Ex Parte Hung

Board of Patent Appeals and Interferences

Feb 12, 2009

09827371 (B.P.A.I. Feb. 12, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID HUNG1
__________

Appeal 2008-5032
Application 09/827,371
Technology Center 1600
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Decided:2 February 12, 2009
__________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for increasing retrievable material from a patient’s breast duct. The

1 The real party in interest is Cytyc Corporation, Inc. (App. Br. 1).
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2008-5032
Application 09/827,371

Examiner has rejected the claims as nonenabled and/or anticipated. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1, 6, 22, and 25-27 are on appeal.3 We will focus on claim 1,
the broadest claim on appeal, which reads as follows:
1. A method for increasing retrievable intraductal fluid, cells
and/or other material from a breast duct of a patient, comprising:
administering intraductally to the patient an agent that increases
secretion of ductal fluid into a breast duct, wherein the agent is selected from
the group consisting of a hypotonic solution, a buffered solution, a
nonabsorbable biocompatible solution, a protein, a colloid, a sugar, a
polymer, mannitol, sorbitol, glucose, glycerol, sucrose, raffinose, fructose,
lactulose, polyethyleneglycol (PEG), maltodextrin, dextran, dextran 70,
hydroxyethyl starch, fluid gelatin, a synthetic colloid, an antibody, a binding
protein, albumin, a hormone, a natural herb, an extract from a natural herb,
silymarin, a surfactant, a growth factor, oxytocin, prolactin, an organic
molecule, a muscle relaxant, and a ductal orifice dilator.
Claims 1, 6, 22, and 26 stand rejected under 35 U.S.C. § 112, first
paragraph, because the Specification “does not enable any person skilled in
the art to which it pertains, or with it is most nearly connected, to make
and/or use the invention commensurate in scope with these claims” (Ans. 4).
Claims 1, 6, 22, 25, and 27 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Martyn,4 as evidenced by Kartinos5 and Mullins6 (Ans. 12).

3 Claims 23 and 24 are also pending but are no longer rejected by the
Examiner (Ans. 2).
4 Padmini Martyn and Ian R. Falconer, The effect of progesterone on
prolactin stimulation of fatty acid synthesis, glycerolipid synthesis and
lipogenic-enzyme activities in mammary glands of pseudopregnant rabbits,
after explant culture or intraductal injection, 231 BIOCHEM. J. 321-328
(1985).
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ENABLEMENT
The Examiner finds that the Specification, “while being enabling for a
method . . . comprising intraductally [administering] to the patient an
effective [amount] of mannitol . . . , does not reasonably provide enablement
for the claim-designated method comprising the intraductal administration of
any and all amounts of any and all of the agents recited in the Markush
group of Claim 1” (Ans. 4).
Issue
Did the Examiner err in concluding that the Specification does not
enable the full scope of the agents recited in the Markush group of claim 1?
Findings of Fact
1. The Specification discusses “a method for preparing for
intraductal retrieval of fluid, cells and/or other material from a breast duct of
a patient, by administering an agent to the patient that increases retrievable
fluid from a breast duct” (Spec. 3: 16-18).
2. The Specification states that, “where an agent is administered
intraductally to a breast duct, . . . the agent can be selected from the group
consisting of . . . nonabsorbable biocompatible solution . . . , mannitol, . . .
dextran (e.g. dextran 70), . . . prolactin, [and] a small organic molecule . . . .”
(id. at 3: 21 to 4: 9.)
3. The Specification also states:
Whether an agent is capable of increasing or at least
maintaining the amount of collectable fluid (with relation to the
amount of fluid infused) in the ductal lumen can be determined
5 Kartinos et al., US 4,339,433, Jul. 13, 1982.
6 Mullins, US 6,235,305 B1, May 22, 2001.
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by routine tests to determine whether collectable fluid in the
duct is increased upon administration of an agent as compared
to administration of a control isotonic solution to a neighboring
control duct.
(Id. at 8: 3-7.)
4. The Specification includes one example “to test the effects of
the introduction of a solution containing mannitol on the secretion of fluid
from the breast ducts of live rabbits” (id. at 14: 23-25). Based on this
experiment, the Specification concludes that more fluid could be collected
from ducts injected with mannitol solution than from ducts injected with
PBS solution (id. at 16: 4-9).
Principles of Law
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the
specification of a patent enable any person skilled in the art to which it
pertains to make and use the claimed invention . . . without ‘undue
experimentation.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (citing
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)). “It is well settled that
patent applicants are not required to disclose every species encompassed by
their claims, even in an unpredictable art.” In re Vaeck, 947 F.2d at 496. In
addition, “sufficient disclosure . . . to teach those of ordinary skill how to
make and how to use the invention . . . means that the disclosure must
adequately guide the art worker to determine, without undue
experimentation, which species among all those encompassed by the
claimed genus possess the disclosed utility.” Id.
“It is not a function of the claims to specifically exclude . . . possible
inoperative substances.” In re Dinh-Nguyen, 492 F.2d 856, 858-59 (CCPA
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1974). “Of course, if the number of inoperative combinations becomes
significant, and in effect forces one of ordinary skill in the art to experiment
unduly in order to practice the claimed invention, the claims might indeed be
invalid.” Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d
1569, 1576-77 (Fed. Cir. 1984).
In addition, “a specification need not disclose what is well known in
the art. However, that general, oft-repeated statement is merely a rule of
supplementation, not a substitute for a basic enabling disclosure.”
Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997)
(citation omitted). “It is the specification, not the knowledge of one skilled
in the art, that must supply the novel aspects of an invention in order to
constitute adequate enablement.” Id.
Analysis
Claim 1 is directed to a method for increasing retrievable fluid, cells,
and/or other material from a breast duct of a patient. The method comprises
administering intraductally to the patient an agent that increases secretion of
ductal fluid into a breast duct, the agent being selected from a Markush
group. The Markush group includes 36 members, including members as
broad as “an organic molecule.”
The Specification discloses that more fluid could be collected from
ducts injected with mannitol solution than PBS (Finding of Fact (FF) 4).
The Specification also discloses that whether an agent is capable of
increasing ductal fluid secretion can be determined by routine tests (FF 3).
However, the Specification does not provide sufficient guidance as to which
agents should be subjected to these tests in order to identify ones that are
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capable of increasing ductal fluid secretion. The Specification, as well as
claim 1, provides a Markush group of potential agents. However, because
this Markush group is so broad (see e.g., Ans. 10-11), we agree that the
Examiner has set forth a prima facie case that it would require undue
experimentation to make and use agents within the full scope of claim 1.
Appellant argues, however, that “a claim can encompass ‘inoperative’
embodiments so long as one of ordinary skill can ascertain this without
undue experimentation” (App. Br.7 6). In particular, Appellant argues:
The Examiner has explicitly stated that the specification is
enabled for a method of preparing for intraductal retrieval of
fluid, cells and/or other material from a breast duct of a patient
comprising administering intraductally to a patient an effective
amount of mannitol that increases the ductal fluid collection
from a breast duct of a patient . . . . As such, one of skill in the
art could easily conclude that the administration of other agents
with similar physical characteristics as mannitol (e.g., high
molecular weight; hydroscopic; etc.) into a breast duct would
potentially increase the amount of ductal fluid within the breast
duct. Examples of other high molecular weight hydroscopic
agents can be found in the Markush group of Claim 1 such as
sorbitol, glucose, glycerol, sucrose, raffinose, fructose,
lactulose, and dextran to name just a few. Since the Appellant
has provided the experimental protocol for the administration of
agents to a breast duct, one skilled in the art would easily be
able to introduce any of the aforementioned high molecular
weight hydroscopic agents into the breast duct of a patient (or
an animal model) to test for an increase in intraductal fluid.
Such an assessment would be routinely performed in the art.
Hence, inoperative embodiments encompassed by claim 1 (i.e.,
agents that are non-hydroscopic) could be easily identified by
one of skill in the art without undue experimentation.

7 Appeal Brief filed August 22, 2007.
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(Id.)
We are not persuaded. While we agree that a claim can encompass
inoperative embodiments, in this case we agree with the Examiner that the
broad Markush group, together with a lack of direction in the Specification
as to which members of the group would have the claimed function, “forces
one of ordinary skill in the art to experiment unduly in order to practice the
claimed invention.” Atlas Powder Co. v. E.I. du Pont De Nemours & Co.,
supra.
With regard to Appellant’s argument that “one of skill in the art could
easily conclude that the administration of other agents with similar physical
characteristics as mannitol (e.g., high molecular weight; hydroscopic [sic,
hygroscopic?]; etc.) into a breast duct would potentially increase the amount
of ductal fluid within the breast duct,” we note that the Markush group of
claim 1 encompasses a large quantity of agents that do not have these
physical characteristics. For example, claim 1 recites “an organic
molecule,” which clearly encompasses molecules that are of low molecular
weight and are not “hydroscopic.” Thus, even if “one of skill in the art
could easily conclude that the administration of other agents with similar
physical characteristics as mannitol . . . would potentially increase the
amount of ductal fluid within the breast duct” (App. Br. 6), this would not
enable the full scope of claim 1.
Appellant also argues:
[O]ne skilled in the art, in this case biochemistry, would clearly
be familiar with the kinds of agents which, when placed within
a body lumen (e.g., breast duct) would increase secretions into
the lumen from surrounding tissues. Even assuming arguendo
that there may be a large number of agents which would fail to
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increase secretion of ductal fluid in a breast duct, the Appellant
has provided an experimental protocol for the administration of
agents to a breast duct so that one skilled in the art would easily
be able to introduce a large number of agents into the breast
duct of a patient (or an animal model) to test for an increase in
intraductal fluid.
(App. Br. 8-9.)
We are not persuaded. In particular, Appellant has not provided
sufficient evidence that one of ordinary skill in the art would be familiar
with the kinds of agents that, when placed within a body lumen, would
increase secretions into the lumen from surrounding tissue. In addition,
although “a specification need not disclose what is well known in the art
. . . , that . . . statement is merely a rule of supplementation, not a substitute
for a basic enabling disclosure.” Genentech, Inc. v. Novo Nordisk A/S,
supra.
Conclusion
Appellant has not shown that the Examiner erred in concluding that
the Specification does not enable claim 1. Claims 6, 22, and 26 have not
been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
ANTICIPATION
The Examiner finds:
Martyn teaches a method for increasing retrievable intraductal
fluid, cells and/or other material from a breast duct of a patient
comprising administering intraductally to the patient prolactin
as either an emulsion or an aqueous solution, made by
dissolving prolactin in NaOH and diluting with phosphate
buffered saline containing Blue Dextran (a nonabsorbable
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biocompatible solution, as evidenced by the teachings of
Kartinos and Mullins).
(Ans. 13.) Thus, the Examiner concludes that Martyn anticipates three
members of the Markush group of claim 1: a nonabsorbable biocompatible
solution (see claim 22), dextran (see claim 25), and prolactin (see claim 27).
Issue
Did the Examiner err in concluding that Martyn anticipates claim 1?
Findings of Fact
5. Martyn discloses that “[i]njection of prolactin intraductally into
11-day-pseudopregnant rabbits stimulated glycerolipid synthesis, fatty acid
synthesis and enzymes involved in fatty acid synthesis, after 3 days”
(Martyn, Abstract).
6. In particular, Martyn discloses that “[p]rolactin was injected
either as emulsion or as aqueous solution, made by dissolving prolactin in
. . . 0.1 M-NaOH and immediately diluting it with phosphate-buffered saline
. . . containing . . . Blue Dextran” (id. at 323).
7. In addition, Martyn discloses an emulsion “prepared by
sonicating briefly 2 parts of aqueous phase, consisting of phosphate-buffered
saline containing . . . bovine serum albumin and . . . Blue Dextran . . . , with
. . . safflower oil” (id.).
8. Martyn also discloses that “mammary glands 3 days after
intraductal injection of prolactin . . . had more secretion as assessed visually
than did untreated, emulsion-treated or progesterone-treated glands within
the same rabbits” (id. at 326).
9. Referring to Table 4, Martyn discloses that “[f]atty acid
synthesis measured by [1-14C]acetate incorporation remained low in explants
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of rabbit mammary glands 5 days after intraductal injection of phosphate-
buffered saline into the glands on day 11 of pseudopregnancy” (id.).
10. Martyn Table 4 is reproduced below:

(Id.) The data in this Table shows that prolactin caused an increase in fatty
acid synthesis in comparison to saline containing Blue Dextran (id.).
However, because there is no comparison to phosphate-buffered saline that
does not contain Blue Dextran, this data does not show that dextran does not
increase fatty acid synthesis as compared to saline alone.
11. Kartinos discloses that “dextran sodium sulfate of a molecular
weight of about 500,000 was evaluated in-vitro as a potential nonabsorbable
osmotic agent for peritoneal dialysis” (Kartinos, col. 2, ll. 63-65).
12. Mullins discloses that that “[e]xamples of non-absorbable
polysaccharides are polysaccharides having a molecular weight of greater
than 8 kDa such as dextrans” (Mullins, col. 1, ll. 54-56).
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987).
“[I]n an ex parte proceeding to obtain a patent, . . . the Patent Office
has the initial burden of coming forward with some sort of evidence tending
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to disprove novelty.” In re Wilder, 429 F.2d 447, 450 (CCPA 1970).
“However, when the PTO shows sound basis for believing that the products
of the applicant and the prior art are the same, the applicant has the burden
of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir.
1990).
[I]t is elementary that the mere recitation of a newly
discovered function or property, inherently possessed by things
in the prior art, does not cause a claim drawn to those things to
distinguish over the prior art. Additionally, where the Patent
Office has reason to believe that a functional limitation asserted
to be critical for establishing novelty in the claimed subject
matter may, in fact, be an inherent characteristic of the prior art,
it possesses the authority to require the applicant to prove that
the subject matter shown to be in the prior art does not possess
the characteristic relied on.
In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977) (quoting In re Swinehart,
439 F.2d 210, 212-13 (CCPA 1971)).
In addition, “[i]f the preamble adds no limitations to those in the body
of the claim, the preamble is not itself a claim limitation and is irrelevant to
proper construction of the claim.” IMS Technology, Inc. v. Haas
Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000).
Analysis
Claim 1 is directed to a method for increasing retrievable intraductal
fluid, cells, and/or other material from a breast duct of a patient. The
method comprises administering intraductally to the patient an agent that
increases secretion of ductal fluid into a breast duct, wherein the agent is
selected from a group that includes a nonabsorbable biocompatible solution,
dextran, and prolactin.
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Martyn discloses administering intraductally to a patient an emulsion
or an aqueous solution containing prolactin and dextran (FF 5-6). Martyn
also discloses that the “mammary glands 3 days after intraductal injection of
prolactin . . . had more secretion as assessed visually than did untreated,
emulsion-treated or progesterone-treated glands within the same rabbits”
(FF 8). Thus, we agree that the Examiner has set forth a prima facie case
that Martyn anticipates claim 1.
Appellant argues, however, that “[t]here is no evidence presented by
the Examiner that Martyn et al. teaches or suggests that the intraductal
administration of prolactin increases intraductal fluid. Martyn et al. teaches
that the administration of prolactin increases fatty acid and glycerolipid
synthesis.” (App. Br. 19.)
We are not persuaded. First, as noted above, Martyn discloses that the
“mammary glands 3 days after intraductal injection of prolactin . . . had
more secretion as assessed visually than did untreated, emulsion-treated or
progesterone-treated glands within the same rabbits” (FF 8). Thus, the
Examiner had reasonable basis for believing that it would increase secretion
of ductal fluid. In addition, the Specification lists prolactin as an agent for
increasing retrievable fluid from a breast duct (FF 1-2). Since the Patent
Office is not in a position to test compounds to see if they have the desired
property, we agree with the Examiner that Martyn’s teachings coupled with
the identification of prolactin in the Specification as a potential agent is
enough to shift the burden to Appellant to show that prolactin is not an agent
that increases ductal fluid secretion. Appellant has not met this burden.
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Appellant also argues that Martyn “does not teach or suggest a
method of using a nonabsorbable biocompatible solution to increase
retrievable ductal fluid from a breast duct” (App. Br. 18). In particular,
Appellant argues:
The nonabsorbable biocompatible agent in the Examiner’s
argument is Blue Dextran which is not an agent which has been
shown to increase the secretion of ductal fluid into a breast
duct. In fact, as evidenced on page 326, Column 1, lines 28-41,
as well as Table 4 on page 326 of Martyn et al., Blue Dextran
mixed with Phosphate-buffered saline had no effect on fatty
acid synthesis. There is no evidence of record that teaches or
suggests that the nonabsorbable biocompatible agent recited by
the Examiner (Blue Dextran) when administered to a breast
duct, increases secretion of ductal fluid into the breast duct.
(Id. at 19.)
We are not persuaded. First, we have already determined that
Appellant has not rebutted the Examiner’s prima facie case that Martyn’s
disclosure of administering prolactin anticipates claim 1. Thus, to show that
claim 1 is anticipated, it is not necessary to show that Martyn’s disclosure of
administering dextran also anticipates claim 1. However, because the
Examiner has rejected claims on this basis that recite agents other than
prolactin (claims 22 and 25), we separately address this argument.
Claim 25 recites that the agent is, inter alia, dextran. Claim 22 recites
that the agent is a nonabsorbable biocompatible solution. Martyn discloses
administering intraductally to a patient an emulsion or an aqueous solution
containing Blue Dextran (FF 5-6). Appellant does not dispute the
Examiner’s finding that Martyn administers a nonabsorbable biocompatible
solution (Ans. 13).
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The Specification lists dextran and a nonabsorbable biocompatible
solution as agents for increasing retrievable fluid from a breast duct (FF 1-
2). Since the Patent Office is not in a position to test agents to see if they
have the desired property, we agree with the Examiner that the identification
of dextran and a nonabsorbable biocompatible solution in the Specification
as useful agents is enough to shift the burden to Appellant to show that Blue
Dextran and the solutions formed therefrom that are administered in Martyn
do not increase ductal fluid secretion.
Appellant argues that Martyn provides evidence that “Blue Dextran
mixed with Phosphate-buffered saline had no effect on fatty acid synthesis”
(App. Br. 19). However, claim 1, and therefore claims 25 and 22, do not
require that the agent increases fatty acid synthesis, merely that it increases
secretion of ductal fluid into a breast duct. Appellant has not shown that
Blue Dextran or the solutions formed therefrom that are administered in
Martyn8 do not increase ductal fluid secretion.
In addition, Appellant argues that the “Examiner cannot recite a prior
art reference that contains two agents (prolactin and Blue Dextran) and then
argue that both agents are acting as one for the purposes of anticipation”
(App. Br. 19-20). We are not persuaded. There is nothing in claim 1 that
requires that the agent be a single compound. In fact, the Markush group of

8 In this regard, we note that one of the solutions disclosed in Martyn
includes prolactin, as well as Blue Dextran (FF 6). Therefore, even if Blue
Dextran is not an agent that increases ductal fluid secretion, Martyn may still
disclose a nonabsorbable biocompatible solution that increases ductal fluid
secretion.
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claim 1 specifically lists members, such as “a nonabsorbable biocompatible
solution,” that contain more than one component.
Conclusion
Appellant has not rebutted the Examiner’s prima facie case that
claims 1, 22, and 25 are anticipated by Martyn. Claims 6 and 27 have not
been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
ORDER
We affirm the rejection of claims 1, 6, 22, and 26 under 35 U.S.C.
§ 112, first paragraph, and the rejection of claims 1, 6, 22, 25, and 27 under
35 U.S.C. § 102(b).
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
15