Ex Parte Bensussan et al

Patent Trial and Appeal Board

Jun 6, 2018

13522095 (P.T.A.B. Jun. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/522,095 07 /13/2012
30743 7590 06/07/2018
W&CIP
11491 SUNSET HILLS ROAD
SUITE 340
RESTON, VA 20190
FIRST NAMED INVENTOR
Armand Bensussan
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.
11450108US 9298
EXAMINER
ALLEN, MICHAEL D
ART UNIT PAPER NUMBER
1642
MAILDATE DELIVERY MODE
06/07/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ARMAND BENSUSSAN,
ANNE MARIE-CARDINE, and MARTINE BAGOT
Appeal2016-008542
Application 13/522,095 1
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and DAVID COTTA,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 17, 19, 22, and
23 (Final Act. 2 2). Examiner entered rejections under 35 U.S.C. § 102(b)
and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify "Institut National de la Sante et de la Recherche
Medicale (INS ERM) of Paris, France" as the real party in interest (App. Br.
3).
2 Office Action mailed August 6, 2015.
Appeal2016-008542
Application 13/522,095
STATEMENT OF THE CASE
Appellants' disclosure "relates to the diagnosis and treatment of
Cutaneous T Cell Lymphomas (CTCL)" (Spec. 1: 6-7). Independent claim
17 is representative and reproduced below:
17. A method of depleting or destroying circulating malignant
T cells expressing NKp46 in a patient having a cutaneous T cell
lymphoma (CTCL), comprising the steps of
identifying a patient having a CTCL selected from the
group consisting of Sesary syndrome, Mycosis Fungoides,
transformed Mycosis Fungoides, Lymphomatoide Papulosis
and CD30+ cutaneous lymphomas, wherein said CTCL
primarily involves the skin, wherein said patient has circulating
malignant T cells expressing NKp46; and
administering to said patient a therapeutically effective
amount of an anti-NKp46 antibody, wherein said anti-NKp46
antibody is conjugated to a cytotoxic agent or a growth
inhibitory agent,
and wherein said anti-NKp46 antibody binds to NKp46
receptors on said circulating malignant T cells in said patient
and inhibits proliferation of or kills said circulating malignant T
cells, thereby depleting or destroying said circulating malignant
T cells.
(Br. 23.)
The claims stand rejected as follows:
Claims 17, 19, 22, and 23 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Romagne. 3
3 Romagne, US 2007/0178106 Al, published Aug. 2, 2007.
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Application 13/522,095
Claims 17, 19, 22, and 23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Romagne and Lee. 4
FACTUAL FINDINGS (FF)
FF 1. Romagne discloses methods of using "antibodies that target
activating receptors present on the surface of [natural killer (NK)] cells, and
which at the same time help to guide activated NK cells to malignant or
infected target cells, thereby enhancing their efficacy" (Romagne i-f 1; see id.
i-f 2; see also i-f 129 (Romagne's "method is ... directed at increasing NK cell
activity in patients having a disease in which increased NK cell activity is
beneficial, which involves, affects or is caused by cells susceptible to lysis
by NK cells")).
FF 2. Romagne discloses:
Several distinct NK-specific receptors have been identified that
play an important role in the NK cell mediated recognition and
killing of HLA Class I deficient target cells. These receptors,
termed NKp30, NKp46 and NKp44, are members of the lg
superfamily. Their cross-linking, induced by specific mAbs,
leads to a strong NK cell activation resulting in increased
intracellular ca++levels, triggering of cytotoxicity, and
lymphokine release. Importantly, mAb-mediated activation of
NKp30, NKp46, and/or NKp44 results in an activation ofNK
cytotoxicity against many types of target cells.
(Romagne i-f 3)
FF 3. Romagne discloses methods of producing antibodies "capable of
activating NK cell cytotoxicity as well as promoting the interaction ofNK
4 Soon Nam Lee, M.D., et al. Adult T-cell Leukemia/Lymphoma with
Features of CD30-Positive Anaplastic Large Cell Lymphoma-A Case
Report-, 12 JKMS 364--8 (1997).
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Application 13/522,095
cells with their target cells, thereby enhancing the ability of the cells to kill
the targets" (Romagne i-f 6).
FF 4. Romagne discloses:
Without being bound by the following theory, it is believed that
the particular effectiveness of the present antibodies is due at
least in part to the ability of F c receptors on the surface of target
cells, e.g. Fe gamma receptors, to interact with the NK cell
activating antibodies themselves. In this way, it is believed that
the activated NK cells are brought into close proximity with
their target cells via the two reactive portions of the antibody
(e.g.[,] the antigen recognizing domain and the Fe domain),
thereby enhancing the efficiency of the treatment.
(Romagne i-f 23.)
FF 5. Romagne discloses that antibodies within the scope of its "invention
include functionalized antibodies, i.e., antibodies that are conjugated or
covalently bound to a toxin, such as ricin, diphtheria toxin, abrin and
Pseudomonas exotoxin" (Romagne i-f 81 ).
FF 6. Romagne discloses methods for treating, inter alia, "Sezary
syndrome (SS)" and "Anaplastic (Ki 1 +)large cell lymphoma" (Romagne
i-f 130; Ans. 2 and 4).
FF 7. Examiner finds that Romagne does not expressly identify the
location of diseases treatable by its invention, i.e., "cutaneously or in skin"
(Ans. 4).
FF 8. Examiner relies on Lee to disclose "that [CD30-Positive] anaplastic
large cell lymphoma (ALCL) ... manifests in skin" (Ans. 4; see id.
(Examiner finds that "[t]he first sentence of the introduction section of Lee
states that CD30 is the same as Ki-1 ")).
FF 9. Appellants disclose that "Cutaneous T Cell Lymphomas (CTCL)
constitute a group of T lymphomas which primarily involve the skin. The
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Appeal2016-008542
Application 13/522,095
CTCL group namely comprises[, inter alia,] Sezary Syndrome ... [and]
CD30+ cutaneous lymphomas" (Spec. 1: 10-13).
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Romagne teaches Appellants' claimed invention?
ANALYSIS
Romagne discloses a method of treating, inter alia, malignancy, such
as Sezary syndrome" and "Anaplastic (Ki 1 +)large cell lymphoma,"
otherwise known as CD30-positive anaplastic large cell lymphoma, in a
subject by administering to the subject an anti-NKp46 antibody that is
conjugated to a cytotoxic agent, such that the malignant cells are killed (see
FF 1---6). Thus, Romagne anticipates the subject matter of Appellants'
claims 17 (see App. Br. 23).
Implicit in Romagne' s disclosed method of treating Sezary syndrome
and CD30-positive anaplastic large cell lymphoma is the identification of
patients having such a disease (cf App. Br. 23). Also implicit in Romagne's
disclosed method of treating Sezary syndrome and CD30-positive anaplastic
large cell lymphoma is the treatment of a cutaneous T cell lymphoma
(CTCL) that primarily involves the skin (see FF 9; cf App. Br. 13
("Romagne does not teach that the cancer to be treated in the patient occurs
cutaneously or in skin")).
Thus, we find no error in Examiner's finding that Romagne
anticipates Appellants' claimed invention and that the mechanism through
which Appellants' claimed invention operates is inherent in the method
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Application 13/522,095
taught by Romagne (see Ans. 2 and 16-22; cf App. Br. 12 ("Romagne did
not know of the link between T cell expression ofNKp46 and CTCLs");
App. Br. 13-15).
For the foregoing reasons, we are not persuaded by Declarant's
assertions that "Romagne simply does not work as described," "Romagne
would, rather than activating NK cells and promoting malignant cell killing,
inevitably lead to the 'killing' of the NK cells themselves," and "Romagne
does not teach administration to the specific patient population set forth in
the claims of ... [Appellants'] application, and does not teach o[r] suggest
killing circulating malignant T-cells" (Bensussan Dec. 5 i-f 4). For the same
reasons, we are not persuaded by Appellants' contentions that
Romagne does not describe treatment of a patient with a CTCL,
wherein said CTCL is selected from the group consisting of[,
inter alia,] Sezary Syndrome ... [and] CD30+ cutaneous
lymphomas, wherein said CTCL primarily involves the skin
and thus Romagne certainly does not teach a step of identifying
patients with said CTCLs as required by the instant claims.
(App. Br. 12; see generally Reply Br. 1-5.)
CONCLUSION
The preponderance of evidence on this record supports Examiner's
finding that Romagne teaches Appellants' claimed invention. The rejection
of claim 17 under 35 U.S.C. § 102(b) as anticipated by Romagne is affirmed.
Claims 19, 22, and 23 are not separately argued and fall with claim 17.
5 Declaration of Armand Bensussan, signed July 13, 2015.
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Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Based on the combination of Romagne and Lee, Examiner concludes
that, at the time Appellants' invention was made, it would have been prima
facie obvious "to treat a patient with CD30+ ALCL with skin manifestations
with the anti-NKp46 antibody or antibody conjugate of Romagne for the
advantage of improving patient prognosis" (Ans. 4). We find no error in
Examiner's conclusion of obviousness. Further, having found Appellants'
claim invention anticipated by Romagne, we similalry find Appellants'
claimed invention obvious in view of Romagne. See Connell v. Sears,
Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) ("anticipation is the
epitome of obviousness").
For the reasons set forth above, with respect to the anticipation
rejection, we are not persuaded by Appellants' contentions regarding
Romagne (see App. Br. 17-20). In addition, having found no deficiency in
Romagne and because Lee does no more than state an inherent property of
CD30-positive anaplastic large cell lymphomas, we are not persuaded by
Appellants' contentions that Lee "fails to cure or mitigate in any way
[Appellants' alleged] defects [in] Romagne, and no combination of
Romagne and Lee renders [Appellants'] ... invention obvious" (id. at 20-
21; see also Reply Br. 5).
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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 17 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Romagne and Lee is
affirmed. Claims 19, 22, and 23 are not separately argued and fall with
claim 17.
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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