Ex parte GIEDLIN

Board of Patent Appeals and Interferences

Oct 21, 1998

07965304 (B.P.A.I. Oct. 21, 1998)

1 Application for patent filed October 23, 1992.
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Paper No. 21
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MARTIN A. GIEDLIN
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Appeal No. 95-0371
Application 07/965,3041
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ON BRIEF
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Before WINTERS and WILLIAM F. SMITH, Administrative Patent Judges, and
McKELVEY, Senior Administrative Patent Judge,
WILLIAM F. SMITH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims
1 through 12, all the claims in the application. Claims 1, 4, 7 and 10 are illustrative
of the subject matter on appeal and read as follows:
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1. A method of treating an autoimmune disease, comprising administering an
effective amount of fludarabine-5'-monophosphate.
4. A method of preventing the symptoms of an autoimmune disease, comprising
administering an effective amount of fludarabine-5'-monophosphate.
7. A method of ameliorating the symptoms of autoimmune disease, comprising
administering an effective amount of fludarabine-5'-monophosphate.
10. A method of prophylactically treating an autoimmune disease, comprising
administering an effective amount of fludarabine-5'-monophosphate.
The references relied upon by the examiner are:
Eur. Pat. App. (Paulson) 0,066,918 Dec. 15, 1982
Priebe et al. (Priebe), 114 Chemical Abstracts, No. 74862b, page 33 (1991).
The three references discussed by this merits panel are:
Priebe et al. (Priebe), “Purine Nucleoside Modulation of Functions of Human
Lymphocytes”, 129 Cellular Immunology, No. 2, 321-328 (Sept. 1990).
Boldt et al. (Boldt), “Effects on Human Peripheral Lymphocytes of in Vivo Administration of
9-$-D-Arabinofuranosyl-2-fluoroadenine-5'-monophosphate (NSC 312887), a New Purine
Antimetabolite”, 44 Cancer Research, 4661-4666 (Oct. 1984).
Carrera, “Potent Toxicity of 2-Chlorodeoxyadenosine toward Human Monocytes
In Vitro and In Vivo”, 86 The Journal of Clinical Investigations, No. 5, 1480-1488
(Nov. 1990).
Claim 7 stands rejected under 35 U.S.C. § 101 as lacking patentable utility. Claims
1, 4 and 5 stand rejected under 35 U.S.C. § 112, first paragraph, as being non-enabled by
the specification. Claims 1 through 12 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by the Chemical Abstracts citation of Priebe. Finally, claims
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1 through 12 also stand rejected under 35 U.S.C. § 103 as unpatentable over the
Chemical Abstracts citation of Priebe in view of Paulson. We reverse the non prior art
rejections and vacate the prior art rejections. In addition, we remand the application for the
examiner to consider other issues.
DISCUSSION
1. Utility
The sole reason given by the examiner for rejecting claim 7 under 35 U.S.C.
§ 101 is set forth in the paragraph bridging pages 3-4 of the examiner’s answer and reads
as follows:
“[t]he claim reads on effecting physiological precesses [sic] that are
not directly related to any disease pathology.”
Suffice it to say that we have no idea what the examiner means by this statement.
Furthermore, the examiner cites at page 4 of the examiner’s answer in support of
this rejection the following case “Splendor form Brassiere, Inc. v. Rapid-American Corp.,
187 USPQ 158 (CCPA 1975).” Turning to that volume and page, we find no such case.
However, a case styled in the manner stated by the examiner is found at
187 USPQ 151. The decision reported therein is that of a United States District Court, not
the Court of Customs Patent Appeals as stated by the examiner. In that case, the district
court raised on its own motion a question of utility under 35 U.S.C. § 101 stating,
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187 USPQ at 156: “if a patented invention fails to achieve the one advantage over the
prior art which the patent specification asserts for it, it can hardly be said to be ‘useful’ as
required by 35 U.S.C. § 101.” If in fact, this is the case the examiner intended to cite, it is
not at all clear what relevance it has to the subject matter and issues at hand.
We can only express our dismay that an examiner would forward such a rejection to
this board. The resources of this board and for that matter appellants should not have to
be spent in reviewing such work. By statute, this board serves as a board of review. 35
U.S.C. § 7 (b) (“The [board] shall . . . review adverse decisions of examiners upon
applications for patents . . . .”) In essence, the examiner has not presented a rejection
which is susceptible of a meaningful review.
The rejection of claim 7 is reversed.
2. Enablement
For reasons unclear from this record, the examiner only rejected claims 1, 4 and 5
as being non-enabled by the specification. From the reasons set forth for this rejection on
pages 4-5 of the examiner’s answer, it is not apparent why those reasons would not also
apply to the remaining claims on appeal.
Be that as it may, the examiner has failed to properly establish that one skilled in the
art would doubt the objective truth of the enabling statements set forth in the specification
of this application. This is the examiner’s initial burden. In re Marzocchi, 439 F.2d 220,
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223, 169 USPQ 267, 369 (CCPA 1971). The statement of the rejection amounts to only a
recitation of unsupported conclusions on the part of the examiner. The examiner’s
consideration of this issue does not appear to take into account either the prior art or the
relevant legal standards. Again, the examiner’s rejection is not susceptible to a meaningful
review.
The rejection of claims 1, 4 and 5 is reversed.
3. Prior Art Rejections
Both prior art rejections are premised upon a Chemical Abstracts citation of
Priebe. To the extent the full text article may not have been readily available to the
examiner at the time the first action was mailed on January 14, 1993, it was available as of
April 14, 1993, since appellants cited the full text Priebe article and supplied a copy
thereof in the Information Disclosure Statement filed on that date (Paper No. 3).
Why the examiner would continue to rely upon an abstract when the more fact filled full text
article is presented to him is not understood. Prior art rejections are fact specific. Where
as here, the examiner relies upon an abstract of a full text article and the full text article is
supplied to the examiner, we will not spend the scarce resources of this board in
determining whether the abstract provides a sufficient basis for concluding that a claimed
invention is anticipated under 35 U.S.C. § 102 or rendered obvious under 35 U.S.C. §
103. Those determinations must be made on the basis of the full text article.
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Accordingly, we vacate the two prior art rejections which are premised upon the
Priebe abstract.
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REMAND
1. Full Text Priebe Article
Upon return of the application, the examiner should consider the full text Priebe
article. If the examiner remains of the opinion that the claims on appeal are either
anticipated or rendered obvious on the basis of this full text article, the examiner should
issue an appropriate Office action setting forth such rejections. If the examiner determines
that the full text Priebe article anticipates any claim or claims on appeal, that Office action
should set forth a detailed analysis in support of the rejection including, at the least, page,
column, and line citations to the full text article where the examiner believes each claim
requirement is described. If the examiner believes that Priebe is useful as evidence of
obviousness under 35 U.S.C. § 103, we urge the examiner to use the model set forth in
The Manual of Patent Examining and Procedures (MPEP) § 706.02(j) for making
rejections under this section of the statute.
2. Boldt and Carrera
The active agent used in the present invention is fludarabine-5'-monophosphate
(fludarabine). Boldt describes the administration of fludarabine to humans. While it does
not appear that the humans involved in the work reported by Boldt were suffering from an
autoimmune disease, the reference may be relevant in determining the patentability of
claims such as 4 and 10 which are directed to administering this active ingredient to
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humans which are not suffering from an autoimmune disease. Rather, claims 4 and 10 are
directed to administering fludarabine to humans in general in order to prevent or
prophylactically treat an autoimmune disease. Depending upon whether the amount of
fludarabine administered to the humans in Boldt would be considered an effective amount
for the purposes of this invention, Boldt may anticipate claims such as claims 4 and 10.
See In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ 1934, 1936 (Fed. Cir. 1990) (“It is a
general rule that merely discovering and claiming a new benefit of an old process cannot
render the process again patentable.”)
Upon return of the application, the examiner should determine whether the amounts
of fludarabine administered in Boldt fall within the metes and bounds of the
“effective amount” required by claims such as claims 4 and 10. If so, the examiner should
then determine whether or not Boldt constitutes an anticipation of these claims.
Carrera is relevant for its discussion of the use of 2-chloro-deoxyadenosine in the
treatment of rheumatoid arthritis (an autoimmune disease). Of most significance, is the
disclosure in the last full paragraph of the left hand column of page 1486 of Carrera which
appears to indicate that fludarabine may function in a similar manner to the active agent
under investigation.
Upon return of the application, the examiner should consider the full text of Carrera
and determine whether or not it suggests that fludarabine would be useful in treating
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rheumatoid arthritis as Carrera suggests 2-chloro-deoxyadenosine is. If so, the examiner
should issue an appropriate office action which sets forth such a rejection. We would
again urge the examiner to use the model for obviousness rejections set forth in MPEP
706.02(j).
REVERSED-IN-PART, VACATED-IN-PART, REMANDED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
WILLIAM F. SMITH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
FRED E. McKELVEY )
Administrative Patent Judge )
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