Ex parte CHARLTON et al.

Board of Patent Appeals and Interferences

Jul 29, 1998

07963676 (B.P.A.I. Jul. 29, 1998)

Application for patent filed October 20, 1992.1
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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(2) is not binding precedent of the Board.
Paper No. 22
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte MILTON P. CHARLTON and MICHAEL TYMIANSKI
____________
Appeal No. 94-2504
Application 07/963,6761
____________
ON BRIEF
____________
Before WILLIAM F. SMITH, METZ, and GRON, Administrative Patent
Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
This is an appeal from an examiner’s final rejection of
Claims 1 and 11-16 under 35 U.S.C. § 112, first paragraph.
Appeal No. 94-2504
Application 07/963,676
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Claims 1, 3, and 5-25 are pending in this application.
1. History of prosecution
A. In a first office action mailed December 7, 1992
(Paper
No. 3), the examiner required the following restriction under
35 U.S.C. § 121:
The claims are drawn to compounds that find
themselves classed in various and numerous parts of
class 514.
Accordingly, selection of a specific invention
as defined by a specific compound is required.
The several inventions are clearly independent and
distinct due to separate search, status, consideration
and/or classification. Further, a reference to one
invention under 35 U.S.C. § 103 would not be a reference
to the others.
Applicant is required to elect one of the above,
even though such be traversed, 37 C.F.R. 1.143.
It is not within the Board’s jurisdiction to review the
propriety of restriction requirements under 35 U.S.C. § 121.
In re Watkinson, 900 F.2d 230, 233, 14 USPQ2d 1407, 1409 (Fed.
Cir. 1990). Nevertheless, we cannot help but notice that
Claims 1-16 which were pending in this application at the time
the restriction requirement was imposed were, as originally
filed, directed to “a method of reducing the damaging effect
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of an injury to cells in mammalian tissue in vivo and
treatment of epilepsy,” not “to compounds” as the examiner
indicated. Moreover, as filed, Claims 2-16 were all dependent
upon Claim 1 which generically defined the treating agent as
“a cell membrane permeant calcium buffer.” Needless to say,
our attempts to comprehend the examiner’s restriction
requirement have been unsuccessful.
In response to the restriction requirement (Paper No. 4,
filed January 6, 1993), applicants interpreted the examiner’s
restriction requirement as requiring restriction between
(I) method Claims 1-16, (II) method Claims 23-25, (III)
compound Claims 17-21, and (IV) composition Claim 22, and an
election of a species of buffer. Accordingly, applicants
elected the method of Claim 10 and BAPTA-AM as the species of
buffer.
In a second office action mailed February 5, 1993 (Paper
No. 6), the examiner withdrew Claims 2-9 and 17-25 from
consideration without explanation and indicated that Claims 1
and 10-16 would be examined. The examiner then summarily
rejected Claims 1 and 10-16 as follows (Paper No. 6, p. 2):
Claims 1 and 10-16 are rejected under 35 U.S.C. §
112,
second paragraph, as being indefinite for failing to
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Application 07/963,676
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particularly point out and distinctly claim the subject
matter which applicant regards as the invention.
The claims should all relate to the host of
the tissue and not as claimed.
Claims 1 and 11-16 are rejected under 35 U.S.C.
§ 112, first paragraph, as the disclosure is enabling
only for claims limited in accord with the entire
disclosure. See M.P.E.P. §§ 706.03(n) and 703.03(z).
“A cell membrane permeant calcium buffer” is
broader than the specific supporting disclosure.
It is also broader than the elected invention.
In response to these rejections (Paper No. 7, filed May
5, 1993), applicants canceled Claims 2 and 4 and amended Claim
1 to specify the “host” and to further define the “calcium
buffer” as a chelating agent having a K within a designatedD
range.
In the FINAL office action mailed May 13, 1993 (Paper
No. 8), the examiner responded to applicants’ amendment and
arguments as follows:
Claims 1 and 10-16 remain examined.
Claims 1 and 11-16 remain rejected for the reasons
of record under 35 U.S.C. 112, 1st paragraph.
The rejected phrase remains too broad and such is
broader than the elected invention.
THIS ACTION IS MADE FINAL.
Appellants filed NOTICE OF APPEAL August 13, 1993.
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Apparently, Claim 10 was considered allowable in independent
form, and Claims 3, 5-9 and 17-25 stood withdrawn from
consideration by the examiner.
2. Introduction
Claims 1 and 11-16 stand finally rejected under 35 U.S.C.
§ 112, first paragraph, because the phrase “‘cell membrane
permeant calcium buffer’ is broader than the specific
supporting disclosure . . . [and] also broader than the
elected invention” (Paper No. 6, page 2). All claims on
appeal stand or fall (Appeal Brief (Br.), p. 3) with
independent Claim 1. Claim 1 on appeal reads:
1. A method of reducing the damaging effect of
an injury to cells in mammalian tissue of a host in
vivo and treatment of epilepsy, said method comprising
treating a host in need of such treatment with a non-
toxic, damage-reducing effective amount of a cell
membrane permeant calcium buffer which is a calcium
ion chelating agent having a K selected from the D
range 1 x 10 to 1 x 10 Molar.-4 -8
Appellants argued in their Appeal Brief (Br.) that the
examiner had not adequately considered the specificity with
which the “calcium buffer” utilized in the method claimed is
described
(Br. 5-6, bridging para.) and submitted the Declarations of
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Daniel Alkon (Alkon) and George J. Augustine (Augustine) to
support their view that the claim defines “a well-defined
class of materials to those in the art and, with the
disclosure given . . . the invention could be practised [sic]
without difficulty using any such material as defined” (Alkon,
p. 3, para. 6; Augustine, p. 3, para. 6).
In the Examiner’s Answer (Ans., pp. 3-4), the examiner
explained what he had meant by “broader than the specific
supporting disclosure” in the first and FINAL office actions:
The claims do not structurally define the compounds to be
used and the K range, a common property of structurallyD
diverse compounds, does not distinguish one potential
drug
class from another. Thus, one skilled in the art would
have to imagine which drug to use.
. . . . .
In this case, the compounds are not defined because
cell membrane permeant calcium buffer does not evoke a
mental image of a chemical structure and the K range isD
such a general property that it does not distinguish a
particular class of compounds.
The examiner added (Ans., pp. 4-5, bridging para.; emphasis in
original):
In addition, claims to treating injury to cells
in a host are not enabled because they are overly broad.
Treating injury to cells in a host reads on treating all
patients since normal physiology and all diseases result
in cell injury. Applicant merely showing effect for cell
injury caused by select conditions, ischemia and
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epilepsy.
Applicant does not provide a general teaching that the
results shown would enable one skilled in the art to
treat
all other diseases. The pharmaceutical arts are
inherently
unpredictable and method of universal treatment is highly
speculative as no single medical method is known which
can
treat all diseases. As such, the limited nature of the
examples and [sic] are not sufficient quid pro quo for
the broad claims in an unpredictable art to an invention
speculative in nature. Ex parte Forman 230 USPQ 546
(PTOB 1986).
In a Reply Brief filed January 5, 1994, appellants argued
that the Examiner’s Answer had raised new arguments. In
response to the new arguments, appellants filed an Amendment
Accompanying Reply Brief (Paper No. 14) which limited the
claimed method to one for “reducing the damaging effect of an
excitotoxic, ischemic or traumatic injury” (Amendment, p. 1).
The examiner entered appellants’ Reply Brief and notified
appellants of that action. The examiner did not
substantively respond to the extensive arguments set forth in
the Reply Brief. See Paper No. 16. However, the examiner
refused entry of the accompanying amendment. See the
handwritten instructions on Paper No. 14. It does not appear
from the record the examiner informed appellants that the
amendment was not entered.
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3. Discussion
We reverse the examiner’s FINAL rejection of Claims 1 and
11-16 under 35 U.S.C. § 112, first paragraph. Appellants
filed their NOTICE OF APPEAL under 35 U.S.C. § 134 on August
13, 1993 (Paper No. 9) after having had Claims 1 and 11-16
twice rejected because “‘[a] cell membrane permeant calcium
buffer’ is broader than the specific supporting disclosure.
It is also broader than the elected invention.” See again the
examiner’s first office action mailed February 5, 1993 and
FINAL office action mailed
May 13, 1993.
In re Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA 1971)
teaches at 223, 169 USPQ 369:
As a matter of Patent Office practice, then, 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 § 112 unless there is reason to
doubt
the objective truth of the statements contained therein
which must be relied on for enabling support.
Moreover, Marzocchi adds at 224, 169 USPQ at 370:
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[I]t 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. Otherwise,
there would be no need for the applicant to go to the
trouble and expense of supporting his presumptively
accurate disclosure.
Here, appellants’ claims stand finally rejected because
“‘[a] cell membrane permeant calcium buffer’ is broader than
the specific supporting disclosure,” with no explanation,
evidence or reasoning in support of the rejection. We are
obliged to reverse this rejection. Whether or not the claims
on appeal are drawn to an invention “broader than the elected
invention” is, of course,
not a matter within the scope of our jurisdiction under 35
U.S.C. § 134.
We are mindful that the examiner ultimately explained the
basis for the rejection in the Examiner’s Answer by setting
forth a new rationale. However, the examiner (1) did not
substantively respond to the arguments contained in the Reply
Brief and (2) refused to consider appellants’ amendment at
their first opportunity to amend the claims in response to the
new rationale. Thus, the posture of this case is that
appellants were first notified of substantive reasons why
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Application 07/963,676
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their claims were rejected in the Examiner's Answer without a
new ground of rejection being made. Appellants filed an
extensive Reply Brief in response to the new rationale and a
proposed amendment. The Reply Brief was entered without a
substantive comment by the examiner, leaving the record barren
as to reasons why appellants' arguments were not persuasive to
the examiner. The amendment was not entered, yet, appellants
were not notified of that action by the examiner.
Taking a step back and reviewing the examination
procedure followed in this application, it is questionable
whether the administrative due process requirements of 35
U.S.C. § 132 were followed. Appellants should not have to
file an appeal brief in order for the examiner to explain for
the first time the substance of a rejection. However, having
that unhappy set of circumstances occur here, appellants were
entitled to a substantive response from the examiner to the
extensive arguments set forth in the Reply Brief instead of
the terse notification that the paper had been "entered and
considered but no further response by the Examiner is deemed
necessary." At the least, appellants should have been
accorded the courtesy of a written notification that the
amendment filed with the Reply Brief was not entered.
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Application 07/963,676
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By statute, this Board operates as a board of review.
See
35 U.S.C. § 7 ("The [board] shall . . . review adverse
decisions of examiners . . . .") For this board to properly
perform its review function, full and fair examination of the
patentability of the claims of an application must have
occurred below. This has not happened in this case. In
essence, the examiner has not presented a case which we can
meaningfully review.
4. Conclusion
We reverse the examiner’s FINAL rejection of Claims 1 and
11-16 under 35 U.S.C. § 112, first paragraph.
Having read the Bibliography attached to each of the
Declarations of Daniel Alkon and George J. Augustine, having
considered the examiner’s record of having “searched” Class
514, subclass 561, having noted the examiner’s statement that
“[t]he claims are drawn to compounds that find themselves
classed in various and numerous parts of class 514" (Paper No.
3), having reviewed the examiner’s “Search Notes,” having
noted the examiner’s statement that “[n]o prior art are [sic]
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relied upon by the examiner in the rejection of claims under
appeal” (Ans., p. 2), and having considered the prosecution of
this case in its
entirety, we recommend that, upon return to the jurisdiction
of the examiner, this application be completely examined under
35 U.S.C. § 131.
REVERSED
William F. Smith )
Administrative Patent Judge )
)
)
)
Andrew H. Metz ) BOARD OF
PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Teddy S. Gron )
Administrative Patent Judge )
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