Ex Parte Marcy et al

Patent Trial and Appeal Board

Apr 5, 2016

12420374 (P.T.A.B. Apr. 5, 2016)

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.
12/420,374 04/08/2009 Alice Marcy 4494-P04581US01/PJH 2362
110 7590 04/06/2016
DANN, DORFMAN, HERRELL & SKILLMAN
1601 MARKET STREET
SUITE 2400
PHILADELPHIA, PA 19103-2307
EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1621
MAIL DATE DELIVERY MODE
04/06/2016 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ALICE MARCY and ANNETTE M. TOBIA
__________

Appeal 2013-010198
Application 12/420,374
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for treatment of a dry mucus membrane disorder. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-
in-part.

1 Appellants identify the Real Party in Interest as Dynamis
Pharmaceuticals, Inc. (see App. Br. 2).
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Statement of the Case
Background
“Dry eye (keratoconjunctivitis sicca or keratitis sicca) is a chronic
dryness of the corneal and conjunctival surfaces and results from a decrease
in the production of tear components or from an altered ratio of the
individual oil, water and mucus components to each other” (Spec. 1). “There
is an interest in treating dry eye with agents that can increase mucin
production” (Spec. 2).
The Claims
Claims 1 and 3–28 are on appeal. Independent claims 1 and 21 are
representative and read as follows:
1. A method for treatment of a dry mucus membrane
disorder selected from the group consisting of dry eyes, dry
mouth and constipation, the method comprising
administering to a patient in need of said treatment an
effective amount of a compound of the formula:

wherein R represents a substituted or unsubstituted
alkyl (C1–C4), said alkyl substituents being selected from the
group of hydroxy, carboxy, and phosphono substituents;
R1 and R2 are the same or different and represent a
radical selected from the group consisting of hydrogen and
hydroxymethyl radicals;
R3 and R4 are the same or different and represent a
hydrogen or hydroxy radical;
R5 and R6 are different and represent either a
hydrogen or hydroxy radical;
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R7 and R8 are different and represent either a
hydrogen or hydroxy radical;
R9, R10 and R11 are the same or different and represent
a radical selected from the group consisting of hydrogen,
alkyl (C1–C2), hydroxyalkyl and hydroxy radicals;
n represents either 0 or 1,
the pharmaceutically acceptable inorganic base,
organic base, inorganic acid, and methane sulfonic acid salts
and isomeric forms of said compound.

21. A method for treating a dry mucus membrane disorder
selected from the group consisting of dry eyes, dry mouth
and constipation in a patient in need thereof by
administering to said patient a therapeutically effective
amount of a therapeutic composition that increases mucin
production in said patient, said composition comprising
meglumine or a pharmaceutically acceptable salt thereof and
a pharmaceutically acceptable carrier medium, said
meglumine being the only therapeutically active component
of said composition that is effective to increase mucin
production in said patient.

The Issue
The Examiner rejected claims 1 and 3–28 under 35 U.S.C. § 103(a) as
obvious over Johnson2 (Ans. 4–5).
The Examiner finds that Johnson teaches “the use of meglumine as an
osmolyte for hydrating the surfaces in the body, such as eye which can be
used concurrently or sequentially with a sodium channel blocker” (Ans. 4).
The Examiner finds that the “treatment of dry eye is taught in claims 5 and
7–13” (Ans. 4). The Examiner finds it obvious “to use meglumine and the
salts of meglumine for the treatment of dry eye, considering that Johnson

2 Johnson et al., US 2008/0090841 A1, published Apr. 17, 2008.
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lists such components as osmolytes, which can be used concurrently, before
and after the use of sodium channel blockers to increase mucosal hydration
and mucosal clearance” (Ans. 4–5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Johnson render the claims obvious?
Findings of Fact
1. Johnson teaches “treatments comprising the use of osmolytes
together with sodium channel blockers that are more potent, more specific,
and/or absorbed less rapidly from mucosal surfaces” (Johnson ¶ 16).
2. Johnson teaches that “[a]ctive osmolytes useful in the present
invention that are ionic osmolytes include any salt of a pharmaceutically
acceptable anion and a pharmaceutically acceptable cation” (Johnson ¶ 88).
3. Johnson teaches that “[p]harmaceutically acceptable cations
that can be used to carry out the present invention include . . . meglumine
(N-methyl D-glucamine) . . . Particularly preferred cations include . . .
meglumine” (Johnson ¶ 90).
4. Claim 1 of Johnson teaches a “method of treating a disease
ameliorated by increased mucociliary clearance and mucosal hydration
comprising administering to a subject in need of increased mucociliary
clearance and mucosal hydration an effective amount of an osmolyte and a
sodium channel blocker” (Johnson 20, claim 1) and claim 5 of Johnson
further teaches the “method of claim 1, wherein the disease is one or more
conditions selected from the group consisting of . . . dry eye” (Johnson 23,
claim 5).
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Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
Claim 1
Appellants contend that “Johnson only contemplates the use of
meglumine salts. Nowhere does Johnson expressly or impliedly suggest the
use meglumine, per se, i.e., in the form of its free base” (Br. 5).
We are not persuaded. Claim 1 is not limited to the “free base” form
of meglumine, expressly encompassing the “methane sulfonic acid salts” as
well as “organic base” and inorganic acid” forms. Appellants provide no
evidence suggesting that the meglumine of Johnson does not fall within the
scope of claim 1. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(“[A]ppellant’s arguments fail from the outset because . . . they are not based
on limitations appearing in the claims.”)
Appellants contend that “Johnson emphatically and unequivocally
teaches the use of an osmotically active agent and a sodium channel blocker
in combination” (Br. 6). Appellants contend that the
use of an osmotically active salt alone would render Johnson
unsatisfactory for its intended purpose, where such purpose
requires two compounds acting in combination. Therefore,
Johnson provides no motivation or rationale to an ordinary
artisan to administer only one half of a proposed
combination, i.e., an osmotically active salt and a sodium
channel blocker.

(Br. 5).
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We do not find these arguments persuasive for claim 1. Claim 1
recites a method “comprising” the administration of meglumine. The
transitional term “comprising” is “inclusive or open-ended and does not
exclude additional, unrecited elements or method steps.” Georgia-Pacific
Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999). Thus,
claim 1 encompasses the use of the osmotically active agent meglumine
along with a sodium channel blocker as taught by Johnson (FF 1, 3), where
Johnson further directly suggests their use for dry eye (FF 4). Thus, in order
to render claim 1 obvious, Johnson may comprise both meglumine and a
sodium channel blocker, which would not render Johnson unsatisfactory for
its intended purpose.
Appellants contend that
Johnson proposes the use of osmolytes, particularly
hypertonic saline, in combination with sodium channel
blockers as hydrating treatments in other ailments resulting
from dysfunctional mucosal membranes. However, this
proposition could not be viewed as a plausible teaching to a
person having ordinary skill in the art, at least with regard to
dry eye and dry mouth, since hypertonic saline is well
known to have a drying effect in both conditions.

(Br. 7).
We are not persuaded. A teaching away requires a reference to
actually criticize, discredit, or otherwise discourage the claimed solution.
See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s
mere disclosure of more than one alternative does not constitute a teaching
away from any of these alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed”).
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Not only does Johnson fail to criticize the use of osmolytes for
treatment of dry eye, Johnson specifically claims the use of osmolytes, in
combination with sodium channel blockers, for treatment of dry eye (FF 4).
Appellants do not identify any specific teaching in Johnson that discourages
or criticizes the use of osmolytes in dry eye.
We have considered the statement in the Barker Declaration3 that
A person having ordinary skill in the art, in view of Johnson,
would be dissuaded from using osmotically active salts (e.g.,
hypertonic saline and meglumine chloride) in the treatment
of a dry mucous membrane disorder, such as dry eye, as the
use of such compositions would appear to exacerbate, rather
than ameliorate the condition in the absence of a sodium
channel blocker.

(Barker Dec. ¶ 7). Dr. Barker’s statement suggests that it is the use of
meglumine alone that would be avoided, not the combination of sodium
channel blockers and meglumine taught by Johnson for dry eye. Because, as
already noted, claim 1 does not exclude the use of sodium channel blockers,
the evidence in the Barker Declaration does not overcome the obviousness
rejection of claim 1.
Claim 17
Appellants contend that “Johnson does not teach or suggest the use of
meglumine as a free base” (Br. 10).
We do not find this argument persuasive because claim 17 uses the
open transitional language “comprising” and does not limit the compound of
formula I to the free base form of meglumine. “[L]limitations are not to be

3 Declaration of Dr. Felix M. Barker II, dated Jan. 29, 2012.
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read into the claims from the specification.” In re Van Geuns, 988 F.2d
1181, 1184 (Fed. Cir. 1993).
Claim 18
Appellants contend that “[c]laim 18 recites ‘said therapeutic agent
consisting essentially of’ an alkylamino-polyhydroxyalkane and thus
necessarily excludes the concomitant application of a sodium channel
blocker as defined in Johnson” (Br. 12). Appellants contend that “the use of
such a sodium channel blocker in the present invention would ‘materially
affect the basic and novel characteristic(s) of the claimed invention’ where
the present invention is directed to the increase in goblet cell concentration,
which thereby increases mucin production” (Br. 12).
We find this argument persuasive, and the Examiner provides no
specific rebuttal (see Ans. 6 “Appellant’s arguments regarding claims . . . 18
. . . have been noted”). In particular, Appellants contend that “[s]odium
channel blockers are known to reduce goblet cell counts” (Br. 12) and the
Specification teaches that the “inner layer of mucus is produced by goblet
cells” (Spec. 1). Thus, because claim 18 requires administration of an agent
that “increases mucin production” and the sodium channel blockers would
have been expected to decrease, rather than increase, mucin production, we
agree with Appellants that the use of sodium channel blockers would
materially affect the basic and novel characteristics of the method of claim
18, and are excluded by the “consisting essentially of” language.
Claims 21 and 27
Appellants contend that claim 21 recites “meglumine being the only
therapeutically active component of said composition that is effective to
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increase mucin production in said patient’” (Br. 15; emphasis omitted).
Appellants contend that “[c]laims 21 and 27 are nonobvious over Johnson
for at least the reason that Johnson fails to teach or suggest the feature of
increasing mucin production in a patient” (Br. 15).
We are not persuaded. Johnson expressly suggests the use of
osmolytes such as meglumine for treatment of dry eye (FF 1, 3, 4). As
Appellants’ earlier arguments acknowledge, the only therapeutically active
component of Johnson that would function to increase mucin production is
meglumine, because sodium channel blockers would not be expected to
increase mucin production (see Br. 13). Both claims 21 and 27 use the open
claim language “comprising” and simply requires that the meglumine is the
“only therapeutically active component . . . effective to increase mucin
production”, not that meglumine is the only therapeutically active
component of the composition. Thus, claims 21 and 27 are open to the use
of additional components including the sodium channel blockers expressly
suggested by Johnson (FF 1).
Conclusion of Law
The evidence of record support the Examiner’s conclusion that
Johnson renders claims 1, 17, 21, and 27 claims obvious.
The evidence of record does not support the Examiner’s conclusion
that Johnson renders claim 18 obvious
SUMMARY
In summary, we affirm the rejection of claims claims 1, 17, 21, and 27
under 35 U.S.C. § 103(a) as obvious over Johnson. Claims 3–16, 22–26 and
28 fall with claims 1, 17, 21, and 27. 37 C.F.R. § 41.37(c)(1)(iv).
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We reverse the rejection of claims 18–20 under 35 U.S.C. § 103(a) as
obvious over Johnson.

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