Ex Parte Chaudry

Patent Trial and Appeal Board

Mar 11, 2013

10657550 (P.T.A.B. Mar. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte IMTIAZ CHAUDRY
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Appeal 2012-001043
Application 10/657,550
Technology Center 1600
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Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
SHERIDAN SNEDDEN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant has requested rehearing of the decision entered December
20, 2012. That decision affirmed the Examiner’s rejection of claims 1, 4-6,
10-13, 22-25, 27-30, 25, and 71-77 under 35 U.S.C. § 103(a).
Appellant’s request has been granted to the extent that the decision
has been reconsidered, but such request is denied with respect to making any
modifications to the decision affirming the Examiner’s rejection under 35
U.S.C. § 103(a).
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Application 10/657,550

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DISCUSSION
We begin by noting that Appellant’s first argument was not previously
presented in either the Appeal Brief or Reply Brief. However, in the interest
of efficiency, we will specifically address this argument.
Argument 1
Appellant contends that:
Osbakken’s teaching of 1-5 MMAD is directed to liquid
solutions/droplets, not solid particulates. Moreover,
Osbakken (as noted above and in the Appeal Brief)
explicitly teaches and provide significant guidance to ensure
that liquid droplets are utilized. In view of these teachings
one of skill in the art would have no rational basis for
forming the combination of fluticasone and an antifungal in
which the fluticasone is provided in solid form.

(Req. Recons. 3).
We have reviewed our Decision in light of this argument. However,
we are not persuaded that our Decision was in error. Appellant’s claim 1 is
drawn to a formulation “comprising an aqueous suspension comprising . . .
suspended solid steroidal anti-inflammatory having the following particle
size distribution.” Thus, Appellants claim is not drawn to solid particulates
alone for delivery, but rather to particulates in an aqueous suspension.
Osbakken also teaches nasal delivery of an aqueous suspension, teaching
“the topical delivery of medications to the nasal cavity and sinuses by
aerosolizing aqueous solutions or suspensions” (Osbakken 6 ¶ 0081;
emphasis added).
Consequently, Osbakken teaches suspensions, which are solid
particulates suspended in an aqueous phase, identical to the formulation
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required by claim 1. Thus, it would have been eminently rational to utilize
fluticasone in a solid form, consistent with the express teaching of
Osbakken. Further, Osbakken expressly teaches a range of particle sizes
whose lowest value of 1.0 microns reasonably overlaps the range recited in
claim 1. See 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.”)
Argument 2
Appellant
notes that prior to the sentence quoted by the Board,
however, the specification also provides that “effects were
not statistically significant indicating that the treatment
groups behaved similarly for the duration of the study,
except for the magnitude of improvement in TNSS.” As
such, Appellant submits that the Board misinterpreted this
portion of the text accompanying Example 6. That is, the all
formulations including fluticasone provide relief over the
reported time period - but the Dey-FP Low Dose Group
realized in an increased magnitude of improvement in
TNSS. Appellant respectfully submits that the Board did not
give the demonstrated increased magnitude of improvement
in TNSS sufficient weight when assessing the determination
of unexpected results in view of the arguably confusing
language in the specification

(Req. Recons. 3-4).
We have reviewed our Decision in light of this argument. However,
we are not persuaded that our Decision was in error. We begin by noting
that the sentence quoted and emphasized by Appellant does not state that the
magnitude of either the Dey-FP high or Dey-FP low dose group
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demonstrated statistically significant improvement over the FLONASE High
or Low dose groups, but rather that some groups differed in a magnitude of
improvement in TNSS (a patient total nasal symptom score which was
composed of the sum of signs and symptoms for runny nose, nasal
congestion, sneezing, and itchy nose). However, the statement is unclear as
to which groups showed a change. Even if the TNSS result differs in
magnitude, there is no evidence that this change in magnitude result would
have been unexpected. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972)
(“[i]t is not enough to show that results are obtained which differ from those
obtained in the prior art: that difference must be shown to be an unexpected
difference”).
By contrast, the sentence we quoted in our Decision clearly states that
“[t]here was no statistically significant differences between the Dey-FP and
FLONASE high and Low Dose groups for any efficacy endpoint analysis
(relief of signs and symptoms of SAR)” (Amdt. to Spec. filed Jan. 6, 2011,
page 6; emphasis added). Therefore, the evidence of Example 6 of the
Specification itself expressly states that there were no statistically significant
differences between the groups, which supports the conclusion that there are
no unexpected results. This also supports the Examiner’s position that “the
general differences depicted in the Figures are merely a difference of degree
at best and not a difference of kind” (Ans. 15).
We also note that the “Table 1” presented in both the Appeal Brief
and Request for Reconsideration is not found in the Specification or
Drawings. Appellant does not indicate or explain where the data was
obtained for Table 1. It is unclear if this data was generated by Appellant’s
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attorney from the Figures, generated using original data, or obtained in some
other fashion. This Table is therefore not properly in evidence. In addition,
the actual data presented in the Specification, particularly figures 1-4, do not
show substantively different results for the Dey-FP low dose group and the
Flonase low dose group. For example, Figure 2 of the Specification shows a
virtual overlap between the two groups on days 5, 9, and 10, and very close
numbers on day 14.
There is no evidence of record which explains why the data in “Table
1” or the data in the Specification are unexpected. Klosak, 455 F.2d at 1080.
At best, there is attorney argument in the Request for Reconsideration that
the “claimed invention provides a significant and surprising improvement
despite both groups receiving the same amount of active.” However,
unexpected results must be established by factual evidence, and attorney
statements are insufficient to establish unexpected results. See In re Geisler,
116 F.3d 1465, 1470-71 (Fed. Cir. 1997). We here emphasize that
Appellant’s have not identified any location in their Specification where
Appellant characterize these results as unexpected. It is only the Appellant’s
attorney in the Brief and Request for Reconsideration who describes these
results as unexpected. Attorney’s arguments in a brief cannot take the place
of evidence. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). See also In
re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (Arguments and
conclusions unsupported by factual evidence carry no evidentiary weight.)

Appeal 2012-001043
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SUMMARY
We have carefully reviewed the original opinion in light of
Appellant’s request, but we find no other point of law or fact which we
overlooked or misapprehended in arriving at our decision. Therefore,
Appellant’s request has been granted to the extent that the decision has been
reconsidered, but such request is denied with respect to making any
modifications to the decision affirming the Examiner’s rejections under 35
U.S.C. § 103(a).

DENIED

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