Ex Parte Matson

Board of Patent Appeals and Interferences

Jan 28, 2011

11323844 (B.P.A.I. Jan. 28, 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.
11/323,844 12/30/2005 Wayne Matson 067407-5179-US03 4464
67374 7590 01/31/2011
MORGAN, LEWIS & BOCKIUS, LLP (SF)
ONE MARKET SPEAR STREET TOWER
SAN FRANCISCO, CA 94105
EXAMINER
KIM, YOUNG J
ART UNIT PAPER NUMBER
1637
MAIL DATE DELIVERY MODE
01/31/2011 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 WAYNE MATSON
__________

Appeal 2010-006917
Application 11/323,844
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a cancer
screening method. The Examiner has rejected the claims as nonenabled.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-006917
Application 11/323,844

2
STATEMENT OF THE CASE
Claims 19, 23, 28, 32, and 33 are on appeal. Claims 20-22, 24-27,
and 29-31 are also pending but have been withdrawn from consideration.
(App. Br.2 6.)
We will focus on claim 19, which is the only independent claim on
appeal. According to the Second Amended Appeal Brief, claim 19 reads as
follows:
19. A screening method for detecting cancer in an individual human
comprising collecting samples of cellular and extracellular materials from
selected areas of the body of said individual and analyzing said samples for
elevated free levels of nucleotide excision products in the extracellular as
compared to the cellular material, wherein the nucleotide excision products
analyzed are selected from the group consisting of 8-hydroxy-
2'-deoxyguanosine, O-6-methylguanine, 2'-deoxyguanosine,
7-methylguanine, 8-nitroguanine, 8-hydroxyguanine, dA-8-hydroxy-
2-deoxyadenosine, 8-hydroxyandenine [sic], 5-hydroxy-2'-deoxycytidine,
5-hydroxyuracil, 3-nitrotyrosine and 3-chlorotyrosine, and wherein
increased levels of said nucleotide excision products indicate of [sic] cancer
of said selected body areas, and generating a signal based on said analysis.
(App. Br. 21: Appendix A.)3
Claims 19, 23, 28, 32, and 33 stand rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the enablement requirement
(Ans. 3). The Examiner finds:

2 “App. Br.” refers to the Second Amended Appeal Brief dated January 19,
2010.
3 Claim 19 as set forth in Appendix A of the Second Amended Appeal Brief
is not entirely consistent with claim 19 as set forth in the Amendment dated
May 1, 2008 (the most recent amendment of the claims). The differences in
claim language between the amendment and claims appendix do not affect
our disposition of the issue on appeal.
Appeal 2010-006917
Application 11/323,844

3
The instant specification appears to give some examples drawn
to the method of detecting or assessing the risk of cervical
cancer based on the above discussed comparisons, with
examples showing elevated levels of particular nucleotide
excision products in extracellular samples. However, the
specification is completely hypothetical with regard to any other
types of cancer and is completely lacking in providing any data
with respect to this hypothesis.
(Id. at 4.) The Examiner concludes that the “issue of enablement is drawn to
whether such generalization can be made for other cancers[, specifically the
elected species, lung cancer,] without any factual showing and specific
guidance drawn to other types of cancer, which is known in the art to
involve extremely complex mechanism” (id.).
ISSUE
Has the Examiner set forth a prima facie case that the full scope of
claim 19 is not enabled?
FINDINGS OF FACT
1. The Specification states:
[T]he present invention provides an analytical technique for
detecting cancer or other disease and/or health conditions based
on measurement of free levels of nucleotide excision products
resulting from DNA or RNA damage, such as 8OH2'dG-8
hydroxy 2' deoxyguanosine; . . . in biological samples from
selected areas of the body. More particularly, the present
invention is based on the hypothesis that specific areas of the
body are semi-isolated in-situ biochemical environments for
nucleotide excision products such as 8OH2'dG . . . , and that the
levels of such free 8OH2'dG . . . in the semi-isolated
environment magnify the combined defects of DNA or RNA
damage and repair mechanisms. By way of specific example,
the effective damage and repair rate increases in DNA in
cancer, or pre-cancerous cells, has been found to be magnified
Appeal 2010-006917
Application 11/323,844

4
by accumulation in the extra-cellular matrix in selected areas of
the body of 8OH2'dG. For example, as applied to cervical
cancer, the cervix has been found to be a semi-isolated in-situ
biochemical environment which may be accessed through
cervico vaginal lavage sampling.
(Spec. 2-3.)
2. The Specification includes an example concerning the use of
cervico vaginal lavage samples in the diagnosis of cervical cancer (id. at 9-
19).
3. The Specification also states:
The invention is susceptible to modification. For example, . . .
pharyngeal or nasal swab, alveolar or bronchial lavage samples
for analysis of 8OH2'dG normalized against levels of
4-Hydroxy Phenyl lactic acid may be employed as a diagnostic
of pharyngeal, nasal, bronchial or lung cancer respectively;
[and] . . . analysis of phlegm for elevated levels of 8OH2'dG
may be employed to provide an early test for lung cancer.
(Id. at 19-20.)
4. In addition, the Specification states:
Preliminary work shows three fold elevations of 8OH2'dG in
sputum and pharyngeal swabs in smokers. The absolute levels
of 8OH2'dG are 10-30 times greater than in plasma which
supports an initial hypothesis that the respiratory tract is a semi-
isolated physiological transport limited area in which the
process of DNA damage and repair will be magnified.
(Id. at 26.)
PRINCIPLES OF LAW
When rejecting a claim under the enablement
requirement of section 112, the PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that
the scope of protection provided by that claim is not adequately
enabled by the description of the invention provided in the
Appeal 2010-006917
Application 11/323,844

5
specification of the application; this includes, of course,
providing sufficient reasons for doubting any assertions in the
specification as to the scope of enablement.
In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
ANALYSIS
As noted by the Examiner, the Specification includes an example
concerning the use of cervico vaginal lavage samples in the diagnosis of
cervical cancer (Ans. 4; Finding of Fact (FF) 2). In addition, the
Specification states that its concept can be used for other cancers, including
lung cancer (FF 3). The Examiner has not adequately explained why this
assertion would have been doubted by those of ordinary skill in the art.
We note the Examiner’s reliance on Rasmusson v. SmithKline
Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005). However, in that case, the
Federal Circuit found that there was substantial evidence supporting the
Board’s finding “that a person of ordinary skill in the art would not have
believed that [the claimed compound] was effective in treating prostate
cancer.” Id. at 1324. Here, the Examiner has not provided sufficient
evidence tending to show that the claimed method would not have been
expected to detect cancer.
The Examiner does rely on Maeng4 for demonstrating that nucleotide
excision products are greatly elevated in cellular samples exposed to a toxic
agent, hexavalent chromium (Ans. 7 & 15). However, it is not seen how this
teaching is contrary to Appellant’s claim that increased levels of nucleotide

4 Maeng et al., Changes of 8-OH-dG levels in DNA and its base excision
repair activity in rat lungs after inhalation exposure to hexavalent
chromium, 539 MUTATION RESEARCH 109-116 (2003).
Appeal 2010-006917
Application 11/323,844

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excision products in the extracellular materials as compared to in the cellular
materials is associated with cancer. Moreover, as noted by Appellant, the
claims are directed to a screening method not to a definitive diagnosis of a
specific cancer (Reply Br. 2).
CONCLUSION
The Examiner has not set forth a prima facie case that the full scope of
claim 19 is not enabled. We therefore reverse the enablement rejection.

REVERSED

cdc

MORGAN, LEWIS & BOCKIUS, LLP (SF)
ONE MARKET SPEAR STREET TOWER
SAN FRANCISCO, CA 94105