Ex Parte Kmiec et al

Board of Patent Appeals and Interferences

Aug 21, 2012

11890595 (B.P.A.I. Aug. 21, 2012)

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.
11/890,595 08/07/2007 Eric B. Kmiec 100186-00007 9092
60612 7590 08/22/2012
MCCARTER & ENGLISH, LLP WILMINGTON
BASIL S. KRIKELIS
Renaissance Centre
405 N. King Street, 8th Floor
WILMINGTON, DE 19801
EXAMINER
SCHNIZER, RICHARD A
ART UNIT PAPER NUMBER
1635
MAIL DATE DELIVERY MODE
08/22/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ERIC B. KMIEC, HETAL PAREKH-OLMEDO,
and TIMOTHY SCHWARTZ
__________

Appeal 2011-012468
Application 11/890,595
Technology Center 1600
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of preventing proliferation of a cancer cell with an oligonucleotide. The
Examiner rejected the claims as anticipated. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

Appeal 2011-012468
Application 11/890,595

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Statement of the Case
Background
“The present invention relates to the discovery that guanosine-rich
oligonucleotides (GROs) are capable of inducing profound effects on cancer
cell cycle progression and viability” (Spec. 3 ¶ 007). The Specification
teaches “certain GROs that demonstrate the ability to selectively interrupt
the cell cycle and induce apoptosis in cancer cells, for example, esophageal
cancer cells” (Spec. 3 ¶ 007).
The Claims
Claims 9, 11-14, 21, and 22 are on appeal. Claim 9 is representative
and reads as follows:
9. A method of preventing proliferation of a cancer cell
comprising administering to a subject a composition comprising
an effective amount of an oligonucleotide molecule having from
19 to 200 nucleotides, wherein the oligonucleotide molecule
comprises at least one G-quartet forming motif comprising 19-24
nucleotide residues, wherein at least 83% of the oligonucleotide
residues are guanosine residues, and wherein the oligonucleotide
molecule induces apoptosis in a cancer cell, and at least one of a
pharmaceutically acceptable carrier, excipient, adjuvant or
combination thereof.

The issue

The Examiner rejected claims 9, 11-14, 21, and 22 under 35 U.S.C. §
102(b) as anticipated by Bratzler
1
(Ans. 5-10).
The Examiner finds that “Bratzler taught methods of treating cancer
through the use of immunostimulatory oligonucleotides such as SEQ ID

1
Bratzler et al., US 2002/0156033 A1, published Oct. 24, 2002.
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Application 11/890,595

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NO:133, which is identical to elected instant SEQ ID NO: 1” (Ans. 6). The
Examiner finds that Bratzler teaches that the “poly-G nucleic acid can
stimulate apoptosis of the cancer cells thereby facilitating antigen processing
by the dendritic cells” (Ans. 6). The Examiner finds that “Bratzler also
taught methods of treating breast cancer by parenteral administration to a
patient of a pharmaceutical composition comprising an immunostimulatory
poly G oligonucleotide such as instant SEQ ID NO: 1 in combination with a
cancer medicament” (Ans. 8).
Appellants contend that “Bratzler reference does not disclose that
SEQ ID NO: 133, either alone or in combination with a cancer medicament,
induces apoptosis or suppresses proliferation of cancer cells. In fact, Bratzler
fails to disclose or suggest that any of the listed oligonucleotides induces
apoptosis or inhibits cell proliferation.” (App. Br. 9).
Appellants contend that “Bratzler specifically teaches that the
disclosed oligonucleotides by themselves have no direct role in treating
cancer. Accordingly, Bratzler fails to expressly anticipate a method for
inducing apoptosis in a cancer cell by administering a G-rich
oligonucleotide” (App. Br. 10).
Appellants contend that “the Examiner has failed to show that
oligonucleotide-induced apoptosis necessarily flows from Bratzler's
disclosure of a synergistic combination composition of an
immunostimulatory oligonucleotide with a cancer medicament” (App. Br.
12-13).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that Bratzler anticipates claim 9?
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Findings of Fact
1. Bratzler teaches “a method for treating a subject having, or at
risk of developing, a cancer, comprising administering to a subject in need
of such treatment a poly-G nucleic acid and a cancer medicament in an
effective amount to treat the cancer or to reduce the risk of developing the
cancer” (Bratzler 1 ¶ 0010).
2. The Examiner finds that Bratzler‟s SEQ ID NO: 133 is identical
to the elected SEQ ID NO: 1 (see Bratzler 7 ¶ 0054; Ans. 6).
3. Bratzler teaches SEQ ID NO: 133, which is
“GGGGGGGGGGGGGGGGGGGG”, where more than 83% of the
oligonucleotide residues are guanosine residues and where the
oligonucleotide is 20 nucleotides in length (see Bratzler 7 ¶ 0054; Ans. 6).
4. Bratzler teaches that the “poly-G nucleic acid can stimulate
apoptosis of the cancer cells thereby facilitating antigen processing by the
dendritic cells” (Bratzler 18 ¶ 0110).
5. Bratzler teaches that “typical dosages range from about 0.1 µg
to 20 mg/kg/day” (Bratzler 24 ¶ 0135).
6. Bratzler teaches that “the Poly-G nucleic acid is free of
unmethylated CG dinucleotides, such as, for example, the nucleic acids
listed above as SEQ ID NO: 95 through to SEQ ID NO: 133” (Bratzler 5 ¶
0052).
7. The Specification teaches that “the term „subject‟ can mean a
cell, population of cells, in vitro, in vivo, or ex vivo; and/or an individual or
patient, for example, a mammal such as a human” (Spec. 10 ¶ 0041).
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8. The Specification teaches that a “therapeutically effective dose
refers to that amount of the therapeutic complex sufficient to result in
amelioration or delay of symptoms” (Spec. 31 ¶ 00107).
9. The Specification teaches that the “mice were treated twice . . .
by IV delivery of vehicle, sense oligonucleotide (10 mg/kg), or nonsense (10
mg/kg) oligonucleotide. . . . the in vivo administration of the G20
oligonucleotide (i.e., SEQ ID NO.1) resulted in a significant decrease in
tumor volume and an increase in animal viability” (Spec. 41 ¶¶ 0152-0153).
Principles of Law
“It is well settled that a prior art reference may anticipate when the
claim limitations not expressly found in that reference are nonetheless
inherent in it.” In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1349
(Fed. Cir. 2002). See, e.g., MEHL/Biophile Int’l Corp. v. Milgraum, 192
F.3d 1362, 1365 (Fed.Cir.1999) (“Under the principles of inherency, if the
prior art necessarily functions in accordance with, or includes, the claimed
limitations, it anticipates.”)
Once a prima facie case of anticipation has been established, the
burden shifts to the Appellant to prove that the prior art product does not
necessarily or inherently possess the characteristics of the claimed product.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed
and prior art products are identical or substantially identical, or are produced
by identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product.”).

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Analysis
Bratzler teaches “a method for treating a subject having . . . a cancer,
comprising administering to a subject in need of such treatment a poly-G
nucleic acid and a cancer medicament in an effective amount to treat the
cancer” (Bratzler 1 ¶ 0010; FF 1). Bratzler teaches that the poly-G
oligonucleotide may include SEQ ID NO: 133, which is
“GGGGGGGGGGGGGGGGGGGG”, where more than 83% of the
oligonucleotide residues are guanosine residues and where the
oligonucleotide is 20 nucleotides in length (see Bratzler 7 ¶ 0054; Ans. 6; FF
3). Bratzler teaches that the “poly-G nucleic acid can stimulate apoptosis of
the cancer cells thereby facilitating antigen processing by the dendritic cells”
(Bratzler 18 ¶ 0110; FF 4).
Appellants contend that the “Bratzler reference does not disclose that
SEQ ID NO: 133, either alone or in combination with a cancer medicament,
induces apoptosis or suppresses proliferation of cancer cells. In fact, Bratzler
fails to disclose or suggest that any of the listed oligonucleotides induces
apoptosis or inhibits cell proliferation.” (App. Br. 9).
We are not persuaded. We agree with the Examiner that Bratzler
reasonably anticipates the method of claim 9, teaching a method of cancer
treatment in which a 20 nucleotide poly-G oligonucleotide is administered to
a subject and where the oligonucleotide results in apoptosis of cancer cells
(FF 1-6). Bratzler directly teaches that poly-G nucleic acids can stimulate
apoptosis of cancer cells (FF 4). Bratzler expressly teaches SEQ ID NO:
133 (FF 2, 3, 6). Bratzler even claims the treatment of subjects with cancer
using poly-G nucleic acid (see Bratzler 30, claim 1).
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Appellants contend that “Bratzler specifically teaches that the
disclosed oligonucleotides by themselves have no direct role in treating
cancer. Accordingly, Bratzler fails to expressly anticipate a method for
inducing apoptosis in a cancer cell by administering a G-rich
oligonucleotide” (App. Br. 10).
We are not persuaded. Even if we ignore the express teaching of
Bratzler that “poly-G nucleic acid can stimulate apoptosis of the cancer cells
thereby facilitating antigen processing by the dendritic cells” (Bratzler 18 ¶
0110; FF 4), Bratzler teaches administering the same composition, SEQ ID
NO: 133, polyG20, to the same patient population, subjects with cancer, for
treatment of the same condition, cancer. See In re Best, 562 F.2d at 1255
(“Whether the rejection is based on „inherency‟ under 35 U.S.C. § 102, on
„prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the PTO‟s
inability to manufacture products or to obtain and compare prior art
products”). On this record, Appellants have proffered no evidence or proof
that Bratzler‟s treatment method does not inherently satisfy the “inducing
apoptosis in a cancer cell” requirement, and Bratzler at least suggests that
the composition functions to induce apoptosis (FF 4).
Appellants contend that “the Examiner has failed to show that
oligonucleotide-induced apoptosis necessarily flows from Bratzler's
disclosure of a synergistic combination composition of an
immunostimulatory oligonucleotide with a cancer medicament” (App. Br.
12-13).
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We are not persuaded. The Examiner has reasonably satisfied the
burden of demonstrating inherency for Bratzler. As we noted above,
Bratzler teaches administering the same composition, SEQ ID NO: 133,
polyG20, to the same patient population, subjects with cancer, for treatment
of the same condition, cancer, and resulting in apoptosis of cancer cells (FF
1-6).
It may be that the Federal Circuit would not interpret claim 9 to
require an efficacy requirement in cancer treatment, but in Montgomery the
Court found that “efficacy is inherent in carrying out the claim steps.” In re
Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012). Montgomery also
teaches that even if the prior art “merely proposed the administration of [an
active agent] for treatment or prevention of [a disease] (without actually
doing so), it would still anticipate.” Id. at 1382.
Conclusion of Law
The evidence of record supports the Examiner‟s finding that Bratzler
anticipates claim 9.

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SUMMARY
In summary, we affirm the rejection of claim 9 under 35 U.S.C. §
102(b) as anticipated by Bratzler. Pursuant to 37 C.F.R. § 41.37(c)(1), we
also affirm the rejection of claims 11-14, 21, and 22 as these claims were not
argued separately.

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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