Ex Parte Ledley

Board of Patent Appeals and Interferences

Jun 9, 2011

10200978 (B.P.A.I. Jun. 9, 2011)

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.
10/200,978 07/23/2002 Fred David Ledley 062324-0401 4987
30542 7590 06/09/2011
FOLEY & LARDNER LLP
P.O. BOX 80278
SAN DIEGO, CA 92138-0278
EXAMINER
SKIBINSKY, ANNA
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
06/09/2011 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 FRED DAVID LEDLEY
____________

Appeal 2010-002891
Application 10/200,978
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2010-002891
Application 10/200,978

2
This is a decision on the appeal under 35 U.S.C. § 134 by the Patent
Applicant from the Patent Examiner’s obviousness rejections of claims 3,
10, 30, 33, 34, 37, 40, 41, and 46. The Board’s jurisdiction for this appeal is
under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF CASE
The Patent Examiner rejected the claims as obvious under 35 U.S.C.
§ 103(a) as follows:
1. Claims 3, 10, 30, 33, 34, 40, and 41 as unpatentable in view of
Quattrocchi,1 Rappaport,2 and Allan3 (Ans. 4); and
2. Claims 34,4 37, and 46 as unpatentable in view of Quattrocchi,
Rappaport, Allan, and McKinnon5 (Ans. 7).
Claim 3 is representative and reads as follows:
3. A method for performing an ongoing assessment of genetic
risk for an individual concerned about a specific clinical
outcome, said method comprising the steps of:
obtaining said individual’s consent for genetic testing and
assessment of genetic risk for a clinical outcome;
providing a mechanism for obtaining a biological sample
for DNA testing from said individual;
testing said biological sample for genes and gene
variations known to be involved in said genetic risk for said
clinical outcome;

1 U.S. Patent No. 5,978,466 issued Nov. 2, 1999.
2 U.S. Patent App. Pub. 2002/0007285 A1 published Jan. 17, 2002.
3 U.S. Patent App. Pub. 2004/0029138 A1 published Feb. 12, 2004.
4 The Examiner included claim 34 in the statement of both rejections.
5 Wendy C. McKinnon et al., The Familial Cancer Program of the Vermont
Cancer Center: Development of a Cancer Genetics Program in a Rural
Area, 6 JOURNAL OF GENETIC COUNSELING 2,131-143 (1997).
Appeal 2010-002891
Application 10/200,978

3
notifying said individual a first time and counseling said
individual about the result of said testing of said biological
sample from said individual and assessment of risk relating to
the development of said clinical outcome;
recording said individual’s identity, consent record,
contact information, clinical concerns and genetic test results in
a secure and private manner;
monitoring genomic research for genes and gene
variations that contribute to said clinical outcome;
notifying said individual a second time when said step of
monitoring genomic research identifies newly discovered genes
and gene variations or additional information about genes or
gene variations that contribute to said risk for said clinical
outcome;
wherein said monitoring and notifying are performed
subsequent to the other steps;
providing a mechanism to store said biological sample;
retesting said biological sample for said newly
discovered genes and gene variations that contribute to said
risk; and
recounseling said individual on said test results and
current assessment of said risk.

DISCUSSION
Rejection 1
Claim 3 is directed to a method “for performing an ongoing
assessment of genetic risk for an individual concerned about a specific
clinical outcome.” The method comprises “testing” a sample from an
individual “for genes and gene variations known to be involved in said
genetic risk for” a “clinical outcome,” counseling the individual,
“monitoring genomic research for genes and gene variations that contribute
to said clinical outcome,” and “retesting” the sample for the “newly
Appeal 2010-002891
Application 10/200,978

4
discovered genes and gene variations.” Counseling is also provided after the
retesting step.
In sum, the method requires two steps of genetic testing, and
counseling after each step. The second step of genetic testing is for genes
and gene variations discovered after the first genetic test was performed.
The Examiner found that Quattrocchi taught an HIV anonymous
testing kit which described testing a sample obtained from an individual and
counseling the individual based on the test result (Ans. 4-5). However, the
Examiner found that Quattrocchi did not describe “monitoring genomic
research for genes, gene variations that contribute to the clinical outcome
and notifying an individual when the monitoring of genomic research
identifies newly discovered genes, gene variations or additional information
about genes, and retesting as recited” in the claim (Ans. 5). For these
additional steps, the Examiner cited Rappaport and Allan.
According to the Examiner, Rappaport taught “a method for
monitoring and providing information about a medical procedure that
involves querying a database for reports related to genetic tests, molecular
profile tests, and genetic medicine (par. [0032])” and providing that
information to users (Ans. 5-6).
Allan was characterized by the Examiner as describing:
. . . tests for gene based markers and marker panels derived
from DNA as well as the study of genetic traits (par. 0004 and
0013) and biological DNA samples (par. 0014 and 0023).
Allan et al. further teach a plurality of testing after individual
patient consent has been received (as in claims 30 and 33) (par.
0025).
Allan also teaches genetic testing and drug therapy
wherein genetic tests are run routinely (i.e. retesting) as new
Appeal 2010-002891
Application 10/200,978

5
medical response profiles (based on an allelic profiles, par.
0003) become available.
(Ans. 6.)
The Examiner concluded that it would have been obvious to apply
Quattrocchi’s HIV method to genetic testing based on Rappaport, which
teaches monitoring databases for information on new genes and Allan’s
teaching that “genetic testing is important in applying knowledge of how a
person will respond to drug therapy (par. 0004-0006)” and its “explicit
guidance to retest patients when new genetic tests are available (par. 25,
lines 17-20).” (Ans. 6-7.)

Issues
Appellant contends that the Examiner did not establish prima facie
obviousness of the claimed subject matter. Appellant argues:
• The application has been pending for over six years. Previously
pending rejections were withdrawn. “The combination of the newly
discovered references is not obvious because no one has done so in the more
than six years since these two references were first publicly available.”
(App. Br. 9.) “The fact that Appellant has been able to successfully
overcome multiple rejections over multiple references by multiple examiners
is evidence that the instant application is not obvious.” (Id.)
• The cited prior art publications do “not teach monitoring genomic
research and notifying an individual a second time when newly discovered
genes or gene variations are identified, as required by the instant claims.”
(Id. at 10-11.)
• The cited prior art publications do not “teach retesting the individual
for the newly discovered genes or gene variations and recounseling with the
Appeal 2010-002891
Application 10/200,978

6
results of the retesting and a current assessment of risk as required by claim
3.” (Id. at 11.)
• The Examiner misconstrued the counseling step of claim 3 (App. Br.
14-15; Reply Br. 6-7).

Six years since application pending; previous rejections withdrawn
It is well-established that “[a]bsent a showing of long-felt need or the
failure of others, the mere passage of time without the claimed invention is
not evidence of nonobviousness.” Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004); accord In re Kahn, 441 F.3d
977, 990-91 (Fed. Cir. 2006). Consequently, the fact that no one combined
“the newly discovered references . . . in the more than six years since these
two references were first publicly available” is insufficient by itself to
establish nonobviousness of the claimed invention (App. Br. 9.)
Evidence that previous rejections were made and then withdrawn by
patent examiners is also not persuasive evidence by itself of nonobviousness.
Appellant did not describe the reason why the previous rejections were
withdrawn and how deficiencies in the previous rejections cast doubt on the
rejection now at issue in this appeal.
In making an obviousness determination, the Examiner must first
identify how the claimed invention differs from the prior art. After such
differences have been ascertained, a reason must be provided as to why
persons of ordinary skill in the art would have made the claimed subject
matter. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007). When
making this determination, the scope of the prior art and level of ordinary
skill must be considered. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
Appeal 2010-002891
Application 10/200,978

7
Appellant did not explain how withdrawal of previous rejections impacts
any of the factors pertinent to an obviousness determination.
Furthermore, while secondary considerations must be considered
when determining the obviousness of a claim under 35 U.S.C. § 103, the
evidence of previously withdrawn rejections, without more explanation,
does not outweigh the strong case of obviousness established here.

Prior art does not teach monitoring, notifying an individual, retesting, and
counseling steps
In attacking the rejection, Appellant largely focuses on alleged
deficiencies in the publications by Quattrocchi and Rappaport, particularly
their alleged failure to monitor and test for “newly discovered” genes (App.
Br. 11-13). However, the Examiner also cited Allan for its teaching of
monitoring for genes and retesting DNA. Allan taught:
In summary, the invention is a method of using biological
markers for the development and prescribing of medicines, such
method comprising the steps of obtaining a biological sample
from a patient; delivering the sample to a centralized analysis
and storage facility; genotyping the sample at the facility,
electronically providing the genotype analysis back to said
patient upon request by said patient or said patient's healthcare
provider in order to enable said healthcare provider to form a
judgement as to the most appropriate drug to administer to said
patient in view of said patient's genotype. . . ..
(Allan at ¶ [0006]; emphases added.) Thus, Allan describes DNA testing
(“genotyping”) as in claim 1.
Allan also describes “monitoring its own “genomic research” for
genotypes involved in a response to a drug, where the genotype corresponds
Appeal 2010-002891
Application 10/200,978

8
to the “genes and gene variations” and the drug response corresponds to the
“clinical outcome” of claim 1. Allan disclosed:
. . . contemporaneously electronically providing the genotype
analysis to a peer review body for data analysis and then
transmitting such analyzed data to a database so as to enable
discovery of one or more associations between a given
genotype and a given response to a given drug; and optionally
contemporaneously electronically providing the reviewed data
and/or the discovered associations back to the facility.
(Id.at ¶ [0006]; emphases added.) Thus, Allen suggests monitoring genomic
research for “newly discovered genes and genes variations.”
Allan also describes retesting of samples for newly discovered genes
as in claim 1:
Additional MRP [medical response profile] tests will be run
routinely as new MRP profiles [such as single nucleotide
polymorphisms at ¶ [0003]] become available and the data will
be added to existing databases for future reference.
(Id. at ¶ [0025].)
Appellant contends that the Examiner mischaracterized the quoted
disclosure:
The “additional MRP [medical response profile] tests” referred
to in Allan merely indicate that the normal battery of tests for
assessing a medical response profile should take into account
the most current information available at the time of testing.
See e.g., Allan, ¶ [0025]. Allan does not disclose, teach or
suggest that new developments are communicated to a person
who has already been tested.
(Reply Br. 5.)
This argument is not persuasive. Allan expressly calls for
“[a]dditional” tests as new data becomes available (Allan at ¶ [0006]).
While Allan in this paragraph did not state that such results would be
Appeal 2010-002891
Application 10/200,978

9
communicated to the patient, it would be understood that the objective of
retesting is to determine whether new gene variations have been identified
that would predict the patient’s response to a drug. Such retesting results
would therefore be highly pertinent to the patient and would undoubtedly be
the type of information the patient would want to know to improve the
outcome of his medical care.
Allan also teaches that individuals who have been identified as non-
responders to a drug may become part of a subsequent clinical trial to look
for alternative genotypes involved in the drug response (id. at ¶ [0127]).
Moreover, Allan recognizes that “current technologies are providing
such [genetic] markers at an extremely rapid rate.” (Id. at ¶ [0004].)
The evidence from Allan (¶¶ [0004], [0006], & [0027]), as well as the
other publications cited by the Examiner (Ans. 6-7 & 10), establish that
persons of ordinary skill in the art would have understood that databases for
genetic markers are constantly being expanded as new markers are added
(e.g., Allan at ¶ [0004]). Thus, an individual might test negative for a
genetic marker because of the marker’s absence from the database.
However, as new genetic marker discoveries are added to the database,
healthcare providers would had reason to retest the individual to determine
whether a predictive clinical genotype has since been discovered which the
individual would benefit from. Given the importance of such information to
treatment outcome, it is medical commonsense that the information would
have been communicated to the patient.
An obviousness “analysis need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
Appeal 2010-002891
Application 10/200,978

10
the art would employ.” KSR, 550 U.S. at 418. In view of the rapid rate of
genetic marker discovery, the ordinary skilled worker would certainly have
had reason to monitor and retest individuals to determine whether new
variations have been discovered that would aid in the individual’s care.
Appellant’s arguments regarding Quattrocchi and Rappaport are
unavailing because, combined with Allan’s teachings, the skilled worker
would have recognized a need to retest individuals for newly discovered
genotype associations.
Appellant contends that claim 3 requires counseling after the first test
and that the Examiner improperly interpreted the claim to read on “pre-test
counseling” instead (Reply Br. 6).
We agree with Appellant that claim 3 would be understood by the
ordinary skilled worker to require counseling after the first DNA test.
However, this step is suggested by the cited prior art. As noted by the
Examiner, Quattrocchi teaches offering counseling to a person told the test
results, and encouraging the patient to speak with a counselor (Ans. 12;
Quattrocchi at col. 4, ll. 18-20 & 25-27). Thus, the preponderance of the
evidence shows that the counseling after a medical test was known in the art.
Moreover, it is medical commonsense that counseling by a professional
would be provided to a patient to explain the results of a genetic test because
the patient might lack the knowledge and expertise to understand it.
For the foregoing reasons, we affirm the rejection of claim 3. Claims
10, 30, 33, 34, 40, and 41 were not separately argued and therefore fall with
claim 3. See 37 C.F.R. § 41.37(c)(1)(vii).

Appeal 2010-002891
Application 10/200,978

11
Rejection 2
Appellant contends that McKinnon does not “cure the deficiency” of
the rejection 1 over Quattrocchi, Rappaport, and Allan (App. Br. 16). As
Appellant has not identified an error in the Examiner’s rejection, and we find
none after review, we affirm the rejection of claims 34, 37, and 46 over
Quattrocchi, Rappaport, Allan, and McKinnon.

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

bim