Ex Parte Heldt et al

Board of Patent Appeals and Interferences

May 24, 2012

10495550 (B.P.A.I. May. 24, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FREDERIC HELDT, FABIO STRADELLA,
and GIUSEPPE STRADELLA
__________

Appeal 2010-011348
Application 10/495,550
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a nasal
spray device. 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 1-3 and 6-13 are on appeal. Claim 1 is representative and
reads as follows:
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1. A nasal spray device comprising a body (1) specifically configured to
be inserted into the nasal passage for dispensing fluid in the nasal passage
and provided with a dispenser orifice (2), a reservoir (10) containing at least
one dose of fluid being disposed statically in said body (1), said reservoir
(10) being closed in sealed manner by two stoppers (20, 30), a first stopper
(20) and a second stopper (30), the fluid being disposed in a fluid chamber
(11) situated between said first and second stoppers (20, 30), said device
further comprising opener means (40) for opening said first stopper (20),
said opener means (40) being disposed statically in said body (1),
actuator means (50) being connected to said second stopper (30) so as to
displace it in said reservoir (10), the actuation of said second stopper (30)
creating pressure in the fluid chamber (11); said pressure displacing and/or
deforming said first stopper (20) towards said opener means (40), in such a
manner that firstly said first stopper (20) is opened, and then fluid is
expelled through said open first stopper (20) towards said dispenser orifice
(2), the device being characterized in that a spray profile (5) is provided
upstream from said dispenser orifice (2) to dispense the fluid in the form of a
fine spray, the device further comprising precompression means (70) so as to
create precompression in the reservoir (10) before said first stopper (20) is
opened by said opener means (40), so as to improve the spraying of the
fluid, and so as to ensure that the entire dose of fluid is dispensed; and
wherein the reservoir comprises a cylindrical wall distinct from and
disposed entirely inside the body such that the body does not define a fluid
sealing surface of the reservoir.

The Examiner rejected the claims under 35 U.S.C. § 103(a) as
unpatentable over Denolly,1 Wolf,2 and Saffir.3
Claims 2-3 and 6-13 have not been argued separately and therefore
stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

1 Patent No. US 6, 987,654 issued to Pascal Denolly, Jul. 12, 2001.
2 US Patent No. 4,767,416 issued to Stephen J. Wolf et al., Aug. 30,1988.
3 US Patent No. 2,153,594 issued to Jacob A. Saffir, Apr. 11, 1939.

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The Issue
The Examiner’s position is that Denolly taught a fluid dispenser
device 10 comprising a body 118 provided with a dispenser orifice 122A.
(Ans. 3.) The Examiner found that Denolly did not expressly disclose (a) a
spray profile upstream from the dispenser orifice that dispenses a fine spray
or (b) a reservoir that is a separate element from and disposed entirely within
the body of the dispenser. (Id. at 4.)
The Examiner found that Wolf taught a spray nozzle 13 for a syringe
10 including a spray profile 17 upstream of a discharge orifice 16.
According to the Examiner, Wolf taught that its spray nozzle allows the
solution in the syringe to be gently applied to a treated area. (Id.)
Additionally, the Examiner found that Saffir taught a syringe assembly
including a separate reservoir 10 located entirely within the main body of the
syringe 17, which allowed the use of replaceable aseptic medicament
cartridges providing both economy of scale and sterility. (Id.)
Therefore, according to the Examiner, a person of ordinary skill in the
art at the time the invention was made would have found it obvious to add
Wolf’s spray nozzle to Denolly’s syringe to provide a means of gently
applying a solution to a treated area. (Id.) Additionally, the Examiner
concluded that it would have been obvious to add Saffir’s replaceable
medicament cartridges to the assembly of Denolly and Wolf to provide an
aseptic and economical source of medicament. (Id.) According to the
Examiner, the claimed invention is the result of a combination that unites old
elements with no change in the respective functions of those old elements
but yielding only predictable results. (Id. at 5.)
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Appellants contend that “[t]he Examiner’s proposed combination of
art would not teach at least the claimed body and dispenser orifice.” (App.
Br. 15.) Appellants assert that Denolly “element 122A is only the end of a
needle 122, which … is an entirely separate component from the alleged
body 118.” (Id.) According to Appellants, “the only fair reading of the
claims is that the dispenser orifice is part of the body, and is not a separate
component.” (Id.) Therefore, Appellants assert that Wolf does not cure this
deficiency because Wolf’s spray nozzle 20 is also “a separate part with
respect to the outer syringe body.” (Id. at 17.) Further, Appellants assert
that Wolf teaches away from a body which is provided with a dispenser
orifice because “Wolf explicitly teaches a dispenser orifice like the one
claimed should be formed separately from the body, so that it may be
separately affixed.” (Id. at 18.)
Appellants also assert that the cited art fails to teach a “reservoir
comprising a cylindrical wall distinct from and disposed entirely inside of
the body” of the device (Id.) According to Appellants, “the alleged
reservoir 112 [of Denolly] is not disposed entirely inside of the allegedly
body 118,” and that Saffir does not cure this deficiency because the
Examiner allegedly did not cite the reference “for any other element other
than a reservoir.” (Id. at 19.)
Further, Appellants assert that a skilled artisan “would not have found
it obvious to combine the cited art in the manner suggested by the
Examiner.” (Id.) According to Appellants, “[t]he Examiner arbitrarily
combines parts of different references in order to arrive at the claimed
subject matter.” (Id.) Additionally, Appellants also assert that “[i]ncluding
at least the reservoir of Saffir would require substantially redesigning
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Denolly” because “Saffir requires a separate cartridge 10 contained within
an outer casing… while Denolly requires a single wall, this wall forming the
fluid chamber.” (Id. at 23.)
In the Reply Brief, Appellants assert that “none of the references cited
by the Examiner discloses or reasonable suggests a nasal spray device or a
body configured to be inserted into a nasal passage.” (Reply Br. 7.)
Specifically, Appellants assert that each reference is directed toward a
syringe having an extruded hypodermic needle designed to penetrate human
tissue. (Id.) According to Appellants, a skilled artisan “would not design a
nasal spray device with a body configured to be inserted into a nasal passage
to have an extruded hypodermic needle end point, as there would be a high
risk of injury caused by the use of such a product.” (Id.)
The issue is whether the preponderance of the evidence supports the
Examiner’s conclusion that the combined references would have made the
claimed nasal spray device obvious.
Analysis
After considering all the evidence and arguments, we conclude that
the record supports a conclusion of prima facie obviousness. In particular,
Appellants assert that “[t]he Examiner’s proposed combination of art would
not teach at least the claimed body and dispenser orifice.” (App. Br. 15.)
Independent claim 1 recites, in part, “a body … provided with a dispenser
orifice,” independent claim 11 recites, in part, “a body … which includes a
dispenser orifice,” and independent claim 13 recites, in part, “a body…
comprising … a dispenser orifice.” (See id.) According to Appellants, “the
only fair reading of the claims is that the dispenser orifice is part of the
body, and is not a separate component.” (Id. at 15.) Therefore, Appellants
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assert that combining Wolf’s spray nozzle 20 comprising a dispenser orifice
with Denolly’s syringe body would not yield a body and dispenser orifice, as
claimed, because Wolf’s spray nozzle 20 is “a separate part with respect to
the outer syringe body.” (Id. at 17.) Further, Appellants assert that Wolf
teaches away from a body which is provided with a dispenser orifice
because “Wolf explicitly teaches a dispenser orifice like the one claimed
should be formed separately from the body, so that it may be separately
affixed.” (Id. at 18.)
We are not persuaded by these arguments. As the Examiner correctly
explained, the claim language “does not recite that the dispenser orifice must
be integral with the body or that the body must be made of one, unitary
piece.” (Ans. 6; see also Hearing Transcript at 5.) Rather, when given the
broadest reasonable interpretation, the claims read on a body that is
“provided with,” “includes,” and “compris[es]” a dispenser orifice as a
separate structure. See Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed.
Cir. 1988)(“It is the claims that measure the invention.”). Therefore, we
agree with the Examiner that the combination of Denolly’s syringe body and
Wolf’s spray nozzle comprising a dispenser orifice satisfied these claim
limitations.
Appellants also contend that the cited art failed to teach or suggest a
“reservoir comprising a cylindrical wall distinct from and disposed entirely
inside of the body” of the device. (App. Br. 18.) In particular, Appellants
assert that “by the Examiner’s own admission in the Final Office Action
dated August 18, 2009 (see page 5, section 13), Saffir is not cited for any
other element other than a reservoir.” (Id. at 19.) Therefore, according to
Appellants, “Saffir fails to teach a body such that the reservoir is disposed
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entirely inside of the body.” (Id.) However, the Appellants’ contention is
based upon a mischaracterization of the Examiner’s findings relating to
Saffir. In the referenced section of the Final Office Action, the Examiner
stated, “Saffir is combined with Denolly and Wolf for the purpose of
including a separate reservoir located entirely within the main body of a
syringe.” (Final Rej. 5, ¶ 13)(emphasis added). Consequently, we are not
persuaded by Appellant’s argument.
Appellants further assert that a skilled artisan “would not have found
it obvious to combine the cited art in the manner suggested by the
Examiner,” and that “[t]he Examiner arbitrarily combines parts of different
references in order to arrive at the claimed subject matter.” (App. Br. 19.)
We disagree with Appellants. As the Examiner correctly explained, each of
the combined references were related to syringes. (Ans. 8.) The Examiner
combined Wolf with Denolly to provide a syringe having a nozzle for gently
applying a fine mist or spray of a solution to an area to be treated. (Id.) The
Examiner included Saffir in the combination to provide a separate chamber
reservoir that allowed greater sterility and economy in the cost of
manufacturing. (Id.) Thus, the Examiner articulated reasoning with rational
underpinnings to support the motivation for combining the references. See
In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
Appellants also assert that “[i]ncluding at least the reservoir of Saffir
would require substantially redesigning Denolly” because “Saffir requires a
separate cartridge 10 contained within an outer casing…while Denolly
requires a single wall, this wall forming the fluid chamber.” (Id. at 23.)
However, Appellants have not established with persuasive evidence that the
Examiner’s proposed modification amounted to anything more than simply
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substituting these different features, i.e., modifying Denolly’s syringe to
include a separate cartridge, as taught by Saffir, in place of the single wall
forming the fluid chamber. (See App. Br. 23.) Consequently, we are not
persuaded by this argument.
In the Reply Brief, Appellants assert that “none of the references cited
by the Examiner discloses or reasonably suggests a nasal spray device or a
body configured to be inserted into a nasal passage.” (Reply Br. 7.)
According to Appellants, a skilled artisan “would not design a nasal spray
device with a body configured to be inserted into a nasal passage to have an
extruded hypodermic needle end point, as there would be a high risk of
injury caused by the use of such a product.” (Id.) We are not persuaded by
this argument. The Examiner’s proposed combination included Wolf’s
spray nozzle. As Appellants have acknowledged, Wolf taught fixing the
spray nozzle over the needle. (See App. Br. 18.) Thus, the combined prior
art provided a syringe comprising a needle covered (i.e., protected) by a
spray nozzle rather than providing a syringe with an “extruded” needle
presenting a high risk of injury, as Appellants contend.
Accordingly, we affirm the Examiner’s obviousness rejection.

CONCLUSION OF LAW
The preponderance of the evidence supports the Examiner’s
conclusion that the combined references would have made the claimed nasal
spray device obvious.

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SUMMARY
We affirm the rejection of claims under 35 U.S.C. § 103(a) as
unpatentable over Denolly, Wolf, and Saffir.

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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