Ex Parte Crockford et al

Patent Trial and Appeal Board

Sep 20, 2012

10203337 (P.T.A.B. Sep. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID ROE CROCKFORD and
JOHN STANLEY HAROLD DENYER
____________

Appeal 2010-009065
Application 10/203,337
Technology Center 3700
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Before STEFAN STAICOVICI, JAMES P. CALVE, and
SCOTT A. DANIELS, Administrative Patent Judges.

DANIELS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
David R. Crockford and John S.H. Denyer (Appellants) seek review
under 35 U.S.C. § 134 from the final rejection of claims 2-4, 6-13, and 15
which are all the claims pending in the application. App. Br. 2. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
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THE INVENTION
Appellants’ invention relates to a drug delivery device for delivering
aerosolized medications to patients with respiratory disorders. More
specifically, the application describes a dosimetric spacer having a holding
chamber 1 and a controller 24 which analyzes the breathing cycle of a
patient and alternatively dispenses drug-laden air, or air not laden with a
drug, from the holding chamber of the spacer to the patient based on the
patient’s breathing cycle. Spec. 5, ll. 18-20, Spec. 7, ll. 4-14; Spec. 10, ll. 8-
9; and figs.1-4.
Claim 6 is the sole independent claim and is representative of the
claimed subject matter on appeal:
6. An apparatus comprising:
a drug delivery device for selectively delivering drug-
laden air or air not laden with the drug;
a sensor for monitoring the breathing pattern of a patient;
a controller arranged to control the drug delivery device to
deliver drug-laden air in pulses which begin when the patient is
monitored by the sensor to begin inhalation;
a feedback indicator which indicates to a patient whether
the monitored breathing pattern is effective for inhaling drug-
laden air or not;
a dose calculator which calculates the dose delivered to the
patient; and
an indicator which indicates to the patient when a desired
dose has been delivered, wherein the controller includes a pulse
length generator which determines the duration of each pulse on
the basis of the monitored breathing pattern of the patient, and
wherein the pulse length generator includes a breathing pattern
analyser which analyses the breathing pattern of a patient in
order to determine the time at which a patient begins to inhale an
end volume, the end volume being the volume of the upper
airways of the patient which, at the end of the inhalation,
contains the end volume of air which does not reach the lungs.
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REJECTIONS
Claims 2-4, 6-13 and 15 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Goodman (US 5,404,871, iss. Apr. 11, 1995),
Denyer (GB 2,316,323 A, pub. Feb. 25, 1998), Mishelevich (US 5,363,842,
iss. Nov. 15, 1994), and Jonson (US 4,819,629, iss. Apr. 11, 1989).1

ANALYSIS
Appellants argue claims 2, 6, 7-11, 13 and 15 as a group, where claim
6 is the only independent claim, and present separate argument as to
dependent claims 3, 4 and 12 which each depend directly from claim 6. See
App. Br. 5-12. We select claim 6 as representative of the group where
claims 2, 7-11, 13 and 15 stand or fall with claim 6, and address in turn
Appellants’ separate arguments as to dependent claims 3, 4 and 12. See 37
C.F.R. 41.37(c)(1)(vii) (2011).
Claim 6 as being unpatentable over Goodman
Relevant to claim 6 and the various combined references, the question
on appeal is reduced to whether Goodman discloses the limitation of “a
pulse length generator which determines the duration of each pulse on the
basis of the monitored breathing pattern of the patient.” App. Br., Clms.

1 Claim 6 is also rejected on the grounds of nonstatutory obviousness-type
double patenting in view of certain claims of co-pending Application No.
10/992,920. Appellants have not appealed this rejection, relying instead
upon potential filing of a Terminal Disclaimer should any claims eventually
be allowed by the Examiner. App. Br. 4. Thus, we do not reach the merits of
the Examiner's provisional double patenting rejection because it would be
premature to do so at this time, consistent with the holding of Ex Parte
Moncla, 95 USPQ2d 1884, 1885 (BPAI 2010) (precedential).

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Appx. Emphasis Added. The Examiner found that it does. Ans. 7.
The Examiner points to teachings in Goodman as inherently
disclosing the “duration” limitation, “wherein the controller includes a pulse
length generator which determines the duration of each pulse on the basis of
the monitored breathing pattern of the patient” and “includes a breathing
pattern analyzer which analyses the breathing pattern of a patient in order to
determine the time at which a patient begins to inhale.” Ans. 4. The
Examiner cites column 5, lines 3-7 and 16-24 of Goodman in support of
these findings:
It is another object to release a controlled amount
of aerosol in one or more pulses having a selected
pulse size, shape, and frequency and number of
pulses to produce a selected particle size
distribution.
Goodman col. 5, ll. 3-7.

It is another object of the invention to deliver
aerosolized compounds in response to a measure
of a patient’s breathing pattern during inspiration.
It is another object to select the optimal point or
points for release of one or more pulses of
medication based on an analysis of the patient’s
inspiratory flow in a first detected flow and to
release the medication on the occurrence of the
determined point or points during a subsequently
detected inspiratory breath.
Goodman col. 5, ll. 16-24.

The Examiner explained that Goodman’s controller determines “the
‘duration’ of [] each pulse (one pulse) on the basis of the monitored
breathing pattern of the patient, with the ‘duration’ being calculated from the
selected size, shape and frequency of the pulse.” Ans. 8. Emphasis Added.
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The Examiner then determined “that with the characteristics listed above,
one of ordinary skill in the art would inherently be able to determine the
‘duration’ of each pulse.” Ans. 7.
The Examiner supports this conclusion by interpreting the term
“duration” according to a common definition, namely, “’[d]uration’ is a
component of time and is defined as: ‘the time during which something
exists or lasts’ (www.m-w.com; Merriam Webster Online Dictionary),” and
provides the comparison that “‘[f]requency’ is also a component of time and
is defined as: ‘the number of repetitions of a periodic process in a unit of
time.’” Ans. 7. Pointing out that both “duration” and “frequency” have time
components, the Examiner reasons, “[t]herefore, one of ordinary skill in the
art would be able to calculate the duration of a pulse if (1) the pulse has a
selected size and shape (selecting a size and shape means selecting a static
value), and (2) the frequency, or the repetitions over time, is known.” Ans.
7-8. This rationale is further illustrated by the Examiner’s example, “if the
frequency of the pulse is 6 cycles/min, then the duration of each pulse is 10
seconds (with the pulses having a static size and shape).” Ans. 8. We find
this persuasive.
The noted dictionary definition broadly defines “duration” as a
component of time. The Examiner’s example relating “frequency” to
duration of a pulse perhaps most clearly explains the period of a cycle as the
inverse of frequency, which to an extent supports the finding that the term
“duration” is merely time dependent nomenclature for a portion (a period, or
a portion of a period) of a wave form. Goodman however does not merely
teach the frequency characteristic of a pulse, but also the size and shape of
the pulse. Goodman col. 5, l. 5. The size of a pulse, as is the size of any
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object, is defined according to generally known standard units of
measurement. Depending as it does on the breathing cycle of a patient over
time, the size of a pulse delivered based on that breathing cycle would
inherently have a time component as a unit of measurement. Further, if the
shape of a particular size pulse is known relative to the breathing cycle of a
patient, then one can contain and define the size within a known boundary,
i.e., shape, along the time dependent breathing cycle of the patient. As such,
we find that the “duration” of a pulse is not a separate or distinct
characteristic of a wave form apart from the selected size, shape and
frequency of a pulse.
Appellants counter that the Examiner has erred in determining that
pulse duration is an inherent or obvious feature of Goodman because “(a)
the features of claim 6 reproduced above are not inherent in the alleged
teachings of [Goodman], and/or (b) even if control over pulse duration were
inherent in the system disclosed in [Goodman], such control would not teach
or suggest the features of claim 6 reproduced above.” App. Br. 6.
“Inherency ... may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999). Appellants contend that “[c]ontrol
over one or more of a ‘size, shape, [or] frequency’ of pulses does not
necessarily entail control by the controller over the duration of the pulses.”
App. Br. 7. We are not convinced by this argument because we do not
consider “duration” as a separate characteristic of a wave form or pulse apart
from size, shape and frequency as these terms are used and understood
together by a person of ordinary skill in the art. As explained above,
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“duration” of any portion of a waveform is by definition nomenclature for a
time component derived from the characteristics of size, shape and
frequency of a wave form.
As noted above, because (1) Goodman teaches that the “size, shape
and frequency” of a pulse may be selected and controlled and (2) the time
component of a pulse, a period, or any portion of a wave form, follows from
these characteristics, in contrast to Appellants’ position, we find that
Goodman’s controller “necessarily” controls the duration of a pulse. See
Ans. 7. See also, Goodman, col. 5, ll. 3-15. Moreover, Goodman also
includes structural support, that is, “[i]t is another object to provide a
variable actuated valve mechanism having an open state and a closed state
for controlling the medication pulse size, shape, and frequency.” Goodman
col. 5, ll. 7-10. The controlled opening and closing of the valve mechanism
clearly define a selected duration of time (for one or more pulses) which is
therefore necessarily present in Goodman even without use of the specific
word. See Goodman, col. 7, l. 49 to col. 8, l. 16
Appellants also argue that “even if the apparatus of [Goodman] did
determine pulse duration...this would not teach or suggest the determination
of pulse duration recited in claim 6.” Reply Br. 7. Appellants specifically
assert that “[t]he Answer fails to demonstrate that determining pulse
duration ‘on the basis of the monitored breathing of a patient’ would have
been obvious from the teachings of the cited references.” Reply Br. 7. We
agree with the Examiner that this “is not found persuasive since Goodman
discloses the use of a sensor 3300 for monitoring the breathing pattern of the
patient, and a controller 3400 that performs the recited function.” Ans. 8.
Goodman describes at column 20, lines 46-49 that “[f]low sensor 3300 is
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located in flow path 3140 where it will not interfere with the delivery of
aerosol to the patient, yet is able to measure both inspiratory and expiratory
flow.” Moreover, Goodman discloses delivery of aerosolized medication
pulses based on a patient’s breathing pattern.
It is another object to select the optimal point or
points for release of one or more pulses of
medication based on an analysis of the patient’s
inspiratory flow in a first detected flow and to
release the medication on the occurrence of the
determined point or points during a subsequently
detected inspiratory breath.

Goodman, col. 5, ll. 18-24. Emphasis added. See also Goodman, col. 8, ll.
18-43.
Accordingly, for the foregoing reasons, we sustain the rejection of
claims 2, 6-11, 13 and 15.

Claim 3 as unpatentable over Goodman and Denyer
The Examiner finds that although the limitation in claim 3 of “a
formulation input” is not taught by Goodman, it is inherently disclosed in
Denyer’s description. Ans. 8. The Examiner supports this finding noting
Denyer’s description at page 11, lines 21-27:
The dose is calculated from a known rate of output
against time for the drug selected, and the sum of all the
nebulizer pulses which the dosimeter has delivered.
Further information on how the doses of drug may be
derived and pre-programmed into the dosimeter may be
obtained from GB 2,294,402 (Medic-Aid Limited et al), the
contents of which are incorporated herein by reference.

Appellants argue that,“[c]laim 3 does not recite that only drug
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concentration is input via the ‘formuation input’. Instead, claim 3 recites that
‘the formulation of the drug being delivered’ is input through the
‘formulation input’. Reply Br. 7-8. Thus, according to Appellants, in
contrast to Denyer, “[t]he formulation of the drug would include not only the
concentration, but also the ingredients used to create the drug solution.”
Reply Br. 8. Appellants’ argument here is persuasive because we agree that
a dosage input into the dosimeter device does not necessitate the input of a
formulation of the medicament into the dosimeter, as the Examiner
proposes.2 For example, the dose input could be pre-programmed according
to a physician’s experience with a particular medicament. The Examiner
does not point to any disclosure in Denyer (or GB 2,294,402, incorporated
specifically therein by reference), or provide an articulated cogent technical
reasoning to support a finding that the input of a drug formulation
necessarily flows from the disclosure of pre-programmed doses of
medicament. See App. Br. 7-8; In re Ochiai, 71 F.3d 1565, 1571 (Fed. Cir.
1995) (obviousness inquiry requires a fact-intensive comparison of the
claimed process with the prior art rather than the mechanical application of
per se rules.); In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections
on obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.”).
The addition of Mishelevic and Jonson does not remedy the
deficiencies of Goodman and Denyer as discussed above. Accordingly, we

2 “Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (citations and internal quotation marks omitted).
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cannot sustain the rejection of claim 3.

Claim 4 as unpatentable over Goodman and Mishelevich
Turning to claim 4, the Examiner found that the combined teachings
of Goodman and Mishelevich “show that it is well known in the art to use a
data log in an inhaler.” Ans. 9. The Examiner further determined:
In col. 4, lines 60-62, Mishelevich discloses that
providing sufficient memory in order to store data
from a large number of inhalations will allow for
compliance review by a healthcare professional.
Thus, one of ordinary skill in the art would have
found it obvious to use a data log in the device of
Goodman in order to allow healthcare
professionals to review the operation of the device.
In order to review the operation of the Goodman's
device, the healthcare professionals would need to
be able to retrieve the pulse size, shape and
frequency of the dosages delivered. Therefore, the
modification would use the relevant information
from the device of Goodman and store them in a
data log, such as the one taught by Mishelevich.
Ans. 9.
Appellants assert that “[t]he Examiner has not demonstrated that the
cited references teach or suggest these features [see, e.g., the Appeal Brief
pp. 9-10]” and contends that Mishelevich is “ambiguous” and merely
“teaches that the data log should simply store ‘data from a large number of
inhalations,’ such as information that would facilitate review of the
respiratory function of the patient, rather than operation of the device.”
Reply Br. 8-9.
Claim 4 recites “a data log for recordal of information relating to each
treatment, including the dose which was delivered.” App. Br., Clms Appx.
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We see no distinction, nor is there any evidence provided by Appellants
from the Specification or any other source, that the claim language
“information relating to each treatment” is any less ambiguous than the
disclosure of Mishelevich. Without any further evidence in the record we
also find that the breadth of the word “dose” is encompassed within the
ordinary meaning of “size, shape and frequency” as these characteristics
relate to medicament pulses to a patient. We do not agree with Appellants’
assertion that “even if it would have been obvious to store pulse, size, shape,
and frequency of dosages delivered (Appellant contends it would not have
been), this would still not teach ‘a data log for recordal of information
relating to each treatment, including the dose which was delivered.’” Reply
Br. 9. An attorney’s arguments in a brief cannot take the place of evidence.
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
The Examiner’s finding that it would be well within the skill of one in
the art to provide Mishelevich’s teaching of a data log with “sufficient
memory” to store the amount of data required by claim 4 is supported by
articulated reasoning and rational underpinnings because the difference
between recording data from each treatment, as opposed to data from a large
number of inhalations or treatments, could be satisfied merely by providing
the data log with sufficient memory. Ans. 9. The Examiner sufficiently
explained that determining a “dose” of medicament would be obvious to one
of ordinary skill in the art knowing the size, shape and frequency of a
pulse(s) of medicament because “[i]n order to review the operation of []
Goodman’s device, the healthcare professionals would need to be able to
retrieve the pulse size, shape and frequency of the dosages delivered.” Ans
9. As such, the rational underpinning and articulated reasoning to support
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the legal conclusion of obviousness is adequately presented by the Examiner
and we sustain the rejection of claim 4. See In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006) (“[R]ejections on obviousness grounds [require] some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.”) (cited with approval in KSR Int’l Co. v.
Teleflex, Inc., 550 U.S. 398, 418 (2007)).

Claim 12 as unpatentable in view of Goodman
With regards to claim 12 the Examiner finds that “the spacer is merely
recited to be a receptacle defining a holding chamber in which the air within
the holding chamber is loaded with the drug prior to treatment.” Ans. 9.
Appellants assert to the contrary that, “a ‘spacer’ is a device that is
connected to an inhaler between the inhaler and a subject.” App. Br. 11.
Appellants further explain in the Reply Brief at page 9, “[s]pacers have a
specific function [] that is different from the functions attributed to inhalers
like the ones shown in the cited references [see, e.g., present specification p.
4 ll. 9-14].”
In the Specification, Figures 1-3 disclose two spacer embodiments.
The embodiments show and describe a multi-dose inhaler (MDI) 3 in Figure
1 (and inhaler 13 in Figures 2 and 3) connected through an inlet 2 (or port 9
in Figures 2 and 3) to a holding chamber 1. Different from the aerosol drug
delivery inhaler disclosed in Goodman, the drug loaded air in the holding
chamber 1 is not exhausted to the atmosphere, but maintained in the holding
chamber 1 until the patient inhales. See Spec. 6. ll. 31-32.
The Examiner’s finding that Goodman discloses a spacer and holding
chamber is inadequately supported because Goodman discloses an inhaler
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which exhausts the contents of the canister 3200 directly to the atmosphere.
“When valve 3150 is actuated or open, channels 3124 and 3154 are in open
communication and the contents of canister 3200 are released to the
atmosphere through nozzle 3160 to form an aerosol.” Goodman, col. 20, ll.
1-4. We agree that a spacer and holding chamber as recited in claim 12 is a
different element(s) from an inhaler, and includes a function not taught or
suggested by Goodman’s disclosed inhaler. See App. Br. 9. The addition of
Denyer, Mishelevich, and Jonson does not remedy the deficiencies of
Goodman as described supra. Thus, we cannot sustain the obviousness
rejection of claim 12.

DECISION
We AFFIRM the rejections of claims 2, 4, 6-11, 13, and 15 and
REVERSE the rejections of claims 3 and 12.
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-IN-PART

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