Ex Parte Cohenford et al

Board of Patent Appeals and Interferences

Apr 12, 2010

10323188 (B.P.A.I. Apr. 12, 2010)

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.
10/323,188 12/18/2002 Menashi A. Cohenford 11.018011 DIV 6778
38732 7590 04/12/2010
CYTYC CORPORATION
Darry Pattinson, Sr. IP Paralegal
250 CAMPUS DRIVE
MARLBOROUGH, MA 01752
EXAMINER
CHUNDURU, SURYAPRABHA
ART UNIT PAPER NUMBER
1637
MAIL DATE DELIVERY MODE
04/12/2010 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 MENASHI A. COHENFORD and BRIAN LENTRICHIA
__________

Appeal 2009-010429
Application 10/323,188
Technology Center 1600
__________

Decided: April 12, 2010
__________

Before ERIC GRIMES, LORA M. GREEN, 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 for detecting the presence of a target nucleic acid of a human
papilloma virus (HPV) in a sample cell. The Patent Examiner rejected the
claims as failing to comply with the written description requirement and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
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STATEMENT OF THE CASE
The invention concerns a method for detecting an HPV nucleic acid
by hybridizing a peptide nucleic acid (PNA) probe with the HPV nucleic
acid. After first suspending the sample cell in a cell preservative solution,
the method performs the subsequent steps in the same cell preservative
solution.
Claims 17, 19-34, and 38 which are all the pending claims, are on
appeal. Independent Claim 17 reads as follows:
17. A method for detecting the presence of a target nucleic acid of a
human papilloma virus (HPV) in a sample cell, comprising the steps of:
suspending a sample cell that may comprise a target nucleic acid of a
HPV in a cell preservative solution;
separating said target nucleic acid from said sample cell wherein said
separated target nucleic acid remains in said cell preservative solution
wherein said cell preservative solution comprises an alcohol in an amount
sufficient to preserve said sample cells without coagulation;
contacting said target nucleic acid in said cell preservative solution
with at least one probe comprising at least one peptide nucleic acid (PNA),
said at least one probe being substantially complementary to portions of
nucleic acids of multiple HPV types;
allowing said at least one probe to hybridize with said target nucleic
acid, if present, in said cell preservative solution; and
detecting hybridization between said at least one probe and said target
nucleic acid in said solution;
wherein the detection of said hybridization is indicative of the
presence of a target nucleic acid of a HPV in a sample cell.

The Examiner rejected the claims as follows:
• claims 17, 19-34 and 38 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement;

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• claims 17, 19-27, 29-34, and 38 under 35 U.S.C. § 103(a) as
obvious over the combination of Kroeger1 and Lorincz;2 and
• claim 28 under 35 U.S.C. § 103(a) as obvious over the combination
of Kroeger, Lorincz, and Hyldig-Nielsen.3

WRITTEN DESCRIPTION
The Issue
The Examiner’s position is that claims 17, 19-34 and 38 contain
subject matter which was not described in the Specification in such a way as
to reasonably convey to one skilled in the art that the inventors had
possession of the claimed invention at the time the application was filed.
(Ans. 4). Specifically, the Examiner found that the following claim
limitations represent new matter:
(a) “separated nucleic acid remains in said cell preservative
solution;”
(b) “contacting target in said cell preservative solution with a
probe;”
(c) “allowing said at least one probe to hybridize with said target
nucleic acid in said cell preservative solution;” and
(d) “detecting hybridization in said solution.”
(Id. at 5, emphasis added). The Examiner found that the Specification as
filed did not describe “said cell preservative solution” as being used in each

1 Patent Application Publication No. WO 98/17829 by Paul Kroeger et al.,
published Apr. 30, 1998.
2 US Patent No. 6,969,585 B2 issued to Lorincz et al., Nov. 29, 2005.
3 US Patent No. 6,169,169 B1 issued to Hyldig-Nielsen et al., Jan. 2, 2001.
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of the method steps as is now claimed. (Id., citing Spec. pp. 12-18, Ex. 1-3).
According to the Examiner, the Specification examples instead recite that
the sample cells were suspended in preservative solution and DNA was
extracted or separated from said solution and hybridization was carried out
in hybridization solution. (Id. at 6). The Examiner found that the
Specification as filed lacks support for performing each of the recited
method steps “in said cell preservation solution.” (Id.)
Appellants contend that the challenged claim phrase is supported by
the Specification as filed. In particular, Appellants assert that the
Specification stated “Hybridization screening … also may be performed in a
preservative solution, such as PreservCyt®, thereby combining cytological
screening of a patient sample (e.g., a PAP smear) with HPV screening.”
(App. Br. 6-7, quoting Spec. at p. 5, ll. 25-27). According to Appellants,
because the Specification stated that hybridization screening may be
performed in a preservative solution, “[i]t is therefore axiomatic that all
steps in the hybridization screening (i.e., the isolation, hybridization and
detection of HPV in a patient sample) would be performed in the
preservative solution.” (App. Br. 7). Further, Appellants assert that “one of
skill in the art would be familiar with different types of hybridization
screening which inherently included a step of separating a target nucleic acid
from a cell sample….” (Id. at 8).
The issue with respect to this rejection is whether Appellants have
established that the claim steps involving “said cell preservation solution”
were supported by the disclosure as filed and are not new matter.

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Findings of Fact Related to the Written Description Issue
1. The Specification as originally filed stated, “Hybridization screening
… also may be performed in a preservative solution, such as
PreservCyt®, thereby combining cytological screening of a patient
sample (e.g., a PAP smear) with HPV screening.” (Spec. at p. 5, ll.
25-27).

Principles of Law
“The test for determining compliance with the written description
requirement is whether the disclosure of the application as originally filed
reasonably conveys to the artisan that the inventor had possession at the time
of the later claimed subject matter, rather than the presence or absence of
literal support in the specification for the claimed language.” In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983) (citations omitted).

Analysis
We agree with Appellants that the Examiner has not provided
sufficient factual basis to support finding that the limitation in question
introduces new matter into the application disclosure. Rather, the Examiner
has relied upon the fact that the examples in the Specification did not
describe performing the challenged method steps in cell preservative
solution. However, as Appellants have correctly asserted (App. Br. 6-8) the
Specification expressly disclosed that hybridization “may be performed in a
preservative solution….” (FF-1). While the Specification did not expressly
describe separating the target nucleic acid from the cell sample, wherein the
target nucleic acid remains in the cell preservative solution and then
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contacting said target nucleic acid in said cell preservative solution, a skilled
artisan would have understood that the disclosure’s reference to the
hybridization reaction included these steps. Therefore, we find that the
Specification, as a whole, reasonably conveys to a person having ordinary
skill in the art that the inventors had possession of the subject matter in
question at the time the present application was filed. See Kaslow, 707 F.2d
at 1375.
Accordingly, we reverse the Examiner’s rejection of claims 17, 19-34
and 38 under § 112, ¶ 1.

OBVIOUSNESS
The Issue
The Examiner concluded that claims 17, 19-27, 29, 34, and 38 would
have been obvious over the combination of combination of Kroeger and
Lorincz. (Ans. 6, 9). Specifically, the Examiner found that Kroeger taught
the claimed method for detecting the presence of a target nucleic acid of a
HPV in a sample cell, with the exception of not specifically teaching the use
of the cell preservative solution in each processing step. (Id. at 6-8).
The Examiner found that Lorincz disclosed a universal collection
medium to analyze cell morphology and biochemical analysis in solution
phase. (Id. at 8). In particular, the Examiner found that Lorincz taught that
the “universal collection medium allows a single cell sample to be used for
multiple assays of different types with a minimum number of assay-specific
processing steps required.” (Id.). According to the Examiner, this meant
that the collection medium could be used to analyze multiple assays “in a
single cell sample….” (Id. at 13, emphasis added). Therefore, the Examiner
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concluded that it would have been obvious to a person of ordinary skill in
the art at the time the invention was made to combine Kroeger’s method of
detecting the presence of HPV in a sample with a method of using a
universal collection medium to carry out multiple assays as taught by
Lorincz to reduce processing time and the number of samples required to
perform different assays. (Id.).
The Examiner separately rejected dependent claim 28 as obvious
based on Kroeger and Lorincz, further combined with Hyldig-Nielsen. (Id.
at 9-10).
Appellants contend that the claims would not have been obvious over
the combined prior art because neither Kroeger nor Lorincz “teach or
suggest, either alone or in combination, all of the limitations of the present
invention.” (App. Br. 12). In particular, Appellants assert that “although the
universal collection medium as described in Lorincz may allow for the use
of a single cell sample for use in multiple different assays, nowhere in
Lorincz is there a teaching or suggestion that the assays can be carried out in
the cell preservative solution.” (Id. at 11). According to Appellants,
“Lorincz teaches the use of a universal collection medium only for collecting
cells.” (Id.). Therefore, Appellants assert “that the Examiner has not
satisfied the burden of proving that Lorincz teaches or suggests [] an assay
that can be carried out in a cell preservation solution.” (Id.) Regarding
claim 28, Appellants assert that Hyldig-Nielson does not overcome the
asserted deficient combination of Kroeger and Lorincz. (Id. at 18).
The issue is whether a person of ordinary skill in the art at the time of
the invention would have found it obvious to use the cell preservative
solution in which a sample cell was first suspended in each subsequent step
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of a known method for detecting the presence of a target nucleic acid of
HPV in the sample cell.
Additional Findings of Fact
2. Kroeger described a method for detecting HPV in a test sample
through hybridization of at least one PNA probe with a target nucleic
acid of a HPV in a sample cell. (Kroeger, p. 2, ll. 3-4, 17-26; ; p. 3, ll.
2-9, 25-37; p. 5, ll. 1-7).
3. Kroeger did not expressly disclose performing each step of the
detection method in a cell preservative solution.
4. Lorincz described a universal collection medium for cell collection.
(Lorincz, Abstract).
5. Lorincz disclosed that its collection medium “preserves both cell
morphology and cellular biochemicals for quantitative analysis in a
cell sample so that multiple assays can be carried out from a single
patient sample.” (Id. at col. 2, ll. 28-32).
6. Lorincz disclosed that a single sample of cells are obtained from a
patient and “stored” in the collection medium. (Id. col. 4, ll. 54-56).
7. Lorincz stated, “From this single sample, cells are extracted and a
cytological examination is performed, the cellular DNA is
qualitatively or quantitatively examined, the cellular RNA is
qualitatively or quantitatively examined, or any combination of
analysis is performed.” (Id. col. 4, ll. 56-60).
8. Lorincz disclosed that its collection medium preserves a sample so
that different analyses may be performed concurrently, or days,
weeks, or even months apart using cells from a single sample. (Id.
col. 4, ll. 35-37, 60-63).
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9. Lorincz provided examples wherein cell samples are stored in various
formulations of the disclosed universal collection medium prior to
being subjected to a standard HPV Test kit. (Id. col. 11, 62 – col. 12,
l. 2; Ex. 3).

Principles of Law
A conclusion that the claimed subject matter would have been prima
facie obvious must be supported by a preponderance of evidence, as shown
by some objective teaching in the prior art or by knowledge generally
available to one of ordinary skill in the art that would have led that
individual to combine the relevant teachings of the references to arrive at the
claimed invention. See In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988).

Analysis
We agree with Appellants that the Examiner’s obviousness rejections
are not supported by a preponderance of the evidence. In particular, the
Examiner found that Lorincz disclosed a universal collection medium, i.e., a
cell preservative solution, for performing multiple assays “in a single cell
sample.” (See Ans. 13, emphasis added.) However, we do not find that
Lorincz taught or suggested this specific use of the medium.
Lorincz disclosed a universal collection medium that “preserves both
cell morphology and cellular biochemicals for quantitative analysis in a cell
sample so that multiple assays can be carried out from a single patient
sample.” (FF-5, emphasis added.) Specifically, Lorincz explained that a
single sample of cells are obtained from a patient and “stored” in the
collection medium. (FF-6). Lorincz further explained that its collection
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medium “preserve[s] a sample for days or weeks or more” so that different
analyses may be performed at different times. (FF-8). Lorincz expressly
stated, “From this single sample, cells are extracted” and various assays can
be performed (FF-7, emphasis added). Thus, Lorincz taught that different
analyses may be performed using cells extracted from a single sample stored
in the collection medium and not that the analyses could be performed in the
medium. Moreover, as described in the Lorincz examples, sample cells
were subjected to standard test kits for nucleic acid assay, and the test kits
did not use the preservation medium. (FF-9).
Consequently, we do not find that the Examiner established that
Lorincz taught or suggested performing each step of Kroeger’s method for
detecting the presence of a target nucleic acid of HPV in a sample cell in a
cell preservation solution, as claimed.
CONCLUSION OF LAW
The evidence does not support finding that the use of a cell
preservation solution in each of the method steps was new matter.
The evidence does not support concluding that the claimed method
would have been obvious over the combined prior art.

SUMMARY
We reverse the rejection of claims 17, 19-34 and 38 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
We reverse the rejection of claims 17, 19-27, 29-34, and 38 under
35 U.S.C. § 103(a) as obvious over the combination of Kroeger and Lorincz.
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We reverse the rejection of claim 28 under 35 U.S.C. § 103(a) as
obvious over the combination of Kroeger, Lorincz, and Hyldig-Nielsen.

REVERSED

lp

CYTYC CORPORATION
DARRY PATTINSON, SR. IP PARALEGAL
250 CAMPUS DRIVE
MARLBOROUGH MA 01752