 0.5 to 15 weight percent,
preferably 1-7 weight percent such as around 4-5 weight percent." Id. at
i-f 12. Finally, Lekare teaches:
In the context of the invention, this combination of a lower
concentration of propylene glycol in conjunction with an
isopropyl alkanoic acid ester allows for good penetration and
release of the antiviral component, while at the same time
avoiding the instability shown by conventional antiviral
compositions.
Id. ati-f7.
3 See, e.g., Lekare i-f 11: "Particularly preferred antiviral agents include
penciclovir, 9-[ 4-hydroxy-2-(hydroxymethyl)butyl]guanine (H2G) and
especially acyclovir." (Emphasis added).
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Ludwig thus teaches a range of acyclovir that encompasses the range
taught by Appellant's claim 1 and a range of polypropylene glycol that falls
within the range recited in claim 1. Lekare similarly teaches a range of
acyclovir and propylene glycol concentrations within the ranges recited in
claim 1 and, further, teaches a range of isopropyl C12-C22 alkanoic ester that
encompasses that recited in claim 1. The close correspondence of the
teachings of both Ludwig and Lekare strongly support the Examiner's prima
facie conclusion of obviousness. See, e.g., In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003) ("In cases involving overlapping ranges, we and our
predecessor court have consistently held that even a slight overlap in range
establishes a prima facie case of obviousness").
Furthermore, Lekare also provides motivation that would have led a
person of ordinary skill in the art to use the ranges taught by the cited prior
art and recited in claim 1, viz., "this combination of a lower concentration of
propylene glycol in conjunction with an isopropyl alkanoic acid ester allows
for good penetration and release of the antiviral component, while at the
same time avoiding the instability shown by conventional antiviral
compositions." Lekare i-f 7.
Appellant's arguments that Lekare also teaches the use of a
glucocorticoid in addition to an acyclic guanosine analogue is immaterial.
First, Ludwig teaches a composition corresponding to that recited claim 1 in
which acyclovir is the sole active component. Second, all elements of each
prior art reference need not read on the claimed invention, rather, the proper
test for obviousness is what the combined teachings would have suggested to
a person of ordinary skill in the art. See In re Kotzab, 217 F.3d 1365, 1370
(Fed. Cir. 2000). In the instant appeal, Ludwig teaches all of the structural
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limitations of Appellant's claim 1 with the exception of the claimed
concentration of the isopropyl C12-C22 alkanoic ester. Ludwig supplies this
missing limitation, together with the remaining structural limitations of
claim 1 and, as we have explained, provides the motivation for a person of
ordinary skill in the art to use the concentrations of the components taught in
the references. We are consequently not persuaded by Appellant that: (1)
the combined references fail to teach all of the limitations of Appellant's
claims; and (2) that a person of ordinary skill in the art would not have had
either reason or motivation to combine the references.
Issue 3
Appellant argues that the cited prior art teaches away from the
claimed invention. App. Br. 28.
Analysis
Appellant repeats their argument supra that it was known in the art at
the time of filing that the topical compositions containing acyclovir as the
sole active ingredient were not efficacious in treating recurrent herpesvirus
infections at the time of the filing of the present application. App. Br. 28-
29. Appellant asserts that the Examiner has provided no indication why a
person of ordinary skill in the art would ignore the teachings of their cited
rebuttal art, published subsequent to Ludwig, all of which teach away from
the use of acyclovir-alone compositions to treat recurrent herpesvirus
infections, and would instead rely upon the teachings of Ludwig to arrive at
the claimed invention. Id.
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We are not persuaded by Appellant's argument. As we have
explained, the preamble and limitation of claim 1 reciting the intended
purpose of the claim, i.e., the treatment of recurrent herpesvirus infection,
are not limiting upon the claim and we therefore accord them no patentable
weight. Appellant's argument that a person of ordinary skill would not
combine the teachings of Ludwig and Lekare to treat recurrent herpesvirus
infections consequently falls by the wayside. Furthermore, and as we have
explained, Ludwig and Lekare together teach all of the structural
requirements of claim 1 and Lekare provides a motivation to combine the
references.
A reference teaches away when "a person of ordinary skill, upon
reading the reference, would be discouraged from following the path set out
in the reference, or would be led in a direction divergent from the path that
was taken by the applicant." In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994). Appellant points to no teachings of the prior art that would
discourage or divert a person of ordinary skill in the art from combining the
references to arrive at the claimed composition; rather, Appellant has argued
only that a person of ordinary skill would have been discouraged by the state
of the art from using the combined teachings for its intended purpose, i.e.,
the treatment of recurrent herpesvirus infections. As we have explained, that
intended purpose is not limiting on the claim and Appellant's argument in
this respect is therefore irrelevant.
Issue 4
Appellant argues that the Examiner has improperly ignored evidence
of unexpected results. App. Br. 30.
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Analysis
Appellant argues that, contrary to the Examiner's findings, acyclovir
was not a known anti-viral compound for treating recurrent herpesvirus
infections. App. Br. 30. Appellant then points to the teachings of Hull,
published subsequent to Appellant's filing date, which allegedly show that
using acyclovir as the sole active agent, as recited in claim 1, is
unexpectedly equally effective as a combination of acyclovir and a
glucocorticoid in the treatment of recurrent herpesvirus infections. Id. at 30-
31.
As discussed above, such arguments are not persuasive, because the
property of the claimed composition that renders it effective in the treatment
of recurrent herpesvirus infections is inherent to the claimed composition,
whether that property was known at the time of invention or not. See Best,
562 F.2d at 1255. Appellant's claims are not directed to a method of
treating recurrent herpesvirus infections but, rather, to a composition of
matter. Appellant cannot claim a composition of matter that is anticipated
by, or obvious over, the prior art simply because Appellant has discovered
an unexpected property of that same composition. Id. We consequently
agree with the Examiner's conclusion that that composition is, for the
reasons we have explained, prima facie obvious over the combined cited
prior art. Furthermore, Appellant argues claims 7-12, 14--16, 24, and 27
together with claim 1. We therefore affirm the Examiner's rejection of the
claims.
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B. Claims 28-31 and 34
Appellant advances the same arguments presented with respect to
claims 1, 7-12, 14--16, 24, and 27, arguing that neither Singh nor Currie cure
the alleged deficiencies of Ludwig and Lekare. App. Br. 26-27.
We have explained why we do not find Appellant's arguments with
respect to Ludwig and Lekare persuasive. We consequently affirm the
Examiner's rejection of claims 28-31 and 34.
DECISION
The Examiner's rejection of claims 1, 7-12, 14--16, 24, 27-31, and 34
as unpatentable under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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