Ex parte WOODLE et al.

Board of Patent Appeals and Interferences

Apr 28, 1998

07858171 (B.P.A.I. Apr. 28, 1998)

Application for patent filed March 27, 1992. According 1
to applicants, this application is a continuation-in-part of
Application 07/642,231, filed January 16, 1991; which is a
continuation-in-part of Application 07/425,224, filed October 20,
1989, now U.S. 5,013,556, patented May 7, 1991, with a different
inventive entity. It appears that the applicants’ references to
Application 07/642,231, filed January 16, 1991, and claim for
priority under 35 U.S.C. § 120, based on and stemming from said
application, are incorrect. On the other hand, we note that
Application 07/642,321, filed January 15, 1991, issued as U.S.
5,213,804 on May 25, 1993, to the same inventive entity as U.S.
5,013,556, patented May 7, 1991, and that the portion of the term of
U.S. 5,213,804 subsequent to May 7, 2008, has been disclaimed.
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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(2) is not binding precedent of the Board.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. 20
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte MARTIN C. WOODLE, IRMA A.J.M. BAKKER-WOUDENBERG,
and FRANCIS J. MARTIN
____________
Appeal No. 95-4004
Application 07/858,1711
____________
ON BRIEF
____________
Before WINTERS, SCHAFER, and GRON, Administrative Patent Judges.
Appeal No. 95-4004
Application 07/858,171
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GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
This is an appeal from an examiner’s rejection of Claims 1
and 4-7, all claims pending in this application. Claims 1 and
4-7 stand finally rejected under 35 U.S.C. § 103 as unpatentable
over the teaching of Popescu et al. (Popescu), U.S. 4,981,692,
patented January 1, 1991 (prior art under 35 U.S.C. § 102(e)
based on its August 18, 1987, filing date), in view of the
teachings of Radhakrishnan, U.S. 4,906,476, patented March 6,
1990 (prior art under 35 U.S.C. § 102(e) based on its December
14, 1988, filing date), and McGregor et al. (McGregor), U.S.
5,079,234, patented January 7, 1992 (prior art under 35 U.S.C.
§ 102(e) based on its March 23, 1989, filing date). All of the
claims “stand or fall together” (Appeal Brief, page 3; Examiner’s
Answer, page 2).
Representative Claim 1 reads:
1. A method of treating a systemic infection which
is localized at a site other than the fixed macrophages
residing in the liver or the spleen, comprising
administering to the subject, by intravenous
injection, a composition of liposomes (i) composed of
vesicle-forming lipids, including 1-35 mole percent of a
diacyl-chain amphipathic vesicle-forming lipid derivatized
with polyethylene glycol having a molecular weight between
about 350 and 5,000 daltons (ii) having a selected mean
particle diameter in the size range between about 0.07-
0.20 microns, and (iii) containing in liposome-entrapped
form, a therapeutic compound effective against the source
of the infection, and
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Application 07/858,171
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by said injecting, achieving at least about a ten-
fold increase in the concentration of liposomes in the
infected tissue over that achievable by the [sic] such
liposomes in the absence of the amphipathic vesicle-forming
lipid derivatized with said polyethylene glycol.
Having meticulously reviewed the specification, the claims,
the prior art cited against the claimed invention, the Appeal
Brief, and the Examiner’s Answer, we find that the examiner has
not satisfied his burden to establish a prima facie case of
unpatentability of the claimed subject matter under 35 U.S.C.
§ 103 in view of the combined teachings of Popescu,
Radhakrishnan, and McGregor. We find that no single prior art
reference cited against the subject matter claimed describes the
“diacyl-chain amphipathic vesicle-forming lipid derivatized with
polyethylene glycol having a molecular weight between about 350
and 5,000 daltons” which is a required component of the vesicle
forming lipids which comprise the liposome composition
administered by intravenous injection in accordance with the
method of Claim 1. Moreover, the prior art considered as a whole
would not have reasonably led persons having ordinary skill in
the art to make and use the vesicle-forming lipids which comprise
that liposome composition to administer a therapeutic compound
effective against a source of infection by intravenous injection
as per the method of Claim 1.
Appeal No. 95-4004
Application 07/858,171
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The examiner relies on Radhakrishnan and McGregor as support
for the following statement (Examiner’s Answer, page 3):
The size and weight of liposomes are within the
capability of one of ordinary skill in the art to
attain, if desiring to achieve particular dosage
and/or organ targets. However, Radhakrishnan uses
liposomes to deliver drugs of liposomal size 0.04-
5 microns to lung (column 7), while McGregor specifies
1000-5000 dalton polymer size to provide biocompatability
(column 3, lines 28-30). Thus, it would be obvious to one
of ordinary skill in the art of Liposome entrapped drug
administration to provide the gentamicin antibiotic to
treat Klebsiella infections of the lung, as included in
the disease conditions of Popescu treatments, modified to
provide increased safety and efficacy as taught by
Radhakrishnan and McGregor.
We find, however, no teaching or suggestion in either
Radhakrishnan or McGregor to use a “diacyl-chain amphipathic
vesicle-forming lipid derivatized with polyethylene glycol having
a molecular weight between about 350 and 5,000 daltons” (emphasis
added) in the method of appellants’ Claim 1 or for any other
purpose. Moreover, the examiner’s findings that Popescu
describes and reasonably suggests a polyethylene glycol
derivatized diacyl-chain amphipathic vesicle-forming lipid
(Examiner’s Answer, page 3) are clearly erroneous.
In its most relevant part, Popescu teaches (Popescu,
column 3, line 64, to column 4, line 12):
The lipids which can be used in the liposome formulations
of the present invention are the phospholipids such as
phosphatidylcholine (PC), phosphatidylethanolamine (PE),
phosphatidylserine (PS), phosphatidylglycerol (PG),
phosphatidic acid (PA), phosphatidylinositol (PI),
Appeal No. 95-4004
Application 07/858,171
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sphingomyelin (SPM), and the like, alone or in combination.
The phospholipids can be synthetic or derived from natural
sources such as egg or soy. Useful synthetic phospholipids
are dymyristoylphosphatidylcholine [sic](DMPC) and
dimyristoylphosphatidylglycerol (DMPG). The liposomes can
also contain other steroid components such as polyethylene
glycol derivatives of cholesterol (PEG-cholesterols),
coprostanol, cholestanol, or cholestane, and combinations
of PC and cholesterol. They may also contain organic acid
derivatives of sterols such as cholesterol hemisuccinate
(CHS), and the like.
While Popescu describes “polyethylene glycol derivatives of
cholesterol (PEG-cholesterols), coprostanol, cholestanol, or
cholestane, and combinations of PC and cholesterol” (Popescu,
column 4, lines 7-9), Popescu nowhere teaches or reasonably
suggests the use of diacyl-chain amphipathic vesicle-forming
lipids derivatized with polyethylene glycol as per Claim 1 of
this appeal. The examiner finds that “PEG-cholesterolos [sic,
cholesterols]” are part of “the instant invention (page 13,
lines 19-26)” (Examiner’s Answer, page 3). We hold that a
finding that PEG-cholesterol is a “diacyl-chain amphipathic
vesicle-forming lipid derivatized with polyethylene glycol” is
clearly erroneous. We hold that PEG-cholesterols are not within
the scope of the method appellants claim.
The examiner’s reference to page 13, lines 19-26, of
appellants’ specification does not support the final rejection.
The specification teaches (Specification, page 13, lines 16-31):
The vesicle-forming lipid is preferably one having two
hydrocarbon chains, typically acyl chains, and a polar
Appeal No. 95-4004
Application 07/858,171
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head group. Included in this class are the phospholipids
such as phosphatidylcholine (PC), PE, phosphatidic acid
(PA), phosphatidylinositol (PI), and sphingomyelin (SM),
where the two hydrocarbon chains are typically between
about 14-22 carbon atoms in length, and have varying
degrees of unsaturation. Also included in this class
are the glycolipids, such as cerebrosides and gangliosides.
Another vesicle-forming lipid which may be employed is
cholesterol and related sterols. In general, cholesterol
may be less tightly anchored to a lipid bilayer membrane,
particularly when derivatized with a high molecular weight
polymers [sic], such as polyalkylether, and therefore be
less effective in promoting liposome evasion of the RES
in the bloodstream.
The specification’s teaching that cholesterol and related sterols
derivatized with polyalkylether are suitable as vesicle-forming
lipids for inclusion in liposome compositions containing
therapeutic compounds for use in treating systemic infection
localized at a site by intravenous injection is not a teaching or
even a suggestion of the method of the claims on appeal. In
short, the examiner clearly erred in finding that cholesterol and
related sterols derivatized with polyalkylether are diacyl-chain
amphipathic vesicle-forming lipids derivatized with polyethylene
glycol having a molecular weight between about 350 and 5,000
daltons. Therefore, we must reverse the examiner’s holding that
Claims 1 and 4-7 on appeal are unpatentable under 35 U.S.C. § 103
over the teaching of Popescu in view of the teachings of
Radhakrishnan and McGregor.
Other Issues
Appeal No. 95-4004
Application 07/858,171
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We bring to the examiner’s attention Woodle et al. (Woodle),
U.S. 5,013,556, which issued May 7, 1991, from Application
07/425,224, filed October 20, 1989, and Martin et al. (Martin),
U.S. 5,213,804, which issued May 25, 1993, from Application
07/642,321, filed January 15, 1991. The inventors of both
patents are Martin C. Woodle, Francis J. Martin, Annie Yau-Young,
and Carl T. Redemann. Copies of both patents are being mailed
with this decision.
We remand this application to the examiner for consideration
of the patentability of the subject matter claimed in this
application in light of the subject matter disclosed and/or
claimed in Woodle and Martin. The examiner should consider and
determine the following:
(1) Whether applicants’ claim for priority under 35 U.S.C.
§ 120 in this application is incorrect. This application and
Application 07/642,231, filed January 16, 1991, do not have the
same inventive entity, do not appear to be commonly assigned, and
do not appear to be directed to either common or even similar
inventions.
(2) Whether the full scope of the subject matter of the
claims on appeal is entitled to the benefit of any one or both of
the filing dates of Application 07/642,321, filed January 15,
1991, and Application 07/425,224, filed October 20, 1989.
Appeal No. 95-4004
Application 07/858,171
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(3) Whether Woodle is prior art under 35 U.S.C. § 102(a)
and/or § 102(e).
(4) Whether Woodle’s Claims 22-27 are prior art under
35 U.S.C. § 102(f) or § 102(g).
(5) Whether Martin is prior art under 35 U.S.C. § 102(e).
(6) Whether Martin's Claims 11-14 are prior art under
35 U.S.C. § 102(f) or § 102(g).
(7) Whether the examiner is barred under 35 U.S.C. § 121
from rejecting the claims of this application for obviousness-
type double patenting of Claims 22-27 of Woodle.
(8) Whether the examiner is barred under 35 U.S.C. § 121
from rejecting the claims of this application for obviousness-
type double patenting of Claims 11-14 of Martin.
(9) Whether the claims of this application should be
rejected for obviousness-type double patenting of Claims 22-27 of
Woodle.
(10) Whether the claims of this application should be
rejected for obviousness-type double patenting of Claims 11-14 of
Martin.
We remand this application to the examiner to consider and
resolve the questions raised in paragraphs (1) to (10) above.
Without full consideration and resolution of these questions, we
fail to see how the examiner can possibly determine the scope and
Appeal No. 95-4004
Application 07/858,171
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content of the prior art, consider the state of and knowledge in
the art at the time the invention was filed, and adequately
determine the patentability of the claimed subject matter, i.e.,
examine the case.
This application, by virtue of its "special" status,
requires an immediate action. Manual of Patent Examining
Procedures § 708.01(d)(6th ed., rev. 3, July 1997). It is
important that the Board be informed promptly of any action
affecting the appeal in this case.
REVERSED; REMANDED
Sherman D. Winters )
Administrative Patent Judge )
)
)
)
Richard E. Schafer ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Teddy S. Gron )
Administrative Patent Judge )
Peter J. Dehlinger
Dehlinger & Associates
P.O. Box 60850
Palo Alto, CA 94306
Appeal No. 95-4004
Application 07/858,171
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