Ex Parte Mazur

Board of Patent Appeals and Interferences

May 28, 2004

09915467 (B.P.A.I. May. 28, 2004)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 17

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LEONARD L. MAZUR
__________

Appeal No. 2004-0394
Application No. 09/915,467
__________

ON BRIEF
__________

Before WILLIAM F. SMITH, ADAMS, and GRIMES, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

REQUEST FOR REHEARING
Appellant requests reconsideration (rehearing) of the Board’s decision entered
February 26, 2004 (Decision), vacating the rejection of record in favor of new grounds
of rejection under 37 CFR § 1.196(b). Appellant’s “Request for Rehearing” (Request) is
premised upon the assertion that the “new grounds for rejection appear based on a
misunderstanding of the time sequence of the prior art.” Request, page 2.
Claims 1 and 6 are illustrative of the subject matter on appeal and are
reproduced below:
1. An educational article of manufacture useful to increase patient awareness of
the teratogenicity of a pharmaceutical, said article of manufacture comprising:
a teratogenic pharmaceutical packaged together with
a contraceptive; and
labeling specifying avoidance of pregnancy while using said teratogenic
pharmaceutical.

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Application No. 09/915,467

6. A pharmaceutical composition of matter comprising:
a first pharmaceutical in an amount potentially teratogenic, and
a second pharmaceutical in an amount effective as a contraceptive,
said composition of matter in a unit dose form.

The references relied upon by the board are:
Hansen et al. (Hansen) 5,120,546 Jun. 9, 1992
Van Os et al. (Van Os) 5,494,047 Feb. 27, 1996
Elsayed et al. (Elsayed) 6,045,501 Apr. 4, 2000
(102(e) date Aug. 28, 1998)
Abrams et al. (Abrams) 6,428,809 Aug. 6, 2002
(102(e) date Aug. 18, 1999)

Physicians’ Desk Reference (PDR) 1878-1880 (46th ed., Medical Economics Company,
Montvale, NJ 1992)

GROUNDS OF REJECTION
Claims 1, 2 and 5 stand rejected under 35 U.S.C. § 103 as being unpatentable
over the combination of Elsayed, Abrams and PDR.
Claims 3 and 4 stand rejected under 35 U.S.C. § 103 as being unpatentable over
the combination of Elsayed, Abrams and PDR in view of Van Os.
Claims 6 and 8-10 stand rejected under 35 U.S.C. § 103 as being unpatentable
over the combination of Elsayed, Abrams and PDR.
Claim 7 stands rejected under 35 U.S.C. § 103 as being unpatentable over the
combination of Elsayed, Abrams and PDR in view of Hansen.
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Application No. 09/915,467

DISCUSSION
According to appellant (Request, page 2), “[i]t is undisputed that the prior art
acknowledges a long-felt need for the problem of teratogen-related birth defects.”
Nevertheless, appellant asserts (Request, page 3), “[d]espite a panoply of proposed
solutions, as recently as 2001 the art had failed to solve this problem. This failure to
solve the long-felt need is shown both by [pregnancy] data collected by the
manufacturer of ACCUTANE® isotretinoin, and by the United States Food & Drug
Administration’s interpretation of this data.” According to appellant (Request, page 4),
“[t]he reason for these pregnancies, despite ostensibly clear admonitions to avoid
pregnancy, is unclear.” However, appellant notes that Woodcock (Appendix to Brief)
asserts “exclusive reliance on ‘human memory’ is not an adequate precaution for
managing severe risks.” Id. According to appellant (id.),
The Food & Drug Administration thus concluded that “additional
systematized measures to manage risk and fully inform patients and
families should be instituted, given the devastating impact of potential side
effects.” … Notably, the FDA advanced this position in 2001 – clearly
showing that the long-felt need remained unsatisfied at that time.”

Accordingly, appellant asserts (Request, bridging paragraph, pages 4-5,
footnotes omitted), since Abrams, Elsayed and PDR “were followed temporally by …
WOODCOCK … and by Roche Pharmaceuticals, Inc., APPENDIX I … the long-felt need
remained unfulfilled as recently as several months before Appellant filed the immediate
application.” In support of this assertion appellant states (Request, page 5, fn. 5):
Notably, ABRAMS, ELSAYED, and THE PHYSICIANS DESK REFERENCE each
preceded ROCHE PHARMACEUTICALS, INC., APPENDIX I (2001), and thus by
definition lacked knowledge of the data presented there. Thus, an earlier
allegation of solving the long-felt need (if such an allegation in fact were
shown in the record) would appear baseless, directly contradicted by the
subsequent 2001 data, and thus unsustainable as a matter of law.
I. Appellant’s implied satisfaction of a long-felt need unsupported by evidence:
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Application No. 09/915,467

Appellant’s Request implies that his invention satisfied a long-felt need which
was not previously satisfied. However, here, as in In re Cavanagh, 436 F.2d 491, 496,
168 USPQ 466, 471 (CCPA 1971), appellant failed to bring forward evidence of his
satisfaction of the need. Accordingly, appellant failed to rebut the prima facie case of
obviousness as set forth in the Decision.
II. Appellant’s reference to “2001 data” is factually incorrect:
We note that appellant relies on Roche Pharmaceuticals, Inc.,(Roche) at Table 1
(see Request, page 4), and the Food and Drug Administration’s (FDA) “interpretation of
this data” (see Request, pages 3-4). While appellant refers to the data presented in
Roche’s Table 1 as “2001 data,” we find that according to the note following Table 1
there was a “[c]umulative data cut-off date of March 31, 2000.” This date is prior to the
April 4, 2000 issue date of Elsayed, and the August 6, 2002 issue date of Abrams,
which we note is after appellant’s filing date. Stated differently, the data presented in
Roche’s Table 1 is prior to the date that the Elsayed and Abrams patents were public
knowledge. 1
Furthermore, the Roche report does not include data for 1999 and 2000 in most
of their reports because the data is unstable for 1999 and 2000. See Roche, section
1.2, fourth paragraph, “[b]ecause the data are unstable for 1999 and 2000, these data
are not included in most of the following review tables.” Accordingly, most of the Roche

1 [A]s a matter of common sense, it is clear that the contents of a patent application which
may be available as ‘prior art’ under § 102(e) to show that another was the first inventor
may not have been known to anyone other than the inventor, his attorney, and the Patent
Office examiner, and perhaps the assignee, if there was one, until it issued as a patent.
As of its filing date it does not show what is known generally to ‘any person skilled in the
art,’ to quote from § 112.
In re Glass, 492 F.2d 1228, 1232, 181 USPQ 31, 34 (CCPA 1974). Accordingly, neither Elsayed nor
Abrams were available to demonstrate what was generally known to a person of ordinary skill in the art as
of the cumulative data cut-off date of March 31, 2000 reported in Roche’s report. See also Hazeltine
Research v. Brenner, 382 U.S. 252, 254-55, 147 USPQ 429, 431 (1965) (under Section 102(e) a patent is
a reference as of its filing date, although its existence is not known until it issues).
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Application No. 09/915,467

report is based on data obtained prior to 1999, and that which is not is only relevant up
to the March 31, 2000 cut-off date. Thus, it follows from appellant’s assertion (Request,
page 3) that the FDA’s comments are based on an interpretation of the Roche data,
that this interpretation would be accurate only with regard to the data obtained prior to
1999. Any inference drawn from data covering the period from 1999 through the March
31, 2000 cut-off data would be based on data that is characterized by Roche as
unstable.
Accordingly, we find appellant’s characterization of the Roche data as “2001
data” to be factually unsupported on this record. Therefore, we are not persuaded by
appellant’s assertion that our earlier finding is “baseless, directly contradicted by the
subsequent 2001 data, and thus unsustainable as a matter of law.”
III. Appellant’s assertion regarding Elsayed is factually incorrect:
Appellant’s assertion (Request, page 4, fn. 1, alteration original) that “ELSAYED
does not ‘provide[ ] patients with a contraceptive device or formulation’ Cf. DECISION at
7,” is also factually incorrect. See Decision, page 4, emphasis added, “the last two
steps (step g and step h) of the Elsayed method require (step g) pharmacies to fill
prescriptions for non-pregnant patients, and (step h) provide patients who are capable
of becoming pregnant a contraceptive device or formulation. See e.g., Elsayed, claim 1
and claim 10.”
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Application No. 09/915,467

IV. An effective program to reduce pregnancy during Accutane treatment:

The Roche data is based, in part, on cases reported by the “Pregnancy
Prevention Program for Women on Accutane-conducted by the Slone Epidemiology
Unit….” Roche, page 1. In this regard, we note that Elsayed disclose that a survey
conducted by the Slone Epidemiology Unit suggests that a pregnancy prevention
program can be effective to reduce pregnancy during Accutane treatment. Specifically,
as set forth on page 3 of the Decision, footnote omitted:
According to Elsayed (column 1, lines 48-57),

Previous methods for controlling the distribution of drugs have been
developed in connection with Accutane (isotretinoin). Accutane, which is
a known teratogen, is a uniquely effective drug for the treatment of
severe, recalcitrant, nodular acne. A pregnancy prevention program was
developed, and the Slone Epidemiology Unit of Boston University
designed and implemented a survey to evaluate these efforts. The survey
identified relatively low rates of pregnancy during Accutane treatment,
which suggests that such a program can be effective.

Regarding appellant’s emphasis (Request, page 4), that Woodcock noted “exclusive
reliance on ‘human memory’ is not an adequate precaution for managing severe risks,”
we note that the methods of the Elsayed invention “may be desirably and
advantageously used to educate and reinforce the actions and behaviors of patients
who are taking the drug, as well as prescribers who prescribe the drug and pharmacies
which dispense the drug.” See Decision, page 3:
Furthermore, Elsayed discloses (column 3, lines 26-31),

Generally speaking, the methods of the present invention may be
desirably and advantageously used to educate and reinforce the
actions and behaviors of patients who are taking the drug, as well
as prescribers who prescribe the drug and pharmacies which
dispense the drug. … A wide variety of educational materials may
be employed to ensure proper prescribing, dispensing and patient
compliance according to the methods described herein, including,
for example, a variety of literature and other materials, such as, for
example, product information, educational brochures, continuing
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Application No. 09/915,467

education monographs, videotapes and the like which may
describe the risks and benefits associated with taking the particular
drug.

Consistent with Elsayed’s emphasis on education, Elsayed
discloses (column 9, lines 21-29),

The drug is preferably supplied to the pharmacy (as well as the
patient) in packaging, such as individual blister packs, which
includes warnings regarding the risks associated with the drug, as
well as the importance of various aspects of the present methods
such as, for example, pregnancy testing and the use of
contraception (in the case of teratogenic drugs), and the dangers
associated with sharing the drug with others, among other aspects.

V. Long-felt need satisfied by another prior to appellant’s date of invention:
Appellant recognizes that the Decision states at page 10 “in our opinion, the
long-felt need was recognized and satisfied by another before the date of the
appellant’s invention[2].” Request, page 6. Nevertheless, appellant asserts (id.), “[t]he
DECISION fails to provide any support for this subjective factual assertion (the DECISION
fails to say exactly who satisfied this, and when).”
Initially, we note that appellant discloses (specification, page 5), “I have found
that one can make teratogenic pharmaceuticals more safe, by combining them as a unit
with a contraceptive. … In so doing, it minimizes the risk that a patient will become
pregnant while taking the teratogen.” As set forth on page 11 of the Decision, “Abrams
discloses a combination isotretinion – contraceptive composition.” As set forth on page
8 of the Decision (alteration original),
as discussed above, Abrams, recognized that “[i]sotretinion and analogs
and isomers used for the treatment of postular acne has a severe danger

2 We recognize appellant’s statement (Request, page 4, fn. 2), “the record has not addressed ‘the date of
[a]ppellant’s invention’; we deal here only with the date of constructive reduction to practice – the
application filing date (July 2001).” We note, however, that the date of invention is presumed to be the
filing date of the application until an earlier date is proved. See e.g., Bausch & Lomb, Inc. v. Barnes-
Hind/Hydrocurve, Inc., 796 F.2d 443, 449, 230 USPQ 416, 420 (Fed. Cir. 1986); Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991). Since there is no evidence on
this record regarding an earlier date of invention, we fail to see appellant’s point.

Appeal No. 2004-0394 Page 8
Application No. 09/915,467

if taken by a woman who [is] pregnant,” and therefore teaches, “[t]he
incorporation of oral contraceptive medication would eliminate the
potential for pregnancy while medicated.” Note again, by way of
illustration, that claim 11 of Abrams is drawn to “[a] pharmaceutical
delivery package comprising a mixture of [i]sotretinoin and an oral
contraceptive.”

Accordingly, Abrams recognizes the need – the severe danger of isotretinion if taken by
a woman who is pregnant; and satisfies the need – a pharmaceutical delivery package
(a pharmaceutical composition), comprising a mixture of isotretinioin and an oral
contraceptive.3 Appellant’s claim 6 is drawn to a pharmaceutical composition
comprising a unit dose form4 of a teratogen (e.g. isotretinoin, see appellant’s claim 9),
and a contraceptive. Contrary to appellant’s assertion (Request, page 6), Abrams
supports our finding of fact and conclusion of law.
Furthermore, as set forth at page 11 of the Decision, “Elsayed discloses the
need to provide educational materials to both the consumer and distributor, as well as,
providing isotretinion together with a contraceptive device or formulation.” See also
Decision, pages 3-4. Note as set forth at page 3 of the Decision, “Elsayed discloses
(column 3, lines 26-31), … the methods of the present invention may be desirably and
advantageously used to educate and reinforce the actions and behaviors of patients
who are taking the drug….” In addition, as set forth on pages 3-4 of the Decision,
Elsayed discloses (column 9, lines 21-29),

The drug is preferably supplied to the pharmacy (as well as the
patient) in packaging, such as individual blister packs, which
includes warnings regarding the risks associated with the drug, as
well as the importance of various aspects of the present methods

3 We note that appellant does not maintain his assertion that Abrams does not contain an enabling
disclosure. Cf. Brief, pages 3-4.

4 According to appellant’s specification, page 13, “[t]he term unit dose form means in a form wherein both
components are intended to be taken together as one big pill or as two small pills together.” Appellant
recognizes (Brief, page 4) that Abrams discloses “combining the two components into a unitary pill,” e.g.,
“one big pill.” Cf. Decision page 10.
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Application No. 09/915,467

such as, for example, pregnancy testing and the use of
contraception (in the case of teratogenic drugs), and the dangers
associated with sharing the drug with others, among other aspects.

At page 4 of the Decision, “we note that the last two steps (step g and step h) of the
Elsayed method require (step g) pharmacies to fill prescriptions for non-pregnant
patients, and (step h) provide patients who are capable of becoming pregnant a
contraceptive device or formulation. See e.g., Elsayed, claim 1 and claim 10.”
Accordingly, Elsayed recognizes the need5; and satisfies the need6 – provide
educational materials to both the consumer and distributor, as well as, providing the
drug with warnings regarding the risks associated with teratogenic drugs7, together with
a contraceptive device or formulation.
Appellant’s claim 1 is drawn to an educational article of manufacture, wherein a
teratogenic pharmaceutical is packaged together with a contraceptive and labeling
specifying avoidance of pregnancy while using the teratogenic pharmaceutical. The
only difference between claim 1 and Elsayed, is that while Elsayed provides patients
who are capable of becoming pregnant a contraceptive device or formulation together
with a teratogenic drug; Elsayed does not expressly state that the two components are
“packaged together.” However, as set forth on page 5 of the Decision, alteration

5 “It is undisputed that the prior art acknowledges a long-felt need for the problem of teratogen-related
birth defects.” Request, page 2.

6 See Decision, page 3 (footnote omitted):
According to Elsayed (column 1, lines 48-57),
… A pregnancy prevention program was developed, and the Slone Epidemiology
Unit of Boston University designed and implemented a survey to evaluate these
efforts. The survey identified relatively low rates of pregnancy during Accutane
treatment, which suggests that such a program can be effective.

7 As set forth on page 2 of the Decision, according to appellant’s specification (page 7),
the term ‘teratogenic’ … include[s] pharmaceuticals associated with an increased risk of
birth defects. The term thus includes pharmaceuticals with FDA-approved labeling citing
an increased risk of birth defects as a potential side effect. Such teratogenic
pharmaceuticals currently listed in the PHYSICIANS’ DESK REFERENCE (Medical
Economics Company, publ. 2000) include, for example, isotretinoin (ACCUTANE®)….
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Application No. 09/915,467

original, Abrams, teaches, “[a] pharmaceutical delivery package comprising a mixture of
[i]sotretinion and an oral contraceptive.” Thus, “a person of ordinary skill in the art
would have been motivated to package8 isotretinioin together with a contraceptive.” Id.
As set forth on page 10 of the Decision, “[o]nce another supplied the key
element, there was no long-felt need or, indeed, a problem to be solved.” Newell
Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir.
1988). For the foregoing reasons, as well as the reasons set forth in the Decision, both
Elsayed and Abrams individually supply the key element to satisfy the long-felt need.
Accordingly, both Elsayed and Abrams, individually or combined, support our finding of
fact and conclusion of law that “the long-felt need was recognized and satisfied by
another before the date of appellant’s invention.” Decision, page 10.

8 We note that appellant defines “packaged together” as “a unitary package for sale as an undivided unit.”
See appellant’s Specification, page 9.

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Application No. 09/915,467

VI. The art does not teach away from the claimed invention:
According to appellant (Request, page 3), the art teaches away from the claimed
combination. In support of this assertion, appellant relies (id.) on Shangold9 (column
11, lines 49-54), which according to appellant “teaches to not use contraceptives where
there is a ‘concomitant use of isotretinoin (Accutane), tretinoin (Renova or Retin-A) or
has taken them within the 30 day period immediately prior to the screening visit.’” In
our opinion, appellant has mischaracterized the cited section of the reference.
Shangold is drawn to a method of contraception and a triphasic oral contraceptive. See
claims. The section of Shangold cited by appellant refers to a portion of the criteria
used by Shangold to exclude subjects from a “randomized, multi-center study to
evaluate three blinded regimens of norgestimate and ethinyl estradiol (NGM/EE) oral
contraceptive and an open-label control regimen.” See Shangold, column 10, line 20
through column 11, line 54. Thus, while Shangold excluded subjects using isotretinoin
(Accutane) from the study, we find no disclosure in Shangold that “teaches to not use
contraceptives where there is a ‘concomitant use of isotretinoin (Accutane)…” as
asserted by appellant.
In addition appellant relies on Gaull10 to teach “combining isotretinoin not with a
contraceptive, but with taurine, a compound ‘which reduces the side effects of
isotretinoin.’” Request, page 3. Apparently, appellant believes that since the art taught
an alternative to the combination of isotretinoin with a contraceptive the art teaches
away from appellant’s claimed invention. We note, however, that the mere fact that

9 Shangold et al. (Shangold) 6,214,815 Apr. 10, 2001

10 Gaull 4,545,911 Oct. 8, 1985
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alternatives may exist does not preclude the development of a new model that is
obvious over the prior art. See In re Beattie, 974 F.2d 1309, 1312-13, 24 USPQ2d
1040, 1042 (Fed. Cir. 1992) (holding that an alternative to a well-entrenched theory
does not preclude a finding of obviousness because the recommendation of a new
system “does not require obliteration of another”). For this same reason, we disagree
with appellant’s assertion (Request, page 6), “if an inventor(s) truly believes they have
satisfied a long-felt need, they would appear disinclined to spend further effort on an
already-completed task.” On this record, the combination of prior art relied upon
provides an obvious alternative to Gaull.
VII. The prior art relied upon provides a suggestion to combine:
Appellant is correct (Request, page 5) in that a suggestion to combine must be
identified in the prior art of record. In re Lee, 277 F.3d 1338, 1343-44, 61 USPQ2d
1430, 1433-1434 (Fed. Cir. 2002). For the reasons set forth in the Decision, we believe
that a suggestion to combine is set forth in the prior art relied upon. For his part,
however, appellant fails to state with particularity the reason why he believes the
Decision fails to identify a suggestion to combine the prior art relied upon. 37 CFR
§ 1.197(b). To the contrary, the Decision recognizes (see e.g., bridging paragraph,
pages 5-6):
“The test for obviousness is what the combined teachings of the
references would have suggested to one of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). Based on
the evidence set forth above, we find that it would have been prima facie
obvious to a person of ordinary skill in the art at the time the invention was
made to package a contraceptive formulation and/or device together with
isotretinoin (Accutane), and label said composition according to the official
labeling information set forth in the PDR.

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Application No. 09/915,467

For the foregoing reasons, as well as those presented in the Decision, we are
not persuaded by appellant’s assertion that the “references do not suggest the claimed
combination.” Request, pages 5-6 and n. 3.
CONCLUSION

We have carefully reviewed the original opinion in light of appellant’s Request,
but we find no point of law or fact that we overlooked or misapprehended in arriving at
our decision. Therefore, appellant’s request has been granted to the extent that the
decision has been reconsidered, but such request is denied with respect to making any
modifications to the Decision.
No time period for taking any subsequent action in connection with this appeal
may be extended under 37 CFR § 1.136(a).

REHEARING DENIED

)
William F. Smith )
Administrative Patent Judge )
)
) BOARD OF PATENT
)
Donald E. Adams ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
Eric Grimes )
Administrative Patent Judge )

Appeal No. 2004-0394 Page 14
Application No. 09/915,467

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