Ex Parte Rook et al

Patent Trial and Appeal Board

Jun 16, 2017

12159058 (P.T.A.B. Jun. 16, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/159,058 10/08/2008 Alain H. Rook 61517US005 2890
32692 7590 06/20/2017
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
EXAMINER
COLEMAN, BRENDA LIBBY
ART UNIT PAPER NUMBER
1624
NOTIFICATION DATE DELIVERY MODE
06/20/2017 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 ALAIN H. ROOK, BERNICE M. BENOIT, MARIA WYSOCKA,
SARAH M. BRAY, RICHARD L. MILLER, and MARK A. TOMAI
Appeal 2015-004819
Application 12/159,0581
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
treating cutaneous T cell lymphoma. The Examiner entered final rejections
for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 Appellants identify the Real Party in Interest as 3M Innovative Properties
Company. App. Br. 2.
Appeal 2015-004819
Application 12/159,058
STATEMENT OF THE CASE
Background
The Specification discloses:
a method of treating cutaneous T cell lymphoma (CTCL).
Patients with advanced CTCL have a significantly impaired
ability to generate a cell-mediated immune response, at least in
part because they have abnormally low numbers of dendritic
cells (DCs), cells that play an important role in cell-mediated
immunity. The impaired cell-mediated immune response makes
it difficult for the patient’s immune system to control and contain
the CTCL disease. The invention uses immune response
modifier (IRM) compounds to stimulate immune responses by
other, still responsive immune cell populations to help control
and contain the CTCL disease.
Spec. 3:25-32.
The Claims
Claims 3, 5-9, 12, and 20 are on appeal. Sole independent claim 3 is
illustrative and reads as follows:
3. A method of treating a patient with cutaneous T cell
lymphoma, the method comprising:
administering to the patient an amount of a
pharmaceutical composition comprising N-[4-(4-amino-2-ethyl-
1 //-imidazo[ 4,5-c]quinolin- l-yl)butyl]methanesulfonamide
effective for ameliorating at least one symptom or clinical sign
of cutaneous T cell lymphoma.
App. Br. 11 (Claims App.).
2
Appeal 2015-004819
Application 12/159,058
The following rejections are before us to review:
Claims 3, 5-9, and 12 were rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Griesgraber.2 Ans. 2.
Claim 20 was rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Griesgraber and Olsen.3 Id. at 3.
OBVIOUSNESS
The issue is whether a preponderance of the evidence relied upon by
the Examiner supports a conclusion of obviousness.
FACTUAL FINDINGS (FF)
FF1. The Specification teaches “the methods of the present invention
include administering sufficient IRM compound to provide a dose of, for
example, from about 100 ng/kg to about 50 mg/kg to the subject, although in
some embodiments the methods may be performed by administering IRM
compound in a dose outside this range.” Spec. 14:3-6.
FF2. Griesgraber discloses:
Imidazoquinoline and tetrahydroimidazoquinoline compounds
that contain sulfonamide or sulfonamide functionality at the 1-
position are useful as immune response modifiers. The
compounds and compositions of the invention can induce the
biosynthesis of various cytokines and are useful in the treatment
of a variety of conditions including viral diseases and neoplastic
diseases.
Griesgraber, Abstract.
2 US 6,677,349 Bl, issued Jan. 13, 2004 (“Griesgraber”).
3 Elise A. Olsen, Interferon in the treatment of cutaneous T-cell lymphoma,
16: Dermatologic Therapy, 311-21 (2003) (“Olsen”).
3
Appeal 2015-004819
Application 12/159,058
FF3. Griesgraber’s Example 236 discloses a method of synthesizing N-[4-
(4-Amino-2-propyl-lH-imidazo[4,5-c]quinolin-l-yl)butyl
Jmethanesulfonamide:
Id. at 145:45-146:30.
FF4. Griesgraber discloses:
Although the exact amount of active compound used in a
pharmaceutical composition of the invention will vary according
to factors known to those of skill in the art, such as the physical
and chemical nature of the compound as well as the nature of the
carrier and the intended dosing regimen, it is anticipated that the
compositions of the invention will contain sufficient active
ingredient to provide a dose of about 100 ng/kg to about 50
mg/kg, preferably about 10 ng/kg to about 5 mg/kg of the
compound to the subject.
Id. at 13:38-47.
FF5. Griesgraber discloses:
The immune response modifying effects of the compounds make
them useful in the treatment of a wide variety of conditions.
Because of their ability to induce the production of cytokines
such as IFN-a and/or TNF-a, the compounds are particularly
useful in the treatment of viral diseases and tumors. This
immunomodulating activity suggests that compounds of the
invention are useful in treating diseases such as, but not limited
to, viral diseases including . . . cutaneous T-cell lymphoma.
'\
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Id. at 14:27-54.
FF6. Griesgraber discloses the results of an experiment in which the
disclosed compounds were tested for levels at which it could induce INF-a
and TNF-a in human peripheral blood mononuclear cells. Griesgraber
167:7-170:40. Griesgraber’s compound of Example 236, is shown to
stimulate both INF-a and TNF-a. Id. at 170:16.
FF7. Olsen discloses that several studies have found a positive effect from
use of IFN-y to treat CTCL. Olsen 318.
FF8. Olsen discloses that “Interferon, particularly IFN-a has remarkable
efficacy in CTCL. It is also one of the few systemic therapies for CTCL in
which side-effects generally ameliorate with dose reduction to a dose that is
likely to still have biological effects.” Olsen 318.
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results,”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
ANALYSIS
Rejection of claims 3, 5-9, and 12 over Griesgraber
The Examiner concludes that:
Griesgraber does not anticipate the instant claims because
. . . the inventor therein does not explicitly disclose an example
of treating CTCL. However, [it] teaches the instantly recited
compound and the instantly recited disease state to be treated. . .
. It is well settled that it is a matter of obviousness for one of
ordinary skill in the art to select a particular component from
among many disclosed by the prior art as long as it is taught that
the selection will result in the disclosed effect, even when the
possible selections number 1200 or in the thousands. . . .
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Therefore, it would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
administer N-[4(4-amino-2-ethyl-lH-imidazo[ 4,5-c]quinoline-l-
yl)butyl]methanesulfonamide to treat CTCL.
Ans. 2-3.
We adopt the Examiner’s findings of fact and reasoning
regarding the scope and content of the prior art (Final Act. 2-4, Ans.
2-8; FF1-6) and agree that the claims are obvious over Griesgraber.
We address Appellants’ arguments below.
Appellants argue “Griesgraber discloses N-[4-(4-amino-2-ethyl-
1 //-imidazo[4,5-c]quinolin-1 -yl)butyl]methanesulfonamide as one of
270 exemplary compounds, . . . each of which exhibits varying
patterns and degrees of cytokine induction activity.” Appeal Br. 3.
Appellants argue that the results of the “Cytokine Induction in Human
Cells” experiment disclosed at column 168, line 5 through column
170, line 40 of Griesgraber “teaches that the 270 sulfonamide-
substituted and sulfamide-substituted imidazoquinoline amines have
varying abilities to induce induction of IFN-a and/or TNF-a” and
thus, have “varying patterns and degrees of cytokine induction
activity” that are useful for treating neoplastic diseases as well as the
various other diseases listed. Id. at 3, 5.
Appellants argue the Examiner “misapplies the holdings of Merck4
and In re Corkill5, which leads to an improper conclusion that the method of
4 Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989).
5 In re Corkill, 111 F.2d 1496 (Fed. Cir. 1985).
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claim 3 is obvious in view of Griesgraber.” Id. at 4. According to
Appellants, in those cases, “selecting a particular species from the prior art
genus produced an entirely predictable result because there was no variation
of character relevant to the claimed subject matter among individual
members of the genus described in the prior art.” Id. at 5. Appellants argue
the instant case is distinguishable because “the 270 compounds described in
Griesgraber do not possess a singular profile of activity relevant to the
method of Appellants’ claim 3” and “have varying abilities to induce
induction of IFN-a and/or TNF-a.” Id. Appellants further argue the various
compounds “may induce other cytokines” but that Griesgraber “does not
teach that all 270 of the exemplified compounds possess all the described
cytokine-inducing activity [or] are useful for treating all of the conditions
listed,” (which includes CTCL). Id. Appellants argue the skilled artisan
would not understand Griesgraber to teach that “that any one compound
would be effective for treating all of the listed conditions” or that all
disclosed compounds “have the same predictable and interchangeable ability
to treat ah of the listed conditions.” Id.
We are not persuaded. Griesgraber discloses that the compounds are
useful as immune response modifiers due to “their ability to induce the
production of cytokines such as IFN-a and/or TNF-a, [making] the
compounds . . . particularly useful in the treatment of viral diseases and
tumors.” FF2, FF5. We agree with the Examiner that “in the absence of
evidence to the contrary, it is reasonable [for the skilled artisan to have
presumed] that compounds which induce IFN-a and/or TNF-a production
would be effective to treat CTCL, which is recited in Griesgraber as
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amenable to such therapy.” Ans. 5. The claimed compound is one of the
compounds found to induce both IFN-a and TNF-a in peripheral blood
mononuclear cells. Id.; FF6. We agree with the Examiner that any of the
disclosed compounds shown to enhance both IFN-a and TNF-a production
in peripheral blood mononuclear cells would have been a reasonable
compound for the skilled artisan to have selected for treatment of CTCL, as
disclosed by Griesgraber, because Griesgraber informs the skilled artisan
that induction of cytokines IFN-a and TNF-a in mammalian cells is
“particularly useful in the treatment of viral diseases and tumors.” FF5.
Thus, we agree with the Examiner that the rationale of Merck controls:
“[D]isclos[ing] a multitude of effective combinations does not render any
particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose taught by the prior
art.” Merck, 874 F.2d at 807 {citingIn re Corkill, 111 F.2d at 1500). Here,
Griesgraber teaches use of the claimed compound for treatment of diseases
including CTCL. Accordingly, the claimed compound’s use for this purpose
is obvious. See also KSR, 550 U.S. at 421:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
The claimed compound’s demonstrated success in producing IFN-a and
TNF-a renders it a “predictable solution” for use in immunomodulation, and
thereby for viral tumor, as taught by Griesgraber.
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Appellants further argue that Griesgraber “utterly lacks any
description regarding the immunomodulatory activity identified in
Appellants’ disclosure as being involved in treating cutaneous T cell
lymphoma (CTCL): upregulation of CD69 expression and increased
cytolytic activity of Natural Killer (NK) cells from CTCL patients.” Id. at 6.
According to Appellants,
these immunomodulatory effects are separate and apart ffom-
although primable by-the cytokine induction described in
Griesgraber. Consequently, no person of ordinary skill in the
art could have deduced that any of the 270 compounds
exemplified in Griesgraber would upregulate CD69 expression
and/or increase cytolytic activity of NK cells from CTCL
patients.
Id. Appellants argue that because Griesgraber does not teach these
immunomodulatory effects and also does not teach that “all of the members
of the genus of 270 exemplified compounds possess this property,” there is
no nexus that would allow a person of ordinary skill in the art to make the
compositions at issue in Merck and In re CorkUl with predictable results. Id.
Appellants further argue “the evidence of record does not show any
relationship between the ability of a compound to induce production of IFN-
a or TNF-a at any particular concentration and the ability of a compound to
treat CTCL.” Reply Br. 2.6
We are not persuaded. Claim 3 requires administering the claimed
compound to a patient in an amount effective to treat at least one symptom
or clinical sign. Griesgraber discloses that use of the claimed compound can
6 Appellants’ Reply Brief is not paginated. We refer to it herein as if it were
consecutively numbered, beginning with page 1 as the title page.
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induce IFN-a and TNF-a production, and that a cytokine-induced
immunomodulation effect of this type can be useful in treating diseases
including CTCL. FF5. Accordingly, use of the compound to treat CTCL is
obvious. Appellants have provided no evidence that a particular threshold
level of induction of cytokine production is necessary to achieve treatment,
nor do they claim a particular response must be achieved; claim 3 recites
“effective for ameliorating at least one symptom or clinical sign of
cutaneous T cell lymphoma.” Without evidence, Appellants’ argument is
unpersuasive. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)
(“Attorney’s argument in a brief cannot take the place of evidence.”).
Furthermore, Appellants’ claimed discovery, that the recited
compound may also upregulate CD69 expression and/or increase cytolytic
activity of natural killer cells from CTCL patients, does not confer
patentability on a compound already disclosed for the same use: “[i]t is a
general rule that merely discovering and claiming a new benefit of an old
process cannot render the process again patentable.” In re Woodruff, 919
F.2d 1575, 1578 (Fed. Cir. 1990). For this reason we are also unpersuaded
by Appellants argument that the recited compound’s ability to upregulate
CD69 expression and increase cytolytic activity of Natural Killer (NK) cells
from CTCL patients is an unexpected result. Reply Br. 4. “To be
particularly probative, evidence of unexpected results must establish that
there is a difference between the results obtained and those of the closest
prior art, and that the difference would not have been expected by one of
ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb
Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
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Appellants’ provide no evidence in support of their argument of unexpected
results, and we find it unpersuasive in light of Griesgraber’s disclosure that
cytokine induction can be used to treat viral tumors. FF5.
Appellants next argue that that “a person of ordinary skill in the art
could not, based on the teaching of Griesgraber, have pursued known
possible solutions with a reasonable expectation of success.” App. Br. 8.
According to Appellants, the facts of this case mirror those of In re Kubin,
561 F.3d 1352, 1359 (Fed. Cir. 2009) in which the Federal Circuit “outlined
two classes of situations where ‘obvious to try’ is erroneously equated with
obviousness under § 103.” Id. Appellants argue the same issue exists here,
because “Griesgraber provides ‘no indication of which parameters were
critical or no direction as to which of many possible choices is likely to be
successful’ [because Griesgraber] fails to describe upregulation of CD69
and/or increasing cytotoxic activity of NK cells in CTCL patients” and does
not provide direction which of the 270 provided compounds would likely be
successful in treating CTCL. Id.
For the reasons discussed above, we are unpersuaded that Appellants’
identification of new mechanism(s) by which the claimed compound is
successful in treating CTCL confers patentability on this known compound.
See Woodruff, 919 F.2d at 1578. Additionally, we disagree that knowing
this new mechanism is necessary for the skilled artisan to have had a
reasonable likelihood of success in applying the claimed compound to the
treatment of CTCL. The “case law is clear that obviousness cannot be
avoided simply by a showing of some degree of unpredictability in the art so
long as there was a reasonable probability of success. . . . [T]he expectation
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of success need only be reasonable, not absolute.” Pfizer, Inc. v. Apotex,
Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). We find that Griesgraber’s data
showing that the claimed compound induced production of both cytokines
IFN-a and/or TNF-a along with identification of CTCL as a disease in
which immunodulation of IFN-a and/or TNF-a would be an effective
method of treat would have given the skilled artisan at least a reasonable
expectation of success in using the claimed compound to treat CTCL. We
affirm the rejection of claim 3. Claims 5-9, and 12, having not been argued
separately, fall with claim 3. 37 C.F.R. § 41.37(c)(l)(iv).
Rejection of claim 20 over Griesgraber and Olsen
The Examiner finds that “Olsen discloses that IFN-a or IFN-y are
useful for the treatment of CTCL.” Ans. 3. The Examiner finds that
“[cjombining two therapies (i.e. IFN-a and an IRM) that are known to treat
the same disease (CTCL) is not a patentably distinguishing feature of an
invention”, and concludes that it “would have been prima facie obvious to
one of ordinary skill in the art at the time the invention was made to treat
CTCL comprising administration of both IFN-a or IFN-y and N-[4-(4-
amino-2-ethyl-lH-imidazo[4,5-c]quinoline-l-
yl)butyl]methanesulfonamide.” Id.
We adopt the Examiner’s findings of fact and reasoning
regarding the scope and content of the prior art (Ans. 3; FF7, FF8) and
agree that claim 20 is obvious over Griesgraber and Olsen.
Appellants sole argument is that “Olsen provides no teaching - and
the Examiner makes no assertion that Olsen provides teaching - that
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overcomes the deficiencies of Griesgraber with respect to the subject matter
of claim 3.” App. Br. 9.
We are not persuaded. For the reasons above, we agree with the
Examiner that Griesgraber teaches the subject matter of claim 3. In addition,
we agree with the Examiner that based on Olsen’s disclosure that IFN-a or
IFN-y are useful to treat CTCL, the skilled artisan would have found it
obvious to administer IFN-a or IFN-y with the claimed compound for
treatment of CTCL. FF7, FF8. We affirm the rejection of claim 20.
SUMMARY
We affirm the rejection of claims 3, 5-9, and 12 under pre-AIA 35
U.S.C. § 103(a) as obvious over Griesgraber. Ans. 2.
We affirm the rejection of claim 20 under pre-AIA 35 U.S.C. § 103(a)
as obvious over Griesgraber and Olsen. Id. at 3.
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
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