Ex Parte Schuler et al

Patent Trial and Appeal Board

Apr 30, 2013

10601127 (P.T.A.B. Apr. 30, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte CARLOS SCHULER, STEVE PABOOJIAN,
DERRICK J. TUTTLE, ADRIAN E. SMITH, DENNIS R. RASMUSSEN,
ANEESH BAKSHI, ANDREW CLARK, BRIAN R.S. WARD,
WILLIAM W. ALSTON, JR., and KEVIN S. NASON
____________________

Appeal 2011-003188
Application 10/601,127
Technology Center 3700
____________________

Before: WILLIAM V. SAINDON, NEIL T. POWELL, and
BEVERLY M. BUNTING, Administrative Patent Judges.

SAINDON, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2011-003188
Application 10/601,127

2
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
decision rejecting claims 53-60. We have jurisdiction under 35 U.S.C.
§ 6(b).

The Claimed Subject Matter
Claim 53, reproduced below, is illustrative of the claimed subject
matter.
53. A method for aerosolizing a pharmaceutical
formulation, the method comprising:
providing a valve within an airway leading
to the lungs to prevent respiratory gases from
flowing to the lungs when a user attempts to
inhale, and then abruptly permitting respiratory
gases to flow to the lungs by opening the valve
when a threshold actuating vacuum caused by the
attempted inhalation is exceeded,
providing a flow regulator within the
airway, wherein the flow regulator varies the flow
resistance through the airway to control the flow of
respiratory gases, wherein the flow resistance
through the flow regulator is low when the
respiratory gases are permitted to flow and
increases when the vacuum generated by the user
increases thereafter; and
using the flow of respiratory gases to extract
a pharmaceutical formulation from a receptacle
and to place the pharmaceutical formulation within
the flow of respiratory gases to form an aerosol.

References
The Examiner relies upon the following prior art references:
McAughey
Clarke
Schultz
US 5,724,959
US 5,727,546
US 6,116,237
Mar. 10, 1998
Mar. 17, 1998
Sep. 12, 2000
Appeal 2011-003188
Application 10/601,127

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Rejections
I. Claims 53-55, 57, and 59 are rejected under 35 U.S.C. § 102(b) as
anticipated by Clarke. Ans. 3.
II. Claim 56 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Clarke and Schultz. Ans. 6.
III. Claims 58 and 60 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Clarke. Ans. 6.
IV. Claim 60 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Clarke and McAughey. Ans. 7.

SUMMARY OF DECISION
We AFFIRM.

OPINION
Rejection I – Anticipation by Clarke1
The Examiner found that Clarke discloses a valve 24 and a flow
regulator 23. Ans. 3-4. Appellants argue that Clarke does not disclose a
separate threshold valve and flow regulator. App. Br. 4-5. First, we note
that claim 53 does not specify a structural relationship between the valve and
flow regulator, and specifically, it does not preclude them being attached to
one another. Claim 53 merely specifies that the method has steps of
providing a valve and a flow regulator that perform the claimed functions.
The Examiner’s findings that portion 24 of vane 27 satisfies the limitations
set forth for the claimed valve and that portion 23 of vane 27 satisfies the

1 Appellants argue the claims of Rejection I as a group; we select claim 1 as
representative. See App. Br. 6.
Appeal 2011-003188
Application 10/601,127

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limitations set forth for the claimed flow regulator are well reasoned. As the
Examiner explains, portion 24 performs the claimed function of preventing
respiratory gasses from flowing into the lungs when a user attempts to inhale
by way of the biasing spring. Ans. 3-4, 8-9. Accordingly, this argument is
unpersuasive.
Appellants next argue that Clarke does not disclose a flow regulator
wherein flow resistance is low when gases are permitted to flow and
increases when the vacuum increases thereafter. App. Br. 5. Appellants
explain that “permitted to flow” should be interpreted to mean “first
permitted to flow.” App. Br. 5-6; Reply Br. 4-5. That Appellants require
the addition of the word “first” to clarify their desired meaning of the claim
suggests that such a word is necessary to distinguish. Indeed, permission is
a state, not just an event that occurs at a single point in time. Air is
permitted to flow whenever it is allowed to flow. Appellants point to
nothing in the Specification that necessitates their narrow interpretation.
Accordingly, we are not apprised of error in the Examiner’s rejection, which
states that gases are permitted to flow in Clarke (fig. 2b) and flow resistance
provided by the flow regulator increases as vacuum increases (fig. 2c). Ans.
4, 9.2
Having reviewed Appellants’ arguments in both Briefs, we are not
apprised of error in the Examiner’s rejection of claim 53. Claims 54, 55, 57,
and 59 fall therewith.

2 We note that even if the claim were amended to include “first permitted,”
the flow regulator 23 of Clarke blocks the least amount of air immediately
(fig. 2a), and blocks an increasing amount of air as vacuum increases and the
flow regulator rotates into the air stream (2b, 2c). The particular aspect of
the claim argued here is directed to increasing resistance through the flow
regulator, not resistance through the airway (which is, itself, merely varied).
Appeal 2011-003188
Application 10/601,127

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Rejection II – Obviousness over Clarke and Schultz
Appellants argue that Schultz does not make up for alleged
deficiencies in Clarke (in the rejection of claim 53). App. Br. 7. Not being
apprised of deficiencies of Clarke in that regard, we sustain Rejection II.
Rejection III – Obviousness over Clarke
Appellants argue that “Clarke et al fails to disclose or teach the
duckbill valve” of claim 58. App. Br. 6. As the Examiner points out, Clarke
describes a duckbill valve in figure 9(a). Ans. 6, 9-10. Accordingly,
Appellants’ argument fails to apprise us of error.
Appellants next argue, with respect to claims 58 and 60, that the
Examiner’s modification is deficient as not being “well within the grasp of
one of ordinary skill” and as not having “evidence to suggest.” App. Br. 7.
These bald allegations are not persuasive in view of the Examiner’s
articulated reasons and factual underpinnings, which evidence that a duckbill
valve is substitutable (being an alternative in the same reference) and that
explain that parallel/serial arrangements are obvious design choices. Ans. 6-
7, 9-10. Appellants provide no explanation as to why we should accept that
such modifications are not “well within the grasp of one of ordinary skill.”
Having reviewed Appellants’ arguments in both Briefs, we are not apprised
of error in Rejection III.
Rejection IV – Obviousness over Clarke and McAughey
The Examiner provides an alternative rejection for claim 60, citing
McAughey for the premise that a parallel arrangement is known in the art.
Ans. 7-8. Appellants merely state that McAughey does not make up for the
deficiencies of Clarke (in the rejection of claim 53). Reply Br. 4. Not being
apprised of deficiencies of Clarke in that regard, we sustain Rejection IV.
Appeal 2011-003188
Application 10/601,127

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DECISION
We AFFIRM the Examiner’s decision regarding claims 53-60. No
time period for taking any subsequent action in connection with this appeal
may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

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