Ex Parte Evans et al

Board of Patent Appeals and Interferences

Jan 5, 2009

10310824 (B.P.A.I. Jan. 5, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ALLAN EVANS AND ROSS MCKINNON
____________

Appeal 2008-6177
Application 10/310,824
Technology Center 1600
____________

Decided: January 5, 2009
____________

Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and JEFFREY
N. FREDMAN, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the Examiner’s final rejection of
claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103, 106, 111, and 113-124.
Jurisdiction is under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
The claims are drawn to methods of applying a topical formulation of
flurbiprofen to the skin for preventing and reducing the occurrence of non-
melanoma skin cancer.
Claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103, 106, 111, and 113-
124 are pending and stand rejected as follows:
1) Claims 1-4, 7, 12, 14-19, 100-103, 106, 111, and 113-124 under 35
U.S.C. § 112, first paragraph, as not being enabled (Ans. 41);
2) Claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103, 106, 111, and 113-
124 under 35 U.S.C. § 103(a) as obvious in view of Falk (US 6,103,704,
Aug. 15, 2000), Brune (US 5,206,029, Apr. 27, 1993), and Nudelman et al.
(US 6,110,955, Aug. 29, 2000) (Ans. 3, 72); and
3) Claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103, 106, 111, and 113-
124 under 35 U.S.C. § 103(a) as obvious over Nudelman (Final Rejection
13; Ans. 113).

1 The Examiner’s statement of the rejection on page 4 of the Answer (Jan.
17, 2007) included claims which are not pending.
2 The Examiner’s statement of the rejection on page 7 of the Answer
included claims which are not pending and excluded claims which were
indicated as rejected on page 3 of the Answer. In the Reply Brief (Section
VI), Appellants properly summarized the rejected claims. We also note that
the Examiner indicated on page 3 of the Answer that the rejection was also
over Falk, alone, but corrected this on page 7 of the Answer.
3 The Examiner’s statement of the rejection on page 11 of the Answer
included claims which are not pending and excluded claims which were
indicated as rejected on page 13 of the Final Rejection. In the Reply Brief
(Section VI), Appellants properly summarized the rejected claims.
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Claims 1, 75, and 100, which are the only independent claims, are
representative and read as follows:
1. A method for preventing the occurrence of non-melanoma skin cancers in
a patient, comprising:
applying a topical formulation to the skin of said patient, said
formulation containing a pharmaceutically effective amount of a non-
steroidal anti-inflammatory drug, wherein said nonsteroidal anti-
inflammatory drug is an arylpropionic acid derivative, and wherein said non-
steroidal anti-inflammatory drug is flurbiprofen.

75. A method for reducing the occurrence of non-melanoma skin cancers in
a patient, comprising:
applying a topical formulation to the skin of said patient, said
formulation containing a pharmaceutically effective amount of a non-
steroidal anti-inflammatory drug, wherein said non-steroidal anti-
inflammatory drug is an arylpropionic acid derivative, and wherein said non-
steroidal anti-inflammatory drug is flurbiprofen.

100. A method for preventing non-melanoma skin cancers in a patient,
comprising:
applying a topical formulation to skin of said patient, said formulation
consisting essentially of a pharmaceutically effective amount of a non-
steroidal anti-inflammatory drug, and wherein said non-steroidal anti-
inflammatory drug is an arylpropionic acid derivative, and wherein said non-
steroidal anti-inflammatory drug is flurbiprofen.

REJECTION UNDER § 112, FIRST PARAGRAPH
Issue
Does the Specification enable preventing skin cancer as recited in
claims 1 and 100?
Principles of Law
“[T]o be enabling, the specification . . . must teach those skilled in the
art how to make and use the full scope of the claimed invention without
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‘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. If the PTO meets
this burden, the burden then shifts to the applicant to provide
suitable proofs indicating that the specification is indeed
enabling.
In re Wright, 999 F.2d at 1561-1562.

Findings of Fact
1. The Specification describes results of using flurbiprofen as a
“chemopreventative NSAID” to prevent skin cancer produced by UV
exposure (Spec. 16-20).
2. “Hairless mice [“SKH-1”], as used in the experiments detailed herein,
have generally been accepted in the art as a good laboratory test model for
predicting the therapeutic results of pharmacological treatments upon
mammals, including humans” (Spec. 17:2-6).
3. SKH-1 hairless mice exposed to UV-light were treated with topical
flurbiprofen (Spec. 18-19).
4. “The development of skin cancer was assessed as the visible appearance
of papillomas, which subsequently developed, in a subset of cases, to
tumours” (Spec. 20:4-6).
5. “Comparing the data from the animals that received the highest
concentration of flurbiprofen with the control group, it was found that there
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was a greater than 80% reduction in the number of animals that developed
skin tumours” (Spec. 23:4-8).
6. A declaration under 37 C.R.R. § 1.132 by Dr. Allan Evans (“Evans
Dec.”), an inventor of the claimed invention, was provided by Appellants.
Dr. Evans stated:
In light of my knowledge of this field, I believe that one
skilled in this art would accept reliable animal model data that
showed a statistically significant reduction in the number or
frequency of skin cancer lesions developed after UV exposure
as reasonably supporting that a given drug therapy was
effective in preventing the development of skin cancer lesions,
pre-skin cancerous lesions, and other related conditions. Data
showing absolute prevention of later skin cancer lesions, pre-
skin cancerous lesions, and other related conditions one
hundred percent of the time would not be necessary to establish
efficacy of a drug for prevention of non-melanoma skin
cancers. Reliable data showing statistically significant reduction
in the occurrence of skin cancer lesions in subjects in addition
to a statistically significant delay in the development of lesions
in subjects would be considered by one skilled in the art to
establish effectiveness of the drug in preventing non-melanoma
skin cancers as is described and claimed in the patent
application.
(Evans Dec. ¶ 4.)
7. Dr. Evans also stated in the same declaration:
Those skilled in the field of the identification, testing and
validation of drugs and drug therapies relating to skin cancer
and other related UV induced skin diseases and disorders,
however, readily accept studies in SKH-1 hairless mice to be a
good predictor of and have a strong correlation to human
efficacy.
(Evans Dec. ¶ 9.) Dr. Evans cited a journal article to support his conclusion.
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Analysis
The Examiner states that the Specification is “enabling for reducing
occurrence of non-melanoma skin cancer development using a topical
application of flurbiprofen as a[n] effective NSAID,” but that the
Specification “does not reasonably provide enablement for preventing the
said cancers” (Ans. 4). In support of this position, the Examiner states:
The specification only exemplifies animal test for
reducing the yield of papillomas and a possible delay in the
onset of tumor development. Human test for evaluating the
biological activities of the instant composition is not described.
Furthermore, the exemplified animal test does not show
complete inhibition or prevention, see figure 1. Therefore, the
specification has only enabled the treating said cancers
(reduction of occurrence of said cancer or the delay in the onset
of tumor development).
(Ans. 6.)
The Examiner bears the burden of providing an explanation as to why
the full scope of the claims is not adequately enabled by the Specification.
In re Wright, 999 F.2d at 1561-1562. In this case, the Examiner’s position
appears to be that the Specification is not enabled for “preventing . . . non-
melanoma skin cancers” as required by independent claims 1 and 100
because the “animal tests” do not show “complete inhibition or prevention”
of a skin cancer (Ans. 6). The Examiner contends that prevention requires
the method to “’forestall skin cancer completely’” (Ans. 15).
The hairless mice model is stated by Appellants to be an accepted
model for skin cancer (FF2, 7). The Examiner has not provided evidence
which is contrary to the statements in the Specification nor those of Dr.
Evans, an inventor, who is also a person knowledgeable in the field to which
the invention pertains (Evans Dec. ¶ 3). According to Dr. Evans, persons of
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ordinary skill in the art would have considered the data in the Specification
showing “statistically significant reduction in the occurrence of skin cancer
lesions in subjects . . . to establish effectiveness of the drug in preventing
non-melanoma skin cancers as is described and claimed in the patent
application” (FF6). Dr. Evans also states that “prevention” would not be
understood by persons of skill in the art to require “absolute prevention”
“one-hundred percent of the time” (FF6).
The Examiner has not identified any defect in Dr. Evans’s opinion,
who is asserted to be “knowledgeable regarding the level of skill contained
by a person of ordinary skill in the art to which the invention pertains”
(Evans Dec. ¶ 3). Thus, the preponderance of the evidence in this
proceeding supports Appellants’ position that the claimed methods are
enabled.
The Examiner’s misapprehension appears to be based on a claim
interpretation that would require non-melanoma skin cancer to be prevented
in 100% of the subjects to which flurbiprofen is topically applied (see Ans.
15). However, as explained by Dr. Evans, prevention claims would be
reasonably understood to have been satisfied when a cancer is prevented in a
significant number of subjects treated with topical flurbiprofen application
(FF6). That is, a claim to “preventing” non-melanoma skin cancer is
enabled when there is evidence that it would prevent the cancer in a
substantial number of subjects to whom it is administered. The claim does
not contain language that would require it to prevent cancer in every subject
to which the flurbiprofen is administered. Rather, the claim is directed to
prevention in a patient. Thus, we conclude that since the claimed method
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would succeed in most patients, it is therefore enabled on a patient by patient
basis. The rejection is reversed.

OBVIOUSNESS REJECTION OVER FALK, BRUNE, AND NUDELMAN
Claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103, 106, 111, and 113-
124 under 35 U.S.C. § 103(a) stand rejected as obvious in view of Falk,
Brune, and Nudelman (Ans. 3, 7).
Issues on appeal for independent claims 1, 75, and 100
1. Does Falk describe methods “for preventing the occurrence of” (claim 1),
“for reducing the occurrence of” (claim 75), and “for preventing” non-
melanoma skin cancers in a patient using an NSAID, as in claims 1, 75, and
100, respectively?
2. Would persons of ordinary skill in the art have had reason to utilize
flurbiprofen as an NSAID in Falk’s method?
3. Does “consisting essentially of” exclude hyaluronic acid from the
formulation of claim 100 “consisting essentially of . . . flurbiprofen” because
hyaluronic acid materially affects the formulation’s basic and novel
properties?
Principles of law
“In 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).
“Express suggestion to substitute one equivalent for another need not
be present to render such substitution obvious.” In re Fout, 675 F.2d 297,
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301 (CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir.
1997) (“Because the applicants merely substituted one element known in the
art for a known equivalent, this court affirms [the rejection for
obviousness].”). Accord KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740
(2007) (“when a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result”).
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
. . . Whether the rejection is based on “inherency” under 35
U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. §
103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art
products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (footnote omitted).
“[W]hen the PTO shows sound basis for believing that the products of
the applicant and the prior art are the same, the applicant has the burden of
showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
“Consisting essentially of” is a transition phrase commonly
used to signal a partially open claim in a patent. Typically,
“consisting essentially of” precedes a list of ingredients in a
composition claim or a series of steps in a process claim. By
using the term “consisting essentially of,” the drafter signals
that the invention necessarily includes the listed ingredients and
is open to unlisted ingredients that do not materially affect the
basic and novel properties of the invention.
PPG Industries v. Guardian Industries Corp., 156 F.3d 1351, 1354 (Fed.
Cir. 1998).
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Findings of Fact (FF)
The Falk patent
8. Falk describes topical compositions for application to the skin comprising
an effective non-toxic dosage amount of a drug for example a
drug which inhibits prostaglandin synthesis for example an
NSAID and an effective non-toxic dosage amount of a form of
hyaluronic acid (preferably hyaluronic acid or salt thereof) for
the transport of the drug to the site of the pathology and/or
trauma
(Falk, at col. 7, ll. 10-17).
9. Falk states that its compositions
may be applied topically to treat diseases and conditions of the
skin and/or exposed tissue at the site of the trauma and/or
pathology, (for example, basal cell carcinoma, the
precancerous, often recurrent, actinic keratoses lesions, fungal
lesions, ‘liver’ spots and like lesions (found for the most part in
the epidermis), squamous cell tumours
(Falk, at col. 7, ll. 42-48).
10. According to Falk, the NSAID blocks prostaglandin synthesis which
“then unblocks the macrophages and permits the macrophages of the patient
proximate the lesion (for example, the basal cell carcinoma) to destroy the
lesion or condition” (Falk, at col. 9, 10-14). Thus, Falk requires an NSAID
to have prostaglandin inhibiting activity for it to be effective against cancer.
11. Falk also states that “[t]reatment by dosage amounts of the composition
(formulation and/or combination) eliminates the condition without
recurrence, even where the lesion has recurred a number of times after
unsuccessful treatments according to the prior art” (Falk, at col. 9, ll. 14-18).
Falk describes several examples in which basal cell carcinoma was treated
with an NSAID formulation resulting in the disappearance of the carcinoma
with “no recurrence” (Falk, at col. 35, ll. 25-27 and 45-47).
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12. The hyaluronic acid in Falk’s composition is used to facilitate or cause
transport of the NSAID into the skin (Falk, at col. 8, ll. 45-48).
13. Falk describes a formulation comprising 1% and 3% of the NSAID
diclofenac and sodium hyaluronate (Falk, at col. 20, ll. 40-50; at col. 23, ll.
45-55).
The Brune patent
14. Flurbiprofen is a racemate comprising S(+) and R(-) forms (Brune, at
cols. 1-2).
15. Brune teaches that “S(+)-flurbiprofen inhibits the liberation of
prostaglandin more markedly than the R(-)-form” (Brune, at col. 2, ll. 25-
27). As shown in Fig. 3 of Brune, at the same concentration, the S-form
inhibits prostaglandin synthesis (“PG-Synthesis”) by 95% while the R-form
inhibits PG synthesis by 53%.
The Nudelman patent
16. Nudelman teaches compounds of Formula I which can be covalently
linked to an NSAID (Nudelman, at col. 3, l. 42 to col. 4, l. 4).
17. Flurbiprofen appears in a list of NSAIDs which are described as useful
(Nudelman, at col. 7, ll. 35-46; at col. 12, ll. 36-43) and thus would be
considered equivalent to other NSAIDs.
18. The compounds can be used for preventing cancers that include
squamous carcinomas (Nudelman, at col. 4, l. 17).
19. Nudelman states that it “is believed that the covalent attachment of a
beta-oxidation inhibitor [such as an NSAID] in the present compounds is
responsible, at least in part, for the enhanced stability and potency of these
compounds” (Nudelman, at col. 13, ll. 1-4).
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Analysis
Independent claims 1, 75, and 100 involve applying a topical
formulation comprising flurbiprofen to prevent the occurrence of non-
melanoma skin cancer (claim 1), reduce its occurrence (claim 75), and
prevent it (claim 100). In claim 100, the topical formulation is stated to
“consist[ ] essentially” of flurbiprofen.
Falk teaches that topically applying an NSAID to skin stops the
recurrence of basal carcinoma (FF9, 11), which is a skin cancer as in claims
1, 75, and 100. Falk does not disclose that the NSAID is flurbiprofen as
required by the claims. However, flurbiprofen is a well-known NSAID
having prostaglandin-inhibiting activity (FF14-15, 17), the same activity
described by Falk as useful to treat skin cancer (FF10). Thus, persons of
ordinary skill in the art would have had reason to use flurbiprofen as the
NSAID in Falk’s formulation for its known and expected prostaglandin
inhibiting activity.

Claims 1-4, 14, and 70-74
Appellants contend that “Falk is focused on the removal of existing
skin cancer and actinic keratoses tumors and lesions, not on ‘preventing the
occurrence of’ skin cancer” as in the claims (App. Br. 16). Appellants state
that Falk describes applying a topical formulation directly to the tumor until
it disappears (id.). They assert that “nowhere does Falk disclose, teach or
suggest that this topical formulation should be applied to the skin to prevent
the occurrence of skin cancer (or to reduce the occurrence of skin cancers),
as is claimed by Appellant” (id. at 18).
Appellants urge:
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Any patient that has been so unfortunate as to be stricken with
non-melanoma skin cancers will readily appreciate the
difference between Falk’s treating of cancer tumors by
chemical removal after the patient has been diagnosed as
having the tumor and Appellant’s prophylactic methods for
preventing the occurrence of the tumors. Nevertheless, the
Office Action equates chemically killing existing lesion and
tumors cells that have been diagnosed by a doctor (i.e.,
“treating” existing skin cancer tumors), with the Appellant's
chemoprevention concept that entails applying a topical
formulation as a prophylactic to the skin in order to
significantly reduce the chances that new skin cancers will
develop on the patient.
(Id.)
Falk clearly states that its NSAID formulation eliminates basal
carcinoma with “no recurrence” (FF11). The Examiner reasonably
understood Falk’s teaching that the cancer did not recur after NSAID
administration to meet “preventing” as recited in the claims because
“recurrence” literally means that cancer did not occur again and is thus
prevented.
Appellants argue that Falk teaches applying its formulation to a
carcinoma already in existence. However, claim 1 does not exclude
flurbiprofen application to an existing carcinoma nor does the claim specify
a specific administration regime that would exclude Falk’s steps in applying
the formulation topically to chemically kill existing lesions. The fact is that
Falk states that after the lesions are eradicated by the chemical treatment
they do not re-appear – and thus are prevented as in the claims.
With regard to the substitution of flurbiprofen for one of the NSAIDs
in the Falk patent, Appellants argue that no “discussion is present anywhere
in Brune regarding the suitability of such medicaments topically for
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preventing the occurrence of non-melanoma skin cancers, or reducing the
occurrence of the same” (App. Br. 19). Therefore, Appellants contend that
there would have been no teaching or motivation for modifying the
teachings of Falk to produce the invention recited in independent claim 1
(id.).
Precise teachings directed to the specific subject matter of a claim are
not required to reach a conclusion of obviousness. KSR, 127 S. Ct. at 1741.
In this case, the teaching that flurbiprofen is equivalent in activity to other
NSAIDS (see FF17 for teaching flurbiprofen in a list of NSAIDs) and that
flurbiprofen has prostaglandin inhibiting activity (FF15) would have
provided the reason to have used it in Falk’s composition. See also In re
Fout, 675 F.2d at 301; In re Mayne, 104 F.3d at 1340; and KSR, 127 S. Ct. at
1740.
For the foregoing reasons, we affirm the rejection of claim 1. We also
affirm the rejection of dependent claims 2-4, 14, and 70-74 (which
incorporate all the limitations of claim 1) because separate arguments for
their patentability were not provided. 37 C.F.R. § 41.37(c)(1)(vii).

Claims 75-78, 88, and 95-99
Appellants contend, but provide no evidence, that persons of ordinary
skill in the art would construe “reducing the occurrence of skin cancer” as
recited in claim 75 “to mean that the occurrence of new skin cancer tumors
is reduced in a significant matter” (App. Br. 21).
This argument is not persuasive. Even if we were to interpret claim
75 to mean reducing the occurrence of “new skin cancer tumors,” Appellants
have not provided evidence that preventing the recurrence of a skin cancer at
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a site where it previously existed – as taught by Falk (FF11) – would not
involve preventing a new cancer from arising from cells present at the same
location. Based on Falk’s teaching that there was no recurrence of basal
carcinoma at treated lesions (FF11), the Examiner had a logical basis for
believing that Falk’s NSAID formulation reduced and prevented the
occurrence of skin cancers at the targeted site. The PTO does not have the
ability “to manufacture products or to obtain and compare prior art
products.” In re Best, 562 F.2d at 1255. Thus, once sound basis is provided
for believing that the prior art accomplishes the same result which is
claimed, the burden properly shifts to the applicant to show they are not.
See In re Spada, 911 F.2d at 708. Appellants have not met this burden.
For the foregoing reasons, we affirm the rejection of claim 75.
Dependent claims 76-78, 88, and 95-99 incorporate all the limitations of
claim 75 and fall with it because separate arguments for their patentability
were not provided. 37 C.F.R. § 41.37(c)(1)(vii).

Claims 100-103, 113, and 120-124
Claim 100 is directed to a “method for preventing non-melanoma skin
cancers” comprising “applying a topical formulation” which is “consisting
essentially” of flurbiprofen. The issue in this rejection is whether
“consisting essentially” excludes hyaluronic acid, as taught by Falk, from
the claim 100 formulation (see App. Br. 21-22).
We interpret the phrase “consisting essentially of” to be partially
open-ended in permitting the inclusion of ingredients which “do not
materially affect the basic and novel properties of the invention.” PPG
Industries v. Guardian Industries Corp., 156 F.3d at 1354. Under this
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interpretation, the underlying question is whether the addition of hyaluronic
acid to the formulation of claim 100 materially affects its basic properties.
We conclude that the answer to this question is “no.” The Specification
teaches that the claimed flurbiprofen is used to prevent skin cancer (FF1).
This is the same activity described by Falk for its NSAID composition
(FF9). The addition of hyaluronic acid to this composition facilitates
NSAID transport into the skin (FF12), but does not change or “materially
affect” the NSAID’s basic property in treating skin cancer. Thus, we
conclude that hyaluronic acid is not excluded from claim 100.
For the foregoing reason and those set forth for claim 1, we affirm the
rejection of claim 100. Claims 101-103, 113, and 120-124, which depend on
claim 100 and incorporate all its limitations, fall with claim 100 because
separate arguments for their patentability were not provided. 37 C.F.R. §
41.37(c)(1)(vii).

Claims 7, 69, 81, 94, 106, and 119
As claims 7, 69, 81, 94, 106, and 119 are argued as a group (App. Br.
22), we select claims 7 and 69 as representative to decide the rejection.
Claim 7, which depends on claim 1, is directed to a topical formulation
which “is substantially free of the S-flurbiprofen enantiomer.” Claim 69,
which also depends on claim 1, is directed to a topical formulation in which
the flurbiprofen “contains low cyclooxygenase inhibition activity.”
Brune discloses that the R-enantiomer of flurbiprofen has less
activity in inhibiting prostaglandin than the S-enantiomer (FF15).
Nonetheless, since Brune discloses that the R-enantiomer inhibits
prostaglandin synthesis – the same activity required by Falk for its NSAIDs
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(FF8, 10) – persons of ordinary skill in the art would have reasonably
expected the R-enantiomer to be effective in preventing cancer and thus a
logical choice as an NSAID for Falk’s method. A “finding that the prior art
as a whole suggests the desirability of a particular combination need not be
supported by a finding that the prior art suggests that the combination
claimed by the patent applicant is the preferred, or most desirable,
combination.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004). In other
words, an invention may be suggested by the prior art and therefore obvious,
even if inferior to alternatives that would be made by following other prior
art suggestions. Thus, we affirm the rejection of claim 7.
The R-enantiomer would inherently have “low cyclooxygenase
inhibition activity” as it has low prostaglandin inhibiting activity as in claim
69. We affirm its rejection, as well.
Claims 81, 94, 106, and 119 falls with claims 7 and 69 because
separate arguments for their patentability were not provided. 37 C.F.R. §
41.37(c)(1)(vii).

Claims 12, 15, 16, 86, 89, 90, 111, 114, and 115
Dependent claims 12, 86, and 111 add the limitation “wherein said
non-melanoma skin cancers comprise basal cell carcinomas, and wherein
said patient previously has been diagnosed as having had a basal cell
carcinoma” to the limitations of independent claims upon which they
depend.
Dependent claims 15, 89, and 114 add the limitation where the
claimed methods further comprise, before applying of the topical
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formulation, “identifying said patient as being at elevated risk of developing
a non-melanoma skin cancer.”
Claims 16, 90, and 115 depend from, and thus add the limitation to
claims 15, 89, and 114, respectively, that patients are identified as being at
elevated risk “whenever said patient previously has been diagnosed as
having had a non-melanoma skin cancer.”
Appellants contend that Falk
relates . . . to the removal of existing skin cancer lesions by
chemical means, it does not address explicitly or otherwise
suggest to one skilled in the art any reason for determining
whether the patient previously has been diagnosed as having
had a basal cell carcinoma, or whether the patient is at elevated
risk of developing non-melanoma skin cancer
(App. Br. 25).
This argument is not persuasive. Falk teaches that topically applying
its NSAID formulation to a basal carcinoma prevents future occurrence
(“recurrence”) of the cancer (FF11). Thus, Falk explicitly discloses the
limitation of applying an NSAID to a patient who “has been diagnosed as
having had a basal cell carcinoma” recited in claims 12, 86, and 111.
With regard to claim 15, 16, and others which refer to a patient
identified “as being at elevated risk of developing a non-melanoma skin
cancer,” the Examiner states that it is “well known that actinic keratosis is
often developed into cancerous cell” and that Falk describes application of
its formulation to actinic keratosis (Ans. 16; FF9). Thus, the Examiner’s
position appears to be that such a skin area would be an increased risk for
developing cancer, meeting the limitation of claim 15, 16, and others.
Appellants have not provided evidence to the contrary.
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For the foregoing reasons, we affirm the rejections of claims 12, 15,
16, 86, 89, 90, 111, 114, and 115.

Claims 17-19, 91-93, and 116-118
Claims 17-19, 91-93, and 116-118 introduce limitations regarding the
amount of NSAID, limiting it to concentrations up to approximately 2% w/v
(claims 17, 91, and 116), up to approximately 1% w/v (claims 18, 92, and
117), and up to approximately 0.5% w/v (claims 19, 93, and 118).
Appellants contend that “Falk does not teach the use of anything less
than 3% by weight NSAID formulations for the treatment of skin cancer or
actinic keratoses” (App. Br. 26). We do not agree. Falk clearly describes
formulations that comprise 1% of an NSAID (FF13) and thus its teaching
falls within the limitations recited in claims 18, 92, and 117.
The limitations of “up to approximately 2%” as in claims 17, 91, and
116 and “up to approximately 0.5%” as in claims 19, 93, and 118, are not
expressly disclosed in Falk. However, determining effective amounts of
NSAID to apply was clearly within the scope of ordinary skill in the art. For
instance, Falk generally refers to therapeutic dosages of the NSAID with
referring to specific amounts (Falk, at col. 7, ll. 9-20), indicating that
effective dosages were routinely determinable. In addition to this, the
claimed value of approximately 2% falls within with the disclosed amounts
of 1% and 3% NSAID. It is well-established that an overlap in ranges
establishes prima facie obviousness. In re Peterson, 315 F.3d 1325, 1329
(Fed. Cir. 2003). Thus, absent evidence to the contrary, we agree with the
Examiner’s conclusion that the claimed amounts would have been obvious
to persons of ordinary skill in the art.
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Appeal 2008-6177
Application 10/310,824

We affirm the rejections of claims 17-19, 91-93, and 116-118.

OBVIOUSNESS OVER NUDELMAN
Claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103, 106, 111, and 113-
124 stand rejected under 35 U.S.C. § 103(a) as obvious over Nudelman
(Ans. 11).
Issue
Does Nudelman describe topical application of flurbiprofen to skin as
recited in claims 1, 75, and 100?
Analysis
Claims 1, 75, and 100 each recite the use of flurbiprofen in preventing
and reducing the occurrence of non-melanoma skin cancer. Nudelman
teaches a flurbiprofen derivative for preventing skin cancer (FF16, 18), but
does not teach flurbiprofen, alone. Rather, Nudelman states that it is
necessary to covalently attach it to a Formula I compound to enhance the
stability and potency of the latter compounds (FF19). Accordingly, persons
of ordinary skill in the art would not have had reason to use flurbiprofen,
alone, unattached to the Formula I compound, for skin cancer prevention.
We reverse the rejection of claims 1-4, 7, 12, 14-19, 69-78, 81, 86, 88-103,
106, 111, and 113-124.

CONCLUSIONS OF LAW
The Specification enables preventing skin cancer as recited in claim 1
and 100. We reverse the enablement rejection of claims 1-4, 7, 12, 14-19,
100-103, 106, 111, and 113-124 under 35 U.S.C. § 112, first paragraph.
20
Appeal 2008-6177
Application 10/310,824

We affirm the obviousness rejection of claims 1-4, 7, 12, 14-19, 69-
78, 81, 86, 88-103, 106, 111, and 113-124 in view of Falk, Brune, and
Nudelman as Falk describes methods “for preventing the occurrence of”
(claim 1), “for reducing the occurrence of” (claim 75), and “for preventing”
non-melanoma skin cancers in a patient using an NSAID; persons of
ordinary skill in the art would have had reason to utilize flurbiprofen as an
NSAID in Falk’s method; “consisting essentially of” does not exclude
hyaluronic acid from the formulation of claim 100; and because the specific
limitations in the separately argued dependent claims are taught or suggested
by Falk in combination with Brune and Nudelman.
We reverse the obviousness rejection of claims 1-4, 7, 12, 14-19, 69-
78, 81, 86, 88-103, 106, 111, and 113-124 in view of Nudelman because
Nudelman does not teach a topical application of flurbiprofen to skin.

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 CFR § 1.136(a).

AFFIRMED

cdc

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