Ex Parte Smith

Board of Patent Appeals and Interferences

Jul 12, 2000

07989593 (B.P.A.I. Jul. 12, 2000)

1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today
(1) was not written for publication in a law journal and
(2) is not binding precedent of the Board.
Paper No. 27
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte
MILTON G. SMITH
__________
Appeal No. 1996-0605
Application 07/989,593
__________
ON BRIEF
__________
Before WINTERS, SPIEGEL, and ADAMS, Administrative Patent Judges,
ADAMS, Administrative Patent Judge.
Appeal No. 1996-0605
Application 07/989,593
2
DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 8, 11, 14 and 23-32, which are all the claims
pending in the application.
Claims 8 and 11 are illustrative of the subject matter on appeal and are
reproduced below:
8. A method of delivering non-enzymatic antioxidants, comprising
administering to a site in need thereof an effective amount of a free radical
quenching composition comprising a liposome containing distributed within said
liposome at least two members selected from the group consisting of beta-
carotene, vitamin E, vitamin C, glutathione, and niacin, optionally at least one
trace metal, and optionally a pharmaceutically acceptable carrier; wherein said
administering is intravenously, intraarterially, intraperitoneally, subcutaneously,
intramuscularly, intraarticularly, intracerebrally; intracerebellarly, intrabronchially,
or intrathecally; whereby the level of said non-enzymatic antioxidants of said site
is increased.
11. A method of increasing the level of antioxidants in a cell of a
mammal, comprising administering to said mammal in need thereof an effective
amount to increase the level of antioxidants in a cell of a mammal of a free
radical quenching composition comprising a liposome containing distributed
within said liposome at least two members selected from the group consisting of
beta-carotene, vitamin E, vitamin C, glutathione, and niacin, optionally at least
one trace metal, and optionally a pharmaceutically acceptable carrier; wherein
said administering is intravenously, intraaterially, intraperitoneally,
subcutaneously, intramuscularly, intraarticularly, intracerebrally, intracerebellarly
intrabronchially, or intrathecally.
The references relied upon by the examiner are:
Appeal No. 1996-0605
Application 07/989,593
1 We note that page 7 of the Examiner’s Answer (Paper No. 22, mailed June 23,
1995) does not identify the claims that pertain to this rejection. However,
appellant’s brief (Paper No. 20, received April 6, 1995) and the Final Rejection
(Paper No. 11, mailed July 7, 1994) treat claims 8, 11, 14 and 23-32 as if they
were rejected under this combination of references. Therefore, we will review
the rejection of claims 8, 11, 14 and 23-32 under 35 U.S.C. § 103 as being
unpatentable over the advertisement of ONDROX (UNIMED) in combination with
Motoyama.
3
Lichtenberger 5,032,585 Jul. 16, 1991
Motoyam et al. (Motoyam) “Synergistic Inhibition of Oxidation in Dispersed
Phosphatidylcholine Liposomes by a Combination of Vitamin and Cysteine”
Archives of Biochemistry and Biophysics, Vol. 270, No. 2 (1989)
Ondrox “Unimed”, Technical Bulletin, (1992)
GROUNDS OF REJECTION
Claims 8, 11, 14 and 23-32 are rejected under 35 U.S.C. § 103 as being
unpatentable over Lichtenberger.
Claims 8, 11, 14 and 23-321 are rejected under 35 U.S.C. § 103 as being
unpatentable over the advertisement for ONDROX (UNIMED) in combination
with Motoyama.
DISCUSSION
In reaching our decision in this appeal, we have given careful
consideration to the appellant’s specification and claims, and to the respective
positions articulated by the appellant and the examiner. We make reference to
the Examiner’s Answer (Answer)(Paper No. 22, mailed June 23, 1995) for the
examiner’s reasoning in support of the rejection. We further reference
Appeal No. 1996-0605
Application 07/989,593
4
appellant’s Brief (Paper No. 20, filed April 6, 1995), Corrections to Appeal Brief
(Paper No. 21, received April 18, 1995) and Reply Brief (Paper No. 23, received
August 23, 1995) for the appellant’s arguments in favor of patentability.
CLAIM GROUPING:
At page 4 of the Brief, appellant states that claims 8 and 23-27 stand or
fall together, and claims 11, 14 and 28-32 stand or fall together. However, we
find no separate arguments as to the claims or designated groups as required by
37 CFR § 1.192(c)(5) (1994) (Claims stand or fall together “unless a statement is
included that the rejected claims do not stand or fall together and, in the
appropriate part or parts of the argument under paragraph (c)(6) of this section,
appellant presents reasons as to why appellant considers the rejected claims to
be separately patentable.” (Emphasis added.)). Therefore, the claims on appeal
are considered to stand or fall together with regard to each ground of rejection.
THE REJECTIONS UNDER 35 U.S.C. § 103:
Obviousness is a legal conclusion based on the underlying facts. Graham
v. John Deere Co., 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966); Continental
Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1270, 20
USPQ2d 1746, 1750 (Fed. Cir. 1991); Panduit Corp. v. Dennison Mfg. Co.,
810 F.2d 1561, 1566-68, 1 USPQ2d 1593, 1595-97 (Fed. Cir. 1987), cert.
denied, 481 U.S. 1052 (1987).
Appeal No. 1996-0605
Application 07/989,593
5
LICHTENBERGER:
At page 4 of the Answer, the examiner states “Lichtenberger teaches
liposomal compositions containing Copper and antioxidants E and C (note col. 7,
lines 40-55; col. 8, lines 15-29; col. 15, lines 38-51; col. 23, lines 35-54[)].” In
response to the examiner’s position, appellant states at page 5 of the Brief that
“[i]n fact, the reference notes that lipid preparations ‘would have little or no
luminal space as would a classical liposomal structure’ (column 22, line 67 et
seq).” Appellant therefore contends that “the reference teaches away from the
claimed invention, since it is the lumenal space, the classical liposomal structure,
in which Applicant’s antioxidant composition rests.” See, Brief, page 5. In
addition, appellant provides the Stone Declaration to support this position. See,
Stone Declaration (Paper No. 12, received October 17, 1994) paragraph
5, page 3, which states “the lack of luminal space would clearly preclude the
ability to use this space to encapsulate chemical or enzymatic antioxidants.”
The examiner responds to the Stone Declaration by stating “. . . fat
soluble vitamins which are also claimed in the instant invention will not sequester
in the aqueous interior of the liposomes, but would be within the lipid bilayer of
the liposomes and thus, there is no issues of lack of luminal space.” See,
Answer, bridging paragraph of pages 6-7. However, Lichtenberger as relied on
by the examiner discloses a liposomal composition containing vitamin E and C.
See, Answer, page 4. In order to meet the limitations of the claims on appeal,
Appeal No. 1996-0605
Application 07/989,593
6
vitamin E and C must both be distributed within the liposome. See, e.g.,
Specification, Figure 8. While the examiner is correct in that the fat-soluble
vitamin E (alpha-tocopherol) will not sequester in the aqueous interior of the
liposome, vitamin C (ascorbic acid) certainly will. See, Specification, Figure 8.
Since, as recognized by the examiner, Lichtenberger teaches liposomal
compositions containing antioxidants E and C, we are confronted with the
problem of where Lichtenberger’s vitamin C is found if not in the aqueous interior
of the liposome.
The Stone Declaration provides the answer. Page 2 of the Stone
Declaration states, “[m]oreover, Lichtenberger at column 21, lines 65-68
suggests that the antioxidants would be added to the diluent and, therefore,
water soluble vitamins would not be encapsulated into any liposomal
preparations.” Specifically, Lichtenberger discloses,
However, for most applications it will generally be
desirable to provide the lipids in the form of a colloidal
or liposomal suspension of the selected composition
in an pharmaceutically acceptable aueous diluent.
While virtually an[y] pharmaceutically acceptable
aqueous diluent may be employed, it has generally
been found that a certain salt, for example in the form
of isotonic saline has significant anti-ulcer activity.
Further, small amounts of heavy metals (or other
polyvalent cations) or anti-oxidant chemicals with the
capability of scavenging free radicals can be added to
the diluent to provide a lipid composition of greater
anti-ulcer efficacy, stability and lumen-coating
effectiveness.
Appeal No. 1996-0605
Application 07/989,593
7
See, Lichtenberger, column 21, lines 57- column 22, line 2.
The initial burden of presenting a prima facie case of obviousness rests
on the examiner. In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444
(Fed. Cir. 1992). On the record before us, the examiner has not provided
sufficient evidence to support a conclusion that the claimed subject matter would
have been prima facie obvious within the meaning of 35 U.S.C. § 103 at the time
of the invention. Lichtenberger does not teach a liposomal composition wherein
both vitamin E and C are distributed with in the liposome as required by the
claims on appeal. We, therefore, reverse the rejection of claims 8, 11, 14 and
23-32 under 35 U.S.C. § 103 over Lichtenberger.
ONDROX IN COMBINATION WITH MOTOYAMA:
The examiner states “UNIMED’s advertisement on ONDROX shows the
availability of mixtures of several antioxidants in a sustained release formulation.
UNIMED teaches that the amounts of the antioxidants are theoretically
synergistic (note the entire advertisement). UNIMED on cover page also teaches
the reasons for the administration of antioxidants.” See, Answer, pages 7-8,
bridging paragraph. At page 8 of the Answer, the examiner states “Motoyama
teaches the synergistic antioxidant effect of vitamins E and C in liposomes (note
the abstract). Motoyama further discloses the antioxidant, glutathione. (page
656, column 1).” At page 8 of the Answer, the examiner concludes that::
The use of liposomes taught by Motoyama in
the teachings of UNIMED would have been obvious
Appeal No. 1996-0605
Application 07/989,593
8
to one of ordinary skill in the art since liposomes are
sustained delivery agents for drugs as well-known in
the art and since Motoyama teaches a synergistic
effect of the combination of antioxidants on oxidation
even in liposome form.
In response to the examiner’s position, appellant argues in the bridging
paragraph of pages 18-19 of the Brief that “[t]he Examiner has not provided
sufficient motivation for a person of ordinary skill in the art to modify a nutritional
composition intended strictly for oral administration (Ondrox’s tablet) with
Motoyama’s in vitro research composition, one in which a liposome contains one
antioxidant and the aqueous medium contains another antioxidant).”
It is well-established that before a conclusion of obviousness may be
made based on a combination of references, there must have been a reason,
suggestion or motivation to lead an inventor to combine those references.
Pro-Mold and Tool Co. v. Great Lakes Plastics Inc., 75 F.3d 1568, 1573, 37
USPQ2d 1626, 1629 (Fed. Cir. 1996). Here the examiner states:
The use of liposomes taught by Motoyama in the
teachings of UNIMED would have been obvious to
one of ordinary skill in the art since liposomes are
sustained delivery agents for drugs as well-known in
the art and since Motoyama teaches a synergistic
effect of the combination of antioxidants on oxidation
even in liposome form.
See, Answer, page 8. At page 11 of the Answer, the examiner states “[i]t is the
examiner’s position that both references teach synergistic effect of antioxidants
Appeal No. 1996-0605
Application 07/989,593
9
and both are concerned with sustained release systems.” However, there is no
suggestion in Motoyama that liposomes are “sustained release systems” or of
using liposomes in a method of delivering non-enzymatic antioxidants, or a
method of increasing the level of antioxidants in a cell of a mammal. The initial
burden of presenting a prima facie case of obviousness rests on the examiner.
In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992).
On the record before us, the examiner has not provided sufficient evidence to
support a conclusion that the claimed subject matter would have been prima
facie obvious within the meaning of 35 U.S.C. § 103 at the time of the invention.
We, therefore, reverse the rejection of claims 8, 11, 14 and23-32 under
35 U.S.C. § 103 over UNIMED in view of Motoyama.
OTHER ISSUES
We note the examiner’s characterization of UNIMED at page 7 of the
Answer, “UNIMED’s advertisement on ONDROX shows the availability of
mixtures of several antioxidants in a sustained release formulation . . . UNIMED
on the cover page also teaches the reasons for the administration of
antioxidants.” We also note that liposomes were known in art at the time the
invention was made to be drug delivery systems. See e.g., Iga et al., United
States Patent No. 5,080,914. Upon return of this application, the examiner
should take a step back and reevaluate patentability of the claimed invention in
view of the art at the time the instant invention was made. If the examiner
Appeal No. 1996-0605
Application 07/989,593
10
believes, after this reevaluation, that the claims on appeal are unpatentable, he
should issue an appropriate Office Action setting forth the rejection. In so doing,
we urge the examiner to use the model set forth in MPEP § 706.02(j) for any
rejection under 35 U.S.C. § 103. Adherence to this model will of necessity make
the examiner examine the claims on appeal on an individual basis, using the
correct legal standards.
SUMMARY
The rejection of claims 8, 11, 14 and 23-32 under 35 U.S.C. § 103 as
being unpatentable over Lichtenberger is reversed. The rejection of claims 8,
11, 14 and 23-32 are rejected under 35 U.S.C. § 103 as being unpatentable over
the advertisement for ONDROX (UNIMED) in combination with Motoyama is
reversed.
REVERSED
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Carol A. Spiegel )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Donald E. Adams )
Administrative Patent Judge )
DA/dm
Appeal No. 1996-0605
Application 07/989,593
11
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