Ex Parte Paboojian et al

Patent Trial and Appeal Board

Jul 5, 2016

09731318 (P.T.A.B. Jul. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
091731,318 12/06/2000 Steve Paboojian
1095 7590 07/07/2016
NOV ARTIS PHARMACEUTICAL CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
ONE HEAL TH PLAZA 433/2
EAST HANOVER, NJ 07936-1080
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.
PAT053246-US-CNT02 1028
EXAMINER
MENDOZA, MICHAEL G
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
07/07/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
phip.patents@novartis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVE P ABOOJIAN,
CARLOS SCHULER, and ANDREW CLARK
Appeal2014-000529
Application 09/731,318
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a system
for aerosolizing a powdered medicament. The Examiner rejected the claims
as failing to comply with the written description requirement and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse the written
description rejection but affirm the obviousness rejection.
1 Appellants identify the Real Party in Interest as Novartis AG (see
App. Br. 2).
Appeal2014-000529
Application 09/731,318
Statement of the Case
Background
"One promising way to deliver various drugs to a patient is by
pulmonary delivery where a drug dispersion or aerosol is inhaled by the
patient to permit the active drug within the dispersion to reach the distal or
alveolar regions of the lung" (Spec. 1: 14--16). "Of particular interest to the
invention are dry powder dispersion devices that are able to aerosolize
powdered medicaments for inhalation by the patient" (Spec. 1 :22-24). The
invention "relates to the design of such receptacles to facilitate removal of
the powder" (Spec. 2:6-7).
The Claims
Claims 1--4 are on appeal2. Claim 1 is representative and reads as
follows:
1. A system for aerosolizing a powdered medicament,
the system comprising:
a dry powder inhaler and a receptacle, the receptacle
compnsmg:
a receptacle body that defines a sealed cavity
containing powdered medicament, wherein the receptacle
body has a top end and a bottom end, wherein the bottom
end of the receptacle body includes a raised central region
that extends upwardly into the cavity, and wherein the
receptacle is shaped and adapted to be insertable into the dry
powder inhaler and wherein the raised central region is
shaped to facilitate extraction of the powdered medicament
when air or another gas is drawn through the cavity so that
the powdered medicament exits the cavity only through the
top end.
2 Claims 13-22 and 31-34 stand allowed (see Ans. 3).
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Application 09/731,318
The issues
A. The Examiner rejected claims 1--4 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Final Act. 2).
B. The Examiner rejected claims 1--4 under 35 U.S.C. § 103(a) as
obvious over Ohki3 (Final Act. 3--4).
A. 3 5 U.S. C. § 112, first paragraph
The Examiner finds that "[t]here is no written description in the
specification reciting that the powdered medicament exits the cavity only
through the top end" (Final Act. 2).
Appellants contend that "the drawings provide clear support for the
claim language. For example, Figure 4 and its associated discussion make
clear that the extraction occurs only through the top end" (App. Br. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the phrase "the powdered
medicament exits the cavity only through the top end" lacks descriptive
support?
Findings of Fact
1. Figure 4 of the Specification is reproduced below:
1).
\
c ,.- l ' '-11..· _ _, 1
~ .t ...... /'
3 Ohki et al., EP 1 106 196 A2, published June 13, 2001.
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Appeal2014-000529
Application 09/731,318
As shown in Fig. 4, wall 24 has a continuous curvature so that
the air flowing through cavity 20 remains generally adjacent
wall 24 with a laminar flow. In this way, a shear stress is
created along substantially the entire length of wall 24 to
remove any adhered powder along wall 24. Further, central
region 26 directs the air up to bottom end 30 so that essentially
no dead volume exists within cavity 20. In this manner,
substantially all the powder is drawn into extraction tube 30.
(Spec. 11 :4--9).
Principles of Law
Generally, features clearly shown by patent drawings cannot be
disregarded. In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972). In addition,
when assessing whether a drawing provides descriptive support for a claim
feature the "legitimate enquiry in each case ... is what the drawing in fact
discloses to one skilled in the art." In re Wolfensperger, 302 F.2d 950, 955
(CCP A 1962).
Analysis
We find that Appellants have the better position. We agree with
Appellants that Figure 4 depicts an embodiment where the powdered
medicament only exits the cavity through one end, and depicts that end as
the top end (FF 1 ). It is well settled that original drawings are part of the
specification and can provide descriptive support for terms not originally
present in the text of the specification.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the phrase "the powdered medicament exits the cavity only through the
top end" lacks descriptive support.
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Application 09/731,318
B. 35 U.S.C. § 103(a) over Ohki
The Examiner finds that Ohki teaches:
a system for aerosolizing a powdered medicament the system
comprising: a dry powder inhaler (fig. 18) and a receptacle
(fig. 17), the receptacle comprising: a receptacle body that
defines a sealed cavity containing powdered medicament (fig.
17), wherein the receptacle body has a top end (24) and a
bottom end (22), wherein the bottom end (22) of the receptacle
body includes a raised central region (23c) that extend
upwardly
(Final Act. 3). The Examiner acknowledges that "Ohki fails to teach
wherein the powdered medicament exits the cavity only through the top end"
but finds that "the system of Ohki is fully capable of performing the
limitation" (Id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Ohki renders obvious an
aerosolizing system wherein "the powdered medicament exits the cavity
only through the top end" as required by claim 1?
Findings of Fact
2. Figure 17 of Ohki is reproduced below:
FIG~17
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Appeal2014-000529
Application 09/73 I,3 I8
Figure I 7 shows that "blister pack 2 I is comprised of a base panel 22, a lid
panel 24, a medical powder storage chamber 25, and a flow-constriction
passage 26" (Ohki ,-r 58).
3. Figure I 8 of Ohki is reproduced below:
FIG.18
Figure 18 shows "air flows through the inflow air passage l 0 and the inflow
holes (HI, HI) into the storage chamber 25. At this time, air flow directed
from the inflow holes (HI, HI) to the outflow holes (H2, H2) passes through
the flow-constriction orifice passage 26" (Ohki i-f 59)
4. Ohki teaches that "[t]urbulent air flow is thus produced within
the medical powder storage chamber by the air flow directed from two
inflow holes (HI, HI) via the internal space of the medical powder storage
chamber to two outflow holes (H2, H2)" (Ohki i-f 56).
Principles of Law
"A whereby clause in a method claim is not given weight when it
simply expresses the intended result of a process step positively recited."
Minton v. National Ass 'n of Securities Dealers, Inc., 336 F.3d I373, I38 I
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Appeal2014-000529
Application 09/731,318
(Fed. Cir. 2003). "The Board held that neither [preamble] term limits or
defines the structure of the claimed compositions, that the preambles merely
recite the intended use for the compositions, and that the disputed terms
therefore do not constitute substantive limitations under the broadest
reasonable interpretation of the pending claims." In re Taylor, 484 Fed.
Appx. 540, 543 (Fed. Cir. 2012).
Analysis
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. In this case, the
dispute centers over the phrase "wherein the raised central region is shaped
to facilitate extraction of the powdered medicament when air or another gas
is drawn through the cavity so that the powdered medicament exits the
cavity only through the top end" in claim 1.
This phrase does not expressly require any specific structure different
from that required by the "raised central region" requirement in claim 1 for
the receptacle body, nor do Appellants establish that this phrase imposes a
structure for the receptacle body that differs from the receptacle body
structure depicted in figure 17 of Ohki (FF 2).
Instead, the phrase simply recites an intended use of the receptacle
body where, during use, when an exit hole is placed in the top end of the
receptacle body, the medicament "exits the cavity only through the top end".
Unlike the method claims4, which require steps of "inserting a bottom end of
an extraction tube", "forming vents", and "flowing a gas stream ... wherein
the powder is entrained in the gas", elements the Examiner found allowable
4 See, e.g., Claim 13, Resp. After Final. Dated June 14, 2012.
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Application 09/731,318
over Ohki (see Final Act. 4), this apparatus claim simply requires an inhaler
and a receptacle, and the only structural requirement for the receptacle is the
presence of a "raised central region" with the functional requirements of the
"wherein" clause that represent intended use recitations.
Therefore, we interpret the "only through the top end" recitation in
claim 1 as an intended use of the receptacle, not as a structural limitation of
the receptacle, because neither the Specification nor Appellants' arguments
identify any structural difference that results from the "only through the top
end" requirement. "[A]pparatus claims cover what a device is, not what a
device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464,
1468 (Fed. Cir. 1990).
Appellants contend that "Ohki et al discloses powder outflow (H2) at
both the top and the bottom of the blister. Since Ohki et al does not disclose
each and every feature set forth in claim 1, it does [not] render claim 1
unpatentable" (App. Br. 6).
We do not find this argument persuasive because Ohki teaches a
receptacle body structure that is reasonably identical to the receptacle
structure required by claim 1 and depicted in Figure 4 of the Specification
(FF 1-2). While we agree that Ohki uses the receptacle differently than the
use described by Appellants, with two outflow holes (FF 3), that difference
in use is only relevant to method claims and to apparatus claims that differ in
structure, not intended use. Patentability "depends on the claimed structure,
not on the use or purpose of that structure." Catalina Marketing Int 'l v.
Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed.Cir. 2002).
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Appellants contend that "the Examiner goes on to posit that it would
have been obvious to one of ordinary skill in the art to puncture only the top
of the receptacle in Ohki ... However, the Examiner provides no evidence,
teaching or reasoning as to why this proposed modification would have been
obvious to the person of ordinary skill." (App. Br. 6).
We find this argument unpersuasive because the Examiner does not
find it obvious to puncture only the top, but rather recognizes that "Ohki
fails to teach wherein the powdered medicament exits the cavity only
through the top end" but finds that "[h ]owever, the system of Ohki is fully
capable of performing the limitation" (Final Act. 3). That is, the Examiner
recognizes the structural identity of the receptacle of Ohki with that of the
claims, and that Ohki' s receptacle would have the capacity to satisfy the
intended use as recited in claim 1. Appellants provide no evidence that the
receptacle of Ohki would be unable to satisfy this intended use recitation.
We recognize Appellants' argument regarding the Examiner's
advisory action statements (see App. Br. 7), agree with Appellants that the
Examiner's reasoning in the Advisory does not apply, but remain persuaded
that Ohki renders the structural requirements of claim 1, as distinct from the
intended uses, obvious for the reasons and evidence given above.
Appellants contend that "Ohki et al teaches away from the Examiner's
proposed modification. For example, Ohki et al discusses the importance of
turbulent flow ... and removing the bottom openings of Ohki et al, the flow
would become less turbulent" (App. Br. 8-9).
We find the teaching away argument unpersuasive. A teaching away
requires a reference to actually criticize, discredit, or otherwise discourage
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Application 09/731,318
the claimed solution. See In re Fulton, 391F.3d1195, 1201 (Fed. Cir. 2004)
("The prior art's mere disclosure of more than one alternative does not
constitute a teaching away from any of these alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed"). Appellants do not identify, and we do not find, any teaching in
Ohki that teaches away from the receptacle depicted in figure 17 or suggests
that such a receptacle would have been undesirable in any way. As
discussed above, that receptacle reasonably renders claim 1, when
interpreted without the intended use language, obvious.
Appellants contend, regarding the "facilitate extraction" statement in
claim 1 that "Ohki et al discloses no such facilitation. Instead, the raised
portion of Ohki et al is designed to cause turbulent flow through the
receptacle (see element 26 and paragraph 0059). The raised portion of Ohki
et al does nothing to facilitate extraction through the top end of Ohki et al' s
system" (Reply Br. 6).
We do not find this argument persuasive because the only structure
that Appellants' identify as functioning to "facilitate extraction" in claim 1 is
the "raised central region", a feature that appears almost identically in figure
17 of Ohki (cf FF 1 and FF 2). Here, where "the claimed and prior art
products are identical or substantially identical ... the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product." In re Best, 562 F.2d
1252, 1255 (CCPA 1977). Appellants have provided no evidence to satisfy
this burden other than attorney argument.
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Application 09/731,318
Conclusion of Law
The evidence of record supports the Examiner's conclusion that Ohki
renders obvious an aerosolizing system wherein "the powdered medicament
exits the cavity only through the top end" as required by claim 1.
SUMMARY
In summary, we reverse the rejection of claims 1--4 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
We affirm the rejection of claim 1under35 U.S.C. § 103(a) as
obvious over Ohki. Claims 2--4 fall with claim 1. 37 C.F.R. § 41.37(c)(l).
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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