Ex Parte Zeng

Patent Trial and Appeal Board

Apr 20, 2017

13298729 (P.T.A.B. Apr. 20, 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.
026723-02-5036-02 6808
EXAMINER
HOLT, ANDRIAE M
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
13/298,729 11/17/2011
28977 7590 04/20/2017
MORGAN, LEWIS & BOCKIUS LLP (PH)
1701 MARKET STREET
PHILADELPHIA, PA 19103-2921
Xian-Ming Zeng
04/20/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte XIAN-MING ZENG
Appeal 2015-003942
Application 13/298,7291
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
preparing a dry powder inhalation composition. The Examiner rejected the
claims for obviousness and obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1 and 16—26, under 35 U.S.C. § 103(a), for obviousness
over Trofast,2 Keller,3 and Ward4 (Ans. 2—8); and
1 Appellant identifies the real party in interest as TEVA Pharmaceuticals,
Inc. App. Br. 2.
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Application 13/298,729
(2) Claims 1 and 16—26, for obviousness-type double patenting over
claims 1—3, 12—16, and 18—23 ofZeng2 3 4 5 (Ans. 8—9).
Claim 1, the sole independent claim on appeal, illustrates the appealed
subject matter and reads as follows (App. Br. 21 (paragraphing added)):
1. A method of preparing a dry powder inhalation
composition comprising the steps of:
(a) mixing a carrier with a first portion of a first
particulate inhalant medicament to form a first mixture;
(b) mixing said first mixture with a second particulate
inhalant medicament to form a second mixture; and
(c) mixing said second mixture with a second portion of
the first particulate inhalant medicament to form a dry powder
inhalation composition,
wherein, in the dry powder inhalation composition from
step (c), the ratio by weight of the second particulate inhalant
medicament to the carrier is less than the ratio by weight of the
first particulate inhalant medicament to the carrier.
OBVIOUSNESS
The Examiner’s Position
The Examiner cited Trofast as disclosing a process having the steps
and features recited in claims 1 and 16—26, except that “Trofast lacks an
explicit teaching about the order of steps used in preparing the dry powders
or that the volume median diameter is from 50pm to 250pm. These
deficiencies are cured by the teachings of Keller and Ward et al.” Ans. 4.
To address those differences between the rejected claims and Trofast,
the Examiner cited Keller as disclosing an inhaled dry powder composition
2 US 6,030,604 (issued Feb. 29, 2000).
3 US 6,645,466 B1 (issued Nov. 11, 2003).
4 US 6,616,914 B2 (issued Sept. 9, 2003).
5 US 8,075,873 B2 (issued Dec. 13, 2011).
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including two active ingredients, and noted in particular Keller’s teaching
that the ingredients in the composition could be “mixed with one another in
any desired sequence.” Ans. 4 (citing Keller 8:53—59 (emphasis omitted)).
The Examiner cited Ward as evidence that the particle size required by the
rejected claims would have been an obvious feature of an inhalable powder
composition. Id. at 5—7; see also App. Br. 15 (Appellant’s claim 17, which
depends from claim 1, reciting that the carrier has a volume median diameter
from about 50 pm to about 250 pm).
As to the order of combining the ingredients required by Appellant’s
claim 1, the Examiner stated as follows:
Keller teaches that the different ingredients can be mixed in any
desired sequence. This teaching encompasses the following
sequence of steps: blending a portion of 1st active particles with
carrier particles to obtain a 1st mixture; combination of a 2nd
active with the 1st mixture to obtain a second mixture; and
finally admixture of the remaining 1 st active particles to obtain
a dry powder formulation. Mixing particulate components to
obtain a dry powder composition is known as demonstrated by
the cited prior art references.
Ans. 6.
The Examiner also acknowledged that Appellant’s Specification
“presented data . . . demonstrating the homogeneity of dry powders
produced using Applicant's claimed method” {id. at 7), but found the data
insufficient to show nonobviousness because no comparison had been made
to prior art processes, and because the experiments underlying the data were
not commensurate in scope with the claimed process. Id. at 7—8. Therefore,
the Examiner concluded, “the claimed invention, as a whole, would have
been prima facie obvious to one of ordinary skill in the art at the time the
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invention was made, because the combined teachings of the prior art is fairly
suggestive of the claimed invention.” Ans. 8.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Appellant does not persuade us that a preponderance of the evidence
fails to support the Examiner’s conclusion of obviousness.
Claim 1 recites a process of preparing a dry powder inhalation
composition. App. Br. 15. The process’s first recited step requires mixing a
carrier with a first portion of a first particulate inhalant medicament to form
a first mixture. Id. The second recited step requires mixing the first mixture
with a second particulate inhalant medicament to form a second mixture. Id.
The third and final recited step requires mixing the second mixture with a
second portion of the first particulate inhalant medicament to form a dry
powder inhalation composition. Id.
Claim 1 also requires the ratio by weight of the second particulate
inhalant medicament to the carrier in the dry powder inhalation composition
from step (c) to be less than the ratio by weight of the first particulate
inhalant medicament to the carrier. Id.
Trofast, like claim 1, describes a process of preparing a dry powder
inhalation composition composed of a carrier (lactose monohydrate, 896.8
parts), a first medicament (formoterol fumarate, 5.2 parts), and a second
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medicament (budesonide, 98 parts). Trofast, 4:30-47 (Example 6). As is
evident, the ratio of formoterol to the carrier is less than the ratio of
budesonide to the carrier, thus meeting claim 1 ’s requirement for one of the
medicaments to be present at a lesser amount than the other medicament.
In Trofast’s process, the lactose and formoterol are first combined to
form “an evenly distributed mixture” (id. at 4:33), and the budesonide is
then added to the lactose/formoterol mixture to yield the final composition
(id. at 4:39-47). Thus, as the Examiner found, Trofast’s process differs
from the process of claim 1 in that Trofast does not mix the ingredients in
the order of steps required by claim 1.
As the Examiner found, however, Keller, which is also similar to
claim 1 and Trofast, discloses a process of preparing a dry powder inhalation
composition by mixing a carrier (lactose monohydrate, 98.8 wt. %), a first
medicament (formoterol fiimarate dihydrate, 0.2 wt. %), a second
medicament (glycopyrrolate, 0.5 wt. %), as well as magnesium stearate (0.5
wt. %). Keller, 14:35 41 (Example 8). Keller explains that the magnesium
stearate is added to the composition to improve the moisture resistance of
the inhaled dry powder formulations. See, e.g., id., Abstract.
Although Keller also does not describe mixing its ingredients in the
order required by claim 1, Keller nonetheless discloses that the components
of its inhalable powder mixtures can be mixed together in any desired order,
as long as the individual drug particles retain their form:
The dry powder formulations can be prepared according
to the invention by mixing together a pharmaceutically inactive
carrier of noninhalable particle size (which, if desired, can
contain a proportion of inhalable particle size), a finely divided
pharmaceutically active compound of inhalable particle size, for
example having a mean particle diameter of at most 10 pm
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(preferably at most 5 pm), and magnesium stearate. In
principle, the constituents can be mixed with one another in any
desired sequence, where, however, mixing should expediently
be carried out in such a way that the particles of the
constituents-apart from the adhesion to the carrier particles-
are essentially retained as such, i.e. are not destroyed, for
example, by granulation and the like. According to a preferred
variant, however, a preliminary mixture of magnesium stearate
with the carrier can first be prepared and then the active
compound particles can be admixed. According to a further
preferred variant, a preliminary mixture of the active compound
with the carrier can first be prepared and then the magnesium
stearate can be admixed.
Keller, 8:46—65 (emphasis added).
Given Keller’s teaching that the components of inhalable dry powder
formulations can be mixed together in any desired sequence, we agree with
the Examiner that, when preparing an inhalable powder composition
containing two medicaments and a carrier as disclosed in Trofast, an
ordinary artisan would have considered it obvious to mix a first portion of a
first medicament with the carrier, combine that mixture with the second
medicament yielding a second mixture, and then mix a second portion of the
first medicament with the second mixture. We, therefore, also agree with
the Examiner that the process recited in Appellant’s claim 1 would have
been prima facie obvious to an ordinary artisan.
Appellant does not persuade us to the contrary.
To show the differences between the claimed subject matter and the
teachings in the cited prior art, Appellant presents a diagrammatic flow
chart-type representation of the process recited in claim 1, as well as similar
representations of the processes described in Trofast and Keller. App. Br. 5—
9; see also Reply Br. 2 (claim 1 in flow chart form). Appellant contends
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that, given the differences between the claimed process and the processes
taught in Trofast and Keller, “[a]s a whole, the cited references fail to teach
or suggest preparing a dry powder inhalation composition by adding
separate portions of the same medicament in two separate steps.” App. Br.
11. Appellant contends that Keller’s teaching, discussed above, that the
components of inhalable powder compositions can be mixed in any desired
sequence, does not factually support the Examiner’s conclusion that the
order of steps recited in Appellant’s claim 1 would have been obvious to an
ordinary artisan. Id. at 11—12.
We are not persuaded. Appellant’s argument, in essence, is that the
process of claim 1 cannot be considered obvious because none of the cited
references describes or suggests, expressly, the precise sequence of steps
required by claim 1.
The Supreme Court, however, has squarely rejected that proposition,
and instead directed that “the [obviousness] analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” KSR Int 7 v. Teleflex Inc.,
550 U.S. 398, 418 (2007); see also id. at 421 (“A person of ordinary skill is
. . . a person of ordinary creativity, not an automaton.”).
Indeed, although we note the differences identified by Appellant
between claim 1 and the teachings in Trofast and Keller, as the Supreme
Court has explained, “the mere existence of differences between the prior art
and an invention does not establish the invention’s nonobviousness.” Dann
v. Johnston, 425 U.S. 219, 230 (1976).
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In the present case, as discussed above, Keller teaches that the
components of inhalable powder compositions can be mixed in any desired
sequence. Based on that teaching, we find that an ordinary artisan, being a
person of ordinary creativity, would have reasonably inferred that, when
preparing an inhalable powder composition containing two medicaments and
a carrier as disclosed in Trofast, a suitable and useful permutation in the
order of mixing those components would be to mix a first portion of one
medicament with the carrier, combine that mixture with the other
medicament to yield a second mixture, and then mix a second portion of the
first medicament with the second mixture.
Appellant does not persuade us, therefore, that the Examiner erred in
concluding that the process recited in Appellant’s claim 1 would have been
prima facie obvious to an ordinary artisan. Moreover, that the Examiner
reviewed Appellant’s Specification to determine whether the sequence of
steps in claim 1 yielded an unexpected result does not persuade us that the
Examiner’s conclusion of prima facie obviousness lacks an adequate
evidentiary basis. See App. Br. 12 (arguing that the Examiner conflated the
concepts of prima facie obviousness and unexpected results).
Appellant also does not persuade us (see Reply Br. 2 4) that the
Board’s prior decision in Ex parte Bieser, 2011 WL 3627348 (BPAI 2011),
demonstrates that the Examiner failed to establish prima facie obviousness
in this instance. In Bieser, the Board held that the Examiner had not
established a prima facie case of obviousness because the cited references
suggested that the sequence of steps described in the prior art was important
to the outcome of the disclosed processes, and the Examiner had not,
therefore, adequately explained why an ordinary artisan would have changed
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the sequence of steps taught in the prior art to arrive at the sequence required
by the claims at issue. See 2011 WL 3627348 at *3—*4. In the present case,
in contrast to the situation in Bieser, Keller expressly teaches that the
components of inhalable powder compositions can be mixed in any desired
sequence. Accordingly, even it was a precedential case (which it is not), the
factual scenario in Bieser is substantially different than the situation before
us in the present case.
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in concluding that the process recited in Appellant’s
claim 1 would have been prima facie obvious to an ordinary artisan.
Because Appellant does not advance specific secondary evidence of
nonobviousness, a preponderance of the evidence supports the Examiner’s
ultimate conclusion of obviousness as to claim 1. We, therefore, affirm the
Examiner’s rejection of claim 1 over Trofast, Keller, and Ward. Because
they were not argued separately, claims 16—20 and 23—26 fall with claim 1.
See 37 C.F.R. § 41.37(c)(iv).
As to claims 21 and 22, Appellant argues that the Examiner did not
sufficiently articulate why the processes recited in those claims would have
been obvious to an ordinary artisan. App. Br. 12—13. In particular,
“Appellant presumes that these claims have not been addressed because
there is no ‘first portion’ (or ‘second portion,’ for that matter) of a first
medicament taught in any of the prior art references, as discussed above.”
Id. at 13.
We select claim 22 as representative of this separately argued group
of claims. See 37 C.F.R. § 41.37(c)(iv). Claim 22 recites, “[t]he method
according to claim 1, wherein the first portion of first particulate inhalant
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medicament is less than 2% weight by weight of the total amount of the
particulate carrier.” App. Br. 16.
As the Examiner explains, the amount of formoterol fumarate mixed
into the composition in Trofast’s Example 6 is 5.2 parts, whereas the total
amount of lactose carrier is 896.8 parts, and therefore, it “would have been
obvious to the skilled artisan that any portion that is added to the carrier is
less than 2%, as the entire portion of the first particulate [formoterol] is
0.578%, which is less than 2% weight by weight of the total amount of the
particulate carrier.” Ans. 14; see also Trofast, 4:30-47 (Example 6).
As discussed above, we agree with the Examiner that the process
recited in claim 1 would have been obvious over Trofast, Keller, and Ward.
Because any portion of the formoterol in Trofast’s Example 6, when
combined with the lactose carrier in a first mixing step, would necessarily be
less than 2% of the total weight of the carrier, we agree with the Examiner
that the process recited in claim 22 also would have been obvious over
Trofast, Keller, and Ward. We, therefore, affirm the Examiner’s rejection of
claim 22 over those references. Because it was argued in the same claim
grouping, claim 21 falls with claim 22. See 37 C.F.R. § 41.37(c)(iv).
OBVIOUSNESS-TYPE DOUBLE PATENTING
In rejecting claims 1 and 16—26, for obviousness-type double
patenting over claims 1—3, 12—16, and 18—23 of Zeng, the Examiner found
that, although the scope of the allegedly conflicting claims was not identical,
the method recited in claim 18 of Zeng anticipates claim 1 of the instant
application, and the product by process limitations of claim 1 of Zeng
substantially overlap the process recited in the instant application. Ans. 9.
The Examiner reasoned, therefore, that the claims of the instant application
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would have been obvious to an ordinary artisan in view of the cited claims
of the Zeng patent. Ans. 9.
Appellant does not identify error in the Examiner’s prima facie case
of obviousness of claims 1 and 16—26 over claims 1—3, 12—16, and 18—23 of
Zeng. Rather, Appellant “has requested that this rejection be held in
abeyance pending the resolution of the above claim rejections under 35
U.S.C. § 103. This double patenting rejection may be overcome, for
example, by filing a Terminal Disclaimer.” App. Br. 13.
Because Appellant does not identify, nor do we discern, error in the
Examiner’s prima facie case of obviousness of claims 1 and 16—26 over
claims 1—3, 12—16, and 18—23 of Zeng, we affirm this rejection as well.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1 and 16—26, under 35 U.S.C. § 103(a), for obviousness over Trofast,
Keller, and Ward.
For the reasons discussed, we also affirm the Examiner’s rejection of
claims 1 and 16—26 for obviousness-type double patenting over claims 1—3,
12—16, and 18—23 of Zeng.
TIME PERIOD
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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