Ex Parte Langereis et al

Patent Trial and Appeal Board

Feb 22, 2016

12746204 (P.T.A.B. Feb. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121746,204 06/04/2010 Sander Langereis
24737 7590 02/24/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
P.O. BOX 3001
BRIARCLIFF MANOR, NY 10510
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2007P01993WOUS 7337
EXAMINER
PERREIRA, MELISSA JEAN
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
02/24/2016 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):
debbie.henn@philips.com
marianne.fox@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SANDER LANGEREIS,
HOLGER GRUELL, LEA LOUISE PAULINE MESSAGER,
JEROEN ALPHONS PIKKEMAAT, and DIRK BURDINSKI
Appeal2013-007042
Application 12/746,204
Technology Center 1600
Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge FREDMAN.
Dissenting Opinion filed by Administrative Patent Judge McCOLLUM.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1under35 U.S.C. § 134 involving claims to a contrast
agent for Magnetic Resonance Imaging. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Koninklijke
Philips Electronics NV (see Br. 3).
Appeal2013-007042
Application 12/746,204
Statement of the Case
Background
"Magnetic Resonance Imaging [MRI] ... allows for the non-invasive
imaging of soft tissue with a superb spatial resolution. As a useful extension
of its diagnostic use, MRI is also proposed for the monitoring of the delivery
of bio-active agents such as therapeutic or diagnostic agents" (Spec. 1, 11.
22-26). "If the contrast between different tissues is insufficient to obtain
clinical information, MRI contrast agents (CAs), such as low molecular
weight complexes of gadolinium, are administered" (Spec. 2, 11. 10-12 ).
The Claims
Claims 1-9 and 11-15 are on appeal. Claim 1 is representative and
reads as follows:
1. A Chemical Exchange-dependent Saturation Transfer
(CEST) contrast agent for Magnetic Resonance Imaging
compnsmg:
a polymersome including a polymeric shell composed
of copolymer amphiphile molecules that interact to form the
shell of the polymersome, wherein each molecule of at least a
subset of said copolymer amphiphile molecules is a
paramagnetic agent and is composed of at least one of a
metallopolymer or polymeric units that are respectively
enriched with metal.
The Issue
The Examiner rejected claims 1-9 and 11-15 under 35 U.S.C.
§ 103(a) as obvious over Terreno '2008,2 Terreno '2007,3 Dori,4 Hardy,5 and
2 Terreno et al., Highly shifted LIPOCEST agents based on the
encapsulation of neutral polynuclear paramagnetic shift reagents,
CHEM. COMMUN. 600-602 (2008).
2
Appeal2013-007042
Application 12/746,204
Discher6 (Ans. 3-8).
The Examiner relies on Terreno '2007 and Terreno '2008 to teach
"nonspherical liposomes/phospholipid vesicles (LIPOCESTs) for MRI
comprising a lipid membrane (e.g. DPPC, DSPE-PEG2000) that
encapsulates/ compartmentalizes paramagnetic Tm(III)-based shift reagents
and metal-coordinated water protons in the cavity" (Ans. 3). The Examiner
acknowledges that neither Terreno reference discloses "that DSPE-PEG2000
is an amphiphilic polymer" (Ans. 5).
The Examiner finds that Dori teaches that "DSPE-PEG2000 is an
amphiphilic polymer" (Ans. 5). The Examiner finds it obvious to
"incorporate the paramagnetic complex (e.g. metallopolymer) into the
liposome membrane as Terreno ['2008] ... envisioned this concept for the
advantage of enhance the magnetic susceptibility effect" (Ans. 5).
The Examiner further relies upon Hardy to disclose polymersomes
and Discher to disclose polymeric vesicles (see Ans. 6-7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that the applied prior art teaches "a
3 Terreno et al., From Spherical to Osmotically Shrunken
Paramagnetic Liposomes: An Improved Generation of LIPOCEST
MRI Agents with Highly Shifted Water Protons, 46 ANGEW. CHEM.
INT. ED. 966-968 (2007).
4 Dori et al., Ligand accessibility as means to control cell response
to bioactive bilayer membranes, 50 J. BIOMED. MATER. RES. 75-81
(2000).
5 Hardy, US 2008/0311045 Al, published Dec. 18, 2008.
6 Discher et al., US 2005/0003016 Al, published Jan. 6, 2005.
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Application 12/746,204
metallopolymer or polymeric units that are respectively enriched with
metal" as required by claim 1?
Findings of Fact
1. The Specification teaches that the "polymeric nature of the
polymersome shell leads to the possibility that the polymer itself can be
rendered paramagnetic by the incorporation of metallopolymer units, the
enrichment of polymeric units with metal, or both. . . . e.g. enrichment by
including lanthanide-based lipids into the polymersome structure, or by
using lanthanide-based copolymers" (Spec. 17, 11. 3-7).
2. The Specification teaches
an amphiphilic compound comprising a lanthanide complex (on
the more polar side of the amphilic compound), and having an
apolar tail which has a tendency to preferably integrate in and
align with the lipid bilayer at the thermosensitive drug carrier's
surface based on hydrophobic molecular interactions. These
amphilic paramagnetic complexes can e.g. be:
... The polymeric nature of the polymersome shell leads to the
possibility that the polymer itself can be rendered paramagnetic
by the incorporation of metallopolymer units, the enrichment of
polymeric units with metal, or both. This refers to e.g.
enrichment by including lanthanide-based lipids into the
po 1 ymersome structure.
(Spec. 16, 1. 20 to 17, 1. 6).
3. Terreno '2008 teaches that "[i]mproved LIPOCEST MRI
contrast agents with highly shifted intraliposomal water protons were
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Appeal2013-007042
Application 12/746,204
prepared by entrapping neutral polynuclear Tm(III)-based paramagnetic
shift reagents in phospholipidic vesicles" (Terreno '2008 600, abstract).
4. Chart 1 of Terreno '2008 is reproduced in part below:
"OOC----'- / w\ .. .-----('Off
:"' N
Tm
-·-
Chart 1 shows the "structures of the Tm(III)-based shift reagents" (Terreno
'2008, 601, col. 1).
5. Terreno '2007 teaches the preparation of "two nonspherical
LIPOCEST preparations entrapping a hydrophilic SR, [Ln-(hpd03a)], and
incorporating an amphiphilic metal complex, [Ln( 1)] in the membrane (20%
of the total molar amount of lipids" (Terreno '2007 967, col. 1).
6. Dori teaches DSPE-PEG-2000 (see Dori 78, table I).
7. Hardy teaches that the "therapeutic to be delivered by
embodiments of this specification may be embedded within the wall of a
nanocarrier, encapsulated in the vesicle and/or attached to the surface of the
nanocarrier" (Hardy iJ 395).
Principles of Law
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. See In re Sneed, 710 F.2d 1544, 1548
(Fed. Cir. 1983).
"The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
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Application 12/746,204
Analysis
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation in
dispute is the requirement for "at least one of a metallopolymer or polymeric
units that are respectively enriched with metal" in claim 1.
Appellants contend that a "metallopolymer is a polymer with a metal
in repeating monomer units. The liposome molecule comprising the
membrane of Terreno 1 ['2008] and Terreno 2 ['2007] does not include a
metal in repeating monomer units and, similarly, does not include a plurality
of polymer units that are respectively enriched with metal" (Br. 5).
The Examiner finds that "the amphiphilic metal complex, [Ln(l )], is a
repeating unit in the nonspherical LIPOCEST vesicle and encompasses the
metallopolymer or polymeric units that are respectively enriched with metal"
(Ans. 10).
While we agree with Appellants that a "metallopolymer" must have
repeating monomer subunits containing a metal element, claim 1 is not
limited to "metallopolymer." Claim 1 is drawn to molecules with "at least
one of a metallopolymer or polymeric units that are respectively enriched
with metal" (emphasis added). The use of the alternative term "or" in claim
1 therefore permits the molecules to be composed solely of the "polymeric
units that are respectively enriched with metal". The Specification expressly
supports the concept of "enrichment by including lanthanide-based lipids into
the polymersome structure" (FF 1 ). The Specification exemplifies particular
lanthanide based amphiphilic compounds including a compound numbered 6
that contains a single lanthanide metal element (FF 2).
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Application 12/746,204
Therefore, the second alternative in claim 1 for "polymeric units that
are respectively enriched with metal" is reasonably interpreted as
encompassing lanthanide amphiphilic compounds with a single metal
element, consistent with the Specification (FF 2). Moreover, to the extent
that the phrase "polymeric units that are respectively enriched with metal" is
ambiguous regarding incorporation of a single metal or a plurality of metals
in a single amphiphilic compound, "during patent prosecution when claims
can be amended, ambiguities should be recognized, scope and breadth of
language explored, and clarification imposed." In re Zletz, 893 F.2d 319, 321
(Fed. Cir. 1989). The disagreement regarding the scope of this claim
language evidences a reasonable ambiguity that requires clarification by
claim amendment.
Having interpreted claim 1 to encompass lanthanide amphiphilic
compounds with a single metal element, where polymersome is composed of
more than one of these compounds, we agree with the Examiner that Terreno
'2008 and Terreno '2007 teach that "the amphiphilic metal complex, [Ln(l )],
is a repeating unit in the nonspherical LIPOCEST vesicle and encompasses
the ... polymeric units that are respectively enriched with metal" (Ans. 10).
Terreno '2008 teaches a lanthanide containing polymeric amphiphile
(FF 3) and Terreno '2007 teaches liposomes enriched with 20% of this
compound in the membrane (FF 5), consistent with the Specification's
teaching of "enrichment by including lanthanide-based lipids into the
polymersome structure" (FF 2).
Appellants remaining arguments focus on their claim interpretation
requiring more than one complex per lipid molecule, an interpretation that is
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Application 12/746,204
not supported by the plain language of claim 1 to "polymeric units that are
respectively enriched with metal" or the Specification.
Thus, we recognize, but find unpersuasive, Appellants' argument that
in Terreno '2007, "the percentage does not in any way indicate more than one
complex is added to a lipid molecule" (Br. 6). While this is factually correct,
because claim 1 does not require that more than one complex is added to a
lipid, the argument is not commensurate in scope with the breadth of the
claim. See In re Self, 671F.2d1344, 1348 (CCPA 1982) ("[A]ppellant's
arguments fail from the outset because ... they are not based on limitations
appearing in the claims.")
We have considered Appellants' remaining arguments, but find them
unpersuasive because they rely upon Appellants incorrect claim
interpretation.
Conclusion of Law
The evidence of record support the Examiner's conclusion that the
cited prior art teaches "a metallopolymer or polymeric units that are
respectively enriched with metal" as required by claim 1
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Terreno '2008, Terreno '2007, Dori, Hardy, and
Discher. Claims 2-9 and 11-15 fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
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Application 12/746,204
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
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Application 12/746,204
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SANDER LANGEREIS,
HOLGER GRUELL, LEA LOUISE PAULINE MESSAGER,
JEROEN ALPHONS PIKKEMAAT, and DIRK BURDINSKI
Appeal2013-007042
Application 12/746,204
Technology Center 1600
Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge, dissenting.
I disagree with the majority's conclusion that the obviousness rejection
of record should be affirmed.
Representative claim 1 is directed to a polymersome "wherein each
molecule of at least a subset of said copolymer amphiphile molecules is a
paramagnetic agent and is composed of at least one of a metallopolymer or
polymeric units that are respectively enriched with metal" (App. Br. 10). I
agree with Appellants that this recitation requires that at least one of the
amphiphile molecules that forms the polymersome contains a metallopolymer
and/or polymeric units, that is, more than one polymeric unit, that are
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Application 12/746,204
respectively enriched with metal (id. at 6-7). I also agree with Appellants
that the Examiner has not adequately shown where the applied art teaches or
suggests an amphiphile molecule that contains either a metallopolymer or
more than one unit that is enriched with metal (id. at 4).
I understand my colleagues' concern that the Specification discloses
amphiphile molecules containing only one metal (Spec. 16: 20 to 17: 6;
FF 2). However, it is my position that such molecules are not encompassed
by the present claim language. Therefore, I would reverse the obviousness
rejection.
DISSENTING
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