Ex Parte Mueting et al

Patent Trial and Appeal Board

Aug 25, 2017

13001630 (P.T.A.B. Aug. 25, 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.
13/001,630 12/28/2010 Michael W. Mueting 64362US005 2970
32692 7590 08/29/2017
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
EXAMINER
ZHANG, HAI Y
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
08/29/2017 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL W. MUETING, DANIEL C. DUAN,
and STEPHEN W. STEIN
Appeal 2016-006055
Application 13/001,630
Technology Center 1700
Before TERRY J. OWENS, BRIAN D. RANGE, and MICHAEL G.
McMANUS, Administrative Patent Judges.
McMANUS, Administrative Patent Judge.
DECISION ON APPEAL
The Examiner finally rejected claims 1—10, 12, 16, 18, 20-22, 26, and
28—30 of Application 13/001,630 under 35 U.S.C. § 103(a) as obvious.
Final Act. (June 12, 2015) 2—11. Appellants1 seek reversal of these
rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction under
35 U.S.C. §6.
For the reasons set forth below, we REVERSE.
1 3M Innovative Properties Company is identified as the real party in
interest. Appeal Br. 3.
Appeal 2016-006055
Application 13/001,630
BACKGROUND
The present application generally relates to a method of making active
pharmaceutical ingredient particles with surface-modified nanoparticles
deposited on the surface of the pharmaceutical particle. Spec. 2.
Claim 1 is representative of the pending claims and is reproduced
below:
1. A method of making active pharmaceutical ingredient
particles having surfaces with surface-modified nanoparticles
deposited thereon, the method comprising:
providing a plurality of media particles having surfaces
with surface-modified nanoparticles deposited on the surfaces
of the media particles;
mixing the plurality of media particles with active
ingredient particles to transfer surface modified nanoparticles
from the media particles to the active ingredient particles and
provide active ingredient particles having surfaces with a
portion of the surface-modified nanoparticles deposited thereon;
and
subsequently, separating the plurality of media particles
from the active ingredient particles having surfaces with the
portion of the surface-modified nanoparticles deposited thereon;
wherein the media particles have at least one feature
which is different from at least one feature of the active
ingredient such that the media particles can be separated from
the active ingredient particles.
Appeal Br. (Claims App. 1).
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Application 13/001,630
REJECTIONS
On appeal, the Examiner maintains the following rejections:
1. Claims 1—10, 12, 16, 18, 20-22, 26, and 28—30 are rejected
under 35 U.S.C. § 103(a) as obvious over Baran et al. (WO 2007/019229
Al; pub. Feb. 15, 2007) (hereinafter “Baran”). Final Act. 2—7.
2. Claims 1—10, 12, 16, 18, 20-22, 26, and 28—30 are rejected
under 35 U.S.C. § 103(a) as obvious over Baran in view of Gogos et al. (US
2005/0228075 Al; pub. Oct. 13, 2005) (hereinafter “Gogos”). Id. at 7—11.
DISCUSSION
Rejection 1. The Examiner rejected claims 1—10, 12, 16, 18, 20-22,
26, and 28—30 as obvious over Baran. Id. at 2—7.
Appellants argue that the rejection is in error on two bases. First,
Appellants argue that Baran does not teach that a surface-modified
nanoparticle can transfer from a media particle to an active ingredient
particle. Appeal Br. 7. Second, Appellants argue that Baran does not teach
separation of media particles from active ingredient particles. Id.
Transfer of Nanoparticle from Media Particle to Active Ingredient
Claim 1 requires media particles, surface-modified nanoparticles, and
active ingredient particles. The Examiner finds that “[bjecause Baran
teaches mixing a medicament, and excipient, such as glass materials, and
surface-modified nanoparticles in a pharmaceutical inhalation powder
formulation, inherently, surface modified nanoparticles will deposited to the
medicament during mix processing step.” Answer 11. Thus, the Examiner
finds that the medicament of Baran is the active ingredient, the excipient of
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Application 13/001,630
Baran is the media particle, and the nanoparticle of Baran satisfies the
nanoparticle limitation of the claim.
Baran teaches a pharmaceutical inhalation powder formulation
consisting of a “medicament, an optional excipient, and surface-modified
nanoparticles.” Baran 17,1. 30. Baran further teaches that “[t]he surface-
modified nanoparticles may be configured in such a way that they are
arranged on the surface of the medicament and/or optional excipient
particles.” Baran 18,11. 3—5. Baran additionally teaches that “the surface-
modified nanoparticles may be primarily contained on the surface of large
excipient particles.” Id. at 18,11. 5—7.
Baran, however, does not explicitly teach the transfer of nanoparticles
from the excipient (media particle) to the active ingredient. Answer 6—7.
Rather, the Examiner briefly finds that “inherently, surface modified
nanoparticles will [be] deposited to the medicament during [the] mix
processing step.” Id. at 7, 11.
Inherency, however, requires that the missing descriptive material is
“necessarily present,” not merely probably or possibly present, in the prior
art. Trintec Indus., Inc. v. Top—U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir.
2002). That is, 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. In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). Here,
the Examiner makes a bare allegation that “inherently, surface-modified
nanoparticles will deposited” by mixing. Final Act. 3; Answer 11. As the
Examiner has the burden of providing reasonable proof that a claim
limitation is an inherent characteristic of the prior art, In re Mousa, 479 F.
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Application 13/001,630
Appx. 348, 352 (Fed. Cir. 2012), this is insufficient to show that transfer of
the nanoparticles “necessarily” occurs.
Accordingly, there is insufficient support for the Examiner’s finding
that Baran teaches that surface-modified nanoparticles can transfer from a
media particle to an active ingredient particle.
Separation of Media Particles from Active Ingredient Particles
Appellants additionally argue that Baran does not teach separation of
media particles from active ingredient particles. Appeal Br. 7.
The Examiner finds that Baran does not explicitly teach separation of
the media particles from the active ingredient particles. Final Act. 3. The
Examiner finds, however, that Baran teaches a sieving step and that a person
of ordinary skill in the art would have been motivated to sieve the
formulation of Baran so as to separate out the media particles2 because
separation “would improve the accuracy and homogeneity of pharmaceutical
composition, because it is known that particle and ingredient segregation
(separation) occurs when particles of different sizes and bulk densities are
b[l]ended together and transported or handled.” Id. at 3^4.
The only moiety taught by Baran that may qualify as a media particle
is the “optional excipient.” Baran 17,1. 29—18,1. 3. Baran teaches that the
excipient may carry the nanoparticles. Id. at 18,11. 3—5. Baran includes no
explicit teaching of transfer from excipient (media particle) to active
2 The Examiner finds that “the bulk particle will [be] separated from the
pharmaceutical inhalation drug particle.” Final Act. 3. As the medicament
is identified in Baran as a particular type of bulk particle (See Baran 14,11.
10-16), we construe “bulk particle” to refer to a media particle.
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Application 13/001,630
ingredient. Answer 11. Nonetheless, from the excipient’s presence, the
Examiner finds that some nanoparticles will “inherently” be transferred to
the active ingredient. Id. We have determined this to be unsupported,
above. Even were the Examiner’s finding of an inherent transfer of
nanoparticles accepted, the Examiner does not find that the amount
transferred must inherently be sufficient to improve any characteristic of the
active ingredient (such as flowability or dispersibility). See Final Act. 3;
Answer 11. Rather, Baran teaches that nanoparticles may be directly applied
to the active ingredient to improve such characteristics. See, e.g., Baran 20-
21 (regarding Examples 1-9). Indeed, the main thrust of Baran is the direct
application of nanoparticles to the active ingredient. Id. Accordingly, a
person of ordinary skill in the art would not be motivated by the teachings of
Baran to arrange the surface-modified nanoparticles on the surface of an
excipient in order to transfer them to an active ingredient, then to separate
the excipient (media particle) from the modified active ingredient. Rather,
such person would apply the surface modified particles directly to the active
ingredient. Baran provides no motivation for the additional transfer and
separation steps.
Accordingly, the Examiner has failed to establish that a person of
ordinary skill in the art at the time the invention was made would have
modified the teaching of Baran so as to use an excipient as a media particle
and subsequently separate such excipient from the active ingredient.
Rejection 2. The Examiner rejected claims 1—10, 12, 16, 18, 20—22,
26, and 28—30, in the alternative, over Baran in view of Gogos. Final Act.
7—11. This alternative rejection is substantially similar to the first, but
additionally relies upon certain teachings of Gogos regarding “applying
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glass spheres as a deagglomeration media into mixing process, and the
coated products were separated from the glass beads by passing through a
sieve.” Final Act. 8. The Examiner finds that Gogos’ disclosure relating to
separation by sieving is an additional teaching of the “separating the
plurality of media particles from the active ingredient particles” limitation.
The glass beads of Gogos are taught to be added to a drum coater as
one means of preventing particles from agglomerating (thus, the glass beads
are referred to as “deagglomeration media”). Gogos 192—194. Gogos
teaches that the glass beads are relatively large — 3mm. Id. 1194. The
Examiner finds that “it would have been obvious to one of ordinary skill in
the art at the time the invention was made to apply[ ] glass spheres as a
deagglomeration media into mixing process and separate the glass beads by
passing through a sieve.” Id. Even if this is accepted as tme, it leads only to
the teachings of Baran paired with the use of glass beads to reduce
agglomeration. It does not yield a process where nanoparticles are adhered
to the large glass beads of Gogos which are used as media particles to
transfer the nanoparticles to active ingredients.
Accordingly, the Examiner has failed to establish that the combined
teachings of Baran and Gogos would have disclosed the claims at issue and
has failed to establish a prima facie case that claims 1—10, 12, 16, 18, 20-22,
26, and 28—30 are obvious over Baran in view of Gogos.
CONCLUSION
The Examiner’s rejections of claims 1—10, 12, 16, 18, 20-22, 26, and
28—30 under 35 U.S.C. § 103(a) as being unpatentable are reversed.
REVERSED
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