Ex Parte Sharif

Board of Patent Appeals and Interferences

Dec 8, 2010

12425774 - (D) (B.P.A.I. Dec. 8, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/425,774 04/17/2009 Najam A. Sharif 2663 US A 3365
26356 7590 12/09/2010
ALCON
IP LEGAL, TB4-8
6201 SOUTH FREEWAY
FORT WORTH, TX 76134
EXAMINER
KOLKER, DANIEL E
ART UNIT PAPER NUMBER
1649
MAIL DATE DELIVERY MODE
12/09/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte NAJAM A. SHARIF
__________

Appeal 2010-010328
Application 12/425,774
Technology Center 1600
__________

Before ERIC GRIMES, MELANIE L. MCCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
ophthalmic pharmaceutical composition comprising gelsolin and a

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 2010-010328
Application 12/425,774

2
pharmaceutical carrier. The Patent Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
Claims 8-11 are on appeal. Claim 8 is representative and reads as
follows:
8. An ophthalmic pharmaceutical composition comprising a
therapeutically effective amount of an agent that sequesters amyloid proteins
in ocular tissue and a pharmaceutical carrier, wherein the agent is gelsolin,
and wherein the pharmaceutical carrier comprises a viscosity enhancer, a
buffering agent, a tonicity agent, a chelating agent, a wetting agent and a
preservative, wherein said ophthalmic composition is capable of being
administered to the eye of a patient suffering from age-related macular
degeneration.

The Examiner rejected claims 8-11 under 35 U.S.C. § 103(a) as
unpatentable over Davies2 and Luna.3
Claims 9-11 have not been argued separately and therefore stand or
fall with claim 8. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issues
The Examiner’s position is that Davies disclosed a pharmaceutical
composition comprising each of the elements of the instantly claimed
composition, except that Davies did not explicitly teach adding a buffering

2 Patent Application Publication No. WO 95/24207 by Philip Davies,
published Sep. 14, 1995.
3 US Patent No. 5,985,608 issued to Elizabeth J. Luna et al., Nov. 16, 1999.
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Application 12/425,774

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agent to its parenteral composition and did not teach adding a chelating
agent. (Ans. 3-4.)
The Examiner found that Luna disclosed a pharmaceutical
composition comprising supervillin, described as having structural and
functional similarity to gelsolin. (Id. at 4.) The Examiner also found that
Luna disclosed that formulating pharmaceutical compositions was within the
skill of the ordinary artisan. (Id.) Additionally, the Examiner found that
Luna disclosed that its compositions “can be formulated in a conventional
manner using one or more physiologically acceptable carriers or excipients.”
(Id.) Further, the Examiner found that Luna disclosed a composition
comprising every component of the instantly claimed pharmaceutical carrier
with the exception of gelsolin. (Id.)
According to the Examiner, it would have been obvious to one of
ordinary skill in the art at the time of the invention to select among the
excipients listed by Luna when making Davies’ pharmaceutical composition,
thereby arriving at the claimed invention. (Id.) The Examiner reasoned that
formulating pharmaceutical compositions was routine in the art such that
selecting from among known additives and excipients to formulate a
composition comprising a known agent, i.e., gelsolin, would have been
obvious to the skilled artisan. (Id.) Additionally, the Examiner explained
that the artisan would have had a reasonable expectation of success because
formulating pharmaceutical compositions was well-known in the art and
Luna taught a composition comprising nearly all elements of the claimed
invention, differing only by comprising a protein structurally and
functionally similar to gelsolin, instead of Davies’ gelsolin. (Id.)
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4
Appellant contends that the term “ophthalmic” in the instantly
claimed invention “limits the claims, especially when read in light of the
later limitation in the claim that the composition must be capable of being
administered to the eye of a patient suffering from age-related macular
degeneration.” (App. Br. 5.) Based upon this claim construction, Appellant
asserts “that neither Davies nor Luna can be considered to be analogous art
to the present invention” because a skilled artisan would not have looked to
Davies or Luna to solve “the problem of creating an ophthalmic composition
that is capable of being delivered to the eye of a patient suffering from age-
related macular degeneration to sequester the amyloid proteins present in the
ocular tissues of such patients.” (Id. at 6-7.)
In particular, Appellant asserts that Davies is directed to the treatment
of cystic fibrosis and neither taught how to sequester amyloid proteins
within the eye, nor suggested ophthalmic compositions. (Id. at 5.) Further,
Appellant asserts that the use of gelsolin in Davies “appears to be as an
excipient or an additive to the composition.” (Id. at 4-5.) Regarding Luna,
Appellant asserts that the reference taught that supervillin proteins and
polypeptides are distinguished from gelsolin by their novel amino terminus.
(Id. at 7.) Additionally Appellant asserts that “Luna does not appear to
mention ophthalmic formulations.” (Id.)
Further, Appellant asserts that even if an artisan combined the prior
art, that combination would not yield the claimed invention. (Id.) Rather,
Appellant asserts that the combination would result in a composition
containing Davies’ elastase inhibitors and/or Luna’s supervillin as an active
ingredient, and possibly gelsolin as an excipient. (Id.) Also according to
Appellant, the skilled artisan would not have expected the composition to
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sequester amyloid proteins to treat age-related macular degeneration, as such
use was not disclosed in the prior art. (Id.) Therefore, the Appellant
contends that the Examiner’s combination “amounts to an improper
‘hindsight reconstruction’….” (Id.)
The issues with respect to this rejection are:
whether the preamble claim phrase “[a]n ophthalmic pharmaceutical
composition” distinguishes the claimed composition from the prior art;
whether the combined teachings of Davies and Luna yield all the
elements of the claimed composition; and
whether the record supports the Examiner’s conclusion that the cited
references would have made the claimed composition obvious.

Findings of Fact
1. We agree with the Examiner’s explicit findings regarding the scope
and content of the prior art references. (See Ans. 3-5.)
2. We find that Luna disclosed that routes of administration for its
compositions included parenteral, oral, and ophthalmic administration.
(Luna col. 23, ll. 55-61.)

Principles of Law
“Where a patentee uses the claim preamble to recite structural
limitations of his claimed invention, the PTO and courts give effect to that
usage. Conversely, where a patentee defines a structurally complete
invention in the claim body and uses the preamble only to state a purpose or
intended use for the invention, the preamble is not a claim limitation.” Rowe
v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997).
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“A reference is reasonably pertinent if, even though it may be in a
different field from that of the inventor’s endeavor, it is one which, because
of the matter with which it deals, logically would have commended itself to
an inventor’s attention in considering his problem.” In re Clay, 966 F.2d
656, 659 (Fed. Cir. 1992).
“[I]t is not necessary in order to establish a prima facie case of
obviousness that there be a suggestion in or expectation from the prior art
that the claimed compound or composition will have the same or a similar
utility as one newly discovered by applicant.” In re Dillon, 919 F.2d 688,
693 (Fed. Cir. 1990) (en banc) (emphasis in original).

Analysis
We are not persuaded by Appellant’s argument that the preamble
phrase “[a]n ophthalmic pharmaceutical composition” distinguishes the
claimed composition from the composition of the combined prior art. (App.
Br. 5.) We agree with the Examiner (Ans. 6) that the body of the claim sets
forth all the limitations of the claimed invention such that the preamble
phrase only states an intended use, i.e., an ophthalmic route of
administration. See Rowe, 112 F.3d at 478.
Nor are we persuaded that the claim recitation “ophthalmic
composition is capable of being administered to the eye of a patient
suffering from age-related macular degeneration” provides a patentable
distinction between the claimed invention and the combined prior art. This
“wherein” clause recites only that the composition is capable of being
administered in the recited manner. The Examiner provided a rational basis
for finding that a skilled artisan would have expected the combined prior art
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composition to have been capable of being administered in the recited
manner. Specifically, the Examiner reasoned that (a) Davies disclosed that
its gelsolin compositions contained “conventional non-toxic
pharmaceutically acceptable carriers, adjuvants and vehicles,” and (b) Luna
disclosed that its compositions comprised “one or more physiologically
acceptable carriers or excipients.” (Ans. 7.) We agree with the Examiner.
Appellant acknowledges that Luna taught parenteral preparations, but
alleges that “Luna does not appear to mention ophthalmic formulations.”
(App. Br. 7.) We are not persuaded by that allegation because our review of
Luna shows that Luna explicitly taught ophthalmic administration. (FF2.)
Both Davies and Luna disclosed that their compositions were suitable for
parenteral administration, and Luna expressly disclosed that its compositions
may be administered by several routes, including parenteral and ophthalmic.
(FF2.) Appellant has not established with persuasive evidence that a skilled
artisan would have concluded that combining Davies’ gelsolin composition
with Luna’s excipients would not have yielded a composition capable of
being administered to the eye of a patient suffering from age-related macular
degeneration.
We are also unpersuaded by Appellant’s assertion that Davies and
Luna represent non-analogous art. (Ans. 6-7.) The claimed invention is
directed to a pharmaceutical composition comprising gelsolin as an active
agent and a pharmaceutical carrier comprising a viscosity enhancer, a
buffering agent, a tonicity agent, a chelating agent, a wetting agent and a
preservative. Davies is reasonably pertinent to the particular problem with
which the inventor was involved because Davies disclosed a composition
comprising the recited active agent, i.e., gelsolin, in combination with
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several of the excipients of the recited pharmaceutical carrier. (Ans. 3.) To
the extent that Appellant suggests (App. Br. 4-5) that Davies did not disclose
gelsolin as an active ingredient, we disagree. As the Examiner explained,
Davies’ disclosure particularly sets forth the compound of Formula 1 and
gelsolin as the active agents in the composition. (Ans. 7.) In our review of
Davies, we find no evidence that gelsolin was merely an excipient. We find
Appellant’s argument inconsistent with Davies’ teaching of gelsolin’s
function (Davies at 4-5) and Davies’ description of its invention as a
composition including “a non-toxic effective amount of a (F)-actin
shortening protein, such as gelsolin” (id. at 6). Luna is reasonably pertinent
because Luna taught an ophthalmic composition comprising supervillin, an
active agent similar to gelsolin, as well as disclosing each excipient of the
instantly claimed pharmaceutical carrier. (Ans. 4.) To the extent that
Appellant asserts (App. Br. 7) that Luna disclosed that supervillin is similar,
but distinguished from gelsolin by its novel amino terminus, we agree.
However, Appellant has not established that this distinction rendered the
reference non-analogous art, see Clay, 966 F.2d at 659, or would have
otherwise rendered the Examiner’s proposed use of Luna’s excipients non-
obvious.
We are also unpersuaded by Appellant’s contention (App. Br. 7) that
the combined prior art would not have yielded the claimed invention
because, as discussed, the combination recites all of the claimed limitations.
Appellant’s assertion (id.) that the prior art did not disclose that gelsolin
sequesters amyloid proteins in the ocular tissue of macular degeneration
patients does not establish that the claimed composition is non-obvious, see
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Application 12/425,774

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Dillon, 919 F.2d at 693, nor that it is the result of improper hindsight
reconstruction.

CONCLUSIONS OF LAW
The preamble claim phrase “[a]n ophthalmic pharmaceutical
composition” does not distinguish the claimed composition from the prior
art.
The combined teachings of Davies and Luna yield all the elements of
the claimed composition.
The record supports the Examiner’s conclusion that the cited
references would have made the claimed composition obvious.

SUMMARY
We affirm the rejection of claims 8-11 under 35 U.S.C. § 103(a) as
unpatentable over Davies and Luna.

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

dm
ALCON
IP LEGAL, TB4-8
6201 SOUTH FREEWAY
FORT WORTH, TX 76134