Ex Parte Sirbasku

Board of Patent Appeals and Interferences

Mar 25, 2010

10293440 (B.P.A.I. Mar. 25, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID A. SIRBASKU
__________

Appeal 2009-010267
Application 10/293,440
Technology Center 1600
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Decided: March 25, 2010
__________

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

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method to aid the identification of a risk for developing breast cancer. The
Patent Examiner rejected the claims as lacking enablement. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
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Application 10/293,440

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STATEMENT OF THE CASE
The invention concerns a method to aid in identifying a familial or
sporadic pattern of risk for developing breast cancer in an individual. The
method comprises screening the individual for a mutation in a gene coding
for a Poly-Ig (Fc) receptor. The Specification describes the Poly-Ig (Fc)
receptor as a tumor suppressor, and states “[w]hen this receptor is absent,
cells replicate without immune control.” (Spec. 9:[0026]).
Claims 1-6, 8, and 15-18, which are all the pending claims, are on
appeal. Claim 1 is representative and reads as follows:
1. A method to aid in identifying a familial or sporadic pattern of risk in
at least one individual for developing breast cancer, the method comprising
screening said at least one individual for a mutation in a gene coding for a
Poly-Ig (Fc) receptor capable of mediating inhibition of cancer cell growth
by an immunoglobulin.

The Examiner rejected the claims under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.

ENABLEMENT
The Issue
The Examiner’s position is that “[t]he claim(s) contain subject matter
which was not described in the specification in such a way as to enable one
skilled in the art to which it pertains, or with which it is most nearly
connected, to make and/or use the invention.” (Ans. 3). In particular, the
Examiner found that the Specification “does not evidence the
implementation of the claimed screening method for the development of
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breast cancer.” (Id. at 4). The Examiner found that Stern1 assessed levels of
secretory component (SC), known in the art as a Poly-Ig receptor, in breast
tumors from 95 patients with primary or metastatic cancer and discovered
that there was a wide variation in SC levels between the two states of cancer.
(Id.) Stern also stated that “mean SC levels were lower in metastatic tissues
than in any group of primary tumors examined.” (Ans. 4.) Therefore, the
Examiner concluded, a person of ordinary skill in the art at the time the
invention was made who reviewed Stern could not have depended upon the
Poly-Ig receptor as a predictable marker for identifying a familial or
sporadic pattern of risk for developing breast cancer comprising screening
for a mutation in a gene coding for a Poly-Ig (Fc) receptor. (Id. at 4-5).
Additionally, the Examiner found that Meric-Bernstam2 “notes while
carriers of BRCA-1 mutations do have a 60% to 85% lifetime risk of breast
cancer, the ability to predict which carrier will develop breast cancer is still
not possible.” (Ans. 5.) According to the Examiner, Meric-Bernstam
provided evidence that even for a well studied and established breast cancer
marker, methods of identifying the development of breast cancer are neither
definitive, nor clearly established. (Id.) Therefore, the Examiner concluded,
in view of the lack of guidance in the specification and the state of the art,
one of ordinary skill in the art at the time of the invention would have been
required to perform undue experimentation to practice the claimed method.
(Id.)

1 Stern, et al., Secretory Component in Breast Cancer, 19 CANCER IMMUNOL.
IMMUNOTHER. 226-230 (1985).
2 Meric-Bernstam, MD, Serum Proteomics for BRCA 1-associated Breast
Cancer, 11 ANNALS OF SURGICAL ONCOLOGY 883-884 (2004).
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Appellant contends that the Examiner has not established that undue
experimentation is required to practice the claimed method. (App. Br. 4-5;
Reply Br. 2). Specifically, Appellant asserts that neither Stern nor Meric-
Bernstam are relevant to the claimed invention. (Id.) Appellant further
asserts that contrary to the Examiner’s suggestion, the claimed invention
does not require a prediction as to which carrier of a mutation in a gene
coding for a Poly-Ig (Fc) receptor will develop breast cancer. (Id.). Rather,
the claimed method instead recites screening for the mutation “to aid in
identifying a familial or sporadic pattern of risk … for developing breast
cancer.” (Id.) According to Appellant, practicing the claimed method
would not require undue experimentation because the location for the gene
coding for a Poly-Ig(Fc) receptor has already been identified (App. Br. 4)
“only routine tests are in fact required to carry out embodiments of [the]
claimed invention” (Reply Br. 2) and further “experiments related to
identifying mutations are described throughout Examples 1-6 of the
specification.” (Appeal Br. 4).
The issue is whether the Examiner established a reasonable basis to
question the enablement of the claimed method for screening at least one
individual for a mutation in a gene coding for a Poly-Ig (Fc) receptor to aid
in identifying a familial or sporadic patter of risk.

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Findings of Fact
1. The Specification states that “the Poly-Ig (Fc) receptor or a similar
Poly-Ig-like (Fc) receptor has been identified as a tumor suppressor.”
(Spec. [0026]).
2. The Specification also states, “Evidence points to the Poly-Ig receptor
or a very similar Poly-Ig-like Fc receptor as the mediator of the
inhibitory effects of IgA and IgM.” (Spec. [0025]).
3. The Specification disclosed that the Poly-Ig receptor gene is located at
locus D1S58 on chromosome 1, “which has been proven to be a ‘hot
spot’ for allelic imbalances in more than 70% of breast cancers.”
(Id.).
4. The Specification also disclosed that the Poly-Ig receptor gene
location has 46% loss of heterozygosity …in breast cancer specimens
… and 30% incidence of allelic imbalance. (Id.).
5. Stern is a journal article that analyzed the levels of the secretory
component (“SC”), also known as the Poly-Ig receptor, in breast
tumors of patients with primary or metastatic cancer. (Stern,
Summary).
6. Stern also stated, “As measured in the blood of breast cancer patients,
SC has been shown to be elevated compared to normal controls.” (Id.
at 226).
7. Stern disclosed that the levels of SC “varied widely” in primary breast
tumor samples measured in the study. (Id. at 229).
8. Stern also disclosed that the study revealed that mean SC levels were
lower in metastatic tissues than in any group of primary tumors
examined. (Id.).
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9. Stern stated that “[t]he results suggest that SC may have importance in
providing a connection between endocrine control of tumor growth
and immune regulation leading to metastatic disease.” (Id.).
10. Meric-Bernstam is an editorial discussing BRCA-1 associated breast
cancer. (Meric-Bernstam, 883).
11. Meric-Bernstam states that “[c]arriers of deleterious BRCA-1
mutations have a 60% to 85% lifetime risk of breast cancer.” (Id.).
12. Meric-Bernstam also states that “[w]e, however, do not yet have the
ability to predict which carriers will develop breast cancer….” (Id.).

Principles of Law
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1365 (Fed. Cir. 1997)(quoting In re Wright, 999 F.2d 1557,
1561 (Fed. Cir. 1993)).
The Examiner has the initial burden to establish a reasonable basis to
question the enablement provided for the claimed invention. In re Wright at
1562.
“Factors to be considered in determining whether a disclosure would
require undue experimentation . . . . include (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance
presented, (3) the presence or absence of working examples, (4) the nature
of the invention, (5) the state of the prior art, (6) the relative skill of those in
the art, (7) the predictability or unpredictability of the art, and (8) the breadth
of the claims.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
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Analysis
We have considered the evidence proffered by the Examiner, but do
not find that the Examiner met the burden of establishing a reasonable basis
to question the enablement provided for the claimed invention. In particular,
we do not agree with the Examiner’s assertion that Stern suggests that
mutations in the Poly-Ig receptor are not dependable as a predictable marker
for identifying a familial or sporadic pattern of risk for developing breast
cancer in a method comprising screening for a mutation in a gene coding for
the receptor. While Stern discovered a wide range of SC (i.e., Poly-IG
receptors) levels in primary tumors, the reference also disclosed that
metastatic lesions had SC values which were lower as a group. (FF-7, 8).
Therefore, Stern concluded that the study “results suggest that SC may have
importance in providing a connection between endocrine control of tumor
growth and immune regulation leading to metastatic disease.” (FF-9.). This
conclusion does not cast doubt upon the usefulness of the Poly-Ig receptor,
or the usefulness of mutations in the gene coding for the receptor, to aid in
the identification of a risk for developing breast cancer. Moreover, the fact
that levels may vary in different individuals, does not mean that the claimed
screening method could not be used “to aid in identifying” breast cancer
risk, e.g. with other predisposing genes (Spec. 11-13).
We also do not share the Examiner’s opinion that Meric-Bernstam
established a reasonable basis to question the enablement for the claimed
invention. Meric-Bernstam addressed BRCA-1 mutations (FF-10) and
disclosed that carriers of the mutation “have a 60% to 85% lifetime risk of
breast cancer” (FF-11). The acknowledgement in the reference that there is
an inability “to predict which carriers will develop breast cancer” (FF-12)
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does not negate the fact that the identification of a mutation in an individual
established a risk of breast cancer. Thus, we do not find that Meric-
Bernstam supports doubting the enablement for Appellant’s method, which
is directed to identifying a pattern of risk for carriers of a mutated gene
rather than a prediction of which of those carriers will develop breast cancer.
The Specification disclosed the relevance of Poly-Ig (Fc) receptor
mutations to breast cancer. For example, the Specification stated that “the
Poly-Ig (Fc) receptor or a similar Poly-Ig-like (Fc) receptor has been
identified as a tumor suppressor” (FF-1) and that “[e]vidence points to the
Poly-Ig receptor or a very similar Poly-Ig-like Fc receptor as the mediator of
the inhibitory effects of IgA and IgM” (FF-2). The Specification also
disclosed that the Poly-Ig receptor gene is located at locus D1S58 on
chromosome 1, “which has been proven to be a ‘hot spot’ for allelic
imbalances in more than 70% of breast cancers” (FF-3) i.e., 46% loss of
heterozygosity in breast cancer specimens and 30% incidence of allelic
imbalance (FF-4).
We find the Specification supports Appellant’s arguments that
(i) “only routine tests are in fact required to carry out embodiments of [the]
claimed invention” (Reply Br. 2), and (ii) “experiments related to identifying
mutations are described throughout Examples 1-6 of the specification” (App.
Br. 4). Therefore, we do not find that the Examiner has established that the
Specification failed to teach those skilled in the art how to make and use the
full scope of the claimed invention without undue experimentation. See
Genentech, Inc. at 1365. Consequently, the Examiner has not satisfied the
burden of establishing a reasonable basis to question the enablement of the
claimed method. See Wright at 1562.
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CONCLUSION OF LAW
We do not find that the Examiner established a reasonable basis to
question the enablement of the claimed method for screening at least one
individual for a mutation in a gene coding for a Poly-Ig (Fc) receptor to aid
in identifying a familial or sporadic pattern of risk.

SUMMARY
We reverse the rejection of claims 1-6, 8, and 15-18. No time period
for taking any subsequent action in connection with this appeal may be
extended under 37 C.F.R. § 1.136(a).

REVERSED

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