Ex Parte Boeckl et al

Patent Trial and Appeal Board

Aug 14, 2017

10609132 (P.T.A.B. Aug. 14, 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.
10/609,132 06/26/2003 Andrew J. Boeckl PAT053288-US-NP 6677
1095 7590 08/16/2017
NOVARTIS PHARMACEUTICAL CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
ONE HEALTH PLAZA 433/2
EAST HANOVER, NJ 07936-1080
EXAMINER
HARMON, CHRISTOPHER R
ART UNIT PAPER NUMBER
3649
NOTIFICATION DATE DELIVERY MODE
08/16/2017 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):
phip.patents@novartis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW J. BOECKL, DALE W. PLOEGER,
DERRICK J. PARKS, and DIANE BRANNIGAN
Appeal 2016-0020151
Application 10/609,132
Technology Center 3600
Before LINDA E. HORNER, GORDON D. KINDER, and
BRENT M. DOUGAL, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Andrew J. Boeckl et al. (Appellants) seek our review under 35 U.S.C.
§ 134(a) of the Examiner’s decision rejecting claims 66-72 and 77-89.
Final Office Action (October 22, 2014) (hereinafter “Final Act.”). Claims
1-65 and 73-76 are canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants name Novartis AG as the real party in interest. Appeal Brief 2
(May 26, 2015) (hereinafter “Appeal Br.”).
Appeal 2016-002015
Application 10/609,132
CLAIMED SUBJECT MATTER
Appellants’ claimed subject matter relates to “controlling the flow of
powder during a package filling process.” Spec. 5,1. 29. Claims 66, 69, 77,
and 83 are independent. Claim 83 is representative of the subject matter on
appeal and is reproduced below.
83. A system for filling receptacles with an
aerosolizable powder pharmaceutical formulation, the apparatus
comprising:
a hopper adapted to contain a bulk supply of a powder
pharmaceutical formulation having a mass median aerodynamic
diameter of from about 1.0 to 5.0 pm, the hopper comprising a
plurality of outlets;
a plurality of chambers, each chamber associated with a
different outlet and in flow communication with the outlet and
moveable relative to the outlet,
a vibratable membrane capable of disturbing a gas within
the hopper, the disturbance of the gas being sufficient to control
the flow of powder through the outlets and into the chambers,
wherein the bulk supply of powder is spaced from the
vibratable member when the powder pharmaceutical formulation
is present in the hopper and the vibratable member is not
vibrating and whereby the chambers may be filled by powder
flowing through the outlets and into the chambers.
Appeal Br. 20 (Claims Appendix).
REJECTIONS
The Final Office Action includes the following rejections:* 2
1. Claims 69, 71, 81, 83-85, and 87 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Boyd et al. (US 5,081,822, issued
2 We list the rejections in a different order from the order presented in the
Final Action so as to address the rejections based on the combination of
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January 21, 1992) (“Boyd”) and Larson (US 3,259,272, issued July
5, 1966).
2. Claims 70-72 and 89 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Boyd, Larson, and Blicher et al. (US 5,437,393,
issued August 1, 1995) (“Blicher”).
3. Claims 77-79, 82-84, 86, and 88 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Omori (US 4,329,830, issued May
18, 1982) and Larson.
4. Claims 78-80 and 89 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Omori, Larson, and Blicher.
5. Claims 66-68 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Omori, Popper (US 4,346,802, issued August
31, 1982), and Larson.
ANALYSIS
First Ground of Rejection: Claims 69, 71, 81, 83-85, and 87 as
unpatentable over Boyd and Larson
Appellants present arguments directed to the patentability of
independent claims 69 and 83, and do not present any arguments directed to
the separate patentability of the dependent claims subject to this ground of
rejection. Appeal Br. 7-10. We select claim 83 as representative, and the
remaining claims subject to this ground of rejection stand or fall with
claim 83. 37 C.F.R. § 41.37(c)(l)(iv).
Boyd and Larson first, and then to address the rejections based on the
combination of Omori and Larson.
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Appellants argue that the Examiner erred in rejecting claim 83
because Boyd’s hopper is designed to dispense caplets and is not adapted to
dispense a bulk supply of powder. Appeal Br. 7-8. Appellants further argue
that the Examiner’s rejection fails to demonstrate why it would have been
obvious to modify Boyd’s apparatus with the teaching of Larson to alter the
apparatus to be a powder dispenser. Id. at 8.
The Examiner finds that “Boyd directly discusses other substances
being delivered into the capsule portions.” Final Act. 10 (citing Boyd,
col. 3,11. 8+). The Examiner is correct. Boyd discloses that “[wjhile
reference here is primarily directed to the placement of a caplet 10 into a
capsule 12, it is to [be] understood that the present invention pertains
generally to the placement of any substance into the capsule 12.” Boyd,
col. 3,11. 10-12. Further, as noted by the Examiner (Ans. 8), Boyd discloses
that it was known in the art to fill gelatin capsules with powdered
medicaments. Boyd, col. 1,11. 24-26. Thus, the proposed modification to
Boyd’s apparatus to render it capable of placing powdered medicament into
the gelatin capsules is consistent with the explicit teachings in Boyd of the
applicability of its apparatus to any substance placed within the capsule.
Further, Larson pertains to a method for dispensing powder. Larson,
col. 1,11. 8-9. In particular, Larson discusses using the apparatus to
dispense powder for growing crystals in a flame-fusion process. Id. at col. 1,
11. 12-13. Larson discloses, however, that “the basic principles of this
invention are applicable to any system in which it is desired to dispense
small quantities of finely divided powder in an ordered manner.” Id. at
col. 1,11. 13-16. Thus, we agree with the Examiner that one of ordinary
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skill in the art would readily see that the technique disclosed in Larson “for
precise and consistent distribution of powder from a hopper” would be
relevant to Boyd for dispensing a powder from a hopper to fill the gelatin
capsule in Boyd. Ans. 9.
Appellants further argue that the suggested modification would not
result in the claimed system because Larson uses a filter screen to help
control the flow of powder and the claimed invention does not include a
screen in its opening. Appeal Br. 8-9 (“the openings in the [claimed]
invention . . . are sized so that powder does not flow therethrough until the
vibratable membrane is actuated.”). This argument is not commensurate
with the claim language. See Final Act. 10-11 (“the features upon which
applicant relies (i.e., the absence of a screen, and flow control of the powder)
are not recited in the rejected claim(s)”). For instance, claim 83 recites, “a
vibratable membrane capable of disturbing a gas within the hopper, the
disturbance of the gas being sufficient to control the flow of powder through
the outlets and into the chambers.” Appeal Br. 20 (Claims App.). The
claimed function of the vibratable membrane is “to control the flow of
powder through the outlets.” The claim does not recite that actuation of the
vibratable membrane starts the flow of powder through the outlets, or that
the outlets are such that undisturbed powder does not flow therethrough. A
review of Appellants’ Specification supports this understanding of the claim
language. For instance, the Specification describes that to control the flow
of powder could mean maintaining the powder in a constantly fluidized
state, and that stopping the powder fluidizer may simply reduce the amount
of powder flowing through the outlets. Spec. 6,1. 19-7,1. 2. In modifying
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the hopper of Boyd to use it to dispense powdered medicament into the
gelatin capsules, one having ordinary skill in the art would be led to employ
the improvement of Larson, which could include the use of Larson’s filter
screen in each of Boyd’s chutes (i.e., outlets) and to use pulses of sound
energy to dispense controlled quantities of the powder into the gelatin
capsules to avoid the problem of “packing” of the powder in the hopper.
Larson, col. 1,11. 44^17, 69-70, col. 3,11. 19-37. As such, the fact that
Larson uses a filter screen to help control the flow of powder does not
demonstrate error in the Examiner’s rejection.
Appellants also contend that the proposed modification would not
result in an apparatus that controls the flow of powder through outlets and
into associated chambers because in Larson there is not a chamber
associated with each of the openings in the screen. Appeal Br. 8. This
argument against Larson individually does not address the Examiner’s
proposed combination, which relies on Boyd’s apparatus having chutes and
associated chambers, for this aspect of the claim. Final Act. 4.
Appellants further contend that Boyd and Larson fail to disclose the
type of powder claimed. Appeal Br. 9. As noted by the Examiner (Ans. 7),
the claims do not positively recite the powder being dispensed, and instead
claim the hopper adapted to dispense the powder. Further, as stated supra,
Boyd teaches that its apparatus can be used to dispense “any substance” into
gelatin capsules and further discloses that it was known in the art to load
gelatin capsules with powdered medicament. Appellants state that Larson is
directed to powders for growing crystals in a flame-fusion process, but
Appellants do not contend that such powders are of a size larger than the
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mass median aerodynamic diameter of the powder recited in the claims.
Larson is addressing the same handling and agglomeration challenges as
discussed in Appellants’ Specification. Larson, col. 1,11. 69-70, col. 2,
11. 51-56 (discussing “normal packing characteristics of the powder”), col. 3,
11. 30-32 (discussing shaking free a portion of the powder from the
remaining powder), col. 3,11. 38-39 (discussing powder becoming
compacted). Further, the Specification describes that Appellants’ system has
applicability to handling of fine powders larger than the aerosolizable
powders referenced in the claims. See Spec. 2,11. 19-27 (describing the
problem to be solved with reference generally to pharmaceutical
formulations, such as those often packaged in blister packs, in a capsule that
is to be swallowed or from which the pharmaceutical formulation may be
aerosolized). Thus, Appellants have not demonstrated how an apparatus
adapted to handle powders of the claimed size results in a non-obvious
structural distinction over a prior art apparatus adapted to handle powder
medicament for use in gelatin capsules that are to be swallowed.
For these reasons, we find no error in the Examiner’s rejection of
claim 83 as unpatentable over Boyd and Larson. Accordingly, we sustain
the first ground of rejection of claim 83, and claims 69, 71, 81, 84, 85, and
87, which fall with claim 83.
Second Ground of Rejection: Claims 70-72 and 89 as unpatentable over
Boyd, Larson, and Blicher
Appellants rely on the arguments discussed above, in support of the
patentability of independent claims 69 and 83 over Boyd and Larson, as the
basis for patentability of dependent claims 70-72 and 89. Appeal Br. 10
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(Appellants arguing only that Blicher “is not relied upon to make up for the
deficiencies of Boyd ... and Larson”). For the reasons set forth above, we
find no deficiencies in the Examiner’s rejection of independent claims 69
and 83 as unpatentable over Boyd and Larson. For these same reasons, we
sustain the second ground rejection of claims 70-72 and 89 under 35 U.S.C.
§ 103(a) as unpatentable over Boyd, Larson, and Blicher.
Third Ground of Rejection: Claims 77-79, 82-84, 86, and 88 as
unpatentable over Omori and Larson
Appellants present arguments directed to the patentability of
independent claims 77 and 83, and do not present any arguments directed to
the separate patentability of the dependent claims subject to this ground of
rejection. Appeal Br. 10-13. We select claim 83 as representative, and the
remaining claims subject to this ground of rejection stand or fall with
claim 83. 37 C.F.R. § 41.37(c)(l)(iv).
Appellants argue that the Examiner erred in rejecting claim 83
because Omori’s powder flows naturally through large chutes and Omori’s
hopper is not adapted to dispense a bulk supply of powder whose flow is
controlled by a vibratable membrane. Appeal Br. 11. Appellants further
argue that the Examiner’s rejection fails to demonstrate why it would have
been obvious to modify Omori’s system with the teaching of Larson in the
manner claimed. Id.
Omori is directed to an “apparatus for packaging powdery or particle-
size material. . . such as powdery medicine.” Omori, col. 1,11. 6-10. Thus,
we find no error in the Examiner’s finding that Omori is “considered fully
capable of processing a pharmaceutical powder as claimed.” Final Act. 2.
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The argument that Omori does not contain a bulk supply of powder whose
flow is controlled by a vibratable member fails to address the Examiner’s
rejection, which is based on a proposed modification of Omori to add the
vibratable member of Larson to obtain the benefit disclosed in Larson, as
discussed in further detail infra.
As to the reason to modify Omori with the teaching of Larson, Larson
pertains to a method for dispensing powder. Larson, col. 1,11. 8-9. As
noted supra, Larson discloses that “the basic principles of this invention are
applicable to any system in which it is desired to dispense small quantities of
finely divided powder in an ordered manner.” Id. at col. 1,11. 13-16. We
agree with the Examiner that one of ordinary skill in the art would readily
see that the technique disclosed in Larson “for precise and consistent
distribution of [finely divided] powder from a hopper” would be relevant to
Omori for dispensing a powdery or particle-sized material such as powdery
medicine from Omori’s hopper. Ans. 9.
Appellants further argue that the suggested modification would not
result in the claimed system because Larson uses a filter screen to help
control the flow of powder and the claimed invention does not include a
screen in its opening. Appeal Br. 12 (“the openings in the [claimed]
invention . . . are sized so that powder does not flow therethrough until the
vibratable membrane is actuated.”). Lor the same reasons discussed supra,
this argument is not commensurate with the claim language. In other words,
in modifying the hopper of Omori to more precisely and evenly dispense
powdered medicament into chambers, one having ordinary skill in the art
would be led to employ the improvement of Larson, which could include the
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use of Larson’s filter screen in Omori’s hopper outlets and to use pulses of
sound energy to dispense controlled quantities of the powder into the
chambers to avoid the problem of “packing” of the powder in the hoppers.
Larson, col. 1,11. 44^17, 69-70, col. 3,11. 19-37.
Appellants also contend that the proposed modification would not
result in an apparatus that controls the flow of powder through outlets and
into associated chambers because in Larson there is not a chamber
associated with each of the openings in the screen. Appeal Br. 12. This
argument against Larson individually does not address the Examiner’s
proposed combination, which relies on Omori’s apparatus having chutes and
associated chambers, for this aspect of the claim. Final Act. 2 (citing Omori,
Fig. 4).
Appellants further contend that Omori and Farson fail to disclose the
type of powder claimed. Appeal Br. 12. As noted by the Examiner (Ans. 7),
the claims do not positively recite the powder being dispensed, and instead
claim the hopper adapted to dispense the powder. Further, as stated supra,
Omori teaches that its hopper is used to dispense particle-size powdery
medicine. Appellants state that Farson is directed to powders for growing
crystals in a flame-fusion process, but Appellants do not contend that such
powders are of a size larger than mass median aerodynamic diameter of the
powder recited in the claims. As noted supra, Farson is addressing the same
handling and agglomeration challenges as discussed in Appellants’
Specification. Farson, col. 1,11. 69-70, col. 2,11. 51-56 (discussing “normal
packing characteristics of the powder”), col. 3,11. 30-32 (discussing shaking
free a portion of the powder from the remaining powder), col. 3,11. 38-39
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(discussing powder becoming compacted). Further, the Specification
appears to describe that this system has applicability to handling of fine
powders larger than the aerosolizable powders referenced in the claims. See
Spec. 2,11. 19-27 (describing the problem to be solved with reference
generally to pharmaceutical formulations, such as those often packaged in
blister packs, in a capsule that is to be swallowed or from which the
pharmaceutical formulation may be aerosolized). Thus, Appellants have not
demonstrated how an apparatus adapted to handle powders of this particular
size result in a non-obvious distinction over a prior art apparatus adapted to
handle particle-size powdery medicine.
For these reasons, we find no error in the Examiner’s rejection of
claim 83 as unpatentable over Omori and Larson. Accordingly, we sustain
the third ground rejection of claim 83, and claims 77-79, 82, 84, 86, and 88,
which fall with claim 83.
Fourth Ground of Rejection: Claims 78-80 and 89 as unpatentable over
Omori, Larson, and Blicher
Appellants rely on the arguments discussed above, in support of the
patentability of independent claims 77 and 83 over Omori and Larson, as the
basis for patentability of dependent claims 78-80 and 89. Appeal Br. 13
(Appellants arguing only that Blicher “is not relied upon to make up for the
deficiencies of Omori and Larson”). For the reasons set forth above, we find
no deficiencies in the Examiner’s rejection of independent claims 77 and 83
as unpatentable over Omori and Larson. For these same reasons, we sustain
the fourth ground of rejection of claims 78-80 and 89 under 35 U.S.C.
§ 103(a) as unpatentable over Omori, Larson, and Blicher.
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Fifth Ground of Rejection: Claims 66-68 as unpatentable over Omori,
Popper, and Larson
Appellants argue claims 66-68 as a group. Appeal Br. 14-15. We
select claim 66 as representative, and claims 67 and 68 stand or fall with
claim 66. 37 C.F.R. § 41.37(c)(l)(iv).
Independent claim 66 contains limitations similar to independent
claims 77 and 83. Appellants recite the limitations of claim 66 and contend
that “Omori and Larson do not disclose or teach these claimed features, as
discussed above.” Appeal Br. 14. For the same reasons presented above in
our analysis of representative claim 83, we likewise do not find these
arguments persuasive of error in the rejection of claim 66 as unpatentable
over Omori and Larson.
According to Appellants, claim 66 “in addition to reciting a vibratable
membrane[,] further recites a vibratable member that is in contact with the
bulk powder.” Appeal Br. 14. Appellants argue that “the Examiner has
failed to show any reason why one of ordinary skill in the art would add both
a vibratable membrane and a vibratable member to the system of Omori
when there is no suggestion to add either one.” Id. Appellants have not
demonstrated error in the rejection by this assertion.
First, the Examiner provided a reason to further modify Omori with
the teachings of Popper. In particular, the Examiner stated that “[i]t would
have been obvious to one of ordinary skill in the art to provide the powder
vibrating member of Popper in the modified invention to Omori [as modified
by Larson] for assisting in powder separation within the hopper.” Final
Act. 4. Thus, contrary to Appellants’ assertion, the Examiner did provide
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both a reason to modify Omori with the teaching of Larson, as discussed
above, and a reason to further modify Omori with the teaching of Popper.
Further, we find the Examiner’s articulated reasoning to be sufficient. Both
Larson and Popper teach techniques to address the problem of packing of
powder in a hopper. Larson, col. 1,11. 69-70, col. 3,11. 38-39; Popper,
col. 1,11. 15-32, col. 1,1. 54 - col. 2,1. 3, col. 3,11. 8-10. Omori pertains to
dispensing particle-size powdery medicine from a hopper. Omori, col. 1,
11. 6-8. We agree with the Examiner that a person of ordinary would
recognize that the techniques of Omori and Popper would improve the
similar dispensing device of Omori in the same way, and, thus, using these
prior art techniques would have been an obvious improvement to Omori.
See KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“[I]f a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill.”) To the extent Appellants are arguing that the
suggestion to modify Omori to add a vibratable membrane and a vibratable
member must be found in the explicit teachings of Omori, this is not the
proper obviousness inquiry. KSR, 550 U.S. 398, 415 (2007) (rejecting the
rigid teaching-suggestion-motivation test and reaffirming a “functional
approach” to the obviousness inquiry).
For these reasons, we find no error in the Examiner’s rejection of
claim 66 as unpatentable over Omori, Popper, and Larson. Accordingly, we
sustain the fifth ground rejection of claim 66, and claims 67 and 68, which
fall with claim 66.
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DECISION
The Examiner’s decision to reject claims 66-72, and 77-89 is
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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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