Ex Parte Bergeron

Board of Patent Appeals and Interferences

Jul 6, 2011

11036130 (B.P.A.I. Jul. 6, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAYMOND J. BERGERON, JR.
__________

Appeal 2011-000099
Application 11/036,130
Technology Center 1600
__________

Before DONALD E. ADAMS, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a pain
amelioration method. The Examiner has rejected the claims as nonenabled
and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm the
obviousness rejection.
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STATEMENT OF THE CASE
Claims 1, 2, 5, and 9 are on appeal (App. Br. 1).
1
The claims have not
been argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 1 is representative and reads as follows:
1. A method for ameliorating pain in a human or non-human mammal
suffering therefrom comprising administering to the mammal an effective
amount of an antinociceptive amine having the formula:

R and R1 are the same or different and may be H or linear or
branched chain alkyl having 1 to 8 carbon atoms,
m is an integer from 0 to 10, inclusive
and wherein the amine exhibits a mean reduction in abdominal writhings
exhibited by mice in the standard acetic acid-induced visceral pain mouse
model of at least 20%; a mixture of the amines; a derivative, salt or complex
of the amine wherein the derivative, salt or complex former is
physiologically acceptable and the formation of said salt, derivative or
complex does not materially affect the pain amelioration properties of the
amine; a mixture of the derivatives, salts and/or complexes or a prodrug that
provides the amine, mixture of t he amines, the derivative, salt or complex, or
a mixture of the derivatives, salts and/or complexes.
Claims 1, 2, 5, and 9 stand rejected under 35 U.S.C. § 112, first
paragraph, because the “specification does not enable any person skilled in

1
Claims 3, 4, 6-8, and 10-24 are also pending but have been withdrawn from
consideration (App. Br. 1).
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the art . . . to make and use the invention commensurate in scope with these
claims” (Ans. 5).
Claims 1, 2, 5, and 9 also stand rejected under 35 U.S.C. § 103(a) as
obvious over Blicke
2
in view of Kocian
3
(Ans. 8-9).
ENABLEMENT
The Examiner finds that “the specification, while being enabling for
making pharmaceutically acceptable salts does not reasonably provide
enablement for making prodrugs, derivatives or complex former of
monoamines and treatment using such compounds” (Ans. 5). In particular,
the Examiner finds:
given that applicant did not fully describe what is encompassed
by a derivative or former complex of the aforementioned
monoamines, one of ordinary skill in the art would not be able
to ascertain if the prodrug, derivative, or former complex
effectively ameliorate pain given that a derivative may not
necessarily comprise the same core structure observed in the
parental compound(s).
(Id. at 6.)
Appellant argues:
the claims further define these compounds as: “wherein the
derivative, salt or complex former is physiologically acceptable
and the formation of said salt, derivative or complex does not
materially affect the pain amelioration properties of the amine;
. . . or a prodrug that provides the amine, mixture of the amines,
the derivative, salt or complex, or a mixture of the derivatives,
salts and/or complexes”

2
F. F. Blicke & Ezra Monroe, Antispasmodics I, 61 J. AM. CHEM. SOC. 91
(1939).
3
J. Kocián, Syndrom dráždivého tračníku, 40 VNITŘ. LÉK. 246 (1994).
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(App. Br. 3). Appellant also argues that it is not “a reasonable basis for this
ground of rejection that the specification does not exemplify/specify
particular „derivatives‟, „complexes‟ and „prodrugs‟ nor methods for their
preparation” (id. at 4).
Issue
Has the Examiner set forth a prima facie case that the Specification
does not enable a method for ameliorating pain comprising administering a
derivative, complex, or prodrug of the recited amine?
Principles of Law
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without „undue experimentation.‟” In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by
the description of the invention provided in the specification of
the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the
scope of enablement.
Id. at 1561-62.
Analysis
As noted by Appellant, claim 1 requires that the derivative or complex
be “physiologically acceptable” and that its formation “does not materially
affect the pain amelioration properties of the amine.” Claim 1 also requires
that the prodrug “provides the amine. . . .” We agree with Appellant that the
Examiner has not adequately supported the position that one of ordinary skill
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in the art would not have been able to make and use these derivatives,
complexes, and prodrugs without undue experimentation.
Conclusion
The Examiner has not set forth a prima facie case that the
Specification does not enable a method for ameliorating pain comprising
administering a derivative, complex, or prodrug of the recited amine. We
therefore reverse the enablement rejection of claims 1, 2, 5, and 9.
OBVIOUSNESS
The Examiner relies on Blicke for teaching “secondary amines, with
the formula RN-(H)(CH2)αR' where R is alkyl and R' is cycloalkyl, that are
strong antispasmodics and encompass applicant‟s elected species” (Ans. 9).
In particular, the Examiner relies on the teaching in Blicke of compound 13
(id.).
The Examiner relies on Kocian for teaching “that Irritable bowel (IB)
is a functional gastrointestinal disorder with chronic or relapsing symptoms
of abdominal pain and impaired frequency and consistency of the faeces,”
“that from the clinical aspect the type with dominant diarrhea . . . and the
type with pain and constipation are known but even combinations of the two
types are encountered,” and “that pain can be relieved by spasmolytics (i.e.
anti-spasmodics) in the smooth musculature of the large bowel” (id. at 9-10).
The Examiner concludes that “one of ordinary skill in the art at the
time of the invention would have found it obvious to utilize and try the
spasmolytic agents of Blicke to treat pain since Kocian teaches that pain
associated with IB can be relieved by spasmolytics” (id. at 10).
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Issue
Does the evidence support the Examiner‟s conclusion that it would
have been obvious to administer an amine of claim 1 to a mammal suffering
from pain?
Findings of Fact
1. Blicke discloses an amine, compound 13, that is within the
scope of claim 1 and that it has weak antispasmodic activity (Blicke 92;
Ans. 9; App. Br. 18-19).
2. Kocian discloses that, with regard to irritable bowel, “[p]ain is
relieved by spasmolytics” (Kocian, Abstract).
3. Blicke II
4
discloses:
Since no extensive, systematic study seems to have been
published which might permit some conclusion to be reached
relative to a relationship between chemical structure and
antispasmodic activity, . . . [i]t cannot be stressed too
emphatically that no trustworthy, broad generalization can be
drawn except on the basis of data obtained from the
examination of hundreds of compounds.
(Blicke II 93.)
Analysis
Blicke discloses an amine, compound 13, that is within the scope of
claim 1 and that it has weak antispasmodic activity (Finding of Fact (FF) 1).
Kocian discloses that pain associated with irritable bowel “is relieved by
spasmolytics” (FF 2). Thus, we agree with the Examiner that it would have

4
F. F. Blicke & F. B. Zienty, Antispasmodics II, 61 J. AM. CHEM. SOC. 93
(1939).
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been obvious to administer an amine of claim 1, specifically compound 13,
to a mammal suffering from pain associated with irritable bowel.
Appellant argues, however, that “having read the disclosure of
Kocian, one skilled in the art who then reads Blicke would naturally be led
to select those antispasmodics disclosed therein which have strong
antispasmodic activity” (App. Br. 19). We are not persuaded. Although a
strong antispasmodic may be more desirable, “the question is whether there
is something in the prior art as a whole to suggest the desirability, and thus
the obviousness, of making the combination, not whether there is something
in the prior art as a whole to suggest that the combination is the most
desirable combination available.” In re Fulton, 391 F.3d 1195, 1200 (Fed.
Cir. 2004) (citation omitted). In the present case, Blicke clearly discloses
that compound 13 has antispasmodic activity (FF 1) and therefore suggests
the desirability of making the combination.
5

Appellant also argues:
given the author‟s own warning against generalizing as to the
relationship between the chemical structure of a compound and
its antispasmodic activity, one skilled in the art would not even
be led by the disclosure of Blicke to select “weakly active”
compound 13 as a spasmolytic, much less its selection to treat
pain.
(App. Br. 20.) We are not persuaded. We agree that Blicke II states that,
“relative to a relationship between chemical structure and antispasmodic
activity, . . . no trustworthy, broad generalization can be drawn” (FF 3).
However, we do not agree that one skilled in the art would therefore not

5
We also note that Blicke‟s compound 14 is listed as “Active” and appears
to be within the scope of claim 1 (Blicke 92).
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even be led to select a compound specifically disclosed as having weak
antispasmodic activity as a spasmolytic to treat the pain associated with
irritable bowel.
In addition, Appellant argues that Kocian does not “support the
general proposition that pain can be relieved by any spasmolytic
(antispasmodic)” (App. Br. 20). In particular, Appellant argues that it “is
self-evident that the main text of the [Kocian] article more specifically
identifies those „spasmolytics‟ which do also possess analgesic properties”
(id.). We are not persuaded. In the Abstract, Kocian states that “[p]ain is
relieved by spasmolytics” (FF 2). Appellant has not pointed to anything, nor
do we detect a clear teaching, in the translation of the full Kocian article
6

indicating that the pain associated with irritable bowel was not thought to be
relieved by spasmolytics generally.
Appellant also points to various references to “demonstrate that one
skilled in the art would not blindly accept the proposition that all anti-
spasmodics are useful for treating pain, particularly in the treatment of IBS”
(App. Br. 21). We are not persuaded. We note initially that none of these
references have been provided. In addition, several of these references are
not prior art and therefore cannot be relied upon to show what would have
been accepted at the time of the present invention. Even with regard to the
references that appear to be prior art, we do not find that the recited quotes,
particularly out of context, are sufficient to convince us that there would not

6
In the Examiner‟s Answer, the Examiner relies on Kocian‟s English-
language Abstract (Ans. 9 & 13). However, a translation of Kocian was
provided to Appellant a little more than a week after the notification date of
the Examiner‟s Answer (7/2/10 Off. Comm.).
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have been a reasonable expectation of success in using antispasmodics
generally for treating the pain associated with IBS.
Conclusion
The evidence supports the Examiner‟s conclusion that it would have
been obvious to administer an amine of claim 1 to a mammal suffering from
pain. We therefore affirm the obviousness rejection of claims 1, 2, 5, and 9.
TIME PERIOD FOR RESPONSE
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

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