Ex Parte Morris et al

Board of Patent Appeals and Interferences

Sep 13, 2010

09933709 (B.P.A.I. Sep. 13, 2010)

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.
09/933,709 08/22/2001 Charles A. Morris 1533.0520001 6249
41835 7590 09/14/2010
K&L GATES LLP
210 SIXTH AVENUE
PITTSBURGH, PA 15222-2613
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
09/14/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CHARLES A. MORRIS,
FRANCIS W. CALHOON, JR., and
HUEY L. WILLIS
____________

Appeal 2009-015190
Application 09/933,709
Technology Center 1600
____________

Before MICHAEL P. COLAIANNI, ERIC GRIMES, and
BEVERLY A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-015190
Application 09/933,709

2
Appellants appeal under 35 U.S.C. § 134 from the Examiner's
rejection of claims 18-24, 26-44, and 47-51. We have jurisdiction under
35 U.S.C. § 6(b).
STATEMENT OF THE CASE
Claims 18, 22, and 23 are representative of the subject matter on
appeal and are set forth below:
18. A free-flowing composition comprising:

about 5 to about 34 weight percent redried cornstarch;

silica having a particle size of between 40 and 50 microns; and

65 to 80 weight percent of at least one fat soluble vitamin.

22. A free flowing composition comprising:
about 5 to about 34 weight percent starch;
silica having a density of at least 12.5 lbs./cu.ft., a particle size of
between 40 and 50 microns, and a surface area of from about 400m2/g to 500
m2/g; and

at least 65 to 80 weight percent of at least one fat soluble vitamin.
23. The composition of claim 22, wherein the at least one vitamin is
selected from the group comprising vitamin A, vitamin D, vitamin E,
vitamin K, vitamin C, vitamin B3 and vitamin B5.

The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Drake 4,010,073 Mar. 1, 1977
Schmidt ('435) 4,486,435 Dec. 4, 1984
Schmidt ('143) 4,603,143 Jul. 29, 1986
Rawlins 4,719,228 Jan. 12, 1988
Appeal 2009-015190
Application 09/933,709

3
THE REJECTIONS
1. Claim 23 is rejected under 35 U.S.C. § 112, second paragraph, as
being indefinite for failing to particularly point out and distinctly claim the
subject matter which applicant regards as the invention.
2. Claims 18-24, 26-44, and 47-51 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Schmidt ‘435 in combination with Schmidt ‘143
and Rawlins or Rawlins in view of Schmidt ‘435 or Schmidt ‘143 by
themselves or in combination.
3. Claims 18-24, 26-44, and 47-51 are rejected under 35 U.S.C.§ 103(a)
as being unpatentable over Schmidt ‘435 in combination with Schmidt ‘143
and Rawlins or Rawlins in view of Schmidt ‘435 or Schmidt ‘143 by
themselves or in combination, further in view of Drake.
ANALYSIS
(with Findings of Fact and Principles of Law)
1. The Rejection of claim 23 under 35 U.S.C. § 112, second paragraph,
as being indefinite
The Examiner indicates that claim 22 recites “fat soluble vitamin”; yet
dependent claim 23 includes B vitamins, which are hydrophilic and not fat
soluble vitamins. Ans. 2.
On page 5 of the Brief, Appellants indicate that claim 23 has been
amended to recite a grouping of fat soluble vitamins. However, it appears
from the Advisory Action mailed on October 3, 2007, that this amendment
was not entered.
Appeal 2009-015190
Application 09/933,709

4
Therefore, this rejection is affirmed. Upon return of this application
to the jurisdiction of the Examiner, we call upon the Examiner and
Appellants to resolve this issue.
2. The Rejection of claims 18-24, 26-44 and 47-51 under 35 U.S.C. §
103(a) as being unpatentable over Schmidt ‘435 in combination with
Schmidt ‘143 and Rawlins or Rawlins in view of Schmidt ‘435 or Schmidt
‘143 by themselves or in combination
The teachings of the applied art as compared with the subject matter
of claim 18 are best summarized in the following table.

Claim 18 Schmidt ‘435 Schmidt ‘143 Rawlins Drake
about to 5
about 34 wt
% redried
cornstach
2 to 8 wt%
cornstarch
Redried
cornstarch
silica having
a particle size
of between
40 and 50
microns
about 0.2 to
about 2.0
wt% silica
Silica having
a particle size
of 300
microns
Silica having
a particle size
of at least 10
microns,
preferably
from 10
microns to 1
mm, and
Example 2
teaches 50
microns

65 to 80 wt
% of at least
one fat
soluble
vitamin
45 to 60 wt%
of a fat
soluble
vitamin

Appeal 2009-015190
Application 09/933,709

5
It is the Examiner’s position that Schmidt ‘435’s teachings of from 45
to 60 weight percent of a fat soluble vitamin would have rendered obvious
Appellants’ claimed amount of from 65 to 80 weight percent of a fat soluble
vitamin. Ans. 9. We agree. A prima facie case of obviousness exists where
the claimed ranges and prior art ranges do not overlap but are close enough
that one skilled in the art would have expected them to have the same
properties. Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 782 (Fed.
Cir. 1985).
It is also the Examiner’s position that Rawlins’ teaching of the particle
size of silica as indicated in the above table would have rendered obvious
Appellants’ claimed particle size of silica of between 40 and 50 microns.
Ans. 4-5.
In response, Appellants argue that while Rawlins teaches silica
particles ranging from 10 microns to 1 mm (including Sipernat 50) in
combination with a pharmaceutically active ingredient (i.e., indomethacin,
ketazolam, diazepam, digoxin, and 6-cyano-3,4-dihydro-2,2-dimethyl-trans-
4-(2-oxo-l-pur-rolidinyl)-2H-benzo[b]pyran-3-ol) that is free-flowing,
Rawlins does not suggest combining silica with a fat soluble vitamin. Br. 7.
Appellants argue that, according to the Examiner, it would have been
expected from reading Rawlins that all size ranges would work with fat
Appeal 2009-015190
Application 09/933,709

6
soluble vitamins, but, as the Declaration of Morris shows, only a relatively
narrow range is actually suitable for maintaining free-flowability.2 Br. 7.
Appellants conclude that thus without any direction or guidance,
Rawlins cannot render obvious a silica particle size in the 40-50 micron
range which maintains free-flowability when fat soluble vitamin is absorbed
at the levels recited in claims 18, 22, 26, and 29 as well as the claims
dependent thereon. Br. 7.
We agree with the Examiner’s position on pages 4-5 of the Answer.
Therein, the Examiner states:
It would have been obvious to use the silica of bigger particle
sizes 40-50 microns in the compositions of Schmidt et al 435 or
143 with a reasonable expectation of success [emphasis added],
since as evidenced by Rawlins, one can obtain free-flowing
powders using silica which has a diameter between 10 microns
to 1 millimeter, in particular 50 microns. Although the
references are silent with respect to the density and the surface
area of the silica particles, since these are commercially
available particles and in the absence of showing otherwise and
the criticality of these factors, it is the position of the examiner
that Rawlins's silica particles which were obtained
commercially possess these properties or manipulatable
parameters to obtain the best possible results.
We note that obviousness does not require absolute predictability,
however, at least some degree of predictability is required. Evidence
showing there was no reasonable expectation of success can support a

2 A more accurate description of the Examiner’s position is that the
particle size range taught in Rawlins suggests Appellants’ claimed particle
size range. Ans. 4.
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Application 09/933,709

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conclusion of non-obviousness. In re Rinehart, 531 F.2d 1048, 1053-54
(CCPA 1976).
In the instant case, Appellants do not offer any evidence showing
there was no reasonable expectation of success of obtaining free flowability
by using the size range taught by Rawlins for the silica particles of Schmidt
‘435.
Schmidt ‘435 is directed to free flowing vitamin powders, wherein
the loading density of the vitamin is as high at 60 weight percent, but is
silent as to the size of the silica particles used in making the free flowing
powder. Rawlins does give guidance as to the size of the silica particles to
achieve free flowability in a pharmaceutical composition comprising a free
flowing powder. Appellants have not convinced us that there would not be a
reasonable expectation of success of using the particle size taught in Rawlins
in the powder of Schmidt ‘435 in the context of a free flowing vitamin
powder.
Appellants argue that the Morris Declaration shows that only the 40 to
50 micron range results in a free-flowing powder containing a high loading
density of fat soluble vitamins. Br. 6. However, we cannot find data
supporting this position, i.e., we find a particle size of 50 microns, but there
is no data across the claimed range of between 40 and 50 microns. Hence,
the Declaration is not commensurate in scope with the claims. The
Examiner also discusses this fact. Ans. 7. For at least this reason, the
Declaration is insufficient. When considering whether proffered evidence
demonstrates patentability, a side-by-side comparison of the claimed
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Application 09/933,709

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invention with the closest prior art which is commensurate in scope with the
claims is needed, with an explanation as to why the results would have been
unexpected by one of ordinary skill in the art. See In re Baxter Travenol
Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d 699,
705 (Fed. Cir. 1984); In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983); In
re Clemens, 622 F.2d 1029, 1035 (CCPA 1980); In re Freeman, 474 F.2d
1318, 1324 (CCPA 1973); In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).
On page 8 of the Brief, Appellants incorrectly state that such a small
variation in size (50 microns versus 40 microns) would remain “free-
flowing” and that therefore the Declaration supports the claimed range, but
arguments of counsel cannot take the place of factually supported objective
evidence. See, e.g., In re Huang, 100 F.3d 135, 139-40 (Fed. Cir. 1996); In
re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
In view of the above, we affirm the rejection.
3. The Rejection of claims 18-24, 26-44 and 47-51 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Schmidt ‘435 in combination
with Schmidt ‘143 and Rawlins or Rawlins in view of Schmidt ‘435 or
Schmidt ‘143 by themselves or in combination, further in view of Drake.
Appellants essentially rely on the same arguments used in the
previous rejection and state that Drake does not cure the alleged deficiencies
of the other applied art.
Hence, for the same reasons that we affirmed the previous rejection,
we affirm this rejection also.
Appeal 200-
Application

9
With respect to Appellants’ arguments that Drake does not teach to
use corn starch to improve stability of fat soluble molecules or how such
stability can be improved while maintaining the free flowability of fat
soluble molecules, we note that “[a]s long as some motivation or suggestion
to combine the references is provided by the prior art taken as a whole, the
law does not require that the references be combined for the reasons
contemplated by the inventor.” In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir.
1992). The Examiner’s reasons for combining Drake with the other
references are sufficient.
In view of the above, we affirm the rejection.
CONCLUSIONS OF LAW AND DECISION
Appellants have not shown error in the Examiner’s rejections, and we
therefore affirm each rejection.

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)(v).
AFFIRMED

cam

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210 SIXTH AVENUE
PITTSBURGH, PA 15222-2613