Ex Parte Mazela et al

Patent Trial and Appeal Board

Aug 24, 2016

12922981 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/922,981 09/16/2010
7590
MARINA E VOLIN
2600 Kelly Road
Warrington, PA 18976
08/24/2016
FIRST NAMED INVENTOR
JanMazela
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
Dl 129/20024 5273
EXAMINER
YOUNG, RACHEL T
ART UNIT PAPER NUMBER
3771
MAILDATE DELIVERY MODE
08/24/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte JAN MAZELA and CHRISTOPHER HENDERSON
Appeal2014-003763
Application 12/922,981
Technology Center 3700
Before LINDA E. HORNER, EDWARD A. BROWN, and
JILL D. HILL, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jan Mazela and Christopher Henderson (Appellants) 1 appeal under 35
U.S.C. § 134(a) from the Examiner's decision rejecting claims 1--4, 6, 8-11,
13-15, and 22-26. 2 We heard oral argument on August 11, 2016. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 The Appeal Brief identifies Discovery Laboratories, Inc., as the real party
in interest. Appeal Br. 2.
2 Claims 5 and 7 are withdrawn from consideration, and claims 12 and 16-
21 are cancelled.
Appeal2014-003763
Application 12/922,981
CLAIMED SUBJECT MATTER
Appellant's disclosure "is directed to an aerosol delivery system and a
ventilation circuit adaptor for pulmonary delivery of aerosolized substances
and/ or for other therapeutic and/ or diagnostic purposes, in combination with
noninvasive or invasive respiratory ventilation support." Spec. i-f 1.
Claims 1, 13, and 2 6 are independent. Claim 1, reproduced below,
illustrates the claimed subject matter:
1. An adaptor for delivering an aerosolized active agent or a
gasified active agent to a patient with concomitant positive
pressure ventilation, comprising:
a) a patient interface port;
b) an aerosol flow channel having an aerosol inlet port and
an aerosol outlet port, wherein the aerosol flow channel has a
length between the aerosol inlet port and the aerosol outlet port
and wherein the aerosol flow channel is adapted to enclose an
aerosol flow along the length of the aerosol flow channel; and
c) a ventilation gas flow channel in fluid communication
with the patient interface port and the aerosol outlet port and
having a gas inlet port and a gas outlet port, and \~1herein the
ventilation gas flow channel is separated from the aerosol flow
channel and is at least partially offset from the aerosol outlet port
and at least partially encircles the aerosol flow channel.
Br. 24 (Claims App.).
REJECTIONS
I. Claims 1, 4, 6, and 26 are rejected under 35 U.S.C. § 102(b) as
anticipated by Niven (US 2006/0078506 Al, published Apr. 13, 2006).
II. Claims 8-10 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Niven and Flynn (US 7,219,668 B2, issued May 22,
2007).
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Application 12/922,981
III. Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Niven, Flynn, and Alston (US 2005/0139211 Al, published June 30,
2005).
IV. Claims 2 and 3 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Niven and Kee (US 5,357,946, issued Oct. 25, 1994).
V. Claims 13, 22, and 25 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Niven and Ivri (US 2005/0229928 Al, issued Oct. 20,
2005).
VI. Claim 14 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Niven, Ivri, and Flynn.
VII. Claim 15 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Niven, Ivri, Flynn, and Kee.
VIII. Claim 23 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Niven, Ivri, and Mackie (US 2005/0178383 Al, published Aug. 18,
2005).
IX. Claim 24 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Niven, Ivri, and Bird (US 3,842,828, issued Oct. 22, 1974).
ANALYSIS
Rejection I
Claims 1, 4 and 6
Appellants present argument for patentability only for claim 1 (Br. 5-
10) and state that claims 4 and 6 stand or fall with claim 1 (id. at 10).
Accordingly, we select claim 1 as representative of the group, and claims 4
and 6 stand or fall with claim 1. See 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv).
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Application 12/922,981
Claim Construction
Before addressing the respective positions of the Examiner and
Appellants in regard to anticipation by Niven, we construe the term
"ventilation gas flow channel" in claim 1. Claim 1 recites "a ventilation gas
flow channel in fluid communication with the patient interface port and the
aerosol outlet port and having a gas inlet port and a gas outlet port"
(emphasis added). Claim 8 depends from claim 1 and recites that "the
ventilation gas flow channel forms a chamber that includes the gas inlet
port, the gas outlet port and the patient interface port" (emphasis added).
During examination at the Patent and Trademark Office, "'claims ...
are to be given their broadest reasonable interpretation consistent with the
specification, and ... claim language should be read in light of the
specification as it would be interpreted by one of ordinary skill in the art."'
See In re Am. Acad. Of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
(citations omitted). Accordingly, the meaning of the "ventilation gas flow
channel" is construed in light of Appellants' Specification.
Figures 2A and 2B of Appellants' Specification depict adaptor 10
including ventilation gas flow chamber 18, ventilation gas inlet port 20,
ventilation gas outlet port 22, and patient interface port 16 located at the
bottom of chamber 28. Spec. i-f 55; Figs 2A, 2B. The Specification
describes ventilation gas flow in adapter 10:
Ventilation gas 23 is introduced through gas inlet port 20 into a
ventilation gas flow channel 19 (shown in Fig. 2D) and follows
a flow path that partially encircles the aerosol flow channel 12,
but may be pulled toward the patient inteiface port 16 under
certain circumstances (e.g., when aerosol flow is not being
generated or when the aerosol flow rate is less than the
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Appeal2014-003763
Application 12/922,981
patient ;s inspiratory jlow (PIF) as indicated by "broken lines;;
in Figs. 2B and 2C).
Spec. i-f 55 (emphasis added). Figure 2B shows how ventilation gas 23
enters gas inlet port 20 and flows through chamber 28 to patient interface
port 16. For this ventilation gas 23 flow pattern, patient interface port 16
provides an outlet port of the ventilation gas flow channel.
Accordingly, we construe the "ventilation gas flow channel" in claim
1 as being sufficiently broad to encompass "a chamber that includes the gas
inlet port, the gas outlet port and the patient inteiface port," (emphasis
added), such as recited in claim 8 and described in paragraph 55 of the
Specification. Our construction is consistent with the doctrine of claim
differentiation.
The Examiner's and Appellants' Positions
The Examiner finds that Niven discloses an adapter 202, 402
comprising patient interface port 206, an aerosol flow channel (from the top
of 412 to the bottom of 406) having an aerosol inlet port (top of 412) and an
aerosol outlet port (bottom of 406), and a ventilation gas flow channel
having gas inlet port 212 and gas outlet port 214. Final Act. 3--4 (citing
Niven, Figs. 18-20 and 24--26). The Examiner finds that Niven's ventilation
gas chamber "flows through chamber 202." Id. at 16.
Appellants contend that Niven does not disclose a gas ventilation gas
flow channel meeting the limitations following the term "wherein" in
paragraph ( c) of claim 1. Br. 7. First, Appellants contend that Niven's
ventilation gas flow channel is not separated from the aerosol flow channel.
Id. at 8. Appellants assert that because the Examiner considers Niven's
chamber 202 to be part of the ventilation gas flow channel, the aerosol flow
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Appeal2014-003763
Application 12/922,981
channel (i.e., conditioning vessel 402) is joined with chamber 202 and is not
"separated from" chamber 202. Id. Appellants assert:
As can be seen, for example, in FIGS. 2B and 2D of the present
application, the ventilation gas flow channel 19, which extends
from the ventilation inlet port 20 to the ventilation gas outlet
port 22 is separated from the aerosol flow channel by the wall
of the aerosol flow channel (see annotated FIG. 2B above), such
that when the adaptor is operating, the mixing of flows of
ventilation gas and the aerosol in the adaptor is prevented or
minimized.
Id. at 8-9 (emphasis added).
These contentions are not persuasive. Our construction of the term
"ventilation gas flow channel" does not limit this element to extend only
from the aerosol inlet port to the aerosol outlet port, but rather, encompasses
a ventilation gas flow channel that includes a chamber that includes a gas
inlet port, a gas outlet port, and a patient interface port. Figure 2B of
Appellants' application shows that mixing of ventilation gas and aerosol will
occur in chamber 28 when ventilation gas 23 is "pulled toward the patient
interface port 16 under certain circumstances." See Spec. para. 55.
Figure 25 of Niven depicts fluid flow connector 400 including aerosol
conditioning vessel 402 and chamber 202 having delivery outlet 206 through
which the aerosolized substance exits chamber 202. See Niven i-fi-f 133, 148.
Figure 25 shows the location of chamber 202 relative to outlet 406 of aerosol
conditioning vessel 402. Consistent with our construction of "ventilation
gas flow channel," Niven's ventilation gas flow channel can be considered
to include ventilation gas inlet port 212, ventilation gas outlet port 214, as
well as chamber 202 and delivery outlet 206. In Appellants' embodiment, a
portion of the ventilation gas flow channel (the portion that encircles the
aerosol flow channel at the top) is separated from the aerosol flow channel,
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Appeal2014-003763
Application 12/922,981
and likewise, in Niven, the portion of the ventilation gas flow channel
comprising ventilation gas inlet 212 and ventilation gas outlet 214, is
separated from aerosol flow channel. Also, even if mixing of ventilation gas
and aerosol occurs in chamber 202, Appellants have not apprised us of error
in the Examiner's finding that Niven's ventilation gas flow channel
including chamber 202 is "separated from the aerosol flow channel," as
much as called for by claim 1.
Second, Appellants contend that Nivens' ventilation gas flow channel
is not at least partially "offset" from the aerosol outlet port. Br. 9. The
Examiner finds that Niven's ventilation gas flow channel is not along the
same axis as the aerosol flow channel, and thus, these channels are offset.
Final Act. 16.
Appellants contend that Niven's ventilation gas flow channel is not
offset from aerosol outlet port 406 because aerosol outlet port 406 serves as
an entry for aerosol into the ventilation gas flow channel. Br. 9. Appellants
assert that Niven's ventilation gas flow channel does not have a discernible
axis, and thus, the Examiner has not shown that the ventilation gas flow
channel is not along the same axis as the aerosol flow channel, and thus, is
offset from the aerosol flow channel. Br. 9.
These contentions are not persuasive. Appellants do not explain what
the claim term "offset" means. And we are unable to find any description in
Appellants' Specification that informs us of the meaning of this term. As
shown in Figure 2B of Appellants' application, aerosol outlet port 30 serves
as an entry for aerosol into chamber 28, and thus, into the ventilation gas
flow channel, consistent with our construction of this term.
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Application 12/922,981
To the extent it is Appellants' position that the claimed ventilation gas
flow channel has a "discernible axis" not along the same axis as the aerosol
flow channel, Appellants do not explain where the axis of the ventilation gas
flow channel is located. In view of our construction of "ventilation gas flow
channel," Appellants have not apprised us of any error in the Examiner's
finding that Niven's gas flow channel is not along the same axis as the
aerosol flow channel, and thus, these channels are "offset."
Third, Appellants contend that, in Niven, the ventilation gas flow
channel does not at least partially encircle the aerosol flow channel. Br. 10.
The Examiner finds that the walls of chamber 202 in Niven form part of the
ventilation gas flow channel because "at least some of the gas enters and
spreads throughout the chamber and around an outlet portion of the aerosol
flow channel at 406." Final Act. 16.
Appellants contend that even if Niven's ventilation gas flow channel
includes chamber 202, chamber 202 does not at least partially encircle the
aerosol flow channel. Br. 10. Rather, Appellants assert that "[a]ny
encircling is de minimis." Id.
These contentions are also not persuasive. Appellants do not appear
to dispute that Niven's chamber 202 encircles the aerosol flow channel by
some amount. Claim 1 does not recite any limitation that requires the
ventilation gas flow channel to encircle the aerosol flow channel by more
than some particular amount. Thus, Appellants do not explain persuasively
why the encircling of the aerosol flow channel by chamber 202 shown in
Niven fails to meet the disputed claim limitation.
For the above reasons, we sustain the rejection of claim 1, and claims
4 and 6 falling with claim 1, as anticipated by Niven.
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Application 12/922,981
Claim 26
Appellants contend that claim 26 is also not anticipated by Niven for
reasons similar to the reasons presented for claim 1 in regard to asserted
differences (1) and (2). Br. 11-13; compare id. at 8-10.
As Appellants' contentions in regard to these asserted differences are
not persuasive for claim 1, we also sustain the rejection of claim 26 as
anticipated by Niven.
Rejection II
Claim 8 depends from claim 1 and recites, inter alia, that "the aerosol
flow channel is of a sufficient length to extend below an entrance of a gas
from the gas inlet port into the chamber and below an exit of the gas from
the chamber into the gas outlet port." Br. 25 (Claims App., emphasis
added). The Examiner finds that Niven does not disclose this limitation.
Final Act. 6.
However, the Examiner finds that Figure 5 of Flynn teaches a
ventilation gas inlet port 20, a patient interface port 26, and an aerosol flow
channel (34 out through 3 8) extending below an entrance of gas from
ventilation gas inlet port 20. Final Act. 6.
The Examiner concludes that it would have been obvious to modify
Niven's aerosol outlet port with an aerosol outlet port extending below the
ventilation inlet port such that the ventilation gas flow channel at least
partially encircles the aerosol flow channel, as taught by Flynn. Final Act. 7.
The Examiner determines that, because Niven's gas inlet port and gas outlet
port are along the same axis, the modified aerosol flow channel would
extend below both the gas inlet port and gas outlet port. Id.
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Application 12/922,981
Appellants contend that Flynn does not cure the deficiencies of Niven
in regard to claim 1. Br. 13-14. In support, Appellants provide an
annotated version of Figure 5 of Flynn. Id. at 15. Appellants contend that,
in Flynn, "the only logical way to construe the ventilation [gas] flow channel
is the entire volume between the inlet 20 and the outlet apertures 32," as
highlighted in the annotated figure. Id. at 14. Appellants contend that even
if the modified device of Niven discloses an aerosol flow channel of
sufficient length to extend below an entrance of gas from the gas inlet port
into the chamber, the modified device of Niven does not teach that the
aerosol flow channel is also of a sufficient length to extend below an exit of
the gas from the chamber into the gas outlet port. Id. at 17-18. Appellants
contend that the closest feature to a gas outlet port in Flynn is at the (bottom)
end of tubular member 26, but the "aerosol flow channel" does not extend
below the end of tubular member 26. Id. at 18.
Appellants' contentions are persuasive. Figure 25 of Niven shows
that aerosol outlet 406 is positioned above a circular opening that appears to
correspond to ventilation gas inlet port 212 shown in Figure 19. Figure 19
appears to shows that ventilation gas inlet port 212 and ventilation gas outlet
port 214 are both at about the same vertical position in the illustrated
orientation of adapter 200.
Even if the outlet of medication container receiver 34 (at valve 3 8) is
below the gas inlet port (i.e., inlet 20) in Flynn (which Figure 5 does not
show clearly), the Examiner does not appear to also identify the location of a
ventilation gas outlet port. Accordingly, the Examiner does not identify any
teaching or suggestion in Flynn that the aerosol flow channel also extends
below such a ventilation gas outlet port.
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Application 12/922,981
Again with reference to Figure 25 of Niven, the Examiner has not
articulated an adequate reason with a rational underpinning as to why one of
ordinary skill in the art would have modified the device to extend the aerosol
flow channel sufficiently to position aerosol outlet 406 below both
ventilation gas inlet port 212 and ventilation gas outlet port 214, as required
by the disputed limitation of claim 8.
Accordingly, we do not sustain the rejection of claim 8, and claims 9
and 10 depending therefrom, as unpatentable over Niven and Flynn.
Re} ection III
Claim 11 depends from claim 8. The Examiner's application of
Alston to teach a one-way valve located at an aerosol outlet port (Final Act.
8-9) fails to cure the deficiencies of the rejection of claim 8. Accordingly,
we do not sustain the rejection of claim 11 as unpatentable over Niven,
Flynn, and Alston.
Rejection IV
Appellants indicate that dependent claims 2 and 3 stand or fall with
claim 1. Br. 21.
Accordingly, we sustain the rejection of claims 2 and 3 as
unpatentable over Niven and Kee.
Rejection V
Appellants contend that system claim 13 and its dependent claims 22
and 25 are patentable because claim 13 includes all limitations of claim 1
and Niven does not teach or suggest all of those limitations. Br. 22.
Because Appellants' position that Niven does not anticipate claim 1 is
not persuasive for the reasons discussed above, we sustain the rejection of
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Application 12/922,981
claims 13, 22, and 25 as unpatentable over Niven and Ivri for the reasons
discussed above for claim 1.
Re} ections VI-IX
Appellants state that dependent claims 14, 15, 23, and 24 stand or fall
with claim 13. Br. 22.
Accordingly, for the same reasons as those for claim 13, we sustain
the following rejections: claim 14 as unpatentable over Niven, Ivri, and
Flynn (Rejection VI); claim 15 as unpatentable over Niven, Ivri, Flynn, and
Kee (Rejection VII); claim 23 as unpatentable over Niven, Ivri, and Mackie
(Rejection VIII); and claim 24 as unpatentable over Niven, Ivri, and Bird
(Rejection IX).
DECISION
We affirm the rejections of claims 1--4, 6, 13-15, and 22-26, and
reverse the rejections of claims 8-11.
No time period for taking any subsequent action in connection with
this appeal may be extended according to 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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