Ex Parte GEORGIOU et al

Patent Trial and Appeal Board

Dec 18, 2018

14105642 (P.T.A.B. Dec. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/105,642 12/13/2013
52034 7590 12/20/2018
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
AUSTIN, TX 78746
FIRST NAMED INVENTOR
George GEORGIOU
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.
CLFR.P0292US.D1 5868
EXAMINER
ZEMAN, ROBERT A
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
12/20/2018 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE GEORGIOU and SANG TAEK JUNG 1
Appeal2017-010514
Application 14/105,642
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Research Development Foundation as the real party in
interest. App. Br. 3.
Appeal2017-010514
Application 14/105,642
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1, 38, and 40 as unpatentable under the
nonstatutory doctrine of obviousness-type double patenting over claims 35-
37 of US 8,679,493 B2 (March 25, 2014) (the "'493 patent"). 2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a method for the screening and
isolation of aglycosylated antibody Fe domain polypeptides. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
2 The Examiner also provisionally rejected claims 1, 38, and 40 as
unpatentable under the nonstatutory doctrine of obviousness-type double
patenting over claims 29 and 30 of US Ser. No. 14/588,017 (the "'017
application"). Final Act. 4--5. The Examiner has withdrawn this rejection.
Ans. 4.
The Examiner also rejected the claims as unpatentable under 35 U.S.C. §
I03(a) over Taylor et al. (US 2007/0048300 Al, March 1, 2007)
("Taylor"). Final Act. 2. In the Answer, the Examiner states that this
rejection had been withdrawn in the Final Office Action, despite the fact
that this Final Rejection was expressly maintained in the Final Office
Action. Ans. 4. Nevertheless, because the Examiner expressly states in
the Answer that the rejection on this ground is withdrawn, and because the
Examiner does not otherwise address Appellants' arguments with respect
to this rejection, we conclude that the rejection is constructively withdrawn
by the Examiner and we therefore do not reach it.
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Application 14/105,642
1. A method of selecting a bacterial cell compnsmg an
aglycosylated antibody Fe domain having specific affinity for an
Fe receptor (FcR) polypeptide comprising the steps of:
a) obtaining a population of Gram negative bacterial
cells, cells of which population express an aglycosylated
antibody Fe domain in their periplasm, wherein the population
expresses a plurality of different Fe domains;
b) contacting the bacterial cells with an F cR
polypeptide under conditions wherein the FcR polypeptide
contacts the aglycosylated Fe domains; and
c) selecting at least one bacterial cell based on binding
of the aglycosylated Fe domain to the FcR polypeptide.
App. Br. 9.
ISSUES AND ANALYSES
We adopt the Examiner's findings, reasoning, and conclusion that
claims 1, 38, and 40 are primafacie obvious over the cited patent. We
address the arguments raised by Appellants below.
Issue
Appellants argue that claim 3 5 of the '493 patent is directed to
obtaining a host cell expressing a specific aglycosylated antibody having a
specific mutant Fe domain and incubating the host cell to produce the
antibody. App. Br. 6. In contrast, Appellants assert, the claims on appeal
are directed to a screening method for selecting bacteria expressing
aglycosylated antibodies with an Fe domain and having desired binding
properties from a gram-negative population of bacterial cells expressing
different mutant Fe domains. Id.
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Application 14/105,642
According to Appellants, step a) of their claim 1 requires: "obtaining
a population of Gram negative bacterial cells, cells of which population
express an aglycosylated antibody Fe domain in their periplasm, wherein the
population expresses a plurality of different Fe domains." App. Br. 6.
Appellants contend that there is no corresponding language in claims 35-37
of the '493 patent that presents any relationship to this step. Id. at 7.
Similarly, with respect to step b ), Appellants argue that claims 35-37
neither teach nor suggest the limitation reciting: "contacting the bacterial
cells with an FcR polypeptide under conditions wherein the FcR polypeptide
contacts the aglycosylated Fe domains." App. Br. 7. With respect to step c),
which is directed to: "selecting at least one bacterial cell based on binding
of the aglycosylated Fe domain to the FcR polypeptide," Appellants argue
that claims 35-37 similarly neither teaches nor suggests this limitation. Id.
The Examiner responds that, contrary to Appellants' assertion, both
claim sets are drawn to "obtaining" cells capable of expressing an
aglycosylated antibody comprising an Fe domain capable of binding an FcR
polypeptide. Ans. 5. The Examiner further finds that the method steps set
forth in Appellants' claim 1 outline the steps used to "obtain" the cells, and
that these methods steps are disclosed by the '493 patent as a means of
obtaining the cells that express a given aglycosylated antibody with an Fe
domain. Id. ( citing '493 patent col. 8, 11. 33--48).
The Examiner finds that Appellants' claims 1, 3 8, and 40 set forth the
specific method steps for "obtaining" the host cells expressing the
aglycosylated antibody as set forth in claim 35 of the '493 patent and its
corresponding Specification. Ans. 6-7 (citing MPEP § 804(II)(B)(2)(a)).
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Application 14/105,642
Therefore, the Examiner concludes, claim 3 5 teaches the limitations of the
claims on appeal. Id.
We are not persuaded by Appellants' arguments. Appellants'
independent claim 1 recites, in relevant part: "obtaining a population of
Gram negative bacterial cells, cells of which population express an
aglycosylated antibody Fe domain in their periplasm," followed by
subsequent steps by which "at least one bacterial cell based on binding of the
aglycosylated Fe" is selected.
Claim 35 of the '493 patent recites:
35. A method for preparing an aglycosylated polypeptide
compnsmg:
a) obtaining a host cell capable of expressing an
aglycosylated antibody comprising an Fe domain capable of
binding an FcR polypeptide, wherein the Fe domain comprises
an amino acid substitution at amino acids 382 and 428 and at
least one additional substitution of any of the following amino
acids:241,251,266,269,276,279,286,295,297,300,315,325,
328,330,332,338,340,341,348,369,378,392,424 and/or 434;
b) incubating the host cell in culture under conditions to
promote expression of the aglycosylated antibody; and,
c) purifying expressed antibody from the host cell.
(Emphasis added). The method by which the "host cell capable of
expressing an aglycosylated antibody comprising an Fe domain capable of
binding an FcR polypeptide" is obtained is described in an exemplary
embodiment of the Specification of the '493 patent:
Other embodiments concern methods for screening for an
aglycosylated polypeptide having an Fe domain that binds a one
or more specific FcR polypeptides comprising: a) obtaining a
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Application 14/105,642
population of Gram negative bacterial cells, cells of which
population express a aglycosylated polypeptide comprising an Fe
domain in their periplasm, wherein the population expresses a
plurality of different Fe domains; b) contacting the bacterial cells
with a first FcR polypeptide under conditions to allow contact
between the FcR polypeptide and the aglycosylated Fe
domains, [ ... ] ; and, c) selecting at least one bacterial cell based
on binding of the aglycosylated Fe domain to the first FcR
polypeptide.
'493 patent col. 8, 11. 33--46. The Specification of the '493 patent thus
defines and describes the scope of the language of claim 3 5 of the '493
patent reciting: "obtaining a host cell capable of expressing an aglycosylated
antibody comprising an Fe domain capable of binding an FcR polypeptide."
Moreover, this description expressly teaches the method recited in
Appellants' claim 1 as being encompassed within.
When determining whether claims on appeal are obvious under the
doctrine of obviousness-type double patenting, we are mindful of the general
prohibition of treating the Specification of the cited patent as prior art. See
In re Kaplan, 789 F.2d 1574 (Fed. Cir. 1986). However, our reviewing
court has established parameters under which the prior patent's Specification
may be used to determine whether the claims on appeal are obvious over the
cited prior patent. Specifically, the court has held that:
[T]he disclosure [ of the prior patent] may be used to learn
the meaning of terms and in "interpreting the coverage of [a]
claim." It may also be used to answer the question whether
claims merely define an obvious variation of what is earlier
disclosed and claimed .... [T]he disclosure "sets forth at least one
tangible embodiment within the claim, and it is less difficult and
more meaningful to judge whether [ something] has been
modified in an obvious manner."
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In re Basel! Poliolefine Italia SP.A., 547 F.3d 1371, 1378-79 (Fed. Cir.
2008) (quoting In re Vogel, 422 F.2d 438,442 (C.C.P.A. 1970) (internal
citations omitted).
In this instance, the Specification of the '493 patent expressly teaches,
in an embodiment, the scope and meaning of the limitation of claim 35's
limitation reciting: "obtaining a host cell capable of expressing an
aglycosylated antibody comprising an Fe domain capable of binding an FcR
polypeptide." This definition and description precisely corresponds the
method set forth in Appellants' claims on appeal. We therefore agree with
the Examiner that Appellants' claims are obvious over claims 35-37 of the
'493 patent.
Appellants reply that, during the prosecution of the parent application
of both the '493 patent and the present application, claim 68 of the parent
application is virtually identical to the main claim pending in the present
application. 3 Reply Br. 2. Appellants argue that, in a Restriction
Requirement dated September 26, 2009, the Examiner set out 6 different
patentably distinct claim groupings. According to Appellants, claim 68 was
set out in Group IV, whereas the claims that gave rise to the '493 patent
were grouped into the Group I invention. Id. Therefore, Appellants assert,
the Office has already determined that the present claims are patentably
distinct from the claims of the '493 patent. Id.
Appellants argue further that the Examiner has taken elements from
an unrelated section of the '493 patent and read those elements into the '493
claims as a sort of "claim interpretation" using the "broadest reasonable
3 Application US Ser. No. 12/827,386.
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interpretation." Reply Br. 2. Appellants contend, however, the Examiner
makes no attempt to interpret elements of claim 35; rather, Appellants assert,
the "obtaining" limitation of claim 35 actually refers to obtaining a host cell
expressing a specific Fe mutant. Id. at 2-3. In other words, argue
Appellants, the Examiner is defining the term "obtaining" in claim 35 of the
'493 patent to mean a screening assay. Id. at 3. Appellants therefore assert
that the Examiner is impermissibly using the Specification of the '493 patent
as prior art. Id. (citing MPEP § 804(II)(B)(2)(a)). Appellants rely upon§
804(II)(B)(2)(a) as stating that the Specification of the '493 patent may be
used only as a dictionary to learn the meaning of the claim. Id.
We are not persuaded by Appellants' arguments. The predecessor of
the Federal Circuit held, in In re Vogel, that:
As pointed out above, in certain instances [the
Specification] may be used as a dictionary to learn the meaning
of terms in a claim. It may also be used as required to answer the
second analysis question above [i.e., whether any claim in the
application define merely an obvious variation of an invention
disclosed and claimed in the patent]. We recognize that it is most
difficult, if not meaningless, to try to say what is or is not an
obvious variation of a claim. A claim is a group of words
defining only the boundary of the patent monopoly. It may not
describe any physical thing and indeed may encompass physical
things not yet dreamed of. How can it be obvious or not obvious
to modify a legal boundary? The disclosure, however, sets forth
at least one tangible embodiment within the claim, and it is less
difficult and more meaningful to judge whether that thing has
been modified in an obvious manner. It must be noted that this
use of the disclosure is not in contravention of the cases
forbidding its use as prior art, nor is it applying the patent as a
reference under 35 U.S.C. § 103, since only the disclosure of the
invention claimed in the patent may be examined.
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Application 14/105,642
Vogel, 422 F.2d at 441--42 (emphasis added). Section 804(II)(B)(2)(a) of
the MPEP similarly states:
To avoid improper reliance on the disclosure of a
reference patent or copending application as prior art in the
context of a nonstatutory double patenting analysis, the
examiner must properly construe the scope of the reference
claims. The portion of the reference disclosure that describes
subject matter that falls within the scope of a reference claim
may be relied upon to properly construe the scope of that claim.
However, subject matter disclosed in the reference patent or
application that does not fall within the scope of a reference
claim cannot be used to construe the claim in the context of a
nonstatutory double patenting analysis as this would effectively
be treating the disclosure as prior art.
We agree with the Examiner that the cited passage of the
Specification of the '493 patent discloses subject matter that falls within the
scope of a reference claim, viz., "obtaining a host cell capable of expressing
an aglycosylated antibody comprising an Fe domain capable of binding an
FcR polypeptide," and that the Examiner properly relied upon this disclosure
to properly construe the scope of claim 35 of the '493 patent. We
consequently affirm the Examiner's rejection of the claims.
DECISION
The Examiner's rejection of claims 1, 38, and 40 under the
nonstatutory doctrine of obviousness-type double patenting is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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