Ex Parte Kinet et al

Board of Patent Appeals and Interferences

Feb 1, 2001

08310902 (B.P.A.I. Feb. 1, 2001)

1
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written for publication and is not binding precedent of the Board.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. 29

UNITED STATES PATENT AND TRADEMARK OFFICE

__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JEAN P. KINET
and JAREMA P. KOCHAN
__________

Appeal No. 1997-2122
Application 08/310,902
__________

ON BRIEF
__________

Before WILLIAM F. SMITH, Administrative Patent Judge, and McKELVEY,
Senior Administrative Patent Judge, and ADAMS, Administrative Patent Judge.

WILLIAM F. SMITH, Administrative Patent Judge.

Appeal No. 1997-2122
Application 08/310,902

2
DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 from the final rejection of claim 3,
the only claim pending in the application. Claim 3 reads as follows:
3. A polypeptide comprising the amino acid sequence corresponding to
the α-subunit of the human FcERI essentially free of the β- and
-subunits of the
human FcERI.
The references relied upon by the examiner are:
Kumar et al. (Kumar), “Gel Filtration In 6M Guanidine Hydrochloride of the α-
Subunit (And its Fragments) of the Receptor for Immunoglobulin E,”
Molecular Immunology, Vol. 19, No. 12, pp. 1561-567 (1982)

Kishi, “A New Leukemia Cell Line With Philadelphia Chromosome Characterized
As Basophil Precursors,” Leukemia Research, Vol. 9, No. 3, pp. 381-90 (1985)

A reference relied upon by this merits panel is:
Conrad et al. (Conrad), “The Interaction Of Human And Rodent IgE With The
Human Basophil IgE Receptor,” The Journal of Immunology, Vol. 130, No. 1, pp.
327-33 (1983)

Claim 3 stands rejected under 35 U.S.C. § 103(a). As evidence of
obviousness, the examiner relies upon Kumar and Kishi. We reverse and enter
a new ground of rejection under 37 CFR § 1.196(b).
Appeal No. 1997-2122
Application 08/310,902

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DISCUSSION

As seen, claim 3 is directed to a polypeptide which comprises the amino
acid sequence corresponding to the α- subunit of the human FcERI essentially
free of the β- and
-subunits of the human FcERI. The examiner relies upon
Kumar for its disclosure of a procedure for isolating the -subunit of the rat
FcERI. The examiner relies upon Kishi for its disclosure of the human cell line
KU812. As set forth in the paragraph bridging pages 4-5 of the Examiner’s
Answer, the examiner’s position is that it would have been obvious to one of
ordinary skill in the art to have “isolated a human FcERI -subunit like the rat
FcERI -subunit of Kumar et al. by substituting the KU812 cells of Kishi… for the
rat basophils that were employed in the purification process of Kumar et al.”
In order for a claimed invention to be unpatentable under the statute, the
subject matter of that claim must have been obvious to a person of ordinary skill
in the art at the time of the invention under review. As is apparent, the
examiner’s theory of the case presupposes that at the time of the present
invention one of ordinary skill in the art understood that KU812 cells express the
human FcERI. Otherwise, why would one of ordinary skill in the art have the
needed reason, suggestion or motivation to combine the references? However,
in responding to appellants’ arguments at page 5 of the Examiner’s Answer, the
examiner states “it is conceded that this fact was not known prior to the making
Appeal No. 1997-2122
Application 08/310,902

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of the invention.” By conceding that workers in this field did not know at the time
of the present invention that KU812 expressed FcERI, the examiner conceded
his case. Absent evidence that those of ordinary skill in the art at the time of the
present invention understood that KU812 did express the receptor of interest, it
is not apparent on what basis it can reasonably be concluded that it would have
been obvious to use KU812 cells in the process of Kumar.
The examiner’s rejection is reversed.
NEW GROUND OF REJECTION UNDER 37 CFR § 1.196(b)
Under the provisions of 37 CFR § 1.196(b), we make the following new
grounds of rejection.
Claim 3 is rejected under 35 U.S.C. § 102(b)/103 on the basis of Conrad.
As set forth above, claim 3 is directed to a polypeptide which comprises
the amino acid sequence corresponding to the -subunit of the human FcERI
which is essentially free of the - and
- subunits of the human FcERI. As
explained in the background portion of the specification, FcERI is a receptor
having high infinity for human IgE.
Conrad isolated the human IgE receptor and studied its cross-reactivity
with mouse and rat IgE. The IgE receptor of Conrad was isolated using the
procedure described in the left-hand column of page 328. As explained, the
receptor was isolated by repetitive affinity chromatography on hIgE-Sepharose.
Appeal No. 1997-2122
Application 08/310,902

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In the first full paragraph of the right-hand column of 331, Conrad indicates that
at the time of that work the surface accessible IgE receptors found on rat
basophilic leukemia cells and rat mast cells were found to be associated with a
second polypeptide termed “ component.” Conrad explains that the surface
labeling used in their study would not be expected to detect a human
 equivalent and that the identification of a human  equivalent “probably awaits
the development of a human cell line bearing the high-affinity IgE receptor.” It is
of interest to note the discussion in the paragraph bridging pages 331-32 of
Conrad that the cells used in that study may have two distinct types of IgE
receptors, i.e., one which binds both human IgE and rodent IgE with high-affinity
and a second which showed high-affinity binding only for human IgE.
Conrad describes the polypeptide which is characterized as a human IgE
receptor which binds human IgE with high-affinity. It is not clear from Conrad
whether that isolated polypeptide is “essentially free of the - and
-subunits of
the human FcERI” as required by claim 3 on appeal. Under these
circumstances, it is reasonable to shift the burden to appellants to establish
whether the procedures described in Conrad for isolating the IgE receptor result
in obtention of the -subunit to the essential exclusion of the - and
- subunits.
As set forth in In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA
1977):
Appeal No. 1997-2122
Application 08/310,902

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Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially
identical processes, the PTO can require an applicant to prove that
the prior art products do not necessarily or inherently possess the
characteristics of his claimed product. . . . Whether the rejection is
based on 'inherency' under 35 U.S.C. § 102, on 'prima facie
obviousness' under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the
PTO's inability to manufacture products or to obtain and compare
prior art products [footnote omitted].

TIME PERIOD FOR RESPONSE
This opinion contains a new ground of rejection pursuant to 37 CFR §
1.196(b) (2000). 37 CFR § 1.196(b) provides that, “A new ground of rejection
shall not be considered final for purposes of judicial review.” 37 CFR § 1.196(b)
also provides that the appellants, WITHIN TWO MONTHS FROM THE DATE OF
THE DECISION, must exercise one of the following two options with respect to
the new ground of rejection to avoid termination of proceedings (§ 1.197(c)) as to
the rejected claims:
(1) Submit an appropriate amendment of the claims so
rejected or a showing of facts relating to the claims so rejected, or
both, and have the matter reconsidered by the examiner, in which
event the application will be remanded to the examiner. . . .

(2) Request that the application be reheard under § 1.197(b)
by the Board of Patent Appeals and Interferences upon the same
record. . . .

Appeal No. 1997-2122
Application 08/310,902

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No time period for taking any subsequent action in connection with this
appeal may be extended under 37 CFR § 1.136(a).
REVERSED; 37 CFR § 1.196(b)

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Fred E. McKelvey, Senior )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Donald E. Adams )
Administrative Patent Judge )

Appeal No. 1997-2122
Application 08/310,902

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William D. Noonan, M.D.
KLARQUIST, SPARKMAN, CAMPBELL, LEIGH
& WHINSTON
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