Ex Parte Weber et al

Patent Trial and Appeal Board

Feb 23, 2017

12649179 (P.T.A.B. Feb. 23, 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.
12/649,179 12/29/2009 RICHARD WEBER ABGENIX.087C1C1 5103
21069 7590
AMGEN INC.
Law - Patent Operations, M/S 28-2-C
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
EXAMINER
HUYNH, PHUONG N
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
02/27/2017 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):
pair_amgen @ firsttofile. com
EFRHelp @ amgen .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD WEBER, XIAO FENG, ORIT FOORD,
LARRY GREEN, JEAN M. GUDAS, BRUCE KEYT, YING LIU,
PALANISWAMI RATHANASWAMI, ROBERT RAYA,
JOSE CORVALAN, IAN FOLTZ, XIAO-CHI JIA, JASPAL S. KANG,
CHADWICK T. KING, SCOTT L. KLAKAMP,
and QIAO JUAN JANE SU1
Appeal 2016-003409
Application 12/649,179
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
antibody which been rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as AMGEN FREMONT INC.
Appeal Br. 4.
Appeal 2016-003409
Application 12/649,179
STATEMENT OF THE CASE
The Specification describes:
novel antibodies, particularly antibodies directed against
deletion mutants of epidermal growth factor receptor and
particularly to the type III deletion mutant, EGFRvIII. The
embodiments also relate to human monoclonal antibodies
directed against deletion mutants of epidermal growth factor
receptor and particularly to EGFRvIII. The embodiments also
relate to variants of such antibodies. Diagnostic and therapeutic
formulations of such antibodies, and immunoconjugates
thereof, are also provided.
Spec. 13.
Claims 71—77, 79-85, 119, 120, 127, and 128 are on appeal. Claim
71 is illustrative and reads as follows:
71. An isolated antibody that binds to EGFRvIII, the
antibody comprising:
a light chain variable region amino acid sequence that is
at least 90 percent identical to the light chain variable region
amino acid sequence in SEQ ID NO: 144;
a heavy chain variable region amino acid sequence that is
at least 90 percent identical to the heavy chain variable region
amino acid sequence in SEQ ID NO: 142; and
a toxin selected from a group consisting of maytansinoids
and saporins conjugated to the antibody.
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Appeal 2016-003409
Application 12/649,179
The claims stand rejected as follows:
Claims 71-74, 76, 77, 79-82, 84, 85, 119, 120, 127, and 128 under 35
U.S.C. § 103(a) as unpatentable Wong2 or Vogelstein3 in view of
Kucherlapati4 and/or Yang5 in further view of Chari.6
Claims 75 and 83 under 35 U.S.C. § 103(a) as unpatentable over
Wong or Vogelstein in view of Kucherlapati and/or Yang in further view of
Chari and in further view of Lam.7
THE FIRST REJECTION UNDER 35 U.S.C. § 103(a)
Issue
The issue with respect to this rejection is whether substantial evidence
supports the Examiner’s rejection of claims 71—74, 76, 77, 79-82, 84, 85,
119, 120, 127, and 128 based on Wong or Vogelstein combined with
Kucherlapati, Yang, and Chari.
The Examiner finds that Wong and Vogelstein both teach monoclonal
antibodies that bind to the peptide LEEKKGNYVVTDHC of mutant
EGFRvIII. Final Act. 10. The Examiner finds that Wong and Vogelstein
teach that the antibodies can be conjugated to a therapeutic such as a
radionuclide or a toxin to kill tumor cells. Id. at 10—11. The Examiner finds
2 Wong et al., US 6,224,868 Bl, issued May 1, 2001 (“Wong”).
3 Vogelstein et al., US 6,455,498 Bl, issued Sept. 24, 2002 (“Vogelstein”).
4 Kucherlapati et al., US 6,075,181, issued June 13, 2000 (“Kucherlapati”).
5 Yang et al., Development ofABX-EGF, a fully human anti-EGF receptor
monoclonal antibody, for cancer therapy, 38 Critical Rev. Oncol./Hematol.
17 (2001) (“Yang”).
6 Chari, WO 01/24763 A2, published Apr. 12, 2001 (“Chari”).
7 Lam et al., US 5,055,291, issued Oct. 8, 1991 (“Lam”).
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Appeal 2016-003409
Application 12/649,179
that the antibodies of Vogelstein intrinsically comprise a light chain variable
region amino acid sequence that is at least 90% identical to SEQ ID NO: 144
or 19 and a heavy chain variable region amino acid sequence that is at least
90 % identical to SEQ ID NO: 142 or 2. Id.
The Examiner finds that neither Wong nor Vogelstein teach human
antibodies nor do they teach the use of maytansinoid as the toxin and that the
references do not teach binding the toxin to the antibody with a peptide
sequence. Id. at 11.
The Examiner finds that Kucherlapati and Yang teach methods for
making human antibodies using XenoMouse technology and Kucherlapati
teaches using EGFR as the antigen of interest. Id. The Examiner finds that
Chari teaches immunoconjugates wherein the toxin is a maytansinoid. Id.
The Examiner concludes that
it would have been obvious to one of ordinary skill in the art at
the time the invention was made to make human monoclonal
antibody that binds to the epitope sequence
LEEKKGNYVVTDHC of the mutant EGFRvIII of the '868
patent or the '498 patent by immunizing the XenoMouse as
taught by the T 81 patent or Yang with the peptide
LEEKKGNYVVTDHC of the '868 patent or the '498 patent and
then conjugating the toxin (i.e., maytansinoid DM-1) as taught
by the WOO 1/24763 publication to the human monoclonal
antibody with a reasonable expectation of success (i.e.,
targeting DM-1 to EGFRvIII using antibody that binds to
EGFRvIII) to treat cancer expressing mutant EGFRvIII.
Final Act. 12.
Appellants contend that none of the cited references teach or suggest
the specific peptide sequences recited in the claims nor teach sequences that
have the requisite identity to the recited sequences. Appeal Br. 14.
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Appeal 2016-003409
Application 12/649,179
Appellants argue that the Examiner has not shown that the antibodies in the
references inherently possess peptides having at least 90% identity with the
recited peptides. Id. at 15. Appellants also argue that there is sufficient data
in the records to support a finding that that the antibodies disclosed in the
references do not inherently possess peptide sequences with the requisite
identity. Id. at 15—16.
Appellants have the better position. The Examiner has not provided
adequate objective evidence that the antibodies produced following the
teachings of the references would inherently contain the recited sequences.
As Appellants point out, the Examiner has shown at best that some of the
antibodies produced might contain the recited sequences. Reply Br. 4. This
is insufficient to establish inherency. See, In re Montgomery, 677 F.3d
1375, 1379-80 (Fed. Cir. 2012) (Inherency may not be established by
probabilities or possibilities.)
Moreover, even if the Examiner has established a prima facie case of
obviousness, Appellants have submitted sufficient evidence to rebut the
determination. Appellants have demonstrated that while using the method
taught by the references will result in antibodies which bind to the amino
acid sequence LEEKKGNYVVDHC, the antibodies do not necessarily
contain the recited peptide sequences. Reply Br. 4—6. Thus, following the
teachings and guidance in the cited prior art would not necessarily result in
antibodies with the claimed sequences. This effectively rebuts the
Examiner’s conclusion that a person of ordinary skill in this art would have
had a reasonable expectation that the antibodies produced by following the
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Appeal 2016-003409
Application 12/649,179
teachings in the cited references would necessarily or inherently possess the
recited peptide sequences.
We conclude that the evidence of record does not support the
Examiner’s conclusion of obviousness.
THE SECOND REJECTION UNDER 35 U.S.C. § 103(a)
The issue with respect to this rejection is whether substantial evidence
supports the Examiner’s rejection of claims 75 and 83 based on Wong or
Vogelstein combined with Kucherlapati, Yang, Chari, and Lam.
Appellants’ arguments with respect to this rejection are identical to
those made above. Appeal Br. 18. For the reasons discussed above, we
reverse this rejection.
SUMMARY
We reverse the rejections based on 35 U.S.C. § 103(a).
REVERSED
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