Ex Parte WOLF et al

Patent Trial and Appeal Board

Sep 19, 2018

13429383 (P.T.A.B. Sep. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/429,383 03/25/2012 IdoWOLF
35938 7590 09/21/2018
Acuity Law Group, P.C.
12707 High Bluff Drive
Suite 200
San Diego, CA 92130-2037
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.
GUR-0005-US2 1394
EXAMINER
AULT, ADDISON D
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
09/21/2018 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IDO WOLF, TAMAR RUBINEK,
BELLA KAUFMAN, and LILACH ABRAMOVITCH 1
Appeal2017-001846
Application 13/429,383
Technology Center 1600
Before RICHARD J. SMITH, TA WEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treatment comprising administering an isolated polypeptide that
includes a claimed amino acid sequence, which have been rejected as
indefinite and anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, "[t]he present invention relates to the
field of therapeutics, and more specifically to the use of the klotho protein
1 Appellants identify the Real Party in Interest as Tel Hashomer Medical
Research Infrastructure and Services Ltd. (Appeal Br. 4.)
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Application 13/429,383
and related compounds for the treatment and diagnosis of cancer, such as
breast cancer and pancreatic cancer as well as other IGF-1 dependent
cancers." (Spec. 1:16-18.)
Claims 1-3, 5, and 9 are on appeal. Claim 1 is illustrative and
reproduced below:
1. A method of treatment, comprising administering to a
subject in need thereof a pharmaceutically effective amount of a
composition comprising an isolated polypeptide including an
amino acid sequence having at least 80% homology to the
amino acid sequence represented by SEQ ID NO: 2, or a DNA
encoding therefor.
(Appeal Br. 8 (Claims App.).)
The Examiner rejects claims 1-3, 5, and 9 under 35 U.S.C. § 112(b)
or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. (Ans.
2.)
The Examiner rejects claims 1-3, 5, and 9 under 35 U.S.C. § I02(b)
as being anticipated by Nemoto, 2 as evidenced by Hanai. 3 (Ans. 3.)
Oral argument for this appeal took place on September 11, 2018.
I.
Issue
The Examiner has rejected claims 1-3, 5, and 9 under 35 U.S.C.
§ 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being
indefinite. Claim 1 recites "an amino acid sequence having at least 80%
homology to the amino acid sequence represented by SEQ ID NO: 2," and
the Examiner concludes that "[t]he term 'represented by' renders the claim
2 Nemoto et al., US 2005/0208015 Al, published Sept. 22, 2005.
3 Hanai et al., WO 00/27885, published May 18, 2000.
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Application 13/429,383
indefinite because it is unclear how or if one amino acid sequence may be
'represented by' another amino acid sequence." (Ans. 2.) Appellants
contend that
[ t ]he plain meaning of "representation" is "something
(such as a picture or symbol) that stands for something
else." There can be no doubt to one of skill in the art that
SEQ ID NO: 2 is not a polypeptide sequence per se, but
rather a textual representation of the amino acid sequence
of a polypeptide. Thus, stating that a polypeptide has
homology to the amino acid sequence represented by SEQ
ID NO: 2 is completely unambiguous.
(Appeal Br. 5.)
The issue with respect to this rejection is whether a preponderance of
the evidence of record support the Examiner's conclusion that the phrase
"the amino acid sequence represented by SEQ ID NO: 2" is indefinite.
Analysis
"[A] claim is indefinite when it contains words or phrases whose
meaning is unclear." In re Packard, 751 F.3d 1310, 1314 (Fed. Cir. 2014).
In this case, we find Appellants to have the better argument. In particular,
we agree with Appellants that a skilled artisan reading the claims in light of
the Specification would understand that "the amino acid sequence
represented by SEQ ID NO: 2" to refer to the single, entire amino acid
sequence described or set forth in SEQ ID NO: 2, rather than some other
amino acid sequence or group of amino acid sequences. (Appeal Br. 8,
Claim 1 ).
Accordingly, we reverse the Examiner's rejection of claims 1-3, 5,
and 9 as indefinite.
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Application 13/429,383
II.
Issue
The Examiner has rejected claims 1-3, 5, and 9 under 35 U.S.C.
§ 102(b) as being anticipated by N emoto, as evidenced by Hanai. The
Examiner concludes that, based on Guidance dated Dec. 29, 2005, regarding
"PTO policy as it relates to [interpretation of] the words 'a' or 'the' [ when
referring] to sequences identified by SEQ ID Nos.," a prior art polypeptide
"only require[ s] two or more amino acids or homology with the polypeptide
set forth in Seq ID No. 2 in order to anticipate" the limitation in claim 1
relating to "sequence having at least 80% homology to ... SEQ ID NO: 2."
(Id. at 4.) The Examiner concludes that, "[b ]ased on this claim
interpretation, the 80% limitation ... is moot, as any dipeptide of sequence
homology will meet the 80% limitation." (Id.)
The Examiner then finds that
Nemoto teaches administration of a pharmaceutically
effective amount of klotho protein ( which is the protein
encoded by Seq ID No. 2) to a subject in need thereof
. . . . Regarding the specified level of homology (i.e. at
least two amino acids), Nemoto does not explicitly teach
the klotho sequence, and thus Hanai is relied upon to teach
that Nemoto, by teaching administration ofklotho protein,
inherently teaches proteins in which at least two amino
acids are in common with the sequence set forth in Seq ID
No.2.
(Id. at 5.) More specifically, the Examiner finds that "[a]n alignment of
Hanai's Seq ID No. 2 against Applicant's Seq ID No. 2" shows that "[t]he
two sequences are nearly 100% identical." (Id.)
The Examiner explains that, "based on the evidence provided in
Hanai, any protein described as klotho would have at least two amino acids
of homology with Applicant's Seq ID No. 2, and thus would meet the
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Application 13/429,383
limitations of Claim 1." (Id.) In the alternative, the Examiner finds that
"[t]he Klotho sequence taught by Hanai has higher than 80% sequence
identity to SEQ ID NO: 2" and, "given the breadth of Applicant's claim
language and the indefiniteness issues, a case of inherency may be made that
Nemoto teaches Applicant's claimed method." (Id. at 9.)
Appellants contend that the Examiner describes the cited PTO
Guidance as stating that "claims referring to 'comprising f! nucleotide
sequence of SEQ ID NO: X' could be any dinucleotide or larger, but that
claims referring to 'comprising the nucleotide sequence of SEQ ID NO: X'
could only be satisfied by the full length of the SEQ ID." (Appeal Br. 6.)
Appellants contend that, since the claims refer to "an isolated polypeptide
including an amino acid sequence having at least 80% homology to the
amino acid sequence represented by SEQ ID No: 2," the claims should be
read as requiring an "isolated polypeptide ... hav[ing] 80% homology to the
full length of SEQ ID N0:2" in accordance with the Guidance. (Id. at 7 .)
Appellants do not separately argue the claims. Accordingly, we limit
our analysis to claim 1 as representative. The issue with respect to this
rejection is whether Nemoto, as evidenced by Hanai, anticipates claim 1.
Analysis
We begin our analysis with claim interpretation. We agree with
Appellants that "an isolated polypeptide including an amino acid sequence
having at least 80% homology to the amino acid sequence represented by
SEQ ID NO: 2" requires an amino acid sequence at least 80% homologous
to the full length of SEQ ID NO: 2. (Appeal Br. 8, Claim 1 (emphasis
added).)
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Application 13/429,383
The Guidance cited by the Examiner states that the limitation, "[a]
nucleic acid comprising a nucleotide sequence of SEQ ID NO: 1,"
encompasses "nucleic acids that comprise ... any portion of SEQ ID NO:
1," whereas the limitation, "[a] nucleic acid comprising the nucleic acid of
SEQ ID NO: 1," claims "only nucleic acids that comprise the full length of
SEQ ID NO: 1, with or without additional nucleotides at either or both
ends." (Ans. 4 (emphasis added).) In this case claim 1 recites an amino acid
sequence having at least 80% homology to "the" amino acid sequence
represented by SEQ ID NO: 2. Thus, pursuant to the Guidance cited by the
Examiner, claim 1 requires an amino acid sequence having at least 80%
homology to the full length of SEQ ID NO: 2.
The Examiner argues that "'an amino acid sequence' having 80%
homology to a second sequence may or may not comprise the entirety of the
second sequence." (Ans. 12.) In particular, the Examiner argues that "[i]f
the claims set forth a step of administering 'an isolated polypeptide having
80% homology to the amino acid sequence of SEQ ID NO: 2 ', the claim
could be interpreted as setting forth administration of a peptide
encompassing the full length ( or at least 80% of the full length) of SEQ ID
NO: 2." (Id.) The Examiner argues, however, that "an isolated polypeptide
'including a sequence having 80% homology' to another sequence
'represented by' a sequence identifier is not as clear, and thus the claim
language chose by Applicant leaves the claim open to other interpretations."
(Id.)
We are not persuaded. To the extent the Examiner's proposed claim
construction is based on the alleged indefiniteness of "represented by SEQ
ID: NO. 2," we find that the phase is not indefinite for the reasons already
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discussed above. To the extent the Examiner's construction is predicated on
the phrase "an isolated polypeptide 'including a sequence having [ at least]
80% homology' to [an amino acid] sequence 'represented by' [SEQ ID NO:
2 ]" ( Ans. 12 ( emphasis added)), we find this phrase to be analogous to the
phrase "[a] nucleic acid comprising the nucleotide sequence of SEQ ID NO:
1" that is discussed in the Dec. 29, 2005 Guidance, and construe the phrase
to mean that the isolated polypeptide may include additional amino acids at
either or both ends of the sequence having at least 80% homology with the
full length of SEQ ID NO: 2.
While we disagree with the Examiner's construction of the claims,
however, the Examiner also provides an alternative basis for finding the
claims to be anticipated by Nemoto as evidenced by Hanai. As discussed
above, the Examiner finds that Nemoto teaches administration of a klotho
protein. (Ans. 8.) The Examiner further finds that the amount administered
in Nemoto must be inherently "pharmaceutically effective" and finds that
Hanai discloses an active domain of a klotho protein that has higher than
80% sequence identity to the full sequence of SEQ ID NO: 2. (Id. at 8-9.)
Given the above, the Examiner finds that "a case of inherency may be made
that Nemoto teaches Applicant's claimed method." (Id. at 9.)
Accordingly, the anticipation rejection over Nemoto as evidenced by
Hanai does not depend on adoption of the Examiner's claim construction
position, because the Examiner finds that the prior art discloses an amino
acid sequence that is at least 80% homologous with the full length of SEQ
ID NO: 2. "[W]hen the PTO shows sound basis for believing that the
products of the applicant and the prior art are the same, the applicant has the
burden of showing that they are not." In re Spada, 911 F.2d 705, 708 (Fed.
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Application 13/429,383
Cir. 1990). The Examiner has articulated a reasonable basis for finding
N emoto to inherently anticipate claim 1 in light of Hanai, and Appellants did
not file a Reply Brief disputing the Examiner's inherency findings. Given
this, we affirm the Examiner's rejection of claim 1 as anticipated by Nemoto
as evidenced by Hanai. Claims 2-3, 5, and 9, which are not separately
argued, fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
For the reasons above, we reverse the Examiner's rejection of claims
1-3, 5, and 9 as indefinite and affirm the Examiner's rejection of claims 1-3,
5, and 9 as anticipated by Nemoto as evidenced by Hanai.
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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