Ex Parte Gadde et al

Board of Patent Appeals and Interferences

Jul 14, 2009

11059027 (B.P.A.I. Jul. 14, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KISHORE M. GADDE and K. RANGA KRISHNAN
__________

Appeal 2009-001256
Application 11/059,027
Technology Center 1600
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Decided1July 14, 2009
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Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating obesity. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, begins to run from the
decided date shown on this page of the decision. The time period
does not run from the Mail Date (paper delivery) or Notification
Date (electronic delivery).
Appeal 2009-1256
Application 11/059,027

Statement of the Case
The Claims
Claims 18-33 and 39-51 are on appeal. We will focus on independent
claim 18, which is representative and reads as follows:

18. A method of treating obesity comprising
administering to a human subject in need of such treatment
an active metabolite of bupropion, and at least one weight-
loss promoting anticonvulsant wherein said anticonvulsant is
of the formula (I).

wherein X is CH2 or oxygen,
R1 is hydrogen or alkyl,
R2, R3, R4 and R5 are independently hydrogen or
lower alkyl, and when X is CH2, R4 and R5 can be alkene
groups joined to form a benzene ring and when X is oxygen,
R2 and R3 and/or R4 and R5 together can be a
methylenedioxy group of the following formula (II)

wherein
R6 and R7 are the same or different and are hydrogen,
lower alkyl or are alkyl and are joined to form a cyclopentyl
or cyclohexyl ring.
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The issues
A. The Examiner rejected claims 18-33 and 39-51 under 35 U.S.C. §
112, first paragraph, as failing to comply with the written description
requirement regarding new matter.
B. The Examiner rejected claims 18-33 and 39-51 under 35 U.S.C. §
112, first paragraph, as failing to comply with the written description
requirement regarding descriptive support.
C. The Examiner provisionally rejected claims 21-26 and 30-33 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1-16 of copending Application No. 11/059,021.
D. The Examiner provisionally rejected claims 18-33 and 39-51 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 18, 19, 22-25, 28, 29, 32, and 33 of copending
Application No. 11/058,981.
A. and B. 35 U.S.C. § 112, first paragraph rejections
The Examiner states that “any disclosure in the instant application that
goes beyond the [sic that] which was disclosed as filed in said application
no. 10/440,404 is New Matter” (Ans. 6). The Examiner finds that “[r]eview
of said 10/440,404 has failed to reveal any disclosure of ‘metabolites of
bupropion’, which is now present in the instant application claims. Only
bupropion per se and not its metabolites are disclosed in said parent
application no. 10/440,404” (Ans. 6). The Examiner finds that “the claims
limitations directed to ‘an active metabolite of bupropion’ are New Matter”
(Ans. 6).
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Application 11/059,027

The Examiner also finds that “claims 18-33 are directed to require an
active metabolite of bupropion, which only correspond in some undefined
way to bupropion. None of these metabolites meet the written description
provision of 35 USC 112, first paragraph, due to lacking chemical structural
information for what they are and chemical structures are highly variant and
encompass a myriad of possibilities” (Ans. 7).
Appellants “submit that the amendments to the [S]pecification and
claims do not constitute impermissible new matter, as the disclosure of
treating a patient with bupropion found in the [S]pecification as filed,
inherently discloses the active metabolites of bupropion and one of skill in
the art would have recognized that fact at the time of filing” (App. Br. 7).
Appellants also contend that “[t]he Examiner's written description
rejection of the pending claims does not take into account the disclosure of
the [S]pecification and claims as amended. Rather, the Examiner's
arguments rest on his mistaken assumption that the [S]pecification cannot be
amended to recite ‘active metabolite of bupropion’” (App. Br. 11).
Appellants contend that in view of the “[S]pecification as amended to
include matter which was inherently disclosed in the [S]pecification as filed,
Appellants submit that the presently pending claims are adequately
supported by the [S]pecification” (App. Br. 12).
In view of these conflicting positions, we frame the new matter issue
before us as follows:
Did the Examiner err in finding that a skilled artisan would not have
found the Specification, as originally filed, as providing descriptive support
for the claim term “active metabolite of bupropion”?
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Findings of Fact (FF)
1. The Specification teaches that “[b]upropion, marketed as an
antidepressant, has a pharmacological action dissimilar to that of zonisamide
or topiramate. Bupropion has been shown to cause significant weight loss in
patients presenting with primary obesity” (Spec. 3).
2. The Specification teaches that the use of “bupropion (or other
compound that enhances monoamine (e.g., serotonin, norepinephrine and/or
dopamine) turnover in the brain via uptake inhibition or other mechanism)
provides an effective treatment for obesity with few side effects” (Spec. 3-
4).
3. The Specification teaches that the anticonvulsant is of
the formula (I).

wherein X is CH2 or oxygen,
R1 is hydrogen or alkyl,
R2, R3, R4 and R5 are independently hydrogen or
lower alkyl, and when X is CH2, R4 and R5 can be alkene
groups joined to form a benzene ring and when X is oxygen,
R2 and R3 and/or R4 and R5 together can be a
methylenedioxy group of the following formula (II)
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wherein
R6 and R7 are the same or different and are hydrogen,
lower alkyl or are alkyl and are joined to form a cyclopentyl
or cyclohexyl ring.

(Spec. 27-28).
4. The Examiner finds that there is no disclosure of “metabolites
of bupropion” in the Specification as filed (Ans. 6).
5. The Wellbutrin product information discloses that “[b]upropion
is extensively metabolized in humans. Three metabolites have been shown
to be active” (Wellbutrin product information 2).
6. The Examiner finds that the metabolites of bupropion
encompass “chemical structures [which] are highly variant and encompass a
myriad of possibilities” (Ans. 7).
7. The Examiner finds that the Specification did not teach “the use
of metabolites of bupropion to treat obesity and reduce the risk of
hypertension, diabetes or dyslipidaemi[]a” (Ans. 11).
Principles of Law
Adequate written description means that, in the Specification, the
applicant must “convey with reasonable clarity to those skilled in the art
that, as of the filing date sought, he or she was in possession of the [claimed]
invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64
(Fed.Cir.1991). “Put another way, one skilled in the art, reading the original
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disclosure, must immediately discern the limitation at issue in the claims.”
Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
“When no such description can be found in the specification, the only thing
the PTO can reasonably be expected to do is to point out its nonexistence.”
Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007). See In re Alton,
76 F.3d 1168, 1175 (Fed.Cir.1996) (holding that when the examiner alleges
that the claimed embodiment is outside the scope of the specification, he
“need only establish this fact to make out a prima facie case”).
An adequate written description of a chemical invention “requires a
precise definition, such as by structure, formula, chemical name, or physical
properties.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d
916, 927 (Fed. Cir. 2004); Regents of the Univ. of Cal. v. Eli Lilly & Co.,
Inc., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164,
1171 (Fed. Cir. 1993).
“A description of what a material does, rather than of what it is,
usually does not suffice.” Rochester, 358 F.3d at 923; Eli Lilly, 119 F.3d at
1568. Instead, the “disclosure must allow one skilled in the art to visualize or
recognize the identity of the subject matter purportedly described.” Id.
In addition, possession of a genus “may be achieved by means of a
recitation of a representative number of [compounds] … falling within the
scope of the genus.” Eli Lilly, 119 F.3d at 1569. “Possession may not be
shown by merely describing how to obtain possession of members of the
claimed genus.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (BPAI 2007)
(citing Rochester, 358 F.3d at 927).
Analysis
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There are three separate questions embedded in the written description
analysis in this case. There is the central question of whether the Applicants
were in possession of the class “active metabolites” of bupropion. There is
the question of whether disclosure of bupropion provides “inherent”
description for the metabolites of bupropion. And, since the originally filed
disclosure was drawn to the “administration” of bupropion, there is the
question of whether there is descriptive support for “administration” of
active metabolites of bupriopion.
(i) New Matter
The Specification, as filed, provides no explicit description for an
“active metabolite of bupropion” (FF 1-4). The Specification provides no
structural information regarding such metabolites nor does the original
disclosure provide that active metabolites of bupropion can be administered
(FF 4).
While there is evidence that three active metabolites of bupropion
were known to the skilled practitioner (FF 5), this evidence does not
demonstrate that the skilled practitioner would have known the genus
“active metabolites” of bupropion as required by the claims.
Since “active metabolite of bupropion” lacks any structural support in
the originally filed specification, the claim term is necessarily solely
functional, describing the “active metabolite” solely by function without any
structural information. Appellants’ amendments to the Specification do add
the three specific metabolites disclosed in the Wellbutrin disclosure, but
provide no general structures for other active metabolites of bupropion (see
Appellants Amendment 3/23/2007 2-3). As the court noted in Enzo, “[a]
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description of an anti-inflammatory steroid, i.e., a steroid (a generic
structural term) described even in terms of its function of lessening
inflammation of tissues fails to distinguish any steroid from others having
the same activity or function . . . A description of what a material does,
rather than of what it is, usually does not suffice.” Enzo Biochem, Inc. v.
Gen-Probe Inc., 323 F.3d 956, 968 (Fed.Cir.2002).
We agree with the Examiner that metabolites of bupropion encompass
“chemical structures [which] are highly variant and encompass a myriad of
possibilities” (Ans. 7; FF 6). While Appellants contend that three
metabolites were known at the time of filing of the application, Appellants
do not contend that these three metabolites are representative of the class
active metabolites of bupropion (see App. Br. 8). Appellants also do not
provide evidence which suggests that the three metabolites are representative
members of the genus of active metabolites. See In re Alton, 76 F.3d 1168,
1175 (Fed.Cir.1996) (“To overcome a prima facie case, an [A]pplicant must
show that the invention as claimed is adequately described to one skilled in
the art”).
We are not persuaded by Appellants argument that “[i]n view of the
[S]pecification as filed, and the [S]pecification as amended . . . . the
presently pending claims are adequately supported by the Specification”
(App. Br. 12). This case is similar to the recently decided ICU Medical
case, in which broad claims to a connector without a spike limitation were
found to lack support in a specification which “describes only medical
valves with spikes.” ICU Medical, Inc. v. Alaris Medical Systems, Inc.,
558 F.3d 1368, 1378 (Fed. Cir. 2009). The court found that “[i]t is not
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Application 11/059,027

enough that it would have been obvious to a person of ordinary skill that a
preslit trampoline seal could be used without a spike. . . . ICU has failed to
point to any disclosure in the patent specification that describes a spikeless
valve with a preslit trampoline seal.” Id. at 1379. Similarly, while it might
have been known to persons of skill in the art that bupropion, after being
administered to a patient, would break down into certain metabolites, that
knowledge does not establish that the inventors recognized metabolite
administration as their invention. While it might have been obvious to
persons of skill in the art that bupropion administration would result in
certain metabolites later being formed in a subject, obviousness is not the
proper test under Section 112. See PIN/NIP, Inc. v. Platte Chemical Co.,
304 F.3d 1235, 1248 (Fed. Cir. 2002) (“The specification describes only
three methods of treating tubers: application of a substituted naphthalene
alone (prior art), application of CIPC alone (prior art), and application of a
mixture of both chemicals. None of these methods is the same as the
spaced, sequential application of the two chemicals, which is the subject
matter of claim 33. New claim 33 is directed to new subject matter.”)
Active metabolites of buproprion were not discussed even in passing
in the original disclosure. We find that adding this subject matter now
would be “exactly the type of overreaching the written description
requirement was designed to guard against.” Purdue Pharma, 230 F.3d at
1327.
(ii) Inherency
Appellants’ theory is that “the amendments to the [S]pecification and
claims do not constitute impermissible new matter, as the disclosure of
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treating a patient with bupropion found in the [S]pecification as filed,
inherently discloses the active metabolites of bupropion and one of skill in
the art would have recognized that fact at the time of filing” (App. Br. 7).
Appellants rely upon Kennecott, where the court stated that “[t]he
disclosure in a subsequent patent application of an inherent property of a
product does not deprive that product of the benefit of an earlier filing date.
Nor does the inclusion of a description of that property in later-filed claims
change this reasonable result.” Kennecott Corp. v. Kyocera Intern., Inc.,
835 F.2d 1419, 1423 (Fed. Cir. 1987).
In Kennecott, there was no dispute that the products necessarily had
an equiaxed microstructure, and the only dispute was whether this inherency
was sufficient to support the claim language. See Id. at 1422-23. In the
current situation, the Examiner finds a factual dispute as to whether
“metabolites of bupropion . . . treat obesity and reduce the risk of
hypertension, diabetes or dyslipidaemi[]a” (Ans. 11; FF 7). The Examiner
also finds that the metabolites of bupropion encompass “chemical structures
[which] are highly variant and encompass a myriad of possibilities” (Ans. 7;
FF 6).
Appellants have provided no evidence to demonstrate that an “active
metabolite of bupropion” will necessarily function to treat obesity or reduce
the risk of hypertension, diabetes or other conditions. Relying on the
statements of an examiner in another application (App. Br. 10) is not
sufficient evidence to persuade us otherwise.
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We think it is reasonable to conclude that it is not inherent that all
“active metabolites of bupropion” will necessarily have the same biological
effect as the bupropion itself.
(iii) Administration
Finally, even if it were conceded that the prior art disclosure of active
metabolites of bupropion inherently satisfies the description requirement
when only bupropion is disclosed, the Wellbutrin prior art does not disclose
administration of the active metabolites of bupropion.
At best, the Wellbutrin disclosure demonstrates that at some time after
administration of bupropion itself, certain metabolites inherently result. This
does not represent either an express or inherent disclosure that Appellants’
original disclosure of administration of zonisamide with buproprion meant
that active metabolites of buproprion could be substituted for the buproprion.
The original disclosure that “other” compounds could be used, see Spec. at
4, is not sufficient to satisfy the written description requirement as to the
particular sub-genus of “other” that Appellants wish to add. See Fujikawa v.
Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In finding that
Wattanasin’s disclosure failed to sufficiently describe the proposed sub-
genus, the Board again recognized that . . . his application contained no
blazemarks as to what compounds, other than those disclosed as preferred,
might be of special interest.”).

Conclusion of Law
The Examiner did not err in finding that a skilled artisan would not
have found the Specification, as originally filed, as providing possession and
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descriptive support for the claim term of an “active metabolite of
bupropion”.
C. and D. Provisional double patenting rejections
The two U.S. patent applications, 11/059,021and 11/058,981,
regarding which the Examiner applied the provisional obviousness type
double patenting rejections, are both currently abandoned. Thus, the double
patenting rejections are moot.
SUMMARY
In summary, we affirm the rejection of claims 18-33 and 39-51 under
35 U.S.C. § 112, first paragraph, written description.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

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