Ex Parte Hickok et al

Board of Patent Appeals and Interferences

Nov 29, 2010

10774144 (B.P.A.I. Nov. 29, 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.
10/774,144 02/06/2004 Durlin Hickok 18.006011 8562
38732 7590 11/30/2010
CYTYC CORPORATION
Darry Pattinson, Sr. IP Paralegal
250 CAMPUS DRIVE
MARLBOROUGH, MA 01752
EXAMINER
GRUN, JAMES LESLIE
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
11/30/2010 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 DURLIN HICKOK, ROBERT HUSSA,
MARK FISCHER-COLBRIE, EMORY V. ANDERSON,
and ANDREW E. SENYEI
__________

Appeal 2010-004671
Application 10/774,144
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, 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
screening and treating method. The Examiner has rejected the claims as

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.
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non-enabled, lacking written description, indefinite, and obvious. We have
jurisdiction under 35 U.S.C. § 6(b). As to at least one rejection of each
claim, we affirm.
STATEMENT OF THE CASE
Claims 67-94 are pending and on appeal (App. Br.2 2-3). We will
focus on claim 67, which reads as follows:
67. A method of screening and treating a subject, comprising:
a) obtaining a sample from a subject who is asymptomatic for preterm or
imminent delivery; b) detecting a fetal restricted antigen in said sample from
said subject and assessing whether the level of fetal restricted antigen is
indicative of a risk of preterm or imminent delivery; and c) if the level of
fetal restricted antigen is indicative of the risk, administering a
progestational agent to the subject, whereby delivery is delayed.
The other claims discussed herein are set forth in Appendix A to the
Amended Appeal Brief (App. Br. 15-19).
Claims 67-76, 79, and 81-94 stand rejected under 35 U.S.C. § 112,
first paragraph, for lacking enablement (Ans.3 5).
Claims 67-94 stand rejected under 35 U.S.C. § 112, first paragraph,
for lacking written description (Ans. 6).
Claims 67-94 stand rejected under 35 U.S.C. § 112, second paragraph,
for being indefinite (Ans. 7).
Claims 67-76 and 79-94 stand rejected under 35 U.S.C. § 103(a) as
obvious over Leavitt4 in view of Johnson,5 Meis,6 or Keirse7 and further in
view of Weiner8 or Andersen9 (Ans. 9).

2 “App. Br.” refers to the Amended Appeal Brief dated March 20, 2009.
3 “Ans.” refers to the Examiner’s Answer dated November 12, 2009.
4 Leavitt et al., WO 94/17405 A1, Aug. 4, 1994.
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Claims 77 and 78 stand rejected under 35 U.S.C. § 103(a) as obvious
over Leavitt in view of Johnson, Meis, or Keirse, further in view of Weiner
or Andersen, and additionally in view of Allen10 or Olsen11 (Ans. 11).
ENABLEMENT
The Examiner finds:
The prior art would suggest that an ability to prolong a
pregnancy at risk for preterm delivery is not a property known
or common to the generic list (see pages 10-12) of
progestational agents disclosed by appellant. . . . Many agents
are considered to be progestational on the basis of
pharmacological tests, yet the results of the use of
progestational agents, such as progesterone-related agents,
generally for prolonging a pregnancy at risk for preterm
delivery . . . would seem unknown and unpredictable because
only specific agents were tested and suggested to have that
ability. . . . Random experimentation unguided by appellant to
determine progestational agents that do or do not function in the
invention suggested by appellant’s specification is undue
experimentation. Absent further guidance from appellant, and

5 Johnson et al., Efficacy of 17α-Hydroxyprogesterone Caproate in the
Prevention of Premature Labor, 293 NEJM 675-680 (1975).
6 Meis, 17 Alpha Hydroxyprogesterone Caproate Prevents Recurrent
Preterm Birth, 187 AM. J. OBSTET. GYNECOL. S54 (2002).
7 Keirse, Progestogen administration in pregnancy may prevent preterm
delivery, 97 BR. J. OBSTET. GYNECOL. 149-154 (1990).
8 Weiner et al., The therapeutic efficacy and cost-effectiveness of aggressive
tocolysis for premature labor associated with premature rupture of the
membranes, 159 AM. J. OBSTET. GYNECOL. 216-222 (1988).
9 Andersen & Merkatz, Preterm Labor, in DANFORTH’S OBSTETRICS AND
GYNECOLOGY, chap. 17, pp. 335-351 (6th ed. 1990).
10 Allen & Harris, The Role of n-3 Fatty Acids in Gestation and Parturition,
226 EXP. BIOL. MED. 498-506 (2001).
11 Olsen et al., Randomized controlled trial of effect of fish-oil
supplementation on pregnancy duration, 339 LANCET 1003-1007 (1992).
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such random unguided undue experimentation, one would not
be assured of the ability to practice the invention commensurate
in scope with these claims.
(Ans. 5-6.)
Issue
Has the Examiner set forth a prima facie case that the Specification
does not enable the full scope of progestational agents recited in claim 67?
Findings of Fact
1. The Specification states that “the term ‘progestational agent’
refers to any agent that favors, or is conducive to, gestation” (Spec. 10).
2. The Specification discloses that “[p]rogestational agents include
any of a group of hormones normally secreted by the corpus luteum and
placenta, and in small amounts by the adrenal cortex, whether naturally or
synthetically produced, and derivatives thereof” (id.).
3. The Specification also discloses that “[a]mong progestational
agents are progesterone-related agents, which refer to a member of a group
of steroid compounds that are progesterones or progesterone derivatives that
retain progesterone activity that inhibits or delays delivery” (id. at 10-11
(emphasis added)).
4. In addition, the Specification, referring to Spicer,12 provides a
list of “[e]xemplary progestational agents for use in accord with the methods
herein,” the list including, among many others, 17α-hydroxyprogesterone
(id. at 11).

12 Spicer et al., US 5,211,952, May 18, 1993.
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5. The Specification also discloses: “Progestational agents also
include omega-3 fatty acids, whether naturally or synthetically produced,
and derivatives thereof. Exemplary omega-3 fatty acids include, for
example, docosahexaenoic acid (DHA). Progestational agents include
gestagens, progestagens, progestins, progestogens, and progestational
hormones.” (Id.)
6. Spicer is directed to method for inhibiting conception
comprising administering a gonadotropin releasing hormone “composition at
a dose sufficient to completely suppress ovarian steroid production, in
combination with a precisely formulated regimen of add-back steroids,”
including a progestational steroid (Spicer, col. 1, ll. 6-13, & col. 3, ll. 26-52).
7. Spicer provides a list of progestational agents that can be used
in its invention, which substantially overlaps with the list set forth in the
Specification (compare Spicer, col. 6, ll. 46-52, to Spec. 11).
8. Peters13 discloses that 15,16-seco-19-nor progestins “possess
potent progestational activity” (Peters, col. 1, ll. 20-25).
9. Peters also discloses administering its compounds to achieve
the desired progestational effect, such as suppressing ovulation (id. at col. 5,
ll. 26-29, & col. 9, ll. 24-30).
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

13 Peters et al., US 5,321,044, Jun. 14, 1994.
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specification of the application.” In re Wright, 999 F.2d 1557, 1561-62
(Fed. Cir. 1993).
Enablement does not require testing every species encompassed by a
claim, even in an unpredictable art. See In re Angstadt, 537 F.2d 498, 504
(CCPA 1976). Instead, “there must be sufficient disclosure, either through
illustrative examples or terminology, to teach those of ordinary skill how to
make and how to use the invention as broadly as it is claimed.” In re Vaeck,
947 F.2d 488, 496 (Fed. Cir. 1991) (footnote omitted).
Analysis
The Specification states that “the term ‘progestational agent’ refers to
any agent that favors, or is conducive to, gestation” (Finding of Fact (FF) 1).
The Specification discloses a broad range of progestational agents (FF 2-5).
The Examiner has not set forth sufficient basis to doubt the assertion that a
broad range of progestational agents may be used.
The Examiner argues:
Appellant has provided nothing on the record to predictably
link the use of a generic progestational agent, such as those
progesterone-related agents or other agents listed in the
specification, as a contraceptive (i.e., preventing a pregnancy,
as in Spicer . . . or Peters . . . ) to its successful use as an agent
for prolonging a pregnancy at risk for preterm delivery.
(Ans. 5-6.) Peters does disclose administering 15,16-seco-19-nor progestins
to achieve the desired progestational effect, such as suppressing ovulation
(FF 8-9). In addition, Spicer discloses administering progestational agents,
together with a gonadotropin releasing hormone, to inhibit conception
(FF 6). However, we do not agree that the Examiner has adequately shown
that these references support the Examiner’s position that undue
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experimentation would have been required to practice the full scope of the
invention.
The Examiner also finds that “appellant’s specification provides no
working examples of pregnancy prolongation other than that demonstrated
in the art with progesterone (da Fonseca et al.) or 17α-hydroxyprogesterone
(Johnson et al., Yemini et al., Keirse, or Meis et al.) or omega-3 fatty acid
supplementation (Allen et al. or Olsen et al.)” (Ans. 6). However, the
Examiner has not adequately explained why these examples, together with
the other disclosures in the Specification, are insufficient to enable the full
scope of claim 67.
Conclusion
The Examiner has not set forth a prima facie case that the
Specification does not enable the full scope of progestational agents recited
in claim 67. We therefore reverse the enablement rejection of claims 67-76,
79, and 81-94.
WRITTEN DESCRIPTION
The Examiner finds that “the specification, as originally filed, does
not provide support for the patient population as is now claimed” (Ans. 6).
In particular, the Examiner finds that “Appellant provides no written
description that only patients with risk factors not including symptoms
should be tested to the exclusion of those with symptoms as is now claimed”
(id. at 7). In addition, the Examiner finds that “appellant does not define,
and one would not readily know absent further guidance from appellant,
what patients are encompassed by the current criteria of ‘asymptomatic’
because only a short inclusive list of possible symptoms is taught” (id.).
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Issue
Has the Examiner set forth a prima facie case that the Specification
does not describe conducting the method on a subject who is asymptomatic
for preterm or imminent delivery?
Findings of Fact
10. The Specification states that, “[d]ue to the subtlety of
symptoms associated with preterm delivery, many subjects are not
diagnosed as having an increased risk of preterm delivery until later in their
pregnancies” (Spec. 1).
11. The Specification also states:
The present methods can be used on any pregnant woman
following about 12 weeks, about 16 weeks, or about 20 weeks
gestation. In addition to screening any woman to determine
whether delivery is imminent, the subjects who should be
screened are those subjects with clinically intact membranes in
a high risk category for preterm delivery, and especially, those
women whose pregnancies are not sufficiently advanced to
ensure delivery of a healthy fetus.
(Id. at 18.)
12. In addition, the Specification states:
[T]here are a large number of factors known to be associated
with the risk of preterm delivery. Those factors include, but are
not limited to, multiple fetus gestations; incomplete cervix;
uterine anomalies; polyhydramnios; nulliparity; previous
preterm rupture of membranes or preterm labor; preeclampsia;
first trimester vaginal bleeding; little or no antenatal care; and
symptoms such as abdominal pain, low backache, passage of
cervical mucus and contractions. Any pregnant woman at
about 12 or more weeks gestation with clinically intact
membranes and having one or more risk factors for preterm
delivery should be tested throughout the risk period; i.e., until
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about 37 weeks gestation. Risk factors for spontaneous
abortion include gross fetal anomalies, abnormal placental
formation, uterine anomalies and maternal infectious disease,
endocrine disorder cardiovascular renal hypertension,
autoimmune and other immunologic disease, and malnutrition.
(Id. at 18-19 (emphasis added).)
Principles of Law
“In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
Analysis
The Specification discloses that the “present methods can be used on
any pregnant woman following about 12 weeks, about 16 weeks, or about 20
weeks gestation” (FF 11). In particular, the Specification discloses that “the
subjects who should be screened are those subjects with clinically intact
membranes in a high risk category for preterm delivery” (FF 11). In
addition, the Specification discloses that “factors known to be associated
with the risk of preterm delivery” include symptoms, as well as other factors
that are not symptoms (FF 12). We agree with Appellants that these
teachings clearly convey that Appellants were in possession of the concept
of using the method on a subject who is asymptomatic for preterm or
imminent delivery. In addition, the Examiner has not shown that one of
ordinary skill in the art would not know what patients are encompassed by
the claim recitation of asymptomatic for preterm or imminent delivery.
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Conclusion
The Examiner has not set forth a prima facie case that the
Specification does not describe conducting the method on a subject who is
asymptomatic for preterm or imminent delivery. We therefore reverse the
written description rejection of claims 67-94.
INDEFINITENESS
The Examiner finds various recitations in the claims to be indefinite
(Ans. 8).
Issue
Has the Examiner set forth a prima facie case that these various
recitations are indefinite?
Principles of Law
“A claim is indefinite if its legal scope is not clear enough that a
person of ordinary skill in the art could determine whether a particular
composition infringes or not.” Geneva Pharms., Inc. v. GlaxoSmithKline
PLC, 349 F.3d 1373, 1384 (Fed. Cir. 2003).
Analysis
We note initially that the failure to enter an amendment is a
petitionable matter. Thus, we will not decide whether the Examiner was
within his rights in failing to enter the amendment.
In addition, we agree with the Examiner that claims 81 and 83 are
indefinite. In particular, we find claim 81 to be indefinite because “‘the’
therapeutically effective amount lacks antecedent basis” and we find
claim 83 to be indefinite because “it is not clear if ‘the’ sample is the same
sample tested in claim 67 or a newly obtained sample” (Ans. 8).
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However, with regard to the other recitations alleged to be indefinite,
we conclude that the Examiner has not provided adequate basis for these
determinations. For example, claim 67 recites “the level” twice. Although
the first recitation of “the level” does not have antecedent basis, we do not
agree that one of ordinary skill in the art would not understand what “the
level” refers to in the context of the claim. Instead, we find that one of
ordinary skill in the art would understand that it refers to the level detected
in the first phrase of step b.
Conclusion
The Examiner has set forth a prima facie case that claims 81 and 83
are indefinite. However, the Examiner has not set forth adequate basis to
reject claims 67-80, 82, and 84-94 on this basis. We therefore affirm the
indefiniteness rejection of claims 81 and 83 and reverse the indefiniteness
rejection of claims 67-80, 82, and 84-94.
OBVIOUSNESS
With regard to the obviousness rejections, the claims subject to each
rejection have not been argued separately and therefore the claims set forth
in each ground of rejection stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner relies on Leavitt for disclosing the “determination[] of
fetal fibronectin (i.e. a fetal restricted antigen . . . ) . . . as [a] biochemical
marker[] of impending imminent preterm delivery and of insulin-like growth
factor binding protein-1 to determine fetal membrane status to aid clinical
decisions regarding administration of treatments to prolong pregnancy in
pregnant patients at 12 to 37 weeks gestation” (Ans. 9).
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The Examiner also finds that “[a]ny of Johnson . . . , Meis . . . , or
Keirse . . . teach the efficacy of progesterone treatments in reducing preterm
delivery” (id.).
In addition, the Examiner finds:
Weiner et al. or Andersen et al. teach that treatment with
tocolytic agents is not beneficial (Weiner et al.) and not
recommended (Andersen et al., page 346; Weiner et al.) in
patients with rupture of membranes. Progestational agents are
known as among the tocolytic agents that function to prevent
or reduce contractions prior to preterm labor (see e.g. Andersen
et al. (page 345)).
(Ans. 9-10.)
The Examiner concludes that it would have been obvious
to have tested a pregnant patient determined to have
biochemical markers indicative of impending preterm delivery
for the status of the fetal membranes and to treat those patients
with intact fetal membranes indicated as at risk of having
impending delivery with a pregnancy-prolonging agent . . . ,
such as the progesterones as taught by any of Johnson et al.,
Meis et al., or Keirse.
(Id. at 10.)
The Examiner additionally relies on Allen or Olsen for disclosing
omega-3 fatty acid, as recited in dependent claims 77 and 78 (id. at 11).
Appellants argue that “[n]owhere in Leavitt et al., Johnson et al., Meis
et al., Keirse, Weiner et al. or Anderson et al., either alone or in
combination, is there any teaching or suggestion of testing and treating an
asymptomatic patient” (App. Br. 12). With regard to the rejection of
claims 77 and 78, Appellants additionally argue that Allen and Olsen do not
overcome this deficiency (id. at 13).
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Issue
Does the evidence support the Examiner’s conclusion that it would
have been obvious to conduct the method on a subject who is asymptomatic
for preterm or imminent delivery?
Findings of Fact
13. Leavitt discloses “an assay that distinguishes those patients
with impending imminent delivery with intact membranes from those in
whom the membranes have ruptured” (Leavitt 3: 29-32).
14. Leavitt also discloses:
[T]he method comprises obtaining a cervicovaginal secretion
sample from a pregnant patient after about week 20 of gestation
and determining the level of fetal fibronectin and IGFBP-I in
the sample. The presence of an elevated fibronectin level in the
sample indicates an increased risk of imminent delivery. . . . For
those patients whose fetal fibronectin assay result indicates an
increased risk of preterm delivery, the test of the patient’s
IGFBP-I level determines whether the membranes are intact. If
the test for IGFBP-1 is negative, the patient can be treated to
prolong the pregnancy.
(Id. at 4: 5-26.)
15. In addition, Leavitt discloses:
In addition to screening any woman to determine whether
delivery is imminent, the patients who should be tested for a
delivery indicator, are those patients with clinically intact
membranes in a high risk category for preterm delivery, and
preferably, all those women whose pregnancies are not
sufficiently advanced to ensure delivery of a healthy fetus.
(Id. at 6: 1-8.)
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16. Leavitt also discloses:
Ninety percent of the fetal morbidity and 100 percent of the
fetal mortality associated with preterm delivery is for those
fetuses delivered prior to 32 to 34 weeks gestation. Therefore,
32 to 34 weeks gestation is an important cutoff for the health of
the fetus, and women whose pregnancies are at least about 20
weeks and prior to 34 weeks in gestation should be tested.
(Id. at 6: 8-15.)
17. In addition, Leavitt discloses:
[T]here are a large number of factors known to be associated
with the risk of preterm delivery. Those factors include
multiple fetus gestations; incompetent cervix; uterine
anomalies; polyhydramnios; nulliparity; previous preterm
rupture of membranes or preterm labor; preeclampsia; first
trimester vaginal bleeding; little or no antenatal care; and
symptoms such as abdominal pain, low backache, passage of
cervical mucus and contractions. Any pregnant woman at 12
or more weeks gestation with clinically intact membranes and
having one or more risk factors for preterm delivery should be
tested throughout the risk period; i.e., until about week 37.
Risk factors for spontaneous abortion include gross fetal
anomalies, abnormal placental formation, uterine anomalies and
maternal infectious disease, endocrine disorder cardiovascular
renal hypertension, autoimmune and other immunologic
disease, and malnutrition.
(Id. at 6: 16-34 (emphasis added).)
Analysis
Leavitt discloses testing “women whose pregnancies are at least about
20 weeks and prior to 34 weeks in gestation” (FF 16). Leavitt also discloses
that, “[i]n addition to screening any woman to determine whether delivery is
imminent, the patients who should be tested for a delivery indicator, are
those patients with clinically intact membranes in a high risk category for
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preterm delivery” (FF 15). In addition, Leavitt discloses that “factors known
to be associated with the risk of preterm delivery” include symptoms, as well
as other factors that are not symptoms (FF 17). Thus, we agree with the
Examiner that Leavitt suggests screening a subject who is asymptomatic.
Conclusion
The evidence supports the Examiner’s conclusion that it would have
been obvious to conduct the method on a subject who is asymptomatic for
preterm or imminent delivery. We therefore affirm the obviousness
rejections of claims 67 and 77. Claims 68-76 and 79-94 fall together with
claim 67. Claim 78 falls together with claim 77.
SUMMARY
We affirm the obviousness rejections of claims 67-94 and the
indefiniteness rejection of claims 81 and 83. However, we reverse the
indefiniteness rejection of claims 67-80, 82, and 84-94, as well and the
enablement and written description rejections.
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

cdc
CYTYC CORPORATION
Darry Pattinson, Sr. IP Paralegal
250 CAMPUS DRIVE
MARLBOROUGH, MA 01752