Ex Parte Gilbert

Board of Patent Appeals and Interferences

Jun 27, 2012

11200772 (B.P.A.I. Jun. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SCOTT J. GILBERT
__________

Appeal 2011-001331
Application 11/200,772
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for claim indefiniteness, anticipation and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
1. A device for delivering a drug comprising:

a delivery tube, the delivery tube having a distal end having a portion
contoured to receive a patient's eye and said delivery tube having a pressure
chamber therein;

at least one nozzle at a distal end of the delivery tube arranged to
direct drug delivered to the eye to a targeted area of the eye, said nozzle in
fluid communication with the pressure chamber;

a source of drug adjacent to the at least one nozzle;

a handle at a proximal end of the delivery tube; and

an energy source in the handle for providing a driving pressure from
about 800 to about 2,000 psi consistent with the Hagen-Pouiselle equation
for driving the drug through the at least one nozzle and out of the delivery
tube for delivery to the targeted area of the eye.

Cited References

Glines 6,716,190 B1 Apr. 6, 2004
Bellhouse 5,899,880 May 4, 1999
Castellano 2002/0099329 A1 Jul. 25, 2002
Schwebel 3,802,430 Apr. 9, 1974
Sadowski 5,697,917 Dec. 16, 1997

Grounds of Rejection
Claim 1 is rejected under 35 U.S.C. § 112, second paragraph, as being
indefinite for failing to particularly point out and distinctly claim the subject
matter which applicant regards as the invention.

Claim 1 is rejected under 35 U.S.C. § 102(b) as being anticipated by Glines
et al.

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Claim 2 is rejected under 35 U.S.C. § 103(a) as being unpatentable over
Glines et al., in view of Bellhouse et al..

Claims 3-18 and 22-26 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Glines et al., in view of Bellhouse et al., in further view of
Castellano.

Claims 19-21 are rejected under 35 U.S.C. § 103(a) as being unpatentable
over Glines et al., in view of Bellhouse et al., in further view of Castellano,
in further view of Schwebel et al..

Claims 27 and 28 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Glines et al., in view of Bellhouse et al., in further view of
Castellano, in further view of Sadowski et al..

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
11.

Discussion Issue 1
Claim 1 is rejected under 35 U.S.C. § 112, second paragraph, as being
indefinite for failing to particularly point out and distinctly claim the subject
matter which applicant regards as the invention.

ISSUE 1
The Examiner concludes that the reference to the Hagen-Pouiselle
equation in claim 1 is indefinite.
Appellant argues that Application of the Hagen-Pouiselle equation is
described and exemplified at pages 24-27, line 17 of the Specification. That
portion of the application sets out how taking any one of the enumerated
components and variables drives the arrangement, dimensions, and
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functional characteristics of the others. Appellant argues that one skilled in
the art is therefore armed with the equation in question, instructed how to
use it, and shown examples of how it is done.
The issue is: Is the reference to the Hagen-Pouiselle
equation in claim 1 indefinite?

ANALYSIS
We do not find that the Examiner has provided evidence or argument
to support a prima facie case of indefiniteness.
“The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the specification.”
Miles Labs., Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir. 1993).
Claims are in compliance with 35 U.S.C. § 112, second paragraph, if “‘the
claims, read in light of the specification, reasonably apprise those skilled in
the art both of the utilization and scope of the invention, and if the language
is as precise as the subject matter permits.’” Hybritech, Inc. v. Monoclonal
Antibodies, Inc., 802 F.2d 1367, 1385 (Fed. Cir. 1986).
Appellant provides the formula for the Hagen-Pouiselle formula in the
Specification pages 23-26, and provide examples of its application. Page 24
of the Specification provides an example of Force in terms of Pressure, 23
lbf.1 Pressures and force calculations from the Hagen-Pouiselle formula are
further disclosed at page 27 of the Specification, e.g. 2000, psi equals 565
pounds of force.

1 P=F/A, where p is pressure, F is force and A is area.
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The Examiner has not established why one of ordinary skill in the art
would be unable to derive a pressure from the Hagen-Pouiselle formula as
outlined in the Specification.
The indefiniteness rejection is reversed.

Discussion of Remaining Rejections

Claim 1 is rejected under 35 U.S.C. § 102(b) as being anticipated by Glines
et al.

Claim 2 is rejected under 35 U.S.C. § 103(a) as being unpatentable over
Glines et al., in view of Bellhouse et al..

Claims 3-18 and 22-26 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Glines et al., in view of Bellhouse et al., in further view of
Castellano.

Claims 19-21 are rejected under 35 U.S.C. § 103(a) as being unpatentable
over Glines et al., in view of Bellhouse et al., in further view of Castellano,
in further view of Schwebel et al..

Claims 27 and 28 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Glines et al., in view of Bellhouse et al., in further view of
Castellano, in further view of Sadowski et al..

ISSUE 2
The Examiner argues that Glines teaches each element claimed. In
particular, the Examiner argues that Glines teaches an energy source (col. 4,
ll. 62-64) in the handle for providing a driving pressure of from about 800 to
about 2,000 psi consistent with the Hagen-Pouiselle equation for driving the
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drug through the at least one nozzle and out of the delivery tube for delivery
to the targeted area of the eye (col. 12, ll. 12-17). (Ans. 5.)
Appellant contends that Glines describes an injection device used
principally for cardiovascular purposes and not for ocular use. Br. 6.
Appellant further argues that the speed of injection, amount of drug, nozzle
aperture, and other factors accounted for through the application of the
Hagen-Pouiselle Equation of the instantly claimed device are not described
or suggested in Glines. Id.
The issue is: Does Glines support the Examiner’s rejection of the
claims for anticipation? Does the combination of references render obvious
the claimed invention?
PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
Moreover:
Where . . . 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
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manufacture products or to obtain and compare prior art
products.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.)

“An intended use or purpose usually will not limit the scope of the
claim because such statements usually do no more than define a context in
which the invention operates.” Boehringer Ingelheim Vetmedica v.
Schering-Plough Corp., 320 F.3d 1339, 1345, 65 USPQ2d 1961, 1965 (Fed.
Cir. 2003) (citing Griffin v. Bertina, 285 F.3d 1029, 1033, 62 USPQ2d 1431,
1434 (Fed. Cir. 2002).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

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ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s arguments as set forth in the Answer and find
that the Examiner has provided evidence to support a prima facie case of
anticipation and obviousness. We provide the following additional
comments for emphasis. We decide all the issues together, as they turn on
the same questions in the case.
Appellant contends that Glines describes an injection device used
principally for cardiovascular purposes and not for ocular use. Br. 6.
We are not persuaded by Appellant’s argument. Glines, col. 12, l. 24,
contemplates use of the propulsion device for administration of drugs to
ocular tissue. Appellant failed to establish that the contour of the device of
Figure 7A of Glines is not contoured and capable of delivery of
medicaments to the eye.
As to Appellant’s argument that the application of the Hagen-
Pouiselle Equation of the instantly claimed device is not described or
suggested in Glines, we are also unpersuaded. Appellant indicates in the
Specification at page 27, that a pressure of 2000 psi is appropriate for
administration to the eye. Glines discloses a propulsion device capable of
administering a pressure from about 1800 psi to 5000psi. (Glines, col. 12, ll.
15.)
Thus, under the principles set forth in In re Best (above), the burden
of proof has shifted to Appellant to show that the device of Glines does not
necessarily or inherently fulfill the requirements of the Hagen-Pouiselle
Equation.
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This Appellant has not done. In addition, claim 1 is not a drawn to a
method, but rather to a device, so the claim requirement for “an energy
source” simply requires a structure capable of providing the pressure of
“about 800 to about 2000 psi”, and the “Hagen-Pouiselle equation”
statement does not impose any specific structural limitation on the device.
Appellant essentially argues that the remaining obviousness rejections
fall for the same reasons addressed above (Br. 8-9.) Having found no
deficiency in Glines, we affirm the obviousness rejections for the reasons of
record and addressed above.

CONCLUSION OF LAW
The cited references support the Examiner’s anticipation and
obviousness rejections, which are affirmed for the reasons of record. The
claim indefiniteness rejection is reversed.

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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