Ex Parte Jenkins et al

Patent Trial and Appeal Board

Dec 7, 2012

11297737 (P.T.A.B. Dec. 7, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte SCOTT A. JENKINS and GARY LIVERSIDGE
__________

Appeal 2011-011660
Application 11/297,737
Technology Center 1600
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Before TONI R. SCHEINER, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-3, 6, 9, 10, 12, 14, and 16-25.
1
We have
jurisdiction under 35 U.S.C. § 6(b).

1
Claims 7, 8, 11, 13, and 15 are also pending, but stand withdrawn from
consideration (App. Br. 8).
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Application 11/297,737

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STATEMENT OF THE CASE
The Specification teaches that the “invention relates to a once-daily
controlled-release pharmaceutical formulation which contains therapeutic
amounts of topiramate and which is capable of being administered to
specific regions along the gastrointestinal tract” (Spec. 1). As taught by the
Specification, the composition delivers “therapeutic amounts of topiramate
to the proximal small bowel, distal small bowel and/or colonic regions of the
gastrointestinal tract” (id. at 3). The Specification teaches that the dosage
form includes “an immediate release (IR) component comprising from about
5 mg to about 250 mg of topiramate which is released within about 1 hour
after administration” (id. at 4).
The Specification describes a pharmacoscintigraphy study of
topiramate, wherein the reference treatment was Trt A, which represents
200mg topiramate as the commercial immediate release reference
formulation, Topamax™ (id. at 23).
Claims 1 and 23 are representative of the claims on appeal, and read
as follows:
1. An oral controlled-release pharmaceutical composition of
topiramate which delivers therapeutic amounts of topiramate to a
specific region of the gastrointestinal tract of an animal comprising:
(A) an immediate-release component comprising from about 5 mg to
about 250 mg of topiramate which is released in the body within about
1 hour after administration; and (B) a delayed release component
comprising from about 5 mg to about 250 mg of topiramate which is
released in the body over a period of time of about 6 hours to 24 hours
after administration.

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23. The composition of claim 1, 8, or 22 wherein topiramate is
release [sic] at a rate ranging from about 5 to about 12.5% of the dose
per hour.

The following grounds of rejection are before us for review:
I. Claims 10, 14, and 24 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite (Ans. 6).
II. Claims 1-3, 6, 9, 10, 12, 14, and 21-25 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by Yam
2
(Ans. 8).
III. Claims 1 and 16-20 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by Yam and Najarian
3
(Ans. 13).

We affirm.

ANALYSIS (Rejection I)
The Examiner rejects claims 10, 14, and 24 as being indefinite (Ans.
6). The Examiner finds that the “term/phrase „substantially equal
bioavailability as counterpart topiramate immediate release formulations‟ is
subjective and is not defined in a limiting way in the specification” (id.).
Specifically, the Examiner finds that the phrase “substantially equal
bioavailability” does not reasonably apprise the skilled artisan of the scope
of the invention, and that there is no discussion in the Specification of what
constitutes a “counterpart formulation” (id. at 6-8).

2
Yam et al., US 2005/0136108 A1, published Jun. 23, 2005.
3
Najarian et al., US 2004/0002462 A1, published Jan. 1, 2004.
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Appellants first argue that they attempted to resolve the issue by
amending the claims in an amendment after final, but that the Examiner
refused entry (App. Br. 13). Appellants request that the Board enter the
amendment (id.).
The Examiner‟s refusal to enter the amendment after final is a
petitionable matter under 37 C.F.R. § 1.181 and not within the jurisdiction of
the Board. 37 C.F.R. § 1.127; In re Berger, 279 F.3d 975, 984 (Fed. Cir.
2002) (citing In re Hengehold, 440 F.2d 1395, 1403-1404 (CCPA 1971)).
Appellants argue further that “the language „substantially equal
bioavailability‟ clearly points out and distinctly defines the metes and
bounds of the subject matter claimed” (App. Br. 14). Specifically,
Appellants assert that the Specification provides “ample examples
comparing bioavailability of the claimed invention with the counterpart
immediate release products” (id. at 16). Appellants further assert that “those
of ordinary skill in the art would have understood that the recitations of
„substantially equal bioavailability‟ or „at least the same bioavailability‟ are
commonly agreed in to convey a 90% Confidence Intervals of such relative
values as the mean Cmax, AUC(0-t) and AUC(0-∞)” (id.).
Appellants further assert that the language “„counterpart topiramate
immediate release‟” would be understood by the skilled artisan, as
demonstrated by the Specification (id. at 17-18 (citing Spec. 25)).
We agree with Appellants, for the reasons set forth by Appellants, that
the skilled artisan would understand the metes and bounds of the claim terms
“substantially equal bioavailability” and “counterpart topiramate immediate
release.” (Id. at 17.) We thus reverse the indefiniteness rejection.
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ANALYSIS (Rejections II and III)
The Examiner rejects claims 1-3, 6, 9, 10, 12, 14, and 21-25 as being
rendered obvious by Yam (Ans. 8). Appellants only separately argue claims
22, 23, and 25, and thus we focus our analysis of the remaining claims on
claim 1, and claims 2, 3, 6, 9, 10, 12, 14, 21, and 24 stand or fall with that
claim. As to claims 22, 23, and 25, Appellants also argue those claims as a
group, thus we choose claim 23 as representative, and claims 23 and 25
stand or fall with that claim.
We agree with the Examiner‟s findings and conclusions, and adopt
them as our own (Ans. 8-11). We also highlight the following teachings of
Yam.
Yam “provides a means for delivering high doses of the lowly soluble
drug topiramate at a stepwise, increasing rate from a solid dosage form
system that is convenient to swallow” (Yam, p. 1, ¶2). Yam provides “two
drug layer compositions within the dosage form that release consecutively to
produce a stepwise or ascending rate of release from the dosage form
depending upon the type and configuration of the osmotic delivery device
and layers” (id. at p. 2, ¶19). The drug composition of Yam allows for
increased absorption of topiramate in the gastrointestinal tract, especially the
colonic region (id. at p. 3, ¶24).

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Figure 3 of Yam is reproduced below:

Figure 3 “illustrates a release profile (release rate as a function of time) of
the active agent topiramate from a representative dosage form having the
general characteristics of FIG. 2, after multiple dosings (id. at p. 4, ¶¶37 and
38). Given the error bars, as seen in Figure 3, doses as high as 8 mg/hr were
obtained, which, assuming a linear release profile, would have resulted in a
release rate of 4 mg/hr in 1 hour (see, e.g., App. Br. 24).
Yam also defines an “immediate-release dosage form” as “a dosage
form that releases drug substantially completely within a short time period
following administration, i.e., generally within a few minutes to about 1
hour” (id. at p. 5, ¶54).
Appellants argue that the Examiner finds that Yam teaches an
immediate-release component comprising from “about 5 mg to about 250
mg of topiramate which is released in the body within about 1 hour after
administration,” noting that the term “about” allows the Examiner to read
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the claimed range as encompassing the release rates shown in Figures 3 and
4 of Yam (App. Br. 22). Appellants assert that they attempted to remove
“about” in the proposed Amendment after final, but that the Examiner
refused entry (id.).
Again, the Examiner‟s refusal to enter the amendment is reviewable
by petition, and not be appeal to the PTAB.
Appellants also argue “Yam‟s phrase „several hours or less‟ excerpted
from par. [0089] would be understood by one of ordinary skill in the art to
have a lower limit of drug release at 1.5 and 4 mg at one hour. Accordingly,
this release rate does not anticipate nor render obvious Appellants‟ claim
limitation of „about 5 mg to about 250 mg of topiramate which is released in
the body within about 1 hour after administration‟” (App. Br. 24).
Appellants further assert that Yam also fails to teach an immediate
release component (Reply Br. 19). Appellants assert that an “immediate
release component . . . must refer to a component that releases the drug
substantially completely within a short time period following administration
generally within a few minutes to about 1 hour” (id. (citing Yam, p. 5, ¶54)).
Appellants reiterate that “[i]n the best case scenario, Yam merely refers to a
release of 4 mg within 1 hour,” and that “[t]here is no indication in Yam that
such release is obtained from a separate immediate release component” (id.).
Appellants‟ arguments have been carefully considered, but are not
deemed persuasive.
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the Specification as it
would be interpreted by one of ordinary skill in the art. In re American
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Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). An
essential purpose of patent examination is to fashion claims that are precise,
clear, correct, and unambiguous. Only in this way can uncertainties of claim
scope be removed, as much as possible, during the administrative process.”
In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
Appealed claim 1 defines the “immediate-release component” as
“comprising from about 5 mg to about 250 mg of topiramate which is
released in the body within about 1 hour after administration.” There is
nothing in claim 1 that requires any particular structure or form to the
“immediate-release component,” only that it comprise “about 5 mg to about
250 mg of topiramate which is released in the body within about 1 hour after
administration.” As noted by the Examiner (Ans. 10), the claim does not
require 5mg to 250 mg of topiramate to be released, but requires about that
amount of topiramate to be released in about 1 hour. Thus, we agree with
the Examiner that Yam teaches dosage forms of topiramate that meet that
limitation as shown in Figure 3 of Yam.
As to Appellants reliance on paragraph 54 of Yam as to what
constitutes an “immediate release” dosage-form or component, the claims
are interpreted in light of Appellants‟ Specification. And Appellants have
not pointed to anything in the instant Specification that contradicts the
interpretation of claim 1 set forth above.
As to claims 22, 23, and 25, Appellants argue that the subject matter
of these claims is not inherent in Yam (App. Br. 25-26). Specifically,
Appellants assert that “because the Examiner has not yet proved that Yam‟s
composition meets all limitations of the claimed composition, e.g., the
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immediate release component, it is not evident that Yam would have the
same pharmacokinetic profiles of the claimed composition” (id. at 26).
Appellants also insert that the additional claim limitations are not intended
use (id. at 26-27).
We disagree. The Examiner finds that the delivery rates are
functional properties of the composition (Ans. 11). Specifically, according
to the Examiner, as Yam teaches a composition that meets all of the
structural requirements of claim 1, and the instant Specification does not
describe any precise structural features that would result in the release rate
set forth in claim 23 (id. at 12). The Examiner thus finds that the “claimed
properties are presumed to be a direct result of the form of the composition
as claimed in claim 1” (id.). Appellants have not explained why the
Examiner‟s reasoning is in error. That is, Appellants have not provided
scientific reasoning or evidence as to why the rate recited in claim 23 would
not result from a dosage form that meets all of the limitations in claim 1.
We thus affirm the rejection as to claim 23.
As to the rejection of claims 1 and 16-20 over the combination of
Yam and Najarian, Appellants assert that Najarian does not remedy the
deficiencies of Yam (App. Br. 27). Thus, we affirm the rejection for the
reasons set forth with respect to the rejection of claim 1 set forth above.

SUMMARY
The rejection of claims 10, 14, and 24 under 35 U.S.C. § 112, second
paragraph, as being indefinite is reversed.
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We affirm the rejection of claims 1 and 23 under 35 U.S.C. § 103(a)
as being rendered obvious by Yam. Claims 2, 3, 6, 9, 10, 12, 14, 21, 22, 24,
and 25 fall with those claims. We also affirm the rejection of claims 1 and
16-20 under 35 U.S.C. § 103(a) as being rendered obvious by Yam and
Najarian.

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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