Ex Parte Ridihalgh

Board of Patent Appeals and Interferences

Mar 18, 2003

09167764 (B.P.A.I. Mar. 18, 2003)

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for publication and is not binding precedent of the Board.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 JOHN L. RIDIHALGH
__________

Appeal No. 2001-1150
Application No. 09/167,764
__________

ON BRIEF
__________

Before WILLIAM F. SMITH, SCHEINER, and GREEN, Administrative Patent
Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1, 3-5 and 8-10. Claims 1 and 6 are representative of the
subject matter on appeal, and read as follows:
1. A therapeutic agent for treating patients afflicted with chronic fatigue
syndrome (CFS), which comprises:
in a pharmaceutically-acceptable carrier, cytokine-producing cells having been
produced by the step of subjecting cells derived from autologous lymph nodes
excised from patients afflicted with CFS to mitogenic stimulation in the presence
of interleukin-2 (IL-2) and anti-CD3 monoclonal antibody in serum-free media for
their expansion.

6. A method for treating patients afflicted with chronic fatigue syndrome
(CFS), which comprises:
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Application No. 09/767,764

administering to said patient the autologous therapeutic agent of claim 1.
The examiner cites the following references:
Caplan, “Chronic fatigue syndrome or just plain tired?” CMAJ, Vol. 159,
pp. 519-20 (1998)

Goldenberg, “Fibromyalgia, chronic fatigue syndrome, and myofascial pain
syndrome,” Current Opinion in Rheumatology, Vol. 9, pp. 135-43 (2000)

Levine, “What We Know About Chronic Fatigue Syndrome and Its Relevance to
the Practicing Physician,” Am. J. Med., Vol. 105 (3A), pp. 100S-103S (1998)

All of the claims stand rejected under 35 U.S.C. § 112, first paragraph, as
containing 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. After careful review of the
record and consideration of the issue before us, we reverse.
DISCUSSION
Claims 1, 3-6 and 8-10 stand rejected under 35 U.S.C. § 112, first
paragraph, on the ground that they contain subject matter that 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.
The rejection cites Levine to demonstrate that chronic fatigue syndrome
(CFS) exhibits a variety of symptoms, thus precluding the use of a laboratory test
for diagnosis and requiring individualizing the treatment of the syndrome to the
symptoms of the individual. Examiner’s Answer, pages 5-6. Levine, as well as
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Caplan, are cited for their teaching that there is no “magic bullet” for the
treatment of CFS. Because of the varying symptoms of CFS, the rejection
asserts that there is not an art recognized definition of a therapeutic effect for
CFS, and that the specification fails to enable the skilled artisan to determine
whether any improvement was due to the administration of lymphocytes. See id.
at 6-7.
The examiner notes that while “[t]he specification discloses treating six
patients with autologous lymphocytes isolated from the patient’s lymph node and
stimulated with antibody against CD3 and with IL-2,” the results varied between
patients and not all of the patients demonstrated improvement. Id. at 4-5. In
addition, the examiner, relying on Goldenberg, faults the data in the specification
for not having a control, i.e., for failing to compare patients receiving the
treatment method of the invention to patients receiving a placebo. See id. at 6-7.
The rejection concludes:
Applicants have not provided adequate guidance for one of
skill to determine when a therapeutic effect has been obtained or
whether the autologous lymphocytes administered to CFS patients
are responsible for any of the observed effects (either positive or
negative). Given the lack of a definition of a therapeutic effect for
CFS in the specification and in the art at the time of filing, the
heterogeneity in CFS and variability of symptoms of CFS over time,
the art recognized need to compare CFS treatments to placebos
taken with the data provided in the specification, it would require
one of skill undue experimentation to determine how to use the
cells or methods claimed to treat CFS.

Examiner’s Answer, pages 7-8.
Appellant argues that “the Examiner just plain does not believe the data,”
and that the declaration of Dr. Klimas establishes that the specification provides
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Application No. 09/767,764

adequate guidance to allow one skilled in the art to practice the claimed
invention. We agree.
The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Alton, 76 F.3d 1168, 1175, 37 USPQ2d 1578, 1581
(Fed. Cir. 1996). “[A] specification disclosure which contains a teaching of the
manner and process of making and using the invention in terms which
correspond in scope to those used in describing and defining the subject matter
sought to be patented must be taken as in compliance with the enabling
requirement of the first paragraph of 35 U.S.C. of § 112 unless there is reason to
doubt the objective truth of the statements contained therein which must be
relied on for enabling support.” In re Marzocchi, 439 F.2d 220, 223, 169 USPQ
367, 369 (CCPA 1971) (emphasis in original). “[It] is incumbent upon the Patent
Office, whenever a rejection on this basis is made, to explain why it doubts the
truth or accuracy of any statement in a supporting disclosure and to back up
assertions of its own with acceptable evidence or reasoning which is inconsistent
with the contested statement.” Id. at 224, 169 USPQ at 370.
With respect to pharmaceutical inventions, the Court of Appeals for the
Federal Circuit has stated:
On the basis of animal studies, and controlled testing in a
limited number of humans (referred to as Phase I testing), the Food
and Drug Administration may authorize Phase II clinical studies.
See 21 U.S.C. § 355(i)(1); 5 C.F.R. § 312.23 (a)(5), (a)(8) (1994).
Authorization for a Phase II study means that the drug may be
administered to a larger number of humans, but still under strictly
supervised conditions. The purpose of a Phase II study is to
determine primarily the safety of the drug when administered to a
larger human population, as well as its potential efficacy under
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different dosage regimens. See 21 C.F.R. § 312.21(b). FDA
approval, however, is not a prerequisite for finding a compound
useful within the meaning of the patent laws. . . . . Usefulness in
patent law, and in particular the context of pharmaceutical
inventions, necessarily includes the expectation of further research
and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to
humans. Were we to require Phase II testing in order to prove
utility, the associated costs would prevent many companies from
obtaining patent protection on promising new inventions, thereby
eliminating an incentive to pursue, through research and
development, potential cures in many crucial areas such as the
treatment of cancer.

In re Brana, 51 F.3d, 1560, 1568 34 USPQ2d 1436, 1442-43 (Fed. Cir. 1995)
(citations omitted).
In this case, the inventor has presented data from Phase I clinical studies
in humans. See Klimas Declaration, Paper No. 5, ¶ 11. Moreover, as noted by
the examiner, most of the patients demonstrated some type of improvement
upon receiving treatment. See Examiner’s Answer, page 5 (“Upon treatment,
patients reported little improvement (page 12, line 1), modest improvement (page
14, line 3), marked improvement after one week, but only 50% showed
improvement overall (page 16, line 3; page 18, line 2; page 20, line 3; page 22,
line 3.”). There is no need for the inventor to demonstrate that the treatment will
be efficacious in every patient exhibiting CFS, i.e., a “magic bullet” for the
treatment of CFS. See, e.g. Brana, 51 F.3d at 1568, 34 USPQ2d at 1442 (“We
hold as we do because it is our firm conviction that one who has taught the
public that a compound exhibits some desirable pharmaceutical property in a
standard experimental animal has made a significant and useful contribution to
the art, even though it may eventually appear that the compound is without value
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Application No. 09/767,764

in the treatment of humans.”). Thus, the examiner has not provided “acceptable
evidence or reasoning which is inconsistent” with the specification that one of
skill in the art would not be able to practice the claimed invention, and therefore
has not met the initial burden of demonstrating nonenablement.
CONCLUSION
Because the examiner has failed to set forth a prima facie rejection that
the specification fails to set forth an enabling disclosure, it is reversed.
REVERSED

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
)
Toni R. Scheiner ) APPEALS AND
Administrative Patent Judge )
) )INTERFERENCES
)
)
)
Lora M. Green )
Administrative Patent Judge )
LG/dym
Jerry K. Mueller
Mueller and Smith
7700 Rivers Edge Drive
Columbus OH 43235

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