Ex Parte Sexton et al

Board of Patent Appeals and Interferences

Jun 28, 2010

10768424 - (D) (B.P.A.I. Jun. 28, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DOUGLAS A. SEXTON and WINTHROP D. CHILDERS
____________

Appeal 2009-007495
Application 10/768,424
Technology Center 3700
____________

Decided: June 29, 2010
____________

Before: JENNIFER D. BAHR, STEVEN D.A. McCARTHY, and STEFAN
STAICOVICI, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
Douglas A. Sexton et al. (Appellants) appeal under 35 U.S.C. § 134
(2002) from the Examiner's decision rejecting claims 1-27. We have
jurisdiction over this appeal under 35 U.S.C. § 6 (2002).

The Invention
Appellants' claimed invention is directed to an inhaler system. Spec.
2:2-3.
Claim 1, reproduced below, is illustrative of the claimed invention.
1. An inhaler system, comprising:
an inhalation/exhalation structure including
an inhalation/exhalation orifice;
a medicament supply system including a
medicament ejector disposed in fluidic
communication with the inhalation/exhalation
orifice, wherein the medicament supply system
controllably ejects medicament droplets from the
medicament ejector; and
a flow control system in fluidic
communication with the medicament ejector, the
flow control system configured to provide an
airflow substantially across a face of the
medicament ejector wherein the airflow passes
first through an inhalation valve and then across
the face of the medicament ejector, wherein the
airflow is oriented to entrain the medicament
droplets and then pass the medicament droplets to
the inhalation/exhalation orifice when a patient
applies an in-breath to the inhalation/exhalation
structure, and wherein the flow control system is
configured to impede a flow of air from the
inhalation/exhalation orifice to the medicament
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ejector when the patient applies an out-breath into
the inhalation/exhalation structure.
The Rejections
Appellants seek review of the following rejections:
Under 35 U.S.C. § 112, first paragraph:
A. Claims 15-17 as failing to comply with the written description
requirement.
Under § 102(e):
B. Claims 1-3, 18, 24, and 26 as anticipated by Grychowski
(US 2005/0039746 A1, published Feb. 24, 2005).
Under § 103(a):
C. Claims 15-17 as unpatentable over Grychowski.
D. Claims 25 and 27 as unpatentable over Grychowski and Poole '431
(US 6,158,431, issued Dec. 12, 2000).
E. Claims 4-7, 13, 14, 19, and 20 as unpatentable over Farmer
(US 2002/0069870 A1, published Jun. 13, 2002) and Grychowski.
F. Claims 8, 10-12, and 21-23 as unpatentable over Farmer, Grychowski,
and Poole '431.
G. Claim 9 as unpatentable over Farmer, Grychowski, Poole '431, and
Poole '626. (US 5,278,626, issued Jan. 11, 1994).
H. Claims 1-3, 15-18, 24, and 26 as unpatentable over Grychowski and
Farmer.
I. Claims 25 and 27 as unpatentable over Grychowski, Farmer, and
Poole '431.

SUMMARY OF DECISION
We AFFIRM-IN-PART.

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ISSUES
Appellants raise the following determinative issues with respect to the
identified rejections:
Rejection A:
(1) Does the Specification, as originally filed, fulfill the written
description requirement of 35 U.S.C. § 112, first paragraph, for the
limitation in claim 15 requiring an airflow path that passes "in laminar
fashion across a face of the medicament ejector"?
Rejections B, C, D:
(2) Does Grychowski describe a "flow control system configured to
provide an airflow substantially across a face of the medicament
ejector"?
Rejections E, F, G:
(3) Does the Examiner provide the requisite factual basis to support a
conclusion that it would have been obvious to modify the pressurized
metered dose inhaler in Farmer so as not to include a housing channel
13, based on the teachings of Grychowski?
Rejections H, I:
(4) Does the Examiner provide the requisite factual basis to support a
conclusion that it would have been obvious to modify the pressurized
metered dose inhaler in Grychowski to be oriented such that the face
of the inhaler extends into the air flow, based on the teachings of
Farmer?

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OPINION
Issue (1) - Written Description
Claim 15 requires a flow control system wherein the inhalation
airflow path passes "in laminar fashion across a face of the medicament
ejector." Appellants rely on figures 2 and 3, page 5, lines 10-12, page 8,
lines 9-14, page 9, lines 18-19, page 10, lines 27-31, and at page 11, lines
18-24 (Appeal Br. 34) to provide support for this limitation, which does not
appear in any originally-filed claims.
Principles of Law
"[T]he test for sufficiency is whether the disclosure of the application
relied upon reasonably conveys to those skilled in the art that the inventor
had possession of the claimed subject matter as of the filing date." Ariad
Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
This test "requires an objective inquiry into the four corners of the
specification from the perspective of a person of ordinary skill in the art."
Id. "Based on that inquiry, the specification must describe an invention
understandable to that skilled artisan and show that the inventor actually
invented the invention claimed." Id. This inquiry is a question of fact. Id.
(citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed.
Cir. 1985)).
Findings of Fact
Figures 2 and 3 of Appellants' drawings depict the general direction of
airflow in two embodiments of the invention. The airflow is depicted as
passing in a curved line near the medicament ejector face. At no point is the
airflow specified as being "laminar" or having any other particular qualities
or features. The various passages cited by Appellants merely state that the
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air flows over the medicament ejector. The passages do not mention the
type of airflow or any particular specifics about the flow of air.
Analysis
Based on our findings above, we do not find that the Specification
explicitly or implicitly describes laminar air flow. In addition, we do not
find that the Specification describes the particulars of the invention, and
specifically the parameters of the flow, such that one of ordinary skill in the
art would be able to deduce the pattern of the airflow depicted in the figures
or described in the Specification. In particular, determining laminar air flow
versus turbulent airflow is a highly complex and largely unsolved aspect of
fluid dynamics. Thus, without clear disclosure of the nature of airflow in
certain regions at certain times, it is beyond one of ordinary skill to
determine the type of air flow based on the minimal description provided in
the Specification.
Conclusion
The Specification, as of the filing date, does not contain a written
description of the airflow path passing "in laminar fashion across a face of
the medicament ejector." We sustain rejection A.

Issue (2) - Anticipation by Grychowski
Claim 1 requires a "flow control system configured to provide an
airflow substantially across a face of the medicament ejector." The
Examiner found that figure 1 of Grychowski inherently describes this
limitation at figure 1 and paragraph 19. Ans. 5, 12-13. Appellants argue
that Grychowski does not describe a "face" of the medicament ejector across
which the airflow passes. Appeal Br. 19-21.
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Discussion
We find that Grychowski describes a medicament ejector (pressurized
metered dose inhaler (MDI) 30) connected to a receptacle 28 that houses the
stem of the ejector. Para. 19. Further, we find that the receptacle 28 is
"shaped and oriented to introduce medicament from the inhaler 30 into the
interior space 6 of the holding chamber." Id. However, we do not find that
Grychowski explicitly describes where the face, or bottom surface, of the
ejector is located; it is not clear if any portion of the ejector has direct
exposure to the air stream. See also Ans. 16 ("Grychowski et al. does not
explicitly show the location of the stem [face] of the MDI").
The Examiner further makes a statement that the "examiner believes
that the stem must inherently fall below the end of the receptacle and into
the airflow so that medicament is not wasted by sticking to the insides of the
receptacle." Ans. 12-13. However, the Examiner's rationale fails to
establish that the stem (face) necessarily falls below the end of the
receptacle. See Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268
(Fed. Cir. 1991) (to establish inherency, the extrinsic evidence "must make
clear that the missing descriptive matter is necessarily present in the thing
described in the reference, and that it would be so recognized by persons of
ordinary skill."). The medicament may not stick to the inside of the
receptacle, depending on the shape of the nozzle and the distance from the
air stream. Thus, it is not clear if the face of the ejector has direct exposure
to the air stream or whether the face of the ejector is located away from the
air stream. The Examiner has not satisfied the initial burden of providing a
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basis in fact and/or technical reasoning to support the finding that the airflow
in Grychowski is across the MDI face (stem). See In re King, 801 F.2d
1324, 1327 (Fed. Cir. 1986).
Conclusion
Grychowski does not describe where the face of the ejector is located
and thus does not describe a "flow control system configured to provide an
airflow substantially across a face of the medicament ejector" as required by
claim 1. The Examiner thus relies on an improper finding in supporting
rejection B, which we do not sustain. The Examiner does not articulate any
reasons in rejections C and D why it would have been obvious to locate the
face of the ejector in Grychowski in contact with the air stream. Thus, we
likewise do not sustain rejections C and D.

Issue (3) - Obviousness in view of Farmer and Grychowski
Independent claims 5 and 19 require a "flow control system
configured to entrain the medicament droplets from a face of the
medicament ejector." The Examiner found that Farmer describes a
medicament ejector (MDI 11) to controllably eject droplets, but that Farmer
does not disclose that the medicament droplets are entrained "'from the face
of the medicament ejector' (i.e., due to the shape of the receptacle)." Ans. 7.
Next, the Examiner found that Grychowski does not have a curved portion
(on the bottom of the MDI), and that modifying Farmer's ejector so as not to
have a bottom portion, like the MDI in Grychowski, would result in a device
more easily manufactured and using less material. Ans. 7.
Appellants argue that the Examiner's proposed modification of Farmer
would be "contrary to the basic operational principals [sic] of both Farmer
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and Grychowski" because Grychowski has the ejector separated from the
airflow path "to allow development of aerosol droplets of proper form" and
Farmer's channel 13 is configured "to direct the medication into the
reservoir." Appeal Br. 31-32.
Findings of Fact
Farmer describes a "metered dose inhaler (MDI) canister 11
positioned in receptacle 15 of MDI housing 12 for delivering medicants 22
through housing channel 13 … into collapsible reservoir 14." Para. 22. In
figure 3, the medicament ejected from the MDI moves toward the open end
of housing channel 13. However, we do not find that it is clear whether the
housing channel 13 directs the medicament or if the shape of the MDI nozzle
directs the medicament.
We find that Grychowski describes MDI 30 inserted into receptacle
28. See para. 19, fig. 1. Grychowski does not describe the receptacle 28 or
the stem of MDI 30 in further detail. Thus, we find that even though
Grychowski does not depict a housing channel 13 on the bottom of MDI 30,
Grychowski does not describe MDI 30 in sufficient detail to ascertain that
the bottom of MDI 30 does not in fact have a housing channel 13.
Discussion
The Examiner proposes to remove the housing channel 13 based on
the teachings of Grychowski, on the basis that Grychowski does not depict a
housing channel 13. Ans. 7. However, Grychowski does not teach or
suggest that a housing channel is not necessary on a MDI device nor does
Grychowski teach an MDI without a housing channel. Instead, Grychowski
simply does not describe the MDI in detail. In addition, while Farmer does
not explicitly describe that housing channel 13 is required, Farmer
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nonetheless describes an MDI having a housing channel that performs a
particular function. See para. 22 (medicants 22 are delivered "through
housing channel 13").
The Examiner has not provided evidence or technical reasoning that
supports the finding that "it appears ... Farmer would work equally well
without [housing channel 13]." Ans. 7. Thus, the Examiner's statement is
speculative. As such, the Examiner has not met the initial factual findings to
support a conclusion of obviousness. See In re Warner, 379 F.2d 1011,
1017 (CCPA 1967) (the examiner has the initial duty of supplying the
requisite factual basis and may not, because of doubts that the invention is
patentable, resort to speculation, unfounded assumptions, or hindsight
reconstruction to supply deficiencies in the factual basis).
Conclusion
The Examiner does not provide the requisite factual basis to support a
finding that Grychowski teaches or suggests that the housing channel 13 of
Farmer is unnecessary. The Examiner does not make any additional
findings with respect to Poole '431 or Poole '626 in rejections F and G that
overcome the factual deficiency of Rejection E. Therefore, we reverse
Rejections E, F, and G.

Issue (4) - Obviousness in view of Grychowski and Farmer
Independent claims 1, 15, 18, 24, and 26 recite the inhalation airflow
is "across a face of the medicament ejector." The Examiner found that
Grychowski is silent at to whether the stem of the MDI falls below the
bottom of receptacle 28. Ans. 10. The Examiner found that Farmer
describes a MDI with the stem below the bottom of its receptacle (except
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with a mouthpiece). Id. The Examiner notes that if Grychowski's stem did
not pass through the bottom of the receptacle then the medicament would
stick to the sides of the receptacle. Id. Therefore, the Examiner concludes
that it would have been obvious to modify Grychowski "such that the face of
the stem of the MDI (30) falls below the end of the receptacle as taught by
Farmer in order to allow the flow of medicament to get entrained in the
airflow without being obstructed by the receptacle" and "to ensure efficient
delivery to the patient." Id.
Discussion
Appellants argue that Farmer "expressly seeks to shelter the output" of
the MDI canister 11 with the housing channel 13. Reply Br. 8. Appellants
allege that this shelter is "necessary to ensure proper aerosol delivery." Id.
While Farmer does not ascribe such a function of housing channel 13,
Farmer nonetheless describes housing channel 13 as the structure through
which medicament passes, as we found above in Issue (3).
Additionally, as we found in Issue (3), Grychowski does not describe
the particular structure of the portions of MDI 30 inside or abutting
receptacle 28. Thus, the Examiner's proposed modification of Grychowski's
MDI assumes certain features of the MDI 30 that are not disclosed. Even if
the lower portion of MDI 30 were similar to that of Farmer's MDI 11,
Farmer describes a housing channel 13. The Examiner's proposed
modification presupposes that the housing channel 13 is not required, but
provides no evidence or technical reasoning that the channel 13 is not
required. See Ans. 10 (stating the "mouthpiece" (channel 13) is "not needed
for holding the MDI upright"). Absent some evidence or technical reasoning
to support that housing channel 13 is not required in the MDI of Farmer and
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that MDI 30 of Grychowski likewise does not require a housing channel
with an arrangement in which the stem of the MDI falls below the bottom of
receptacle 28, the Examiner's rejection does not discharge the initial duty of
supplying the factual basis to support a prima facie case of obviousness. See
Warner, 379 F.2d at 1017.
Conclusion
The Examiner has not provided the requisite factual basis to support
the conclusion that it would have been obvious to orient the MDI of
Grychowski as depicted in Farmer but without Farmer's housing channel.
The Examiner does not make any additional findings with respect to Poole
'431 in rejection I that overcomes the factual deficiency of Rejection H.
Therefore, we reverse Rejections H and I.

DECISION
We sustain Rejection A. We do not sustain rejections B, C, D, E, F,
G, H, and I. Therefore, we affirm the Examiner's decision with respect to
claims 15-17 and reverse the Examiner's decision with respect to claims 1-
14 and 18-27.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART
Appeal 2009-007495
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