Ex Parte Gumaste et al

Patent Trial and Appeal Board

Aug 31, 2017

12828133 (P.T.A.B. Aug. 31, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/828,133 06/30/2010 Anand Gumaste MICRODOSE 09.01 6242
27667 7590
HAYES SOLOWAY P.C.
4640 E. Skyline Drive
TUCSON, AZ 85718
09/05/2017 EXAMINER
TSAI, MICHAEL JASPER
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
09/05/2017 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):
admin@hayes-soloway.com
nsoloway@hayes-soloway.com
dlandau @hayes-soloway.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANAND GUMASTE, SCOTT FLEMING, and PHILIP CHAN
Appeal 2016-005288
Application 12/828,1331
Technology Center 3700
Before HUBERT C. LORIN, NINA L. MEDLOCK, and
BRUCE T. WIEDER, Administrative Patent Judges.
WIEDER, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1, 4—7, 10-14, 17—20, 23—25, 28—31,
34—36, 39, 40, 42^44, and 47—51. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is MICRODOSE
THERAPEUTX, INC. (Appeal Br. 6.)
Appeal 2016-005288
Application 12/828,133
CLAIMED SUBJECT MATTER
Appellants’ claimed “invention relates to a device and method for and
dry nebulization of an aerosolizable material.” (Spec., pg. 1,11. 7—8.)
Claims 1, 14, 25, and 36 are the independent claims on appeal.
Claim 1 is illustrative. It recites:
1. A device for delivering dry powder medication to infants
and respiratory-compromised patients, ventilated patients or
unconscious patients, comprising a housing defining an aerosol
chamber into which an aerosolized medication may be
introduced;
an outlet for said chamber;
a facemask connected to the outlet;
a nebulizer including a vibratory element for aerosolizing
said dry powder medication and introducing aerosolized
medication into the chamber;
a microprocessor and control for the vibratory element;
a manual actuator for permitting a patient, a user, or a
caretaker to activate the vibratory element via manual actuation,
wherein said manual actuation causes the vibratory element to be
activated for a predetermined length of time that is independent
of the duration of manual actuation and wherein said manual
activation of the vibratory element introduces a controlled
amount of aerosolized dry powder medication into the chamber
independent of the infant’s or respiratory-compromised,
ventilated or unconscious patient’s inhalation strength, rate and
timing;
a sensor for sensing an inhalation and/or exhalation cycle
of the infant or patient, wherein the sensing of the inhalation
and/or exhalation cycle by the sensor enables the vibratory
element to operate for a duration that provides for an amount of
chase air to carry or follow the medication into the infant or
patient;
a controller for controlling the vibratory element over two
or more inhalation cycles; and
a dose-controlled blister pack carrying the medication,
said dose-controlled blister pack comprising at least one drug
2
Appeal 2016-005288
Application 12/828,133
ejection aperture, and wherein the medication is introduced into
the chamber through said at least one drug ejection aperture.
REJECTIONS
Claims 1, 4, 6, 12, 13, 36, 39, 40, 43, 47, and 48 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Abrams (US 6,152,130, iss.
Nov. 28, 2000), Voges (US 6,196,218 Bl, iss. Mar. 6, 2001), and Giorgini
(US 4,345,592, iss. Aug. 24, 1982).
Claims 5, 7, 42, and 44 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Abrams, Voges, Giorgini, and Hakkinen (US 4,986,269,
iss. Jan. 22, 1991).
Claim 10 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Abrams, Voges, Giorgini, and Brewer (US 7,100,608 B2, iss.
Sept. 5, 2006).
Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Abrams, Voges, Giorgini, and Fry (US 4,938,209, iss. July 3, 1990).
Claims 14, 17—20, 23, and 24 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Abrams, Voges, and Hakkinen.
Claims 25, 28, 30, 34, and 35 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Abrams and Voges.
Claims 29 and 31 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Abrams, Voges, and Hakkinen.
Claims 49 and 51 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Abrams, Voges, Giorgini, and Japuntich
(US 6,584,976 B2, iss. July 1, 2003).
Claim 50 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Abrams, Voges, and Japuntich.
3
Appeal 2016-005288
Application 12/828,133
ANALYSIS
Claim 1
The Examiner finds that “Abrams discloses a device for delivering dry
powder medication (dry powder inhaler)” but “does not specifically disclose
a manual actuator.” (Final Action 2, 3.) However, the Examiner finds that
“Voges teaches a medicament dispenser that comprises a manual actuator
(Manual actuation) (Voges, col. 5, lines 50-55).” {Id. at 4.) The Examiner
determines that “it would have been obvious to one of ordinary skill in the
art at the time the invention was made to add to the device of Abrams a
manual actuator as taught by Voges to provide manual actuation in case of
malfunction of the sensing and control circuit.” {Id.)
Appellants argue that “one of ordinary skill in the art would have no
motivation to combine” the teachings of Abrams and Voges. (Appeal
Br. 25.) Specifically, Appellants argue that Abrams
actually teaches away from the use of a manual actuator:
Moreover, as noted above, in Wilke et al.’s
disclosed device [U.S. Pat. No. 3,948,264],
vibration of the powder is activated by depressing
a push button. This can be difficult and painful for
some users (e.g., patients suffering from extreme
arthritis). Finally, in order to use Wilke et al.’s
disclosed inhaler most efficaciously, the user must
depress the vibration-actuating push button at
precisely the same time that the user begins
inhalation. This can also be difficult for some
users (e.g., very young patients, patients suffering
from neuromuscular disorders, etc.)....
Accordingly, the present invention solves the
aforementioned drawbacks of related art devices
by providing an air flow sensor for controlling
various components of an inhalation device.
Abrams, col. 1, line 65 - col. 2, line 19.
4
Appeal 2016-005288
Application 12/828,133
(Appeal Br. 26.)
“A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553
(Fed. Cir. 1994). In this case, Abrams discloses that the push button in
Wilke “can be difficult and painful for some users” and that the user must
depress the push button at the proper time which “can also be difficult for
some users.” (Abrams, col. 1, line 67—col. 2 line 7.) In short, Abrams
discloses disadvantages “for some users” associated with the push button in
the prior art Wilke device. But Abrams also discloses that a manual push
button actuator is usable to actuate an inhaler. (See Abrams, col. 1,1. 63-
col. 2,1. 13.) Therefore, we are not persuaded the Abrams “teaches away
from the use of a manual actuator.” See Gurley, 27 F.3d at 553.
Appellants next argue that “[tjhere is no suggestion whatsoever in
either reference that a manual actuator may be desirable as a ‘backup’ to the
Abrams device” and “the Examiner’s proposed modification to Abrams is
based on improper hindsight gleaned from Appellants’ disclosure.” (Appeal
Br. 28.)
The test for obviousness is not what any one reference would have
suggested, but rather what the combined teachings would have suggested to
one of ordinary skill in the art. See In re Keller, 642 F.2d 413, 426 (CCPA
1981). Here, the Examiner does not rely on the references individually but
relies on the combination of Abrams and Voges, as well as Giorgini. (See
Final Action 2—5.)
Nonetheless, the Examiner must show that “there was an apparent
reason to combine the known elements in the fashion claimed by the patent
5
Appeal 2016-005288
Application 12/828,133
at issue.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In
re Kahn, 441 F.3d 997, 988 (Fed. Cir. 2006)).
In this case, the Examiner determines that “it would have been
obvious to one of ordinary skill in the art at the time the invention was made
to add to the device of Abrams a manual actuator as taught by Voges to
provide manual actuation in case of malfunction of the sensing and control
circuit.” (Answer 4.) The Examiner determines that one of ordinary skill in
the art
would have found that providing different options of actuation
to be beneficial for different users and would appreciate a
manual actuator such as malfunctioning of the sensing and
control circuitry or even users that may have a breathing force
insufficient for triggering the sensor of the device to deliver
medicaments to patients in need as evidenced by Davies (U.S.
Pub. No. 2004/0025871) (Davies, para. 0205).
{Id. at 20.) Davies discloses a “manual override enabling manual actuation”
of an access means of an inhaler for “situations where [automatic] actuation
does not happen (e.g., due to power failure).” (Davies 1205.)
Appellants, however, contend that Davies “has nothing to do with
sensing and control circuity [sic] or the use of a manual actuator to release
medicament” and “does nothing to further support the deficient motivation
used in the rejection.” (Reply Br. 6.)
We are not persuaded of error. The Examiner does not rely on Davies
as disclosing “sensing and control circuity [sic] or the use of a manual
actuator to release medicament.” The Examiner finds these limitations in
Abrams and Voges. (Answer 2-4.) The Examiner refers to Davies simply
to show that one of ordinary skill in the art would have found “providing
different options of actuation to be beneficial” in an inhaler. {Id. at 20.)
Thus, the Examiner articulates an apparent reason to combine the teachings
6
Appeal 2016-005288
Application 12/828,133
of Abrams and Voges, and provides a rational underpinning supported by
record evidence that is not gleaned from Appellants’ disclosure.
Appellants next argue that “modifying Abrams with a manual actuator
would not allow for such programmable, self-adjusting and automatic
operation and would therefore improperly change the principle of operation
of the Abrams device.” (Appeal Br. 29.) Specifically, Appellants argue that
“neither Abrams nor Voges teaches a manual actuator in addition to an
automated sensing function” and “[cjombining Voges with Abrams would
not add to Abrams’ device but would replace the programmable, self-
adjusting and automatic operation of Abrams with a manual switch.” (Reply
Br. 5.)
We are not persuaded of error. In the Examiner’s proposed
modification of Abrams, “the automatic feature of Abrams is not being
replaced by the manual actuator” (See Final Action 18). Rather, the
Examiner determines that “it would have been obvious to one of ordinary
skill in the art at the time the invention was made to add to the device of
Abrams a manual actuator as taught by Voges to provide manual actuation
in case of malfunction of the sensing and control circuit.” (Answer 4,
emphasis added.) Additionally, and also as discussed above, the Examiner
does not rely on the references individually but relies on the combination of
the references. (See Final Action 2—5.)
Appellants also argue “that the Federal Circuit has previously held
that an automatically operated device disclosed in the prior art is insufficient
to render obvious an invention that incorporates manual operation.” (Appeal
Br. 30, citing ACS Hosp. Sys., Inc. v. Montefiore Hosp., 732 F.2d 1572, 1576
(Fed. Cir. 1984).
7
Appeal 2016-005288
Application 12/828,133
The patent at issue in ACS related to “a rental television system
comprising a key operated actuating switch, an override switch, and a signal
light.” ACS, 732 F.2d at 1574. The Federal Circuit disagreed with the
district court’s findings regarding the scope and content of the prior art. In
particular, the Federal Circuit determined that “while override switches are
used in a wide variety of applications, the examples of override switches
cited by the district court are not relevant to the claimed subject matter as a
whole.” Id. at 1576. Specifically, the Federal Circuit found that “the
functions of the switching elements in the [accused and claimed] systems are
different.” Id. We do not agree with Appellants that ACS’ holds “that an
automatically operated device disclosed in the prior art is insufficient to
render obvious an invention that incorporates manual operation.” (See
Appeal Br. 30.) Therefore, we are not persuaded of error.
Appellants further argue that Voges “teaches away from the use of dry
powder inhalers.” (Appeal Br. 31.)
As discussed above, the Examiner relies on Voges for disclosing a
manual actuator on an inhaler. The Examiner does not rely on Voges for
disclosing the type of medicine usable in the inhaler (e.g., dry powder or
liquid). Appellants do not persuasively argue why the disclosure of a
manual actuator on “an inhaler that dispenses a flowable substance,” (see
Voges, col. 3,11. 21—22) teaches away from use of a manual actuator on a
dry powder inhaler.
In view of the above, we are not persuaded that the Examiner erred in
rejecting claim 1 under § 103.
8
Appeal 2016-005288
Application 12/828,133
Independent claim 14, 25, and 36
Although Appellants address independent claims 14, 25, and 36 under
separate topic headings in the appeal brief, Appellants rely on the arguments
provided for claim 1. (See Appeal Br. 33—37.) For the reasons discussed
above, we are not persuaded that the Examiner erred in rejecting
independent claims 14, 25, and 36.
Dependent claims 4—7, 10—13, 17—20, 23, 24, 28—31, 34, 35, 39, 40, 42—44,
and 47—51
For the reasons discussed above, we sustain the Examiner’s rejections
of claims 4-7, 10-13, 17-20, 23, 24, 28-31, 34, 35, 39, 40, 42-44, and 47-
51, which were not argued separately except based on their dependence on
their respective independent claims. (See Appeal Br. 33—39.)
DECISION
The Examiner’s rejections of claims 1, 4—7, 10-14, 17—20, 23—25, 28—
31, 34—36, 39, 40, 42-44, and 47—51 under 35 U.S.C. § 103(a) are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
9