Ex Parte GEORGIOU et al

Patent Trial and Appeal Board

Feb 13, 2019

14472779 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/472,779 08/29/2014
108197 7590 02/15/2019
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
FIRST NAMED INVENTOR
George GEORGIOU
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.
UTSB.Pl017US 8633
EXAMINER
MONSHIPOURI, MARYAM
ART UNIT PAPER NUMBER
1656
NOTIFICATION DATE DELIVERY MODE
02/15/2019 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE GEORGIOU and EVERETT STONE 1
Appeal2017-006568
Application 14/472,779
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
RACHEL H TOWNSEND, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134(a) from the Examiner's Final
Rejection of claims 1-24, to a modified enzyme which have been rejected
1 Appellants identify the Real Party in Interest as Board of Regents of the
University of Texas System. Br. 3.
2 We have considered and herein refer to the Specification of Aug. 29. 2014
("Spec."); Final Office Action of Oct. 28, 2015 ("Final Act."); Appeal Brief
of Mar. 7, 2016 ("Br."); Response to Non-Compliant Appeal Brief of Sept.
6, 2016 ("Response"); Examiner's Answer of Jan. 17, 2017 ("Ans."); and
Reply Brief of Mar. 1 7, 2017 ("Reply Br.").
Appeal2017-006568
Application 14/472,779
for non-statutory, obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b ). 3
We REVERSE.
STATEMENT OF THE CASE
"Systemic depletion of various amino acids has been shown to be
effective in killing a wide variety of tumor types with minimal toxicity to
non-cancerous tissues." Spec. ,r 4. "Certain cancers, such as prostate, small
cell lung carcinomas, glioblastomas, and hepatocellular carcinomas, have
been shown to be heavily dependent on extracellular cysteine/cystine in
order to proliferate and survive." Id. "A therapeutic that depletes both
cystine and cysteine can thus completely deprive tumors of this essential
metabolite." Id. The Specification describes "a modified polypeptide,
particularly an enzyme variant with L-cyst( e )ine degrading activity derived
from primate enzymes related to cystathionine-y-lyase (CGL) enzymes."
Spec. ,r 6.
Claims 1-124 are on appeal. Claim 1 is representative and reads as
follows:
1. An isolated, modified primate cystathionine-y-lyase
(CGL) enzyme having at least one substitution relative to a
native primate CGL amino acid sequence (see SEQ ID NOs: 1
and 7-10), said at least one substitution including a threonine at
position 59 of the native primate CGL sequence.
Response, Claims Appendix.
3 Arguments were heard on Feb. 5, 2019. A copy of the transcript will be
added to the record when it becomes available.
4 Appellants canceled claims 13-24. See Response 2.
2
Appeal2017-006568
Application 14/472,779
The claims stand rejected as follows:
Claims 1---6 have been rejected for non-statutory obviousness-type
double patenting over claims 1-19 of Georgiou I. 5
Claims 1-12 have been rejected for non-statutory obviousness-type
double patenting over claims 1-12 of Georgiou II. 6
Claims 1-12 have been rejected for non-statutory obviousness-type
double patenting over claims 1-10 of Georgiou III. 7
DISCUSSION
Issue
The issue is the same for all three rejections. Therefore we shall treat
the rejections together.
The issue is whether the Examiner has established that the invention
defined in the present claims are an obvious variation of the inventions
disclosed and claimed in the Georgiou patents.
The Examiner finds that the crystal and amino acid structures of GCL
enzymes is known in the prior art. Ans. 4. The Examiner finds that it was
known in the art that the amino acid at position 59 is involved in creating
5 Georgiou et al. US 8,709,407 B2, issued Apr. 29, 2014 ("Georgiou I").
6 Georgiou et al., US 9,279,119 B2, issued Mar. 8, 2016. The Final Action
refers to claims 1-32 ofUSSN 14/225,518. Final Act. 4. That application
matured into Georgiou II with claims 1-12 which correspond to original
claims 1-12 as amended.
7 Georgiou et al., US 9,481,877 B2, issued Nov. 11, 2016 ("Georgiou III").
The Final Action refers to claims 1-28 ofUSSN 14/472,750. Final Act. 4.
That application issued as Georgiou III with claims 1-10 which correspond
to claims 4, 11, 14, 15, and 18-23. Georgiou I, II, and III will be
collectively referred to as "the Georgiou patents."
3
Appeal2017-006568
Application 14/472,779
structural flexibility at an active site and is a conserved residue. Id. The
Examiner concludes
based on this extensive knowledge in the prior art regarding the
structures of y- lyases, before the effective filing date of the
claimed invention-, substitution at position 59 of CGL
enzymes, including those instantly claimed (with one of the 22
known and natural amino acids), was readily motivating and
obvious, as it would reasonably be expected to result in some
degree of increase or decrease ( alteration) in enzymatic activity,
depending on the specific amino acid substitution. Since, as
applicant is aware, the list of natural amino acids is not
exhaustive, such substitution attempt followed by a well-
established CGL assay is neither undue experimentation nor
beyond the skill of ordinary artisan.
Ans. 4--5.
Appellants contend that the claimed substitution at position 59 of the
native primate CGL sequence is different from those suggested by the
reference claims and produced an enzyme that has improved activity over
the native primate enzyme. Appeal Br. 4. Appellants also argue that the
Examiner has not cited any reference which suggests the claimed
substitution or provides a motivation to make the substitution. Appeal Br.
5-6. Appellants also argue that the claimed substitution unexpectedly
results in different substrate specificity. Reply Br. 2; see also Appeal Br. 4.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case ofunpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
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Application 14/472,779
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"[T]he law of obviousness-type double patenting looks to the law of
obviousness generally. As ... explained in Amgen, '[t]his part of the
obviousness-type double patenting analysis is analogous to an obviousness
analysis under 35 U.S.C. § 103."' AbbVie Inc. v. The Mathilda and
Terrence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1378-79
(Fed. Cir. 2014).
Where a prior art reference provides only "an invitation to scientists to
explore a new technology that seems a promising field of experimentation,"
and gives only general guidance and is not at all specific as to the particular
form of the claimed invention and how to achieve it, it may make an
approach 'obvious to try' but it does not make the invention obvious. In re
0 'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)
Analysis
We have considered the arguments presented by both the Examiner
and Appellants and conclude that Appellants have the better position. We
agree with Appellants that the Examiner has not articulated a sufficient
reason why one skilled in the art would make the specific substitution
recited in the claims.
While we agree with the Examiner that the reference patents teach
that a substitution at position 59 may affect the performance of the enzyme,
the Examiner points to nothing in the record to support the conclusion that
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Application 14/472,779
the specific substitution recited in the claims would likely be successful
resulting in a functional enzyme, much less one that would result in an
improved activity or a different specificity. Following the Examiner's
rubric, one skilled in the art would need to test 18 8 different amino acid
substitution to see if any of them changes the activity of the enzyme. This is
at best an invitation to experiment, not a teaching or suggestion which would
render the claimed substitution obvious.
Appellants have argued that the claimed substitution results in a novel
enzyme with exhibits an unexpected property- degradation of cyst( e )ine.
Reply Br. 2. While we do not address the issue of whether this new property
was unexpected, we note that Appellants are arguing a limitation that is not
present in the claims. See, In re Dill, 604 F. 2d 1356, 1361 (CCPA 1979)
("The evidence presented to rebut a prima facie case of obviousness must be
commensurate in scope with the claims to which it pertains.") For example,
claim 1 of Georgiou I and II recite the limitation that the claimed enzyme
"has methionine gamma-lyase activity." Georgiou I, col. 55, 1. 58; Georgiou
II col. 63, 1. 22. Nothing similar appears in the claims on appeal.
Conclusion of Law
We conclude that the Examiner has not established that the invention
defined in the present claims are an obvious variation of the inventions
disclosed and claimed in the Georgiou patents.
8 The Georgiou patents claim three amino acid substitutions for the glutamic
acid present at position 59, asparagine, isoleucine and valine. There are 22
amino acids that can be used.
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Application 14/472,779
SUMMARY
We reverse the rejections for non-statutory obviousness-type double
patenting.
REVERSED
7