Ex Parte Davidson et al

Patent Trial and Appeal Board

Aug 24, 2016

11943871 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111943,871 11/21/2007
53137 7590 08/26/2016
VIKSNINS HARRIS & PADYS PLLP
7851 Metro Parkway
Suite 325
Bloomington, MN 55425
FIRST NAMED INVENTOR
Beverly L. Davidson
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.
l 7023.033US2 4256
EXAMINER
BURKHART, MICHAEL D
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
08/26/2016 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):
docketing@vhpglobalip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BEYERL Y L. DAVIDSON and PAUL B. McCRAY JR. 1
Appeal2014-002006
Application 11/943,871
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
uECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of delivering transgenes to airway epithelial cells. The Examiner
rejects the claims as lacking written descriptive support and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the Real Party in Interest is the University of
Iowa Research Foundation. (App. Br. 2.)
Appeal2014-002006
Application 11/943,871
STATEMENT OF THE CASE
Claims 1, 2, 4--10, and 14 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A method of delivering a transgene to an airway
epithelia cell comprising contacting the cell with a pseudotyped
retrovirus virion, wherein the virion comprises (a) a viral
envelope consisting of packaging cell plasma membrane and
baculovirus envelope glycoprotein 64 (GP64), and (b) a nucleic
acid comprising a promoter and the transgene; wherein the
pseudotyped retrovirus virion is resistant to complement
inactivation.
(App. Br. 20).
Appellants seek review of the following rejections:
I. Claims 1, 2, 4--10, and 14 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement.
II. Claims 1, 2, 4--10, and 14 under 35 U.S.C. § 103(a) as
unpatentable over Schauber '641 2 in view of Collins. 3
I. Written Description: New Matter
The Examiner's rejects the claims as containing new matter because
the Specification lacks support for a viral envelope "consisting of [a]
packaging cell plasma membrane" (Ans. 2-3).
2 Schauber et al., US 6,790,641 B2, issued Sept. 14, 2004 ("Schauber '641"),
with an effective filing date based on the provisional Application No.
60/376,767 of May 1, 2002 ("Schauber '767").
3 Collins et al., US 5,240,846, issued Aug. 31, 1993 ("Collins").
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Application 11/943,871
Appellants contend that "this phrase should be given its ordinary and
customary meaning as understood by one skilled in the art, and should be
interpreted to include the components normally associated with it (i.e.,
membrane lipids and endogenous proteins)" (Reply Br. 9; see App. Br. 10).
The issue presented is: does the preponderance of evidence of record
support the Examiner's position that the limitation "consisting of packaging
cell plasma membrane" is not supported in the Specification?
Findings of Fact
FF 1. The Specification provides that a "host cell is a cell into which a
vector of interest may be introduced" (Spec. 27).
FF2. According to the Specification, a "packaging cell line provides the
viral proteins required for particle assembly" (Spec. 7). Packaging
cells are created from host cells.
Retrovirus vectors allow ( 1) transfection of the packaging
vectors and envelope vectors into the host cell to form a
packaging cell line that produces essentially packaging-vector-
RNA-free viral particles, (2) transfection of the transgene
vector into the packaging cell line, (3) the packaging of the
transgene vector RNA by the packaging cell line into infectious
viral particles, and ( 4) the administration of the particles to
target cells so that such cells are transduced and subsequently
express a transgene.
(Spec. 11.)
FF3. The Specification explains that "the packaging cell line [is] able to
efficiently package the highly defective transgene vector into viral
particles, and bud the particles into the culture supernatant (in vitro) or
extracellular environment (in vivo) without also budding helper virus
(the packaging vectors)" (Spec. 32).
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Application 11/943,871
Principle ofLaw
The examiner ... "bears the initial burden ... of presenting a
prima facie case of unpatentability." In re Oetiker, 977 F.2d
1443, 1445 (Fed. Cir. 1992). Insofar as the written description
requirement is concerned, that burden is discharged by
"presenting evidence or reasons why persons skilled in the art
would not recognize in the disclosure a description of the
invention defined by the claims." . . . If ... the specification
contains a description of the claimed invention, albeit not in
ipsis verb is (in the identical words), then the examiner ... , in
order to meet the burden of proof, must provide reasons why
one of ordinary skill in the art would not consider the
description sufficient.
In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
Analysis
We find that Appellants have the better position and agree that based
on the understanding of the ordinary skilled artisan in conjunction with the
teaching of the Specification that the viral envelope consists of viral
envelope glycoproteins and host cell plasma membrane from which the virus
buds particles. The Specification supports this position by explaining that
packing cells are understood to package a defective transgene vector into
particles (FF3). The Specification explains that a packing cell line is derived
from a host cell and that the genes necessary for packaging the virus are
inserted into the host cell (FF2). The host cell can be any cell that can
receive the requisite vectors for viral production and replication and by
introducing these vectors the host cell transforms into a packing cell line
(FFl). The ordinary artisan understands that in the process of budding virus
from the cell the viral particle will pick up some cell membrane in the
process (FF3).
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Appeal2014-002006
Application 11/943,871
Accordingly, we reverse the new matter rejection with respect to the
limitation of "consisting of packaging cell plasma membrane."
II. Obviousness over Schauber and Collins
The Examiner's position is that Schauber teaches "packaging systems
for producing pseudotyped lentiviruses (a subset of retroviruses) that may
have the Autographa californica multinuclear polyhedrosis virus gp64
envelope gene" (Ans. 4). According to the Examiner, Schauber also
discloses that "transgenes include those [genes] that provide a useful,
therapeutic benefit" (id.). "[T]he GP64 protein is considered to be
heterologous to the host cell (e.g. human or mammalian) as it is a
baculovirus protein" (id.). The Examiner recognizes that Schauber suggests
"the treatment of cystic fibrosis, a disease of the airway epithelia, by gene
therapy using retroviral vectors, there is no actual disclosure of targeting
airway epithelial cells, or of using the CF transmembrane regulator (CFTR)
gene" (id.). The Examiner looks to Collins for teaching "the delivery of a
functional CFTR gene using retroviral vectors in order to treat cystic
fibrosis" (id. at 5).
Appellants contend that the newly added material of the regular
Schauber application, material that is not present in the provisional Schauber
application "is not prior art to the present claims" (App. Br. 14). Appellants
contend that Schauber "does not teach a pseudotyped virion comprising a
viral envelope consisting of packaging cell plasma membrane and GP64
(i.e., lacking CRP), as recited by the pending claims" (id. at 17).
The issue presented is: does the preponderance of evidence of record
support the Examiner's conclusion that the combined teachings of Schauber
and Collins renders the claims obvious?
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Appeal2014-002006
Application 11/943,871
Findings ofFact
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (see Ans. 3-5, 7-9; Final Act. 3-5). For
emphasis only we highlight the following:
FF4. Schauber's provisional application teaches:
[A] method of producing a recombinant lentivirus. The method
comprises transforming a host cell with a first nucleotide
sequence comprising a gag, a pol, or gag and pol genes; and a
second nucleotide sequence comprising a gene that encodes a
CRP [(complement resistant protein)]. Optionally, the second
nucleotide sequence additionally includes a heterologous env
gene. Alternatively, the env gene is provided on a separate
construct. Preferably, the CRP comprises DAF. Preferably, the
env gene comprises a VSV-G or gp64 env gene.
(Schauber '767 15:2-7.)
FF5. Schauber '767 teaches:
[A] lentivital vector that contains a trans gene, as well as a
pharmaceutical composition comprising the lentiviral
vector. . . . The transgene is typically a therapeutic gene. An
example of a therapeutic transgene directed at treatment of
hemophilia is one that encodes a blood clotting factor, such as a
polynucleotide encoding factor VIII or a polynucleotide
encoding factor IX.
(Schauber '7677:10-14.)
FF6. Collins teaches transforming airway epithelial cells. "[T]he delivery
vehicle of choice is a recombinant retrovirus capable of infecting
human epithelial cells .... [The vector] comprises DNA of at least [a]
portion of the retroviral genome necessary for infection, and the
normal CFTR gene operatively linked thereto" (Collins 3 :25-30).
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Appeal2014-002006
Application 11/943,871
Principle ofLaw
"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'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
Appellants contend that ( 1) the Schauber '641 reference is not prior
art (App. Br. 13-14), and (2) that the disclosure in Schauber '767, the
provisional application, is not sufficient to establish a prima facie case of
obviousness (App. Br. 14--18)
Prior Art
With respect to the prior art issue, Appellants contend that they
reduced to practice the invention prior to the effective filing date of the
newer added material in Schauber '641, the regular US application (App. Br.
14). Appellants contend that the priority date of the present Application is
October 15, 2003. Schauber '641 was filed on April 29, 2003, having a
publication date of Nov. 6, 2003, and priority to a provisional application
Schauber '767 filed May 1, 2002. Appellants' position is that only some of
the disclosure in Schauber '767 is entitled to a priority date of May 1, 2002
and that the newly added material in Schauber '641, the regular US
Application is not entitled to that priority date (App. Br. 13-14).
Appellants' assert that the "new material ... is not prior art to the present
claims" (App. Br. 14). Appellants provide the McCray Declaration4 to
support the position of prior conception (App. Br. 14). "As indicated in the
previously-filed [McCray] Declaration, prior to the filing of the Schauber
4 Declaration under 37 U.S.C. § 1.131 of Paul B. McCray, Jr. signed Jan. 18,
2011 ("Declaration").
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Appeal2014-002006
Application 11/943,871
['641] Regular US Application (i.e., prior to [the filing on] April 29, 2003),
the inventors cloned the envelope glycoprotein from Autographa californica
multicapsid nucelopolyhedrovirus (GP64)" (App. Br. 14).
We are not persuaded by Appellants' contentions. The Declaration
establishes that "[t]he invention was conceived prior to November 6, 2003 as
part of a larger project focused on testing heterologous envelopes with the
FIV lentiviral vector system" (Declaration i-f 2). The Examiner, however,
relies only on the teachings of Schauber '767 that "has an e.f.d. [(effective
filing date)] of5/1/2002 for those teachings" (Ans. 7). We agree with the
Examiner that the Declaration is insufficient to overcome the rejection
because it is insufficient to establish that conception was prior to the earliest
effective filing date of May 1, 2002. At best, the McCray Declaration
establishes conception before Nov. 6, 2003, which is the publication date of
the Schauber '641 application, but not the filing date of that application
which is April 29, 2003, or the applications' May 1, 2002 e.f.d. Thus, we
agree with the Examiner's position that the McCray Declaration "does not
antedate the effective filing date of Schauber ['641]" (Final Act. 5 5; see also
Office Action mailed Mar. 29, 2011, 4 ("the declaration of Mr. McCray does
not antedate the effective filing date of Schauber et al[.] as it only provides
evidence of conception of the instant invention prior to 11/6/2003. As set
forth above, the effective date of Schauber et al is 5/1/2002")).
Accordingly, the disclosure of Schauber '767 as well as Schauber
'641 is prior art with respect to the present Application.
5 Office Action mailed Mar. 27, 2013.
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Appeal2014-002006
Application 11/943,871
Claim 1
We are also not persuaded by Appellants contention the disclosure of
Schauber '767, the provisional application, is insufficient to render the
claims obvious when combined with the teachings of Collins. We adopt the
Examiner's findings of fact and reasoning regarding the scope and content of
the prior art (see Ans. 3-5, 7-9; Final Act. 3-5) and agree that the claims are
rendered obvious by Schauber and Collins. We address Appellants'
arguments below.
Appellants contend that "by using the term 'consisting of the claims
recite that the viral envelope contains only the packaging cell plasma
membrane, which would inherently include membrane lipids and any
membrane proteins endogenous to the packaging cell, and the non-
endogenous protein GP64" (App. Br. 10). "[H]owever, the envelope could
not contain other non-endogenous proteins, such as CRPs discussed by
Schauber" (App. Br. 11 ).
Claim interpretation is at the heart of patent examination because a
claim cannot be compared to the prior art before its scope is properly
ascertained. Cf In re Abbott Diabetes Care Inc., 696 F.3d 1142, 1146 (Fed.
Cir. 2012)). "[D]uring examination proceedings, claims are given their
broadest reasonable interpretation consistent with the specification." In re
Hyatt, 211F.3d1367, 1372 (Fed. Cir. 2000). At issue is the limitation "a
viral envelope consisting of packaging cell plasma membrane and
baculovirus envelope glycoprotein 64 (GP64)." Therefore, we first tum to
the Specification to interpret the term "packaging cell plasma membrane."
The Specification provides that packing cells are produced from host
cells, but does not otherwise limit the host cell other than being capable of
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Appeal2014-002006
Application 11/943,871
supporting viral replication (FFl and FF3). In order to produce a packaging
cell, a suitable host cell is transformed with packing vectors and envelope
vectors (FF2). Thus, a packing cell will contain many proteins that are not
endogenous to a host cell because a packaging cell must contain all genes
and proteins necessary for producing of a virion particle.
The Examiner explains that
the CRP proteins of Schauber ... are human membrane
proteins expressed in human cells ... , and thus are not only
found in the plasma membrane of such cells, but are considered
"endogenous" because they are human proteins in human cells.
Thus, the virions of Schauber ... are considered to consist of
"packaging cell plasma membrane" and GP64 according to
applicants own definition of such [viral envelopes]
(Ans. 8.) We note that there is nothing in the Specification that would
somehow exclude host cells from over expressing endogenous proteins.
Therefore, we find no error with the Examiner's position that the CRP
protein of Schauber is considered "endogenous" with respect to the human
cell line that supports the viral particle production. Thus, the virions
produced by Schauber would reasonably consist only of packing cell plasma
membrane and GP64.
In summary, we agree with the Examiner that the cited references
support a prima facie case of obviousness. Appellants have not provided
sufficient rebuttal evidence or evidence of secondary considerations that
outweighs the evidence supporting the prima facie case. As Appellants do
not argue the claims separately, claims 2 and 4--10 fall with claim 1.
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Appeal2014-002006
Application 11/943,871
Claim 14
Appellants contend that neither Schauber nor Collins singly or in
combination "teach or suggest a viral envelope consisting of only packaging
cell plasma membrane and GP64" (App. Br. 18).
We are not persuaded with Appellants' contentions, and agree that the
Examiner has reasonably explained why Appellants' claims do not exclude
CRP from the plasma membrane of a human cell line. Specifically, the
Examiner's position is that expressing genes that are normally found in
human cells is not excluded by the use of "heterologous" as used in the
Specification. Thus, "the human CRP proteins of Schauber ... cannot be
considered 'heterologous' as applicants insist because they are human
membrane proteins expressed in human cells. As such, they are naturally
found in human cells and do not meet applicants definition of
'heterologous"' (Ans. 7).
In summary, we agree with the Examiner that the cited references
support a prima facie case of obviousness with respect to claim 14.
SUMMARY
We reverse the rejection of claims 1, 2, 4--10, and 14 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement.
We affirm the rejection of claims 1, 2, 4--10, and 14 under 35 U.S.C.
§ 103(a) as unpatentable over Schauber in view of Collins
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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