Ex Parte Strong et al

Board of Patent Appeals and Interferences

Mar 8, 2011

10072272 (B.P.A.I. Mar. 8, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte H. ANDREW STRONG, MOHAMMAD AZAB,
YONG HAO, JOHN MILLER KOESTER, and
TROY ALBERT REAVES, JR.
__________

Appeal 2010-002076
Application 10/072,272
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims to a method for
treating an occult choroidal neovascular lesion. The Examiner rejected the
claims as obvious.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-002076
Application 10/072,272

2
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
“Eighty to ninety percent of the severe vision loss due to AMD
[age-related macular degeneration] . . . is attributable to the form
characterized by choroidal neovascularization (CNV), also called ‘wet’
AMD. CNV is an ingrowth of choroidal capillaries through a break in the
outer aspects of Bruch’s membrane” (Spec. 1).
“CNV in wet AMD can be generally divided into two classes,
‘classic’ CNV[] and ‘occult’ CNV. The two forms are distinguishable by
angiography conducted with fluorescein dye” (id.).
Appellants’ invention “is directed to a method to treat occult CNV
lesions using photodynamic therapy [PDT]” (id. at 4), which is “a two-step
process consisting of an intravenous injection of a photosensitizer (light-
activated drug) [such as verteporfin] followed by light application” that
selectively destroys the CNV lesion without significant damage to overlying
retinal tissue (id. at 3).
The Specification expresses surprise that PDT successfully treated
occult CNV, “in view of a study (Arch Ophthalmol. 117:1329-1345 by the
TAP Study Group), which showed that lesions classified as predominantly
classic had a large treatment benefit with verteporfin PDT, whereas lesions
classified as minimally classic did not” (id. at 4).
Claims 1, 2, and 5-20 stand rejected and are on appeal (App. Br. 2).2
Claim 1, the only independent claim, is representative and reads as follows:

2 Appeal Brief filed February 17, 2009.
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1. A method for treating an occult choroidal
neovascular (CNV) lesion in a subject comprising
selecting a subject with an occult CNV lesion comprising
an occult component of >50% and <100% of the lesion and
assessed as having either (a) a small lesion with a size less than
5 disc areas, or (b) poor visual acuity of less than 65 letters
prior to treatment, or both (a) and (b); and
providing photodynamic therapy (PDT) to the subject
having said CNV lesion.

The following rejections are before us for review:
(1) Claims 1, 2, 5-12, 14-18, and 20, under 35 U.S.C. § 103(a) as
obvious over TAP Report 13 (Ans. 3-6); and
(2) Claims 13 and 19, under 35 U.S.C. § 103(a) as obvious over the
TAP Report and Zeimer4 (Ans. 6-7).
DISCUSSION
The Examiner cites the TAP Report as disclosing a study on the
efficacy of photodynamic therapy using verteporfin, which, according to the
Examiner, benefitted “patients with ≥50% classic CNV (or ≤50% occult
CNV). Furthermore, the upper limit of the claimed invention (99% occult
CNV) is also obvious because of the teaching that ‘the subgroup with no
classic CNV (100% occult CNV) had a large treatment benefit’ from pg.
1339 of the TAP Report” (Ans. 4).
Thus, the Examiner contends:

3 Neil M. Bressler (corresponding author) et al., Photodynamic Therapy of
Subfoveal Choroidal Neovascularization in Age-related Macular
Degeneration with Verteporfin. One-Year Results of 2 Randomized Clinical
Trials--TAP Report 1, 117 ARCH. OPHTHALMOL. 1329-1345 (1999).
4 U.S. Patent No. 5,935,942 (filed December 14, 1994).
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[I]t would have been obvious to one of ordinary skill in the art
at the time of invention to practice the method steps of TAP
Report to treat patients with occult CNV lesion having an
occult component of >50% to <100% of the lesion, because as
shown by the Report, one of ordinary skill in the art would have
had a reasonable expectation of success to observe some degree
of improvement in ocular condition of the patients suffering
from said occult CNV.

(Id. at 6.)
Appellants contend that the TAP Report shows that PDT using
verteporfin was no more effective than placebo in improving visual acuity in
the subgroup of patients having lesions in which >50% and <100% of the
lesion area had an occult component (App. Br. 6-9). Thus, Appellants
conclude:
No rationale has been provided to suggest why one of
skill in the art would choose to disregard a major finding of a
multi-center clinical research study and attempt to treat patients
having occult CNV lesions with an occult component of >50%
to <100%, for whom the TAP Report 1 clearly states that PDT
treatment is ineffective in improving visual acuity or slowing
progression of occult CNV.

(Id. at 9.)

Moreover, Appellants contend, while the TAP Report characterized
the studied eyes with respect to Appellants’ claimed parameters of lesion
size and visual acuity:
[T]he TAP Report 1 provides no correlation between the
percent occult character of the patient’s CNV lesion and visual
acuity or lesion size, and no guidance is provided that would
lead to the selection of the claimed sub-population having poor
visual acuity, or small lesion size, or both, in combination with
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occult CNV lesions having an occult component >50% and
<100% lesion area.

(Id. at 10.) Thus, Appellants conclude, “the TAP Report 1 provides neither a
reasonable expectation of success nor any motivation to practice the
instantly claimed methods” (id.). Appellants also contend that their
Specification presents evidence of unexpected results (id. at 13-14).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

Regarding the type of rejection before us, in KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 415 (2007), the Supreme Court emphasized “an
expansive and flexible approach” to the obviousness question, but also
reaffirmed the importance of determining “whether there was an apparent
reason to combine the known elements in the fashion claimed by the patent
at issue.” Id. at 418 (emphasis added).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
We agree with Appellants that the Examiner’s obviousness conclusion
is not supported by a preponderance of the evidence. Claim 1 requires the
practitioner to provide photodynamic therapy (PDT) to a specific population
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of patients, those having a CNV lesion in which the occult component of the
lesion constitutes greater than 50% but less than 100% of the lesion. The
treated patients must also (a) have lesions smaller than 5 disc areas, or (b)
have a visual acuity less than 65 letters, or meet both criteria (a) and (b).
As Appellants point out, the TAP Report evaluated the efficacy of
PDT treatment on patients in which the occult component constituted greater
than 50% but less than 100% of the CNV lesions, as recited in claim 1 (see
TAP Report 1340 (Table 5)). As seen in the TAP Report, the percentage of
patients that lost less than 15 letters of visual acuity 12 months after PDT
treatment was essentially the same (0.6% percentage point difference) as in
the placebo recipients (see id.).
Based on these results, the TAP Report explicitly states that “[n]o
appreciable difference was observed in the group of patients with lesions in
which the area of classic [i.e. non-occult component of the] CNV was
greater than 0% but less than 50% of the area of the entire lesion at baseline”
(id. at 1339; see also 1341 (“lesions in which the area of classic CNV was
greater that 0% but less than 50% of the area of the entire lesion as baseline
had no visual acuity benefit with treatment”)). The TAP Report ultimately
recommended “verteporfin therapy in the treatment of patients with
predominantly classis sub-foveal CNV caused by AMD, especially when the
lesion has classic CNV and no occult CNV” (id. at 1344 (emphasis added)).
Thus, based on the Report’s recommendation, and the fact that the
TAP Report found essentially no difference between PDT and placebo
treatments with respect to the patients meeting the occult percentages recited
in Appellants’ claim 1, we are not persuaded that an ordinary artisan would
have been prompted to treat those patients with PDT, as claim 1 requires.
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We acknowledge, as the Examiner points out, that PDT produced a
46% difference compared to placebo in patients with lesions with some
occult component to their lesions (see TAP Report 1340 (Table 5)). Again,
however, when the TAP Report analyzed the results of the subpopulation
having lesions meeting the occult percentages of claim 1, no benefit beyond
that observed in placebo patients was seen.
We also acknowledge the TAP Report’s statement that the “subgroup
with no classic CNV had a large treatment benefit; however, the number of
patients in this subgroup was small and did not meet the eligibility criteria
for the trials” (TAP Report 1339). Given the Report’s finding that the
results from this subset of patients was not usable because the subgroup was
too small, we are not persuaded that an ordinary artisan would have been
prompted to go beyond the study’s ultimate recommendation of treating
patients with predominantly classical, as opposed to occult, lesions, as claim
1 requires.
To further tip the preponderance of the evidence toward non-
obviousness, Appellants have presented data supporting their position that,
in contrast to the TAP Report’s suggestion that predominantly occult lesions
are not amenable to PDT treatment, selecting the claimed subpopulation of
such patients, with predominantly occult lesions and either or both of small
lesions (less than 5 disc areas) and poor visual acuity (less than 65 letters),
produces a significant visual acuity benefit 24 months after treatment as
compared to placebo (see Spec. 45 (Table 2)).
“[W]hen an applicant demonstrates substantially improved results . . .
and states that the results were unexpected, this should suffice to establish
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unexpected results in the absence of evidence to the contrary.” In re Soni,
54 F.3d 746, 751 (Fed. Cir. 1995).
In the instant case, while the Examiner states that the results are not
commensurate in scope with the claimed subject matter, and do not present
“a clear and convincing case of unexpected results” (Ans. 9), the Examiner
has not provided any clear explanation or evidence as to why that is the case.
Given the results presented by Appellants compared to the results obtained
by the TAP Report, and the absence of any clear explanation or evidence
from the Examiner as to why Appellants’ data is insufficient, we are not
persuaded that the Examiner had a proper basis to discount Appellants’
proffered evidence.
In sum, for the reasons discussed, we are not persuaded that a
preponderance of the evidence supports the Examiner’s prima facie case of
obvious, and even if this were considered a close case in that regard, the
Examiner has not adequately explained why Appellants’ evidence of
unexpected results is insufficient to overcome a prima facie case of
obviousness based on the TAP Report. We therefore reverse the Examiner’s
rejection of claim 1, and its dependents, as obvious over the TAP Report.
Claims 13 and 19 depend ultimately from claim 1. As the Examiner
did not identify any teachings in Zeimer that remedy the shortcomings
discussed above with respect to the TAP Report vis-à-vis claim 1, we also
reverse the Examiner’s rejection of claims 13 and 19 over the Tap Report
and Zeimer.

Appeal 2010-002076
Application 10/072,272

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SUMMARY
We reverse the Examiner’s obviousness rejection of claims 1, 2, 5-12,
14-18, and 20 over the TAP Report 1.
We also reverse the Examiner’s obviousness rejection of claims 13
and 19 over the TAP Report and Zeimer.

REVERSED

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