Ex Parte Pynson et al

Board of Patent Appeals and Interferences

Sep 10, 2012

11025555 (B.P.A.I. Sep. 10, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOEL PYNSON, BENOIT BESSIERE, and BRIAN D. RATHERT
__________

Appeal 2011-005504
Application 11/025,555
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, 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 obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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Application 11/025,555

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STATEMENT OF CASE
17. A method of preparing an injector device for use comprising the steps
of:
opening a vial that has a shuttle containing an intraocular lens
disposed therein;
attaching a distal nozzle section to said shuttle while said shuttle is
disposed in said vial, such that the shuttle is disposed within a lumen of the
distal nozzle section;
lifting said distal nozzle section away from said vial with the shuttle
attached thereto and thereby removing said distal section, said shuttle and
said intraocular lens from said vial; and
after the step of lifting, attaching a proximal body section to the distal
nozzle section.

Cited References

Butts et al. US 6,387,101 B1 May 14, 2002
Bastia et al. US 7,452,329 B2 Nov. 18, 2008

Grounds of Rejection
Claims 17-19 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Butts.
Claims 15, 16, 22, and 23 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Butts in view of Bastia.

FINDINGS OF FACT
The Examiner‟s findings of fact are set forth in the Answer at pages 3-
7.

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Application 11/025,555

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Discussion
ISSUE
The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time of the invention to modify the method of Butts by
instead using the distal nozzle section to lift the shuttle from the
vial and attaching the proximal body section after the lifting
step since this would merely require reversing the order in
which the device is assembled and would not materially affect
either the assembly of the device nor the function of the device
upon completion of the assembly. Reversing these steps would
not produce unexpected results. One skilled in the art would
recognize that the orientation of the shuttle within the vial could
be flipped so that either attachment end would face the opening
of the vial. As shown in Figure 31, when the shuttle is engaged
with the distal nozzle section, the shuttle will be placed within a
lumen of said section.

(Ans. 4.)

Appellants argue that
Claim 17 recites “attaching a distal nozzle section to said
shuttle while said shuttle ... such that the shuttle is disposed
within a lumen of the distal nozzle section.” By contrast, Butts
discloses (in FIG. 44) attaching a shuttle with shuttle extending
from proximal portion of the injector such that the shuttle is
exposed. The claimed attachment technique, with attachment
of the shuttle within a lumen of the distal portion, provides
advantages of maintaining the enclosed intraocular lens in
solution, and as advantages of improved alignment of the
intraocular lens within the injector owing to the ability to more
securely support the shuttle. The Examiner has provided no
support for modifying the technique disclosed in Butts beyond
the allegation that it “would merely require reversing the order
in which the device is assembled” without addressing the
location of the shuttle within the lumen.
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Application 11/025,555

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(App. Br. 5.)

The issue is: Does the cited prior art teach or suggest the invention as
claimed?

PRINCIPLES OF LAW
“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). Moreover,
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense.

Id. at 421.

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ANALYSIS
We agree with the Examiner‟s fact finding, statement of the rejection
and responses to Appellants‟ arguments as set forth in the Answer. We find
that the Examiner has set forth a prima facie case of obviousness on the
evidence before us. We provide the following additional comment.
Appellants argue that the Examiner has provided no support for
modifying the technique disclosed in Butts beyond the allegation that it
“„would merely require reversing the order in which the device is
assembled‟” without addressing the location of the shuttle within the lumen.
(App. Br. 5.)
The Examiner responds
Butts discloses that upon connecting the shuttle to the distal
nozzle portion, the shuttle is contained within a lumen of the
distal nozzle portion. (See Figure 31 depicting the shuttle 1018
stored within a lumen of the distal nozzle portion 1022.) Upon
modifying the method of Butts by first attaching the shuttle to
the distal nozzle portion, the shuttle would be disposed within a
lumen of the distal nozzle portion as recited in Appellant's
claimed invention.

(Ans. 6.) Thus, Butts does disclose the shuttle within the lumen. The
Examiner further notes that attaching the shuttle first within the lumen of the
distal nozzle section will maintain the lens within solution and will help to
ensure alignment would have been readily apparent to one of ordinary skill
in the art.
Appellants have failed to respond to the Examiner‟s arguments and
evidence of the shuttle stored within a lumen of the distal nozzle portion.
That is, Figure 31 of Butts depicts the shuttle 1018 stored within a lumen of
the distal nozzle portion 1022. Appellants have also failed to rebut the
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Examiner‟s reasoning that reversal of the order in which the device is
assembled would not materially affect either the assembly of the device or
the function of the device upon completion of the assembly. Moreover,
Appellants have not provided evidence that it would have beyond the level
of skill of the ordinary artisan to reverse the order of Butts in which the
device is assembled. On balance we conclude that the evidence supports the
Examiner‟s prima facie case of obviousness.
With respect to the obviousness rejection over Butts in combination
with Bastia, Appellants argue that
Bastia discloses placing a sheath over an ultrasonic probe
prior to use to maintain hygiene when the probe is inserted into
the body. One of ordinary skill in the art would not, based on
the cited references, include to include such a sheath on a,
presumably, sterile distal portion of an intraocular lens injector
that is located in a, presumably, sterile package as disclosed in
Butts.

(App. Br. 5.)

The Examiner finds, however, that
adding a sheath around the distal portion would add an
additional line of sterility for the portion of the injector that the
[intraocular lens (IOL)] travels through, and further, would help
maintain the sterility of this portion of the injector between the
time when the package is opened and when the distal portion is
ready to be used in surgery.

(Ans. 6.)
We find the Examiner has the better argument, as the sleeve of Bastia
represents a predictable solution a person of ordinary skill has good reason
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to pursue to maintain the sterility of a medical device. The obviousness
rejections are affirmed for the reasons of record.

CONCLUSION OF LAW
The cited references support the Examiner‟s obviousness rejections,
and they are affirmed.
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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