Ex Parte Alkan et al

Patent Trial and Appeal Board

Apr 16, 2018

11360071 (P.T.A.B. Apr. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/360,071 02/23/2006
32692 7590 04/18/2018
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
FIRST NAMED INVENTOR
SefikAlkan
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.
59683US003 8909
EXAMINER
PURDY, KYLE A
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
04/18/2018 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SEFIK ALKAN,
WILLIAM C. KIEPER, JOHN P. VASILAKOS, JASON D. BONK,
GEORGE W. GRIESGRABER, KENNETH E. LIPSON, JIE J. LIU,
JAMES D. MENDOZA, DORIS STOERMER, PAUL D. WIGHTMAN,
NAIYONG JING, and WILLIAM J. SCHULTZ
Appeal2017-007665
Application 11/360,071 1
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1 and 6-9
(App. Br. 2). 2 Examiner entered a rejection under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the real party in interest as "3M Company ... and its
affiliate 3M Innovative Properties Company" (App. Br. 2).
2 Appellants' pending claims 10-30 stand withdrawn from consideration
(App. Br. 2).
Appeal2017-007665
Application 11/360,071
STATEMENT OF THE CASE
Appellants disclose, inter alia, "an immunomodulatory composition
that includes an immune response modifier moiety coupled to a targeting
moiety" (Spec. 3). Appellants' claim 1 is representative and reproduced
below:
1. An immunomodulatory composition comprising:
an immune response modifier (IRM) moiety coupled to a
targeting moiety, wherein the IRM moiety comprises a 2-
aminopyridine fused to a five membered nitrogen-containing
heterocyclic ring and is an agonist of at least one Toll-like
receptor (TLR);
further comprising a spacer arm to which the IRM moiety
and the targeting moiety are attached, wherein the spacer arm
length is from about 20 A to about 100 A; and
wherein the targeting moiety is an antibody.
(App. Br. 9.)
The claims stand rejected as follows:
Claims 1 and 6-9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Wightman, 3 Dalton, 4 and
Hammerbeck. 5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
3 Wightman et al., US 2004/0202720 Al, published Oct. 14, 2004.
4 Dalton et al., US 7,344,700 B2, issued Mar. 18, 2008.
5 Hammerbeck et al., US 2005/0158325 Al, published July 21, 2005.
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Appeal2017-007665
Application 11/360,071
ANALYSIS
Wightman's disclosure "is directed to the attachment of cytokine
inducing and/ or suppressing immune response modifiers (IRMs) to
particulate support materials that include a metal to form !RM-support
complexes" (Wightman i-f 31 ).
The IRM of Appellants' claim 1 "comprises a 2-aminopyridine fused
to a five membered nitrogen-containing heterocyclic ring and is an agonist
of at least one Toll-like receptor (TLR)" (App. Br. 9). Similarly,
Wightman's "IRM compound may be an agonist of at least one TLR" and
"may comprise a 2-aminopyridine fused to a five membered nitrogen-
containing heterocyclic ring" (Wightman i-fi-116-17; see Ans. 2).
Wightman discloses that "IRMs can be attached to a particulate
support material through either covalent attachment or non-covalent
attachment. Non-covalent attachment of an IRM to a particulate support
material includes attachment by ionic interaction or hydrogen bonding"
(Wightman i-f 103; see Ans. 3). In this regard, Wightman's disclosure
"provides an !RM-support complex that includes at least one IRM
compound covalently attached to a tether, such as an ... antibody ... , which
couples by physical attraction (e.g., static forces, hydrogen bonding,
hydrophobic-hydrophilic interactions) to the particulate support material"
(Wightman i-f 43; see Ans. 2).
In addition, Wightman discloses that "the IRM can be attached to a
particulate support material using a linking group," i.e. spacer arm, and the
importance of spacing the IRM from the reagent, i.e. tether, antibody, or
substrate, to which it may be covalently bound so "that the substrate does
not interfere with a biologically effective interaction between the active core
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Appeal2017-007665
Application 11/360,071
and [] T cells that results in IRM activity such as cytokine production"
(Wightman i-f 111; see Ans. 3).
Taken as a whole, Wightman suggests the covalent bonding of an
IRM, which falls within the scope of Appellants' claim 1, to an antibody, i.e.
a targeting moiety, which targets a particulate support material, through the
use of a linking group, i.e. spacer arm.
Although Wightman discloses the importance of distancing the IRM
from the substrate to which it may be attached, Examiner recognizes that
Wightman does not identify the precise length of a spacer arm and relies on
Dalton to make up for this deficiency in Wightman (see Ans. 4). Dalton
"relates to radiolabeled selective androgen receptor modulator (SARM)
compounds and their use in imaging and prevention/therapy of prostate
cancer" (Dalton 1: 16-18). Dalton, like Wightman, recognizes the
importance of a spacer arm or linking group, wherein Dalton discloses that
[ t ]he necessity of incorporating a linking group (Li) in
the radiolabeled compound ... is dependent on the identity of
the SARM, the radionuclide (RI), and the metal chelator (Ch),
if present. For example, if the radionuclide (RI) and the
optional metal chelator (Ch) cannot be attached to the SARM
without substantially diminishing the SARM's affinity for the
androgen receptor, then a suitable linking group can be used.
(Dalton 43: 7-14; see generally Ans. 4.) In this regard, Dalton discloses that
"[s]uitable lengths for the linker moiety is 1-50 angstroms" (Dalton 43: 28-
29; see Ans. 4).
Thus, taken as a whole, the combination of Wightman and Dalton
makes obvious an immunomodulatory composition comprising an IRM
moiety coupled to an antibody targeting moiety, wherein the IRM moiety
comprises a 2-aminopyridine fused to a five membered nitrogen-containing
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Appeal2017-007665
Application 11/360,071
heterocyclic ring and is an agonist of at least one TLR, which further
comprises a spacer arm to which the IRM moiety and the targeting moiety,
i.e., antibody, are attached, wherein the spacer arm length is 1-50 A, which
overlaps the spacer arm length required by Appellants' claim 1. Thus, we
find no error in Examiner's prima facie case of obviousness (see Ans. 2--4;
see also id. at 4 (Appellants' "invention as a whole is primafacie obvious to
one of ordinary skill in the art at the time the invention was made, as
evidenced by the references, especially in the absence of evidence to the
contrary")). 6
We agree with Appellants' assertion that Wightman's antibody
"serves as a means of attaching the IRM to the particle support" (see App.
Br. 3; see also Wightman i-fi-143 and 103). Stated differently Wightman's
antibody is a targeting moiety for Wightman's particle support. Thus, we
are not persuaded by Appellants' contention that Wightman's antibody "has
no biological activity" (see App. Br. 6; see id. at 3 (Wightman's antibody or
"tether has no biological function ... ; instead, it serves as a means of
6 We recognize Examiner's finding that "Wightman fails to teach the
antibody as having activity against a tumor wherein the antibody recognizes
at least one antigen or marker specific for breast, colon, pancreatic, prostate,
lung or liver cancer or melanoma," and reliance on Hammerbeck to make up
for this asserted deficiency in Wightman (Ans. 3). Appellants' claim 1 does
not, however, require an antibody targeting moiety having "activity against a
tumor" or recognizing "at least one antigen or marker specific for breast,
colon, pancreatic, prostate, lung or liver cancer or melanoma" (see App. Br.
9; cf Ans. 3). Therefore, we do not further address Examiner's reliance on
Hammerbeck for a disclosure of subject matter not required by Appellants'
claim 1. The Board may rely upon less than all the references cited by the
Examiner. See In re May, 574 F.2d 1082, 1090 (CCPA 1978); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976).
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Appeal2017-007665
Application 11/360,071
attaching the IRM to the particle support"); Reply Br. 27 (Appellants assert
that Wightman's antibodies are "pharmacologically inactive")).
As discussed above, Wightman recognizes the importance of spacing
the IRM from the reagent, i.e. tether, antibody, or substrate, to which it may
be covalently bound so "that the substrate does not interfere with a
biologically effective interaction between the active core and [] T cells that
results in IRM activity such as cytokine production" (Wightman i-f 111 ).
Similarly, as Appellants recognize, "Dalton specifies a spacer length that is
appropriate to reduce [] chemical interference" (App. Br. 6; see also Dalton
43: 7-14 and 28-29). Because Wightman expressly suggests spacing the
IRM away from a reagent to which it is bound to prevent interference with
biologically effective interactions, we are not persuaded by Appellants'
contention that "[b ]ecause there is no evidence that the metal particles of
Wightman interfere with the IRM, there is no reason to incorporate the
teachings of Dalton" (App. Br. 6; see id. at 6-7; Reply Br. 2).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Wightman, Hammerbeck,
and Dalton is affirmed. Claims 6-9 are not separately argued and fall with
claim 1.
7 Appellants' Reply Brief is not paginated. Therefore, our reference to a
page number of Appellants' Reply Brief, refers to a page number had
Appellants paginated the Reply Brief consecutively beginning with the first
page.
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Application 11/360,071
TIME PERIOD FOR RESPONSE
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
7